chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Mydriasis, Off label use, Pain, Photophobia, Product use issue
Clinical narrative: her baby's pediatrician told her the patient could pass antibodies to the baby through breastfeeding; her baby's pediatrician told her the patient could pass antibodies to the baby through breastfeeding; headache; light sensitivity; vision changed; extreme fatigue /Exhaustion; overall body aches; sweaty /Sweating Profusely; her pupils were dilating and constricting; her pupils were dilating and constricting; Brain Fog; This is a spontaneous report received from a contactable consumer (patient). The consumer reported information for both mother and baby. This is the maternal report.  A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Apr2021 at age of 36 years at single dose for COVID-19 immunisation. Medical history included ongoing asthma, had basically had all of her life; since she was about 8 years old. Her grandfather had strokes. Her father died of a heart attack. Patient had no concomitant medications. Patient received her first Pfizer Covid vaccine dose on 20Apr2021. She stated that after the vaccine was administered (on 20Apr2021), she started to experience extreme fatigue and needed to sleep. After waking up from a nap, she noticed vision changed, headache with light sensitivity, overall body aches, and sweaty. Her husband told her that her pupils were dilating and constricting. Her MD advised her to go to the ED. Patient stated why the patient taking covid vaccination was asthma, medical worker and having a 9-month-old baby. Patient stated that she had been experiencing vision problems and a severe headache. Said her pupils had been dilating and contracting. Patient had severe headache, vision problems; pupils keep dilating and contracting, exhaustion, brain fog, sweating profusely on 20Apr2021. Said her symptoms started yesterday 20Apr2021, stopped, and then started again today. Stated she had questions about her side effects and asked should she go the Emergency Room; especially for the headache. Said today they were just as bad as yesterday; except she was not as exhausted today as she was yesterday. Patient stated that her main reason was because her baby's pediatrician told her the patient could pass antibodies to the baby through breastfeeding. Patient denied any medications, labs, testing, or treatments relevant to report. AE(s) did not require a visit to Emergency Room and Physician Office. Patient stated no adverse events after prior vaccinations; only an antibiotic. Outcome of exhaustion was recovering and the other events was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446591 Same reporter/drug, different patient/event (baby case)
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: her baby's pediatrician told her the patient could pass antibodies to the baby through breastfeeding; her baby's pediatrician told her the patient could pass antibodies to the baby through breastfeeding; headache; light sensitivity; vision changed; extreme fatigue /Exhaustion; overall body aches; sweaty /Sweating Profusely; her pupils were dilating and constricting; her pupils were dilating and constricting; Brain Fog; This is a spontaneous report received from a contactable consumer (patient). The consumer reported information for both mother and baby. This is the maternal report.  A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Apr2021 at age of 36 years at single dose for COVID-19 immunisation. Medical history included ongoing asthma, had basically had all of her life; since she was about 8 years old. Her grandfather had strokes. Her father died of a heart attack. Patient had no concomitant medications. Patient received her first Pfizer Covid vaccine dose on 20Apr2021. She stated that after the vaccine was administered (on 20Apr2021), she started to experience extreme fatigue and needed to sleep. After waking up from a nap, she noticed vision changed, headache with light sensitivity, overall body aches, and sweaty. Her husband told her that her pupils were dilating and constricting. Her MD advised her to go to the ED. Patient stated why the patient taking covid vaccination was asthma, medical worker and having a 9-month-old baby. Patient stated that she had been experiencing vision problems and a severe headache. Said her pupils had been dilating and contracting. Patient had severe headache, vision problems; pupils keep dilating and contracting, exhaustion, brain fog, sweating profusely on 20Apr2021. Said her symptoms started yesterday 20Apr2021, stopped, and then started again today. Stated she had questions about her side effects and asked should she go the Emergency Room; especially for the headache. Said today they were just as bad as yesterday; except she was not as exhausted today as she was yesterday. Patient stated that her main reason was because her baby's pediatrician told her the patient could pass antibodies to the baby through breastfeeding. Patient denied any medications, labs, testing, or treatments relevant to report. AE(s) did not require a visit to Emergency Room and Physician Office. Patient stated no adverse events after prior vaccinations; only an antibiotic. Outcome of exhaustion was recovering and the other events was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446591 Same reporter/drug, different patient/event (baby case)
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Biliary colic, Computerised tomogram, Feeding disorder
