chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Myalgia, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: convulsive chills, fever- (high); convulsive chills; fever- (high); all of my muscles and joints were flaring in extreme pain; all of my muscles and joints were flaring in extreme pain; I could NOT move my vaccine  arm more than 3 inches and my whole body hurt; my vision was extremely blurry; When I tried to walk, it was slow; achy/whole body hurt; tired, and took a nap; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient (no pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) via an unspecified route of administration on the left arm on 05Jan2021 11:00 AM at single dose for COVID-19 immunisation.  Medical history included having Covid the 3rd week in Mar2020, Positive for Antibodies in early May2020. Fairly sick but not emergency situation "Long haulers" covid symptoms that continued through Nov2020. Patient still had skin pain. Other medical history included hashimoto's. Past drug event included known allergy to codeine. The patient's concomitant medications included 25 mg of Levothyroxine in two weeks. No other vaccine in four weeks. On 05Jan2021 at 12:30, patient felt achy, tired, and took a nap. By 2:00ish. The patient's vision was extremely blurry and continued for 2 days. At 05Jan2021 8 pm- 6 hours later of convulsive chills, fever- (high) and all of her muscles and joints were flaring in extreme pain. Patient could not move vaccine arm more than 3 inches and whole body hurt as if she had been hit by a train. When patient tried to walk, it was slow. Patient groped walls for support. Patient had a televisit with a doctor friend who said this was not a normal side effect and go to emergency room (ER). Doctor or other healthcare professional office/clinic visit. Covid test post vaccination included nasal swab, Covid -19 diagnostic on 08Jan2021 with pending result. No treatment received for events. The outcome of convulsive chills fever was unknown. The outcome of other events was recovered in Jan2021.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: convulsive chills, fever- (high); convulsive chills; fever- (high); all of my muscles and joints were flaring in extreme pain; all of my muscles and joints were flaring in extreme pain; I could NOT move my vaccine  arm more than 3 inches and my whole body hurt; my vision was extremely blurry; When I tried to walk, it was slow; achy/whole body hurt; tired, and took a nap; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient (no pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) via an unspecified route of administration on the left arm on 05Jan2021 11:00 AM at single dose for COVID-19 immunisation.  Medical history included having Covid the 3rd week in Mar2020, Positive for Antibodies in early May2020. Fairly sick but not emergency situation "Long haulers" covid symptoms that continued through Nov2020. Patient still had skin pain. Other medical history included hashimoto's. Past drug event included known allergy to codeine. The patient's concomitant medications included 25 mg of Levothyroxine in two weeks. No other vaccine in four weeks. On 05Jan2021 at 12:30, patient felt achy, tired, and took a nap. By 2:00ish. The patient's vision was extremely blurry and continued for 2 days. At 05Jan2021 8 pm- 6 hours later of convulsive chills, fever- (high) and all of her muscles and joints were flaring in extreme pain. Patient could not move vaccine arm more than 3 inches and whole body hurt as if she had been hit by a train. When patient tried to walk, it was slow. Patient groped walls for support. Patient had a televisit with a doctor friend who said this was not a normal side effect and go to emergency room (ER). Doctor or other healthcare professional office/clinic visit. Covid test post vaccination included nasal swab, Covid -19 diagnostic on 08Jan2021 with pending result. No treatment received for events. The outcome of convulsive chills fever was unknown. The outcome of other events was recovered in Jan2021.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Arthralgia, Chills, Gait disturbance, Injected limb mobility decreased
Clinical narrative: convulsive chills, fever- (high); convulsive chills; fever- (high); all of my muscles and joints were flaring in extreme pain; all of my muscles and joints were flaring in extreme pain; I could NOT move my vaccine  arm more than 3 inches and my whole body hurt; my vision was extremely blurry; When I tried to walk, it was slow; achy/whole body hurt; tired, and took a nap; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient (no pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) via an unspecified route of administration on the left arm on 05Jan2021 11:00 AM at single dose for COVID-19 immunisation.  