chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Limb discomfort
Clinical narrative: that last shot made me immediately sick but I only had my arm sore and it actually gave me lots of energy but still have the headache; I only had my arm sore; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 (Lot number: EWOISI) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "nauseous" (unspecified if ongoing); "bad headache" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Covid vaccine details: , Product: COVID 19, Brand: PRized , lot number=7534, lot unknown: False, administration date: 17Mar2021, administration time: 06:00 PM, vaccine location: Left arm, dose number: 1), administration date: 17Mar2021, when the patient was 55 years old, for COVID-19 immunisation, reaction(s): "I was nauseous", "headache", "really tired". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "that last shot made me immediately sick but I only had my arm sore and it actually gave me lots of energy but still have the headache"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "I only had my arm sore"; HEADACHE (non-serious), outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of illness, limb discomfort, headache.  Additional information: Then the second Pfizer shot in the left arm again was on for 7:21 and that last shot made me immediately sick but I only had my arm sore and it actually gave me lots of energy but still have the headache. No prior vaccination patient received. Patient was not tested post vaccination for COVID-19. Patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Limb mass, Vaccination site pain
Clinical narrative: soreness at injection site; had a big knot on his arm; indigestion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Lot number: Unknown) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (ongoing), notes: has had for a while; "kidney disease", start date: 2020 (ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "soreness at injection site"; LIMB MASS (non-serious) with onset 2021, outcome "recovered" (2021), described as "had a big knot on his arm"; DYSPEPSIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "indigestion".  Additional information: Patient received the first dose about three weeks ago (at the time of report) in his left arm and experienced soreness at injection site, had a big knot on his arm and indigestion. These events have resolved. Patient works from home. He tried to work but laid back down. He feels a little better after sleeping. No previous immunization with the Pfizer vaccine considered as suspect. No Other Products and Relevant Tests.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Thermal burn
Clinical narrative: she had a severe burn after the first vaccine; metallic taste in mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 11:00 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart flutter" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL taken for blood pressure measurement; LIPITOR [ATORVASTATIN] taken for blood cholesterol; BABY ASPIRIN. The following information was reported: DYSGEUSIA (non-serious) with onset 26Feb2021, outcome "not recovered", described as "metallic taste in mouth"; THERMAL BURN (non-serious) with onset 27Feb2021, outcome "recovered" (Mar2021), described as "she had a severe burn after the first vaccine". Therapeutic measures were not taken as a result of dysgeusia, thermal burn.  Additional information: Caller stated she had been on a heart monitor at the time of the first injection and where the leads were on her chest she assumed because perspiration from chemicals within 24 hours she had a severe burn after the first vaccine and she had been wearing the leads for a month with no problem. Caller stated the burn may have been something about a chemical reaction from the COVID vaccine and when she had the burn she already reported it to her cardiologist so if any other of her cardiologist patients had this same problem she would be made aware. The chemical burns from the Holter monitor took about 3 days to heal. Patient did not visit to Emergency Room and Physician Office.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle aches in his upper legs at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 13Apr2021, for COVID-19 immunisation. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "muscle aches in his upper legs at night".  Additional Information: It was reported that the patient brother took the COVID shot, and had taken the second shot and on his first one had muscle aches in his upper legs at night, the second shot didn't bother him.She was scared to take the second one.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Movement disorder, Personality change
