chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Erythema, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: The rash started on her palms, and migrated to different parts of her body; arm pain; hives and some redness on her belly; hives and some redness on her belly; "back of her ear looked swollen" and also involved her knees and toes.; "back of her ear looked swollen" and also involved her knees and toes.; "back of her ear looked swollen" and also involved her knees and toes.; This is a spontaneous report from a contactable consumer or other non hcp via medical information team. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch Number: EN6201) via an unspecified route of administration, administered in left arm on 15Apr2021 at 14:30 (at the age of 53-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. The reporter stated that his wife is healthy and does not take any other medications. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. Patient family medical history was reported as none. Patient Medical History including any illness at time of vaccination reported as none. It was reported that both parents have the vaccine and are fine. It was reported that she received her first dose of the Pfizer-BioNTech Covid19 vaccine and developed a rash a week later on 21Apr2021. He reported that her rash showed up out of nowhere and had nothing to do with the arm that she received the vaccine in. The rash started on her palms and migrated to different parts of her body including hives and some redness on her belly and the back of her ear looked swollen and also involved her knees and toes. The rash was short lived and resolved within 24 hours after treating with an antihistamine. It was reported that his wife noticed the rash at 10:00 pm that night. It was reported that she also had arm pain on 16Apr2021 that lasted for 2-3 days. Reporter stated that she is due for her second dose this Thursday and they are asking if she should still receive that dose or not. Patient received treatment with antihistamine for rash. Patient relevant Tests reported as none. The outcome of the event the rash started on her palms and migrated to different parts of her body was recovered on 22Apr2021 and the outcome of event arm pain was on unknown date in Apr2021. The outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: The rash started on her palms, and migrated to different parts of her body; arm pain; hives and some redness on her belly; hives and some redness on her belly; "back of her ear looked swollen" and also involved her knees and toes.; "back of her ear looked swollen" and also involved her knees and toes.; "back of her ear looked swollen" and also involved her knees and toes.; This is a spontaneous report from a contactable consumer or other non hcp via medical information team. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch Number: EN6201) via an unspecified route of administration, administered in left arm on 15Apr2021 at 14:30 (at the age of 53-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. The reporter stated that his wife is healthy and does not take any other medications. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. Patient family medical history was reported as none. Patient Medical History including any illness at time of vaccination reported as none. It was reported that both parents have the vaccine and are fine. It was reported that she received her first dose of the Pfizer-BioNTech Covid19 vaccine and developed a rash a week later on 21Apr2021. He reported that her rash showed up out of nowhere and had nothing to do with the arm that she received the vaccine in. The rash started on her palms and migrated to different parts of her body including hives and some redness on her belly and the back of her ear looked swollen and also involved her knees and toes. The rash was short lived and resolved within 24 hours after treating with an antihistamine. It was reported that his wife noticed the rash at 10:00 pm that night. It was reported that she also had arm pain on 16Apr2021 that lasted for 2-3 days. Reporter stated that she is due for her second dose this Thursday and they are asking if she should still receive that dose or not. Patient received treatment with antihistamine for rash. Patient relevant Tests reported as none. The outcome of the event the rash started on her palms and migrated to different parts of her body was recovered on 22Apr2021 and the outcome of event arm pain was on unknown date in Apr2021. The outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: Woke up that night with bad chills; Had low grade fever / fever kept increasing to about 102.7 F; Very tired/fatigued; Sweating a lot; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 26Apr2021 at 12:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included mild asthma. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), desvenlafaxine succinate monohydrate (PRISTIQ) and multivitamin (MANUFACTURER UNKNOWN); all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 at 13:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 02:00, the patient woke up that night with bad chills. On 27Apr2021, later that morning, the patient had low grade fever and was very tired/fatigued. Around 11:30, he took Motrin, felt better and around 15:30 felt very tired again and fever came back. He slept and fever kept increasing to about 102.7 Fahrenheit at 19:45 and around 20:30 took more Motrin. Fever came down and he was sweating a lot then after that no more fever. On 28Apr2021 (Wednesday), he felt pretty tired but was able to return to work. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ibuprofen (MOTRIN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events had low grade fever / fever kept increasing to about 102.7 F and sweating was resolved on 27Apr2021 while bad chills and very tired/fatigued was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Cough, Dyspnoea, Oropharyngeal pain, Throat irritation
