chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise
Clinical narrative: Chills; Feeling unwell; Tiredness; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Lot number: ER8737) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood pressure" (unspecified if ongoing), notes: verbatim: high blood pressure. The patient took concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 17Apr2021, outcome "unknown", described as "Tiredness"; HEADACHE (non-serious) with onset 17Apr2021, outcome "recovering", described as "Headache"; CHILLS (non-serious) with onset 19Apr2021, outcome "unknown", described as "Chills"; MALAISE (non-serious) with onset 19Apr2021, outcome "unknown", described as "Feeling unwell".  Additional Information: The patient was taking Concomitant Product, High blood pressure medication. The patient stated that since the vaccine he experienced tiredness, headache, chills, and feeling really unwell. He experienced tiredness almost day to day.The headache started about 24 hours plus or minus after the vaccine. He stated that since yesterday the headache was improved and the chills and feeling unwell all started today. The patient occasionally felt the feeling unwell and chills.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Disease recurrence, Hypokinesia
Clinical narrative: my back was sore; my back was sore; I could barely move; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 59 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 15Apr2021 10:30 (Lot number: EW0161) at the age of 59 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Herniated disc in lower back" (unspecified if ongoing), notes: years ago. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1, Lot number: ER8732, Anatomical location: Left arm, Administration time: 10:30 AM), administration date: 25Mar2021, when the patient was 59 years old, for covid-19 immunization, reaction: "Intense low back pain". The following information was reported: BACK PAIN (non-serious), DISEASE RECURRENCE (non-serious) all with onset 17Apr2021 16:00, outcome "not recovered" and all described as "my back was sore"; HYPOKINESIA (non-serious) with onset 17Apr2021 16:00, outcome "not recovered", described as "I could barely move". The events "my back was sore", "my back was sore" and "i could barely move" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of back pain, disease recurrence and hypokinesia.  Additional information: Patient reported intense low back pain. She had intermittent issues with her back, her first shot was on a Thursday, and she woke up Sunday morning with back pain that she could not associate with anything. No heavy lifting or twisting that usually causes her bouts. She went to my primary, received a prescription for a MethylPREDNISolone pak, and felt better within 24-48 hours. Received the second shot on a Thursday, and by Saturday, her back was sore. Again, nothing lead up to the pain. By Sunday  she could barely move. Her episodes are never that close together. Went to an urgent care to get the steroids a day sooner and realized the timing of her events coincided with her vaccines. The patient had not received any other vaccine within 4 weeks or other medications within 2 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient was not allergic to any medications, food or other products.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as single dose for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "She got swollen under her arm". Additional information: She reported that her husband, 62 years old, got their 1st shots of the Pfizer Covid-19 vaccine on 30Mar2021. A couple of weeks before, he had a heart attack on 10Mar2021 and received 2 stents. He had another stent put in today, 19Apr2021. He is scheduled for his 2nd shot on 21Apr2021 on Wednesday. She doesn't think he can go. He might be able to go by Friday or Monday. She reports that her husband did not feel any side effects however she got swollen under her arm. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Piloerection, Vaccination site swelling
Clinical narrative: chills; goose bumps; feeling very cold; left arm injection site swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Mar2021 09:00 (Lot number: ER8732, Expiration Date: 31Jul2021) at the age of 62 years as dose 1,single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "chills"; PILOERECTION (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "goosebumps"; FEELING COLD (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "feeling very cold"; VACCINATION SITE SWELLING (non-serious) with onset 25Mar2021, outcome "recovered", described as "left arm injection site swelling". Therapeutic measures were taken as a result of chills, piloerection, feeling cold, vaccination site swelling.  Additional information: This report was not related to a study or programme. No, additional vaccines administered on same date of the Pfizer suspect. Prior vaccinations within 4 weeks were none. First Pfizer BioNTech COVID-19 Vaccine at about 9:00AM, and that entire evening, and throughout the night, she had chills, and goose bumps. She clarified she drove 50 miles to get her Pfizer BioNTech COVID-19 Vaccine. She said that evening, she was up the entire night with goose bumps, and feeling very cold. She did a lot of self-massage with heat therapy, drank tons of water, and had a professional massage.