chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: broken out in hives on his arm below the injection site; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982; expiry date: not known), via an unspecified route of administration in the left arm  on 14Jan2021 11:00 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. No history of previous immunization with the vaccine. On Friday morning (15Jan2021), he noticed he broken out in hives on his arm below the injection site; he had been putting some Benadryl cream on it. He stated that he still had 2 red marks on his arm, but the swelling had gone down. The patient did not require emergency room or physician office visit. The outcome of the event was recovering.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fevers; chills; significant myalgia; fatigue; This is a spontaneous report from a non-contactable physician reported for herself. This 41-year-old female patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via intramuscular at left arm on 15Jan2021 09:30 am at single dose for covid-19 immunisation. Medical history was unknown. Concomitant medications were none. The patient previously received fluconazole (DIFLUCAN) experiencing allergies and the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via intramuscular at left arm on 26Dec2020 03:00 PM at single dose for covid-19 immunisation. The patient was not pregnant. The patient had no other vaccine in four weeks or other medications in two weeks. The patient had no COVID prior vaccination, no COVID tested post vaccination. The patient experienced fevers, chills, significant myalgia, fatigue on 15Jan2021 at 09:30PM. No treatment was received. Outcome of all events was recovered on Jan2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive for covid; positive for covid; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program Pfizer First Connect. A 61-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm, intramuscular on 31Dec2020 at 0.25 mL, single for preventative. Time the Vaccination was Given between 7:30 to 08:00 am. Medical history was none. There were no concomitant medications. The patient took the first dose of the covid vaccine on 31Dec2020. She took a rapid test on Tuesday 12Jan2021 and found out she was positive for covid, she did not know the name of the test specifically. She stated she was lucky that she had mild covid symptoms. The outcome of event was unknown.  No Follow Up attempts are Possible; Information on Lot/Batch Number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Fever; chills; headache; myalgia; fatigue; sore arm; This is a spontaneous report from a Non-contactable Consumer (Patient). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at Left arm on 17Jan2021 14:00 at single dose for covid-19 immunization. Patient was not pregnant. Medical history included COVID-19 prior vaccination. The COVID-19 vaccine was administered at Hospital. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's received the first dose of BNT162B2 on 26Dec2020 at left arm for covid-19 immunization. The patient experienced Fever, chills, headache, myalgia, fatigue, sore arm on 17Jan2021 23:00. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 17Jan2021. No treatment received for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; chills; headache; myalgia; fatigue; sore arm; This is a spontaneous report from a Non-contactable Consumer (Patient). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at Left arm on 17Jan2021 14:00 at single dose for covid-19 immunization. Patient was not pregnant. Medical history included COVID-19 prior vaccination. The COVID-19 vaccine was administered at Hospital. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's received the first dose of BNT162B2 on 26Dec2020 at left arm for covid-19 immunization. The patient experienced Fever, chills, headache, myalgia, fatigue, sore arm on 17Jan2021 23:00. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 17Jan2021. No treatment received for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Vaccination site pain
Clinical narrative: minor muscle aches at the sight of the injection; minor aches/super minor aches; minor muscle pain; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot# EL3248), via an unspecified route of administration in left arm on 17Jan2021 10:30 at single dose for COVID-19 immunization.  Medical history included the patient had a spit of asthma since a child and she didn't have any trouble after the vaccine.  Concomitant medication included ongoing montelukast sodium (SINGULAIR) for asthma taking for 3 or 4 years.  Vaccination Facility Type: hospital. Vaccine Administered at Military Facility?  No. History of all previous immunization with the Pfizer vaccine considered as suspect: none. Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. Prior Vaccinations (within 4 weeks): none. Family Medical History: none. The patient experienced minor muscle aches at the sight of the injection, minor aches/super minor aches, minor muscle pain, all on 17Jan2021 with outcome of recovering. Relevant test none. Investigation Assessment: No. She had some minor muscle pain and maybe some minor aches. Today was the day that you felt like you always do when you go back to work after being sick. She had minor muscle pain that was low grade right away, minor, started right away and consistent through today but not like it kept you up. She also had super minor aches, not feeling herself, but not bad in any way. The minor muscle aches started later on the 17Jan2021 at the sight of the injection, like a bruise. She is planning to receive the second dose on 07Feb2021. No event required a visit to physician or emergency room.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Vaccination site pain
