chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Staphylococcus test, Urine analysis
Clinical narrative: he developed a fever and fever lasted for 10 days/2 days after receiving the second dose, he developed a low grade fever; This is a spontaneous report from contactable consumer (Patient). A 78-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration on 02Feb2021 as single dose for COVID-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EH9899) via an unspecified route of administration on 12Jan2021 as 1st single dose for COVID-19 immunization. Medical history included hypertension. The patient's concomitant medications were not reported. On 22Jan2021, ten days later of first dose, he developed a fever and fever lasted for 10 days and on 03Feb2021, a day later receiving the second dose, he developed a low grade fever. Patient tested for COVID 5 times, did full bloodwork, chest x-ray, steph and flu test all tests were negative. On 01Feb2021, patient tested for hepatitis, urine analysis, CBC (full blood count) result was negative for all. The patient received treatment for the event was took Tylenol and Advil. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 1st of two reports. A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown) via unspecified route of administration on 23Jan2021 as 1st dose single for COVID-19 Immunisation. Medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced sore arm. On an unknown date in 2021, the patient underwent antibody test after 1st dose and the results were negative. Caller asked for information about antibody testing and if he should be concerned the vaccine isn't working properly since he read after 1st dose of vaccine he should have approximately 50% protection. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021167494 same drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, SARS-CoV-2 antibody test
Clinical narrative: Rash on her front and back torso, which was very itchy; This is a spontaneous report from a contactable other healthcare professional. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 30Dec2020, as 1st dose, 0.3 ml single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 30Dec2020 evening, on the same day of vaccination, the patient developed rash on her front and back torso, which was itchy and lasted for a few weeks. The patient had it checked by the HCP and decided not to get the 2nd dose of the vaccine since. The patient's lab test and procedure included SARS-CoV-2 antibody test: negative, nonresponsive, performed on an unspecified date. The clinical outcome of the event was unknown.  Information on the Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea, SARS-CoV-2 test, Sneezing, Throat irritation
Clinical narrative: Pain and swelling at injection site; Pain and swelling at injection site; Scratchy throat; Runny nose; Coughing; Sneezing; Postnatal drip; This is a spontaneous report from a contactable consumer (patient herself). A 45-years-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, administered in left arm on 03Feb2021 at 09:00 (age at vaccination: 45 years) as a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient did not receive any other vaccine in 4 weeks. The patient was vaccinated in pharmacy or drug store. On 04Feb2021 13:00, the patient experienced pain and swelling at injection site, scratchy throat, runny nose, coughing, sneezing, postnatal drip. On 04Feb2021, the patient underwent sars-cov-2 test results were pending. The patient did not receive any treatment for the events. The patient did not get COVID prior to vaccination. The patient was tested for COVID post vaccination for which the results are pending. The outcome of all the events was recovering.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain and swelling at injection site; Pain and swelling at injection site; Scratchy throat; Runny nose; Coughing; Sneezing; Postnatal drip; This is a spontaneous report from a contactable consumer (patient herself). A 45-years-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, administered in left arm on 03Feb2021 at 09:00 (age at vaccination: 45 years) as a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient did not receive any other vaccine in 4 weeks. The patient was vaccinated in pharmacy or drug store. On 04Feb2021 13:00, the patient experienced pain and swelling at injection site, scratchy throat, runny nose, coughing, sneezing, postnatal drip. On 04Feb2021, the patient underwent sars-cov-2 test results were pending. The patient did not receive any treatment for the events. The patient did not get COVID prior to vaccination. The patient was tested for COVID post vaccination for which the results are pending. The outcome of all the events was recovering.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Just received the vaccine, hurt hand shoveling snow; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as single dose, for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient just received the vaccine, and his hurt hand while "shoveling snow". The patient was asking if he could take a pain reliever. The outcome of the event was unknown.   Information on lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Migraine
