chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pancreatic disorder
Clinical narrative: problems with his pancreas; he was having a lot of stomach pain; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Feb2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced problems with his pancreas, he was having a lot of stomach pain on 15Mar2021. It was reported that the patient experienced problems with his pancreas, he had not been able to get his Creon medication and he was having a lot of stomach pain. The events were reported as serious due to seriousness criteria-caused/prolonged hospitalization, the patient hospitalized for events from 15Mar2021. He was supposed to come in today (16Mar2021) and had his second injection but he went in the hospital due to problems with his pancreas, he had not been able to get his Creon medication and he was having a lot of stomach pain so they admitted him last night. Not really like an hours 20 minutes. She did not have time to go through a report. Her husband would probably be out of the hospital tomorrow (17Mar2021), the reporter wanted to know if he could come in and do it then or could he make his own appointment there at the site. Because he was supposed to have it in 3 weeks and tomorrow the date would be exactly 3 weeks. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness
Clinical narrative: Dizzy; This is a spontaneous report from a contactable consumer. A 93-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201, expiration date: unknown), via an unspecified route of administration in right arm on 10Feb2021 at 02:40, second dose via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Feb2021, the patient experienced dizzy. The dizziness would stay as long as she stands up, but if she sat down, she was fine. They did not think much of it and did not really but anything together. She was calling to try and get some help/advice on what to do. They have tried motion sickness pills and called the doctor and has seen the doctor 2-3 times. She cannot think of anything else to do in order to help. She was hoping we would be able to provide some advice and say something that they should do in order to help. The patient's blood was draw, but did not find anything else going on. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Bell's palsy
Clinical narrative: Bell's palsy; anxiety; This is a spontaneous report from a contactable consumer (patient's friend). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at a single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient received the Covid-19 vaccine and ended up in the hospital with Bell's Palsy. The reporter was not sure if this was related to the vaccine. The reporter wanted to know if there were any similar reports of this. The reporter also stated that the patient also experienced anxiety after the vaccine administration. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dermatitis, Facial paralysis, Hypoaesthesia, Mass
Clinical narrative: Her left arm and face were numb; mass/swelling on her face; The left side of her face is drooping; face became swollen; face became swollen and inflamed; face was still swollen and sore; This is a spontaneous report from a contactable consumer (patient) and a contactable nurse. This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208, expiration date: 30Jun2021) via intramuscular in the left arm on 12Mar2021 at 14:10 at single dose for COVID-19 immunisation. Medical history included hyperlipidemia, pneumonia and flu. The patient had family medical history of diabetes. Concomitant medications included estrogens conjugated (PREMARIN) ongoing. The patient was not pregnant. The patient no other vaccine in four weeks or other medications in two weeks. The left side of the patient's face became swollen and inflamed. Five days later the left side of her face was still swollen and sore. The left side of her face was drooping. Events started date was 12Mar2021 at 15:00 PM. No treatment for AE was received, except events "mass/swelling on her face" and "Her left arm and face were numb". The patient had no COVID prior vaccination, no COVID tested post vaccination. A nurse reported that the 2nd dose was scheduled for 05Apr2021. The patient had last blood work (reported as BW) on Sep2020 with comments: normal. The left side of patient's face was drooping on 14Mar2021. The nurse stated patient went to ER. Her left arm and face were numb. They noticed a mass/swelling on her face. Outcome of the events "mass/swelling on her face", "Her left arm and face were numb" was unknown, of the other events was not recovered.; Sender's Comments: A contributory role of BNT162B2 to event the left side of her face is drooping is considered possibly based on temporal association and known safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Swelling