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extremely tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Feb2021 10:30 (Lot number: EL9266) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: environmental" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 24Feb2021, outcome "recovered" (25Feb2021), described as "extremely tired". The event "extremely tired" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of fatigue.  Additional information: Facility type vaccine was other. No other vaccine in four weeks. Other medications in two weeks. After first dose extremely tired on day 3. Was fine the next day. After second dose: very sore arm for less than 24 hours, a few days later developed pimples/hives inside of mouth and had a very red throat, non-painful throat. Pimple come and go, 4 Weeks later woke up to hives all over my torso along with the pimples in mouth. Hive went away after about a week. Redness in throat is at a minimum now, but still getting a smaller pimple almost every day. Saw ENT and Dentist about throat not linking the possible connection to the vaccine. Both felt there was nothing serious to be concerned with. Ae resulted in doctor or other healthcare professional office/clinic visit. No treatment for AE. No covid prior vaccination. Not tested for covid post vaccination. Known allergies were environmental.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Rhinorrhoea
Clinical narrative: Watery eyes; Runny nose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Lot number: ep7533) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LACRIMATION INCREASED (non-serious) with onset 22Apr2021, outcome "unknown", described as "Watery eyes"; RHINORRHOEA (non-serious) with onset 22Apr2021, outcome "unknown", described as "Runny nose".  Additional information:Patient was receive dose 1 on 01Apr2021 (Lot - ep7533) and she was due for her second dose today, but yesterday began having watery eyes and a runny nose and isn't sure if they will let her with those symptoms. Patient wanted to know Should I get the second dose because she experienced side effect after the first dose of the vaccine.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: she started having Flu-like symptoms: sore throat and runny nose without fever; she started having Flu-like symptoms: sore throat and runny nose without fever; Flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), RHINORRHOEA (non-serious), outcome "unknown" and all described as "she started having Flu-like symptoms: sore throat and runny nose without fever"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Radicular pain
Clinical narrative: she experienced lower leg nerve pain that went up to her lower back.; she experienced lower leg nerve pain that went up to her lower back.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEURALGIA (non-serious), RADICULAR PAIN (non-serious), outcome "unknown" and all described as "she experienced lower leg nerve pain that went up to her lower back."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in her ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Apr2021 (Lot number: ER8734) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Metastatic Breast Cancer" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "Gastric Reflux" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "cancer and osteoporosis, mostly the cancer" (unspecified if ongoing); "cancer and osteoporosis, mostly the cancer" (unspecified if ongoing). Concomitant medication(s) included: LETROZOLE taken for breast cancer (ongoing); LEVOTHYROXINE taken for hypothyroidism (ongoing); PANTOPRAZOLE taken for reflux gastritis (ongoing); ATORVASTATIN taken for blood cholesterol abnormal (ongoing); BABY ASPIRIN taken for prophylaxis; PREDNISONE taken for rheumatoid arthritis (ongoing); OXYCODONE taken for breast cancer (ongoing); XGEVA taken for neoplasm malignant, osteoporosis (ongoing); COLACE; ADVIL. The following information was reported: TINNITUS (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Ringing in her ears". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: Patient reported that she has been taking letrozole about two years but could be off. Levothyroxine roughly 20 years. Pantoprazole been taking about say 10 years. Atorvastatin been taking for at least 10 years. Baby aspirin roughly 10 years maybe longer on that one. Prednisone been on that roughly a year and a half. Oxycodone been taking or about 2 years. she for-gets on that. Caller does not have dosage; been taking Xgeva for about a year and a half, She forgot again, they have changed her on that, she has been on it then off it then back on it. Further, stated within 5 to 10 minutes of getting the shot she had severe ringing in her left ear for about 20 seconds real strong. Patient states it went down to a lesser ringing but pretty much constant. Patient said that she does not know if she should have the second one because she heard that the symptoms are worse with the second dose. She said that she can tolerate the ringing now, but if it gets worse she does not know if she can tolerate it, especially if it was like the 20 seconds after she first received the vaccine. Patient states that she takes a lot of medications she will find her list to read them all. there is quite a bit. Patient also stated that, she takes Colace and Advil over the counter as needed. she takes vita-mins, just put down multivitamin should cover it. Patient also reported that, she is not taking any medications for the events she was experiencing.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The following information was reported: pain in in extremity (her brother "just had a sore arm" after getting the vaccine"), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Systemic: Seizure-Medium
