chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site pain
Clinical narrative: severe chills; severe headache; Injection site pain; Fatigued; severe aches and pains (felt like broken glass in my bones).; Tired; Diarrhea; stomach cramps; Gas; This a spontaneous report from a contactable consumer, the patient. A 42-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL4237), via an unspecified route of administration in the left arm on 17Mar2021 at 13:45 hours (at the age 42-years-old) as single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 25Feb2021 at 13:00 hours (at the age of 42-years-old), as single dose for COVID-19 immunisation. Medical history included IBS (Irritable Bowel Syndrome) from an unknown date. Concomitant medications included probiotics (METAGENICS) for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021 at 20:00 hours, patient experienced diarrhea, gas/stomach cramps and was very tired. On 18Mar2021 at 01:30 hours, patient also experienced severe chills, headache and injection site pain. Patient continued to experience severe headache and pain. Therapeutic measure included self-treatment with EXCEDRIN which resulted into subsiding of the tension headache and body pain at 15:30 hours on 18Mar2021. The patient experienced fatigue and mostly slept rest of the day. The clinical outcome of tiredness, diarrhea, gas/stomach cramps, severe chills, headache, fatigue and injection site pain was resolving.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Vertigo
Clinical narrative: Constant headache beginning 1.5 days after shot; Vertigo with increasing frequency; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6199) via an unspecified route of administration on the left arm on 11Mar2021 at 17:30 (age at vaccination was 23-year-old) for COVID-19 immunisation. Her medical history included arachnoid cyst and allergy to cashew, pistachio, mango, papaya, ceftin and cats. Concomitant medication (received within 2 weeks of vaccination) included norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate (LO LOESTRIN FE) used for an unreported indication. She did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, she was not diagnosed with COVID-19 and since the vaccination, she had not been tested positive for COVID-19. On 12Mar2021 at 14:00, vertigo with increasing frequency, diarrhea the day after shot. On 13Mar2021 (beginning 1.5 days after the shot), she experienced constant headache primarily on the back of the head. Still hurts a week after shot. No therapeutic measures were taken to treat these events. The clinical outcome of headache, vertigo and diarrhea was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Insomnia, Musculoskeletal chest pain, Oropharyngeal pain
Clinical narrative: sore ribs; sleep loss; Sinus congestion; Headache; Cough; Sore throat.; cough worsened; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot: EN6207) via an unspecified route of administration in the Left Arm on 14Mar2021 at 13:30 (at the age of 68-years) as a single dose for COVID-19 Immunisation. Medical history included Neuropathy in feet, Seasonal allergies and Corn products. The patient previously took Caffeine and experienced allergy . Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Zolpidem (MANUFACTURER UNKNOWN), Doxepin (MANUFACTURER UNKNOWN), Alendronate (MANUFACTURER UNKNOWN) and Multivitamins (MANUFACTURER UNKNOWN) and Flute. Since the vaccination, patient had not tested positive for COVID-19. On 14Mar2021 at 19:30, the patient had experienced sinus congestion, headache, cough and sore throat and cough worsened. Four days later, patient still had sinus congestion, headache and cough which had resulted in sore ribs and sleep loss. Therapeutic measures were taken as a result of sinus congestion, headache, cough, cough worsened, sore throat, rib pain, sleep loss and included treatment with aspirin, drinking hot liquids, applying warm compress and benedryl, but it did not help with congestion. The clinical outcome of sore throat was recovered, of the sinus congestion, headache, cough, rib pain, sleep loss were not resolved and of cough aggravated was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: sore ribs; sleep loss; Sinus congestion; Headache; Cough; Sore throat.; cough worsened; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot: EN6207) via an unspecified route of administration in the Left Arm on 14Mar2021 at 13:30 (at the age of 68-years) as a single dose for COVID-19 Immunisation. Medical history included Neuropathy in feet, Seasonal allergies and Corn products. The patient previously took Caffeine and experienced allergy . Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Zolpidem (MANUFACTURER UNKNOWN), Doxepin (MANUFACTURER UNKNOWN), Alendronate (MANUFACTURER UNKNOWN) and Multivitamins (MANUFACTURER UNKNOWN) and Flute. Since the vaccination, patient had not tested positive for COVID-19. On 14Mar2021 at 19:30, the patient had experienced sinus congestion, headache, cough and sore throat and cough worsened. Four days later, patient still had sinus congestion, headache and cough which had resulted in sore ribs and sleep loss. Therapeutic measures were taken as a result of sinus congestion, headache, cough, cough worsened, sore throat, rib pain, sleep loss and included treatment with aspirin, drinking hot liquids, applying warm compress and benedryl, but it did not help with congestion. The clinical outcome of sore throat was recovered, of the sinus congestion, headache, cough, rib pain, sleep loss were not resolved and of cough aggravated was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: Vertigo; Nausea; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on 15Mar2021 at 08:30 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included asthma and vertigo. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not receiving concomitant medications. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 17Mar2021 at 18:00, two days after vaccination, the patient suffered from severe vertigo and nausea. The patient did not receive any treatment for the adverse event. The clinical outcome of the events nausea and vertigo was recovered in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Palpitations, Pharyngeal swelling, Vaccination site pain