Clinical narrative: Her left arm and face were numb; mass/swelling on her face; The left side of her face is drooping; face became swollen; face became swollen and inflamed; face was still swollen and sore; This is a spontaneous report from a contactable consumer (patient) and a contactable nurse. This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208, expiration date: 30Jun2021) via intramuscular in the left arm on 12Mar2021 at 14:10 at single dose for COVID-19 immunisation. Medical history included hyperlipidemia, pneumonia and flu. The patient had family medical history of diabetes. Concomitant medications included estrogens conjugated (PREMARIN) ongoing. The patient was not pregnant. The patient no other vaccine in four weeks or other medications in two weeks. The left side of the patient's face became swollen and inflamed. Five days later the left side of her face was still swollen and sore. The left side of her face was drooping. Events started date was 12Mar2021 at 15:00 PM. No treatment for AE was received, except events "mass/swelling on her face" and "Her left arm and face were numb". The patient had no COVID prior vaccination, no COVID tested post vaccination. A nurse reported that the 2nd dose was scheduled for 05Apr2021. The patient had last blood work (reported as BW) on Sep2020 with comments: normal. The left side of patient's face was drooping on 14Mar2021. The nurse stated patient went to ER. Her left arm and face were numb. They noticed a mass/swelling on her face. Outcome of the events "mass/swelling on her face", "Her left arm and face were numb" was unknown, of the other events was not recovered.; Sender's Comments: A contributory role of BNT162B2 to event the left side of her face is drooping is considered possibly based on temporal association and known safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: flu symptoms; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (female) reported that a female patient of unknown age (reporters sister-in-law) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unknown date at single dose for covid-19 immunization. The patients medical history and concomitant medications were not reported. The patient had flu symptoms and it started 8 hrs after vaccination. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: difficult in breathing; cough; This is a spontaneous report received from Pfizer. A contactable consumer reported for herself that: A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. After the vaccine in Mar2021, the patient experienced a little bit difficult in breathing and little cough. It was unknown if any treatment was received for the reported events. The outcome of the events was unknown.  Information on lot number/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Dyspnoea
Clinical narrative: became more short of breath; Exacerbation of COPD; This is a spontaneous report received from a non-contactable Other HCP. A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/Lot EN6205), via an unspecified route of administration on 02Mar2021 at single dose for covid-19 immunization. The patient medical history and Concomitant medication were not reported. The patient previously took first dose of BNT162B2 at single dose for covid-19 immunization. Patient had end stage COPD and noted that she became more short of breath 1-2 days after receiving her 2nd dose on 02Mar2021. It was also reported that provider from the Covid-19 vaccine clinic called patient to follow up on her recent covid-19 vaccine that was done on 01Mar2021. She tried to manage it on her own at home but noted in the couple of weeks that it was not improving. She would be more short of breath with and w/o ambulation. Her husband, (Name), took her to an express care. Today (16Mar2021) whom evaluated her with blood work, chest x-ray and gave her a breathing tx. States she was prescribed abx and prednisone. She does not see much change yet since discharge. On her discharge paperwork, she notes that she was instructed to let covid vaccine clinic and pcp know about her potential reaction vs. Exacerbation of copd. Pt states she is scheduled to see her pcp on Monday, 22Mar2021, along with her pallative care team. Outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information, Short of breath is most likely related to the end stage COPD, which is not related to the suspected drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Oropharyngeal pain, Pharyngeal swelling, Pyrexia, Speech disorder
Clinical narrative: can't speak because his throat is so bad; fever 100.8 last night of 16Mar2021; throat was swollen; throat was painful/throat is still sore; tonsillitis; tickle in the throat; This is a spontaneous report from a contactable healthcare professional (patient's friend). A 30-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 11Mar2021 16:00 as single dose for COVID-19 immunisation. Medical history included patient was a kidney donor and has only one kidney. There were no concomitant medications. Podiatrist calling for a friend who can't speak because his throat was so bad on an unspecified date. Adds the patient got the first dose of the Pfizer COVID 19 vaccine Thursday 11Mar2021 at 1600 in an unknown site. Friday (12Mar2021) and Saturday (13Mar2021), he had a tickle in his throat. His throat was swollen and painful on 14Mar2021 