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Rash erythematous, Urticaria
Clinical narrative: Pain/soreness, red rash/welt, itching on left arm near shoulder and armpit. Began 7 days after shot and symptoms mostly resolved within 4 days. Internet search indicates these symptoms are consistent with "covid arm" associated with Moderna shot.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Headache, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Headache-Mild
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: After the vaccine the patient reported that they were dizzy and felt lightheaded. The patient was given water to drink and later taken to the emergency room. Prior to the vaccines, the patient reported that they were at the doctors office and they got blood drawn.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray normal, Cough, Dyspnoea, Pyrexia
Clinical narrative: Covid19 Adverse Event.  1st vaccine received on 01/12/2022.  86 y/o with PMHx DM, HTN, HLD, MI, Cardiac Stents, Chronic Kidney dz stage 3 presents to ED with c/o cough, fevers, SOB and inability to lay flat so has had to sleep sitting up for the past 2 weeks.  CXR- no acute process, Room air sats 98% and pt febrile.  Treated with IV ABx and IV steroids.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Sleep disorder
Clinical narrative: Covid19 Adverse Event.  1st vaccine received on 01/12/2022.  86 y/o with PMHx DM, HTN, HLD, MI, Cardiac Stents, Chronic Kidney dz stage 3 presents to ED with c/o cough, fevers, SOB and inability to lay flat so has had to sleep sitting up for the past 2 weeks.  CXR- no acute process, Room air sats 98% and pt febrile.  Treated with IV ABx and IV steroids.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscular weakness, Peripheral swelling
Clinical narrative: intense headache started two days; Intense swelling of legs/weakness worse than first incident; Intense swelling of legs/weakness worse than first incident; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date 08Apr2021 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; HYDROCHLOROTHIAZIDE. Vaccination history included: BNT162B2 (Dose 1, Single, Lot number: EN6207, Administration Time: 13:30, Vaccine Location: Left arm), administration date: 18Mar2021, when the patient was 64 years old, for Covid-19 Immunization, reaction(s): "hard to bend weakness in legs"; BNT162B2 (Dose 1, Single, Lot number: EN6207, Administration Time: 13:30, Vaccine Location: Left arm), administration date: 18Mar2021, when the patient was 64 years old, for Covid-19 Immunisation, reaction(s): "Intense headache frontal lobe", "Intense swelling of legs", "hard to bend weakness in legs". The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "not recovered", described as "intense headache started two days"; PERIPHERAL SWELLING (non-serious), MUSCULAR WEAKNESS (non-serious) all with onset Apr2021, outcome "recovering" and all described as "Intense swelling of legs/weakness worse than first incident". Therapeutic measures were not taken as a result of headache, peripheral swelling, muscular weakness. Additional Information: The patient did not receive any other vaccine in four weeks. On 2nd shot, the patient experienced intense headache started two days after, still present; intense swelling of legs/weakness worse than first incident, happened within 5 hours of shot lasted 24 hours still minor swelling. The patient has not been diagnosed with COVID-19 prior vaccination and has not been tested for COVID-19 post vaccination. The patient has no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021437779 same drug/reporter/patient, different dose
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse event, Asthenia, Blood pressure increased, COVID-19, Fatigue
Clinical narrative: Covid19 Adverse Event.  1st vaccine received on 08/08/2021.  30 y/o with PMHx Lupus, Lupus Nephritis with ESRD on Hemodialysis, HTN, GERD, Pancreatitis, Marijuana use presents to ED with c/o generalized weakness, fatigue, headaches and muscle/body aches since received Covid19 booster vaccine on 02/05/2022.  Pt immunocompromised due to monthly Brilinta infusions, steroids and Cellcept.  As a result of Covid19 vaccine booster side effects, pt missed two hemodialysis sessions resulting in elevated BP requiring ICU stay for Cardene gtt.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Intensive care, Myalgia, Pain, Therapy interrupted
Clinical narrative: Covid19 Adverse Event.  1st vaccine received on 08/08/2021.  30 y/o with PMHx Lupus, Lupus Nephritis with ESRD on Hemodialysis, HTN, GERD, Pancreatitis, Marijuana use presents to ED with c/o generalized weakness, fatigue, headaches and muscle/body aches since received Covid19 booster vaccine on 02/05/2022.  Pt immunocompromised due to monthly Brilinta infusions, steroids and Cellcept.  As a result of Covid19 vaccine booster side effects, pt missed two hemodialysis sessions resulting in elevated BP requiring ICU stay for Cardene gtt.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis
Clinical narrative: I have stuffy nose and nothing else; she is having cold symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  AA 35 year-old female patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASAL CONGESTION (non-serious) with onset Apr2021, outcome "unknown", described as "I have stuffy nose and nothing else"; NASOPHARYNGITIS (non-serious) with onset Apr2021, outcome "unknown", described as "she is having cold symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site for first dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in leg left, administration date 30Mar2021 10:45 (Lot number: ER2613) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR]; MONTELUKAST; CITALOPRAM. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain at injection site for first dose". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Patient did not received any other vaccine in four weeks. Patient was not diagnosed with covid prior and post vaccination. Vaccination facility was other.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021476696 Same reporter, patient, and product; different events and dose
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Only had one hour of sleep after the COVID-19 shot and couldn't sleep from it; This is a spontaneous report received from a contactable reporter (Consumer).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "Only had one hour of sleep after the COVID-19 shot and couldn't sleep from it".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This is a spontaneous report received from a contactable reporter (Consumer).  A male patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Pain in arm". Additional Information: While reporting for himself, the reporter mentioned a guy who had both of his shots of the Covid-19 vaccine and just had pain in his arm. His arm hurt for 2 -3 days but it got better, that's all.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021441411 same reporter, different patient.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Caller had his 1st Pfizer vaccine dose on 3/24/21 and "had a mild sore left arm."; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 12:30 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypogonadism", start date: 2018 (unspecified if ongoing), notes: Had been giving himself Testosterone shots since 2018. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Mar2021, outcome "recovering", described as "Caller had his 1st Pfizer vaccine dose on 24Mar21 and "had a mild sore left arm".  Additional information: He has never had any problems. He is methodical about giving shots in his thigh. He had no problem with first vaccine. His arm was a little sore, but no big deal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pharyngitis streptococcal
Clinical narrative: contracted strept throat; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PHARYNGITIS STREPTOCOCCAL (non-serious) with onset Apr2021, outcome "recovered" (23Apr2021), described as "contracted strept throat"; ILLNESS (non-serious) with onset Apr2021, outcome "recovered" (23Apr2021), described as "sick". Therapeutic measures were taken as a result of pharyngitis streptococcal, illness.  Additional information: The patient was seeking information on any drug interactions with the Pfizer Covid 19 vaccine and antibiotic, penicillin v potassium 500mg BID. She was due for her second dose and wondering if it would be safe for her to get it while on this antibiotic.The patient stated she had strep throat and was taking penicillin. She wanted to know if she can get her second dose. She wanted to know if there was a reaction with drug combined. Patient reported that she got her first dose of Pfizer Covid 19 vaccine on 02Apr2021 and scheduled for her second dose this afternoon. The patient was contracted strept throat this weekend, either Saturday or Sunday (17Apr2021 or 18Apr2021) and symptoms came on super quickly. She was pretty sick Monday and Tuesday and started treatment with antibiotics (penicillin v potassium 500mg BID) yesterday (22Apr2021) and she feel perfectly fine on that day. The symptoms were gone, she didn't have a sore throat and didn't feel sick. She feel totally fine right then. The patient was very frustrating as her doctor referred to the pharmacist and her pharmacist again referred her to the doctor. She was just trying to make the best decision for her health and  didn't want to make a decision that might kill her.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Night sweats, Pain, Pain in extremity
Clinical narrative: arm sore; body aches; chills; night sweats; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 11:15 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High BP" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; LEVOTHYROXINE SODIUM; AMLODIPINE BESILATE; ASPIRIN (E.C.). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Apr2021, outcome "not recovered", described as "arm sore"; PAIN (non-serious) with onset 05Apr2021, outcome "not recovered", described as "body aches"; CHILLS (non-serious) with onset 05Apr2021, outcome "not recovered", described as "chills"; NIGHT SWEATS (non-serious) with onset 05Apr2021, outcome "not recovered", described as "night sweats". The events "arm sore", "body aches", "chills" and "night sweats" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of pain in extremity, pain, chills, night sweats.  Additional information: Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Treatment (Pain meds, muscle relaxer, MRI requested) was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neck pain, Pain assessment, Paraesthesia
