chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Pyrexia
Clinical narrative: I have headache like migraine headache on the side, off and on like every four hour every three or four hour; Fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced fever on 25Dec2020. The patient also had a headache like migraine headache on the side, off and on like every four hour every three or four hour on an unspecified date. Clinical outcome of fever was recovered on Dec2020, while for migraine headache was unknown.  Follow-up attempts are not possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness since receiving the vaccine; This is a spontaneous report from a contactable nurse (patient).  A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: ELO140), via an unspecified route of administration on the right arm on 26Dec2020 17:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included reported as none and the patient had no known allergies.  The patient's concomitant medications were not reported. It was mentioned that prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. On 27Dec2020 05:00, the patient experienced dizziness since receiving the vaccine. The patient did not receive any treatment for the adverse event. Outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: fair amount of bleeding after the needle was removed/lot of bleeding at the injection site; This is a spontaneous report from a contactable physician.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history and concomitant medications were not reported. On an unknown date, it was reported that a resident at the hospital had a fair amount of bleeding after the needle was removed. It also mentioned that a lot of bleeding at the injection site. The reporter was unsure if the resident received the Pfizer of Moderna vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Headache, Nausea
Clinical narrative: Shortness of breath; heaviness in chest; headache; dizziness; nausea; The patient also received first dose of unspecified other vaccine on the same day of COVID vaccine; This is a spontaneous report from a contactable nurse (patient) reported  for herself.  A 53-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 29Dec2020 11:30 at single dose for COVID-19 immunization at a hospital. The patient also received first dose of unspecified other vaccine on the same day of COVID vaccine (29Dec2020) at left arm. The patient's medical history included diabetes type 2, arthritis, known allergies to Shrimp and penicillin. The patient's concomitant medications received within 2 weeks of vaccination included unspecified medications. No other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took lisinopril and experienced drug hypersensitivity (Known allergies: Lisinopril). The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 post the vaccination. On 29Dec2020 11:30, the patient experienced shortness of breath, heaviness in chest, headache, dizziness and nausea. Treatment for above events included antihistamine. The outcome of the events shortness of breath, heaviness in chest, headache, dizziness and nausea was recovered in Dec2020. The events were reported as non-serious by the reporter.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: Shortness of breath; heaviness in chest; headache; dizziness; nausea; The patient also received first dose of unspecified other vaccine on the same day of COVID vaccine; This is a spontaneous report from a contactable nurse (patient) reported  for herself.  A 53-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 29Dec2020 11:30 at single dose for COVID-19 immunization at a hospital. The patient also received first dose of unspecified other vaccine on the same day of COVID vaccine (29Dec2020) at left arm. The patient's medical history included diabetes type 2, arthritis, known allergies to Shrimp and penicillin. The patient's concomitant medications received within 2 weeks of vaccination included unspecified medications. No other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took lisinopril and experienced drug hypersensitivity (Known allergies: Lisinopril). The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 post the vaccination. On 29Dec2020 11:30, the patient experienced shortness of breath, heaviness in chest, headache, dizziness and nausea. Treatment for above events included antihistamine. The outcome of the events shortness of breath, heaviness in chest, headache, dizziness and nausea was recovered in Dec2020. The events were reported as non-serious by the reporter.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Throat tightness
Clinical narrative: Facial Flushing; throat constriction; feeling faint; This is a spontaneous report from a contactable pharmacist. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, lot number: EJ1685, intramuscular in the left arm, first dose on 28Dec2020 07:45 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced facial flushing, throat constriction, and was feeling faint on 28Dec2020 at 07:45 AM with outcome of recovered on an unspecified date. The patient received treatment for the events with diphenhydramin, methylpred and famotidine. The patient had no covid prior to vaccination nor was she tested post vaccination. The events was reported as non-serious. The events resulted to emergency room/department or urgent care.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching on my left arm, face and neck; This is a spontaneous report from a contactable Other Health Professional (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: ELO140, via an unspecified route of administration in the arm left, first dose on 28Dec2020 16:15 at a single dose for Covid-19 immunization. Medical history was none, she had no known allergies. There were no concomitant medications. The patient was not pregnant. The patient did not receive any other vaccine within four weeks prior to covid vaccine. She had no covid prior vaccination nor was she tested post vaccination. The patient experienced a little itching on her left arm, face and neck, but other than that, nothing else, all on 28Dec2020 at 04:30 PM with outcome of recovered in Dec2020. No treatment received for the event.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Fatigue