Clinical narrative: This is a spontaneous report from a contactable pharmacist via the medical information team. A 48-year-old female patient received bnt162b2 (COVID-19 VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 16Apr2021, the patient experienced severe vomiting and nausea. On an unspecified date, it got so bad over the next day or two, she couldn't eat started vomiting, and had to go to the Emergency Room where she didn't know if she was treated with medication. They could not find anything wrong with her gallbladder or pancreas. That lasted from Friday and not abiding - thought it may be a reaction from the COVID-19 vaccine. She needed someone to drive her home, they took her back to ER and gave her a new anti-nausea, but she still hasn't been able to eat food yet. On an unspecified date, the patient experienced slight stomach ache, throwing up, violently ill, able to limp home, very weak, could not lift her head off the pillow, and could not lift her head up. On 20Apr2021, she didn't seem to have symptoms, no fever or anything, that she had a UTI. They performed a CT which showed inflammation in the stomach, and maybe the gallbladder was a little irritated too. The patient underwent lab test and procedure which included ultrasound: gallbladder and pancreas normal on 18Apr2021 and Gallbladder had no stones/no pathology on 20Apr2021. The patient underwent CT scan with inflammation in the stomach and urine test with UTI on 20Apr2021. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Gastritis, Head discomfort, Malaise, Nausea
Clinical narrative: This is a spontaneous report from a contactable pharmacist via the medical information team. A 48-year-old female patient received bnt162b2 (COVID-19 VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 16Apr2021, the patient experienced severe vomiting and nausea. On an unspecified date, it got so bad over the next day or two, she couldn't eat started vomiting, and had to go to the Emergency Room where she didn't know if she was treated with medication. They could not find anything wrong with her gallbladder or pancreas. That lasted from Friday and not abiding - thought it may be a reaction from the COVID-19 vaccine. She needed someone to drive her home, they took her back to ER and gave her a new anti-nausea, but she still hasn't been able to eat food yet. On an unspecified date, the patient experienced slight stomach ache, throwing up, violently ill, able to limp home, very weak, could not lift her head off the pillow, and could not lift her head up. On 20Apr2021, she didn't seem to have symptoms, no fever or anything, that she had a UTI. They performed a CT which showed inflammation in the stomach, and maybe the gallbladder was a little irritated too. The patient underwent lab test and procedure which included ultrasound: gallbladder and pancreas normal on 18Apr2021 and Gallbladder had no stones/no pathology on 20Apr2021. The patient underwent CT scan with inflammation in the stomach and urine test with UTI on 20Apr2021. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Urinary tract infection, Urine analysis, Vomiting
Clinical narrative: This is a spontaneous report from a contactable pharmacist via the medical information team. A 48-year-old female patient received bnt162b2 (COVID-19 VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 16Apr2021, the patient experienced severe vomiting and nausea. On an unspecified date, it got so bad over the next day or two, she couldn't eat started vomiting, and had to go to the Emergency Room where she didn't know if she was treated with medication. They could not find anything wrong with her gallbladder or pancreas. That lasted from Friday and not abiding - thought it may be a reaction from the COVID-19 vaccine. She needed someone to drive her home, they took her back to ER and gave her a new anti-nausea, but she still hasn't been able to eat food yet. On an unspecified date, the patient experienced slight stomach ache, throwing up, violently ill, able to limp home, very weak, could not lift her head off the pillow, and could not lift her head up. On 20Apr2021, she didn't seem to have symptoms, no fever or anything, that she had a UTI. They performed a CT which showed inflammation in the stomach, and maybe the gallbladder was a little irritated too. The patient underwent lab test and procedure which included ultrasound: gallbladder and pancreas normal on 18Apr2021 and Gallbladder had no stones/no pathology on 20Apr2021. The patient underwent CT scan with inflammation in the stomach and urine test with UTI on 20Apr2021. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Muscle rigidity, Nausea, Neck pain
Clinical narrative: sore arm; sore neck/ neck pain; sore throat; headache; nausea; vomiting (threw up twice); joint pain; could not move her arm for 6 days; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 15Apr2021 as single dose and had previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on 16Mar2021 as single dose for covid-19 immunization. Patient medical history included COVID from an unspecified date in Jan2021 and dizziness from an unspecified date in Jan2021 which went away after five days of first dose and concomitant medications were not reported. Patient did not get tested for COVID-19. Patient said after first dose of the covid-19 vaccine she had a really sore arm, her second dose was last Thursday (15Apr2021) had a sore arm, sore neck/neck pain, sore throat, headache and nausea that lasted over 5 days, vomiting (threw up twice) could not move her arm for 6 days and joint pain and stated she had symptoms for 6 days after the second dose. Caller asked is it usual to have symptoms for six days. Caller asked if you have antibodies from having covid, can you have a stronger response to the second dose and have more side effects. Caller stated a doctor on TV had covid and was sick for 6 to 7 days after his vaccine. She read an article from a provider  about people with Rh negative factor and O negative blood had very mild symptoms of covid-19 and would like to speak to someone, relayed PMI number and hours, she had to go but will call number given, caller disconnected, will fax AE. The outcome of the events was unknown.   