chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: fever of 99.4 developed day 7; Headaches/strong recurring headaches past three nights/headaches always around temple areas; This is a spontaneous report from a contactable consumer (mother).   A 14-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 13May2021 11:30 (Batch/Lot Number: ER8735) as DOSE 1, SINGLE (at the age of 14 years) for covid-19 immunisation.  Medical history included seasonal pollen allergies from an unknown date, ongoing food allergy, ongoing Allergy to tree nuts, Cashew, pistachio, ongoing oral food allergy from an unknown date, ongoing seasonal allergy Pollen allergy -Rhinitis ongoing -pollen, adenotonsillectomy from an unknown date, removed tonsil adenoids at age 8 , anaphylactic shock from an unknown date, carries an epinephrine injector always, rhinitis from an unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for seasonal allergy from an unspecified start date and ongoing.  The patient experienced headaches/strong recurring headaches past three nights/headaches always around temple areas (reported as disability, medically significant) on 16May2021 20:00 with outcome of recovered, fever of 99.4 developed day 7 on 20May2021 with outcome of unknown.  The patient underwent lab tests and procedures which included body temperature: 99.4   on 20May2021, body temperature: 101.5   on 04Jun2021.  Therapeutic measures were taken as a result of headaches/strong recurring headaches past three nights/headaches always around temple area.  Headaches are nightly and require Tylenol and ibuprofen at night to sleep, strong recurring headaches past three nights which seem to subside in the morning. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts possible. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nervousness, Pain in extremity
Clinical narrative: Inside her body is shaking; dizziness; tiredness all day; soreness in her hand; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0167), via an unspecified route of administration on 11May2021 between 03:00 to 03:30 (at the age of 45-year-old), as dose 2, single in left arm for COVID-19 immunisation at Pharmacy/drug store. The patient's medical history included ongoing hypothyroid problem. Concomitant medication included levothyroxine started taking from last 7 years for hypothyroid problem, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FP7533), via an unspecified route of administration on 20Apr2021 between 03:00 to 03:30 (at the age of 45-year-old), as single dose in left arm for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks. On 11May2021, 1 hour after administration of second dose of vaccine, the patient experienced soreness in her hand for a duration of 1 day. On 12May2021, 1 day after the administration of second dose of vaccine, the patient experienced tiredness in the evening for all day. On 13May2021, 2 days after the administration of second dose of vaccine, morning time when she woke up inside her body was shaking and got dizziness; continued even on the 10th day. Patient did not require a visit to Emergency Room or Physician Office. Patient did not receive any treatment for the events. The clinical outcome of event soreness in her hand was resolved on 12May2021, clinical outcome of event tiredness all day was resolving; and clinical outcome of all other events was unknown.  Additional information is requested.  Follow-up attempts have been completed and no further information is expected
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Pain in extremity
Clinical narrative: Pain in the elbow, I can't bend my arm and it hurts when any kind of pressure on it, really weird; Pain in the elbow, I can't bend my arm and it hurts when any kind of pressure on it, really weird; Pain in the elbow, I can't bend my arm and it hurts when any kind of pressure on it, really weird; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EW0183; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 14May2021 (at the age of 30-years-old) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications included none. The patient experienced pain in the elbow, cannot bend arm and it hurts when any kind of pressure on it, really weird on an unspecified date in 2021. Patient got Pfizer first dose on last Friday (14May2021). When she bent my elbow, got pretty decent pain and that arm really weird, but she did not do any extreme work or activity, was never hurt like this before. Had pain in the elbow and cannot bend my arm and it hurts when any kind of pressure on it. Patient stated, I called urgent care then they told me to call this# that's why I am calling you. Patient stated that there was no expiration date and did not know. The patient did not see NDC# and UPC#. Had vaccine dose in left upper arm. Patient did not take any treatment. The patient stated still having the problem (event). When probed for event outcome, consumer stated, "I really this morning." Investigation assessments include none. Clinical outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: that bothered them was a sore arm; This is a spontaneous report from a Pfizer sponsored program. A female patient (reported herself) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated that both her husband and she have gotten the COVID doses and the only thing that bothered them was a sore arm. The patient had a 29-year-old son who won't get vaccinated because he says it's not FDA approved. She would really like Pfizer to push the FDA to get this COVID vaccine approved because she believes that a lot of people in the age range of 25-35 are waiting for the FDA to approve it. She wanted to know if someone from Pfizer would reach out to her in regard to the approval process and wanted to know what's taking so long, for the FDA to approve it. Since caller and her husband had a side effect.  