Medical history included having Covid the 3rd week in Mar2020, Positive for Antibodies in early May2020. Fairly sick but not emergency situation "Long haulers" covid symptoms that continued through Nov2020. Patient still had skin pain. Other medical history included hashimoto's. Past drug event included known allergy to codeine. The patient's concomitant medications included 25 mg of Levothyroxine in two weeks. No other vaccine in four weeks. On 05Jan2021 at 12:30, patient felt achy, tired, and took a nap. By 2:00ish. The patient's vision was extremely blurry and continued for 2 days. At 05Jan2021 8 pm- 6 hours later of convulsive chills, fever- (high) and all of her muscles and joints were flaring in extreme pain. Patient could not move vaccine arm more than 3 inches and whole body hurt as if she had been hit by a train. When patient tried to walk, it was slow. Patient groped walls for support. Patient had a televisit with a doctor friend who said this was not a normal side effect and go to emergency room (ER). Doctor or other healthcare professional office/clinic visit. Covid test post vaccination included nasal swab, Covid -19 diagnostic on 08Jan2021 with pending result. No treatment received for events. The outcome of convulsive chills fever was unknown. The outcome of other events was recovered in Jan2021.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pain, Pyrexia, Vision blurred
Clinical narrative: convulsive chills, fever- (high); convulsive chills; fever- (high); all of my muscles and joints were flaring in extreme pain; all of my muscles and joints were flaring in extreme pain; I could NOT move my vaccine  arm more than 3 inches and my whole body hurt; my vision was extremely blurry; When I tried to walk, it was slow; achy/whole body hurt; tired, and took a nap; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient (no pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) via an unspecified route of administration on the left arm on 05Jan2021 11:00 AM at single dose for COVID-19 immunisation.  Medical history included having Covid the 3rd week in Mar2020, Positive for Antibodies in early May2020. Fairly sick but not emergency situation "Long haulers" covid symptoms that continued through Nov2020. Patient still had skin pain. Other medical history included hashimoto's. Past drug event included known allergy to codeine. The patient's concomitant medications included 25 mg of Levothyroxine in two weeks. No other vaccine in four weeks. On 05Jan2021 at 12:30, patient felt achy, tired, and took a nap. By 2:00ish. The patient's vision was extremely blurry and continued for 2 days. At 05Jan2021 8 pm- 6 hours later of convulsive chills, fever- (high) and all of her muscles and joints were flaring in extreme pain. Patient could not move vaccine arm more than 3 inches and whole body hurt as if she had been hit by a train. When patient tried to walk, it was slow. Patient groped walls for support. Patient had a televisit with a doctor friend who said this was not a normal side effect and go to emergency room (ER). Doctor or other healthcare professional office/clinic visit. Covid test post vaccination included nasal swab, Covid -19 diagnostic on 08Jan2021 with pending result. No treatment received for events. The outcome of convulsive chills fever was unknown. The outcome of other events was recovered in Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site discomfort
Clinical narrative: paresthesia of the left hand; extreme heaviness of the left arm within 30 minutes after receiving the second dose of Covid19 vaccine in that arm; This is a spontaneous report from a contactable nurse reporting for herself. A female patient of unspecified age received the second dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose on the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose for COVID-19 immunization. The patient reported paresthesia of the left hand and extreme heaviness of the left arm within 30 minutes after receiving the second dose of Covid19 vaccine in that arm on an unspecified date. She asked if one shouldn't get both vaccination in the same arm. She also asked about dosing of acetaminophen or NSAIDs before receiving the second dose of the Covid19 vaccine or using antipyretics or histamines after receiving the Covid19 vaccine. Outcome of the events was unknown. The reporting nurse assessed the adverse events as non-serious.   Information on the lot/ batch number has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Fatigue; fever; chills; Nausea; Vomiting; This is a spontaneous report from a contactable physician. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date (dose number= 1, lot number: EK5730) then on 06Jan2021, 11:30 (dose number= 2, lot number: EL3248), both at a single dose, via an unspecified route of administration (anatomical location: Arm Left) for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient experienced fatigue few hours after the second vaccine (06Jan2021) followed by fever, chills and nausea/vomiting. The latter lasted about 6 hours but was horrible. Treatment received for the adverse event were paracetamol (TYLENOL) and ondansetron (ZOFRAN). The outcome of the events was recovered on Jan2021.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Headache, Malaise