Clinical narrative: Dizzy; Symptoms of the migraine still persists; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported), via an unspecified route of administration on 20Jan2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Jan2021, the patient felt dizzy. On an unknown date in Jan2021, the symptoms of the migraine was persisting. The patient was seeking information on this side effect and asked that did other people get migraine and how long was it supposed to last. The patient was seeking guidance for the second shot. The outcome of symptoms of the migraine still persists was not resolved and dizzy was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: had a sore arm for 1-2 days; Yesterday, she developed a rash on her back on the left side where she had received the injection.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history included as shingles outbreak, about 10 years ago, where it radiates to other parts of the body. The patient's concomitant medications were not reported. It was reported that patient would like to know whether the reaction she experienced is from the Pfizer covid shot. It was reported that patient received first dose of the covid vaccine and had a sore arm for 1-2 days. Yesterday, patient developed a rash on her back on the left side where she had received the injection. When asked about the under her shoulder, under left thigh, no information was provided. On an unspecified date, the patient experienced had a sore arm for 1-2 days, on 04Feb2021, the patient experienced, yesterday, she developed a rash on her back on the left side where she had received the injection. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Itchy and prickly/she had a mild sense of itchiness; Itchy and prickly/she had a mild sense of itchiness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (age: 83; unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported, Expiration Date was not provided) dose 1, via an unspecified route of administration on 04Feb2021 as single dose for covid-19 immunization. Medical history included Allergic to the elements like greens from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient wanted to know if itchiness was a normal side effect of the PFIZER-BIONTECH COVID-19 VACCINE - Got the 1st dose 04Feb2021 and 10 hours after she felt like itchy and prickly (04Feb2021). She stated had the first dose 24 hours ago. About 10 hours in, she had a mild sense of itchiness, which was dissipating now. She has had that itchiness when she goes outdoors. She was Allergic to the elements like greens, etc. She got that when she goes outdoors. She would like to find out if this was a side effect. The outcome of event was unknown.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Swelling, Ultrasound scan
Clinical narrative: This is a spontaneous report from a contactable other health care professional. This is the first of the 2 cases, this case is for first dose of BNT162B2. A female patient of  51:Age (Unit: unknown) received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration and administered in left arm on 05Jan2021 as single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient also received second dose of BNT162B2 on 26Jan2021 and experienced adverse events. Patient experience side effects after receiving the first and second dose of the COVID-19 vaccine. Patient received the first dose of the vaccine on 05Jan2021, in which she noticed a couple days before receiving the second dose that she had swollen and enlarged lymph nodes specifically on the left supraclavicular side just above left clavicle. She noticed a bump on her neck on 23Jan2021. These lymph nodes appear rounded, hypoechoic, largest 1.2cm. Additional smaller node with some internal debris measuring up to 4 mm in level 5B was found as well. Patient states that the right side did not have any findings and reported that she received the vaccines in the left arm. The patient underwent lab tests and procedures which included mammogram: large lymph nodes, discovered three large lymph nodes under arm in axilla ranging in size, but the largest was measured at 20 x 17 mm on the left side, ultrasound scan: lymph nodes that were small preexisting lymph nodes that were small, but appeared to have increased in size when examined. Prominent lymph nodes in left axilla measuring up to 7 mm. The outcome of events were unknown. Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose abnormal, Hyperhidrosis, Nausea
Clinical narrative: Blood glucose spiked to-300 then plunged to-55 Uber the course of-1.5 hrs; Slight nausea; Some sweating for-40 minutes.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL8982), via an unspecified route of administration in left arm on 03Feb2021 at 08:45 AM as 1ST DOSE, SINGLE for covid-19 immunization (67 years old when vaccinated). The patient medical history and concomitant medications were not reported. The patient had no other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 04Feb2021, at 03:30 PM, patient experienced, blood glucose spiked to-300, then plunged to -55 Uber the course of-1.5 hrs. Slight nausea and some sweating for-40 minutes. The patient underwent lab tests and procedures which included blood glucose: spiked to 300, blood glucose: then plunged to 55. The patient did not receive treatment due to the events. The outcome of events was recovered on an unspecified date in 2021.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Headache, Malaise, Neck pain, Pain
Clinical narrative: Could not stand; Body aches; Neck pain; Headache; Felt very unwell; This is a spontaneous report from a non-contactable consumer reporting for a patient. A 93-year-old male patient received unknown dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection), via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not available/provided) (age at vaccination: 93 years) as single for covid-19 immunization was administered at health clinic. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient was not diagnosed with COVID-19. On 02Feb2021 (same day patient received vaccine), patient awoke from sleep with body aches, headache, neck pain.  