Clinical narrative: She has been experiencing a sore throat; lost of her voice; a lot of coughing; Throat very irritated; Sometimes feels like she needs a little bit of air; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 61-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 28Apr2021 (at the age of 61-year-old) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced a sore throat, lost of her voice, a lot of coughing, throat very irritated, sometimes felt like she needs a little bit of air. She does not have a fever, no headache, no chills or any other symptoms. She doesn't have flu symptoms, and she doesn't know if it was a coincidence and if it was allergies. She has taken some over the counter medication. She doesn't know what to do. It has been a whole year without anything. She has been in her house. She doesn't know if these were side effects or what happened. She needs to know if this is normal or if this is just a regular cough. She was fine when she went to get the vaccine. She called her doctor and they were on break. Outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Day after 2nd injection, a rash in the chest area that has persisted as of today 5/3/21; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0117) via an unspecified route of administration in the left arm on 28Apr2021 at 08:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 08:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 09:00, day after 2nd injection the patient experienced a rash in the chest area that persisted as on the day of reporting on 03May2021. Therapeutic measures were taken as a result of event and included treatment with hydrocortisone (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (BENADRYL) dose. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event a rash in the chest area was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot, Pain in extremity, Pruritus
Clinical narrative: was a little tired; arm just started itching and blew"arm just started itching and blew up to a big, red ring/her arm started itching; her arm now has a big red circle around it and it's kind of hot; her arm now has a big red circle around it and it's kind of hot; Pain in arm; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8735) via an unspecified route of administration, administered in arm left on 22Apr2021 11:00 (at the age of 61-years-old) as dose 2, single for COVID-19 immunization. Medical history included back pain, knee pain and diabetes mellitus. The patient began experiencing back pain years ago; she had been experiencing knee pain for a few years. She was diagnosed with diabetes 10-15 years ago. Concomitant medications included gabapentin (GABAPENTIN); atorvastatin (ATORVASTATIN); bupropion hydrochloride (WELLBUTRIN); trazodone (TRAZODONE); levothyroxine (LEVOTHYROXINE) and metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8737) via an unspecified route of administration, administered in arm left on 01Apr2021 as dose 1, single for COVID-19 immunization. On an unspecified date, the patient was having side effects after a week from receiving her second COVID vaccine; the patient was little tired. On 27Apr2021, the patient's arm just started itching and blew arm just started itching and blew up to a big, red ring/her arm started itching; her arm now has a big red circle around it and it's kind of hot to the touch. She also had pain in arm. Pain in arm was reported as worsened. She was concerned because these symptoms did not happen right away. She added that it just seems strange that 5 days later after the COVID- 19 vaccine her arm would do that. She was still experiencing the itching sometimes; it hurts too much to scratch her arm, so she rubs it and that helps. Big red circle on arm it pretty much stayed the same. The heat and itching in her arm have gotten better but the pain has gotten worse. The outcome of the event the patient was a little tired was unknown. The outcome of the event arm just started itching and blew arm just started itching and blew up to a big, red ring/her arm started itching and her arm now has a big red circle around it and it's kind of hot was recovering. The outcome of the event erythema and pain in arm was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chills, Fatigue, Nausea, Neck pain
Clinical narrative: nausea; back pain; body pain; fatigue; chills; neck swelling; more in the back side of the neck, causing her pain.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 34-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Apr2021 (age at vaccination was 34 years) as DOSE 1, SINGLE for covid-19 immunization. Medical history included hypothyroidism (Consumer reports she has hypothyroidism) from an unknown date and unknown if ongoing. There were no concomitant medications. Reporter stated that the patient was vaccinated on 29Apr2021, Thursday. On 30Apr2021 at 05:00 PM (reported as Friday), the patient experienced nausea, back pain, body pain, fatigue, chills and neck swelling. The patient reported that the neck swelling was due to the two bumps both sides of neck and palm sized, and one more in the back side of the neck, causing her pain. Consumer called in requesting information about whether she should being vaccinated with second dose after these adverse effects with first dose. Outcome of the events was unknown.  No follow-up attempts are possible; Information about Lot/Batch Number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Swelling