Clinical narrative: Light headedness/Dizziness/Feeling like I am going to faint; Body weakness like uncontrollable fatigue; Body weakness like uncontrollable fatigue; severe stomach pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiration date: 30Mar2021), via an unspecified route of administration on 27Dec2020 at single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis and fibromyalgia. Concomitant medication included duloxetine hydrochloride (CYMBALTA) as thyroid medication (when probed for thyroid medication, consumer stated, "CYMBALTA." (Indication was not clarified further)) and the patient also took her thyroid medications, medication for fibromyalgia. Consumer stated that she just got the COVID vaccine, her first COVID vaccine yesterday (27Dec2020) and she was experiencing some side effects that were more severe than just pain in my arm. When clarified if had pain in arm, consumer stated "No",  she was experiencing light headedness, dizziness, feeling like I am going to faint, severe stomach pain, body weakness like uncontrollable fatigue in Dec2020. The outcome of the events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain in extremity
Clinical narrative: Sore arm; fatigue; lightheaded; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old female patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 28Dec2020 16:15 to 28Dec2020 16:15 at left arm, at single dose for covid-19 immunization. Medical history was none. Allergies to medications, food, or other products was no. Concomitant medication included bupropion hydrochloride (WELLBUTRIN). The patient was not pregnant at the time of vaccination. The patient experienced sore arm, fatigue, lightheaded on 29Dec2020 14:00. No treatment was received for all event. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.  Information about Lot/Batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Fatigue, Headache
Clinical narrative: chills; chills and fever/ 99.2 degrees Fahrenheit; body aches; tired and lethargic/ feels very fatigue; tired and lethargic; severe headache; This is a spontaneous report from a contactable nurse (patient). A 54-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELO140), via an unspecified route of administration on 28Dec2020 09:15 at single dose on left deltoid for COVID-19 immunization in hospital. Medical history included allergies; COVID-19 and received her positive result on 22Oct2020, the reporter didn't know if that was pertinent, she was out of work for 15 days. Concomitant medication included lisinopril, clarithromycin (CLARITIN) for allergies, mometasone furoate (FLONASE) for allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her flu vaccine was in Oct2020. The patient received the vaccine on 28Dec2020 and was having side effects. No shortness of breath, but she did have some side effects. She felt fine most of the day. In the afternoon around 2PM (28Dec2020 14:00), she developed a severe headache and took 600mg ibuprofen and it didn't touch it. She took another 600mg of ibuprofen in the evening. She felt tired and lethargic on 28Dec2020 20:00 so she went to bed. This morning (29Dec2020) she had body aches and feels very fatigue. She still has a headache. She has chills and fever on 29Dec2020 08:00. Her temperature was 99.2 degrees Fahrenheit about 2 hours before (29Dec2020). The severe Headache was compared to last night it was better, but she still had slight headache. About tired and lethargic, driving to work she wanted to go to sleep. she was at work at her desk and she was not as tired as before. The lot number was on the card she was given. She was not sure if it was ELO140 or EL0140. No emergency room or physician office was required for any adverse event. The outcome of headache, tired and lethargic was recovering, of chills and fever was not recovered, of body aches was unknown. For events severe headache, tired and lethargic, chills and fever, the seriousness was reported as non-serious, the relatedness was related with COVID vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: chills; chills and fever/ 99.2 degrees Fahrenheit; body aches; tired and lethargic/ feels very fatigue; tired and lethargic; severe headache; This is a spontaneous report from a contactable nurse (patient). A 54-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELO140), via an unspecified route of administration on 28Dec2020 09:15 at single dose on left deltoid for COVID-19 immunization in hospital. Medical history included allergies; COVID-19 and received her positive result on 22Oct2020, the reporter didn't know if that was pertinent, she was out of work for 15 days. Concomitant medication included lisinopril, clarithromycin (CLARITIN) for allergies, mometasone furoate (FLONASE) for allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her flu vaccine was in Oct2020. The patient received the vaccine on 28Dec2020 and was having side effects. No shortness of breath, but she did have some side effects. She felt fine most of the