Clinical narrative: Normal soreness at the site; headache; back ache; This is a spontaneous report from a contactable nurse reported for self. This female patient received the second dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via an unspecified route of administration on 08Jan2021 at single dose in right arm for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient previously received first dose of BNT162B2 (Lot number unknown) at 18Dec2020 at single dose in left arm for COVID-19 immunisation and stated lymph node swelling noticed in the left clavicle area and did hurt at the beginning for a few days. The patient experienced "headache and back ache only" and "Normal soreness at the site" in Jan2021. The patient reported no lymph swelling after the second dose. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable nurse. This nurse reported for a female patient of unspecified age (coworker's wife) who received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced diarrhea as well after getting the Covid-19 Vaccine in Jan2021. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever of 101; This is a spontaneous report from a contactable consumer reported for herself. A 28-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiration date unknown), via an unspecified route of administration on left arm on 17Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that she had the second dose of Pfizer Covid 19 vaccine yesterday on 17Jan2021, and has had 101 fever for 8 hours on 18Jan2021. Wanted to know if she can take fever reducing medication. No treatment received for the event. Outcome of the event was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Tongue ulceration
Clinical narrative: canter sore on tongue; This is a spontaneous report from a contactable other HCP. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 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. The patient developed a canter sore on tongue on an unspecified date. Event outcome was unknown.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: fever; chills; headache; tired; feeling not good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (lot number: EL1283) second dose on 11Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history was not reported. Concomitant medications included cyanocobalamin (B12). The patient previously received BNT162B2 (lot number: EK7530) first dose on 21Dec2020 (age 49-year-old) at single dose for COVID-19 immunisation and experienced dry cough on 23Dec2020 and tested positive on 28Dec2020 after receiving the first dose. She received the second dose on 11Jan2021. She started having fever, chills and a headache. The headaches come and go in waves. She was tired and took a nap and woke feeling not good. She is now taking B12 and it is helping her. The outcome of the events was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: fever; chills; headache; tired; feeling not good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (lot number: EL1283) second dose on 11Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history was not reported. Concomitant medications included cyanocobalamin (B12). The patient previously received BNT162B2 (lot number: EK7530) first dose on 21Dec2020 (age 49-year-old) at single dose for COVID-19 immunisation and experienced dry cough on 23Dec2020 and tested positive on 28Dec2020 after receiving the first dose. She received the second dose on 11Jan2021. She started having fever, chills and a headache. The headaches come and go in waves. She was tired and took a nap and woke feeling not good. She is now taking B12 and it is helping her. The outcome of the events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm after the first dose of COVID Vaccine; This is a spontaneous report from a contactable other health professional (Patient). A 64-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK57530), via an unspecified route of administration on 17Dec2020 09:10 at left arm, at single dose for covid-19 immunization. Medical history was none.  There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient got the Flu Vaccine last part of Sep2020 or Beginning of Oct2020. The patient experienced sore arm after the first dose of covid vaccine on 17Dec2020. She received the first dose on 17Dec2020 and tolerated pretty well. She only had a sore arm. It started the same day on 17Dec2020, a couple of hours after getting the vaccine. It went away a day to a day and a half after it started. After that she was fine. the outcome of the event was recovered in Dec2020. Reporter considered the event Sore arm after the first dose of COVID Vaccine was not serious. Event did not result in Emergency Room/Physician Office. She also stated, even though she got so sick with getting the vaccine she was just continuously  telling her self this is better than having COVID. She stated she even told people even if she knew after getting the shot she would have this reaction she would still take it. She has seen death occur from COVID and does not want that to happen.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Vaccination site pain
Clinical narrative: pain in arm/injection site; Headache; weakness; fatigue; This is a spontaneous report from a contactable pharmacist reporting for himself. A 46-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose in arm for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  After his first dose, the patient experienced Headache, weakness, fatigue, pain in arm/injection site on an unspecified date.  The event outcome was unknown.  Information about Batch/Lot number has been requested.