Clinical narrative: nausea; back pain; body pain; fatigue; chills; neck swelling; more in the back side of the neck, causing her pain.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 34-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Apr2021 (age at vaccination was 34 years) as DOSE 1, SINGLE for covid-19 immunization. Medical history included hypothyroidism (Consumer reports she has hypothyroidism) from an unknown date and unknown if ongoing. There were no concomitant medications. Reporter stated that the patient was vaccinated on 29Apr2021, Thursday. On 30Apr2021 at 05:00 PM (reported as Friday), the patient experienced nausea, back pain, body pain, fatigue, chills and neck swelling. The patient reported that the neck swelling was due to the two bumps both sides of neck and palm sized, and one more in the back side of the neck, causing her pain. Consumer called in requesting information about whether she should being vaccinated with second dose after these adverse effects with first dose. Outcome of the events was unknown.  No follow-up attempts are possible; Information about Lot/Batch Number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: nausea; back pain; body pain; fatigue; chills; neck swelling; more in the back side of the neck, causing her pain.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 34-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Apr2021 (age at vaccination was 34 years) as DOSE 1, SINGLE for covid-19 immunization. Medical history included hypothyroidism (Consumer reports she has hypothyroidism) from an unknown date and unknown if ongoing. There were no concomitant medications. Reporter stated that the patient was vaccinated on 29Apr2021, Thursday. On 30Apr2021 at 05:00 PM (reported as Friday), the patient experienced nausea, back pain, body pain, fatigue, chills and neck swelling. The patient reported that the neck swelling was due to the two bumps both sides of neck and palm sized, and one more in the back side of the neck, causing her pain. Consumer called in requesting information about whether she should being vaccinated with second dose after these adverse effects with first dose. Outcome of the events was unknown.  No follow-up attempts are possible; Information about Lot/Batch Number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chills, Fatigue, Nausea, Neck pain
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient reported for herself). A 34-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date: unknown), at the age of 34, via an unspecified route of administration, administered at an unspecified anatomical location, on Apr 29, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient had a side effect after the first dose of the vaccine. On an unspecified date, patient had swelling around the back part of her neck. The swelling has not gone down and there are swollen lymph nodes. She said 14 days ago she was told to wait for 10 days until symptoms go away or lower. Some symptoms gone already, but others were not, such as swollen lymph nodes. She wanted to know if she should see her doctor again or not since they were still swollen. She asked if it was normal and should she consult with her doctor as to if she should get the second dose. She received a response stating that you should not get the Pfizer-BioNTech COVID-19 vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. They referred her to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The outcome of the events: not resolved. No follow-up attempts needed. Information about batch/lot number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient reported for herself). A 34-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date: unknown), at the age of 34, via an unspecified route of administration, administered at an unspecified anatomical location, on Apr 29, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient had a side effect after the first dose of the vaccine. On an unspecified date, patient had swelling around the back part of her neck. The swelling has not gone down and there are swollen lymph nodes. She said 14 days ago she was told to wait for 10 days until symptoms go away or lower. Some symptoms gone already, but others were not, such as swollen lymph nodes. She wanted to know if she should see her doctor again or not since they were still swollen. She asked if it was normal and should she consult with her doctor as to if she should get the second dose. She received a response stating that you should not get the Pfizer-BioNTech COVID-19 vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. They referred her to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The outcome of the events: not resolved. No follow-up attempts needed. Information about batch/lot number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient reported for herself). A 34-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date: unknown), at the age of 34, via an unspecified route of administration, administered at an unspecified anatomical location, on Apr 29, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient had a side effect after the first dose of the vaccine. On an unspecified date, patient had swelling around the back part of her neck. The swelling has not gone down and there are swollen lymph nodes. She said 14 days ago she was told to wait for 10 days until symptoms go away or lower. Some symptoms gone already, but others were not, such as swollen lymph nodes. She wanted to know if she should see her doctor again or not since they were still swollen. She asked if it was normal and should she consult with her doctor as to if she should get the second dose. She received a response stating that you should not get the Pfizer-BioNTech COVID-19 vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. They referred her to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The outcome of the events: not resolved. No follow-up attempts needed. Information about batch/lot number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue
Clinical narrative: Shortness of breath; Tired; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration on an unknown date (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced shortness of breath and tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event shortness of breath and tired was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Vomiting
Clinical narrative: vomiting; coughing; sore throat; This is a spontaneous report from a contactable consumer (wife). A 33-year-old male patient (husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 28Apr2021 (reported as on Wednesday) (at the age of 33-years-old) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications was not reported. On an unspecified date in 2021, after vaccination, the patient experienced vomiting, coughing and sore throat. It was reported, Today (at the time of report) after vaccination, the patient was having symptoms of vomiting, coughing and a sore throat. Reporter was asking should the patient go get tested for COVID or are these symptoms from the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Gait inability
Clinical narrative: Extreme pain in bones of right foot; Couldn't walk or move foot; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Apr2021 at 15:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and unspecified vitamin (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. On 26Apr2021 at 18:45 (reported as 18:30), 3 hours after the vaccination, only reaction the patient experienced was extreme pain in bones of right foot which lasted 12 hours and gone. It was reported that there was no visible bruising or swelling but no way to alleviate pain and couldn't walk or move foot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme pain in bones of right foot and couldn't walk or move foot was recovered on 27Apr2021 at 06:45.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest X-ray, Chest discomfort, Chest pain, Chills
Clinical narrative: experiencing chest pain/tightness over entire chest area; experiencing chest pain/tightness over entire chest area; 103 Fever; Body aches; Chills; Probably a pulled muscle; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration on 29Apr2021 at 16:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma as a young child. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration on 08Apr2021 at 16:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021, the patient experienced 103 fever, body aches and chills. On 01May2021 at 12:00, fever was gone however, the patient experienced chest pain/tightness over entire chest area. He had been to emergency room on 02May2021 at 04:00 AM and the patient's EKG and chest X-ray were normal and was told probably a pulled muscle. On 03May2021 at 14:00, the patient still had chest pain/tightness. On 30Apr2021, the patient underwent body temperature test and the result was 103 (units unspecified). On 02May2021, the patient underwent EKG and chest X-ray and the result was normal. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 103 fever was resolved on 01May2021 at 12:00 and of the events probably a pulled muscle, body aches, chills and chest pain/tightness was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Muscle strain, Pain, Pyrexia
Clinical narrative: experiencing chest pain/tightness over entire chest area; experiencing chest pain/tightness over entire chest area; 103 Fever; Body aches; Chills; Probably a pulled muscle; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration on 29Apr2021 at 16:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma as a young child. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration on 08Apr2021 at 16:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021, the patient experienced 103 fever, body aches and chills. On 01May2021 at 12:00, fever was gone however, the patient experienced chest pain/tightness over entire chest area. He had been to emergency room on 02May2021 at 04:00 AM and the patient's EKG and chest X-ray were normal and was told probably a pulled muscle. On 03May2021 at 14:00, the patient still had chest pain/tightness. On 30Apr2021, the patient underwent body temperature test and the result was 103 (units unspecified). On 02May2021, the patient underwent EKG and chest X-ray and the result was normal. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 103 fever was resolved on 01May2021 at 12:00 and of the events probably a pulled muscle, body aches, chills and chest pain/tightness was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, SARS-CoV-2 test
Clinical narrative: It caused "my" period to skip; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 27Apr2021 at 17:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. On 21Apr2021, the patient underwent COVID-19 test via nasal swab and the result was negative (also reported as prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19). The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included unspecified birth control medication from an unknown date and unknown if ongoing. On 28Apr2021, it was reported that it caused the patient's period to skip. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19 (also reported as Yes). The clinical outcome of the event it caused "my" period to skip was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Oropharyngeal pain, Pharyngeal swelling, Pruritus, Rash