day. In the afternoon around 2PM (28Dec2020 14:00), she developed a severe headache and took 600mg ibuprofen and it didn't touch it. She took another 600mg of ibuprofen in the evening. She felt tired and lethargic on 28Dec2020 20:00 so she went to bed. This morning (29Dec2020) she had body aches and feels very fatigue. She still has a headache. She has chills and fever on 29Dec2020 08:00. Her temperature was 99.2 degrees Fahrenheit about 2 hours before (29Dec2020). The severe Headache was compared to last night it was better, but she still had slight headache. About tired and lethargic, driving to work she wanted to go to sleep. she was at work at her desk and she was not as tired as before. The lot number was on the card she was given. She was not sure if it was ELO140 or EL0140. No emergency room or physician office was required for any adverse event. The outcome of headache, tired and lethargic was recovering, of chills and fever was not recovered, of body aches was unknown. For events severe headache, tired and lethargic, chills and fever, the seriousness was reported as non-serious, the relatedness was related with COVID vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Hypersensitivity, Malaise, Nasal congestion
Clinical narrative: body aches/achy; Headache; not feeling great; congestion; Two hours after receiving the vaccine she had a runny nose; 4 hours after she was experiencing some itching in the back of her throat, on her chest, and on her back.; 4 hours after she was experiencing some itching in the back of her throat, on her chest, and on her back.; Allergic reaction; heated flushing feeling in her cheeks; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for herself. A 56-year-old female patient  received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E49899), via an unspecified route of administration on 27Dec2020 at single dose for covid-19 immunization. It was the first dose. Medical history included allergic to shellfish. There were no concomitant medications. Two hours after receiving the vaccine on 27Dec2020 she had a runny nose. Then, 4 hours after she was experiencing some itching in the back of her throat, on her chest, and on her back. She didn't have a rash. She did feel like what she was having was an allergic reaction. She had a heated flushing feeling in her cheeks. It was very similar to the reaction she has when she eats shellfish. The allergic side effects have subsided. When she was having the reaction she took one Claritin, and it ended up going away. Yesterday the 28Dec2020. She was also achy. She had a headache, and body aches. She wasn't feeling great, but they have gone away. She also had congestion. Those all started the 28Dec2020 in the morning. The outcome of the events was recovered on an unknown date in Dec2020.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rhinorrhoea, Throat irritation
Clinical narrative: body aches/achy; Headache; not feeling great; congestion; Two hours after receiving the vaccine she had a runny nose; 4 hours after she was experiencing some itching in the back of her throat, on her chest, and on her back.; 4 hours after she was experiencing some itching in the back of her throat, on her chest, and on her back.; Allergic reaction; heated flushing feeling in her cheeks; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for herself. A 56-year-old female patient  received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E49899), via an unspecified route of administration on 27Dec2020 at single dose for covid-19 immunization. It was the first dose. Medical history included allergic to shellfish. There were no concomitant medications. Two hours after receiving the vaccine on 27Dec2020 she had a runny nose. Then, 4 hours after she was experiencing some itching in the back of her throat, on her chest, and on her back. She didn't have a rash. She did feel like what she was having was an allergic reaction. She had a heated flushing feeling in her cheeks. It was very similar to the reaction she has when she eats shellfish. The allergic side effects have subsided. When she was having the reaction she took one Claritin, and it ended up going away. Yesterday the 28Dec2020. She was also achy. She had a headache, and body aches. She wasn't feeling great, but they have gone away. She also had congestion. Those all started the 28Dec2020 in the morning. The outcome of the events was recovered on an unknown date in Dec2020.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Vaccination site pruritus
Clinical narrative: Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated itching that began localized to the injection site then spread all over the body. Felt like a burning sensation as well and an itch you can't scratch on 29Dec2020. Patient received Benadryl as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered. The events were reported as non-serious.  No follow-up attempts are possible; Information about batch/lot number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Decreased appetite, Malaise, SARS-CoV-2 test positive