Clinical narrative: diarrhea; nausea; loss of appetite; chills; body aches; malaise; headache; sore throat; This is a spontaneous report from a contactable nurse, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EH9899), intramuscular in the left arm from on 16Dec2020 20:00 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, thyroid nodule, and known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 17Dec2020 20:00, 24 hours after receiving the first dose of BNT162B2 the patient experienced chills, body aches, malaise, headache and sore throat. On 18Dec2020 20:00, 48 hours after receiving the first dose of BNT162B2 the patient experienced diarrhea, nausea and loss of appetite. The patient was treated for the chills, body aches/malaise, headache and sore throat, diarrhea, nausea and loss of appetite with ibuprofen (Manufacturer Unknown). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events, chills, body aches/malaise, headache, sore throat, diarrhea, nausea and loss of appetite, were all recovered on an unknown date.   No follow-up attempts possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain
Clinical narrative: diarrhea; nausea; loss of appetite; chills; body aches; malaise; headache; sore throat; This is a spontaneous report from a contactable nurse, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EH9899), intramuscular in the left arm from on 16Dec2020 20:00 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, thyroid nodule, and known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 17Dec2020 20:00, 24 hours after receiving the first dose of BNT162B2 the patient experienced chills, body aches, malaise, headache and sore throat. On 18Dec2020 20:00, 48 hours after receiving the first dose of BNT162B2 the patient experienced diarrhea, nausea and loss of appetite. The patient was treated for the chills, body aches/malaise, headache and sore throat, diarrhea, nausea and loss of appetite with ibuprofen (Manufacturer Unknown). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events, chills, body aches/malaise, headache, sore throat, diarrhea, nausea and loss of appetite, were all recovered on an unknown date.   No follow-up attempts possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Pain, Pyrexia
Clinical narrative: Headache; blurry vision; fevers; body ache; chills; Second dose on 07Jan2021 (19days) after firts dose on 19Dec2020; This is a spontaneous report from a contactable physician (patient).  A 40-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231 and expiration date not provided), via an unspecified route of administration left arm second dose on 07Jan2021 07:45 at singled dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 for covid-19 immunisation (first dose, Anatomical Location: Arm Left and lot number EJ1685).  On 07Jan2021, the patient experienced Headache, blurry vision, fevers, chills, body ache. The patient did not received treatment for the events. Second dose on 07Jan2021 (19days) after first dose on 19Dec2020. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. Since vaccination patient was not tested for COVID-19.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Headache; blurry vision; fevers; body ache; chills; Second dose on 07Jan2021 (19days) after firts dose on 19Dec2020; This is a spontaneous report from a contactable physician (patient).  A 40-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231 and expiration date not provided), via an unspecified route of administration left arm second dose on 07Jan2021 07:45 at singled dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 for covid-19 immunisation (first dose, Anatomical Location: Arm Left and lot number EJ1685).  On 07Jan2021, the patient experienced Headache, blurry vision, fevers, chills, body ache. The patient did not received treatment for the events. Second dose on 07Jan2021 (19days) after first dose on 19Dec2020. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. Since vaccination patient was not tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Oral herpes
Clinical narrative: Active cold sore; Feeling sick; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a female patient of an unspecified age (Age: 59, Unit: unknown) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 20Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was scheduled for the second dose tomorrow, 09Jan2021 but was asking if she can take the second dose because is feeling sick and has active cold sore since an unspecified date. She would like to know if there is any recommendation on if she should wait to get the second dose. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: achy; threwup twice; This is a spontaneous report from a contactable health care professional (patient).  A 22-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received the second dose of the vaccine and has been really achy since then. She also mentioned that in the past 2 hours, she threw up twice. She wanted to know if this was normal. The outcome of the events was unknown.   Information on the Lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Hypoaesthesia, Neck pain