Information on the lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itching; hives; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0183), via an unspecified route of administration on 11May2021 at 15:00 (at the age of 67-year-old) as dose 1, single for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing , blood cholesterol from an unknown date and unknown if ongoing. Concomitant medications included doxazosin mesilate taken for an unspecified indication, start and stop date were not reported, amlodipine besilate taken for an unspecified indication, start and stop date were not reported, lisinopril taken for an unspecified indication, start and stop date were not reported, rosuvastatin calcium taken for an unspecified indication, start and stop date were not reported, acetylsalicylic acid (ASPIRIN 81) taken for an unspecified indication, start and stop date were not reported, bioflavonoids nos, lecithin, quercetin, ubidecarenone (CO-Q-10 PLUS) taken for an unspecified indication, start and stop date were not reported. On 12May2021, the patient experienced itching, hives. She had the same reaction to sulfa but this one was much worse. Patient was asking if there was anything in the vaccine that she was allergic to. The patient was scheduled for the second dose on 01Jun2021. Therapeutic measures were taken as a result of events included benadryl. The outcome of the events were resolving.   Follow-Up (09Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast swelling, Chills, Muscle spasms, Pyrexia
Clinical narrative: Chills; Fever; The next day after vaccine, I started abnormal vaginal bleeding 10 days before my period; My breasts are swollen and hurt; My breasts are swollen and hurt; Cramping all over my body and in my uterus; Cramping all over my body and in my uterus; This is a spontaneous report from a contactable consumer (patient). A 21-years-old female patient received second dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in arm right on 09May2021 at 11:30 (at the age of 21-years-old) as single for COVID-19 immunization. The patient did not had medical history and did not receive any concomitant medications. The patient previously received the first dose of BNT162B2, administered in arm right on 24Apr2021 at 11:30 for COVID-19 immunization. It was unknown whether the patient was pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10May2021 at 09:00, the patient experienced abnormal vaginal bleeding 10 days before her period, her breasts was swollen and hurt, she had terrible cramping all over her body and in her uterus, she had an ongoing fever and chills. She was still bleeding it was day 11. No one was helping her and she was in so much pain. The events did not led to prolongation of hospitalization. The patient did not receive any treatment for the events. The outcome of all the events was not resolved.  Information on the lot/batch number has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine spasm, Vaginal haemorrhage
Clinical narrative: Chills; Fever; The next day after vaccine, I started abnormal vaginal bleeding 10 days before my period; My breasts are swollen and hurt; My breasts are swollen and hurt; Cramping all over my body and in my uterus; Cramping all over my body and in my uterus; This is a spontaneous report from a contactable consumer (patient). A 21-years-old female patient received second dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in arm right on 09May2021 at 11:30 (at the age of 21-years-old) as single for COVID-19 immunization. The patient did not had medical history and did not receive any concomitant medications. The patient previously received the first dose of BNT162B2, administered in arm right on 24Apr2021 at 11:30 for COVID-19 immunization. It was unknown whether the patient was pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10May2021 at 09:00, the patient experienced abnormal vaginal bleeding 10 days before her period, her breasts was swollen and hurt, she had terrible cramping all over her body and in her uterus, she had an ongoing fever and chills. She was still bleeding it was day 11. No one was helping her and she was in so much pain. The events did not led to prolongation of hospitalization. The patient did not receive any treatment for the events. The outcome of all the events was not resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Joint swelling
Clinical narrative: My joints are so swollened and inflammed, and sore; My joints are so swollened and inflammed, and sore; My joints are so swollened and inflammed, and sore; This is a spontaneous report from a Pfizer sponsored program. A contactable Health care professional (Nurse) reported for a female patient.  A 70-year-old non-pregnant female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for Covid-19 immunisation. The patient medical history was not reported. The patient concomitant medication included hydroxychloroquine sulfate 200mg tablet (PLAQUENIL SULFATE), atorvastatin calcium 10mg tablet, Tizanidine hcl 2mg capsule, Gabapentin 300mg capsule. The patient stated that (on an unspecified date) my joints are so swollen and inflammed, and sore. I have missed 3-4 day of Xeljanz because of covid. The outcome of events was not recovered.  Follow-up activities closed. Batch/lot number not available.
