chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation, Vaccination site pain
Clinical narrative: Headache; Tiredness; The caller states he has some pain at the injection site; aller verifies he took the following at 9:25 am today, 08Feb2021: Blood pressure: 151/100; blood pressure was usually 140-145 somewhere in ther; emperature: it was low grade at 96.7 degrees, his temperature normally runs about 98.5, 98.7; Nausea; Diarrhea; Joint pain in hands; Congestion; This is Spontaneous report from a contactable consumer. This is report 1 of 4. This report is in regards to the husband. The husband completes the report on behalf of himself. A 68-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EM9810), via intramuscular, administered in right arm on 06Feb2021 10:00 (at the age of 68-years-old) as a dose 1,single for covid-19 immunization. Medical history included ongoing diabetes mellitus, surgery (He also had a surgery a year ago on his right foot for his grand toe. He had three surgeries on that toe, and one surgery on his second toe. He was been working with a podiatrist because his toes do not want to heal right because of his diabetes. He was on antibiotics). He was tired and weary yesterday in the afternoon. He had some breathing problems yesterday afternoon that occurred. He became a little congested yesterday afternoon. He confirms the congestion started yesterday afternoon, on 07Feb2021. He was working with some stuff that was dusty and was doing some stuff around the house. So, he initially thought the symptoms he was experiencing were due to that. However, the symptoms are persisting. On 08Feb2021, at around 1am this morning, the nausea and diarrhea kicked in. He took Imodium for the diarrhea and kind of helped stem it but it hasn't stopped it. The joint pain in his hands started yesterday evening and its staying the same. He had some pain at the injection site, it was some pain that popped up later on. He states it doesn't hurt but if he touches it, he knows where the injection was given. Caller verifies he took the following at 9:25 am today, 08Feb2021: Blood pressure: 151/100; blood pressure was usually 140-145 somewhere in there, O2 oxygenation was 95%, temperature: it was low grade at 96.7 degrees, temperature normally runs about 98.5, 98.7. The Outcome of the event congestion and joint pain in hands was not recovered, while for other events was unknown. Description of Product Complaint: The caller explains him and his wife went Saturday and had the Pfizer COVID-19 vaccine at 10am. At around 1am this morning, the caller started to experience nausea and diarrhea. He took Imodium for the diarrhea and kind of helped stem it but it hasn't stopped it. Caller verifies he has no UPC Lot number or expiry date for the Imodium he took. He clarifies he believes it was the last one and he discarded of it. No further details were provided or obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a little sore arm; This is a spontaneous report from contactable consumer (patient). This consumer reported similar events for 02 patients. This report is for 1 of 2 patient. A female patient with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date, after the vaccination, the patient experienced little sore arm. The events assessed as non-serious. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171722 same reporter/event/drug, different patient
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Discomfort, Fatigue, Influenza like illness, Pain
Clinical narrative: extreme exhaustion; flu like symptoms set in; chills; body aches; uncomfortable; a little achy; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot/Batch number: unknown) via an unspecified route of administration on 05Feb2021 at 04:45 pm on the left arm as a single dose for COVID-19 immunisation. The patient's medical history included depression. The patient's concomitant medications were not reported. Patient did not take any other medications with in four weeks of vaccination. Patient's other medications within two weeks included Effexor. The patient was not tested for COVID prior vaccination. Patient's COVID past vaccination was none. The patient stated that within the 1st 24 hrs of vaccination on 06Feb2021 at 08:00 am, the patient felt uncomfortable& a little achy. On the second day after vaccination, the patient had flu like symptoms, chills, body aches in joints and lower back. On the third day, the patient experienced chills, body aches and extreme exhaustion. The patient was treated with OTC medication for the events. The outcome of the events was resolving.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a little sore arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This report is for 2 of 2 patient. A patient of unspecified age and gender received bnt162b2 (BNT162B2, 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 a covid-19 Immunization. The patient's medical history and concomitant were not reported. Caller stated that they were lucky enough to get first Pfizer shot last Friday, got their cards and are supposed to go back on 26Feb2021. Stated that she was trying to update their phone number for contact. Wanted to know how to reach them to update their number. Clarified that this is for the Pfizer Covid vaccine. Stated that administrator did not know if they would be there at the second location and would call them. Stated that they both had a little sore arm. The patient experienced had a little sore arm on an unspecified date in 2021 with outcome of unknown.    Information about Lot/batch number is requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171712 same reporter/event/drug, different patient