Clinical narrative: tunnel vision; experienced a sudden onset of vertigo; presyncope; My hands became cold and numb; My hands became cold and numb; fatigue; sore arm, leg/thigh aching; sniffles; sore throat; brief dry cough; slight headache; neck ache; This is a spontaneous report from a contactable Nurse (patient). A 34-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 05Jan2021 at 12:30 at single dose in left arm for covid-19 immunization. Medical history included Mild ADHD/ADD. The patient's concomitant medications were not reported. Approximately 5 minutes after receiving vaccination, she was standing in the observation room (where they had all of them stay for at least 15 minutes to ensure no severe reactions) and experienced a sudden onset of vertigo, tunnel vision and pre-syncope. Her hands became cold and numb and she was trying to talk to another staff member who was arranging/scheduling her second vaccination dose at the same time when this event occurred, but it subsided quickly and she started to feel normal again. All these events occurred at 12:45 on 05Jan2021. She reported this event right away and they had her stay in the room longer. She was stable at that point but experienced these symptoms again but very mildly twice more while she walked back to her car to go home. Other side effects on 05Jan2021 that started in the evening and for the following 2-3 days included fatigue, sore arm, leg/thigh aching, sniffles/sore throat, brief dry cough and slight headache/neck ache. Very mild and tolerable symptoms. All events were reported as non-serious by reporter. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. The outcome of all events was resolved in Jan2021.   Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Peripheral coldness, Presyncope, Rhinorrhoea
Clinical narrative: tunnel vision; experienced a sudden onset of vertigo; presyncope; My hands became cold and numb; My hands became cold and numb; fatigue; sore arm, leg/thigh aching; sniffles; sore throat; brief dry cough; slight headache; neck ache; This is a spontaneous report from a contactable Nurse (patient). A 34-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 05Jan2021 at 12:30 at single dose in left arm for covid-19 immunization. Medical history included Mild ADHD/ADD. The patient's concomitant medications were not reported. Approximately 5 minutes after receiving vaccination, she was standing in the observation room (where they had all of them stay for at least 15 minutes to ensure no severe reactions) and experienced a sudden onset of vertigo, tunnel vision and pre-syncope. Her hands became cold and numb and she was trying to talk to another staff member who was arranging/scheduling her second vaccination dose at the same time when this event occurred, but it subsided quickly and she started to feel normal again. All these events occurred at 12:45 on 05Jan2021. She reported this event right away and they had her stay in the room longer. She was stable at that point but experienced these symptoms again but very mildly twice more while she walked back to her car to go home. Other side effects on 05Jan2021 that started in the evening and for the following 2-3 days included fatigue, sore arm, leg/thigh aching, sniffles/sore throat, brief dry cough and slight headache/neck ache. Very mild and tolerable symptoms. All events were reported as non-serious by reporter. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. The outcome of all events was resolved in Jan2021.   Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Tunnel vision, Vertigo
Clinical narrative: tunnel vision; experienced a sudden onset of vertigo; presyncope; My hands became cold and numb; My hands became cold and numb; fatigue; sore arm, leg/thigh aching; sniffles; sore throat; brief dry cough; slight headache; neck ache; This is a spontaneous report from a contactable Nurse (patient). A 34-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 05Jan2021 at 12:30 at single dose in left arm for covid-19 immunization. Medical history included Mild ADHD/ADD. The patient's concomitant medications were not reported. Approximately 5 minutes after receiving vaccination, she was standing in the observation room (where they had all of them stay for at least 15 minutes to ensure no severe reactions) and experienced a sudden onset of vertigo, tunnel vision and pre-syncope. Her hands became cold and numb and she was trying to talk to another staff member who was arranging/scheduling her second vaccination dose at the same time when this event occurred, but it subsided quickly and she started to feel normal again. All these events occurred at 12:45 on 05Jan2021. She reported this event right away and they had her stay in the room longer. She was stable at that point but experienced these symptoms again but very mildly twice more while she walked back to her car to go home. Other side effects on 05Jan2021 that started in the evening and for the following 2-3 days included fatigue, sore arm, leg/thigh aching, sniffles/sore throat, brief dry cough and slight headache/neck ache. Very mild and tolerable symptoms. All events were reported as non-serious by reporter. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. The outcome of all events was resolved in Jan2021.   Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain in extremity