Clinical narrative: Injection site burned when administered; Felt dizzy and light headed; Heart raced and started sweating; Heart raced and started sweating; Throat felt swelled at base; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot Number: EN6204) as a single dose, via an unspecified route of administration in the left arm on 18Mar2021 at 09:00 for COVID-19 immunisation (at the age of 30 years old). The patient had no medical history. The patients concomitant medication included LOLOESTRIN for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced injection site burned when administered after 4minutes, dizzy and lightheaded, Heart raced and started sweating, throat felt swollen at base on 18Mar2021 at 09:00.  The patient was treated with BENADRYL for the event. At the time of report, the clinical outcome of the events injection site burned, dizziness, heart racing, sweating and throat swelling were recovered.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Temperature for about 56 hours with about 40 hours being 104-105  range; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number:EN6201 ), via an unspecified route of administration in the left arm on 18Feb2021 at 12:00 and second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 11Mar2021 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. The patient was not pregnant at the time of report. The medical history included high BP, Asthma.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had received BP medication within two weeks of vaccination. On 11Mar2021 at 20:30  patient had experienced high temperature for about 56 hours with about 40 hours being 104-105  range. The clinical outcome of the High temperature was unknown at the time of this report. Therapeutic measures were taken as a result of the High temperature and included treatment with Tylenol. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: positive for COVID-19; exposed to COVID; This is a spontaneous report from a contactable consumer (patient's mother). A 22-year-old female patient (reporter's daughter) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 12Mar2021, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter (patient's mother) reported that she, her husband, and her daughter all received the first dose of the Pfizer COVID-19 vaccine last Friday, 12Mar2021. She stated that her daughter was exposed to COVID-19 the next day on 13Mar2021, started having symptoms on Wednesday and was tested for COVID-19. She received her results today and her daughter was positive for COVID-19 on 17Mar2021. All three of them were scheduled to receive their second dose of the Pfizer COVID-19 vaccine on 02Apr2021 and the reporter would like to know what her daughter should did about receiving her second dose. The reporter would also like information on what her and her husband should do regarding their second doses scheduled on 02Apr2021 since they were now considered exposed to COVID-19 because the daughter lives with them in their household. The daughter has been quarantined and isolated away from the rest of the family. The reporter would like to know if her daughter has to reschedule her second dose of the Pfizer COVID-19 vaccine due to her having COVID-19 would she have to restart the vaccination series and also would like to know if receiving the first dose of the Pfizer COVID-19 vaccine might help decrease symptoms of COVID-19 or make it less severe should her and her husband become positive. The reporter wanted to know if her and her husband will be "any worse off" since they received the first dose of the Pfizer COVID-19 vaccine if they did end up testing positive for COVID-19. Clarified with reporter and wanted to verify that the vaccine would make an infection stronger due to the way the vaccine works. The reporter stated that she was on hold for an hour and a half and then she was transferred to a Pharmacy in another department then that pharmacist said, "I'm not sure why you were transferred to this department." 3 family were vaccinated last week Friday. The patient's (daughter's) boyfriend tested positive for COVID-19. The patient underwent lab tests and procedures which included that she was tested positive on Wednesday,17Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Gait disturbance, Suspected COVID-19