Sex: F
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: have a tooth infection; This is a spontaneous report from a contactable consumer (Patient) and Follow-up received on (21May2021) spontaneous report from a Pfizer sponsored program COVAX US Support processed together with initial.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 01May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included tooth repair from an unknown date and unknown if ongoing I had tooth work last year and every now and then my cheek swells. The patient's concomitant medications were not reported. On an unspecified date the patient stated that she is scheduled to get the second dose of the Pfizer BioNTech covid vaccine tomorrow and questioned if it's ok to take antibiotics. "I had tooth work last year and every now and then my cheek swells. When I go see my dentist, he says there's an infection and prescribes antibiotics. I'm going to call my dentist (about a current swollen cheek) and I know he's going to prescribe antibiotics again. This has been going on for a while. I didn't have any reaction from the first dose of the vaccine, no pain or anything.  I read online that it's ok to take antibiotics and get the vaccine, so I just wanted to be sure. wondering if they can still take antibiotics for tooth infection that developed after the first dose. The Outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. .
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: pain under her armpit; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, she felt pain under her armpit. She wants to know if this is a known side effect of the vaccine, how long it will last, and what she can do to minimize the pain. Outcome of the event was unknown.  Follow up attempts are needed. Further information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Feeling flu like symptoms; This is a spontaneous report from a contactable consumer (patient, self-reported). A 51-year-old female patient received first and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date (age at vaccination: 51 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received the Pfizer Covid vaccine and was feeling flu like symptoms on an unspecified date and want to know if these symptoms have been reported after receiving the vaccine. If the side effects she read to you fit with the symptoms you were experiencing, than they have been reported as normal side effects after taking the Pfizer Covid vaccine. These might not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects might occur Pfizer-BioNTech COVID-19 vaccine was still being studied in clinical trials. The patient advised that your doctor/healthcare provider was in the best position to advise you about the appropriate action to take as your doctor/healthcare provider was most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case. Caller reported that these symptoms are occurring after her second dose of the Pfizer COVID vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested, further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: took Claritin, 2 or 3 tablets 200mg each of Motrin, and Lisinopril 20mg or 40mg prior to getting the vaccine; sore arm; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for a female patient of an unspecified age received bnt162b2 (Pfizer-BiNTech Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot Number: EW0178), dose 1 via an unspecified route of administration on 19May2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included loratadine (CLARITINE); ibuprofen (MOTRIN [IBUPROFEN]) and lisinopril for an unspecified indication. The patient experienced sore arm in May2021, took claritin, 2 or 3 tablets 200mg each of motrin, and lisinopril 20mg or 40mg prior to getting the vaccine on 19May2021. Patient stated that "Prior to taking the vaccine I had taken 5mg of Claritin, 2 tablets of 200mg each of Motrin, Lisinopril 20mg and my son took 1 Claritin 5mg and I would like to know if that is ok, will cause efficacy issues with the vaccine? I haven't taken any afterwards, even with the sore arm". Description of complaint: Caller took medication the same day as getting the COVID 19 vaccine on 19May2021. Caller stated that she had taken one 5mg tablet of Claritin, probably 2 but maybe 3 tablets 200mg each of Motrin, and Lisinopril 20mg prior to taking the vaccine that day. Caller stated she wants to make sure the medication did not impact the effectiveness of their vaccines? Caller stated she received the first dose on 19May2021, the lot number is EW0178 and unknown NDC number and expiry date.  Communication: Full details not obtained as caller declined to proceed with report at this time. Outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Skin tightness, Troponin
