chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: soreness; her bowels were a little iffy; Feeling Ill; rumbling bowels; diarrhea; upset stomach; nausea; vomiting; accelerated heart rate; dizziness; fever; chills; This is a spontaneous report from a contactable consumer. A 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK8730; Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 14:45 at SINGLE DOSE for covid-19 immunisation. Medical history included arthropod sting, hypersensitivity, sinus disorder, hypertension, blood cholesterol, covid-19.C oncomitant medications included fluticasone taken for hypersensitivity, sinusitis; hydrochlorothiazide, lisinopril taken for hypertension, simvastatin taken for blood cholesterol. The patient previously took z-pak. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No visit to emergency room and physician office. No patient's medical history (including any illness at time of vaccination), relevant tests and family medical history. On 25Mar2021, the patient experienced had minimal soreness, no discomfort, 26Mar2021, she awoke with accelerated heart rate, upset stomach, rumbling bowels, and ran to the bathroom and vomited. Then she had diarrhea. Eventually her heart rate slowed, it was elevated for a while and slowed to normal that morning. she had 6-7 episodes of each- the vomiting and the diarrhea. In between those episodes, she had chills, dizziness, then fever. It rolled along, then her heart rate gradually slowed down. Her symptoms stopped after 2-3 rounds of diarrhea episodes. Her chills came on after she experienced accelerated heart rate. The chills stopped after the first or second throwing up/diarrhea episodes. She had brief dizziness following that. She had a couple or one more episode of throwing up and diarrhea. She got warm, calling it a fever and it did not last long. She has a tendency to get dizziness and takes Flonase to keep her allergies at bay. She thinks the dizziness this time went along with her chills and fever. On 27Mar2021, her stomach had a little discomfort, but nothing major. On 28MAr2021, 02:45 she awakened feeling ill and though she might vomit. It ended up being diarrhea and had 3 episodes of that, spaced out. It was over at 09:00. On 29Mar2021, her stomach was queasy and it went away by evening. On 1Apr2021, she had been experiencing tummy aches, taking Tums and her bowels were a little iffy. Therapeutic measures were taken for dizziness with Flonase. The outcome of the events nausea, vomiting, diarrhea, upset stomach, soreness and abdominal discomfort were unknown and events accelerated heart rate, dizziness, fever, chills and illness were recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Neoplasm skin, Peripheral swelling
Clinical narrative: lump on her arm/a small lump; lump on her arm that was red and swollen; lump on her arm that was red and swollen; This is a spontaneous report from a Pfizer sponsored program, from a contactable nurse and consumer. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  Patient stated got the second covid vaccine and got a lump on her arm that was red and swollen its been about a week and there was a small lump there. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: did not feel well; severe chills; felt feverish; achy; This is a spontaneous report received from a contactable consumer. A 56-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration In the left arm on 12Apr2021 09:30 AM at single dose for COVID-19 Immunization. Medical history was unknown. The patient had no allergies to medications, food, or other products. Concomitant medications included caffeine/paracetamol (EXCEDERIN) and zolmitriptan (ZOMIG). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Mar2021 at 56 years old for COVID-19 Immunization. Approximately 14 hours after inject to about 19 hours after inject, the patient intermittently had severe chills, felt feverish, also was achy and did not feel well from 12Apr2021 11:30 PM. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.Outcome of the events was recovered. This report was reported as non-serious.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis, Tongue discomfort
Clinical narrative: sores in my mouth; my tongue felt like I burned it; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 09Apr2021 at 15:00 (Batch/Lot Number: ER8737) as a single dose for COVID-19 immunization. Medical history included no medication or food allergies, but the patient did reach mildly to insect bites. The patient swells up more than normal, but not strong enough to need medical attention. Concomitant medications included multivitamins; no other vaccine in four weeks. The patient was not tested post vaccination. The day after the vaccine, on 10Apr2021 at 12:00PM, the patient's tongue felt like she burned it and 3 days after the vaccine (12Apr2021), she had sores in her mouth. No treatment was administered for the events. The events resolved on an unspecified date in Apr2021.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: tired; headache; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 05Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 62 years). Medical history included fibromyalgia. Concomitant medication included etanercept (ENBREL). The patient experienced tired and headache on 05Apr2021 12:00. The patient's hospitalization was prolonged as a result tired and headache on an unspecified date. The patient underwent lab tests and procedures which included Nasal Swab: unknown on 13Apr2021. Patient is not pregnant. Outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Depression, Emotional distress, Pain in extremity