Upon follow-up (21Apr2021): This is a follow up spontaneous report from a female contactable consumer. This female consumer (patient) reported.  Upon follow-up (23Apr2021): This is a follow up spontaneous report from a female contactable consumer. This female consumer (patient) reported that: Only adverse event present and no PQC present.  Upon follow-up (21Apr2021): This is a follow up spontaneous report from a female contactable consumer. This female consumer (patient) reported about relevant medical history which was captured above and in the relevant fields.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Vomiting
Clinical narrative: sore arm; sore neck/ neck pain; sore throat; headache; nausea; vomiting (threw up twice); joint pain; could not move her arm for 6 days; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 15Apr2021 as single dose and had previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on 16Mar2021 as single dose for covid-19 immunization. Patient medical history included COVID from an unspecified date in Jan2021 and dizziness from an unspecified date in Jan2021 which went away after five days of first dose and concomitant medications were not reported. Patient did not get tested for COVID-19. Patient said after first dose of the covid-19 vaccine she had a really sore arm, her second dose was last Thursday (15Apr2021) had a sore arm, sore neck/neck pain, sore throat, headache and nausea that lasted over 5 days, vomiting (threw up twice) could not move her arm for 6 days and joint pain and stated she had symptoms for 6 days after the second dose. Caller asked is it usual to have symptoms for six days. Caller asked if you have antibodies from having covid, can you have a stronger response to the second dose and have more side effects. Caller stated a doctor on TV had covid and was sick for 6 to 7 days after his vaccine. She read an article from a provider  about people with Rh negative factor and O negative blood had very mild symptoms of covid-19 and would like to speak to someone, relayed PMI number and hours, she had to go but will call number given, caller disconnected, will fax AE. The outcome of the events was unknown.   Upon follow-up (21Apr2021): This is a follow up spontaneous report from a female contactable consumer. This female consumer (patient) reported.  Upon follow-up (23Apr2021): This is a follow up spontaneous report from a female contactable consumer. This female consumer (patient) reported that: Only adverse event present and no PQC present.  Upon follow-up (21Apr2021): This is a follow up spontaneous report from a female contactable consumer. This female consumer (patient) reported about relevant medical history which was captured above and in the relevant fields.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Skin burning sensation
Clinical narrative: a rash "shaped like 25 cents" which burns, on her left arm, surrounding where she received the vaccine/ got a rash on her skin that started to burn; a rash "shaped like 25 cents" which burns, on her left arm, surrounding where she received the vaccine/ got a rash on her skin that started to burn; This is a spontaneous report from a contactable consumer. A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 21Apr2021 09:11 (Batch/Lot number was not reported) as single dose at left arm for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced after she left, she developed a rash "shaped like 25 cents" which burns, on her left arm, surrounding where she received the vaccine. She's got a rash on her skin that started to burn. Outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Faecal calprotectin, Faecal calprotectin abnormal, Paraesthesia
Clinical narrative: tingling of feet and face; He had his Inflectra infusion, three days after his first shot of the Pfizer COVID19 vaccine; Stated that his cal protectnin number jumped up after he got the vaccine; This is a spontaneous report received from a contactable reporter. A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. Medical history included cal protectnin. Concomitant medications were not reported. Caller was calling for her son that is also on Inflectra. He got his first dose of the Pfizer BioNTech COVID19 vaccine. He had his Inflectra infusion, three days after his first shot of the Pfizer COVID19 vaccine. He has his second dose on Friday, and she is wondering if it is safe to get his second dose at 21 days or if he should wait longer. It seems that she is asking if there was an interaction. She later mentions that after his first dose of the COVID19 vaccine he had a reaction: tingling of feet and face. Caller states that she was very frustrated with us. She feels like we're not providing her with the information she needs, and she has to make a tough decision for her child. Both are our medicines (Inflectra and Pfizer COVID19 vaccine) and we should have this information. Patient that stated that her son had Pfizer Vaccine for Covid earlier in the month and three days after had an Inflectra infusion. Stated that he is coming up for an appointment for