Age: 0.67
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: red warm welt at injection site; red warm welt at injection site; red warm welt at injection site; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported same event for two patients. This case was for report 1st of two reports. A 8-month-old female Infant received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number DL2971, Expiry Date: 30Nov2022), intramuscular at Thigh Right on 13-JAN-2021 at the 8-month-old at 0.5 mL, single for immunization.  The medical history included Pulmonary hypertension and Foramen ovale patent, all from 25Sep2020(diagnosed on 25Sep2020). The concomitant medications were none. The patient was 11 pounds 6 ounces at time of vaccination. Patient received vaccine on 13Jan2021 in Right Thigh, on 14Jan2021 a warm red welt at the injection site was reported. Treatment was a cool compress to the site and the welt resolved in a couple of days. The outcome of the event was recovered in Jan2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021058526 same reporter/drug/event, different patient
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Gingival pain, Throat irritation, Urticaria
Clinical narrative: Chest tightness; hives on the side of her neck; scratchiness in throat; gums were throbbing; This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EJ1686, Expire Date: 30Mar2021), intramuscular at Deltoid Left on 15Jan2021 11:08 at the 76 years old at 0.3 mL, single for COVID-19 immunization. The patient medical history included allergies issues with shellfish (allergic reactions), hyperlipidemia and hypertension. The concomitant medications were none. There was no additional vaccines administered on same date of the suspect. The patient was experienced for over 20 minutes with no side effects. After she left on an hour after administration (15Jan2021 12:08), she started feeling scratchiness in throat, her gums were throbbing and chest tightness. She did say she didn't take any Benadryl. She didn't have airway issues, but she did have hives on the side of her neck on 15Jan2021 12:08. She got the shot on 15Jan2021. The side effects started shortly after she left on an hour after administration. Her symptoms were relieved by 15Jan2021 21:30, and she got the shot at 11:08 am. The patient had allergic reactions in the past. She knew what to expect. She got the shot in her Left Deltoid. The reporter had a gut feeling she didn't need to get the second dose.  The reporter assessed all the events were not serious. She did not require medical intervention. She did not go to the Emergency room or Physician Office. The patient was not hospitalized, or in the ICU. The Causality was not provided by the reporter. The outcome of the events was recovered on 15Jan2021 21:30.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: She only had a little aches with the first dose; This is a spontaneous report received from a contactable consumer (patient).   A 61-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140 and Expiration date was unspecified) on 24Dec2020 as single dose, unspecified route and location (at 61 years of age), for COVID-19 immunisation.  Medical history included that she has had Covid before and was in the hospital.  She lost 22 pounds because she couldn't eat. No concomitant medication was reported.  The patient reported She only had little aches with the first dose on an unspecified date.  Outcome of event for aches was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Pain, Pain in extremity, Pyrexia
Clinical narrative: sore arm; massive migraine; fever of 102.5; achy body; not feeling well; room spinning; This is a spontaneous report from a contactable consumer (Patient).  A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm on 16Jan2021 at single dose for covid-19 immunization. The patient's medical history andconcomitant medications were not reported. The patient received the first dose of BNT162B2 (lot number: EH9199), via an unspecified route of administration at left arm on 26Dec2020 at single dose for covid-19 immunization, after the first dose she had sore arm. The patient received second dose on 16Jan2021 after getting her first one 21 days ago, she had a terrible reaction to the second one and experienced massive migraine, fever of 102.5 degrees Fahrenheit, achy body, not feeling well, sore arm, room spinning, and it has been 48 hours or if this is an adverse reaction, or what is normal. she wants to if that is side effect with the vaccine, her side effects were much stronger after the second dose. She said that she was not sure because the first time she had vaccine she had minor side effect. The patient's fever that is better today (18Jan2021), it is 100 degrees Fahrenheit. She said she still doesn't feel 100%, but her husband who was a dentist, and their friends that were dentists, no one else was having a reaction, and she was not having an allergic reaction, it was just weird. For her fever she took Tylenol. The outcome of the fever was recovering, and the outcome of the other events was unknown. Information about lot and batch number was requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: sore arm; massive migraine; fever of 102.5; achy body; not feeling well; room spinning; This is a spontaneous report from a contactable consumer (Patient).  