Clinical narrative: First dose: She felt like she could hardly move; she felt like a new person; First dose: She felt like she got hit by mac truck, she was that tired; First dose: She felt like she got hit by mac truck, she was that tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Mar2021 15:40 (Lot number: EH6204) at the age of 63 years as dose1,single for covid-19 immunisation. Relevant medical history included: "Allergic to cats, dogs, and everything outside" (unspecified if ongoing); "Neuropathy" (ongoing); "Blood pressure" (ongoing). Concomitant medication(s) included: CLONAZEPAM taken for neuropathy peripheral; CAPTOPRIL taken for blood pressure management.  The following information was reported: FEELING ABNORMAL (non-serious), FATIGUE (non-serious) all with onset 23Mar2021, outcome "recovered" (25Mar2021) and all described as "First dose: She felt like she got hit by mac truck, she was that tired"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "First dose: She felt like she could hardly move"; PERSONALITY CHANGE (non-serious) with onset 25Mar2021, outcome "unknown", described as "she felt like a new person".  Additional information: It was reported that, patient had other concomitant Products Allergy shot: She goes to a clinic weekly to receive. Unknown name. She has been taking for over a year as patient was allergic to cats, dogs, and everything outside. Allergy shot: On the weeks that she received the first and second dose of her covid vaccine, she skipped getting her allergy shot that week. She normally gets her allergy shots every week. She gets vitamin B12 injections once a month, but she knows those were not vaccines. She received the first dose of the covid vaccine on 22Mar2021. She did have a reaction to the first dose. She just felt like she got hit by mac truck, she was that tired. She did not check for a fever. She did not have a headache. On 25Mar2021, she felt like a new person. She was out of work for two days. Clarifies that she was only out of work for one day. She went to work on the second day, and felt like she could hardly move.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 1st dose/arm pain for 3-4 weeks at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 15:30 (Lot number: EN6204) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LYSINE; FISH OIL; SAW PALMETTO [SERENOA REPENS]. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Mar2021, outcome "not recovered", described as "1st dose/arm pain for 3-4 weeks at injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. The patient received other medications within 2 weeks of vaccination which included multi-vitamin. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The did not receive any other vaccines within 4 weeks prior to the COVID vaccine Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received second dose of vaccine on 06Apr2021 at 15:15 pm. The case was assessed as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 10:30 (Batch/Lot number: EW0162) at the age of 26 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 14Apr2021 13:30, outcome "not recovered", described as "headache".  Additional information: There was no History of all previous immunization with the Pfizer vaccine considered as suspect, no additional Vaccines administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) was reported as none.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia oral, Nausea, Oropharyngeal pain
Clinical narrative: fatigue; nausea; mouth numbness; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 15:15 (Lot number: EP7533) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LYSINE; SAW PALMETTO [SERENOA REPENS]; FISH OIL. Vaccination history included: Bnt162b2 (Dose number: 1, Lot number: EN6204, Administration date: 09Mar2021, Administration time: 03:30 PM, Vaccine location= Left arm), administration date: 09Mar2021, when the patient was 43 years old, for Covid-19 immunisation, reaction(s): "arm pain for 3-4 weeks at injection site". The following information was reported: FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "fatigue"; NAUSEA (non-serious) with onset Apr2021, outcome "unknown", described as "nausea"; HYPOAESTHESIA ORAL (non-serious) with onset Apr2021, outcome "unknown", described as "mouth numbness"; OROPHARYNGEAL PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "sore throat". Therapeutic measures were not taken as a result of fatigue, nausea, hypoaesthesia oral, oropharyngeal pain.  Additional information: Patient had no allergies. Patient received multi-vitamin as concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: excruciating bone pain only in the places which have osteoporosis; My muscles were just as bad; I felt a little off the rest of the day; Dose 1: administration date Mar2021/ had my second dose of Pfizer on March 18th; Had minor headache the evening of vaccine; woke up nauseous during the evening; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Cyclic vomiting syndrome" (unspecified if ongoing); "depression" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT taken for anxiety, depression. Vaccination history included: Bnt162b2 (Dose 1; LOT number: Unknown; Administrator route: Intramuscular; vaccine location:Left arm), administration date: Mar2021, when the patient was 61 years old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 18Mar2021, outcome "recovering", described as "Had minor headache the evening of vaccine"; NAUSEA (non-serious) with onset 18Mar2021, outcome "recovering", described as "woke up nauseous during the evening"; MALAISE (non-serious) with onset 19Mar2021, outcome "recovering", described as "I felt a little off the rest of the day"; BONE PAIN (non-serious) with onset 20Mar2021, outcome "recovering", described as "excruciating bone pain only in the places which have osteoporosis"; MUSCLE DISCOMFORT (non-serious) with onset 20Mar2021, outcome "recovering", described as "My muscles were just as bad"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Mar2021, outcome "unknown", described as "Dose 1: administration date Mar2021/ had my second dose of Pfizer on March 18th". Therapeutic measures were not taken as a result of headache, malaise, bone pain, muscle discomfort. Therapeutic measures were taken as a result of nausea.  