Clinical narrative: Now, she has the exact symptoms as when she had Covid; She can barely walk up the stairs; loss of appetite; This is a spontaneous report from a contactable consumer (on behalf of her sister) via Medical information team. A female patient of unspecified age (Age: 60, Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration on 20Mar2021, as 1st single dose for COVID-19 immunization. Medical history included COVID-19 on Dec2020. The patient's concomitant medications were not reported. The reporter stated that the patient had COVID in early December and had severe muscle aches and pain, loss of appetite, headache but not a fever. After vaccination, she had the exact symptoms as when she had COVID. Patient feels like she has COVID again. It was reported that she could barely move in December. She stated that it was from the shot because she was fine up until she went for her shot. She started feeling it later on that night and the next morning (which she states was today). Patient could barely walk up the stairs. She stated they understand that they will be worse after the second dose. The reporter enquired if these symptoms are normal and how long they would last and if she can expect for it to be worse after the second dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's mother) from Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 17Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It has been reported that, the patient might have been infected with the virus prior to receiving the COVID-19 vaccine. On 20Mar2021, after receiving the first dose, (reported as Saturday evening around 5:00-6:00 PM) patient experienced, chills, aches, and temperature. On 21Mar2021, 2 days after vaccination, (reported as Sunday), patient had a rapid test for Covid, and it was positive. It was also reported that, he didn't have any reaction, apart from Covid but patient felt fine that day. Patient will finish isolation on 30Mar2021 and was scheduled to receive the second dose on 07Apr2021, but Pharmacist that he should take a test to confirm that he was negative to get the second vaccine. Outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm for 1.5 days; This is a spontaneous report from a non-contactable pharmacist reporting for a patient. A non-pregnant female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EL3247) intramuscularly in the left arm as a single dose on 09Mar2021 at 10:45 (age at vaccination unknown) for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Mar2021, the patient experienced sore arm and it lasted for 1.5 days. The patient did not receive any treatment for the event. The clinical outcome of the event sore arm was resolved on an unknown date of Mar2021 at the time of this report.   No follow-up attempts are possible No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: soreness and pain on injection site; fatigue; muscle aches; unable to focus; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EB6202), via an unspecified route of administration in the right arm on 17Mar2021 at 11:30 (at the age of 24-years-old), as single dose for COVID-19 immunisation. Medical history included decreased blood sugar, vitamin D deficiency, ovarian cyst and was diagnosed with COVID-19 virus prior to vaccination. The patient was allergic to bananas (fruit allergy). Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 17Mar2021, the patient experienced soreness and pain on injection site, fatigue, muscle aches and was unable to focus. No therapeutic measures were taken for the reported events. The clinical outcome of the soreness and pain on injection site, fatigue, muscle aches and unable to focus were not recovered/ongoing.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: First symptoms of covid; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), dose 1 via an unspecified route of administration, administered in right arm on 12Mar2021 as single dose for COVID-19 immunization. Medical history included ongoing Graves disease, ongoing hyperthyroidism (both diagnosed 12 years ago), ongoing obesity. The patient's concomitant medications included ongoing levothyroxine sodium (SYNTHROID) for thyroid (been on it for twelve years). No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations. On 22Mar2021 she had the first symptoms of covid. On 26Mar2021 she received that antibiotic cocktail and now she is good. She is to get her second dose this coming Friday, 02Apr2021. She wanted to know if she can get the second dose. The outcome for the events was recovered in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache
Clinical narrative: pressure movement headaches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on Feb2021 as 2nd dose, single for COVID-19 immunization; exemestane (EXEMESTANE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 25 mg, daily for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The consumer reported that she was taking generic exemestane 25 mg daily manufactured by for 3 years as of this August. The consumer reports she had experienced a frozen shoulder in the neck while taking generic exemestane. At the beginning of Feb 2021, the consumer received her second dose of the Pfizer covid-19 vaccine. For about the past two months, the consumer had been experiencing pressure movement related headaches, described as getting a headache when she coughs, bends down, or strains. The consumer thought that the pressure movement headaches might be due to exemestane or perhaps even the Pfizer covid-19 vaccine, although she felt it was more likely to be due to exemestane. She also felt it was also very possible the pressure movement headaches are not related to exemestane or the Pfizer covid-19 vaccine at all. The consumer asked that the Pfizer covid-19 vaccine can cause headache and how long do the headaches last. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: To delete the event headaches "might be due to exemestane or perhaps even the Pfizer covid-19 vaccine".
