chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Body temperature, Fatigue, Insomnia
Clinical narrative: Sore arm; abdominal pain; migraine; intense body pain; joint pain; swollen ankles; 99 degree fever; fatigue; insomnia; This is a spontaneous report from a contactable consumer (patient). A 62-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 right arm on 19Mar2021 at 13:45 at the age of 62-year-old as a dose 1, single for COVID-19 immunisation. Medical history included Post-traumatic stress disorder, fibromyalgia-in remission. The patient was allergic to yellow jackets, lactose intolerant, some anaesthesia shut the patient's bladder done. Concomitant medications included suvorexant (BELSOMRA), quetiapine fumarate (SEROQUEL), alprazolam, citalopram hydrobromide (CELEXA) and aspirin all started on an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 19Mar2021 at 13:45, after the vaccination, the patient experienced sore arm, abdominal pain, migraine, intense body and joint pain, swollen ankles, 99-degree fever, fatigue and insomnia. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatment were not taken for the reported events. The outcome of the events was recovered on an unknown date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Migraine, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; abdominal pain; migraine; intense body pain; joint pain; swollen ankles; 99 degree fever; fatigue; insomnia; This is a spontaneous report from a contactable consumer (patient). A 62-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 right arm on 19Mar2021 at 13:45 at the age of 62-year-old as a dose 1, single for COVID-19 immunisation. Medical history included Post-traumatic stress disorder, fibromyalgia-in remission. The patient was allergic to yellow jackets, lactose intolerant, some anaesthesia shut the patient's bladder done. Concomitant medications included suvorexant (BELSOMRA), quetiapine fumarate (SEROQUEL), alprazolam, citalopram hydrobromide (CELEXA) and aspirin all started on an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 19Mar2021 at 13:45, after the vaccination, the patient experienced sore arm, abdominal pain, migraine, intense body and joint pain, swollen ankles, 99-degree fever, fatigue and insomnia. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatment were not taken for the reported events. The outcome of the events was recovered on an unknown date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dysuria, Pain
Clinical narrative: I had continuous fever and its fluctuate it doesn't drop; in the morning it was 102 and spikes in night goes up to 103; Chills; Joint pain; It burns to urinary; The second dose did not work for me; I am having trouble with pain relief medicine not doing their job; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch no: not reported/Lot number- ER8727) via an unspecified route of administration in arm left (reported as left) on 21Mar2021 (at the age of vaccination of 69-years-old) as dose 2, single for COVID-19 immunization. Patient also received ibuprofen (oral suspension) via an unspecified route of administration on an unspecified date. Patient's relevant medical history included with blood pressure, cholesterol, gout, kidney stones and enlarged prostate. Concomitant medications included ongoing amlodipine for the Indication of Blood pressure, ongoing Atorvastatin for the Indication of Cholesterol, ongoing allopurinol for the Indication of Gout, ongoing potassium citrate for the Indication of Kidney stones and ongoing tamsulosin for the Indication of Enlarged prostate, all were from unknown start date. On 22Mar2021, patient had continuous fever and it was fluctuated it does not drop; in the morning it was 102 and spikes in night goes up to 103, chills, joint pain, it burns to urinary, and he had trouble with pain relief medicine not doing their job. Patient reported as he had Covid-19 Vaccine on 21Mar2021, and the nurse told me that he could expect the side effects and they would last for 24-36 hours. On 22Mar2021, patient started experiencing side effects however this was his 4th day which he had continuous fever and it was fluctuate it does not drop, in the morning it was 102 and spikes in night goes up to 103 that's pretty much the fever for 4 days that kind he had and he taken Ibuprofen as Treatment for which it worked for the first dose and for the second dose did not work. Patient had trouble with pain relief medicine not doing their job and asked for any better option for this, hence Ibuprofen coded as Conservatively captured as co-suspect. Also, he had chills, joint pain and have been treated for enlarge prostate, drinking lot of water like he supposed to but it burns to urinary some and it does not a big urgency, so he had some effects with prostate. Investigation Assessment was reported as No. Treatment was received with Ibuprofen for the events. Outcome of the events was not recovered.   