A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm on 16Jan2021 at single dose for covid-19 immunization. The patient's medical history andconcomitant medications were not reported. The patient received the first dose of BNT162B2 (lot number: EH9199), via an unspecified route of administration at left arm on 26Dec2020 at single dose for covid-19 immunization, after the first dose she had sore arm. The patient received second dose on 16Jan2021 after getting her first one 21 days ago, she had a terrible reaction to the second one and experienced massive migraine, fever of 102.5 degrees Fahrenheit, achy body, not feeling well, sore arm, room spinning, and it has been 48 hours or if this is an adverse reaction, or what is normal. she wants to if that is side effect with the vaccine, her side effects were much stronger after the second dose. She said that she was not sure because the first time she had vaccine she had minor side effect. The patient's fever that is better today (18Jan2021), it is 100 degrees Fahrenheit. She said she still doesn't feel 100%, but her husband who was a dentist, and their friends that were dentists, no one else was having a reaction, and she was not having an allergic reaction, it was just weird. For her fever she took Tylenol. The outcome of the fever was recovering, and the outcome of the other events was unknown. Information about lot and batch number was requested.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Hypersensitivity, Malaise
Clinical narrative: sight impairment/did not see very well/unable to read during report; injection site pain; tiredness; muscle pain; feeling unwell; frequent urination every 15 minutes; signs of severe allergic reaction including dizziness, weakness and sight impairment; signs of severe allergic reaction including dizziness, weakness and sight impairment; signs of severe allergic reaction including dizziness, weakness and sight impairment; This is a spontaneous report from two contactable consumers. A 95-year-old male patient received 1st dose of BNT162B2 (Pfizer BioNTech COVID-19 Vaccine ), via an unspecified route of administration in upper right arm on 16Jan2021 11:00 at single dose for vaccination. Medical history included diabetes from 1950 (also reported as 1991) and ongoing. There were no concomitant medications. The patient experienced not in very good shape/terrible reactions on 16Jan2021 12:00. Requested information regarding events relative to the product. Further clarified this event as to include injection site pain; tiredness; muscle pain; feeling unwell; frequent urination every 15 minutes; signs of severe allergic reaction including dizziness, weakness and sight impairment. Patient clarified that all of these events had onset of about 12:00pm-1 hour after Pfizer BioNTech COVID-19 Vaccine administered (16Jan2021 12:00) and had for the most part remained the same since onset, but for sight impairment was on 18Jan2021. The patient did not see very well; caller had to read some of the information provided in this report from forms that patient was unable to read during report. The muscle pain was marginal. The weakness was the same or worse. He wanted a pain reliver or pill. Patient did not plan to get the second dose due to adverse events. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No emergency room/physician office visit. Family medical history relevant to the events was none. The outcome of injection site pain was recovered on 18Jan2021, tiredness, feeling unwell, dizziness was not recovered, muscle pain, frequent urination every 15 minutes was recovering, severe allergic reaction, weakness, sight impairment was unknown.  Information on the lot/batch number has been requested.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pollakiuria, Vaccination site pain, Visual impairment