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Electrocardiogram, Erythema, Headache, SARS-CoV-2 test
Clinical narrative: Generalized erythema; After dose 2 woke day after w/same headache but it only lasted 8 to 10 hours; This is a spontaneous report from a contactable other hcp. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 2 via an unspecified route of administration, administered in Arm Left on 20Feb2021 16:00 (Batch/Lot Number: 1-N6201) as 2nd Dose, SINGLE DOSE for covid-19 immunisation. Medical history included sinus issues environmental 'dust mites, ash trees which came sinus issues,  exposure to sars-cov-2 from an unknown date and unknown if ongoing. The patient concomitant medication was not reported. The patient previously took first dose bnt162b2 for covid-19 immunisation and experienced Chest tightness/achiness, mild/partial loss of smell, headache, sinus discomfort (pressure, ache), Breast tenderness and patient previously took penicilline and experienced urticaria. About 5 or 80 years ago retested and not allergic any longer. The patient experienced after dose 2 woke day after w/same headache but it only lasted 8 to 10 hours on 21Feb2021 and generalized erythema on an unspecified date. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-COV2 other than Pfizer-BioNTech COVID-19 vaccine prior to the event being reported.  the patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 vaccine vaccination. The patient did not dermatological/mucosal, generalized urticaria (hives), angioedema (not hereditary), generalized pruritus with skin rash, generalized pruritus without skin rash, generalized prickle sensation, gastrointestinal, diarrhea, abdominal pain, nausea, vomiting. The patient underwent lab tests and procedures which included chest x-ray: normal, electrocardiogram: normal, sars-cov-2 test: negative on an unspecified date. The patient did not receive any treatment for the event after dose 2 woke day after w/same headache but it only lasted 8 to 10 hours. The outcome of the events after dose 2 woke day after w/same headache but it only lasted 8 to 10 hours was reported as recovered on an unspecified date and generalized erythema was reported as unknown.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: headache; fever; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 immunisation. It was reported that the patient received 2nd dose of Pfizer vaccine and had reaction last night (Apr2021) headache and fever. Today (07Apr2021) just feel his headache. The patient wanted to know what kind of medicine he can take for pain, can he take Tylenol. Outcome of the headache was not recovered and fever was recovered in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Migraine, Nausea, Pain in extremity
Clinical narrative: headache too on the one side of her head. It was just like migraines; face was swollen started with cheeks and then all over the face; Nausea, felt like throwing up; tiredness; headache too on the one side of her head. It was just like migraines; arm is sore; tingling in mouth; This is a spontaneous report received from a contactable consumer (Patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0162, Expiration date: Unknown), via an unknown route of administration on 08Apr2021 10:00 (at the age of 64-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included migraine medication. On 08Apr2021 the patient experienced, tingling in mouth, started when she got into the car after the vaccination. It started a little bit then.  She thought it would go away. She was kind of thinking about it, it was not severe. It was like her mouth is like a little bit swollen but it is nothing like she had a hard time swallowing or anything like that. It was still going on. Her arm was sore. She stated "she knows this is a common side effect. It was still sore. She did a lot of stretching, and it was fine and it is just the usual. On 09Apr2021, at night before she went to bed, she felt some soreness in her face like this morning she woke up and it was swollen, her cheeks were very swollen and her whole face was swollen. Caller read on the information that usually people get side effects right there, but she had a delayed reaction.  The swelling was scary. Caller has a headache too on the one side of her head.  She did take a pain reliever.  The headache was still there. It was like migraines. Usually, she takes a migraine medicine but she took Tylenol for headache but the headache was still there on the right side. Same day, on 09Apr2021 she also experienced nausea, felt like throwing up which started morning, and went away. It was just for the first few minutes this morning; it came and went away. She added she had tiredness. She added that a lot of things happened this morning.  it is like she had a delayed reaction. Caller added her vaccine appointment was 10 o clock 08Apr2021, so she felt side effects around that same time 24 hours later. Patient was worried and asked that she was scheduled in three weeks for the second vaccine, and what should she do at that time.  She wanted to know if her side effects will be more severe and if the amount of vaccination in the second vaccine is the same amount or is it more than the second. Outcome for nausea, felt like throwing up was resolved on 09Apr2021. Outcome for other events it was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swelling face