Clinical narrative: back pain; couldn't stand up; hand felt funny the whole rest of the day on Saturday, the palm of her hand; skin felt tight and heavy; arm was tight and heavy; difficult to walk; painful; This is a spontaneous report from a contactable consumer. This 45-year-old female consumer (patient) reported that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 10Apr2021 (Batch/Lot Number: ER8730) as 1ST DOSE, SINGLE for covid-19 immunisation. (at the age of 48 years). Medical history included sickle cell anaemia from 01Sep1972 and ongoing she has sickle cell and not just sickle cell trait , ongoing drug hypersensitivity reported that she has been told since she was a kid that she is allergic to penicillin , hypersensitivity from an unknown date and unknown if ongoing reported that she is allergic to other medications but did not provide details. The patient's concomitant medications were not reported. The patient experienced hand felt funny the whole rest of the day on saturday, the palm of her hand, skin felt tight and heavy on 10Apr2021 12:30, couldn't stand up on 11Apr2021, painful on Apr2021 (unspecified day).  , arm was tight and heavy on 10Apr2021, back pain on 11Apr2021 11:30, difficult to walk on Apr2021 (unspecified day).  The caller stated she got first dose of the vaccine on 10Apr2021. Immediately her hand felt funny the whole rest of the day on Saturday, the palm of her hand. Sunday she had the same heavy feeling. Monday when it first appeared midday she couldn't grab anything with her right hand, she could not grab a pen. She stated the skin felt tight and heavy. She couldn't grab or hold or put pressure on her two feet. She couldn't stand up. She could not stand on her legs on the Monday around midday and it just got worse and worse and she could not hold on to anything to stand up. She stayed like that Monday night, and Tuesday it was severe. She could not turn from side to side, it was very very painful. Tuesday night she was thinking she needed to go to the ER but did not want to go and she just asked God to help her. Wednesday she heard people saying their symptoms lasted two days and it started subsiding around midday. Gradually it went away. Thursday she was still sore but was back to her baseline by Thursday. The agent stated she reported her arm was tight and heavy and was having back pain and it was difficult to walk for 48 hours and then she was fine.  She stated she says back because it went down to legs and she could not stand on two legs. The patient underwent lab tests and procedures which included computerised tomogram: no blood clot in lungs   on 03May2021, troponin: heart was ok on 03May2021.The outcome of the events hand felt funny the whole rest of the day on Saturday, the palm of her hand, skin felt tight and heavy, couldn't stand up was, arm was tight and heavy and back pain resolved on 15Apr2021, Painful was on Apr2021 (unspecified date) and difficult to walk was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: Stuffy nose; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (mRNA, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single, then via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that consumer reports speaking person, who caller asked if they were fighting a cold, the person reported still having a stuffy nose ever since receiving both Pfizer vaccinations two months ago. Treatment was reported as nothing in addition to concomitant medications. The outcome of event was not resolved.  Information on Batch/Lot number has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia, Vomiting
Clinical narrative: fever of 101.6 degrees; nausea; vomiting; This is a spontaneous report from a contactable consumer (patient's mother). A 17-year-old male patient (reporter's son) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number, expiration date and NDC number of Pfizer COVID vaccine: Not Provided), dose 1 via an unspecified route of administration on 20May2021 (age at vaccination: 17-years-old) dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that caller was the mother of a teenager who received the first dose of the Pfizer covid vaccine on 20May2021. The patient now experiencing a fever of 101.6 degrees, nausea, and vomiting on an unknown date in May2021. She would like to know if she should worry or was this normal. It was confirmed that the side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine. The outcome of the events was unknown.  Follow up attempts are needed. Further information has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Muscle spasms
Clinical narrative: Severe muscle spasms in the bicep of arm he got the vaccine/now it is (muscle spasms) spread to other muscle groups; He could not sleep; This is a spontaneous report from a contactable physician (patient's wife). A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in Arm Left on 03May2021 at 11:00 (at an age of 45-year-old) as dose 1, single dose for COVID-19 immunization. The patient medical history was not reported and had no problems with vaccines in past. Concomitant medications were not reported. The patient had no other vaccines given the same day or 4 weeks prior. On 03May2021, approximately 3-4 hours after the injection (dose 1), he developed a severe muscle spasm in the bicep of the same arm of the injection. Physician saw the contraction of the head of the bicep muscle. The first night was very frequent, overnight, and he could not sleep. He had not had that before the vaccine and did not do any exercises that could have caused it. After 5-6 days, it had improved but now spasms had spread in other muscle groups (at the time of report), like the quadriceps and on the back, but less severe compared to the arm. Spasms have continued, although improved and it was mainly at night now (at the time of report). The reporter was concerned if this could happen to anywhere in the body. Wonders if this could happen to any other part of body for the rest of his life. The reporter asked if patient should get his second dose if he has developed severe muscle spasms after the first dose. Physician did not feel that it was medically significant. On 03May2021, patient recovered from event could not sleep, the patient had not yet recovered from severe muscle spasm.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program PFE PAP SP Lyrica. A contactable adult female consumer (patient) reported for herself that she received bnt162b2 (Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated it works very well for her. And she has a sore arm from vaccination shot. The outcome of event was unknown. Follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Eye swelling