Clinical narrative: Contracted Covid after receiving the first vaccine; Contracted Covid after receiving the first vaccine; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunisation.  Medical history included asthma, dry cough due to inhalation from fires over the years.  The patient's concomitant medications were not reported. Contracted Covid after receiving the first vaccine was reported. The patient received the first dose of the Covid vaccine, then contracted Covid. He now had the option to receive antibodies through plasma. Since he had the vaccine, was that still an option? Or was that a no-no? He received the vaccine at work on 21Dec2020. He got sick on 22Dec2020 and he was at home. He didn't feel like eating, and can't lay down because it made it worse to cough. He didn't know what vitamins they were giving him. The patient probably should be in a hospital, but was not. The outcome of events was not recovered.  Information on Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Fever was up to 102.4; Chills; Body ache; This is a spontaneous report from a contactable consumer (patient herself). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 27Dec2020, the patient experienced fever was up to 102.4, chills, and body ache. Therapeutic measures were taken as a result of the events that included ibuprofen (Motrin). Clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Malaise, Nausea, Pain
Clinical narrative: Diarrhea; she had body aches; Tingling in her Jaw and in her mouth; Headache; Nausea; She is having extreme difficulties; not feeling well; Not sleeping well during the night; tingling in her Jaw; This is a spontaneous report from a contactable Consumer(mother). A female patient received (BNT162B2), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The reporter was giving her daughter's name she was the respiratory therapist at the hospital and she received the Pfizer Covid Vaccine last Monday in Dec2020 and she was having extreme difficulties today. She had diarrhea, she had body aches, she had tingling in her mouth, headache, her nausea and all of the sudden it started with yesterday in Dec2020 and perhaps the day before it started with the tingling in her Jaw and in her mouth and she woke up today and not feeling well and she took a nap after not sleeping well during the night and when she woke up from the nap she had extreme body aches, diarrhea, nausea, headache. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Poor quality sleep
Clinical narrative: Diarrhea; she had body aches; Tingling in her Jaw and in her mouth; Headache; Nausea; She is having extreme difficulties; not feeling well; Not sleeping well during the night; tingling in her Jaw; This is a spontaneous report from a contactable Consumer(mother). A female patient received (BNT162B2), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The reporter was giving her daughter's name she was the respiratory therapist at the hospital and she received the Pfizer Covid Vaccine last Monday in Dec2020 and she was having extreme difficulties today. She had diarrhea, she had body aches, she had tingling in her mouth, headache, her nausea and all of the sudden it started with yesterday in Dec2020 and perhaps the day before it started with the tingling in her Jaw and in her mouth and she woke up today and not feeling well and she took a nap after not sleeping well during the night and when she woke up from the nap she had extreme body aches, diarrhea, nausea, headache. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Muscle spasms
Clinical narrative: throat sore and pain in neck; her throat is sore, feels like it may be swelling; some neck pain; it feels like muscle spasms; extremely tired; soreness in her arm; Chills; Nausea; felt weak/having some weakness; massive headache/mild headache; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration on 28Dec2020 11:00 on left arm at a single dose for COVID-19 immunization. The patient was positive for Covid back in Jun2020, it was a bad case that she was hospitalized for 6 days, that she did not have to go on respirator. She stated these days she still struggled with chest pains and still struggled with her taste, she went to the emergency room in Sep2020 with some issues from that. The patient concomitant medications were none. The patient stated she was retired who works security at a hospital that she got her first dose of the Pfizer Covid vaccine yesterday on 28Dec2020. She was calling to report some side effects from the vaccine. She was skeptical about shot but she went ahead and got the vaccine, she took it and waited the 15 minutes and everything was fine except some soreness in her arm, about an hour after the shot, she felt extremely tired, could not even read, by last night she was getting chills, nauseated and weak, all she wanted to do was sleep, she had a massive headache. She kept thinking she was going to have to go to the ER. She woke up this morning and her throat was sore, felt like it may be swelling, felt sick. She took two advil and her headache was better. She was taking tumeric and ginger root and honey with lemon for her throat. She knew she was not sick that it is just the vaccine and she would power through it but wanted to call. She was starting to feel better but still having some weakness, still tired, had pain in the arm of the injection site, a mild headache. She stated these side effects are still ongoing but are improved. She was also having some neck pain started this morning sometime, but does not know exact time, it feels like muscle spasms. Caller wanted to know if because she had Covid before her side effects are so bad. The patient did not do any relevant tests. The outcome of the events soreness in her arm, extremely tired, Headache was recovering, the outcome of the events Chills, Nausea was recovered in Dec2020 and the other events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Oropharyngeal pain, Pharyngeal swelling, SARS-CoV-2 test