and he couldn't stand it and went to the ER. On 14Mar2021, at the ER he had a negative Strep test and was told he had tonsillitis and was given antibiotics. Clarifies patient was treated with Zithromax for 5 days. Adds yesterday he said he had three more days of antibiotics. Reports today the patient was only able to eat ice pops and his throat was still swollen although he was getting better. He said his throat was still sore and he has been too afraid to eat anything except popsicles but was planning to try soup. Mentions patient said he had a fever last night 16Mar2021 of 100.8. They were trying to figure out if this was related to the vaccine or did he get sick with something else and should he get the next dose. States the second dose was scheduled for 01Apr2021. The events tickle in the throat, throat was swollen, and throat was painful/throat is still sore resulted in emergency room visit and was considered as medically significant. Therapeutic measures were taken as a result of tickle in the throat, throat was swollen, throat was painful/throat is still sore, can't speak because his throat is so bad, and tonsillitis. The outcome of the events tonsillitis and can't speak because his throat is so bad was unknown and recovering for the rest of the events.  Information about lot/batch has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events "tickle in the throat, throat was swollen and throat was painful/throat is still sore" cannot be completely excluded based on temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Streptococcus test, Throat irritation, Tonsillitis
Clinical narrative: can't speak because his throat is so bad; fever 100.8 last night of 16Mar2021; throat was swollen; throat was painful/throat is still sore; tonsillitis; tickle in the throat; This is a spontaneous report from a contactable healthcare professional (patient's friend). A 30-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 11Mar2021 16:00 as single dose for COVID-19 immunisation. Medical history included patient was a kidney donor and has only one kidney. There were no concomitant medications. Podiatrist calling for a friend who can't speak because his throat was so bad on an unspecified date. Adds the patient got the first dose of the Pfizer COVID 19 vaccine Thursday 11Mar2021 at 1600 in an unknown site. Friday (12Mar2021) and Saturday (13Mar2021), he had a tickle in his throat. His throat was swollen and painful on 14Mar2021 and he couldn't stand it and went to the ER. On 14Mar2021, at the ER he had a negative Strep test and was told he had tonsillitis and was given antibiotics. Clarifies patient was treated with Zithromax for 5 days. Adds yesterday he said he had three more days of antibiotics. Reports today the patient was only able to eat ice pops and his throat was still swollen although he was getting better. He said his throat was still sore and he has been too afraid to eat anything except popsicles but was planning to try soup. Mentions patient said he had a fever last night 16Mar2021 of 100.8. They were trying to figure out if this was related to the vaccine or did he get sick with something else and should he get the next dose. States the second dose was scheduled for 01Apr2021. The events tickle in the throat, throat was swollen, and throat was painful/throat is still sore resulted in emergency room visit and was considered as medically significant. Therapeutic measures were taken as a result of tickle in the throat, throat was swollen, throat was painful/throat is still sore, can't speak because his throat is so bad, and tonsillitis. The outcome of the events tonsillitis and can't speak because his throat is so bad was unknown and recovering for the rest of the events.  Information about lot/batch has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events "tickle in the throat, throat was swollen and throat was painful/throat is still sore" cannot be completely excluded based on temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood disorder, Cerebrovascular accident, Computerised tomogram, Disturbance in attention, Hypoaesthesia
Clinical narrative: blood clot formation that went to my brain; stroke; numbness; paralyzed; vision is messed up; trouble concentrating; This is a spontaneous report from a contactable consumer (patient) . This 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown, may be EN8199 or EN6199), via an unspecified route of administration on 11Mar2021 at single dose in right arm about 16:00 for COVID-19 immunisation. Medical history included ongoing probably overweight and blood clot about 20 years ago. The patient's concomitant medications were not reported. It was reported that, the patient who was administered the first dose of Pfizer-BioNTech COVID-19 Vaccine on 11Mar2021. He reported on 14Mar2021 he got a blood clot and had a stroke. He asked if he should or should not still get the second dose of the Pfizer-BioNTech COVID-19 Vaccine related to these events. He had in the hospital from 14Mar2021 to 15Mar2021. He was supposed to have an appointment with his Family Care Physician, Doctor