Clinical narrative: Diarrhea; severe chills; sore arm; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) then received the second dose (lot number: EK 9231, expiration date: not reported) on 08Jan2021 13:45 both via an unspecified route of administration on the left arm at a single dose for COVID-19 immunization. Medical history included that the patient had allergies to medications, food, or other products such as Penicillin, Sulfa drug and pork. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), ascorbic acid (VIT C), ergocalciferol (VIT D) and biotin (BIOTIN). On 08Jan2021 22:45, 9 hours after vaccine the patient experienced diarrhea, severe chills and sore arm. As treatment, patient received ibuprofen (ADVIL) and fluids. The outcome of the events was recovered. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number (first dose) has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Off label use, Product use issue, Vaccination site pain
Clinical narrative: Injection site soreness; Pregnant; Pregnant; Pregnant; This is a spontaneous report received from a contactable pharmacist (who is also the patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1283), intramuscular in left arm, on 09Jan2021 12:15, at single dose, for COVID-19 immunization, in her workplace clinic. The patient medical history was not reported. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS).  The patient is pregnant. Last menstrual date was on 12Jun2020, gestational period is 30 weeks and delivery date will be on 19Mar2021. The patient experienced injection site soreness on 09Jan2021 at 12:15. No treatment was given for the event. The patient did not have COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. The outcome of the event vaccination site pain was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Urticaria
Clinical narrative: red hives; chills; body aches; low fever; This is a spontaneous report from a contactable other healthcare professional (patient).  A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, via an unspecified route of administration on Left arm from 08Jan2021 12:45 to 08Jan2021 12:45 as SINGLE DOSE for COVID-19 immunisation.  Medical history reported as none. There were no concomitant medications. On 08Jan2021 at 18:45 (6 hours after receiving vaccine), the patient broke out in red hives, experienced chills, body aches and low fever. The outcome of the events was recovered. No treatment was given for the events. Since the vaccination, the patient has not been tested for COVID-19.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: 1st vaccine- mild headache and mild arm soreness; 1st vaccine- mild headache and mild arm soreness; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via unknown route of administration, on 18Dec2020 (at the age of 35 years old) as a single dose in the right arm via unknown route of administration for COVID-19 immunization at hospital facility. Relevant medical history was unknown. It was unknown if patient has any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On unknown date, after the first dose, the patient experienced mild headache and mild arm soreness. No treatment was received for the events mild headache and mild arm soreness. The outcome of the events mild headache and mild arm soreness was unknown. The patient was not pregnant at time of vaccination. Since the vaccination, the patient had not been tested for COVID-19.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia, Vaccination site pain
Clinical narrative: Extreme pain in arm where injection was placed; Numbness in hands; Tingling sharp pain throughout entire arm and under arm; Tingling sharp pain throughout entire arm and under arm; Weakness in arm that injection was placed.; This is a spontaneous report from a contactable Other HCP (patient). This 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via intramuscular route of administration, on 07Jan2021 at 11:00 AM as a single dose in the right arm for COVID-19 immunization at hospital facility. Relevant medical history was none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC), lamotrigine (LAMICTAL). The patient previously received the first dose of BNT162B2 (lot number/expiration date: unknown) on unknown date via unknown route of administration for COVID-19 immunization. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 08:00 PM, after the second dose, the patient experienced extreme pain in arm where injection was placed, numbness in hands, tingling sharp pain throughout entire arm and under arm and weakness in arm that injection was placed. No treatment was received for the events extreme pain in arm where injection was placed, numbness in hands, tingling sharp pain throughout entire arm and under arm and weakness in arm that injection was placed. The outcome of the events extreme pain in arm where injection was placed, numbness in hands, tingling sharp pain throughout entire arm and under arm and weakness in arm that injection was placed was unknown. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient had not been tested for COVID-19.     The lot number for the vaccine, BNT162B2 dose 1, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site vesicles