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: severe diarrhea; Headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL9269 and Expire Date: unknown) (age at the time of vaccination: 51) via unspecified route of administration, in right arm, on 06Feb2021 09:30 as DOSE 1, 0.3 ML SINGLE for Covid-19 immunisation. Medical history of patient included asthma and diabetes mellitus from an unspecified date and unknown if ongoing. Patient stated she had asthma all her life, and was born with it. Concomitant medications were none. Patient wanted to report a side effect, stated she got the first dose of the Pfizer Covid vaccine on Saturday 06Feb2021, stated one of the side effects is that it gave her severe diarrhea and stated there was no way to hold it. She got the vaccine around 9:30am, and a couple hours after it, started with the headache then the diarrhea. It did not stop with the diarrhea until 3PM the next day, 07Feb2021. She is a caregiver. The outcome of event was recovered on 07Feb2021.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Chest pain, Heart rate, Heart rate increased
Clinical narrative: previously have small psoriasis on neck; spot on neck became inflamed, hot, itchy.; spot on neck became inflamed, hot, itchy.; Which lead me to some anxious moments with racing heart; Which lead me to some anxious moments with racing heart; tightness/soreness in chest; tightness/soreness in chest; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ek9231), dose 1 via an unspecified route of administration, administered in left arm on 11Jan2021 07:30, as single dose for COVID-19 immunisation was in hospital. The patient medical history was not reported. Concomitant medications included citalopram and lisinopril. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. Post vaccination, the patient had not been tested for COVID. On an unknown date in Jan2021, the patient experienced previously had small psoriasis on neck. After each dose, spot on neck became inflamed, hot, itchy. Which lead me to some anxious moments with racing heart and tightness/soreness in chest. The patient underwent lab tests and procedures which included heart rate: racing in Jan2021. The patient did receive treatment to the events. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Pruritus, Psoriasis
Clinical narrative: previously have small psoriasis on neck; spot on neck became inflamed, hot, itchy.; spot on neck became inflamed, hot, itchy.; Which lead me to some anxious moments with racing heart; Which lead me to some anxious moments with racing heart; tightness/soreness in chest; tightness/soreness in chest; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ek9231), dose 1 via an unspecified route of administration, administered in left arm on 11Jan2021 07:30, as single dose for COVID-19 immunisation was in hospital. The patient medical history was not reported. Concomitant medications included citalopram and lisinopril. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. Post vaccination, the patient had not been tested for COVID. On an unknown date in Jan2021, the patient experienced previously had small psoriasis on neck. After each dose, spot on neck became inflamed, hot, itchy. Which lead me to some anxious moments with racing heart and tightness/soreness in chest. The patient underwent lab tests and procedures which included heart rate: racing in Jan2021. The patient did receive treatment to the events. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: welt like rash under one of her breast and a round red circle on top of one another.; Itching by her chest; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On an unspecified date, after vaccination, within 4 hours later when she went to bed, she was itching by her chest. She looked in the mirror and had a welt like rash under one of her breast and a round red circle on top of another one. She does not know if it is from the vaccine or not. She had no other symptoms, and it was gone the next morning when she woke up. Outcome of the events were resolved on an unspecified date.  Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Malaise, Muscular weakness
Clinical narrative: felt real weak in her legs; not feeling well; Stomach upset; felt weak; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number, NDC number and expiry date was not provided), dose 2 via an unspecified route of administration on 03Feb2021 (at the age of 76-years-old), as dose 2, single for covid-19 immunization. Medical history included ongoing asthma diagnosed when she was a child. There were no concomitant medications. Family medical history relevant to ae was not provided. The patient had previously taken the first dose of the bnt162b2 (batch number: EL9263) on 13Jan2021 (at 13:30-16:00, as reported) for covid-19 immunization (Unknown dose shot in right shoulder once, as reported). Patient age at first and subsequent immunizations if dates of birth or immunizations not available