next Monday or Tuesday. He had to go to the emergency room because of these events where he was admitted to the hospital from 14Mar2021-15Mar2021 when he was discharged home under family care. They let him go so soon on 15Mar2021 because he insisted on it, if he was just going to be laying in the hospital he could be laying at home. There was not much they could do in the hospital except observe him, monitoring symptoms of when his numbness and the being paralyzed like in the face for improvement, then they figured the clots were clearing up. They put him on an Aspirin and other unknown things to keep events from reoccurring soon after these events. He was still does not feel 100%, his vision was messed up, he has trouble concentrating, vision was blurred sometimes; that was what happened, he knew he had a stroke when his vision went south on him on 14Mar2021. While in the hospital they did everything except no x-rays; he had CT scan, lots of bloodwork and stuff like that. He does not have further information on those tests or results. The seriousness of the events blood clot formation that went to my brain, stroke, numbness and paralysed was reported as serious (hospitalized). The outcome of events was reported as unknown.  Information about lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Paralysis, Visual impairment
Clinical narrative: blood clot formation that went to my brain; stroke; numbness; paralyzed; vision is messed up; trouble concentrating; This is a spontaneous report from a contactable consumer (patient) . This 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown, may be EN8199 or EN6199), via an unspecified route of administration on 11Mar2021 at single dose in right arm about 16:00 for COVID-19 immunisation. Medical history included ongoing probably overweight and blood clot about 20 years ago. The patient's concomitant medications were not reported. It was reported that, the patient who was administered the first dose of Pfizer-BioNTech COVID-19 Vaccine on 11Mar2021. He reported on 14Mar2021 he got a blood clot and had a stroke. He asked if he should or should not still get the second dose of the Pfizer-BioNTech COVID-19 Vaccine related to these events. He had in the hospital from 14Mar2021 to 15Mar2021. He was supposed to have an appointment with his Family Care Physician, Doctor next Monday or Tuesday. He had to go to the emergency room because of these events where he was admitted to the hospital from 14Mar2021-15Mar2021 when he was discharged home under family care. They let him go so soon on 15Mar2021 because he insisted on it, if he was just going to be laying in the hospital he could be laying at home. There was not much they could do in the hospital except observe him, monitoring symptoms of when his numbness and the being paralyzed like in the face for improvement, then they figured the clots were clearing up. They put him on an Aspirin and other unknown things to keep events from reoccurring soon after these events. He was still does not feel 100%, his vision was messed up, he has trouble concentrating, vision was blurred sometimes; that was what happened, he knew he had a stroke when his vision went south on him on 14Mar2021. While in the hospital they did everything except no x-rays; he had CT scan, lots of bloodwork and stuff like that. He does not have further information on those tests or results. The seriousness of the events blood clot formation that went to my brain, stroke, numbness and paralysed was reported as serious (hospitalized). The outcome of events was reported as unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Diarrhoea, Nervousness, Respiratory distress
Clinical narrative: severe respiratory distress; coughing; shakes; chills; massive diarrhea and vomiting; massive diarrhea and vomiting; scared to get the 2nd dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration on 13Mar2021 09:30 as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown. The patient medical history and concomitant medications were not reported. Patient reported that she got the 1st dose on 13March2021 at 09:30 AM. She experienced "real bad side effects: severe respiratory distress, coughing, to the point her husband almost called to take her to the hospital. Next morning, she reported shakes, chills, massive diarrhea and vomiting. Patient reported she is scared to get 2nd one.  She commented, "I heard through the grapevine some people have nothing after 1st one and have something after 2nd one". Outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: severe respiratory distress; coughing; shakes; chills; massive diarrhea and vomiting; massive diarrhea and vomiting; scared to get the 2nd dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration on 13Mar2021 09:30 as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown. The patient medical history and concomitant medications were not reported. Patient reported that she got the 1st dose on 13March2021 at 09:30 AM. She experienced "real bad side effects: severe respiratory distress, coughing, to the point her husband almost called to take her to the hospital. Next morning, she reported shakes, chills, massive diarrhea and vomiting. Patient reported she is scared to get 2nd one.  She commented, "I heard through the grapevine some people have nothing after 1st one and have something after 2nd one". Outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Diarrhoea, Dyspnoea, Respiratory distress