Clinical narrative: she had blisters in her mouth and around her mouth; her eyes were swollen; This is a spontaneous report from a contactable Pharmacist. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date (age at vaccination 35-year-old) as dose 1, single for covid-19 immunization. The patients medical history and concomitant medications were not reported. One day after vaccination patient experienced blisters in her mouth and around her mouth and her eyes were swollen. Treatment included for adverse event eye swelling was steroid drops. The outcome of event was recovered on an unspecified date.  Information about lot/batch number has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Influenza, Malaise
Clinical narrative: experienced Flu; Joint Paint; Fever; Muscle Pain; Headache; Tiredness; Nausea; Arm Pain; Injection Site Pain; He is feeling sick after second dose; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program . A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 20May2021 (at the age of 26-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date (at the age of 26-years-old) for COVID-19 immunisation. The patient reported that he experienced Flu, Joint Paint, Fever, Muscle Pain, Headache, Tiredness, Nausea, Arm Pain and Injection Site Pain. He had his first shot of the Pfizer BioNTech Covid-19 Vaccine last day 20May2021 (as reported). Caller wanted to know if he would be allowed to take Dayquil to relieve the current side effects he was experiencing. The patient received his second dose last day (20May2021) but cannot recall exact date of 1st. He was feeling sick after second dose. His symptoms were not much different than what was on the fact sheet. He did not wish to report them at all. He just had a question. His symptoms were very typical of the flu with the usual joint pain, fever, muscle pain, headache and tiredness. He took the day off of work. He just wanted to know if he should take Dayquil tomorrow so he could function and go to work. The patient was referred to HCP. Outcome of the events was unknown.  Follow-up needed. Information about batch/lot number has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: experienced Flu; Joint Paint; Fever; Muscle Pain; Headache; Tiredness; Nausea; Arm Pain; Injection Site Pain; He is feeling sick after second dose; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program . A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 20May2021 (at the age of 26-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date (at the age of 26-years-old) for COVID-19 immunisation. The patient reported that he experienced Flu, Joint Paint, Fever, Muscle Pain, Headache, Tiredness, Nausea, Arm Pain and Injection Site Pain. He had his first shot of the Pfizer BioNTech Covid-19 Vaccine last day 20May2021 (as reported). Caller wanted to know if he would be allowed to take Dayquil to relieve the current side effects he was experiencing. The patient received his second dose last day (20May2021) but cannot recall exact date of 1st. He was feeling sick after second dose. His symptoms were not much different than what was on the fact sheet. He did not wish to report them at all. He just had a question. His symptoms were very typical of the flu with the usual joint pain, fever, muscle pain, headache and tiredness. He took the day off of work. He just wanted to know if he should take Dayquil tomorrow so he could function and go to work. The patient was referred to HCP. Outcome of the events was unknown.  Follow-up needed. Information about batch/lot number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: I have a rash that is itchy when they pop up and then are lumped up and red; I have a rash that is itchy when they pop up and then are lumped up and red; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0176), via an unspecified route of administration, administered in arm left on 04May2021 09:30 (at the age of 53-years-old) as dose 1, single for covid-19 immunisation. Patient's medical history and family medical history was none. Prior to vaccinations within four weeks no medication received prior to the first administration. The patient's concomitant medications were not reported. The patient had a rash that was itchy when they pop up and then were lumped up and red on May2021. The patient got it a week ago. Also asking question as how long it was going to go on and was it going to be worse with the second dose. It was reported that side effects after second shot might be more intense than the ones they experienced after first shot. These side effects were normal signs that on body was building protection and should go away within a few days. The event does not require a visit to emergency room and physician office. Relevant test was none. The outcome of events was not resolved.  Additional information is requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on arm about 7 days after 1st dose; This is a spontaneous report from a contactable consumer (patient). A 22-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in arm left on 11May2021 17:00 (at the age of 22-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced rash on arm about 7 days after first dose on 18May2021 09:00. The patient did not receive any treatment for the adverse event. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Head discomfort