Additional information: Patient being weaned off Amitriptyline which took for nausea. It was interacting with the 50mg Zoloft I have been put on for anxiety and depression. I am now seeing a therapist for depression. With the loss of (name withheld) 6 years ago and the loss of my mother this past year plus the virus I can't say life has been joyous. Working on my mental health. The pain was so bad patient was in tears. My muscles were just as bad. It lasted about six hours and then subsided. When patient woke up Sunday by bones felt better, but muscles have been horrible since that time. The patient did not have allergies to medications, food, or other products. Patient was not diagnosed with COVID-19 prior to vaccination. Patient not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Apr2021 08:15 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing), notes: Verbatim: High Blood Pressure. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 10Apr2021, outcome "recovered" (12Apr2021), described as "Headache"; CHILLS (non-serious) with onset 10Apr2021, outcome "recovered" (12Apr2021), described as "Chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: doesn't feel herself; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  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: MALAISE (non-serious), outcome "unknown", described as "doesn't feel herself".  Additional information: The report is cross referenced to report ID: HCMS4A03. Received call from consumer regarding the Pfizer COVID vaccine. While reporting for herself, she mentioned that others who are in her family, her mom, had her shot. The only thing she is telling her is that she doesn't feel herself. Her sister had it and feels fine. This report is to capture information on her mother. She did not wish to complete a report on her mother. No further details provided. Unable to confirm if patient received Pfizer's COVID vaccine. Reason for no lot number: of Unspecified COVID vaccine: Caller unwilling to complete the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: sore arm for a couple days; aches for 24 hours, mostly in torso; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Mar2021 11:30 (Lot number: ER2613) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TETANUS VACCINE, administration date 08Mar2021; OMEPRAZOLE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm for a couple days"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "aches for 24 hours, mostly in torso".  Additional information: The patient had received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient was not been tested for COVID-19. Patient had no allergies to medications, food, or other products. Location of injection information was available for other vaccines within 4 weeks prior. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: 4 hours after shot I had chills for 5 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 11:00 (Lot number: EN6204) as dose 1, single for covid-19 immunisation. Relevant medical history included: "high cholesterol" (unspecified if ongoing), notes: extremely high cholesterol, maintains around 310; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: Yes. Many food items, penicillin and variations, many statin drugs; "Known allergies: Yes,many food items" (unspecified if ongoing). Concomitant medication(s) included: FLAGYL [METRONIDAZOLE]; VITAMIN B2 [RIBOFLAVIN]; CRANBERRY. The following information was reported: CHILLS (non-serious) with onset 21Mar2021 15:00, outcome "recovering", described as "4 hours after shot I had chills for 5 hours". Therapeutic measures were not taken as a result of chills.  Additional information: No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Drug hypersensitivity, Rash morbilliform
Clinical narrative: Patient diagnosed with Polyethylene Glycol sensitivity; patient developed a mobiliform rash that continued to worsen; patient developed a mobiliform rash that continued to worsen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 05Feb2021 (Lot number: EL9264) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,, Product: COVID-19, Brand: Pfizer,, Lot number: EL3247,, Anatomical site of injection: Left shoulder, Route of administration: Intramuscular), administration date: 15Jan2021, when the patient was 47 years old, for COVID-19 Immunization. The following information was reported: DRUG HYPERSENSITIVITY (non-serious) with onset 26Feb2021, outcome "recovered with sequelae" (2021), described as "Patient diagnosed with Polyethylene Glycol sensitivity"; RASH MORBILLIFORM (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 26Feb2021, outcome "recovered with sequelae" (2021) and all described as "patient developed a mobiliform rash that continued to worsen". The events "patient diagnosed with polyethylene glycol sensitivity", "patient developed a mobiliform rash that continued to worsen" and "patient developed a mobiliform rash that continued to worsen" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash morbilliform, condition aggravated.  Additional information: The patient had received any other vaccines within 4 weeks prior to the COVID vaccine. Three weeks after second injection, patient developed a morbilliform rash that continued to worsen. Rash improved after a round of steroids. Patient diagnosed with polyethylene glycol sensitivity. The patient had received treatment with two rounds of steroids for adverse event rash. Prior to vaccination, was the patient was not diagnosed with COVID-19. AE required visit to: Physician office.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain
Clinical narrative: maybe some soreness for 24 hours; slight dizziness after about 4 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 10:30 (Lot number: ER 8734) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TETANUS VACCINE, start date: 08Mar2021, stop date: 08Mar2021; OMEPRAZOLE. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: ER2613, Lot unknown: False, Administration date: 26Mar2021, Administration time: 11:30 AM, Dose Number: 1, Vaccine location: Right arm), administration date: 26Mar2021, when the patient was 51 years old, for Covid-19 immunisation, reaction(s): "aches for 24 hours, mostly in torso", "sore arm for a couple days". The following information was reported: DIZZINESS (non-serious) with onset 12Apr2021 14:30, outcome "recovering", described as "slight dizziness after about 4 hours"; PAIN (non-serious) with onset 12Apr2021 15:00, outcome "recovering", described as "maybe some soreness for 24 hours". Therapeutic measures were not taken as a result of dizziness, pain.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: At 2nd dose, sore arm for 2 days; body aches from neck down to legs that lasted 1 day; massive headaches off and on for 2 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 11:45 (Lot number: ER8737) at the age of 33 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single;, lot number=EN1199, administration time=12:30 PM, vaccine location=Left arm), administration date: 09Mar2021, when the patient was 33 years old, for covid-19 immunization, reaction(s): "Sore arm for 1 day after 1st dose", "Diagnosed with CRVO of the eye -March 30th", "Mini Stroke/blockage in left eye". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "At 2nd dose, sore arm for 2 days"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "body aches from neck down to legs that lasted 1 day"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "massive headaches off and on for 2 days". The events "at 2nd dose, sore arm for 2 days", "body aches from neck down to legs that lasted 1 day" and "massive headaches off and on for 2 days" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity, pain, headache.  Additional information: Facility type vaccine was Pharmacy or Drug Store. No Known allergies. No other vaccine in four weeks. No other medications in two weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left upper arm sore after first injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EP7534) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "stroke" (unspecified if ongoing), notes: about 10 years ago; "anxiety" (unspecified if ongoing), notes: After having stroke; "depression" (unspecified if ongoing), notes: After having stroke; "Severe indigestion" (unspecified if ongoing); "Burping all the time" (unspecified if ongoing); "sleep" (unspecified if ongoing); "immune system was compromised" (unspecified if ongoing), notes: 10 years ago. Family history included: "Alzheimer's" (unspecified if ongoing), notes: Her mother had Alzheimer's and breast cancer and passed away; "breast cancer" (unspecified if ongoing), notes: Her mother had Alzheimer's and breast cancer and passed away. Concomitant medication(s) included: PAXIL CR taken for anxiety, depression; PRILOSEC [OMEPRAZOLE MAGNESIUM] taken for dyspepsia, eructation; TRAZODONE taken for sleep disorder. Vaccination history included: Flu vaccine (Probably was about 4 months ago or something). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Left upper arm sore after first injection". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: She had been on Prilosec for over 10 years. Since COVID she had not been working that much. When she first got the shot she was nervous because she was on a wait list. The soreness started probably within 24 hours, they gave two Tylenol and had her take them. She adds that the arm soreness from the first vaccine pretty much had gone away but she is a side sleeper and she stayed off of it. In the middle of the night, she rolled over on it and said it was still sore so she got the second dose in her right arm. She confirms she received her 2nd dose on 14APR2021, ER8737, given around 10:30 am this morning. She clarifies she would take a quarter of the pill because she could not take a full one, it drugs her and if she does not get at least 8 hours of sleep, it will be in her system. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Severe Headache after first vaccine; Severe Muscle Aches after first vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 (Lot number: EN6201) at the age of 76 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "very sick/illness" (unspecified if ongoing), notes: She had some kind of episode 2 years ago in December before Covid came out. She was very, very sick. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 22Feb2021, outcome "recovered" (24Feb2021), described as "Severe Headache after first vaccine"; MYALGIA (non-serious) with onset 22Feb2021, outcome "recovered" (24Feb2021), described as "Severe Muscle Aches after first vaccine".  