Clinical narrative: sore arm; distressed; depressed; This is a spontaneous report from a contactable consumer (patient). This 81-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Apr2021 at single dose for COVID-19 Immunization. Medical history included covid headaches and arthritis. Concomitant medications included prednisone acetate, supplements and vitamins. The patient had the Monoclonal waited 90 days to get the first dose, but never got antibodies from the monoclonal. The patient had covid headaches. She didn't have the headaches since she got the vaccine. She felt better all around: mentally, physically. She was still not going out. She hadn't felt this good since last year. She had no reaction after her first dose just a sore arm. The patient was scheduled to get second Covid shot later than 21 days after the first on 30Apr2021, marked for 03May2021. She was told there was a 4 day window. She asked if this was true. She was concerned about the second covid vaccine shot timeline. She needed to know she will be okay. She was housebound and was going crazy. She was so distressed/depressed and needed to get out of here. Once she got the second shot she can leave and see her grandchildren and children. It was not fair that she was scheduled for 03May2021. It was supposed to be 21 days after and she was very upset. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sluggishness
Clinical narrative: Fever; Feeling sluggish; This is a spontaneous report from a contactable consumer. A 6-decade-old (mid-to-late 50s) male patient (brother-in-law) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 08Apr2021 at approx. 14:55 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) as a single dose for COVID-19 immunisation. The next day, 09Apr2021, he had a fever and was feeling sluggish. The outcome of the events was recovered on 10Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Lethargy, Pain, Pyrexia
Clinical narrative: Fever; Extreme body aches; headache; lethargy; earache; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received second dose of BNT162B2 (BNT162B2; Lot number and expiry date not available), via an unspecified route of administration, in left arm on 08Apr2021 at 18:00 (at the age of 31-year-old) as a single dose for COVID-19 immunization. Medical history included sickle cell trait. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Lot number and expiry date not reported), via an unspecified route of administration, in left arm on 18Mar2021 at 18:00 as a single dose for COVID-19 immunization. The patient had no known allergies. The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced fever, extreme body aches, headache, lethargy and earache on 09Apr2021. The events were reported as non-serious. The patient underwent lab tests and procedures which included nasal swab test: unknown results. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number can be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever; Extreme body aches; headache; lethargy; earache; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received second dose of BNT162B2 (BNT162B2; Lot number and expiry date not available), via an unspecified route of administration, in left arm on 08Apr2021 at 18:00 (at the age of 31-year-old) as a single dose for COVID-19 immunization. Medical history included sickle cell trait. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Lot number and expiry date not reported), via an unspecified route of administration, in left arm on 18Mar2021 at 18:00 as a single dose for COVID-19 immunization. The patient had no known allergies. The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced fever, extreme body aches, headache, lethargy and earache on 09Apr2021. The events were reported as non-serious. The patient underwent lab tests and procedures which included nasal swab test: unknown results. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number can be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: chills; feeling fatigue; This is a spontaneous report from a Pfizer sponsored program. A contactable male consumer (patient) reported that a male patient of unspecified age received BNT162B2 first dose on 24Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had his 1st dose of the Pfizer Covid-19 vaccine 18 days ago(24Mar2021) and is scheduled to return for his 2nd dose on 14Apr2021. He mentioned that after getting the 1st shot, at first he experienced no adverse events but later on he started to have chills and feeling fatigue. He wants to know if these are normal. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: armpit was swollen; This is a spontaneous report from a contactable consumer (patient's cousin). An adult male patient in in his late 40s / early 50s received BNT162B2 at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient experienced armpit was swollen after receiving his first COVID-19 shot. Outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she has been very sick since yesterday; This is a spontaneous report from a Pfizer- sponsored program. A contactable female consumer (patient) reported for herself that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Apr2021 single dose for COVID-19 immunization. Medical history included COVID positive before at around 05Jun2020. The patient had 1st dose of BNT162B2 on 18Mar2021 for COVID-19 immunization. The patent has been very sick since yesterday (10Apr2021). She said she was feeling this same symptom when she was a COVID-19 positive. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Very sore injection site, chills, fever (100.7), fatigue for about 14 hours starting about 16 hours after injection.; Very sore injection site, chills, fever (100.7), fatigue for about 14 hours starting about 16 hours after injection.; Very sore injection site, chills, fever (100.7), fatigue for about 14 hours starting about 16 hours after injection.; Very sore injection site, chills, fever (100.7), fatigue for about 14 hours starting about 16 hours after injection.; This is a spontaneous report from a contactable consumer. A 54-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: Er8735), via an unspecified route of administration, administered in Left Arm on 08Apr2021 16:30 as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: En6208) for covid-19 immunization. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 09Apr2021 08:30, It was reported that, very sore injection site, chills, fever (100.7), fatigue for about 14 hours starting about 16 hours after injection. Therapeutic measures was not taken. The outcome of event was recovered/resolved.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Soreness; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number and expiration date were not reported), via an unspecified route of administration on 09Apr2021 at single dose for COVID-19 immunization. Medical history included back pain. Concomitant medication included paracetamol (TYLENOL) taken for back pain. The patient experienced soreness on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Pain in extremity
Clinical narrative: Sore Arm; This is a spontaneous report from a contactable consumer reported for herself. This 61-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) via an unspecified route of administration In the left upper arm on 20Mar2021 09:35 AM at single dose for COVID-19 Immunization. Medical history included migraines and family history of migraines. Concomitant medications was unknown. The patient stated that she had only a sore arm on 20Mar2021 after the first dose of the vaccine. The patient said started the day of the vaccine and lasted for a couple of days then it was gone. The patient had a CT Scan of her sinuses and throat; about a week or so ago; had not received any results. The patient had no prior vaccinations (within 4 weeks). Outcome of the event was recovered.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: Heart Palpiations; elevated resting heart rate; This is a spontaneous report from a contactable consumer reported for herself. This 31-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150) via an unspecified route of administration In the right arm on 07Apr2021 12:45 PM at single dose for COVID-19 Immunization. Medical history included migraine. Family history of penicillin allergy. Concomitant medications included folic acid supplement. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced heart palpitations/elevated resting heart rate on 07Apr2021 12:45 AM. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 50-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 17:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced elevated temperature, body aches, fatigue on 09Apr2021 16:00. Outcome of event was recovering. No treatment received.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve injury, Pain in extremity, Paraesthesia, Vaccination site erythema, Vaccination site pain
Clinical narrative: sore arm; more of a tingle/tingling arm; like a nerve, maybe she hit a nerve; injection site pain; injection site swelling; injection site redness; This is a spontaneous report from a contactable consumer (husband). A 79-year-old female patient (unknown pregnant at time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 in the arm as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in 2021 as single dose for COVID-19 immunization. On unspecified date, patient still had a sore arm, she just wanted to shake it, more of a tingle, like a nerve, maybe she hit a nerve. Patient saw her PCP doctor last week (Apr2021) and she was told that it sometimes happened. Patient experienced tingling arm 1 month after 2nd injection. She also experienced injection site pain, injection site swelling or redness on unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: sore arm; more of a tingle/tingling arm; like a nerve, maybe she hit a nerve; injection site pain; injection site swelling; injection site redness; This is a spontaneous report from a contactable consumer (husband). A 79-year-old female patient (unknown pregnant at time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 in the arm as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in 2021 as single dose for COVID-19 immunization. On unspecified date, patient still had a sore arm, she just wanted to shake it, more of a tingle, like a nerve, maybe she hit a nerve. Patient saw her PCP doctor last week (Apr2021) and she was told that it sometimes happened. Patient experienced tingling arm 1 month after 2nd injection. She also experienced injection site pain, injection site swelling or redness on unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report received from a non-contactable consumer (patient). This 25-year-old female patient receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 08Apr2021 at 03:00 PM (lot unknown) as single dose at Right arm for COVID-19 immunization. The patient did not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Medical history and concomitant medications were not reported. The patient experienced Nausea, vomiting, fever, chills, headache on 02Apr2021. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was Not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Vaccination site pain