another Inflectra infusion which is 3 weeks later. Wanted to know if he should get the vaccine again and if it was too much in a given time frame. Clarified that his infusions are eight weeks apart. Stated that the pharmacy told her that he was to not take any other medication with the Inflectra which made her hesitant. Stated that they did the vaccine and was told by the doctor it was okay. Wanted to know how long to wait between first and second vaccine knowing he had an infusion three weeks after it. Wanted to know if it was 42 days in-between. Stated that his cal protectnin number has been going down since October. Stated that his cal protectnin number jumped up after he got the vaccine. Stated that it was not greater than 8000 and has gradually decreased. Wanted to know if they should wait longer for second for the second vaccine to make sure that it was not messing with his Inflectra. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Hypersomnia, Hypoaesthesia, Vision blurred
Clinical narrative: blurry eyes; Headache; numb face and arms; Felt dizzy; Had to call out of work to rest and sleep all day; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on 19Apr2021 16:00 as single dose for COVID-19 immunization. The patient's medical history included diabetes. Concomitant medication was not reported. The patient received second dose of Pfizer BioNTech Covid 19 vaccine on Monday 19Apr2021 around 4pm. The next day the patient experienced numb face and arms, felt dizzy, and had to call out of work to rest and sleep all day. Today he felt okay but started feeling dizzy with a headache and blurry eyes. He has diabetes but has been taking his blood sugar in the morning and they have been okay. He has been taking tylenol for the headaches. The patient said he was driving to work next day and face and arm went numb. Had to turn around and go back home. Next day tried going to work again, face and arm went numb also was dizzy and slight headache. Wants to know if this side effect has been reported and what do we suggest. It was reported that the patient went to see his animals and I (sentence incomplete). I am calling you because of the side effects that I am having from the vaccine. Also, I want to know if this was the part of the side effects that was going on with me. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Headache, Hypoaesthesia, Ocular discomfort
Clinical narrative: blurry eyes; Headache; numb face and arms; Felt dizzy; Had to call out of work to rest and sleep all day; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on 19Apr2021 16:00 as single dose for COVID-19 immunization. The patient's medical history included diabetes. Concomitant medication was not reported. The patient received second dose of Pfizer BioNTech Covid 19 vaccine on Monday 19Apr2021 around 4pm. The next day the patient experienced numb face and arms, felt dizzy, and had to call out of work to rest and sleep all day. Today he felt okay but started feeling dizzy with a headache and blurry eyes. He has diabetes but has been taking his blood sugar in the morning and they have been okay. He has been taking tylenol for the headaches. The patient said he was driving to work next day and face and arm went numb. Had to turn around and go back home. Next day tried going to work again, face and arm went numb also was dizzy and slight headache. Wants to know if this side effect has been reported and what do we suggest. It was reported that the patient went to see his animals and I (sentence incomplete). I am calling you because of the side effects that I am having from the vaccine. Also, I want to know if this was the part of the side effects that was going on with me. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: blurry eyes; Headache; numb face and arms; Felt dizzy; Had to call out of work to rest and sleep all day; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on 19Apr2021 16:00 as single dose for COVID-19 immunization. The patient's medical history included diabetes. Concomitant medication was not reported. The patient received second dose of Pfizer BioNTech Covid 19 vaccine on Monday 19Apr2021 around 4pm. The next day the patient experienced numb face and arms, felt dizzy, and had to call out of work to rest and sleep all day. Today he felt okay but started feeling dizzy with a headache and blurry eyes. He has diabetes but has been taking his blood sugar in the morning and they have been okay. He has been taking tylenol for the headaches. The patient said he was driving to work next day and face and arm went numb. Had to turn around and go back home. Next day tried going to work again, face and arm went numb also was dizzy and slight headache. Wants to know if this side effect has been reported and what do we suggest. It was reported that the patient went to see his animals and I (sentence incomplete). I am calling you because of the side effects that I am having from the vaccine. Also, I want to know if this was the part of the side effects that was going on with me. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Hypersomnia, Hypoaesthesia, Vision blurred