Clinical narrative: severe respiratory distress; coughing; shakes; chills; massive diarrhea and vomiting; massive diarrhea and vomiting; scared to get the 2nd dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration on 13Mar2021 09:30 as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown. The patient medical history and concomitant medications were not reported. Patient reported that she got the 1st dose on 13March2021 at 09:30 AM. She experienced "real bad side effects: severe respiratory distress, coughing, to the point her husband almost called to take her to the hospital. Next morning, she reported shakes, chills, massive diarrhea and vomiting. Patient reported she is scared to get 2nd one.  She commented, "I heard through the grapevine some people have nothing after 1st one and have something after 2nd one". Outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Diarrhoea, Nervousness, Respiratory distress
Clinical narrative: Chills; Vomiting; Diarrhea; shakes; Shortness of breath; Coughing; respiratory distress; This is a spontaneous report from a contactable retired nurse. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EN6198; expiration date: unknown), at vaccination age 64-year-old via an unspecified route of administration in the right arm on 13Mar2021 09:30 as a single dose for covid-19 immunisation. The patient medical history was none. There were no concomitant medications. The patient reported that she had side effects after getting her first dose of the Pfizer COVID-19 vaccine Saturday morning (13Mar2021) at 09:30am. She mentioned that she developed side effects Monday (15Mar2021) night that she also had all day Tuesday (16Mar2021), it was pretty significant. She mentioned that she is concerned about getting the second dose, and she is thinking that she is not going to get that after having her first dose. She stated that her side effects lasted all night Monday night, she had shortness of breath and coughing. She added that on Tuesday morning she started having chills, shakes, throwing up or vomiting, and having massive diarrhea all day long. She also mentioned that she thought it was serious, and she was going to have to go to the hospital soon. She wasn't going to have a choice if it hadn't gotten better. She reported that all her side effects are better, and that for treatment, she took some Delsym cough medicine and diarrhea medicine, Imodium, she thinks it was called. She says she took one dose of the cough medicine yesterday morning, and she has taken 3 doses of Imodium today. She wondered if she should take the second shot or if she would get the same symptoms again. She says she is hesitant to take second one because she doesn't want respiratory distress again (Mar2021), it was horrible, and she has never had massive diarrhea before to where she couldn't get to the bathroom, it was the worst thing she has went through. The outcome of the events was recovering.; Sender's Comments: The contributory role of the suspect productbnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EN6198; expiration date: unknown), to reported events is possible.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Chills; Vomiting; Diarrhea; shakes; Shortness of breath; Coughing; respiratory distress; This is a spontaneous report from a contactable retired nurse. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EN6198; expiration date: unknown), at vaccination age 64-year-old via an unspecified route of administration in the right arm on 13Mar2021 09:30 as a single dose for covid-19 immunisation. The patient medical history was none. There were no concomitant medications. The patient reported that she had side effects after getting her first dose of the Pfizer COVID-19 vaccine Saturday morning (13Mar2021) at 09:30am. She mentioned that she developed side effects Monday (15Mar2021) night that she also had all day Tuesday (16Mar2021), it was pretty significant. She mentioned that she is concerned about getting the second dose, and she is thinking that she is not going to get that after having her first dose. She stated that her side effects lasted all night Monday night, she had shortness of breath and coughing. She added that on Tuesday morning she started having chills, shakes, throwing up or vomiting, and having massive diarrhea all day long. She also mentioned that she thought it was serious, and she was going to have to go to the hospital soon. She wasn't going to have a choice if it hadn't gotten better. She reported that all her side effects are better, and that for treatment, she took some Delsym cough medicine and diarrhea medicine, Imodium, she thinks it was called. She says she took one dose of the cough medicine yesterday morning, and she has taken 3 doses of Imodium today. She wondered if she should take the second shot or if she would get the same symptoms again. She says she is hesitant to take second one because she doesn't want respiratory distress again (Mar2021), it was horrible, and she has never had massive diarrhea before to where she couldn't get to the bathroom, it was the worst thing she has went through. The outcome of the events was recovering.; Sender's Comments: The contributory role of the suspect productbnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EN6198; expiration date: unknown), to reported events is possible.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Diarrhoea, Dyspnoea, Respiratory distress