No follow-up attempts are possible. Information on Batch number, Lot number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: I had continuous fever and its fluctuate it doesn't drop; in the morning it was 102 and spikes in night goes up to 103; Chills; Joint pain; It burns to urinary; The second dose did not work for me; I am having trouble with pain relief medicine not doing their job; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch no: not reported/Lot number- ER8727) via an unspecified route of administration in arm left (reported as left) on 21Mar2021 (at the age of vaccination of 69-years-old) as dose 2, single for COVID-19 immunization. Patient also received ibuprofen (oral suspension) via an unspecified route of administration on an unspecified date. Patient's relevant medical history included with blood pressure, cholesterol, gout, kidney stones and enlarged prostate. Concomitant medications included ongoing amlodipine for the Indication of Blood pressure, ongoing Atorvastatin for the Indication of Cholesterol, ongoing allopurinol for the Indication of Gout, ongoing potassium citrate for the Indication of Kidney stones and ongoing tamsulosin for the Indication of Enlarged prostate, all were from unknown start date. On 22Mar2021, patient had continuous fever and it was fluctuated it does not drop; in the morning it was 102 and spikes in night goes up to 103, chills, joint pain, it burns to urinary, and he had trouble with pain relief medicine not doing their job. Patient reported as he had Covid-19 Vaccine on 21Mar2021, and the nurse told me that he could expect the side effects and they would last for 24-36 hours. On 22Mar2021, patient started experiencing side effects however this was his 4th day which he had continuous fever and it was fluctuate it does not drop, in the morning it was 102 and spikes in night goes up to 103 that's pretty much the fever for 4 days that kind he had and he taken Ibuprofen as Treatment for which it worked for the first dose and for the second dose did not work. Patient had trouble with pain relief medicine not doing their job and asked for any better option for this, hence Ibuprofen coded as Conservatively captured as co-suspect. Also, he had chills, joint pain and have been treated for enlarge prostate, drinking lot of water like he supposed to but it burns to urinary some and it does not a big urgency, so he had some effects with prostate. Investigation Assessment was reported as No. Treatment was received with Ibuprofen for the events. Outcome of the events was not recovered.   No follow-up attempts are possible. Information on Batch number, Lot number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Malaise
Clinical narrative: cough; headache; feeling sick; This is a spontaneous report from a Pfizer-sponsored program Covax US Support. A contactable consumer reported for male patient of an unspecified age (Father) that he received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on 05Mar2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cough, headache, feeling sick on an unspecified date. His second dose was scheduled on 26Mar2021. Reporter asked if it was okay to get the second dose. The outcome of event was unknown.  Follow up attempts are Completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Renewed itching after 2nd dose; This is a spontaneous report received from a contactable consumer (patient) reported in response to non-HCP letter sent in cross reference case. A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL92102) (also reported as EL9262 May2021), dose 2 intramuscular, administered in Arm Left (upper) on an unspecified date in Jan2021 (Mid-afternoon, at the age of 77-years-old) as dose 2, single for COVID-19 immunisation. Patient's medical history (including any illness at time of vaccination) was unknown and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK4176, expiration date: Mar2021), dose 1 intramuscular, administered in Arm Left (upper) on 31Dec2020 (at the age of 77-years-old) as dose 1, single for COVID-19 immunisation and experienced It's really itchy on his back and several other places left upper arm and bum (Urticaria and Itchy) from 14Jan2021. Vaccination Facility type was Pharmacy or drug store. The patient experienced Renewed itching after 2nd dose on an unspecified date in Jan2021 (3rd week) and the patient stated First dose after 2 weeks was getting better but got worse after the 2nd dose. To the question on event required the initiation of new medication/ other treatment procedure, the patient answered that to many people in waiting room first, was very nervous. No social distance has not gone back for more treatment itching not severe to go back in there. The event outcome was unknown.    No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fall, Pyrexia, Skin lesion