Clinical narrative: whole upper body became itchy; hives on her upper body; the hives are "bumps and red/they are getting to her neck and she feels like may be a few getting to her face; swelling in her throat that hurt; swelling in her throat that hurt; rash was worse on her left arm/it also went "over my back and boobs and bellybutton; This is a spontaneous report from a contactable consumer (patient). A 25-years-old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration, administered in left arm on 22Apr2021 (Thursday) as dose 1, single (at the age of 25-years-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 25Apr2021, 3 days after the vaccine, patient got hives on her upper body and whole upper body became itchy and stated that throughout the rest of the week, it worsened, so patient saw her doctor on Saturday who prescribed her medicine and told her the hives were due to the vaccine. Patient stated that she has already had a week with hives and that hives normally go away within 24 hours. Patient stated that the hives were bumps and red and they were getting to her neck, and she feels like may be a few getting to her face, but she was not sure on Apr2021. On an unspecified date of 2021, patient rash was worse on her left arm where she received her vaccine versus the right arm, and states that it also went over my back and breasts and bellybutton. On an unspecified date of 2021, patient also had swelling in her throat that hurt, but stated she was never not able to breathe. Patient stated that she still has to get second dose of Pfizer COVID vaccine. Patient stated that she has read that when allergies come to being weird after the first dose of Pfizer COVID vaccine, that the person may not need the second dose. On 01May2021, patient went to the doctor on 1May2021 (Saturday), said it was fine for patient to get the second dose of Pfizer COVID vaccine, but the caller was interested in what Pfizer has in regard to information about getting the second dose of Pfizer COVID vaccine. Patient had doctor office visit for the events. Therapeutic measures were taken as a result of pruritus, rash, urticaria and erythema. The outcome of hives on her upper body was not recovered and unknown for rest of the events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: whole upper body became itchy; hives on her upper body; the hives are "bumps and red/they are getting to her neck and she feels like may be a few getting to her face; swelling in her throat that hurt; swelling in her throat that hurt; rash was worse on her left arm/it also went "over my back and boobs and bellybutton; This is a spontaneous report from a contactable consumer (patient). A 25-years-old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration, administered in left arm on 22Apr2021 (Thursday) as dose 1, single (at the age of 25-years-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 25Apr2021, 3 days after the vaccine, patient got hives on her upper body and whole upper body became itchy and stated that throughout the rest of the week, it worsened, so patient saw her doctor on Saturday who prescribed her medicine and told her the hives were due to the vaccine. Patient stated that she has already had a week with hives and that hives normally go away within 24 hours. Patient stated that the hives were bumps and red and they were getting to her neck, and she feels like may be a few getting to her face, but she was not sure on Apr2021. On an unspecified date of 2021, patient rash was worse on her left arm where she received her vaccine versus the right arm, and states that it also went over my back and breasts and bellybutton. On an unspecified date of 2021, patient also had swelling in her throat that hurt, but stated she was never not able to breathe. Patient stated that she still has to get second dose of Pfizer COVID vaccine. Patient stated that she has read that when allergies come to being weird after the first dose of Pfizer COVID vaccine, that the person may not need the second dose. On 01May2021, patient went to the doctor on 1May2021 (Saturday), said it was fine for patient to get the second dose of Pfizer COVID vaccine, but the caller was interested in what Pfizer has in regard to information about getting the second dose of Pfizer COVID vaccine. Patient had doctor office visit for the events. Therapeutic measures were taken as a result of pruritus, rash, urticaria and erythema. The outcome of hives on her upper body was not recovered and unknown for rest of the events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Pyrexia, Vaccination site pain
Clinical narrative: he had fever; strong pain under armpit and injection site.; very painful lump under the armpit/strong pain under armpit; very painful lump under the armpit; This is a spontaneous report from a contactable consumer (patient) reported for himself.  A 50-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8733, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The medical history was not reported. There were no concomitant medications. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration, administered on an unspecified date as dose 1, single for covid-19 immunisation. As per the report, he was vaccinated on Friday and on an unspecified date on Saturday, he had fever and a strong pain under armpit and injection site. Consumer reported that he has a very painful lump under the armpit. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Acne, Discomfort, Pruritus, Rash