Clinical narrative: Awoke with Dizziness 10May2021 could not pick my head up from the bed x 2 hours.  Dizziness lasted until 20May2021in spurts especially when I had to bend head down.; Awoke with Dizziness 5/10/ 2021 could not pick my head up from the bed x 2 hours.  Dizziness lasted until 5/20/2021 in spurts especially when I had to bend head down.; Weakness; This is a spontaneous report received from a contactable other hcp via reporting system. A 64-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Batch/Lot Number: EW0170), dose 1 via an unspecified route of administration, administered in Arm Left on 21Apr2021 09:00 (at the age 64-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included metoprolol and ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) for an unspecified indication. The patient experienced dizziness and head discomfort on 10May2021 at 06:00 and weakness in May2021. The patient stated that "awoke with dizziness 10May2021 could not pick my head up from the bed x 2 hours. dizziness lasted until 20May2021 in spurts especially when i had to bend head down". Therapeutic measures were taken as a result of events; fluticasone 50MCG SPR Roxane & Zyrtec was given. Outcome of the event weakness was unknown and other events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose decreased, Eating disorder, Headache, Rash, Vomiting
Clinical narrative: Vomiting; Low blood sugar; unable to walk without help even sitting in wheelchair; Rash; had reaction to vaccine; Headache; Having hard time eating and drinking; This is a spontaneous report from a contactable consumer (parent). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Batch/Lot number was not reported), via an unspecified route of administration on 14May2021 (at the age of 12-years-old) as dose number unknown, single for COVID-19 immunization. Medical history included Immunodeficiency and Gene mutation. The patient's concomitant medications were not reported. Reporter stated, her child had his Pfizer vaccine (COVID vaccine) on Friday (14 May 2021) and he was fine on Friday, Saturday and Sunday but on Monday patient experienced vomiting, took him to the Hospital of (withheld), he had low blood sugar, he had rash, (headache) and was unable to walk without the help even sitting up in the wheelchair and patient is having hard time eating and drinking as of now. The outcome of the events was reported as unknown.  Information about Lot/Batch number has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Walking disability
Clinical narrative: Vomiting; Low blood sugar; unable to walk without help even sitting in wheelchair; Rash; had reaction to vaccine; Headache; Having hard time eating and drinking; This is a spontaneous report from a contactable consumer (parent). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Batch/Lot number was not reported), via an unspecified route of administration on 14May2021 (at the age of 12-years-old) as dose number unknown, single for COVID-19 immunization. Medical history included Immunodeficiency and Gene mutation. The patient's concomitant medications were not reported. Reporter stated, her child had his Pfizer vaccine (COVID vaccine) on Friday (14 May 2021) and he was fine on Friday, Saturday and Sunday but on Monday patient experienced vomiting, took him to the Hospital of (withheld), he had low blood sugar, he had rash, (headache) and was unable to walk without the help even sitting up in the wheelchair and patient is having hard time eating and drinking as of now. The outcome of the events was reported as unknown.  Information about Lot/Batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Psoriasis
Clinical narrative: has daily pain in her hands; having a flare up of psoriasis; This is a spontaneous report based on information received by Pfizer from Novartis (mfr control no. NVSC2021US103908) a contactable consumer reported. A 55-years-old female patient received bnt162b2 (BNT162B2 Solution for injection), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced has daily pain in her hands and having a flare up of psoriasis on an unspecified date.  Patient stated having a flare up of psoriasis after taking the COVID vaccine also has daily pain in her hands. The outcome of the events was unknown.  Follow-up needed. Information about batch/lot number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Malaise
Clinical narrative: not feeling well today; back pain/Tried swimming in pool today and got back pain.; This is a spontaneous report from a Novartis. A contactable 74-years-old male consumer (patient) received bnt162b2 (COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 06May2021 (at the age of 74-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  It was reported that patient received second Covid vaccine on 06May2021 and not feeling well today or back pain in 2021. Tried swimming in pool today and got back pain. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Dizziness, Dyspnoea, Fatigue