Clinical narrative: Fever; Chills; Dizziness; knots under skin; fell flat on my face; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported) via an unspecified route of administration, in the right arm on 17Mar2021(at the age of 63-years-old) as Dose 2, single for COVID-19 immunization. Medical history was not reported. The patient reported that he was not allergic to medication he used every day. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN620G) via an unspecified route of administration, in the left arm on 24Feb2021(at the age of 63-years-old) as Dose 1, single for COVID-19 immunization and on 24Mar2021 at 16:00 experienced swollen arms and lymph node, arms and wrists hurt. The patient concomitant medication included other unspecified medications in two weeks of vaccination. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 29Mar2021, the patient experienced fevers, chills, knots under skin, dizziness when outside and fell flat on his face and he was back in bed. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: Myalgia; Slight fever; Joint pain; Fatigue; Chills; Worsening of tinnitus; Headache; Gastrointestinal distress; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6199, expiration date: unknown) via an unspecified route of administration, administered in Arm Right on 25Mar2021 11:15 (at the age of 50-years) as dose2, single for covid-19 immunization at workplace clinic. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration. administered in Arm Right on 04Mar2021 11:00 (Batch/Lot Number: EN5318) (at the age of 50-years-old) as SINGLE for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient medical history included hypertension and had covid-19 from an unknown date and unknown if ongoing. Patient concomitant medications included Losartan, Lexapro and Eliquis all were taken for an unspecified indication, start and stop date were not reported for any. The patient previously took avelox and experienced drug allergy. On 26Mar2021, the patient experienced myalgia, slight fever, joint pain, fatigue, chills, worsening of tinnitus, headache, gastrointestinal distress and had swollen lymph nodes. The patient did not received any treatment for the events. The outcome of all the events was not recovered.  No follow-up attempts were needed. No further information was expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Pyrexia, Tinnitus
Clinical narrative: Myalgia; Slight fever; Joint pain; Fatigue; Chills; Worsening of tinnitus; Headache; Gastrointestinal distress; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6199, expiration date: unknown) via an unspecified route of administration, administered in Arm Right on 25Mar2021 11:15 (at the age of 50-years) as dose2, single for covid-19 immunization at workplace clinic. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration. administered in Arm Right on 04Mar2021 11:00 (Batch/Lot Number: EN5318) (at the age of 50-years-old) as SINGLE for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient medical history included hypertension and had covid-19 from an unknown date and unknown if ongoing. Patient concomitant medications included Losartan, Lexapro and Eliquis all were taken for an unspecified indication, start and stop date were not reported for any. The patient previously took avelox and experienced drug allergy. On 26Mar2021, the patient experienced myalgia, slight fever, joint pain, fatigue, chills, worsening of tinnitus, headache, gastrointestinal distress and had swollen lymph nodes. The patient did not received any treatment for the events. The outcome of all the events was not recovered.  No follow-up attempts were needed. No further information was expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymph node pain, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: High fever (103), injection site issues (hot, swollen, painful), swollen painful lymph nodes (radiating pain); High fever (103), injection site issues (hot, swollen, painful), swollen painful lymph nodes (radiating pain); High fever (103), injection site issues (hot, swollen, painful), swollen painful lymph nodes (radiating pain); High fever (103), injection site issues (hot, swollen, painful), swollen painful lymph nodes (radiating pain); This is a spontaneous report received from a contactable consumer (patient herself). A 35-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6206, expiry date: unknown) via unspecified route of administration in right arm on 07Mar2021 15:00 as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: ER8733, expiry date: unknown) via unspecified route of administration in right arm on 28Mar2021 15:00 (age at vaccination: 35-years) as dose 2, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. Patients medical history included Factor 5 Leiden, Hiatal hernia and egg allergy from an unspecified date and unknown if ongoing. Concomitant medication included Protonix, taken for unspecified indication, start and stop date not reported, received within 2 weeks of vaccination. Patient experienced high fever (103), injection site issues (hot, swollen, painful), swollen painful lymph nodes (radiating pain) on 28Mar2021 04:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No treatment as received due to the adverse events. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number are available.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: extremely sick; huge fever; chills; nauseated; extremely tired; sleepy; hurt all over/ every bone in her body was hurting; diarrhea; it flet like the flu; felt out of it; headache; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 63-years-old female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EN6205, NDC number: unknown, Expiry Date: unknown), via an unknown route of administration in left arm on 15Mar2021 at 14:40 (at the age of 63-years-old) as dose 1, single for COVID-19 immunization. Limited information available as consumer hung up the call abruptly, hence product details (NDC, UPC, LOT and expiration date) and further details were unknown. The patient's medical history included asthma and had allergies; both were from unknown date and unknown if ongoing. Concomitant medications included amlodipine (AMLODIPINE), montelukast sodium (SINGULAIR MINI), ascorbic acid, rosa canina fruit (VITAMIN C & ROSEHIP), cetirizine hydrochloride (ZYRTEC ALLERGY) and zinc; all were taken for an unknown indication from an unknown date. On 16Mar2021, twelve hours after the vaccine at about 2:00 am, the patient experienced huge fever, chills, nauseated, extremely tied, diarrhea, felt out of it, headache, it felt like the flu and was sleepy, hurt all over/ every bone in her body was hurting. On an unknown date, she got extremely sick. She received the first dose of the Pfizer COVID 19 vaccine on 15Mar2021. Caller stated her second dose scheduled on 05Apr2021, but she does not know if she should get the second dose because she got extremely sick after first dose. Twelve hours after the vaccine at 02:00 am, she woke up with a huge fever, chills, nauseated, extremely tied and sleepy, hurt all over and had diarhea. She never felt that bad before stating every bone in her body was hurting. Described it as the weirdest thing stating it felt like the flu. She thought she should wake her husband up and go to the ER. Her husband called her HCP because she was so sick. She would not call her symptoms severe or call it an allergic reaction. Her HCP advised to take two Benadryl and sleep it off. The caller basically had every side effect on the list and it lasted almost 2 days, it was so weird. Usually did not have anything go wrong, it was so bizarre and she was leery about getting the second vaccine scheduled on 05Apr2021. The caller felt worse after the vaccine than when she had covid itself. She had COVID on 16 December2020 (around Christmas) and waited 90 days to get the first dose of the vaccine. On 8Jan2021, she had a positive antibody test. Caller stated HCP advised to do antibody titers and when they wane, get the second dose. The outcome of events huge fever', chills', nauseated', diarrhea', felt out of it', headache', it felt like the flu' and sleepy' was recovered on an unknown date in 2021, the outcome of the remaining events was unknown.   Follow up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: extremely sick; huge fever; chills; nauseated; extremely tired; sleepy; hurt all over/ every bone in her body was hurting; diarrhea; it flet like the flu; felt out of it; headache; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 63-years-old female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EN6205, NDC number: unknown, Expiry Date: unknown), via an unknown route of administration in left arm on 15Mar2021 at 14:40 (at the age of 63-years-old) as dose 1, single for COVID-19 immunization. Limited information available as consumer hung up the call abruptly, hence product details (NDC, UPC, LOT and expiration date) and further details were unknown. The patient's medical history included asthma and had allergies; both were from unknown date and unknown if ongoing. Concomitant medications included amlodipine (AMLODIPINE), montelukast sodium (SINGULAIR MINI), ascorbic acid, rosa canina fruit (VITAMIN C & ROSEHIP), cetirizine hydrochloride (ZYRTEC ALLERGY) and zinc; all were taken for an unknown indication from an unknown date. On 16Mar2021, twelve hours after the vaccine at about 2:00 am, the patient experienced huge fever, chills, nauseated, extremely tied, diarrhea, felt out of it, headache, it felt like the flu and was sleepy, hurt all over/ every bone in her body was hurting. On an unknown date, she got extremely sick. She received the first dose of the Pfizer COVID 19 vaccine on 15Mar2021. Caller stated her second dose scheduled on 05Apr2021, but she does not know if she should get the second dose because she got extremely sick after first dose. Twelve hours after the vaccine at 02:00 am, she woke up with a huge fever, chills, nauseated, extremely tied and sleepy, hurt all over