Clinical narrative: headache too on the one side of her head. It was just like migraines; face was swollen started with cheeks and then all over the face; Nausea, felt like throwing up; tiredness; headache too on the one side of her head. It was just like migraines; arm is sore; tingling in mouth; This is a spontaneous report received from a contactable consumer (Patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0162, Expiration date: Unknown), via an unknown route of administration on 08Apr2021 10:00 (at the age of 64-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included migraine medication. On 08Apr2021 the patient experienced, tingling in mouth, started when she got into the car after the vaccination. It started a little bit then.  She thought it would go away. She was kind of thinking about it, it was not severe. It was like her mouth is like a little bit swollen but it is nothing like she had a hard time swallowing or anything like that. It was still going on. Her arm was sore. She stated "she knows this is a common side effect. It was still sore. She did a lot of stretching, and it was fine and it is just the usual. On 09Apr2021, at night before she went to bed, she felt some soreness in her face like this morning she woke up and it was swollen, her cheeks were very swollen and her whole face was swollen. Caller read on the information that usually people get side effects right there, but she had a delayed reaction.  The swelling was scary. Caller has a headache too on the one side of her head.  She did take a pain reliever.  The headache was still there. It was like migraines. Usually, she takes a migraine medicine but she took Tylenol for headache but the headache was still there on the right side. Same day, on 09Apr2021 she also experienced nausea, felt like throwing up which started morning, and went away. It was just for the first few minutes this morning; it came and went away. She added she had tiredness. She added that a lot of things happened this morning.  it is like she had a delayed reaction. Caller added her vaccine appointment was 10 o clock 08Apr2021, so she felt side effects around that same time 24 hours later. Patient was worried and asked that she was scheduled in three weeks for the second vaccine, and what should she do at that time.  She wanted to know if her side effects will be more severe and if the amount of vaccination in the second vaccine is the same amount or is it more than the second. Outcome for nausea, felt like throwing up was resolved on 09Apr2021. Outcome for other events it was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; fatigue; This is a spontaneous report from a contactable female consumer. A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as unknown single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient experienced headache and fatigue after the use of the product. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Fatigue, Headache, Hypersensitivity
Clinical narrative: Headache; Kind of tight lumps in my throat like hard swollen; kind of difficulty; Tired; Jaw very stiff like it was pulled down; Blood pressure has been up; Anxiety; thought I have become an allergies reaction; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A female patient of an unspecified age of height about 5feet 2 inches and weight probably about 148 (pounds)received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date on Thursday after the first dose she got a headache and that come up well, it was pretty normal, the headache. Probably about ten minutes after she started seemed like kind of tight lumps in her throat like kind of hard swollen. She thought she had allergic reaction because she reported to have lots of allergies to medications (unspecified medication) and other things too that happened. She also reported vaccination site" (not clarified) all this happening with the vaccination, about the swallowing and all about the tightness, had this probably about an hour. She wished she was in an ER(not clarified). She reported to have gone home and checked the history if it help but she was tired and slept but woke up with Jaw very stiff like it was pulled down. She asked if that was a normal side effect with jaw stiffness. Her blood pressure was up since then. She was concerned about her blood pressure, possibly anxiety related but she don't do this so, may be an allergic reaction." On an unspecified date patient received dose 2 of Covid-19 vaccine. Outcome of all the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.      No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Pharyngeal swelling
Clinical narrative: Headache; Kind of tight lumps in my throat like hard swollen; kind of difficulty; Tired; Jaw very stiff like it was pulled down; Blood pressure has been up; Anxiety; thought I have become an allergies reaction; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A female patient of an unspecified age of height about 5feet 2 inches and weight probably about 148 (pounds)received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date on Thursday after the first dose she got a headache and that come up well, it was pretty normal, the headache. Probably about ten minutes after she started seemed like kind of tight lumps in her throat like kind of hard swollen. She thought she had allergic reaction because she reported to have lots of allergies to medications (unspecified medication) and other things too that happened. She also reported vaccination site" (not clarified) all this happening with the vaccination, about the swallowing and all about the tightness, had this probably about an hour. She wished she was in an ER(not clarified). She reported to have gone home and checked the history if it help but she was tired and slept but woke up with Jaw very stiff like it was pulled down. She asked if that was a normal side effect with jaw stiffness. Her blood pressure was up since then. She was concerned about her blood pressure, possibly anxiety related but she don't do this so, may be an allergic reaction." On an unspecified date patient received dose 2 of Covid-19 vaccine. Outcome of all the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.      No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Nausea; Fatigue; Random jumps in blood pressure; BP is still very unstable; Random jumps in heart rate; heart rate jumps are worse; extreme heart rate jump; This is a spontaneous report from contactable consumer (patient). A non-pregnant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: TER8733), via an unspecified route of administration in left arm, on 06Apr2021 at 09:30 AM (at the age of 64 years), as first dose, single dose, for COVID-19 immunization. The patient's medical history included high cholesterol. The patient's concomitant medications included ezetimibe (ZETIA), colecalciferol (VITAMIN D), and ascorbic acid (VITAMIN C). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Apr2021 at 12:00 PM, the patient experienced nausea and fatigue related to random jumps in blood pressure (BP) and heart rate. After visits to physician and emergency room (ER), no other cause was found. The patient was put on losartan as treatment, but BP is still very unstable and heart rate jumps are worse (Apr2021). The patient cannot walk to bathroom without extreme heart rate jump, this was going on for weeks and not getting better. The patient assessed the events as non-serious. Since the vaccination, the patient has been tested for COVID-19 (nasal swab) on 16Apr2021 that was negative. The patient had not recovered from the events.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test