Patient felt very unwell, could not stand, sat on edge of bed for approximately 1 hour until the symptoms passed and patient was able to get back to sleep. When patient woke in the morning, felt well and had no further symptoms. It was unknown if patient received any treatment for the adverse events. The case was reported as non-serious. The outcome of all the events was recovered on an unknown date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: chills; body aches; Fever 102.1; This is a spontaneous report received from a contactable other hcp (patient). A 22-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 04Feb2021 11:30 as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. Birth control medication was reported as concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 05Feb2021 21:00, the patient experienced chills, body aches and fever 102.1. The patient underwent lab tests and procedures which included body temperature: 102.1 on 05Feb2021. The outcome of events was recovering.   Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Exhaustion for more than a week following the vaccine; This is a spontaneous report from a contactable consumer. This 59-year-old female consumer reported that: A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 28Jan2021 10:00 (age at the time of vaccination was 59) as first dose, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Patient not diagnosed with covid-19 prior to vaccination. Patient was not received any other vaccine prior four weeks of vaccination and patient did not receive any medication prior two weeks of vaccination. Since vaccination patient not tested for covid-19. On unspecified date the patient experienced exhaustion for more than a week following the vaccine. Therapeutic measures were not taken as a result of the event. The outcome of the event was reported as recovering.  Information on the lot/batch number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore, today is better, but still sore; This is a spontaneous report from a non-contactable consumer or other non hcp(patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient experienced arm was sore, today is better, but still sore on an unspecified date in Feb2021. The reporter inquired can she rub alcohol or apply something in it. The outcome of the event was reported as resolving.  No follow-up attempts are possible. Information on the lot/batch number cannot obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Malaise, Pain
Clinical narrative: aching all over her body everything was aching; bedridden; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EL3248; expiration date: Apr2021) via an unspecified route of administration administered in arm right on 28Jan2021 as single dose for covid-19 immunization (at the age of 78-years-old). Consumer said she had medical history of breast cancer and has undergone chemotherapy and radiation on an unknown date 2-3 years ago and unknown if ongoing and had ongoing blood pressure and thyroid from an unknown date. Patient has not had any positive test for Covid prior to the vaccine. Concomitant medication(s) included anastrozole taken for breast cancer from an unspecified start date and ongoing; furosemide; losartan; metoprolol and amlodipine all those were taken for blood pressure, start and stop date were not reported and warfarin, omeprazole, and vitamin D3 taken for an unspecified indication and levothyroxine taken for thyroid disorder and start and stop date were not reported. The consumer stated that she received first dose of vaccine and on 29Jan2021 she had aching all over her body and everything was aching, and she was just bedridden the 2 days till 30Jan2021 however she did not go outside of the house after that because of not feeling well on Jan2021. She further mentioned that aching was not like before, it was all over her body before, before everything was aching, now the aching was just on her arms, on right arm in particular. She further stated that she was scheduled for the second dose 18Feb2021 and first dose of the vaccine was given on her right arm because she has breast cancer on the left side. She wanted to ask if having side effects like this after the first shot was an indication the person may have had the covid prior to the vaccine and that was why there is a reaction like this after the vaccine and if the second shot going to be the same. The outcome of the event bedridden was recovered on 30Jan2021 and patient was recovering from the event of pain and outcome was unknown for the event of malaise.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: legs in pain; headache; chills; fever of about 100°F; she's still been feeling very tired; This is a spontaneous report from a contactable consumer. A 78-year-old female patient reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and Expiration date was unknown) via an unspecified route of administration on 03Feb2021 at 09:00 AM as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine of the patient included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date was unknown) via an unspecified route of administration on 13Jan2021 as 1st dose, single for COVID-19 immunization with no adverse events and stated that everything was fine. On the next day 04Feb202, Everything was fine until around 3 AM the next day and when she woke up from her sound sleep she had experienced pain in her legs, head ache, chills, and a fever of about 100 degree farenheit. She mentioned that she took Tylenol for her fever and currently some of the side effects already went away but she was still been feeling very tired. Patient wanted to know if it was also common to experience these side effects after the 2nd dose and for how long these side effects would last and if she needed to consult a doctor or should she just wait it out. The patient underwent lab tests and procedures which included body temperature 100 degree Fahrenheit on 04Feb2021. The outcome of the event very tired was not recovered and outcome for rest of events was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: legs in pain; headache; chills; fever of about 100°F; she's still been feeling very tired; This is a spontaneous report from a contactable consumer. A 78-year-old female patient reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and Expiration date was unknown) via an unspecified route