and had diarhea. She never felt that bad before stating every bone in her body was hurting. Described it as the weirdest thing stating it felt like the flu. She thought she should wake her husband up and go to the ER. Her husband called her HCP because she was so sick. She would not call her symptoms severe or call it an allergic reaction. Her HCP advised to take two Benadryl and sleep it off. The caller basically had every side effect on the list and it lasted almost 2 days, it was so weird. Usually did not have anything go wrong, it was so bizarre and she was leery about getting the second vaccine scheduled on 05Apr2021. The caller felt worse after the vaccine than when she had covid itself. She had COVID on 16 December2020 (around Christmas) and waited 90 days to get the first dose of the vaccine. On 8Jan2021, she had a positive antibody test. Caller stated HCP advised to do antibody titers and when they wane, get the second dose. The outcome of events huge fever', chills', nauseated', diarrhea', felt out of it', headache', it felt like the flu' and sleepy' was recovered on an unknown date in 2021, the outcome of the remaining events was unknown.   Follow up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Somnolence
Clinical narrative: extremely sick; huge fever; chills; nauseated; extremely tired; sleepy; hurt all over/ every bone in her body was hurting; diarrhea; it flet like the flu; felt out of it; headache; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 63-years-old female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EN6205, NDC number: unknown, Expiry Date: unknown), via an unknown route of administration in left arm on 15Mar2021 at 14:40 (at the age of 63-years-old) as dose 1, single for COVID-19 immunization. Limited information available as consumer hung up the call abruptly, hence product details (NDC, UPC, LOT and expiration date) and further details were unknown. The patient's medical history included asthma and had allergies; both were from unknown date and unknown if ongoing. Concomitant medications included amlodipine (AMLODIPINE), montelukast sodium (SINGULAIR MINI), ascorbic acid, rosa canina fruit (VITAMIN C & ROSEHIP), cetirizine hydrochloride (ZYRTEC ALLERGY) and zinc; all were taken for an unknown indication from an unknown date. On 16Mar2021, twelve hours after the vaccine at about 2:00 am, the patient experienced huge fever, chills, nauseated, extremely tied, diarrhea, felt out of it, headache, it felt like the flu and was sleepy, hurt all over/ every bone in her body was hurting. On an unknown date, she got extremely sick. She received the first dose of the Pfizer COVID 19 vaccine on 15Mar2021. Caller stated her second dose scheduled on 05Apr2021, but she does not know if she should get the second dose because she got extremely sick after first dose. Twelve hours after the vaccine at 02:00 am, she woke up with a huge fever, chills, nauseated, extremely tied and sleepy, hurt all over and had diarhea. She never felt that bad before stating every bone in her body was hurting. Described it as the weirdest thing stating it felt like the flu. She thought she should wake her husband up and go to the ER. Her husband called her HCP because she was so sick. She would not call her symptoms severe or call it an allergic reaction. Her HCP advised to take two Benadryl and sleep it off. The caller basically had every side effect on the list and it lasted almost 2 days, it was so weird. Usually did not have anything go wrong, it was so bizarre and she was leery about getting the second vaccine scheduled on 05Apr2021. The caller felt worse after the vaccine than when she had covid itself. She had COVID on 16 December2020 (around Christmas) and waited 90 days to get the first dose of the vaccine. On 8Jan2021, she had a positive antibody test. Caller stated HCP advised to do antibody titers and when they wane, get the second dose. The outcome of events huge fever', chills', nauseated', diarrhea', felt out of it', headache', it felt like the flu' and sleepy' was recovered on an unknown date in 2021, the outcome of the remaining events was unknown.   Follow up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Computerised tomogram, Headache, Neck pain
Clinical narrative: headaches; neck and shoulder pain; neck and shoulder pain; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization and denosumab (PROLIA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included cancer. The patient concomitant medication was not reported. On an unspecified date patient got Prolia injection last time with first dose and had headaches, neck and shoulder pain. Patient had cancer and goes for her regular CAT scan. Patient wants to know: the CAT scan gives contrast, will that cause an interaction. The patient underwent lab tests and procedures which included computerised tomogram and the result was unknown. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information expected.