was not provided. No other medication were administered within four weeks prior to the first administration date of the suspect vaccine. Prior vaccinations patient had no adverse event. The patient stated that she felt real weak in her legs. Clarified that it is for the Pfizer Coronavirus shot. Wanted to know what to do about it. It was reported that the patient feeling weak started 3 days ago and feeling week in her legs which started 2 days ago. The patient stated she is still doing what she has been doing. Vaccination facility type was nursing home. On an unspecified date, the patient experienced "felt real weak in her legs", not feeling well, on 07Feb2021 felt weak and at 20:00, stomach upset. The adverse events did not cause emergency room or physician office visit. Treatment was for taken with Pepto Bismol as a result of stomach upset. Outcome of the events were not recovered.   Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Pustule, Rash, Tuberculin test
Clinical narrative: grown pustules, was really red and itching; grown pustules, was really red and itching; grown pustules, was really red and itching; Rash under left eye; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), dose 1 via an unspecified route of administration, administered in Arm Left on 24Jan2021 (age at vaccination: 72 years) as dose1, single for covid-19 immunisation. Family history included patient's daughter and patient's father were Diabetic. Patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 28Jan2021, in the morning the patient experienced a rash under her left eye and the next day on 29Jan2021 it had grown pustules, was really red and itching. Treatment includes she applied alcohol and started using Neosporin ointment applied to the rash about twice daily and the rash is improving, going away, but it is still dark, and feel the roughness where the rash is; but the pustules are gone that she has and it is going away. Relevant lab tests included- on Dec2020 she had a tuberculin skin test that was negative for her job. The outcome of all events was resolving.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Feeling of body temperature change
Clinical narrative: but would go from hot to cold; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, lot number: EM9810) via an unspecified route of administration on 03Feb2021 (age at vaccination: 71 years) as single dose for COVID-19 immunisation. History of all previous immunization with Pfizer vaccine considered as suspect was reported as None. Additional vaccines administered on the same date was None. Patient did not had received prior vaccinations within 4 weeks. Adverse events following prior vaccinations were None. She said that she had a cortisone shot in her hip before to treat her hip bursitis. It was on 21Dec2020, prior to her vaccination. The patient had her first dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, lot number: EL8982) via intramuscular route of administration on 13Jan2021 in left arm (age at vaccination: 71 years) as single dose for COVID-19 immunisation. Concomitant medication was not reported. The patient experienced but would go from hot to cold on an unspecified date. She stated that she never had a fever. It was reported that that when they were going over the side effects for her second vaccination, she said that it was everything she had been experiencing the last 3 weeks since her first injection. She reported that she would be going back to physician on 09Feb2021. The outcome of the event was unknown.  Follow-up attempts are completed. No further information was expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Nausea, Pyrexia
Clinical narrative: Fever; chills; joint pain; back pain; nausea; This is a spontaneous report from a contactable other health professional (patient reported for herself). A 70-year-old female patient (Non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in left arm on 02Feb2021 at 03:45 PM (at the age of 70-year-old), as unknown dose, single for COVID-19 immunisation. The patient medical history included COVID prior to vaccination. The patient other medical history included hypothyroid and diabetes metabolic syndrome. The patient had non known allergies. The patient concomitant medications were not reported. The patient did not receive other vaccine in four weeks. On 03Feb2021, after the vaccination, the patient experienced fever, chills, joint pain, back pain, and nausea. The patient was not tested for COVID post vaccination. The patient had a visit to physician office for the events. The patient did not receive any treatment to treat the events. On an unspecified date in Feb2021, the patient was resolved from all the events.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Pain in left armpit; Tender to touch; Body aches; Tiredness; Headache; Muscle pain; This is a spontaneous report from a Non-contactable Other Health Professional (Patient reported for herself). A 23-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration, administered in left arm on 06Feb2021 at 08:30 (at the age of 23-year-old), as a single for COVID-19 immunisation in public health clinic/veteran's administration facility. The patient's medical history and concomitant medications were not reported. Historical vaccine given to patient was dose 1 received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 16Jan2021 at 08:30 (at the age of 23-year-old), as a single for COVID-19 immunisation in public health clinic/veteran's administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 06Feb2021 at 20:00, the patient experienced pain in left armpit, tender to touch, body aches, tiredness, headache, muscle pain. Adverse events resulted in was reported as none. No treatment was received for the events. The outcome of the events was reported as resolving.  