Clinical narrative: Chills; Vomiting; Diarrhea; shakes; Shortness of breath; Coughing; respiratory distress; This is a spontaneous report from a contactable retired nurse. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EN6198; expiration date: unknown), at vaccination age 64-year-old via an unspecified route of administration in the right arm on 13Mar2021 09:30 as a single dose for covid-19 immunisation. The patient medical history was none. There were no concomitant medications. The patient reported that she had side effects after getting her first dose of the Pfizer COVID-19 vaccine Saturday morning (13Mar2021) at 09:30am. She mentioned that she developed side effects Monday (15Mar2021) night that she also had all day Tuesday (16Mar2021), it was pretty significant. She mentioned that she is concerned about getting the second dose, and she is thinking that she is not going to get that after having her first dose. She stated that her side effects lasted all night Monday night, she had shortness of breath and coughing. She added that on Tuesday morning she started having chills, shakes, throwing up or vomiting, and having massive diarrhea all day long. She also mentioned that she thought it was serious, and she was going to have to go to the hospital soon. She wasn't going to have a choice if it hadn't gotten better. She reported that all her side effects are better, and that for treatment, she took some Delsym cough medicine and diarrhea medicine, Imodium, she thinks it was called. She says she took one dose of the cough medicine yesterday morning, and she has taken 3 doses of Imodium today. She wondered if she should take the second shot or if she would get the same symptoms again. She says she is hesitant to take second one because she doesn't want respiratory distress again (Mar2021), it was horrible, and she has never had massive diarrhea before to where she couldn't get to the bathroom, it was the worst thing she has went through. The outcome of the events was recovering.; Sender's Comments: The contributory role of the suspect productbnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EN6198; expiration date: unknown), to reported events is possible.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Erythema, Fatigue, Induration
Clinical narrative: Day 1: arm was sore, and the area was red, slightly swollen, and hard Day 1-2: feverish, body chills, extreme fatigue, decreased appetite  Day 6: large rash near vaccine site on left arm, extremely itchy, red, swollen, bumpy, hard Day 7: rash on arm still present, still itchy, more red, less swollen
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site rash, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Day 1: arm was sore, and the area was red, slightly swollen, and hard Day 1-2: feverish, body chills, extreme fatigue, decreased appetite  Day 6: large rash near vaccine site on left arm, extremely itchy, red, swollen, bumpy, hard Day 7: rash on arm still present, still itchy, more red, less swollen
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Day 1: arm was sore, and the area was red, slightly swollen, and hard Day 1-2: feverish, body chills, extreme fatigue, decreased appetite  Day 6: large rash near vaccine site on left arm, extremely itchy, red, swollen, bumpy, hard Day 7: rash on arm still present, still itchy, more red, less swollen
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Pyrexia, Retching, Tremor
Clinical narrative: Fever of 102, chills, shakes, dry heaves starting the night of my injection. Fever lasted 2 days.  Ate very little for those 2 days.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot
Clinical narrative: Patient felt warm and lightheaded after receiving vaccine. Her temperature was 98 and BP 134/95. Patient stayed for 30 minutes and was given water. After drinking water she felt better.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Dizziness, Loss of consciousness
Clinical narrative: Client was in car in observation area post vaccination. Per clients wife client stated that he was dizzy then fell unconscious for about 10 seconds. med activated. Client stated that he felt lightheaded. Client evaluation by  med.  All vitals normal Alert and Oriented x4.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Hypotension, Immediate post-injection reaction, Presyncope