Additional information: The patient had some kind of episode 2 years ago in December before Covid came out. She said she was very, very sick. February after that was when Covid came out. During her illness in that December she had every symptoms like Covid. Her doctor told her that it probably wasn't Covid and there was another flu that had come around. The illness she experienced was severe enough that she went and set up her living trust. The patient did not have any family medical history relevant to adverse events. No additional vaccines were administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had her first vaccination on 22Feb2021 between 10:00-11:30 am given in left upper arm. The vaccine was not administered at Facility. Her reaction started the same day with a severe headache. The next day on 23Feb2021, she woke up with the severe headache and muscle aches. On 24Feb2021, she woke up and was fine, symptoms were gone. The adverse events did not require a visit to Emergency Room or Physician Office. No relevant tests were done.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose decreased, Chills, Fatigue, Palpitations
Clinical narrative: Normal arm tenderness first day post vaccine.; weakness; extreme fatigue; chills; heart palpitations; Felt similiar to a low blood glucose feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 14:00 (Lot number: ER2613) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: TENDERNESS (non-serious) with onset Apr2021, outcome "recovered", described as "Normal arm tenderness first day post vaccine."; ASTHENIA (non-serious) with onset Apr2021, outcome "recovered", described as "weakness"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered", described as "extreme fatigue"; CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "chills"; PALPITATIONS (non-serious) with onset Apr2021, outcome "unknown", described as "heart palpitations"; BLOOD GLUCOSE DECREASED (non-serious) with onset Apr2021, outcome "unknown", described as "Felt similiar to a low blood glucose feeling". Therapeutic measures were not taken as a result of tenderness, asthenia, fatigue, chills, palpitations, blood glucose decreased.  Additional information: It was reported that the patient had normal arm tenderness first day post vaccine. Beginning on the Tuesday, 6 days post vaccine started having periods of weakness and extreme fatigue. Felt similar to a low blood glucose feeling. This was accompanied with chills and heart palpitations. Continued off and on till Thursday morning. The patient had not received any other vaccines within four weeks and not received any medications within two weeks. The patient not had covid prior vaccination and not tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Normal arm tenderness first day post vaccine.; weakness; extreme fatigue; chills; heart palpitations; Felt similiar to a low blood glucose feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 14:00 (Lot number: ER2613) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: TENDERNESS (non-serious) with onset Apr2021, outcome "recovered", described as "Normal arm tenderness first day post vaccine."; ASTHENIA (non-serious) with onset Apr2021, outcome "recovered", described as "weakness"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered", described as "extreme fatigue"; CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "chills"; PALPITATIONS (non-serious) with onset Apr2021, outcome "unknown", described as "heart palpitations"; BLOOD GLUCOSE DECREASED (non-serious) with onset Apr2021, outcome "unknown", described as "Felt similiar to a low blood glucose feeling". Therapeutic measures were not taken as a result of tenderness, asthenia, fatigue, chills, palpitations, blood glucose decreased.  Additional information: It was reported that the patient had normal arm tenderness first day post vaccine. Beginning on the Tuesday, 6 days post vaccine started having periods of weakness and extreme fatigue. Felt similar to a low blood glucose feeling. This was accompanied with chills and heart palpitations. Continued off and on till Thursday morning. The patient had not received any other vaccines within four weeks and not received any medications within two weeks. The patient not had covid prior vaccination and not tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Second Shot: Bad headache, chills, body aches for 24 hrs.; Second Shot: Bad headache, chills, body aches for 24 hrs.; Body aches for 24 hrs.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Feb2021 (Lot number: EN6201) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number : 1, Anatomical Location: Arm Left, Batch/lot number : EL3302, Time: 12:00), administration date: 23Jan2021, for COVID-19 Immunization, reaction(s): "Excessive thirst for 12 hrs". The following information was reported: CHILLS (non-serious), HEADACHE (non-serious) all with onset 19Feb2021, outcome "recovered" (20Feb2021) and all described as "Second Shot: Bad headache, chills, body aches for 24 hrs."; PAIN (non-serious) with onset 19Feb2021, outcome "recovered" (20Feb2021), described as "Body aches for 24 hrs.". Therapeutic measures were not taken as a result of chills, headache, pain.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient had no allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) via Novartis pharmaceutical corporation. The reporter is the patient.  A 37 year-old 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: PAIN (non-serious), outcome "unknown", described as "sore".  Additional information: Patient stated that she recently had COVID-19 vaccine, and was a little sore.