Age: 61.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Arthralgia, Chest pain, Dry mouth, Insomnia
Clinical narrative: Start tasting the medication (Unspecified Medication); I felt was I take the medication for 2 days; Pain; felt like a little swelling; Soreness of arm/the pain in shoulder going down the arm/arm was in pain; Arm muscles is still achy; Dryness in my mouth for 2 days; Tenderness; swelling in upper lip; My left lip was swollen and my toe was swollen; Pain in my shoulder going down the arm and like it start shaking; Pain in my shoulder going down the arm and like it start shaking; I start having anxiety because of the fear I guess; lot of anxiety started kicking around I guess because of the pain of the chest; I start having anxiety because of the fear I guess; lot of anxiety started kicking around I guess because of the pain of the chest; I could not sleep; Tingling; This is a spontaneous report from a contactable consumer (patient). A 61-year-old patient of unspecified gender received unknown dose number of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date on Monday (at the age of 61-year-old) as single dose for COVID-19 immunization and received Cortisone injection one week prior to the COVID-19 vaccine. Medical history included preexisting health condition (unspecified) and concomitant medications of the patient included some unspecified medication. When patient received the vaccination, patient informed them about preexisting conditions and with the preexisting condition and had cortisone shot prior a week. On an unspecified date on the very first day of vaccination patient start tasting the medication (unspecified), patient take the medication for 2 days. On the second day of vaccination, patient experienced the pain, the soreness of the arm, felt like a little swelling, dryness in mouth for 2 days, on Wednesday [third day] patient was feeling a little better but still had little soreness of the arm and little dryness and then I went to bed. On Thursday patient was not feeling bad, was feeling okay, a little dryness and felt a little tenderness and soreness of the arm, not much and then woke up at about 4 am in the morning [Friday] and had like swelling in toe and swelling in upper lip and the pain in shoulder going down the arm/arm was in pain/ arm muscles was still achy and like it start shaking and then patient had anxiety because of the fear and pain of the chest. This morning when patient woke up, patient could not sleep and went to sleep again and when woke up around 10 started to feel a little better, the swelling was gone, and the pain of the arms was gone but it still had a little tingling. So patient was just calling to find out are those things normal. Outcome of the event swelling, dry mouth, pain in arm, lip swelling, toe swelling were resolved and for other events were unknown.  No follow-up attempts are possible. Information about lot/batch number has been requested.
Age: 61.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Myalgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Start tasting the medication (Unspecified Medication); I felt was I take the medication for 2 days; Pain; felt like a little swelling; Soreness of arm/the pain in shoulder going down the arm/arm was in pain; Arm muscles is still achy; Dryness in my mouth for 2 days; Tenderness; swelling in upper lip; My left lip was swollen and my toe was swollen; Pain in my shoulder going down the arm and like it start shaking; Pain in my shoulder going down the arm and like it start shaking; I start having anxiety because of the fear I guess; lot of anxiety started kicking around I guess because of the pain of the chest; I start having anxiety because of the fear I guess; lot of anxiety started kicking around I guess because of the pain of the chest; I could not sleep; Tingling; This is a spontaneous report from a contactable consumer (patient). A 61-year-old patient of unspecified gender received unknown dose number of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date on Monday (at the age of 61-year-old) as single dose for COVID-19 immunization and received Cortisone injection one week prior to the COVID-19 vaccine. Medical history included preexisting health condition (unspecified) and concomitant medications of the patient included some unspecified medication. When patient received the vaccination, patient informed them about preexisting conditions and with the preexisting condition and had cortisone shot prior a week. On an unspecified date on the very first day of vaccination patient start tasting the medication (unspecified), patient take the medication for 2 days. On the second day of vaccination, patient experienced the pain, the soreness of the arm, felt like a little swelling, dryness in mouth for 2 days, on Wednesday [third day] patient was feeling a little better but still had little soreness of the arm and little dryness and then I went to bed. On Thursday patient was not feeling bad, was feeling okay, a little dryness and felt a little tenderness and soreness of the arm, not much and then woke up at about 4 am in the morning [Friday] and had like swelling in toe and swelling in upper lip and the pain in shoulder going down the arm/arm was in pain/ arm muscles was still achy and like it start shaking and then patient had anxiety because of the fear and pain of the chest. This morning when patient woke up, patient could not sleep and went to sleep again and when woke up around 10 started to feel a little better, the swelling was gone, and the pain of the arms was gone but it still had a little tingling. So patient was just calling to find out are those things normal. Outcome of the event swelling, dry mouth, pain in arm, lip swelling, toe swelling were resolved and for other events were unknown.  No follow-up attempts are possible. Information about lot/batch number has been requested.
