chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sickness for 3 days; 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) (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: ILLNESS (non-serious), outcome "recovered", described as "sickness for 3 days". Additional information: Reporter stated that, patient had first dose two week ago but doesn't want to give an exact date. Experienced sickness for 3 days after the first dose, was asking if can refuse to take the second dose. While connecting the call to DSU, the caller hangs up. Provided the PMI phone number and hours of operation. Created an AE Form.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: Altered taste - tastes too sweet or tastes too salty, tired she sleeps all the time/She has similar symptoms as when she had Covid 19; Altered taste - tastes too sweet or tastes too salty, tired she sleeps all the time/She has similar symptoms as when she had Covid 19; 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 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Dec2020 (unspecified if ongoing), notes: she had Covid 19 first week of December.; "Hypertensive" (unspecified if ongoing), notes: About 20 years ago. There were no concomitant medications. Patient had no medical history (including any illness) at time of vaccination. No family history. No additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. Vaccination history included: Bnt162b2 (Batch/lot number - EP7534 , dose 1, Anatomical location: Left arm), administration date: 24Mar2021, for COVID-19 immunization. It was reported that after the first vaccine there was no problem at all.   The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Apr2021, outcome "not recovered" and all described as "Altered taste - tastes too sweet or tastes too salty, tired she sleeps all the time/She has similar symptoms as when she had Covid 19". It was reported that symptoms were still persisting at the time of the report. This report was not related to a study or program. The events did not result in emergency room and/or physician office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle contracture, Muscle disorder
Clinical narrative: She is in misery and every morning when she gets up, she is just hoping she doesn't fall over because her muscles are so contracted; Muscular problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Feb2021 (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: Covid-19 vaccine (Dose 1, Unknown manufacturer.), for Immunization. The following information was reported: MUSCLE CONTRACTURE (non-serious), outcome "unknown", described as "She is in misery and every morning when she gets up, she is just hoping she doesn't fall over because her muscles are so contracted"; MUSCLE DISORDER (non-serious), outcome "unknown", described as "Muscular problems".  Additional information: Since the patient had that vaccine second dose patient was experienced a lot of muscular problems. Patient is in misery and every morning when she gets up, she was just hoping she did not fall over because her muscles are so contracted. Patients stated that she would rather take her chances of getting the virus than getting more shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Full blood count decreased
Clinical narrative: Blood count was low; 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 29Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "sickle cell traits" (unspecified if ongoing), notes: Scheduled for Vitamin B shot on 11May2021 - sickle cell traits. Was getting shot every 2 weeks. The patient's concomitant medications were not reported.  The following information was reported: FULL BLOOD COUNT DECREASED (non-serious), outcome "unknown", described as "Blood count was low". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported that she received the 1st dose of the vaccine on April 29th and scheduled to get the 2nd dose on May 20th. She said she was scheduled for a Vitamin B shot on May 11th for her sickle cell traits. She also said she was regularly getting shots every 2 weeks and her blood count was low.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: I'm just tired; I'm very tired; my arm is sore; the post nasal drip, kind of  like chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 06May2021 (Lot number: EW0167) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood pressure" (unspecified if ongoing), notes: Verbatim: High Blood pressure; "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes. Concomitant medication(s) included: BENICAR taken for hypertension; METFORMIN taken for diabetes mellitus; BABY ASPIRIN. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "I'm just tired; I'm very tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "my arm is sore"; CHILLS (non-serious), outcome "unknown", described as "the post nasal drip, kind of  like chills". Therapeutic measures were taken as a result of pain in extremity.  Additional information: Consumer stated, Well, I am calling about possible side effects. I took the vaccine yesterday afternoon so, I have the, they gave me a sheet with the possible side effects but I just want to call, the follow up because it didn't say whether it's like any severe reaction or severe side effect. I'm just tired, is that common? Because it's the first vaccine shot, I'm very tired. Of course, my arm is sore and I thought I'll get a cold, you know, the post nasal drip, kind of  like chills, not a fever, I don't have a fever but I do feel like I have chills. Consumer stated, I just took a Tylenol, just because my arm is sore, just a Tylenol. Consumer stated, 500 for 2, (500mg). Dose of Metformin: Consumer stated, 1000 for 2 tablets. (further clarification unknown).  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Paraesthesia