Clinical narrative: sight impairment/did not see very well/unable to read during report; injection site pain; tiredness; muscle pain; feeling unwell; frequent urination every 15 minutes; signs of severe allergic reaction including dizziness, weakness and sight impairment; signs of severe allergic reaction including dizziness, weakness and sight impairment; signs of severe allergic reaction including dizziness, weakness and sight impairment; This is a spontaneous report from two contactable consumers. A 95-year-old male patient received 1st dose of BNT162B2 (Pfizer BioNTech COVID-19 Vaccine ), via an unspecified route of administration in upper right arm on 16Jan2021 11:00 at single dose for vaccination. Medical history included diabetes from 1950 (also reported as 1991) and ongoing. There were no concomitant medications. The patient experienced not in very good shape/terrible reactions on 16Jan2021 12:00. Requested information regarding events relative to the product. Further clarified this event as to include injection site pain; tiredness; muscle pain; feeling unwell; frequent urination every 15 minutes; signs of severe allergic reaction including dizziness, weakness and sight impairment. Patient clarified that all of these events had onset of about 12:00pm-1 hour after Pfizer BioNTech COVID-19 Vaccine administered (16Jan2021 12:00) and had for the most part remained the same since onset, but for sight impairment was on 18Jan2021. The patient did not see very well; caller had to read some of the information provided in this report from forms that patient was unable to read during report. The muscle pain was marginal. The weakness was the same or worse. He wanted a pain reliver or pill. Patient did not plan to get the second dose due to adverse events. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No emergency room/physician office visit. Family medical history relevant to the events was none. The outcome of injection site pain was recovered on 18Jan2021, tiredness, feeling unwell, dizziness was not recovered, muscle pain, frequent urination every 15 minutes was recovering, severe allergic reaction, weakness, sight impairment was unknown.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Feeling cold, Headache
Clinical narrative: feeling cold; achy joints; mild to moderate headache; patient received second dose of bnt162b2 on 09Jan2021; head and torso fever while extremities like ice; head and torso fever while extremities like ice; Sporatic sweats; chills; body ache; Lingering lethargy; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EJ1685), via an unspecified route of administration on 09Jan2021 07:00 at single dose at right arm for covid-19 immunization. Medical history included asthma, rheumatoid arthritis, raynaud's, known allergies: nickel and latex. Concomitant medications in two weeks included salbutamol (ALBUTEROL), fluticasone propionate (FLONASE), ascorbic acid (VIT C), ergocalciferol (VIT D) and multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The patient previously took erythromycin and experienced drug allergy, and received first dose of bnt162b2 on 23Dec2020 for covid-19 immunization and experienced splitting trident occipital headache/Dull ache in frontal skull region. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. 2nd injection-15hrs post injection, patient began feeling cold and achy joints, mild to moderate headache on 09Jan2021 10:00 pm, by 3am head and torso fever while extremities like ice. Over several days ran fevers from 99.1 to 103.6 F. Sporatic sweats, chills, and body ache attacks. Symptoms gradually subsided in severity and duration until resolving one week post injection. Patient also had lingering lethargy in Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive treatment for events. Outcome of events lingering lethargy and 'patient received second dose of bnt162b2 on 09Jan2021' was unknown, and outcome of other events was recovering.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Inappropriate schedule of product administration, Lethargy, Pain, Peripheral coldness
Clinical narrative: feeling cold; achy joints; mild to moderate headache; patient received second dose of bnt162b2 on 09Jan2021; head and torso fever while extremities like ice; head and torso fever while extremities like ice; Sporatic sweats; chills; body ache; Lingering lethargy; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EJ1685), via an unspecified route of administration on 09Jan2021 07:00 at single dose at right arm for covid-19 immunization. Medical history included asthma, rheumatoid arthritis, raynaud's, known allergies: nickel and latex. Concomitant medications in two weeks included salbutamol (ALBUTEROL), fluticasone propionate (FLONASE), ascorbic acid (VIT C), ergocalciferol (VIT D) and multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The patient previously took erythromycin and experienced drug allergy, and received first dose of bnt162b2 on 23Dec2020 for covid-19 immunization and experienced splitting trident occipital headache/Dull ache in frontal skull region. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. 