Clinical narrative: PATIENT EXPERIENCED VASOVAGAL RESPONSE TO VACCINATION IMMEDIATELY AFTER ADMINISTRATION. PATIENT FAINTED FOR SEVERAL SECONDS, THEN EXPERIENCED DIZZINESS, LOW BLOOD PRESSURE, AND PROFUSE SWEATING. ALL SYMPTOMS RESOLVED WITHIN APPROXIMATELY 10 MINUTES.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: PATIENT EXPERIENCED VASOVAGAL RESPONSE TO VACCINATION IMMEDIATELY AFTER ADMINISTRATION. PATIENT FAINTED FOR SEVERAL SECONDS, THEN EXPERIENCED DIZZINESS, LOW BLOOD PRESSURE, AND PROFUSE SWEATING. ALL SYMPTOMS RESOLVED WITHIN APPROXIMATELY 10 MINUTES.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Syncope
Clinical narrative: Patient received dose of J&J COVID-19 vaccine at local vaccine clinic. Reportedly, a couple minutes later, patient experienced vasovagal syncope for which a Code Blue was called by clinic staff. 911 was also called. Patient was evaluated by ED physician on scene at the clinic, where patient had regained consciousness and responded to questions. Patient was then transported to ED next door by ED staff where patient was monitored and ultimately discharged home.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Eye pain, Fatigue, Feeling abnormal
Clinical narrative: 1 day after, low grade fever/unsettled stomach/chills/dazed/fatigue 4 days after dizzy enough to hold onto walls/headache/red & sore eyes watery/debilitating 5-7 days dizziness has decreased, not debilitating but still there when bending over, looking up, moving fast, unsettled stomach decreased but comes in waves  still happening
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lacrimation increased, Ocular hyperaemia, Pyrexia
Clinical narrative: 1 day after, low grade fever/unsettled stomach/chills/dazed/fatigue 4 days after dizzy enough to hold onto walls/headache/red & sore eyes watery/debilitating 5-7 days dizziness has decreased, not debilitating but still there when bending over, looking up, moving fast, unsettled stomach decreased but comes in waves  still happening
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral swelling, Swelling, Swelling face
Clinical narrative: numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206), via an unspecified route of administration on 08Mar2021 at 11:15 (at the age of 58 years) at a single dose in the right arm for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included irbesartan; nifedipine; spironolactone; and estradiol. The patient did not receive any other vaccines within 4 weeks prior COVID vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not pregnant at the time of vaccination. On 08Mar2021 at 11:30, the patient experienced numbness, tingling and swelling on the right side of face and head down right arm and chest. The events resulted to Emergency room/department or urgent care visit. The patient was hospitalized on an unspecified date due to the events. Patient was given Benadryl antihistamine w/IV Cat-Scan other work up as treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: I broke out in a rash, red bumps in between my fingers of my hands. They were lumpy with bumps and they also radiated to my shoulders. The front of my legs up to my knees also broke out in a rash.  I went to the ER but the doctor could not tell me why i got this. He thought it was eczema. He prescribed me steroids.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Paraesthesia, Rash, Sinusitis
Clinical narrative: I broke out in a rash, red bumps in between my fingers of my hands. They were lumpy with bumps and they also radiated to my shoulders. The front of my legs up to my knees also broke out in a rash.  I went to the ER but the doctor could not tell me why i got this. He thought it was eczema. He prescribed me steroids.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Client reported dizziness in post-vaccination observation. Client also reported feeling sweaty. Obtained vital signs on the client (below). Client was given water and observed by MD in post-vaccination area. Client reported feeling better after resting for approximately 15 minutes. No need for EMS at this time, client recovered and was able to leave of own volition.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives on back of neck and right side of face.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Palpitations, Vision blurred
Clinical narrative: Within 5 minutes, patient began to have blurry vision, chest pounding, and trouble breathing. Epinephrine (patient thinks 2 doses) and Benadryl administered in the field. Patient brought to hospital by ambulance where she received IV SoluMedrol, Pepcid, Benadryl, and fluids scheduled throughout hospitalization. Patient improved and was discharged the following day (3/27/21).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: Within 5 minutes, patient began to have blurry vision, chest pounding, and trouble breathing. Epinephrine (patient thinks 2 doses) and Benadryl administered in the field. Patient brought to hospital by ambulance where she received IV SoluMedrol, Pepcid, Benadryl, and fluids scheduled throughout hospitalization. Patient improved and was discharged the following day (3/27/21).