No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Pain in left armpit; Tender to touch; Body aches; Tiredness; Headache; Muscle pain; This is a spontaneous report from a Non-contactable Other Health Professional (Patient reported for herself). A 23-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration, administered in left arm on 06Feb2021 at 08:30 (at the age of 23-year-old), as a single for COVID-19 immunisation in public health clinic/veteran's administration facility. The patient's medical history and concomitant medications were not reported. Historical vaccine given to patient was dose 1 received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 16Jan2021 at 08:30 (at the age of 23-year-old), as a single for COVID-19 immunisation in public health clinic/veteran's administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 06Feb2021 at 20:00, the patient experienced pain in left armpit, tender to touch, body aches, tiredness, headache, muscle pain. Adverse events resulted in was reported as none. No treatment was received for the events. The outcome of the events was reported as resolving.  No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue
Clinical narrative: Chills; Tiredness; Pain stomach; This is a spontaneous report from a contactable consumer. A 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN9581) via an unspecified route of administration, in right arm on 02Feb2021 11:30 (at the age of 81-years-old) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL3249) via an unspecified route of administration on 12Jan2021 at 9:30am as 1st dose, single for covid-19 immunisation. No additional vaccines administered on same date of the pfizer suspect. Patient explained that it had been a week since getting her second shot and she went through the chills (on 03Feb2021) and muscle aches, but the acute tiredness is still on going. Caller clarified that there were no muscle aches. She explained she did have pains in the stomach (on 02Feb2021). This started 6 hours after the second dose and lasted about 8 hours. Acute tiredness this started Wednesday (on 03Feb2021) and had gotten worse. It is now a little better but still ongoing and exhausted. Adverse event did not require a visit to emergency room or physician office. Outcome of the event fatigue was recovering, pain stomach recovered on 03Feb2021 and chills recovered on 04Feb2021.  Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Ear pain, Headache, Myalgia
Clinical narrative: Sore and achy arm started 4 hours post 2nd vaccine, woke 3am with 99.6F fever, chills, muscle aches (back, neck and legs), headache and right ear ache.  Fever down to 98.7F without any fever reducers; Still having chills; muscle/body aches; 99.6F fever; headache; right ear ache; This is a spontaneous report from a contactable consumer (patient herself). A 45-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 12:00 (age at vaccination 45-year-old) (Batch/Lot Number: EL3247) as DOSE 2, SINGLE for covid-19. The patient's medical history included Hashimoto's Thyroid Disease (for 20 years now), Arthritis in toe joints (for 10 years now) and allergy only environmental allergens (Outdoor and indoor). The historical vaccine first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in Left Arm on 27Jan2021 11:30 AM for COVID-19 immunization. Concomitant medications included levothyroxine sodium (SYNTHROID) and eicosapentaenoic acid ethyl ester (VASCEPA) taken for an unspecified indication, start and stop date were not reported. It was reported that patient experienced Sore and achy arm started 4 hours post 2nd vaccine (18Feb2021 03:00), woke 3am with 99.6F fever, chills, muscle aches (back, neck and legs), headache and right earache. Fever down to 98.7F without any fever reducers at 7.30am but back up to 100F an hour later. At 10 am down to 97.6F. Still having chills and muscle/body aches. Other medications in two weeks includes Synthroid 75 mcg daily, Vascepa 200 mg twice a day. The patient did not receive any treatment for adverse events. Patient did not diagnose with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore and achy arm started 4 hours post 2nd vaccine, woke 3am with 99.6F fever, chills, muscle aches (back, neck and legs), headache and right ear ache.  