Clinical narrative: throat sore and pain in neck; her throat is sore, feels like it may be swelling; some neck pain; it feels like muscle spasms; extremely tired; soreness in her arm; Chills; Nausea; felt weak/having some weakness; massive headache/mild headache; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration on 28Dec2020 11:00 on left arm at a single dose for COVID-19 immunization. The patient was positive for Covid back in Jun2020, it was a bad case that she was hospitalized for 6 days, that she did not have to go on respirator. She stated these days she still struggled with chest pains and still struggled with her taste, she went to the emergency room in Sep2020 with some issues from that. The patient concomitant medications were none. The patient stated she was retired who works security at a hospital that she got her first dose of the Pfizer Covid vaccine yesterday on 28Dec2020. She was calling to report some side effects from the vaccine. She was skeptical about shot but she went ahead and got the vaccine, she took it and waited the 15 minutes and everything was fine except some soreness in her arm, about an hour after the shot, she felt extremely tired, could not even read, by last night she was getting chills, nauseated and weak, all she wanted to do was sleep, she had a massive headache. She kept thinking she was going to have to go to the ER. She woke up this morning and her throat was sore, felt like it may be swelling, felt sick. She took two advil and her headache was better. She was taking tumeric and ginger root and honey with lemon for her throat. She knew she was not sick that it is just the vaccine and she would power through it but wanted to call. She was starting to feel better but still having some weakness, still tired, had pain in the arm of the injection site, a mild headache. She stated these side effects are still ongoing but are improved. She was also having some neck pain started this morning sometime, but does not know exact time, it feels like muscle spasms. Caller wanted to know if because she had Covid before her side effects are so bad. The patient did not do any relevant tests. The outcome of the events soreness in her arm, extremely tired, Headache was recovering, the outcome of the events Chills, Nausea was recovered in Dec2020 and the other events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: throat sore and pain in neck; her throat is sore, feels like it may be swelling; some neck pain; it feels like muscle spasms; extremely tired; soreness in her arm; Chills; Nausea; felt weak/having some weakness; massive headache/mild headache; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration on 28Dec2020 11:00 on left arm at a single dose for COVID-19 immunization. The patient was positive for Covid back in Jun2020, it was a bad case that she was hospitalized for 6 days, that she did not have to go on respirator. She stated these days she still struggled with chest pains and still struggled with her taste, she went to the emergency room in Sep2020 with some issues from that. The patient concomitant medications were none. The patient stated she was retired who works security at a hospital that she got her first dose of the Pfizer Covid vaccine yesterday on 28Dec2020. She was calling to report some side effects from the vaccine. She was skeptical about shot but she went ahead and got the vaccine, she took it and waited the 15 minutes and everything was fine except some soreness in her arm, about an hour after the shot, she felt extremely tired, could not even read, by last night she was getting chills, nauseated and weak, all she wanted to do was sleep, she had a massive headache. She kept thinking she was going to have to go to the ER. She woke up this morning and her throat was sore, felt like it may be swelling, felt sick. She took two advil and her headache was better. She was taking tumeric and ginger root and honey with lemon for her throat. She knew she was not sick that it is just the vaccine and she would power through it but wanted to call. She was starting to feel better but still having some weakness, still tired, had pain in the arm of the injection site, a mild headache. She stated these side effects are still ongoing but are improved. She was also having some neck pain started this morning sometime, but does not know exact time, it feels like muscle spasms. Caller wanted to know if because she had Covid before her side effects are so bad. The patient did not do any relevant tests. The outcome of the events soreness in her arm, extremely tired, Headache was recovering, the outcome of the events Chills, Nausea was recovered in Dec2020 and the other events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Vaccination site pain
Clinical narrative: numbness in pinky of left arm; soreness at spot of injection; fatigue; This is a spontaneous report from a contactable consumer. An adult female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not available), via an unspecified route of administration on 27Dec2020 at single dose on her left arm for Covid-19 immunization. The patient medical history was not reported. The patient had received unknown other medications within 2 weeks of vaccination. The patient experienced numbness in pinky of left arm and soreness at spot of injection and fatigue on 27Dec2020. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Off label use, Pain in extremity, Product use issue