Age: 61.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Swelling, Taste disorder, Tenderness, Tremor
Clinical narrative: Start tasting the medication (Unspecified Medication); I felt was I take the medication for 2 days; Pain; felt like a little swelling; Soreness of arm/the pain in shoulder going down the arm/arm was in pain; Arm muscles is still achy; Dryness in my mouth for 2 days; Tenderness; swelling in upper lip; My left lip was swollen and my toe was swollen; Pain in my shoulder going down the arm and like it start shaking; Pain in my shoulder going down the arm and like it start shaking; I start having anxiety because of the fear I guess; lot of anxiety started kicking around I guess because of the pain of the chest; I start having anxiety because of the fear I guess; lot of anxiety started kicking around I guess because of the pain of the chest; I could not sleep; Tingling; This is a spontaneous report from a contactable consumer (patient). A 61-year-old patient of unspecified gender received unknown dose number of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date on Monday (at the age of 61-year-old) as single dose for COVID-19 immunization and received Cortisone injection one week prior to the COVID-19 vaccine. Medical history included preexisting health condition (unspecified) and concomitant medications of the patient included some unspecified medication. When patient received the vaccination, patient informed them about preexisting conditions and with the preexisting condition and had cortisone shot prior a week. On an unspecified date on the very first day of vaccination patient start tasting the medication (unspecified), patient take the medication for 2 days. On the second day of vaccination, patient experienced the pain, the soreness of the arm, felt like a little swelling, dryness in mouth for 2 days, on Wednesday [third day] patient was feeling a little better but still had little soreness of the arm and little dryness and then I went to bed. On Thursday patient was not feeling bad, was feeling okay, a little dryness and felt a little tenderness and soreness of the arm, not much and then woke up at about 4 am in the morning [Friday] and had like swelling in toe and swelling in upper lip and the pain in shoulder going down the arm/arm was in pain/ arm muscles was still achy and like it start shaking and then patient had anxiety because of the fear and pain of the chest. This morning when patient woke up, patient could not sleep and went to sleep again and when woke up around 10 started to feel a little better, the swelling was gone, and the pain of the arms was gone but it still had a little tingling. So patient was just calling to find out are those things normal. Outcome of the event swelling, dry mouth, pain in arm, lip swelling, toe swelling were resolved and for other events were unknown.  No follow-up attempts are possible. Information about lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: fever of 100.9/eventually peaking at 102.8; Chills; Body aches; bad body aches it hurt to walk across her apartment to the bathroom even; This is a spontaneous report from a contactable consumer (patient). A 23-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 25Mar2021 at 14:45 (at the age of 23-year-old) as a dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. The patient was allergic to Zythromax. The patient received Loloestrin birth control within two weeks of vaccination. The patient also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FN6205) via an unspecified route of administration in the right arm on 04Mar2021 at 15:45 (at the age of 23-year-old) as a single dose for COVID-19 immunization and on 05Mar2021 at 14:00, the patient was tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. On 26Mar2021 at 02:00, the patient woke up with a fever of 100.9. The patient called out of work and spent entire next day in bed with horrific chills and an off and on fever eventually peaking at 102.8 around 17:00. Sometime after that, the patient felt asleep and slept until around 7:00 the next morning and by then her fever had broken. The whole day that she was feverish, she had such bad body aches it hurt to walk across her apartment to the bathroom even and she spent the day off and on sleeping. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken for the resulted adverse events. The outcome of the events fever, chills and body aches were recovered on an unknown date in Mar2021 and of other event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: allergic reaction of hives/Hives on bilateral arms; This is a spontaneous report from contactable consumer. A 39-year-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER8733), via intramuscular, administered in left arm (as reported Injected in left arm in the muscle) on 31Mar2021 08:25 (at the age of 39-year-old) as dose 1, single for covid-19 immunisation at clinic. The patient took paracetamol (TYLENOL; Lot Number: SLA051; Expiration Date: Jun2024) at 500 mg, via an unspecified route of administration from 31Mar2021 to an unspecified date, for an unspecified indication. Medical history included patient had severe food allergies diagnosed first in 1986: allergic to oranges, milk, mild