of administration on 03Feb2021 at 09:00 AM as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine of the patient included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date was unknown) via an unspecified route of administration on 13Jan2021 as 1st dose, single for COVID-19 immunization with no adverse events and stated that everything was fine. On the next day 04Feb202, Everything was fine until around 3 AM the next day and when she woke up from her sound sleep she had experienced pain in her legs, head ache, chills, and a fever of about 100 degree farenheit. She mentioned that she took Tylenol for her fever and currently some of the side effects already went away but she was still been feeling very tired. Patient wanted to know if it was also common to experience these side effects after the 2nd dose and for how long these side effects would last and if she needed to consult a doctor or should she just wait it out. The patient underwent lab tests and procedures which included body temperature 100 degree Fahrenheit on 04Feb2021. The outcome of the event very tired was not recovered and outcome for rest of events was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts were completed. No further information was expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Discomfort, Sciatica
Clinical narrative: Back pain, discomfort, and possibly sciatica pain; Back pain, discomfort, and possibly sciatica pain; Back pain, discomfort, and possibly sciatica pain; This is a spontaneous report from a contactable consumer or other non hcp.  A 65-years-old male patient received BNT162B2,(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as Ist dose, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced back pain, discomfort, and possibly sciatica pain, back pain, discomfort, and possibly sciatica pain on an unspecified date. Therapeutic measures were taken as a result of back pain, discomfort, and possibly sciatica pain, back pain, discomfort, and possibly sciatica pain. Outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Muscle strain, Pain
Clinical narrative: soreness, flu-like symptoms, headache, and body aches; soreness, flu-like symptoms, headache, and body aches; soreness, flu-like symptoms, headache, and body aches; muscle pull; This is a spontaneous report from a contactable female consumer. A female patient with unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 04Feb2021 at 8 am as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received first dose of vaccine on an unspecified date. On an unspecified date after the vaccination, the patient experienced side effects such as soreness, flu-like symptoms, headache, body aches and muscle pull. She states at 08:30PM, the caller took Tylenol for a muscle pull that was not from the shot, but from doing an exercise class. later that night, she didn't feel too good, so she took another Tylenol. She states that she is hearing that people should not take Tylenol or Advil with the COVID Shot. Caller is wondering what information is available on this. she just wants to know if her product will be effective now that she took Tylenol. She also asked, if she should give her flu-like symptoms, headache, and body aches a day or two before they go away after receiving both doses of Pfizer's COVID vaccine. Treatment taken includes Tylenol. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt tired; This is a spontaneous report from a contactable other hcp(nurse) reported for friend. A 37-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient not had a covid prior vaccination. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as 1st dose single for COVID-19 immunisation. The patient did not have COVID prior to vaccination. It was unknown if the patient received any other vaccine in four weeks. The patient experienced felt tired on an unspecified date. It was reported as, "My friend felt tired a day after her second injection. Side effects was resolved the next. Unknown severity of tiredness level". Treatment received was unknown. Outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine with aura
Clinical narrative: Migraine the next, including double vision (migraine with aura); This is a spontaneous report received from a contactable other health care professional (Patient). A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EJ1685), via an unspecified route of administration on 01Feb2021 at 12:45 (at the age of 68-year-old), as 1st dose, single, in left arm for COVID-19 immunisation at Hospital. The patient's medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, on an unspecified date. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Codeine and experienced drug hypersensitivity. On 02Feb2021 at 09:00, the patient experienced migraine the next, including double vision (migraine with aura). Gone in the evening, but returned the next morning, with 3rd strong headache. Patient did not received treatment for the adverse event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events was resolved on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site oedema, Vaccination site pain
Clinical narrative: Slightly tender; redness at injection site; I went to take off the band aid, it was red, when I put pressure on it, it was slightly tender.It's a light red; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 78-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581 and Expiry date: Unknown) intramuscularly administered in Arm Right on 03Feb2021 11:00 as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient medical history: Exactly 48 hours ago at 11:00 am is when she had the injection. She did not notice it at first. There was a bandage on it and about 20 hours after the vaccination, she went to pull bandage off and noticed it at the site. It was after about 24 hours and was slightly tender if any pressure was put on it. About 20 hours after the injection, there was no more tenderness. The redness remained the same. She measured the area. It is actually a light red, not bright red. On 03Feb2021 the patient experienced redness at injection site. on 04Feb2021 07:00 slightly tender. The outcome of event slightly tender was recovering. The outcome of event redness at injection site was not recovered. The outcome of event i went to take off the band aid, it was red, when i put pressure on it, it was slightly tender, Its a light red was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Limb injury, Pain in extremity