2nd injection-15hrs post injection, patient began feeling cold and achy joints, mild to moderate headache on 09Jan2021 10:00 pm, by 3am head and torso fever while extremities like ice. Over several days ran fevers from 99.1 to 103.6 F. Sporatic sweats, chills, and body ache attacks. Symptoms gradually subsided in severity and duration until resolving one week post injection. Patient also had lingering lethargy in Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive treatment for events. Outcome of events lingering lethargy and 'patient received second dose of bnt162b2 on 09Jan2021' was unknown, and outcome of other events was recovering.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feeling cold; achy joints; mild to moderate headache; patient received second dose of bnt162b2 on 09Jan2021; head and torso fever while extremities like ice; head and torso fever while extremities like ice; Sporatic sweats; chills; body ache; Lingering lethargy; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EJ1685), via an unspecified route of administration on 09Jan2021 07:00 at single dose at right arm for covid-19 immunization. Medical history included asthma, rheumatoid arthritis, raynaud's, known allergies: nickel and latex. Concomitant medications in two weeks included salbutamol (ALBUTEROL), fluticasone propionate (FLONASE), ascorbic acid (VIT C), ergocalciferol (VIT D) and multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The patient previously took erythromycin and experienced drug allergy, and received first dose of bnt162b2 on 23Dec2020 for covid-19 immunization and experienced splitting trident occipital headache/Dull ache in frontal skull region. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. 2nd injection-15hrs post injection, patient began feeling cold and achy joints, mild to moderate headache on 09Jan2021 10:00 pm, by 3am head and torso fever while extremities like ice. Over several days ran fevers from 99.1 to 103.6 F. Sporatic sweats, chills, and body ache attacks. Symptoms gradually subsided in severity and duration until resolving one week post injection. Patient also had lingering lethargy in Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive treatment for events. Outcome of events lingering lethargy and 'patient received second dose of bnt162b2 on 09Jan2021' was unknown, and outcome of other events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: pain in the body; swelling; This is a spontaneous report from a non-contactable consumer (patient's mother). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 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. The patient experienced pain in the body and swelling on an unspecified date with outcome of unknown. The reporter reported that her daughter also presented side effects for the administration of the first dose of the vaccine, but these side effects were not present after the administration of the second dose of the immunization.  No follow-up attempts are possible; information on lot/batch cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: allergic reaction with hives up and down her body; allergic reaction with hives up and down her body/ on her neck, arms, chest, back, buttocks, and down her legs; This is a spontaneous report from a contactable consumer on behalf of his wife. A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. Medical history included blood pressure high diagnosed a month before 18Jan2021 (Dec2020), she had no new medications though. There were no concomitant medications or recent vaccinations. The patient started experiencing an allergic reaction with hives up and down her body on unspecified date in Jan2021, so she sought care from her primary care provider (PCP) who prescribed her steroids (clarified to being prednisolone) methylprednisolone (lot number: 20C0087P, Expiry Date: Mar2022), she was taking 4mg doses as directed by the day, she was on third day of that medication; Benadryl, she had been taking 50mg every 4-6 hours by mouth; Zyrtec (lot number: 120026688, Expiry Date: Aug2022), she had been taking 10mg twice a day by mouth; and Pepcid (lot number: SMF084, Expiry Date: Jul2023), she had been taking 10mg once a day mouth. The reporter says her hives were all over her body: on her neck, arms, chest, back, buttocks, and down her legs. The event outcome was recovered on 18Jan2021, reported as the hives were gone. The only different thing she had recently was the vaccine, so she was concerned about getting the second dose on the 25Jan2021 and she was worried. The reporter said his wife sought help from her PCP along with another provider but they have no answers for them.  