Clinical narrative: redness around the injection site, she describes the redness as spread and with blisters; redness around the injection site, she describes the redness as spread and with blisters; This is a spontaneous report from a contactable Other HCP reporting for herself. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated she received the first dose of the vaccine on 08Jan2021 and is experiencing a lot of redness around the injection site, she describes the redness as spread and with blisters. Onset date of the events was 08Jan2021. She wanted to know if there's information about this side effects. The outcome of the events was unknown.  Information on lot/ Batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Lymphadenopathy, Neck pain
Clinical narrative: Neck and shoulder pain; neck and shoulder pain; Not horrible, just uncomfortable; Swollen lymph node at left collar bone; This is a spontaneous report from a contactable consumer reporting on behalf of a patient.  A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899, expiration date unknown) via an unspecified route of administration on 07Jan2021 (at the age of 32-years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date unknown) via an unspecified route of administration on 17Dec2020 (at the age of 32 years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced neck and shoulder pain on 08Jan2021 which was described as, not horrible, just uncomfortable. The patient also experienced a swollen lymph node at the left collar bone on 08Jan2021. The patient did not receive any treatment for the events. The clinical outcomes of neck and shoulder pain, discomfort and swollen lymph nodes was reported as  recovering  It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever up to 102 F approx 15-25 hours post vaccination.; This is a spontaneous report from a contactable Nurse (the patient).  A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Ek9231, expiration date unknown) via an unspecified route of administration on 06Jan2021 at 18:00 (at the age of 32-years-old), at an unspecified dose in the left arm for COVID-19 vaccination.  Medical history was reported as "none." The patient had no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine at a workplace clinic. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899, expiration date unknown ) via an unspecified route of administration on 16Dec2020 18:00  (at the age of 32-years-old), at an unspecified dose in the left arm for COVID-19 vaccination. Concomitant medication included levonorgestrel (MIRENA). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever up to 102 farenheit approximately fifteen to twenty-five hours post vaccination beginning on 07Jan2021 at 09:00. Treatment information was not provided. The clinical outcome of pyrexia was reported as recovered on an unspecified date in Jan2021. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fall, Fatigue, Myalgia, Nausea
Clinical narrative: Experienced vasovagal syncope after standing, resulting in fall; Experienced vasovagal syncope after standing, resulting in fall; Awoke with severe chills; nausea; body/muscle aches; body/muscle aches; left arm pain; extreme thirst; fatigue; This is a spontaneous report from a contactable consumer. A 44-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via an unspecified route of administration on 08Jan2021 14:30 in left arm at single dose for covid-19 immunization. There was no medical history and concomitant medications. Allergies to medications, food, or other products was no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered was in hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Jan2021 01:30 am, patient woke with severe chills, nausea, body/muscle aches, left arm pain, nausea, extreme thirst. Patient experienced vasovagal syncope after standing, resulting in fall. Worst symptoms were lasted about 30 minutes, muscle aches and fatigue continue about 16 hours later. All events were reported as non-serious. No treatment was received for these events. Outcome of all events were recovering.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Syncope, Thirst
Clinical narrative: Experienced vasovagal syncope after standing, resulting in fall; Experienced vasovagal syncope after standing, resulting in fall; Awoke with severe chills; nausea; body/muscle aches; body/muscle aches; left arm pain; extreme thirst; fatigue; This is a spontaneous report from a contactable consumer. A 44-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via an unspecified route of administration on 08Jan2021 14:30 in left arm at single dose for covid-19 immunization. There was no medical history and concomitant medications. Allergies to medications, food, or other products was no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered was in hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Jan2021 01:30 am, patient woke with severe chills, nausea, body/muscle aches, left arm pain, nausea, extreme thirst. Patient experienced vasovagal syncope after standing, resulting in fall. Worst symptoms were lasted about 30 minutes, muscle aches and fatigue continue about 16 hours later. All events were reported as non-serious. No treatment was received for these events. Outcome of all events were recovering.