Clinical narrative: soreness at injection site; fatigue; joint pain; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant at time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 at 14:15 (lot number: ew0162) on the left arm as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]) and loratadine that received within 2 weeks of vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Mar2021 at 14:15 (lot number: er2613) on the left arm as single dose for COVID-19 immunization; and on 19Mar2021, patient experienced injection site pain and soreness, fatigue, extreme thirst. Patient previously also took codeine family and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021, patient experienced soreness at injection site, fatigue, joint pain. There was no treatment received for the adverse event. The outcome of the events was recovered on unspecified date.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site bruising, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Lemon size knot at site very red and hot to touch; Lemon size knot at site very red and hot to touch; Lemon size knot at site very red and hot to touch, bruiseing around edges hurts down arm; Lemon size knot at site very red and hot to touch, bruiseing around edges hurts down arm; This is spontaneous report from a contactable consumer (patient). A 44-year-old female patient (not pregnant at the time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Apr2021 at 12:00 (Lot number: Ep7533) on the left arm as single dose for COVID-19 immunization. Medical history included allergies to Msg. There were no concomitant medications that no other medications the patient received within 2 weeks of vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 at 12:00 (Lot number: En6207) on the left arm as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient did not test for COVID-19. On 10Apr2021 at 10:00, patient experienced lemon size knot at site very red and hot to touch, bruising around edges hurts down arm. There was no treatment received for the adverse events. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Depression, Emotional distress, Fatigue, Insomnia
Clinical narrative: Severe depression; anxiety; deep emotional distress; Fatigue; Insomnia; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Apr2021 (Lot number: ER8735) on the right arm as single dose for COVID-19 immunization. Medical history included ADHD, hypothyroidism. No Allergies. Concomitant medication included lisdexamfetamine mesilate (VYVANSE). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 (Lot number: EP7534) on the right arm as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient did not test for COVID-19. The patient did not have covid prior vaccination and did not have covid tested post vaccination. On 09Apr2021, patient experienced severe depression, anxiety, deep emotional distress, fatigue, insomnia. Events resulted in Doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse events. The outcome of events was not recovered. This report was assessed by the reporting consumer as non-serious.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Patient received 2nd dose of the covid vaccine and was still experiencing nausea on unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Avulsion fracture, Dermatitis, Eczema, Erythema, Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer. A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 05Feb2021 or 08Feb2021 as single dose to help prevent and make the caller immune (COVID-19 immunization). Medical history included blood pressure high diagnosed 15 years ago, high cholesterol diagnosed 10 years ago. The patient's concomitant medications were none. Historical vaccine included BNT162B2, first dose, received 2 weeks prior to the second dose. The patient has developed a skin condition since she has had her second dose of the vaccine, it came up about 3-4 days after it. She had the skin condition in her hairline and eye, it is improved but when she comes off of the cream it comes back, it is starting to get red again, flake and itch. She received the second dose of the vaccine on 05Feb2021 or 08Feb2021 the skin condition showed up in the following week. She applied a cortisone cream before contacting her doctor and the skin condition was still there, unknown lot or expiration date as she finished the tube and threw it out. The patient thought she had eczema and her doctor thought it may be dermatitis. She has been doing and antibiotic ointment and cortisone cream and the skin condition is still there and irritating. She has never had any skin conditions before. The caller's doctor recommended another cortisone cream but he didn't want her to use it more than a week or a week and a half. She discontinued it yesterday because she has been on it so long. Hydrocortisone cream 1% over the counter- lot 9736488T1, expiration date Jan 2022. The antibiotic cream the caller's doctor prescribed is Ketoconazole 2% cream, lot REVA9-2018, expiration date Oct 2022. Treatment received. Outcome was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: This is a spontaneous report from a contactable consumer. A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 05Feb2021 or 08Feb2021 as single dose to help prevent and make the caller immune (COVID-19 immunization). Medical history included blood pressure high diagnosed 15 years ago, high cholesterol diagnosed 10 years ago. The patient's concomitant medications were none. Historical vaccine included BNT162B2, first dose, received 2 weeks prior to the second dose. The patient has developed a skin condition since she has had her second dose of the vaccine, it came up about 3-4 days after it. She had the skin condition in her hairline and eye, it is improved but when she comes off of the cream it comes back, it is starting to get red again, flake and itch. She received the second dose of the vaccine on 05Feb2021 or 08Feb2021 the skin condition showed up in the following week. She applied a cortisone cream before contacting her