Clinical narrative: eyes kind of cloudy; dizzy and off balance; Headache; dizzy and off balance; whole right arm and face numb; Drowsiness; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8734, on 19Apr2021 16:00 at single dose in left arm for COVID-19 immunization. Medical history included ongoing Diabetes mellitus since 2011. Concomitant medication was none. The patient previously received first dose of BNT162B2, Lot: GR8735, on 28Mar2021. The patient received his second dose of the Pfizer Covid-19 vaccine at 1600 on Monday (19Apr2021). Yesterday (20Apr2021), he went to work to feed his horses and he couldn't work.  He was drowsy, his whole face and right arm was numb, he rested all day. Today (21Apr2021) as he was driving to work he pulled over.  He had a headache and was drowsy and his eyes were kind of cloudy. The patient was drowsy early this morning again, it came back like yesterday morning.  He laid down in his truck and rested and he got better. His arm and face being numb started yesterday around 9am and stopped between 1800 to 1900. At the jobsite, it was lunchtime and he drove the employees, reported his eyes bring kind of cloudy was better now. This morning he was drowsy and dizzy, off balance.  He stayed in his truck. His balance was getting back to normal again. He had been taking Tylenol for his headache. The outcome of Drowsiness, eyes kind of cloudy, dizzy and off balance was resolving. The outcome of whole right arm and face numb was resolved on 20Apr2021. The outcome of Headache was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Headache, Hypoaesthesia, Ocular discomfort
Clinical narrative: eyes kind of cloudy; dizzy and off balance; Headache; dizzy and off balance; whole right arm and face numb; Drowsiness; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8734, on 19Apr2021 16:00 at single dose in left arm for COVID-19 immunization. Medical history included ongoing Diabetes mellitus since 2011. Concomitant medication was none. The patient previously received first dose of BNT162B2, Lot: GR8735, on 28Mar2021. The patient received his second dose of the Pfizer Covid-19 vaccine at 1600 on Monday (19Apr2021). Yesterday (20Apr2021), he went to work to feed his horses and he couldn't work.  He was drowsy, his whole face and right arm was numb, he rested all day. Today (21Apr2021) as he was driving to work he pulled over.  He had a headache and was drowsy and his eyes were kind of cloudy. The patient was drowsy early this morning again, it came back like yesterday morning.  He laid down in his truck and rested and he got better. His arm and face being numb started yesterday around 9am and stopped between 1800 to 1900. At the jobsite, it was lunchtime and he drove the employees, reported his eyes bring kind of cloudy was better now. This morning he was drowsy and dizzy, off balance.  He stayed in his truck. His balance was getting back to normal again. He had been taking Tylenol for his headache. The outcome of Drowsiness, eyes kind of cloudy, dizzy and off balance was resolving. The outcome of whole right arm and face numb was resolved on 20Apr2021. The outcome of Headache was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: eyes kind of cloudy; dizzy and off balance; Headache; dizzy and off balance; whole right arm and face numb; Drowsiness; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8734, on 19Apr2021 16:00 at single dose in left arm for COVID-19 immunization. Medical history included ongoing Diabetes mellitus since 2011. Concomitant medication was none. The patient previously received first dose of BNT162B2, Lot: GR8735, on 28Mar2021. The patient received his second dose of the Pfizer Covid-19 vaccine at 1600 on Monday (19Apr2021). Yesterday (20Apr2021), he went to work to feed his horses and he couldn't work.  He was drowsy, his whole face and right arm was numb, he rested all day. Today (21Apr2021) as he was driving to work he pulled over.  He had a headache and was drowsy and his eyes were kind of cloudy. The patient was drowsy early this morning again, it came back like yesterday morning.  He laid down in his truck and rested and he got better. His arm and face being numb started yesterday around 9am and stopped between 1800 to 1900. At the jobsite, it was lunchtime and he drove the employees, reported his eyes bring kind of cloudy was better now. This morning he was drowsy and dizzy, off balance.  He stayed in his truck. His balance was getting back to normal again. He had been taking Tylenol for his headache. The outcome of Drowsiness, eyes kind of cloudy, dizzy and off balance was resolving. The outcome of whole right arm and face numb was resolved on 20Apr2021. The outcome of Headache was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Lymph node pain, Lymphadenopathy, Myalgia, Neuralgia
Clinical narrative: arm soreness; weird lymph node pain all over her body; weird muscle or nerve pain in her legs; weird muscle or nerve pain in her legs; skin hurts all over; Her groin lymph nodes and lymph nodes in her neck were really painful; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported for her 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration on 07Apr2021 as SINGLE DOSE for COVID-19 immunization. The medical history and concomitant medication were not reported. Approximately on unknown date in 2021, about a week in patient had arm soreness and she's been having weird lymph node pain all over her body. Her groin lymph nodes and lymph nodes in her neck were really painful. It started with weird muscle or nerve pain in her legs. She has gone to her doctor and they don't know what to do. On an unknown date in 2021, the patient performed with a blood test and x-ray, but the results are not provided. Her skin hurts all over. We're not sure what it is, but I'm concerned about her getting her 2nd vaccine. Patient mother asking, the skin pain is a symptom of lymphadenopathy. Patient mother asking what the protocol for managing these side effects. Patient mother also enquired about lymphadenopathy would be worse after the second dose. The caller also asked about the efficacy of the first shot. The response included, https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-publication-results-landmark.The cumulative incidence of COVID-19 cases over time among placebo and vaccine recipients began to diverge by 12 days after the first dose, and 52.4% vaccine efficacy (95% confidence interval: 29.5, 68.4) was observed between dose 1 and dose 2, indicating the early onset of a partially protective effect of immunization. Two doses of vaccine provide the maximum protection observed. The outcome of the events was unknown. No PQC involved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain of skin, X-ray