reaction to eggs, compromised immune system, respiratory illness: Asthma, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes), anal cancer (previously) and obesity. The patient's family medical history included mother had lung cancer. The patient's concomitant medications were not reported. Patient took 2 of Tylenol about half an hour after getting the shot. Patient was not administered with any other additional vaccines on same date of the Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No adverse events after prior vaccinations were reported. Caller stated she received the first dose of the Pfizer COVID vaccine this morning and she had an allergic reaction of hives/ hives on bilateral arms which occurred around 4pm today (on 31Mar2021 16:00). Caller would like to know if she should go to her doctor's office or if she can treat them on her own. There was no prescriber. No ER or physician's office required, and she can ride it out at home. Patient has Benadryl if she needs it. Patient wanted to be sure that taking the Benadryl and Tylenol should be all right for this type of response. At the time of this report, the outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: A little tired, first vaccine/ only felt a little tired but not too much; Pain on left side of shoulder, intense, first vaccine/ had intense pain on his left side of shoulder; This is a spontaneous report from a contactable consumer, the patient.   A 52-years-old male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 05Mar2021 at 11:00-11:30 (not specified) as dose 1, single (age at the time of vaccination 52 years) for covid-19 immunisation in the left upper shoulder. The patient medical history included prostrate. He also stated he had a history of bronchitis since he was small. The bronchitis was worrisome with bad weather and a month prior there was bad weather and he had the chills. The patient stated his family did not have any medical history to report. Concomitant medication(s) included tamsulosin and finasteride started about a year and a half ago for his prostate. The patient stated with his first vaccine on 05Mar2021 he only had intense pain on his left side of shoulder, it was still there on Saturday and by Sunday the pain was much better. By Monday he was back to normal, only felt a little tired but not too much and he was able to do things on an unspecified date. Tuesday/Wednesday he was fine. The patient did not undergo any lab test. The patient did not take any therapeutic treatment for events. No additional vaccines were administered on same date as of the Pfizer suspect. No other vaccinations were taken within four weeks prior to the first administration date of the suspect vaccine. The patient did not visit emergency room or the physician's office. The outcome of event pain on left side of shoulder was recovered on an unknown date in Mar2021 and event only felt a little tired was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Diarrhoea, Headache
Clinical narrative: sickness (Illness); Muscle pain; Joints on fire; Headache; Fever; Chills; Sweats; Cold sores; Diarrhea; This is a spontaneous report from a contactable other hcp reporting on behalf of patient. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown, expiry date: unknown), via an unspecified route of administration on 26Feb2021 (at the age of 58-year-old) as dose number unknown, single dose for covid-19 immunization. Patient's medical history included ongoing otitis externa, covid-19 from Nov2020 to an unknown date (patient was hospitalized for Covid-19 for 5 days) and ongoing osteoporosis from 01Mar2021. Concomitant medications included abaloparatide (TYMLOS) taken subcutaneously for osteoporosis from Jun2020 to 26Feb2021 at 80 mcg OD. On 27Feb2021, the patient experienced sickness (Illness), muscle pain, joint on fire, headache, fever, chills, cold sore, diarrhea and sweats. The patient underwent lab tests and procedures which included body temperature: Fever that went away on 01Mar2021. The outcome of all the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Illness, Myalgia, Oral herpes, Pyrexia
Clinical narrative: sickness (Illness); Muscle pain; Joints on fire; Headache; Fever; Chills; Sweats; Cold sores; Diarrhea; This is a spontaneous report from a contactable other hcp reporting on behalf of patient. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown, expiry date: unknown), via an unspecified route of administration on 26Feb2021 (at the age of 58-year-old) as dose number unknown, single dose for covid-19 immunization. Patient's medical history included ongoing otitis externa, covid-19 from Nov2020 to an unknown date (patient was hospitalized for Covid-19 for 5 days) and ongoing osteoporosis from 01Mar2021. Concomitant medications included abaloparatide (TYMLOS) taken subcutaneously for osteoporosis from Jun2020 to 26Feb2021 at 80 mcg OD. On 27Feb2021, the patient experienced sickness (Illness), muscle pain, joint on fire, headache, fever, chills, cold sore, diarrhea and sweats. The patient underwent lab tests and procedures which included body temperature: Fever that went away on 01Mar2021. The outcome of all the events was unknown.   No follow-up attempts are possible. No further information is expected.