Clinical narrative: is nursing twins; is nursing twins; slight headache; arm soreness; This is a spontaneous report from a contactable other health professional (patient). This other health professional reported information for both mother and babies. This is the maternal report. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 16Dec2020 11:00 AM at left arm, at single dose for protect as a healthcare provider. Medical history was none. There were no concomitant medications. The patient experienced like arm soreness and slight headache on 16Dec2020, that was pretty much it. Arm soreness started that afternoon on 16Dec2020, she received the vaccine in the morning, at 11am, and maybe like shortly after she noticed, it was there for 1-2 days and went away, and she had since recovered completely. Slight headache started that afternoon on 16Dec2020, and that resolved by the evening, she took Tylenol and it went away. And she was nursing twins, they are about 14 months now. She was aware of the risks of getting it, and the only reason she reported it, is it may be beneficial from a research standpoint, she doubts many lactating mothers, especially twins, are involved. She is personally not concerned, she is probably expecting similar for her second dose, and there is not much research. Her next is dose 06Jan2021. The outcome of the events slight headache was recovered on 16Dec2020, the outcome of the event arm soreness was recovered in Dec2020.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518603 Same reporter/drug, different patient/event. baby case;US-PFIZER INC-2020518630 Same reporter/drug, different patient/event. bady case
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Malaise, Pain, Pyrexia
Clinical narrative: Feeling sick; Fever of 102 degrees; Coughing; Aching; This is a spontaneous report from a Pfizer-sponsored program entitled Pfizer First Connect. A contactable consumer reported for his sister (health professional) that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date in Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient took the COVID vaccine but she was feeling sick, had a fever of 102 degrees, she was coughing and aching from couple of days after having couple of days in Dec2020. The events outcome was unknown. The reporter mentioned if patient goes to the hospital or not, asked if they should go to the hospital and. The patient was wondering if that was normal.  The information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vaccination site urticaria
Clinical narrative: tiredness; muscle ache at injection site with penny sized welt at injection site; muscle ache at injection site with penny sized welt at injection site; This is a spontaneous report from a contactable nurse (patient) via Pfizer sales representative. A female patient of unspecified age (reported as Age: 32; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not available), via an unspecified route of administration on 28Dec2020 at 12:30 PM at single dose for COVID-19 immunization. The patient medical history included had COVID 34 days before in 2020. The patient's concomitant medications were not reported. Currently patient was experiencing tiredness, muscle ache at injection site with penny sized welt at injection site in Dec2020. Event took place after use of product. The outcome of the events was unknown.  Information on the Lot/Batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dehydration, Fatigue, Hypersomnia, Influenza like illness, Nasal congestion
Clinical narrative: pain in the administration site; tired; feeling dehydrated; had a low degree fever; nostrils were stuffed or clogged; pain in the arm; went to sleep 3 hours earlier than usually did, waking up five hour later; feeling like that was about to had flu; This is a spontaneous report from a contactable consumer. This consumer reported same events for two patients (Herself and Her friend).This is the Friend report. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknown date at single dose for covid-19 immunization. It was the second dose. The patient's medical history and concomitant medications were not reported. The Consumer reported that the same symptoms were experienced by a friend of her after the administration of the second dose of the Pfizer's COVID-19 vaccine. The same symptoms included felt only pain in the administration site, at night felt really tired, went to sleep 3 hours earlier than usually did, waking up five hour later with pain in the arm and feeling dehydrated, also feeling like that was about to had flu, had a lowdegree fever, and nostrils were stuffed or clogged. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518390 Same Reporter and Drug and event, different Patient.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: pain in the administration site; tired; feeling dehydrated; had a low degree fever; nostrils were stuffed or clogged; pain in the arm; went to sleep 3 hours earlier than usually did, waking up five hour later; feeling like that was about to had flu; This is a spontaneous report from a contactable consumer. This consumer reported same events for two patients (Herself and Her friend).This is the Friend report. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknown date at single dose for covid-19 immunization. It was the second dose. The patient's medical history and concomitant medications were not reported. The Consumer reported that the same symptoms were experienced by a friend of her after the administration of the second dose of the Pfizer's COVID-19 vaccine. The same symptoms included felt only pain in the administration site, at night felt really tired, went to sleep 3 hours earlier than usually did, waking up five hour later with pain in the arm and feeling dehydrated, also feeling like that was about to had flu, had a lowdegree fever, and nostrils were stuffed or clogged. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518390 Same Reporter and Drug and event, different Patient.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: pain in the administration site; a strong headache; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient took his first dose of BNT162B2 for covid-19 immunization on an unspecified date. The patient was experiencing pain in the administration site, and a strong headache that has been fading away. The action taken in response to the events for BNT162B2 was not applicable. The outcome of event "strong headache" was recovering, the another event "pain in the administration site" was unknown.   Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Off label use, Product use issue