Clinical narrative: Right neck pain which was burning, searing, non-radiating; Tingling in neck, top of shoulder and right jaw and cheek; Numbness; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 13Apr2021 12:45 (Lot number: EP6995) at the age of 66 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious) with onset 15Apr2021, outcome "recovering", described as "Right neck pain which was burning, searing, non-radiating"; PARAESTHESIA (non-serious) with onset 15Apr2021, outcome "recovering", described as "Tingling in neck, top of shoulder and right jaw and cheek"; HYPOAESTHESIA (non-serious) with onset 15Apr2021, outcome "recovering", described as "Numbness". The events "right neck pain which was burning, searing, non-radiating", "tingling in neck, top of shoulder and right jaw and cheek" and "numbness" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of neck pain. Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia. Additional Information: Patient was not diagnosed with COVID-19 prior to the vaccination. Patient did not receive any other vaccines within four weeks prior to the vaccination. Patient was treated and was not responsive to extra strength of paracetamol (TYLENOL) or ibuprofen (MOTRIN) and the only relief for neck pain was to lie flat on right side with heat and not move head. The patient also experienced tingling in neck, top of shoulder, right jaw and cheek followed by numbness, which was not completely abated at time of this report. The pain was less in the morning (AM) and would escalate in mid-afternoon and evening. The pain was rated 9 out of 10. It continued for five days then started to improve. Patient had not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Nausea, Vertigo
Clinical narrative: dizzy; Vertigo, room spinning for 5-10 minutes; nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 09Apr2021 (Lot number: EW0158) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Oct2020 (unspecified if ongoing), notes: it was just a mild case. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 17Apr2021, outcome "recovered" (Apr2021), described as "dizzy"; VERTIGO (non-serious) with onset 17Apr2021, outcome "recovered" (Apr2021), described as "Vertigo, room spinning for 5-10 minutes"; NAUSEA (non-serious) with onset 17Apr2021, outcome "recovered" (Apr2021), described as "nauseous". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 09Apr2021. States that 9 days later, on Saturday, late at night, she started having vertigo. Says the room was spinning for 5-10 minutes. States she was also dizzy and nauseated. States these symptoms went away 4-5 days later. She donated blood twice after, and had antibodies. She wants to know if the antibodies in her system may have caused the reaction she had with the 1st dose of the vaccine. In addition to this, the consumer also mentioned that she had coffee after her 1st dose and wants to know if this may be why she had a reaction. States her second shot of the Covid Vaccine is scheduled for 30Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild soreness at injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 13:30 (Lot number: EN6202) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Mild soreness at injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient did not receive any treatment or any covid vaccine prior vaccination and had no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: dizzy; headache; This is a spontaneous report received from a contactable reporter(s) nurse (Other HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Apr2021, outcome "unknown", described as "dizzy"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "headache".  Additional information: Reported headache 48 hours "normal adverse events". Woke up last night same symptoms. Asked if she could have been exposed, immune response, or if this was an adverse reaction. She was to attend a baby shower, and the reasoning for her question.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abscess
Clinical narrative: On Thursday morning at 5 a.m., when she woke up she had an abscess between her neck and shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Apr2021 11:20 (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABSCESS (non-serious), outcome "unknown", described as "On Thursday morning at 5 a.m., when she woke up she had an abscess between her neck and shoulder".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills; mild headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "mild headache". Additional Information: Optional information: No significant medical history. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Body temperature decreased, Inappropriate schedule of product administration