Clinical narrative: Really sharp pain in left arm/pain 6-8 inches below the injection site; Had an injury to his left arm; This is a spontaneous report from a contactable consumer (the patient's son). A 91-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in left arm on an unspecified date (reported as 11 days ago) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had an injury to his left arm, he went to his orthopedic doctor who proposed a cortisone shot. Reporter wants to know if he can take the cortisone shot given that he receives his first dose 11 days ago. On an unspecified date, the patient experienced really sharp pain in left arm/pain 6-8 inches below the injection site. It was reported that Reporter mentioned that his father had some pain 6-8 inches below the injection site. He wants to know if this was normal and state father had an injury to his left arm, he went to his orthopedic doctor and the doctor proposed a cortisone shot. He was due to receive the second dose on the 23rd or so, stated he had a really sharp pain in his left arm, states he can't say it came from shot, stated it might be from the patient's workout with 3lb arm weights. Reporter stated the patient was going to the orthopedic doctor today, they might want to do a cortisone shot in that left shoulder, Reporter wants to know if this was a good idea given that he was between the two doses of the vaccine. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Temperature of 99.1F to 99.4F,  Caller says 3 hours later his temperature was 99.9F.; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EM9810, Pfizer NTEC), via an unspecified route of administration in left arm on 04Feb2021 as 1st dose, single for covid-19 immunization. Medical history included diabetes, diagnosed 20 years ago, high cholesterol and abnormal blood pressure from an unknown date and unknown if ongoing. Concomitant medication included insulin, metformin taken for diabetes mellitus, rosuvastatin taken for blood cholesterol and hydrochlorothiazide, valsartan (VALSARTAN AND HYDROCHLOROTHIAZIDE) taken for blood pressure abnormal and amlodipine, patient stated that he has been taking these medications for about 20 years. Patient stated that he had his first shot on 04Feb2021 around 01:00PM and has got a fever next morning (05Feb2021). He says his highest temperature to date is 99.9 degrees Fahrenheit, which was about 30 minutes ago. He says he hadn't had a fever before. Patient stated that for his fever he took Ibuprofen. He said when he got up that morning (05Feb2021) it was 99.4 degrees Fahrenheit, and it went down to 99.1 degrees Fahrenheit, so he said ok and did not take Ibuprofen, then about two hours later it was 99.9 degrees Fahrenheit, so he took Ibuprofen 800mg. He says he was prescribed this to take one by mouth as needed for pain, he was taking Ibuprofen back in probably Mar2020 for walking pneumonia. The patient underwent lab tests and procedures which included pyrexia: 99.9 f on 05Feb2021, sars-cov-2 test: negative on 2020 (Unspecified date). Therapeutic measures were taken as a result of temperature of 99.1f to 99.4f,  caller says 3 hours later his temperature was 99.9f. The outcome for the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Dyspnoea, Throat tightness
Clinical narrative: SOB; throat tightness; abdominal pain; This is a spontaneous report from a non-contactable other healthcare professional reported that a 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9809), via intramuscular, administered in right arm on an unspecified date (Age at vaccination was 73 years) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date during his 15 minutes waiting period after the injection the patient began to experienced Shortness of breath (SOB), throat tightness and abdominal pain. No treatment included therapy, follow up response to treatment was excellent. Stable to go home and follow up with PCP. The report assessed as non serious. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Malaise, Myalgia, Nausea
Clinical narrative: muscle pain; unwell; tired; nausea; dizzy; This is a spontaneous report from a contactable consumer. This 67-Year-old female consumer reported. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On an unspecified date, the patient experienced some side effects such as muscle pain which bothered her the most. That morning, she also started feeling unwell, tired, nausea, and dizzy a week after her 1st dose of COVID vaccine. Wanted to know if those were the side effects from the vaccine and how long those would last. Seriousness of the events was reported as non-serious. Outcome of the events was reported as unknown. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: A little tenderness in the arm; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported a side effect that she experienced after receiving the first dose of the Pfizer-BioNtech Covid-19 vaccine, with the first dose she stated she never get a reaction to the vaccine only a little tenderness in the arm. She received the second dose of the Pfizer-BioNtech Covid-19 vaccine (today) on 05Feb2021. She has not experienced any side effect to the second dose. She would like to know if this means that her immune system is not developing a strong immune response as in someone who has a reaction to the vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: He has developed muscle aches and pains; This is a spontaneous report from a contactable consumer (wife). A 89-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration in 2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, patient has developed muscle aches and pains. His second dose is scheduled for 13Feb2021. The outcome of event was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: severe chills; a little bit of soreness; headache; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient (age: 68, unit: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), via an unspecified route of administration on 27Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that she got the first dose of the vaccine on Wednesday the 27th. The next day she had a little bit of soreness and a headache, which was not a big deal and was minor. On the 5th and 6th day she had severe chills and stayed under a blanket and this lasted 2 days. She is scheduled for her next dose on the 17th (she stated she is unsure if these dates are correct). She stated the doctor said usually the symptoms are worse after the second dose. She asked, can she expect to have the same symptoms and will they be worse. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Groin pain
Clinical narrative: Pain in the right hip and right groin.; Pain in the right hip and right groin.; This is a spontaneous report from a contactable female Nurse. A female patient (Age: 85; Unit: Unknown) of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 29Jan2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported her symptoms as pain in the right hip and right groin, also stated that she did not have these symptoms before the vaccine and is wanting to know if symptoms were related to the vaccine. The clinical outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Facial spasm, Feeling abnormal, Insomnia
Clinical narrative: Dizziness; Off balance; Warmness in molar; Spasm in the face, neck to molar area twitched for 2 hours; Foggy mind; Cannot sleep; Flashing light on peripheral sight every time she blinks; Mushy sensation on the injection site; Weird sensation on her arms and legs; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 66; unit: unknown) received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration on 28Jan2021 as single dose for covid-19 immunisation. The patient's medical history included flu shot 7-8 years ago and experienced allergic reactions (Thimerosal). The patient's concomitant medications were not reported. Patient previously took Thimerosal and experienced allergic reaction. On 28Jan2021, 2-3 hours later after receiving 1st dose of vaccine she experienced weird sensation on her arms and legs. On 29Jan2021, patient had mushy sensation on the injection site. On 30Jan2021, patient experienced spasm in the face, neck to molar area twitched for 2 hours, foggy mind and cannot sleep and flashing light on peripheral sight every time she blinks. On 31Jan2021, patient still has flashing light and experienced dizziness, off balance, warmness in molar and flashing lights again in the evening. Patient was still advised by her doctor to take 2nd shot. Not sure if the symptoms are caused by tooth infection. Her HCP advised her to seek medical attention with ophthalmologist. She was also advised that m-RNA vaccine will not trigger infection as this is not a live virus. Outcome of events was unknown.   Information on the Lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Photopsia, Sensory disturbance, Tooth disorder, Vaccination site discomfort
Clinical narrative: Dizziness; Off balance; Warmness in molar; Spasm in the face, neck to molar area twitched for 2 hours; Foggy mind; Cannot sleep; Flashing light on peripheral sight every time she blinks; Mushy sensation on the injection site; Weird sensation on her arms and legs; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 66; unit: unknown) received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration on 28Jan2021 as single dose for covid-19 immunisation. The patient's medical history included flu shot 7-8 years ago and experienced allergic reactions (Thimerosal). The patient's concomitant medications were not reported. Patient previously took Thimerosal and experienced allergic reaction. On 28Jan2021, 2-3 hours later after receiving 1st dose of vaccine she experienced weird sensation on her arms and legs. On 29Jan2021, patient had mushy sensation on the injection site. On 30Jan2021, patient experienced spasm in the face, neck to molar area twitched for 2 hours, foggy mind and cannot sleep and flashing light on peripheral sight every time she blinks. On 31Jan2021, patient still has flashing light and experienced dizziness, off balance, warmness in molar and flashing lights again in the evening. Patient was still advised by her doctor to take 2nd shot. Not sure if the symptoms are caused by tooth infection. Her HCP advised her to seek medical attention with ophthalmologist. She was also advised that m-RNA vaccine will not trigger infection as this is not a live virus. Outcome of events was unknown.   Information on the Lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable other hcp (Nurse). This female nurse reported that a female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 08Jan2021 as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received first dose of BNT162B2 (BNT162B2 Batch/Lot number: not reported), via an unspecified route of administration on 18Dec2020 as first dose single for covid-19 immunisation. On an unknown date, the patient experienced sore arm. The patient underwent lab tests and procedures which included antibody test: negative on 01Feb2021. It was reported that patient had no side effects from either dose Only a "sore arm" which is her normal after a vaccine. The clinical outcome of event was unknown.  Follow-up attempts have been completed and no further information is expected.