Clinical narrative: This morning she felt bad; She has an autoimmune disease/ received BNT162B2; She has an autoimmune disease/ received BNT162B2; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included autoimmune disease and has been under stress from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced felt bad this morning on an unspecified date with outcome of unknown. Caller was a therapist, behavioral specialist and works and they are all over. It's a hospital and she was in the psychiatric phase of it as a therapist. They are offering the free COVID-19 vaccine since she was working 1 on 1 with clients and some of them are not the most reputable. She has an autoimmune disease and known she should get it, but has had so many doubts and has been under stress. Took care of a brother who was blind who recently had major shoulder surgery and her 91 years old mother who lived with her. Has been stressed and noticed her autoimmune disease was flaring up. Wanted to know was it safe for her to get the vaccine. Knows she should get the vaccine because 2 of her clients had tested positive for COVID and their parents, but when she tested she was negative and her family was also negative. No further details provided. Is so afraid to get the vaccine that she canceled her appointment at the hospital. Was scheduled today to get it. They are offering it to her free since she works there. This morning she felt bad and she had been going through the stress the last month. Mentions she didn't even get the flu this year. No further details provided and does not clarify if she didn't get the flu virus or flu shot.    Information about lot/batch number has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Body chills; fever; headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), via an unspecified route of administration (left arm) on 29Dec2020 08:15 at single dose for Covid-19 immunization. The patient's medical history included hypertension (HTN) and high cholesterol. Concomitant medications included losartan, atorvastatin, and amlodipine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced body chills, fever, and headache on 29Dec2020 22:00 with outcome of recovering. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: mild headache; This is a spontaneous report from a contactable nurse (patient).  This 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot GJ1685), via an unspecified route of administration, on 22Dec2020 (reported also as 23Dec2020, to be clarified) at 3:00 PM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at Nursing Home/Senior Living Facility, age at vaccination was 35-years-old. No other vaccine was received in four weeks. Medical history and concomitant medications were unknown. On 22Dec2020 at 07:00 PM, the patient got mild headache. The event was reported as non-serious. The patient was tested for Covid post vaccination through a nasal swab in Dec2020 and was negative. Outcome was recovered on Dec2020. No treatment was received for the event.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in arm when using arm or to touch; This is a spontaneous report from a contactable nurse.   A 56-year-old female nurse received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 28Dec2020 at 12:30 PM at single dose for COVID-19 immunization on right arm.Relevant medical history included ongoing osteoarthritis and high cholesterol. Concomitant medications included  atorvastatin calcium (LIPITOR ORIFARM), escitalopram oxalate (LEXAPRO) and pantoprazole. On 28Dec2020 at 07:00 PM patient started experiencing soreness in arm when using arm or to touch. At the time of the reporting the patient was recovering from the event.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Face started to tingle then went numb roughly 45-55 minutes after receiving.; Face started to tingle then went numb roughly 45-55 minutes after receiving.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received bnt162b2 (lot number: EL0140, Pfizer- BioNTech), intramuscularly at arm left, first dose on 23Dec2020 07:45, at single dose, for COVID-19 immunization. Medical history included environmental allergies, iron deficiency anemia, endometriosis, allergies to penicillin, and allergies to preservatives in flu vaccine from an unknown date. The patient is not Pregnant at the time of vaccination. Concomitant medication included ibuprofen, colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12), magnesium, all from an unspecified date, for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Age at vaccination is 45 Years old. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced face started to tingle then went numb roughly 45-55 minutes after receiving (reported as from 23Dec2020, 08:30 AM). Not sure if that is an actual reaction but it occurred. The event was reported as non-serious. Therapeutic measures were taken as a result of face started to tingle then went numb roughly 45-55 minutes after receiving, treatment included BENADRYL orally taken. The outcome of the event was recovered in Dec2020.