Clinical narrative: arm soreness; weird lymph node pain all over her body; weird muscle or nerve pain in her legs; weird muscle or nerve pain in her legs; skin hurts all over; Her groin lymph nodes and lymph nodes in her neck were really painful; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported for her 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration on 07Apr2021 as SINGLE DOSE for COVID-19 immunization. The medical history and concomitant medication were not reported. Approximately on unknown date in 2021, about a week in patient had arm soreness and she's been having weird lymph node pain all over her body. Her groin lymph nodes and lymph nodes in her neck were really painful. It started with weird muscle or nerve pain in her legs. She has gone to her doctor and they don't know what to do. On an unknown date in 2021, the patient performed with a blood test and x-ray, but the results are not provided. Her skin hurts all over. We're not sure what it is, but I'm concerned about her getting her 2nd vaccine. Patient mother asking, the skin pain is a symptom of lymphadenopathy. Patient mother asking what the protocol for managing these side effects. Patient mother also enquired about lymphadenopathy would be worse after the second dose. The caller also asked about the efficacy of the first shot. The response included, https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-publication-results-landmark.The cumulative incidence of COVID-19 cases over time among placebo and vaccine recipients began to diverge by 12 days after the first dose, and 52.4% vaccine efficacy (95% confidence interval: 29.5, 68.4) was observed between dose 1 and dose 2, indicating the early onset of a partially protective effect of immunization. Two doses of vaccine provide the maximum protection observed. The outcome of the events was unknown. No PQC involved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: went in for her second dose on Tuesday she also got shingles; This is a spontaneous report from a contactable other healthcare professional. This other healthcare professional reported same events for two patients (patient himself and his mom). This is the second of two reports.  A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 78 years of age), via an unspecified route of administration, administered in arm right on 13Apr2021 (Batch/Lot Number: ER8729) as 2nd dose, single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Historical vaccine included BNT162B2 dose 1 on 22Mar2021 (lot number: EN6208) (at 78 years of age) for COVID-19 immunisation. The patient went in for her second dose on Tuesday, she also got shingles. It was mentioned that the patient recently got diagnosed today (unspecified) so she was not taking anything currently but she takes some antiviral (not sure exactly what it was). It was clarified that the patient had not yet taken treatment for the event but the reporting other healthcare professional was sure that she will be. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021381912 same reporter/drugs/events; different patients
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: redness and itchy at injection site arm; redness and itchy at injection site arm/it itches; This is a spontaneous report from a contactable consumer (mother-in law of patient) or other non-health care professional.  A 94-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient medical history, concomitant medications were not reported. On an unspecified date patient experienced redness and itchy at injection site arm (vaccination site erythema), redness and itchy at injection site arm/it itches (vaccination site pruritus). The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Dizziness, Epistaxis
Clinical narrative: intestinal upset; blood in nose mucous; Headache/low grade headache; dizziness; sinus stinging; runny nose; diarrhea; numbness in fingers; tiredness; weakness; This is a spontaneous report from a contactable consumer (the patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 10Apr2021 13:15 (at the age of 61-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included azithromycin. The patient previously took and had known allergies to Sulphur. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the patient experienced the following events: headache for 2 days, dizziness, then low grade headache for 1 week, sinus stinging and runny nose, blood in nose mucous, diarrhea for 1 week, intestinal upset, numbness in fingers, and overall tiredness and weakness for over one week. No treatment was received for the events. The outcome of the events was recovered in Apr2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information about the Lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Rhinorrhoea, Sinus pain