Clinical narrative: my right arm had tingling effect feeling, I have to rub rub until it get away; was really wired I couldn't get the sleep; had a little fatigue; 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 received bnt162b2 (BNT162B2), administered in arm right, administration date 03May2021 (Lot number: EW0171) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, Lot# EW0150), administration date: 05Apr2021, for COVID-19 immunization. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "my right arm had tingling effect feeling, I have to rub rub until it get away"; INSOMNIA (non-serious), outcome "unknown", described as "was really wired I couldn't get the sleep"; FATIGUE (non-serious), outcome "unknown", described as "had a little fatigue". Therapeutic measures were taken as a result of paraesthesia, insomnia, fatigue.  Additional information: The patient put some oil on her arm; Just Tylenol. The patient tried to sleep but she didn't sleep because it was bothering her so much. No Investigation Assessment.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Feeling abnormal, Malaise, Nasopharyngitis, Product dose omission issue
Clinical narrative: I'm not feeling very good; I don't know if I am trying to come down with a cold; my stomach is bothering me as well; she is not feeling good since yesterday; Missed dose; 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.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Lot number: ER8734) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Stage 4 Cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PRODUCT DOSE OMISSION ISSUE (non-serious) with onset 29Apr2021, outcome "not recovered", described as "Missed dose"; MALAISE (non-serious), outcome "unknown", described as "I'm not feeling very good"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "I don't know if I am trying to come down with a cold"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "my stomach is bothering me as well"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she is not feeling good since yesterday".  Additional information- She had stage 4 cancer.  Caller clarified that she was diagnosed with the Stage 4 Cancer prior to receiving the covid vaccine. She also clarifies that the second dose was originally scheduled on 29APR2021, but she missed that, and so she decided to call the Medical Center where she got her first dose and they rescheduled her for today, 11MAY2021, but she was missing today dose. Caller asks is this the last time she could come in for a second dose or she had to go somewhere else.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; 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), administration date 19Apr2021 (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: SINUSITIS (non-serious) with onset 06May2021, outcome "unknown", described as "sinus infection".  Additional information: Reporter stated that both he and his wife received their first PFizer Covid vaccine dose on 19Apr2021. They are due for their second dose of the vaccine soon. However, they both have sinus infections and were pressribed an antibiotic to take. The sinus infection started approx. 06May2021. He wants to know if he needs to wait to get the second dose of the vaccine. In response it was informed to reporter that Pfizer was unable to make treatment recommendations. Spoke from attached document CONS-COVID-19 vaccine-use of antivirals and antibiotics at vaccination (v1.0) and referred reporter to speak with HCP for treatment recommendations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling hot, Lymphadenopathy, Nausea
Clinical narrative: nausea; lightheadedness; tiredness; palms of his hands felt like needles; face gets extremely hot; Lymph nodes in his neck was swollen/Glands started swelling again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 15:00 (Batch/Lot number: unknown) at the age of 54 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, Lot Number: Unknown , Route: injection , Anatomical Location: left arm , First dose that he had left arm soreness 4-6 hours after the injection. , He used Tylenol and Ibuprofen every couple of hours and alternated it for left arm soreness.), administration date: Feb2021, for covid-19 immunisation, reaction(s): "Left arm soreness". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 09May2021 08:00, outcome "not recovered", described as "Lymph nodes in his neck was swollen/Glands started swelling again"; PAIN IN EXTREMITY (non-serious) with onset 10May2021 12:00, outcome "recovered" (10May2021 12:30), described as "palms of his hands felt like needles"; FEELING HOT (non-serious) with onset 09May2021 08:00, outcome "recovered" (10May2021), described as "face gets extremely hot"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; DIZZINESS (non-serious), outcome "unknown", described as "lightheadedness"; FATIGUE (non-serious), outcome "unknown", described as "tiredness". Therapeutic measures were not taken as a result of lymphadenopathy, pain in extremity, feeling hot, nausea, dizziness, fatigue.  Additional information: The patient had the second dose on 11Mar2021 and his lymph nodes in his neck was swollen, had nausea, light-headedness and tiredness. Reported today that before breakfast that he had not eaten or drank anything, and his glands started swelling again. Stated that his left gland was golf ball size and anytime he eats that it swells again. Both palms of his hands felt like needles and his face gets extremely hot. His hands felt like needles started at noon and went away in 30 minutes. Adverse event did not require a 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.