Information on the batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm (left arm)/At the injection site; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (himself and his wife). This report is for himself. A 75 (unit unknown) male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 14Jan2021 at single dose in left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Pfizer on 14Jan2021. On 11Feb2021, he was scheduled for the next vaccine which was more than the 21 days. (place name) was only administering the Moderna vaccine, but he received the Pfizer vaccine, which was fine, but he had the appointment scheduled for the second dose according to the Moderna vaccine time frame. He wanted to know need to have that appointment changed. On 14Jan2021, the patient experienced a sore arm (L ARM) an hour after vaccination he felt the soreness, it lasted maybe less than a day. At the injection site, but it was no biggie. The patient asked what was the timing of the second dose of Pfizer-BioNTech COVID-19 vaccine and if she can receive it earlier or later than 3 weeks. The outcome of event was resolved in Jan2021.  Information on the batch/lot number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021059580 same reporter/drug/event, different patients
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Feeling of body temperature change, Skin burning sensation
Clinical narrative: Skin feels like she rubbed icy hot all over her body /it feel like her face is on fire /She felt like she was running a fever but was not. She was hot and cold during the night; it burns; felt hot and cold; This is a spontaneous report from a contactable consumer (patient). A 27-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 17Jan2021 at single dose at left arm for covid-19 immunisation .  Medical history reported as none.  There were no concomitant medications. On 17Jan2021, the patient experienced skin feels like she rubbed icy hot all over her body, like if she scratched or touch it, it burns. There is no redness or rash.  Her work just sent her home because she is required to wear an N95 mask. Her breath against the mask makes it feel like her face is on fire and she cannot wear it. She felt like she was running a fever but was not.  She was hot and cold during the night, but her temperature was 98 degrees Fahrenheit.  She just took Benadryl and they sent her home. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination.  Information on lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Headache, Pruritus, Skin burning sensation, Vaccination site erythema
Clinical narrative: Itching/itchy/back was itching like crazy; her shoulder and it was red and it looked like a hive/like pinpoint little dots/this happened in the same shoulder where she received the vaccine; her shoulder and it was red and it looked like a hive/like pinpoint little dots/this happened in the same shoulder where she received the vaccine; Slight, dull headache; son sprayed her back with a fragranced alcohol and and it started burning; she thought it was a mosquito bite; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL1284), intramuscularly on 06Jan2021 at about 13:00 at single dose in Left arm for COVID-19. There were no medical history and no concomitant medications. She was not allergic to anything. The patient previously took shingles vaccine  for immunization before. The patient reported that in the middle of the week (in Jan2021) she started feeling itchy. She said that she did not take anything and never took the flu shot. She was itching so bad last night (on 17Jan2021) she was going nuts. Her doctor told her get BENADRYL. She looked at her shoulder and it was red and it looked like a hive. She said that 5 minutes later and it went away without her taking her BENADRYL. She took the BENADRYL  dose that she picked up from  and that put her out. She stated that she took 10ml. She was a little itchy. She stated that if you look at the area on her shoulder, it was like pinpoint little dots now and you can barely see it. She said that this happened in the same shoulder where she received the vaccine. She said that she w supposed to get the next one next Wednesday. The patient asked if this was a side effect or just a coincidence. She stated that her symptoms started about a week after the shot sometime, but she did not know the exact day. It was around 13Jan2021 or 14Jan2021. It happened in a matter of seconds and she thought she was seeing things, then it went away. It was red and raised and was gone within 5 minutes at the most. It was weird. She said that she thought it was a mosquito bite. The patient stated that her back was itching like crazy. She stated that she put alcohol on it and it went away. Her son sprayed her back with a fragranced alcohol and it started burning. She also had a slight dull headache in Jan2021 and she had never had that in her life. The outcome of events her shoulder and it was red and it looked like a hive/like pinpoint little dots/this happened in the same shoulder where she received the vaccine was recovered in Jan2021. The outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: Itching/itchy/back was itching like crazy; her shoulder and it was red and it looked like a hive/like pinpoint little dots/this happened in the same shoulder where she received the vaccine; her shoulder and it was red and it looked like a hive/like pinpoint