Fever down to 98.7F without any fever reducers; Still having chills; muscle/body aches; 99.6F fever; headache; right ear ache; This is a spontaneous report from a contactable consumer (patient herself). A 45-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 12:00 (age at vaccination 45-year-old) (Batch/Lot Number: EL3247) as DOSE 2, SINGLE for covid-19. The patient's medical history included Hashimoto's Thyroid Disease (for 20 years now), Arthritis in toe joints (for 10 years now) and allergy only environmental allergens (Outdoor and indoor). The historical vaccine first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in Left Arm on 27Jan2021 11:30 AM for COVID-19 immunization. Concomitant medications included levothyroxine sodium (SYNTHROID) and eicosapentaenoic acid ethyl ester (VASCEPA) taken for an unspecified indication, start and stop date were not reported. It was reported that patient experienced Sore and achy arm started 4 hours post 2nd vaccine (18Feb2021 03:00), woke 3am with 99.6F fever, chills, muscle aches (back, neck and legs), headache and right earache. Fever down to 98.7F without any fever reducers at 7.30am but back up to 100F an hour later. At 10 am down to 97.6F. Still having chills and muscle/body aches. Other medications in two weeks includes Synthroid 75 mcg daily, Vascepa 200 mg twice a day. The patient did not receive any treatment for adverse events. Patient did not diagnose with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness/woke up dizzy/feel very dizzy; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 08Feb2021, post vaccination in morning the patient woke up dizzy. The patient reported patient is fine if walking from room to room, so Patient is fine when sitting down, walking room to room or anything felt very dizzy. The outcome of the event was reported as unknown at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ear started ringing; going to the doctor; This is a spontaneous report from a contactable consumer (patient). A 51-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EL9265) via an unspecified route of administration on 01Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history included sleep disorder. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot/Batch number: EL1284) via an unspecified route of administration on 11Jan2021 as a dose 1, single for COVID-19 immunization. The patient concomitant medications included zolpidem tartrate (AMBIEN) for sleep occasionally. The patient was wondering if anybody is reporting any severe tinnitus side effects of the vaccine. The caller stated that the day after she received her second vaccine on 03Feb2021, her ear started ringing to the point. The caller stated that she was going to the doctor tomorrow to try to figure out the reason. The outcome of the event was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Illness, Vomiting
Clinical narrative: Diarrhea; He was sick; Vomiting; This is a spontaneous report from a contactable consumer.   A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 25Jan2021 (age at vaccination: 79 years) as DOSE 2, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 06Jan2021 as dose 1, single for covid-19 immunization. On 07Feb2021 02:30, the patient experienced diarrhea, vomiting and was sick. The reporter stated that on Sunday morning at about 00:30, he woke up and he started having diarrhea and about 2:30 am, he started vomiting, he was sick all day long yesterday and he is still sick this morning. The reporter got to go through all his paperwork and all and it said was that this could be some symptoms of the COVID Vaccine. The outcome of the event illness was not recovered, and all the other events was unknown.  Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching in my scalp; heat bothers it more that the cold weather; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EK9231 and Expiration date was not reported), first dose via an unspecified route of administration on 07Jan2021 (at the age of 78 years) single for covid-19 immunisation. Patient Medical history included hypertension and Heart Attack from an unknown date and unknown if ongoing. Concomitant medication(s) included clopidogrel bisulfate (Plavix, 75 MG), Metoprolol, Benazepril and amlodipine besilate (Norvasc, 2.5 MG) taken for an unspecified indication, start and stop date were not reported. On an unspecified date (4 days after vaccination) the patient experienced itching in scalp which is bothered in heat more that the cold weather. Outcome of the event was unknown.   Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Laboratory test, Pruritus
Clinical narrative: Itching in my scalp; heat bothers it more that the cold weather; the second dose is when it is really been acting up; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of BNT162B2 (COVID-19 VACCINE PFIZER, Solution for injection, NDC/UPC number: Unknown, Expiry date: Unknown) via an unspecified route of administration on 28Jan2021 (at the age of 78-year-old) (Lot number: EL9265) as single dose for Covid-19 immunisation. The patient's medical history included hypertension and heart attack. Concomitant medications included clopidogrel bisulfate (PLAVIX) at 75 mg, metoprolol and benazepril. About the concomitant medication, consumer stated, "she wanted to say it was NORVASC, but did not want to tell wrong. That was going to be amlodipine besylate and that was the 2.5 mg (further not clarified)". The patient previously took first dose of BNT162B2 (COVID-19 VACCINE PFIZER) (at the age of 77-years-old) on 07Jan2021 (Lot number: EK9231) as single dose for Covid-19 immunisation and experienced itching in scalp. It was reported that, itching in scalp; heat bothered it more that the cold weather in Jan2021. Consumer stated, "she had both the shots. One of the side effects said itching. It was settled in scalp. She had itching in scalp, so, was trying to find out if there was anything that she could put on it to stop the itching". Consumer stated, "itching in scalp was about 4 days after the first but it was very lite was not aggravating or irritated or nothing but with the second dose is when it is really been acting up. Heat bothers it more that the cold weather. Cold weather does not seem to itch that much". Regarding lab data, consumer stated, "Not in the last 2 weeks. But they went every three months. They both had the same medical doctor, the cardiologist". She did not take any treatment in response to the event. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the injection site after 3 hours of injection and resolved after 10 hours; This is a spontaneous report from a non-contactable consumer (patient). A 38-years-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in right arm on 04Feb2021 (at the age of 38-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Facility type vaccine was Workplace clinic. Reportedly, patient did not had covid prior vaccination and was not tested for covid post vaccination. On 04Feb2021, the patient experienced soreness at the injection site after 3 hours of injection and resolved after 10 hours. No treatment was received for adverse event. The outcome of event was recovered on unspecified date of Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain
Clinical narrative: Shot was done in the shoulder of left arm - pain is in the armpit and side of left breast, very achey; Shot was done in the shoulder of left arm - pain is in the armpit and side of left breast, very achey; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration in the left arm on 07Feb2021 (at the age of 36-year-old) as single dose for COVID-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified antibiotic, unspecified steroid, ibuprofen, loratadine (CLARITIN); taken all for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 07Feb2021, the patient stated that shot was done in the shoulder of left arm and pain was in the armpit and side of left breast, very ache. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was reported as not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeding disorder, Headache, Hyperhidrosis
Clinical narrative: Monday morning I woke up feeling tired, but finally on the mend; Body aches; Muscle soreness; Chills; Body was super sensitive to touch; Couldn't sleep; Fever of 102; Headache and neck pain; Headache and neck pain; I had mild nausea and couldn't eat much.; I had mild nausea and couldn't eat much.; Sweating; This is a spontaneous report from a contactable other hcp. A 38-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Em9809 and expiration date was not reported), via an unspecified route of administration in arm left on 05Feb2021 at 14:30 (at the age of 38-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: El8982 and expiration date was not reported), via an unspecified route of administration in left arm on 15Jan2021 at 02:30 PM as dose 1, single for COVID-19 immunisation. The patient had no allergies. Facility type where vaccine was administered was public health clinic/veterans administration facility. The patient did not take other vaccine in four weeks. On 05Feb2021 at 11:00, the patient experienced chills, body was super sensitive to touch, couldn't sleep, fever of 102, headache and neck pain, "she had mild nausea and couldn't eat much", body aches, muscle soreness, sweating, "monday morning she woke up feeling tired, but finally on the mend" on 08Feb2021. Within 10 hours of receiving the second dose, the patient began having chills and almost like his body was super sensitive to touch. She couldn't get comfortable and couldn't sleep all that night. She began developing a fever of 102 and developed a major headache and neck pain. She had mild nausea and couldn't eat much. She was able to drink liquids ok. The fever, chills and body aches lasted from Friday night until Sunday afternoon around noon. Then the sweating started. She was sweating throughout the day and Sunday evening woke up covered in sweat and needed to change his clothes and sheets twice throughout the night. Monday morning she woke up feeling tired, but finally on the mend. She had muscle soreness in her shoulder and neck and a mild headache. The patient did not test for COVID post vaccination and no COVID prior vaccination. The patient did not receive any other treatment for the adverse events. The patient underwent lab tests and procedures which included pyrexia: 102 on 05Feb2021. Outcome of the events fever, chills and body aches were recovered on 07Feb2021 and the outcome of other events were recovering.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Nausea, Neck pain, Pain