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: nausea; lightheadedness; tiredness; palms of his hands felt like needles; face gets extremely hot; Lymph nodes in his neck was swollen/Glands started swelling again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 15:00 (Batch/Lot number: unknown) at the age of 54 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, Lot Number: Unknown , Route: injection , Anatomical Location: left arm , First dose that he had left arm soreness 4-6 hours after the injection. , He used Tylenol and Ibuprofen every couple of hours and alternated it for left arm soreness.), administration date: Feb2021, for covid-19 immunisation, reaction(s): "Left arm soreness". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 09May2021 08:00, outcome "not recovered", described as "Lymph nodes in his neck was swollen/Glands started swelling again"; PAIN IN EXTREMITY (non-serious) with onset 10May2021 12:00, outcome "recovered" (10May2021 12:30), described as "palms of his hands felt like needles"; FEELING HOT (non-serious) with onset 09May2021 08:00, outcome "recovered" (10May2021), described as "face gets extremely hot"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; DIZZINESS (non-serious), outcome "unknown", described as "lightheadedness"; FATIGUE (non-serious), outcome "unknown", described as "tiredness". Therapeutic measures were not taken as a result of lymphadenopathy, pain in extremity, feeling hot, nausea, dizziness, fatigue.  Additional information: The patient had the second dose on 11Mar2021 and his lymph nodes in his neck was swollen, had nausea, light-headedness and tiredness. Reported today that before breakfast that he had not eaten or drank anything, and his glands started swelling again. Stated that his left gland was golf ball size and anytime he eats that it swells again. Both palms of his hands felt like needles and his face gets extremely hot. His hands felt like needles started at noon and went away in 30 minutes. Adverse event did not require a 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: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspepsia, Fatigue, Headache, Menstrual disorder
Clinical narrative: noticed an increase in heart burn; Period changes; headaches; tiredness; nausea; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: EW0172) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: adhesives" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: latex; "Known allergies: Nutmeg" (unspecified if ongoing), notes: Known allergies: Nutmeg; "Known allergies: Ginger, cinnamon, turmeric, all spice" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "IMMUNE difficulties" (unspecified if ongoing); "Constipation" (unspecified if ongoing); "malabsorption" (unspecified if ongoing); "Digestive issues" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Hypoglycemia" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; STOOL SOFTENER; MULTI VITAMIN & MINERAL. Past drug history included: Hycosan, reaction(s): "Known allergies: Hyposam", notes: Known allergies: Hyposam; Ciprofloxacin, reaction(s): "Known allergies: Ciprofloxacin", notes: Known allergies: Ciprofloxacin. The following information was reported: DYSPEPSIA (non-serious) with onset Mar2021, outcome "unknown", described as "noticed an increase in heart burn"; MENSTRUAL DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "Period changes"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "joint pain".  Additional information: The patient had headaches, tiredness, nausea, joint pain and have also noticed an increase in heart burn since her first shot in March, and period changes as well. The patient was diagnosed with Covid 19 prior to the vaccination and not tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: noticed an increase in heart burn; Period changes; headaches; tiredness; nausea; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: EW0172) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: adhesives" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: latex; "Known allergies: Nutmeg" (unspecified if ongoing), notes: Known allergies: Nutmeg; "Known allergies: Ginger, cinnamon, turmeric, all spice" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "IMMUNE difficulties" (unspecified if ongoing); "Constipation" (unspecified if ongoing); "malabsorption" (unspecified if ongoing); "Digestive issues" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Hypoglycemia" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; STOOL SOFTENER; MULTI VITAMIN & MINERAL. Past drug history included: Hycosan, reaction(s): "Known allergies: Hyposam", notes: Known allergies: Hyposam; Ciprofloxacin, reaction(s): "Known allergies: Ciprofloxacin", notes: Known allergies: Ciprofloxacin. The following information was reported: DYSPEPSIA (non-serious) with onset Mar2021, outcome "unknown", described as "noticed an increase in heart burn"; MENSTRUAL DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "Period changes"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "joint pain".  Additional information: The patient had headaches, tiredness, nausea, joint pain and have also noticed an increase in heart burn since her first shot in March, and period changes as well. The patient was diagnosed with Covid 19 prior to the vaccination and not tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: she received when got vaccine such as chills, a headache; She says she is also experiencing dizzy spells which are not listed.; Tiredness; Aches; She says her left arm was painful when she got the vaccine; it is still sore now but it is not as painful; she received when got vaccine such as chills, a headache; 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 received bnt162b2 (BNT162B2), administered in arm left, administration date 08May2021 11:30 (Lot number: EW0173) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "anxiety" (unspecified if ongoing), notes: she just takes anxiety and depression medications but she would rather leave them out.; "depression" (unspecified if ongoing), notes: she just takes anxiety and depression medications but she would rather leave them out. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, lot number: EW0164, Expire Date: Unknown, Time: 2:30pm, anatomical location: left arm), administration date: 18Apr2021, for COVID-19 immunisation, reaction(s): "painful arm and tiredness", "painful arm and tiredness"; Flu vaccine (she had a reaction to the flu vaccine years ago and her reaction was full on flu for about 2 weeks.), for immunisation, reaction(s): "she got the full on flu". The following information was reported: CHILLS (non-serious), outcome "unknown", HEADACHE (non-serious) with onset 08May2021, outcome "recovered" (10May2021) and all described as "she received when got vaccine such as chills, a headache"; DIZZINESS (non-serious) with onset 09May2021, outcome "not recovered", described as "She says she is also experiencing dizzy spells which are not listed."; PAIN IN EXTREMITY (non-serious) with onset 08May2021, outcome "recovering", described as "She says her left arm was painful when she got the vaccine; it is still sore now but it is not as painful"; FATIGUE (non-serious) with onset 08May2021 11:45, outcome "recovering", described as "Tiredness"; PAIN (non-serious) with onset 08May2021, outcome "recovered" (10May2021), described as "Aches".  Additional information: Prior to vaccination patient had a reaction to the flu vaccine years ago. She says it was a long time ago. She does not know the lot number, NDC number, or expiration date for that flu shot. She says her reaction was that she got the full on flu for about 2 weeks.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she received when got vaccine such as chills, a headache; She says she is also experiencing dizzy spells which are not listed.; Tiredness; Aches; She says her left arm was painful when she got the vaccine; it is still sore now but it is not as painful; she received when got vaccine such as chills, a headache; 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 received bnt162b2 (BNT162B2), administered in arm left, administration date 08May2021 11:30 (Lot number: EW0173) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "anxiety" (unspecified if ongoing), notes: she just takes anxiety and depression medications but she would rather leave them out.; "depression" (unspecified if ongoing), notes: she just takes anxiety and depression medications but she would rather leave them out. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, lot number: EW0164, Expire Date: Unknown, Time: 2:30pm, anatomical location: left arm), administration date: 18Apr2021, for COVID-19 immunisation, reaction(s): "painful arm and tiredness", "painful arm and tiredness"; Flu vaccine (she had a reaction to the flu vaccine years ago and her reaction was full on flu for about 2 weeks.), for immunisation, reaction(s): "she got the full on flu". The following information was reported: CHILLS (non-serious), outcome "unknown", HEADACHE (non-serious) with onset 08May2021, outcome "recovered" (10May2021) and all described as "she received when got vaccine such as chills, a headache"; DIZZINESS (non-serious) with onset 09May2021, outcome "not recovered", described as "She says she is also experiencing dizzy spells which are not listed."; PAIN IN EXTREMITY (non-serious) with onset 08May2021, outcome "recovering", described as "She says her left arm was painful when she got the vaccine; it is still sore now but it is not as painful"; FATIGUE (non-serious) with onset 08May2021 11:45, outcome "recovering", described as "Tiredness"; PAIN (non-serious) with onset 08May2021, outcome "recovered" (10May2021), described as "Aches".  Additional information: Prior to vaccination patient had a reaction to the flu vaccine years ago. She says it was a long time ago. She does not know the lot number, NDC number, or expiration date for that flu shot. She says her reaction was that she got the full on flu for about 2 weeks.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: little dizzy; 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 male patient received bnt162b2 (BNT162B2), administration date 07Feb2021 (Lot number: EL9264) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "kidney stones" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "little dizzy". No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pain
Clinical narrative: My arm is like really sore at the vaccination site, on my right arm; It is still sore;; My whole right arm is swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Apr2021 (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: VACCINATION SITE PAIN (non-serious) with onset 10May2021 12:00, outcome "unknown", described as "My arm is like really sore at the vaccination site, on my right arm; It is still sore;"; PERIPHERAL SWELLING (non-serious) with onset 10May2021 12:00, outcome "unknown", described as "My whole right arm is swollen".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Illness, Inappropriate schedule of product administration, Influenza