Clinical narrative: Missed her second dose appointment; a low body temperature; running a temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Missed her second dose appointment"; BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "a low body temperature"; BODY TEMPERATURE ABNORMAL (non-serious), outcome "unknown", described as "running a temperature". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She was scheduled to get the second dose last 16Apr2021 which is more than 21 days apart from the first dose. However, the reporter missed her second dose because she had a low body temperature on that day. Yesterday, she was released by her doctor and now she is ready to get the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Muscle spasms, Sensitive skin
Clinical narrative: Still struggling with muscle spasming and some skin sensitivity a week after second shot.; Still struggling with muscle spasming and some skin sensitivity a week after second shot.; Still struggling with muscle spasming and some skin sensitivity a week after second shot.; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 35 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 13Apr2021 (Lot number: ER8733) at the age of 35 years as dose 2, single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medications included: MULTIVITAMIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;COLECALCIFEROL;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]; FISH OIL; PROBIOTICS; ADVIL [IBUPROFEN]; PEPCID [FAMOTIDINE]. Vaccination history included: BNT162B2 (Dose 1, Lot number: EN6202, Anatomical location: Left arm, Administration time: 03:45 PM), administration date: 23Mar2021, when the patient was 35 years old, for covid-19 immunization, reactions: "I got painful skin sensitivity" and "found a large muscle knot nearby". The following information was reported: MUSCLE SPASMS (non-serious), SENSITIVE SKIN (non-serious), DISEASE RECURRENCE (non-serious) all with onset Apr2021, outcome "unknown" and all described as "Still struggling with muscle spasming and some skin sensitivity a week after second shot.". The event "still struggling with muscle spasming and some skin sensitivity a week after second shot." was evaluated at the physician office visit. Therapeutic measures were taken as a result of muscle spasms, sensitive skin and disease recurrence.  Additional information: Treatment received were muscle relaxers, advil, massage, heat, and waiting. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient was not allergic to any medications, food or other products and was not diagnosed with other illness, medical history and chronic health conditions.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt bad after first dose; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Mar2021 09:30 (Lot number: ER8730) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 2020 (unspecified if ongoing), notes: before Holiday. The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "felt bad after first dose".  Additional Information: The patient took Pfizer COVID vaccine because he had COVID before Holiday (2020) and for added protection. He was active and gets around. He had friends who had COVID and he had a bad run with it. The patient did not receive additional vaccines on same date of the Pfizer suspect. Adverse event did not require a visit to emergency room or physician office. There were no relevant tests done by the patient.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021438332 Same patient and drug, different dose and events
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Menstrual period after first injection more painful and heavy than usual; Menstrual period after first injection more painful and heavy than usual; Menstrual period after first injection more painful and heavy than usual; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergic to artichokes" (unspecified if ongoing), notes: allergic to artichokes. The patient's concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious), DYSMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), outcome "recovering" and all described as "Menstrual period after first injection more painful and heavy than usual". Therapeutic measures were not taken as a result of menstrual disorder, dysmenorrhoea, heavy menstrual bleeding.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Patient did not received any other vaccine in four weeks. And no other mediation in two weeks. Patient did not had COVID-19 prior vaccination. Patient was not tested for COVID post vaccination. Vaccine administration time: 09:30 AM.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: left size of face went numb but regained feeling within 3 hours; weakness in left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 (Lot number: ER8733) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPOAESTHESIA (non-serious) with onset 31Mar2021, outcome "unknown", described as "left size of face went numb but regained feeling within 3 hours"; MUSCULAR WEAKNESS (non-serious) with onset 31Mar2021, outcome "unknown", described as "weakness in left arm". Therapeutic measures were not taken as a result of hypoaesthesia, muscular weakness.  Additional Information: After first dose within 1 hour left size of face went numb but regained feeling within 3 hours. Experienced weakness in left arm up to 4 days later. No vaccine in four weeks. Medications in two weeks was none. No covid prior vaccination. No covid tested post vaccination. No Known allergies.  No follow-up attempts are possible. No further information is expected.