little dots/this happened in the same shoulder where she received the vaccine; Slight, dull headache; son sprayed her back with a fragranced alcohol and and it started burning; she thought it was a mosquito bite; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL1284), intramuscularly on 06Jan2021 at about 13:00 at single dose in Left arm for COVID-19. There were no medical history and no concomitant medications. She was not allergic to anything. The patient previously took shingles vaccine  for immunization before. The patient reported that in the middle of the week (in Jan2021) she started feeling itchy. She said that she did not take anything and never took the flu shot. She was itching so bad last night (on 17Jan2021) she was going nuts. Her doctor told her get BENADRYL. She looked at her shoulder and it was red and it looked like a hive. She said that 5 minutes later and it went away without her taking her BENADRYL. She took the BENADRYL  dose that she picked up from  and that put her out. She stated that she took 10ml. She was a little itchy. She stated that if you look at the area on her shoulder, it was like pinpoint little dots now and you can barely see it. She said that this happened in the same shoulder where she received the vaccine. She said that she w supposed to get the next one next Wednesday. The patient asked if this was a side effect or just a coincidence. She stated that her symptoms started about a week after the shot sometime, but she did not know the exact day. It was around 13Jan2021 or 14Jan2021. It happened in a matter of seconds and she thought she was seeing things, then it went away. It was red and raised and was gone within 5 minutes at the most. It was weird. She said that she thought it was a mosquito bite. The patient stated that her back was itching like crazy. She stated that she put alcohol on it and it went away. Her son sprayed her back with a fragranced alcohol and it started burning. She also had a slight dull headache in Jan2021 and she had never had that in her life. The outcome of events her shoulder and it was red and it looked like a hive/like pinpoint little dots/this happened in the same shoulder where she received the vaccine was recovered in Jan2021. The outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: Dizzy; throwing up; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249), via an unspecified route of administration on left arm at 13:00 on 15Jan2021 at single dose for COVID-19 immunization. Medical history included diabetes, blood pressure abnormal and blood cholesterol abnormal. Concomitant medication included amlodipine taking for two or three years for blood pressure, atorvastatin taking for a year for cholesterol, canagliflozin (INVOKANA) taking for two years for diabetes, losartan taking for two or three years for blood pressure, metformin taking for two years for diabetes and pioglitazone taking for two years, all ongoing. Last night on 17Jan2021, the patient was throwing up and felt dizzy. She still felt that a little today. She was planning to get the second dose 05Feb2021. The outcome of events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: he has been deaf since he got out; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. He has been a truck driver all his life. The patient reported that he has been deaf since he got out, on an unknown date. He stated that his heart doctor wanted him to take a nuclear test on 20Jan2021. Patient did not want to take a test if it will interfere with his shot and he wanted to know if this will interfere with his shot. The final outcome of the event was unknown. Information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm (left arm)/At the injection site; This is a spontaneous report from a Pfizer sponsored program,  from a contactable consumer. This consumer reported similar events for two patients (himself and for his wife). This report is for his wife. A 78 (unit unknown) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 14Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 11Feb2021, she was scheduled for the next vaccine which was more than the 21 days. (County name) was only administering the (vaccine name), but she received the Pfizer vaccine, which was fine, but we have the appointment scheduled for the second dose according to the (vaccine name) time frame. She asked if she need to have that appointment changed. The patient experienced a sore arm (left arm) an hour after after vaccination we felt the soreness, it lasted maybe less than a day. At the injection site, but it was no biggie. She was asking what was the timing of the second dose of Pfizer-BioNTech COVID-19 vaccine and if she can receive it earlier or later than 3 weeks. The outcome of event was resolved in Jan2021.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) :  same reporter/drug/event, different patients