Clinical narrative: Inappropriate schedule of vaccine administered; sick; don't have appetite; cold flu; headache; The initial case was missing the following minimum criteria: [specify criteria (e.g., no suspect product)]. Upon receipt of follow-up information on [29Jun2021], this case now contains all required information to be considered valid. 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), administration date 24May2021 (Lot number: EW0179) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "inflamed ulcer" (unspecified if ongoing); "colon problems" (unspecified if ongoing); "colon procedure", start date: 26Mar2021 (unspecified if ongoing); "bowel obstruction", start date: 1990 (unspecified if ongoing); "nervousness" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "stomach problems" (unspecified if ongoing); "trembling" (unspecified if ongoing); "diabetic" (unspecified if ongoing), notes: My concern is I am 80 and diabetic,. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number-1), administration date: 07May2021, when the patient was 75 years old, for Covid-19 immunization, reaction(s): "sick". The following information was reported: ILLNESS (non-serious) with onset May2021, outcome "unknown", described as "sick"; DECREASED APPETITE (non-serious) with onset May2021, outcome "unknown", described as "don't have appetite"; INFLUENZA (non-serious) with onset May2021, outcome "unknown", described as "cold flu"; HEADACHE (non-serious) with onset May2021, outcome "unknown", described as "headache"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 24May2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered".  Additional information: It was reported that, consumer stated ok I am trying to get help, I have been sick after getting the shot, maybe I am calling the wrong place, I have get both of my shots. Consumer stated, I am trying to get to the doctor the find out because I have been sick for 2 weeks. Consumer stated, My concern is I am 80 and diabetic, I am not eating I don't have appetite, it's like the cold flu, it's like the flu that's what I am saying, headache, I was already sick when I took the shot. Consumer stated, I would like to say thanks that I am alive today, I have been able to witness. I have been going through a lot of different sicknesses but I have gone through them and do the right thing.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: minimum pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 42 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: PAIN (non-serious), outcome "unknown", described as "minimum pain". Therapeutic measures were taken as a result of pain.  Additional information: The patient had cold compress to ease the pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient's parent). A 16-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 16, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), at the age of 16, for COVID-19 immunization. The patient experienced dizziness and vertigo, with outcome of unknown. No follow-up attempts needed. information about batch/lot number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09May2021 09:30 (Lot number: EW0170) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "alcohol, to slow her drinking" (ongoing), notes: alcohol, to slow down her drinking. Concomitant medication(s) included: BACLOFEN taken for alcoholism (ongoing). Vaccination history included: Bnt162b2 (Dose number: 1, Anatomical Location: Right Arm, Batch/lot number: EW0161), administration date: 18Apr2021, for covid-19 immunization, reaction(s): "soreness in arm after first dose". The following information was reported: NAUSEA (non-serious) with onset 11May2021 08:00, outcome "not recovered", described as "nausea"; VOMITING (non-serious) with onset 11May2021 08:00, outcome "not recovered", described as "vomiting".  Additional information: The reporter was asking could this be a side effect of the vaccine or the Baclofen. Baclofen: started 6-9 months ago, more towards 9 months. The dose changes every other week. They increase it. Each pill is 20 mg, and he thinks she is taking about 125 mg daily. The patient had not visited the Emergency Room or her Primary Medical Doctor, they thought it would go away by now. Nausea and throwing up started Tuesday, 11May2021, and it continues, it was worse. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was no.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: she had issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 46 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 46 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 (1st dose), for Covid-19 immunization.  The following information was reported: ADVERSE DRUG REACTION (non-serious), outcome "unknown", described as "she had issues".  Additional information: The patient's side effects following second dose , fine during the first, and the second when she had issues. It was reported that, it was fine now, normal stuff, and was over.  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: sore arm; 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), administration date 2021 (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: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm".  Additional information: They both got their COVID vaccine first shots 2 weeks ago. He had nothing but a sore arm. His wasn't sore past a day. number and expiry date were not reported. The report is cross referenced to report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 29-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EP6955), at the age of 29, in left arm, on Mar 26, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had pain in extremity/arm hurt, onset Mar 26, 2021, with outcome of recovered. Additional information: No prior vaccinations (within 4 weeks). No AE(s) following prior vaccinations. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Shivering/Teeth chattering; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: EW0176) 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: CHILLS (non-serious), outcome "unknown", described as "Shivering/Teeth chattering".  Additional information: Patient got the vaccine (Covid-19 Vaccine) earlier today patient was received first shot and it was around 4 O'clock and now it was 2:30 in the morning but like 30 minutes ago patient started like patient don't know patient just had a bunch of shivering but patient wasn't patient not had cold or hot, it was weird it just like patient teeth was chattering. Patient don't know if it was normal but it was a lot.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Pain in extremity