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT WAS FOUND TO BE 17 YEARS OF AGE POST VACCINATION.  VACCINE IS INDICATED FOR 18 YRS AND OLDER.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Nausea, Vomiting
Clinical narrative: violent throwing up, nauseau and weakness. Began 3 hours after the shot.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Paraesthesia oral, Swollen tongue
Clinical narrative: After leaving facility,  lips were tingling and tongue felt swelling.  Little chest pain.  Got home and took 2 Benadryl.  Symptoms stopped in about 20 min.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: Came in today and reported had rash after 1st dose on 2/24/21 and after 2nd dose on 3/17/21. Reported rash to bilat arms, hands, and ankles. Did not report any side effects from first dose when came in to receive 2nd dose.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Injection site pain, Lymphadenopathy
Clinical narrative: Swelling in lymph nodes under armpit. Pain at level 6 in lymph node arm in injection site.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Ear pain, Fatigue, Headache, Injection site pain
Clinical narrative: Fever, body aches, tiredness, headache, soreness on injection site, under the arm, up the neck and pain in the ear.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pyrexia
Clinical narrative: Fever, body aches, tiredness, headache, soreness on injection site, under the arm, up the neck and pain in the ear.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Cough, Dyspnoea, Fatigue
Clinical narrative: Shortness of breath**; cough; fatigue; slight loss of taste and loss of smell; sore throat; runny nose; vomiting tendency; slight nausea: symptoms started showing late afternoon (after 24 hours) around 4pm on Tuesday, March 30, 2021.   Symptoms were very predominant the day after, Wednesday, March 31, 2021 since 7am.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Oropharyngeal pain, Rhinorrhoea, Vomiting
Clinical narrative: Shortness of breath**; cough; fatigue; slight loss of taste and loss of smell; sore throat; runny nose; vomiting tendency; slight nausea: symptoms started showing late afternoon (after 24 hours) around 4pm on Tuesday, March 30, 2021.   Symptoms were very predominant the day after, Wednesday, March 31, 2021 since 7am.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Eye pruritus, Fatigue, Myalgia
Clinical narrative: I had the usual symptoms of a vaccine reaction like extreme muscle pain in my upper back/neck, chills, and fatigue.  But then on Monday I noticed a very tender left armpit, and I also have very itchy eyes, something I never have.  I also developed a small purple patch on my leg, and a little skin sore on my left arm.  It looks like more may be developing.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Skin discolouration, Tenderness
Clinical narrative: I had the usual symptoms of a vaccine reaction like extreme muscle pain in my upper back/neck, chills, and fatigue.  But then on Monday I noticed a very tender left armpit, and I also have very itchy eyes, something I never have.  I also developed a small purple patch on my leg, and a little skin sore on my left arm.  It looks like more may be developing.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood culture negative, Blood phosphorus, C-reactive protein increased, Pain in extremity
Clinical narrative: Polyarthritis affecting hands, wrists, shoulders, knees - significant pain and inability to ambulate without significant pain; behaves like reactive arthritis/autoimmune disease, intermittent fever, CRP markedly elevated at 133 (normal < 10); requiring Prednisone for treatment; unresolved as of 3/3/1/21
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Polyarthritis, Pyrexia, Red blood cell sedimentation rate increased, Rheumatoid factor negative, White blood cell count increased
Clinical narrative: Polyarthritis affecting hands, wrists, shoulders, knees - significant pain and inability to ambulate without significant pain; behaves like reactive arthritis/autoimmune disease, intermittent fever, CRP markedly elevated at 133 (normal < 10); requiring Prednisone for treatment; unresolved as of 3/3/1/21
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Large rash around injection site .  Itchy  swollen.  Currently using cortisone
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pyrexia
Clinical narrative: Fever ranging from 99.6 to 101.7 and lethargy lasted about 24 hours
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: 30 minutes after the injection my tong started tingling. I spent 1 hour at the facility, and I drank apple juice.  The tingling didn't get any worse so I went home. It last 4 hours