Clinical narrative: dizziness immediately after the vaccine; severe joint pain; tinnitus; I could barely walk; My bones started hurting me a lot and they still hurting me today; got like tired; shortness of breath; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EW0158) via an unspecified route of administration on 02May2021 as single dose for covid-19 immunization. The patient's medical history included covid-19 from an unknown date in Jan2021 to an unknown date. She was am recovering from severe Covid she had in January and was hospitalized so she would say that's the main thing. Concomitant medications included albuterol [salbutamol] (ALBUTEROL). On an unspecified date in May2021, the patient experienced dizziness immediately after the vaccine together with severe joint pain and also tinnitus. She got the first dose of vaccine on 02May2021 and she was scheduled on 23May2021 for the second dose. It was confirmed that the patient administered Pfizer Covid-19 Vaccine. On an unspecified date in May2021, the patient stated well she had dizziness immediately then and after she could barely walk and then after she don't know for how long but her bones started hurting her a lot and they still hurting her today and her ear started ringing. The patient also got like tired and had more shortness of breath on an unspecified date in May2021 than usual but that went away. The patient was seeking for an advice whether she should take the second one or not. The patient did not receive any treatment for the adverse events experience by her. The outcome of the events my bones started hurting me a lot and they still hurting me today was not recovered, got like tired and shortness of breath was recovered on an unspecified date in May2021 while, the outcome of remaining events was unknown.  Follow-up attempts are needed. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Tinnitus
Clinical narrative: dizziness immediately after the vaccine; severe joint pain; tinnitus; I could barely walk; My bones started hurting me a lot and they still hurting me today; got like tired; shortness of breath; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EW0158) via an unspecified route of administration on 02May2021 as single dose for covid-19 immunization. The patient's medical history included covid-19 from an unknown date in Jan2021 to an unknown date. She was am recovering from severe Covid she had in January and was hospitalized so she would say that's the main thing. Concomitant medications included albuterol [salbutamol] (ALBUTEROL). On an unspecified date in May2021, the patient experienced dizziness immediately after the vaccine together with severe joint pain and also tinnitus. She got the first dose of vaccine on 02May2021 and she was scheduled on 23May2021 for the second dose. It was confirmed that the patient administered Pfizer Covid-19 Vaccine. On an unspecified date in May2021, the patient stated well she had dizziness immediately then and after she could barely walk and then after she don't know for how long but her bones started hurting her a lot and they still hurting her today and her ear started ringing. The patient also got like tired and had more shortness of breath on an unspecified date in May2021 than usual but that went away. The patient was seeking for an advice whether she should take the second one or not. The patient did not receive any treatment for the adverse events experience by her. The outcome of the events my bones started hurting me a lot and they still hurting me today was not recovered, got like tired and shortness of breath was recovered on an unspecified date in May2021 while, the outcome of remaining events was unknown.  Follow-up attempts are needed. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Hypoaesthesia, Hypoaesthesia oral, Magnetic resonance imaging
Clinical narrative: Ten minutes into the drive, the left side of the tongue and mouth went numb; Ten minutes into the drive, the left side of the tongue and mouth went numb; The numbness continued down the throat and up through the nasal on the left side; This is a spontaneous report received from a contactable consumer or other non hcp. A 65-year-old female patient received bnt162b2 (Formulation: Solution for injection, Batch/Lot Number: EW0151), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 11:00 (at the age 65-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included Rubella vaccine (The caller has had a vaccine not work and that is why the caller had to get the rubella shot 44 years ago). The caller states she sat for 15 minutes at the vaccination facility. Ten minutes into the drive, the left side of the tongue and mouth went numb on 30Apr2021. The caller received the first dose Pfizer shot on the left side. The numbness continued down the throat and up through the nasal on the left side on 30Apr2021. The patient called the doctor and ended up in emergency room in case the caller was having a stroke. The caller had a lot of testing done and it was determined it was not a stroke, the caller was having a reaction to the first dose Pfizer Covid shot. The reactions happened within 30 minutes of receiving the first dose Pfizer Covid shot. The caller clarifies she was discharged from the emergency room after an MRI, two CAT scans and a bunch of blood work. The caller states this was a costly shot. The caller states the tongue and lip recovered completely and the nose and throat recovered completely. The patient underwent lab tests and procedures which included blood test: normal on 30Apr2021, computerised tomogram: normal on 30Apr2021, magnetic resonance imaging: normal on 30Apr2021. Description of complaint: The caller has had a vaccine not work and that is why the caller had to get the rubella shot 44 years ago. The caller ended up with a Congenital Rubella daughter and had to get the Rubella shot again. Caller unable to provide NDC/lot/expiration for the Rubella shot that did not work. Caller states that doctor is long gone. Outcome of the event the numbness continued down the throat and up through the nasal on the left side was recovered on 01May2021 and other events recovered on 02May2021.  Information on Lot/Batch number was available. Additional information has been requested.