Clinical narrative: Arm hurts; When she touched it it hurts.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Apr2021 09:00 (Lot number: ER8731) at the age of 29 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 (1st dose, Lot No: EP6955, Expiry date: unknown, Left arm), administration date: 26Mar2021, when the patient was 29 years old, for Covid-19 immunization, reaction(s): "Arm hurts". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm hurts"; HYPERAESTHESIA (non-serious), outcome "unknown", described as "When she touched it it hurts." Additional information: The patient took Pfizer COVID vaccine as her decision because of her girl. The Vaccination Facility Type: a place where people were getting it in, a big building. 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. The events did not cause healthcare professional office/ Emergency room. Patient received no other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. The patient did not have any AE(s) following prior vaccinations and no Medical History (including any illness at time of vaccination). The patient did not have diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes). The patient did not have any Family Medical History Relevant to AE(s) and Relevant Tests.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: First shot i had severe flu like symptoms and extreme structural pain for 4 days.; First shot i had severe flu like symptoms and extreme structural pain for 4 days.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 17:30 (Lot number: ER8127) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "All mammal meat (and products derived) including chicken, pork, turkey, beef and all land animals." (unspecified if ongoing), notes: All mammal meat (and products derived) including chicken, pork, turkey, beef and all land animals. There were no concomitant medications. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), PAIN (non-serious), outcome "recovered" (2021) and all described as "First shot i had severe flu like symptoms and extreme structural pain for 4 days.". Therapeutic measures were not taken as a result of influenza like illness, pain.  Additional information: Facility type vaccine was doctors office/urgent care. Patient not received other vaccine in four weeks. No other medications in two weeks. No treatment for ae. No covid prior vaccination. Covid was not tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site hurt worse with the first shot than the 2nd dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 82 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site hurt worse with the first shot than the 2nd dose".  Additional information: Caller stated her Mother's injection site hurt worse with the first shot than the 2nd dose, she felt it was the technique of the person giving the injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Illness
Clinical narrative: really sick/very sick; My eyeballs hurt; 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), administration date 24Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lung cancer" (unspecified if ongoing); "Lung cancer surgery" (unspecified if ongoing), notes: she had Lung Cancer surgery last year. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "really sick/very sick"; EYE PAIN (non-serious), outcome "unknown", described as "My eyeballs hurt".  Addition information: The reporter stated that she had the first dose of the vaccine and was very sick from it, she had all of the side effects that were listed, she was sick for a couple of weeks. She was really sick.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Varicose vein, Vascular pain
Clinical narrative: The veins also ached; all of the veins in my right arm (the one that received the injection) had swollen up and were very prominent; This is a spontaneous report received from 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 right, administration date 20Apr2021 17:30 (Lot number: ER8735) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Prolactinoma" (unspecified if ongoing); "Allergy: Bees" (unspecified if ongoing); "Allergy: cats" (unspecified if ongoing); "Allergy: scorpions" (unspecified if ongoing); "Allergy: spider bites" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Batch/lot number: ER8730    , Date of start of drug: 23Mar2021 04:30 PM , Anatomical Location: Arm Left    , Dose Number: 1), administration date: 23Mar2021, when the patient was 43 years old, for Covid-19 Immunization. The following information was reported: VASCULAR PAIN (non-serious) with onset 20Apr2021 17:45, outcome "recovered" (20Apr2021 21:30), described as "The veins also ached"; VARICOSE VEIN (non-serious) with onset 20Apr2021 17:45, outcome "recovered" (20Apr2021 21:30), described as "all of the veins in my right arm (the one that received the injection) had swollen up and were very prominent". Therapeutic measures were not taken as a result of vascular pain, varicose vein.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.