Clinical narrative: Small pimples on the legs; Itching; Feeling uncomfortable; he has some rash on his arms and parts of his stomach and his back, some on his hands, legs and shoulder; This is a spontaneous report from a contactable consumer (patient himself). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EW0164, Expiry date, NDC number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 16Apr2021 (Age at vaccination 71-years-old) as dose 1, single for covid-19 immunisation. Medical history included thyroid disorder, prostate cancer from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for thyroid disorder, start and stop date were not reported; dutasteride, tamsulosin hydrochloride (ASOFLON DUO) taken for prostate cancer, start and stop date were not reported. The patient got the first Pfizer Covid vaccine on 16Apr2021, the next one must be 7May2021, but he got the first vaccine, it was 8 days after and on 24Apr2021 he had some rash on his arms and parts of his stomach and his back, some on his hands, legs and shoulder, it was itching a lot, small pimples on the legs, feeling uncomfortable, stated a doctor gave him some pills and it was for some allergy that he may have. After he took the medication went for 3 days and the rash is not going way. Worried about getting the next vaccine, seeking guidance and stated he also was eating fish this day as well, but has never had any reaction. The medications the doctor gave him for the rash are prednisone 5mg one time a day for 3 days, no refills. Product is in a pharmacy vial, NDC, Lot, and expiration date are unknown. For the itchings the doctor gave him loratadine. States this helped and the itching is better, but the rash is still there. Stated he also took Motrin for the itching. Therapeutic measures were taken for the events. The patient received treatment for the events. The clinical outcome for the events experienced he has some rash on his arms and parts of his stomach and his back, some on his hands, legs and shoulder was not recovered, itching was recovering, and rest other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pain
Clinical narrative: Significant body aches; Chills; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to peanut. Concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown, if the patient received any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced significant body aches, chills and brain fog. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events significant body aches, chills and brain fog was resolved on an unknown date.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: Passed blood in urine/on two occasion he passed blood in urine; This is a spontaneous report from a contactable consumer (caregiver/patient's parent) via h. An 18-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date, NDC number, UPC number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter called on behalf of son, aged 18 and reported he received first dose of Pfizer Covid 19 vaccine last Friday and then experienced blood in his urine the next day. Then today (unspecified date) he had blood in his urine again. It has happened twice, and the reporter asked was there any information on this. Father declined transfer to drug safety, has no insurance, son has no PCP Response and after searching  and spoke as per No Information and was referred back to HCP. Reporter questioned was that common for the vaccine, he has been transferred three times. Reporter was informed about health authority and was provided with the number. Reporter stated could they transfer or not; Please transfer me. Call could not be transferred to Pfizer Medical information department as the lines were busy. Product details (LOT, Expiration Date, NDC and UPC) and Pharmacy details could not be probed as the reporter hung up the call abruptly. Limited information was available over the call. After listening to a recording of the call, I can confirm the caller/reporter spelled his last name. He did give his first name, and it did sound, but he said it so fast it was not clear, and the Med Info agent did not have him confirmed the spelling of his first and last name and the caller did not spell his first name. It was stated that Could they help to confirm if reporter provided first name of reporter self since agency report provided first name and last name, they identified that the reporter of agency and this report was the same person since phone number was the same and event was similar. It was said that caller provided the name as however it was not spelled on call so was erroneously captured. help to confirm on the name of reporter was seeker since previous report was provided reporter first name and last name was unknown and it was identified that reporter of previous report and this report was the same person since phone number was the same and event was similar. The patient underwent lab tests and procedures which included passed blood in urine/on two occasion he passed blood in urine. Outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Discomfort, Fatigue
Clinical narrative: Exhausted; Body aches; Coughing; Fever; chills; Congestion; Chest pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route of administration in the left arm on 26Apr2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and kidney disease. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), benzalkonium chloride, sodium chloride (ALIVE), dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL) and dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EXT5318) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 15:00, the patient experienced exhausted, body aches, coughing, fever, chills, congestion and chest pain. Since the day the patient got the vaccine he had the symptoms at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events exhausted, body aches, coughing, fever, chills, congestion and chest pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.