Clinical narrative: Monday morning I woke up feeling tired, but finally on the mend; Body aches; Muscle soreness; Chills; Body was super sensitive to touch; Couldn't sleep; Fever of 102; Headache and neck pain; Headache and neck pain; I had mild nausea and couldn't eat much.; I had mild nausea and couldn't eat much.; Sweating; This is a spontaneous report from a contactable other hcp. A 38-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Em9809 and expiration date was not reported), via an unspecified route of administration in arm left on 05Feb2021 at 14:30 (at the age of 38-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: El8982 and expiration date was not reported), via an unspecified route of administration in left arm on 15Jan2021 at 02:30 PM as dose 1, single for COVID-19 immunisation. The patient had no allergies. Facility type where vaccine was administered was public health clinic/veterans administration facility. The patient did not take other vaccine in four weeks. On 05Feb2021 at 11:00, the patient experienced chills, body was super sensitive to touch, couldn't sleep, fever of 102, headache and neck pain, "she had mild nausea and couldn't eat much", body aches, muscle soreness, sweating, "monday morning she woke up feeling tired, but finally on the mend" on 08Feb2021. Within 10 hours of receiving the second dose, the patient began having chills and almost like his body was super sensitive to touch. She couldn't get comfortable and couldn't sleep all that night. She began developing a fever of 102 and developed a major headache and neck pain. She had mild nausea and couldn't eat much. She was able to drink liquids ok. The fever, chills and body aches lasted from Friday night until Sunday afternoon around noon. Then the sweating started. She was sweating throughout the day and Sunday evening woke up covered in sweat and needed to change his clothes and sheets twice throughout the night. Monday morning she woke up feeling tired, but finally on the mend. She had muscle soreness in her shoulder and neck and a mild headache. The patient did not test for COVID post vaccination and no COVID prior vaccination. The patient did not receive any other treatment for the adverse events. The patient underwent lab tests and procedures which included pyrexia: 102 on 05Feb2021. Outcome of the events fever, chills and body aches were recovered on 07Feb2021 and the outcome of other events were recovering.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sensitive skin
Clinical narrative: Monday morning I woke up feeling tired, but finally on the mend; Body aches; Muscle soreness; Chills; Body was super sensitive to touch; Couldn't sleep; Fever of 102; Headache and neck pain; Headache and neck pain; I had mild nausea and couldn't eat much.; I had mild nausea and couldn't eat much.; Sweating; This is a spontaneous report from a contactable other hcp. A 38-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Em9809 and expiration date was not reported), via an unspecified route of administration in arm left on 05Feb2021 at 14:30 (at the age of 38-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: El8982 and expiration date was not reported), via an unspecified route of administration in left arm on 15Jan2021 at 02:30 PM as dose 1, single for COVID-19 immunisation. The patient had no allergies. Facility type where vaccine was administered was public health clinic/veterans administration facility. The patient did not take other vaccine in four weeks. On 05Feb2021 at 11:00, the patient experienced chills, body was super sensitive to touch, couldn't sleep, fever of 102, headache and neck pain, "she had mild nausea and couldn't eat much", body aches, muscle soreness, sweating, "monday morning she woke up feeling tired, but finally on the mend" on 08Feb2021. Within 10 hours of receiving the second dose, the patient began having chills and almost like his body was super sensitive to touch. She couldn't get comfortable and couldn't sleep all that night. She began developing a fever of 102 and developed a major headache and neck pain. She had mild nausea and couldn't eat much. She was able to drink liquids ok. The fever, chills and body aches lasted from Friday night until Sunday afternoon around noon. Then the sweating started. She was sweating throughout the day and Sunday evening woke up covered in sweat and needed to change his clothes and sheets twice throughout the night. Monday morning she woke up feeling tired, but finally on the mend. She had muscle soreness in her shoulder and neck and a mild headache. The patient did not test for COVID post vaccination and no COVID prior vaccination. The patient did not receive any other treatment for the adverse events. The patient underwent lab tests and procedures which included pyrexia: 102 on 05Feb2021. Outcome of the events fever, chills and body aches were recovered on 07Feb2021 and the outcome of other events were recovering.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm for 24 hours.; Became achey the next evening and subsided a few hours later. No other information provided.; This is a spontaneous report from a contactable consumer (patient). A 50-years-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 06Feb2021(at the age of 50-year-old) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not receive any other vaccine in four weeks and other medications in two weeks. Patient had no covid prior vaccination and not tested covid post vaccination. On an unspecified date, the patient experienced sore arm for 24 hours, became achey the next evening and subsided a few hours later. No other information provided. Patient did not receive treatment for events. The outcome of the events was recovered on an unspecified date in 2021.  Information on lot/batch number has been requested.  Follow-up attempts completed. No further information expected.