doctor and the skin condition was still there, unknown lot or expiration date as she finished the tube and threw it out. The patient thought she had eczema and her doctor thought it may be dermatitis. She has been doing and antibiotic ointment and cortisone cream and the skin condition is still there and irritating. She has never had any skin conditions before. The caller's doctor recommended another cortisone cream but he didn't want her to use it more than a week or a week and a half. She discontinued it yesterday because she has been on it so long. Hydrocortisone cream 1% over the counter- lot 9736488T1, expiration date Jan 2022. The antibiotic cream the caller's doctor prescribed is Ketoconazole 2% cream, lot REVA9-2018, expiration date Oct 2022. Treatment received. Outcome was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash on side of body shingles like; Rash on side of body shingles like; This is a spontaneous report received from a non-contactable consumer. A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 06Apr2021 14:00 as single dose for covid-19 immunization in pharmacy or drug store. The patient medical history and concomitant medications were not reported. No Pregnancy.Prior to vaccination,  the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included Covid-19 vaccine, dose 1 for covid-19 immunisation. The patient experienced rash on side of body shingles like on 10Apr2021 with outcome of not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever 100 degrees F; This is a spontaneous report from a contactable consumer (parent). A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown), via an unspecified route of administration in left arm on 12Apr2021 at 09:15 (at the age of 36-year-old) as a single dose for COVID-19 immunization. The patient's medical history included hypertension. The patient did not have allergies to medications, food, or other products. Concomitant medication included lisinopril received within 2 weeks of vaccination at 40 mg, once a day. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown) on 22Mar2021 in left arm as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced fever 100 degrees F on 12Apr2021 at 13:00. The patient underwent lab test and procedure which included body temperature: 100 degrees F on 12Apr2021. No treatment medication was received for the adverse event. The outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Pain, Somnolence
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. After reporter got the 2nd shot of the Pfizer COVID-19 vaccine, she had 48 hours of flu like symptoms, aching, extremely fatigued, headache that went away, just like someone opened the blinds, very quickly, 5 weeks from last shot, she got the same symptoms and they lasted for 7 days. Reporter could do nothing, went from the couch to the bed, ached all over. Reporter went to urgent care, had two swabs in 48 hours, negative for COVID-19 swabs one done on Thursday and Saturday went to urgent care and both were negative. Her friend(patient) is experiencing the same thing. Reporter thought maybe she got another bug, patient started to tell reporter that hers came back after 9 weeks after. Patient is 70, she is not doing well, every time she sits down she falls asleep. It's like something gets triggered.  Reporter is going to encourage her friend to report this as well. Outcome for events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02Apr2021 14:10 (Lot number FR8733 or ER8733) as SINGLE DOSE for covid-19 immunization. Medical history included ongoing High cholesterol, ongoing COPD, ongoing to help his blood circulation. Prior Vaccinations (within 4 weeks) was None. The patient received first dose of bnt162b2 (lot number: EN6199 or FN6199) on 05Mar2021 14:10 Intramuscular in left arm for COVID-19 Immunization. Concomitant medication(s) included atorvastatin taken for High cholesterol from an unspecified start date (for years) and ongoing; budesonide, formoterol fumarate (SYMBICORT) taken for chronic obstructive pulmonary disease from an unspecified start date (for about a year, maybe more than that) and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken To help his Blood circulation from an unspecified start date (for at least 10 years) and ongoing. The patient experienced dizziness on 04Apr2021 after his second Pfizer COVID-19 vaccination shot and it has lasted approximately 7-8 days. The event did not require a visit to Emergency Room or Physician Office. The outcome was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anaesthesia, Hypoaesthesia, Pain in extremity
Clinical narrative: she did not have much pain in her arm; sometimes feels like arm is numb; kind of like it is under anesthesia, from the site of injection until her pinky on the left side; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (Batch/Lot Number: Not Provided) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient did not have much pain in her arm but she sometimes felt like her arm was numb, kind of like it was under anesthesia, from the site of injection until her pinky on the left side.  It comes and goes.  Sometimes she did not feel anything, sometimes it felt numb again. The outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Soreness at injection site 12 hrs later; Fever; headache; chills; muscle aches; This is a spontaneous report from a non-contactable consumer (patient). A 25-years-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11Apr2021 (Lot Number: En6208,) as SINGLE DOSE, for covid-19 immunisation. The patient medical history was not reported. There was no other vaccine in four weeks or other medications in two weeks. There was no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient received first dose of bnt162b2 via an unspecified route of administration, administered in Arm Left on 21Mar2021 09:30 AM (Lot Number: EN6198) for Covid-19 immunization. The patient experienced soreness at injection site 12 hrs later on 12Apr2021, Fever, chills, headache, muscle ache. The patient received no treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome was recovering.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual discomfort