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Photopsia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), MIGRAINE (non-serious) all with onset 09Apr2021, outcome "unknown" and all described as "terrible headache, migraine headache"; PHOTOPSIA (non-serious) with onset 09Apr2021, outcome "unknown", described as "Flashing lights". The events "terrible headache, migraine headache", "terrible headache, migraine headache" and "flashing lights" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of headache. Additional information: On Wednesday of this last week, I had my second shot and I was fine on the day I got it the next day was fairly good and then on Friday, Saturday and Sunday, I had terrible headache and I had flashing lights like a migraine headache and now I did go to urgent care because the headache was so bad and the flashing light the migraine headache was bad, they had to give me a medication to help that. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: long term fatigue beyond 4-5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: FATIGUE (non-serious), outcome "unknown", described as "long term fatigue beyond 4-5 days".  Additional information: The reporter enquired that if they recommend patients receive their second dose of the vaccine if they have had this type of reaction. The reporter stated all of the patients were older and immunocompromised and she does not think these were adverse reactions.   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-2021422098 Same reporter, event, product/ different patient;US-PFIZER INC-2021416973 Same reporter, event, product/ different patient;US-PFIZER INC-2021422098 Same reporter, event, product/ different patient
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: long term fatigue beyond 4-5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient in her 70's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 8 decade 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: FATIGUE (non-serious), outcome "unknown", described as "long term fatigue beyond 4-5 days".  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-2021422097 Same reporter, event, product/ different patient;US-PFIZER INC-2021416973 Same reporter, event, product/ different patient; US-PFIZER INC-2021422097 Same reporter, event, product/ different patient
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: had a bad reaction and got really sick after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 74 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 74 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: ILLNESS (non-serious), outcome "unknown", described as "had a bad reaction and got really sick after the first dose".  Additional information: The reporter stated they had some patients reporting some symptoms after the vaccine. She stated they had three female patients, all in their 70s, reporting long term fatigue beyond 4-5 days. And another female patient who was 74 years old who had a bad reaction and got really sick after the first dose. She asked if they recommend patients receive their second dose of the vaccine if they have had this type of reaction. She stated all of the patients were older and immunocompromised and she does not think these were adverse reactions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Apr 10, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed fatigue, chills and pain in extremity/sore arms, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021422132.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Depressed mood, Panic attack
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 19-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER5727), at the age of 19, intramuscularly, on Mar 28, 2021, single dose, for COVID-19 immunisation. Medical history included non-smoker (unspecified if ongoing); and abstains from alcohol (unspecified if ongoing). Patient has an allergy to morphine (unspecified if ongoing). Concomitant medication included adalimumab taken for Crohn's disease, start date: Feb 9, 2021 (ongoing). The patient experienced depressed mood, panic attack/recurring panic attack and crying, onset Apr 1, 2021, with outcome of not recovered. Additional Information: It was unknown if patient was enrolled in a COVID-19 vaccine trial. No follow-up attempts possible. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Chills, Dizziness, Dysphagia, Dysphonia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: W/in 15min the pt had pain on left side up her neck and down her arm. Said neck "aching as if she was getting a sore throat". Had concerns of an allergic rxn so admin 1 dose of benadryl. No reports of difficulty breathing, swelling, or itching. W/in next 10 minutes her voice started cracking severely. Called emergency services number because she started to experience chills and some shaking in addition to voice loss and pains on L side. Declined hospitalization. F/u 3hrs later and pt ok but still no voice.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Neck pain, Oropharyngeal pain, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: W/in 15min the pt had pain on left side up her neck and down her arm. Said neck "aching as if she was getting a sore throat". Had concerns of an allergic rxn so admin 1 dose of benadryl. No reports of difficulty breathing, swelling, or itching. W/in next 10 minutes her voice started cracking severely. Called emergency services number because she started to experience chills and some shaking in addition to voice loss and pains on L side. Declined hospitalization. F/u 3hrs later and pt ok but still no voice.