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: left neck moderate to severe pain; pain started radiating down her left arm and down left leg; weakening her joints on those extremities/ shoulder pain; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EK5730, expiry date: unknown), via an unspecified route of administration, on 16Dec220, at a single dose on arm right for COVID-19 immunization. Medical history included diabetes mellitus 2, hypertension (HTN), migraines, back pains, hypothyroidism, and allergies to latex and kiwi. The patient received the vaccine at a military base. She did not receive other vaccines in four weeks. The patient was not pregnant at the time of vaccination. She had no COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included unspecified medications; she received other medications in two weeks. The patient previously took gabapentin and topiramate (TOPAMAX), in which she experienced allergies. On the second day after receiving the vaccine, 18Dec2020 04:00 AM, the patient started feeling left neck moderate to severe pain, and the pain started radiating down her left arm and down left leg, weakening her joints on those extremities. This continued severely for 3 days. At this time, she continued to feel mild left neck, shoulder and arm pain intermittently. She could not report this immediately due to not having her vaccine documents which she forgot at her workplace as she proceeded to vacation. She had paused in getting the second dose that was due on 07Jan2021, waiting to hear from Pfizer. The patient received NSAIDS and Muscle relaxant medications as treatment for the reported adverse events. Outcome of the events was recovering.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: Fever; Malaise; Fatigue; This is a spontaneous report from a contactable nurse (reported for himself). A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 08Jan2021 at 16:00 (lot number: EL1284) and first dose on an unspecified date (lot number: EJ1685); both via an unspecified route of administration on his left arm at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. No vaccines received within 4 weeks prior to COVID vaccine. On 09Jan2021 at 13:00, the patient experienced fever, malaise and fatigue. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included ibuprofen 800 mg and cooling measures. Outcome of the events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Sluggishness
Clinical narrative: foggy minded; on first vaccine it made him feel a little sluggish; tired; This is a spontaneous report from a contactable pharmacist. A 36-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular from 18Dec2020 to 18Dec2020 at SINGLE DOSE for COVID-19 immunisation. Medical history included ADHD.  Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and escitalopram oxalate (LEXAPRO). On an unspecified date, the patient stated that on first vaccine, it made him feel a little sluggish, tired and foggy minded. Outcome of the events was unknown.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for event mental dullness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body mass index, Body temperature, Fatigue, Limb discomfort
Clinical narrative: soreness at the injection site; I slept off and on from 8:00pm to 12:00am - I did not really feel like moving from the couch, but got up to go to bed; my entire left arm felt "odd" - not painful, just different than my right arm; very tired; joints/muscles on my left side (neck, leg, arm) started to ache; joints/muscles on my left side (neck, leg, arm) started to ache; This is a spontaneous report from a non-contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration (left arm), on 08Jan2021 at 12:00, at a single dose for COVID-19 immunization. The patient's medical history included stomach flu (about 2 years ago), pneumonia (14 years ago), and oral surgery (recently). Concomitant medications included lisdexamfetamine mesilate (VYVANSE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), calcium, ergocalciferol (VIT D) and red yeast rice. The patient previously received influenza vaccine. The patient has no known allergies. Patient's body mass index (BMI) was 32.5. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the pharmacy or drug store. About 30 min after vaccination on 08Jan2020, the patient's entire left arm felt "odd" not painful, just different than my right arm.  About 6 hours after the shot, the patient started getting very tired, and my joints/muscles on my left side (neck, leg, arm) started to ache.  She slept off and on from 20:00 to 12:00 and she did not really feel like moving from the couch, but got up to go to bed. She checked for fever around 19:30 and 12:00 but had none. She took one of my left over 600 mg ibuprofen (from a recent oral surgery) as treatment, then went to bed and woke up feeling much better. Today, she only has soreness at the injection site (as she normally did with a flu vaccine). She decided to be proactive and took another 600 ibuprofen around 15:00 and felt consistent all day. Patient stated that how she felt the evening of the vaccine was not painful; just "different" than she experienced before. Outcome of the events was recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.