Clinical narrative: I recently got the vaccine while on my period and I feel that it exacerbated my symptoms; This is a spontaneous report from a contactable consumer reported for self.  This female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation. The patient recently got the vaccine while on period and felt that it exacerbated symptoms. The patient spoke with many of friends and consulted online resources and they all agree. Women who get vaccinated while menstruating have much worse reactions than those who are not. The patient believe you should research this further because it can be really harmful. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: faster heart beats; This is a spontaneous report from the Pfizer-sponsored program Pfizer via a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 31Mar2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was asking whether the second dose was supposed to be on 21Apr2021. She was also asking whether it was alright to receive the second dose of the vaccine after experiencing faster heart beats after being given the first dose of the vaccine. Outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Severe leg (confined to the thigh/quad area) muscle pain; This is a spontaneous report received from a non-contactable consumer (patient). This 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EP7534) via unspecified route of administration in left arm on 30Mar2021 at single dose for COVID-19 immunization. Medical history included strong seasonal allergies, eosinophilic esophagitis. No known allergies to medications, food, or other products. Concomitant medications were not provided. On 04Apr2021, the patient experienced severe leg (confined to the thigh/quad area) muscle pain following a routine run 3 days after the injection. The intense pain worsened over the subsequent days peaking at about 6 days from onset when the right leg suddenly got better leaving the left still in extreme pain. At 8 days from onset the pain slowly started to subside. Patient was still in moderate pain at day 10 from onset. Over the counter pain meds were not effective, so patient tried 50mgs tramadol, also not effective, 200mgs celecoxib 2x/day brought some relief. This report was assessed as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood blister
Clinical narrative: Blood Blisters; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.On an unspecified date, the patient experienced blood blisters after receiving her first dose of the Covid-19 Vaccine. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue
Clinical narrative: exhaustion; stomach upset; This is a spontaneous report from a contactable consumer. A 80-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. He received his second dose also on Saturday and experienced exhaustion afterwards. He told me that he had a similar reaction and stomach upset on 11Apr2021 for about a day after the first dose. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021406911 same patient/reporter/drug in separate time
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Pain, Vaccination site pain
Clinical narrative: had different aches and pains anyways/ Especially in the arm that he received the covid vaccine in; Body aches; He did notice his arthritis seemed to be more intense; This is a spontaneous report from a contactable consumer (patient). This 74-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Apr2021 at 8:00 AM in left arm at single dose for COVID-19 immunization. Medical history was blood pressure abnormal. No family medical history relevant to events. Concomitant medications included blood pressure medication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Mar2021 at 12:00PM in left arm as single dose for COVID-19 immunization at the age of 73-year. No other prior vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer suspect. Patient received second dose of the covid vaccine on Thursday, 08Apr2021, had body aches on 08Apr2021. It is hard for him to personally know exact dates. Patient had different aches and pains anyways. Especially in the arm that he received the covid vaccine in because he pulled a muscle in that arm. He had issues with that arm before, so it was hard for him to tell. He did notice his arthritis seemed to be more intense on 08Apr2021. He did not have a fever. He was now back to his normal aches and pains. He did not have any medications, medical history or testing to add that he felt was relevant. He was a typical old guy with aches and pains and that sort of thing. This report was assessed as non-serious. The events did not require a visit to Emergency Room or Physician Office. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Exhaustion; This is a spontaneous report from two contactable consumers via the Pfizer representative. An 80-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unknown date via an unknown route for Covid-19 immunization. Medical history and concomitant drug were not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunization and experienced similar reaction of exhaustion and stomach upset for about a day after the first dose. He received his second dose on "Saturday" (unknown date) and experienced exhaustion afterwards. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.