Clinical narrative: Nausea; Fatigue; Random jumps in blood pressure; BP is still very unstable; Random jumps in heart rate; heart rate jumps are worse; extreme heart rate jump; This is a spontaneous report from contactable consumer (patient). A non-pregnant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: TER8733), via an unspecified route of administration in left arm, on 06Apr2021 at 09:30 AM (at the age of 64 years), as first dose, single dose, for COVID-19 immunization. The patient's medical history included high cholesterol. The patient's concomitant medications included ezetimibe (ZETIA), colecalciferol (VITAMIN D), and ascorbic acid (VITAMIN C). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Apr2021 at 12:00 PM, the patient experienced nausea and fatigue related to random jumps in blood pressure (BP) and heart rate. After visits to physician and emergency room (ER), no other cause was found. The patient was put on losartan as treatment, but BP is still very unstable and heart rate jumps are worse (Apr2021). The patient cannot walk to bathroom without extreme heart rate jump, this was going on for weeks and not getting better. The patient assessed the events as non-serious. Since the vaccination, the patient has been tested for COVID-19 (nasal swab) on 16Apr2021 that was negative. The patient had not recovered from the events.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast tenderness
Clinical narrative: breast pain/tenderness for the last 9 days; breast pain/tenderness for the last 9 days; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Apr2021 as, 2nd dose single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient received a 2nd dose of the Pfizer COVID vaccine on 18Apr2021 and have been experiencing breast pain/tenderness for the last 9 days, but she was not experiencing any lumps or swollen glands. The outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling of the gland; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced a side effect after getting the vaccine which was swelling of the gland. The outcome of swelling of the gland was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Skin disorder
Clinical narrative: Swollen lymph nodes on the left side; Little bumps on his face had worsened; This is a spontaneous report from a contactable consumer (patient's friend). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration in left arm, on 08Apr2021 (afternoon), as first dose, single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had his first vaccine on 08Apr2021, and he is scheduled for his second dose this Thursday (29Apr2021) and told his friend he has swollen lymph nodes still; it started late (15Apr2021). They are on the left side, the same side as the patient got the shot on. The patient had swollen lymph nodes, and he has little bumps on his face on 15Apr2021 for which he had been using diphenhydramine hydrochloride (BENADRYL) cream as treatment. Little bumps on the patient's face had worsened. According to what the patient's friend was reading on the Pfizer site, that can happen but usually only starts within a few days of the vaccine. The patient's friend was asking, if the patient still has these, if he should still take the second vaccine on Thursday. The patient had not recovered from the events.  Information about lot or batch number for the suspect product will be requested in follow-up attempts.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: was a little achy; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on an unspecified date, as second dose, single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included amlodipine besilate (NORVASC), metoprolol tartrate (manufacturer unknown), and spironolactone (manufacturer unknown) all taken for an unspecified indication and start and stop dates were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on an unspecified date, as first dose, single dose for COVID-19 immunisation. After receiving the first dose of BNT162B2, patient experienced sore arm on an unspecified date. After receiving the second dose of BNT162B2, the patient was a little achy on an unspecified date. Patient took a warm bath as a result of being a little achy. The outcome of event was unknown. Causality was assessed as related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: Ear pain; This is a spontaneous report from a contactable consumer (the patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first Pfizer COVID vaccine dose. She was due for her second dose today, 10May2021. She stated she was having ear pain and was anticipating taking antibiotics to treat it. She wanted to know if she were to start taking antibiotics, should she wait to take the second dose of the vaccine? The outcome of ear pain was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: "a good amount" of swelling in his arm after the injection; This is a spontaneous report from a non-contactable consumer (the patient) via a company representative. A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the arm on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had "a good amount" of swelling in his arm the day after his first injection. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: fever; swollen lymph nodes; This is a spontaneous report from a Pfizer-sponsored from a contactable consumer (patient reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04May2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient's medical history included previously contracted with Covid-19. The patient's concomitant medications were not reported. The patient received the first dose of the Pfizer COVID-19 vaccine 5 days ago, on 04May2021, and was experiencing some side effects from the vaccine which include fever and swollen lymph nodes on 09May2021. She was trying to understand if it was normal to have these symptoms after 5 days of the first dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.