Clinical narrative: intestinal upset; blood in nose mucous; Headache/low grade headache; dizziness; sinus stinging; runny nose; diarrhea; numbness in fingers; tiredness; weakness; This is a spontaneous report from a contactable consumer (the patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 10Apr2021 13:15 (at the age of 61-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included azithromycin. The patient previously took and had known allergies to Sulphur. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the patient experienced the following events: headache for 2 days, dizziness, then low grade headache for 1 week, sinus stinging and runny nose, blood in nose mucous, diarrhea for 1 week, intestinal upset, numbness in fingers, and overall tiredness and weakness for over one week. No treatment was received for the events. The outcome of the events was recovered in Apr2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information about the Lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: fever; chills; fatigue; pain; This is a spontaneous report received from a contactable consumer. A 57-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), from an unspecified route and location on 16Apr2021 as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant products were not reported. The patient experienced fever, chills, fatigue, and pain on Apr2021. The patient wanted to know how symptoms may be with the second Pfizer Covid 19 Vaccine?. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Migraine
Clinical narrative: Horrific migraines; metallic taste following dose; This is a spontaneous report from a contactable consumer. A 36-year-old female patient received BNT162B2 second dose on unspecified date about a month ago (Mar2021) at single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 first dose on unspecified date for Covid-19 immunization. Patient had Horrific migraines. Reports no history of migraines.  Exhibited four days ago. Also indicates metallic taste following dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt like the sensation that it was running through body; through legs, arms, chest/ mainly a sensation in legs, traveling from the top of legs down to feet/ No pain/ didn't last very long; This is spontaneous report from a non-contactable consumer (patient). A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on an unspecified date (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated he received the Pfizer COVID vaccine and had a side effect. Patient stated when he received his first dose, he felt like the sensation that it was running through his body; through his legs, his arms, his chest. There was mainly a sensation in his legs, traveling from the top of his legs down to his feet. No pain, it just felt like it was moving through his body and it didn't last very long. Patient asking if this is a common side effect. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Feeling abnormal, Headache
Clinical narrative: Felt really strange; My body kept heating up, heating up, and heating up and then I got a headache; My body kept heating up, heating up, and heating up and then I got a headache; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. patient received her first shot on Sunday afternoon and when she was there the first 3 minutes, she felt really strange and her body kept heating up, heating up, and heating up and then she got a headache. Patient asked if that was a side effect or if it was normal. It lasted anywhere from 8-10 minutes. Patient asked If she decide not the get the second shot will the first shot protect her. patient asked "I wouldn't die, would I?" patient was recovered from the events in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Pain in extremity
Clinical narrative: feeling discomfort and pain in the arm where he had the shot; feeling discomfort and pain in the arm where he had the shot; This is a spontaneous report from a contactable consumer or other non hcp (Patient).    A 44-years-old male patient received bnt162b2 (BNT162B2), dose 1 at 11:37 am via an unspecified route of administration and unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Second dose was scheduled for 12May2021. The patient medical history and concomitant was not reported. On an unspecified date, after first dose he started feeling discomfort and pain in the arm where he had the shot, and took 2 Tylenol at 2:45 pm. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dysphagia, Lip disorder, Pruritus, Rash macular
Clinical narrative: Itching and red spots on the hands; Itching and red spots on the hands; Bump under the lips; Hard time swallowing; Skipping steps/ balance issue; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on an unspecified date (62-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced a bad reaction, itching and red spots on the hands, bump under the lips, hard time swallowing, skipping steps/ balance issue. Patient wanted to know should she get the second dose or not. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I started experiencing hives and itchy welts; This is a spontaneous report from a non-contactable consumer (patient) reported for herself. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient had the first dose of the Pfizer covid 19 vaccine on 16Apr2021, Friday at noon. Late last night (Apr2021) she started experiencing hives and itchy welts. Reporter asked if it was okay to take an antihistamine. Patient asked if she had a side effect after the first dose of the vaccine. If she should get the second dose. Reporter asked if it was this a common side effect. 09May2021, scheduled for second dose. outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.