chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, SARS-CoV-2 test, Sinus congestion
Clinical narrative: fatigue; sinus and chest congestion; sinus and chest congestion; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: not reported), dose 1 via an unspecified route of administration on 13Apr2021 as 1st dose, single for COVID-19 immunisation. The patient medical history included COVID-19 from Jan2020 to an unknown date (she had the corona virus in Jan2020, she tested positive then). The patient's concomitant medications were not reported. On 18Apr2021, the patient experienced fatigue, sinus and chest congestion. On an unknown date, the patient underwent a COVID test, but results were still pending. The patient asked if that could be side effects to vaccine. Her second vaccine was due for May2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Back pain, Headache, Malaise, Muscle fatigue
Clinical narrative: Headache; Back Pain; muscular weariness; Tired eyes; feel strange as sick; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (Pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 10Apr2021 at 08:45 AM (lot number: EW0150) at single dose for COVID-19 immunization. The relevant medical history was reported as none. Concomitant medications were not reported. On 17Apr2021 at 17:00, the patient had headache, back pain, muscular weariness, tired eyes. She felt strange as sick. It's been almost two weeks since she got the vaccine but only on Saturday she started with a headache. When she empused herself she was in pain head for two days but they became all the symptoms together a week after. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events were reported as non-serious. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: got the fever today; chills in the morning; This is a spontaneous report from a contactable consumer (reported for herself) via medical information team.  A 38-year-old-female patient received first dose of BNT162B2 (Pfizer covid-19 vaccine, solution for injection, Lot number and Expiration date: Not reported) via an unspecified route of administration as a single dose on an unknown date, for Covid-19 immunization. Medical history and concomitant medications were not reported. On 21Apr2021 (the day of this report), she experienced fever. She had the chills in the morning. It was stated that she had like a 100.4 degree F and recently when she checked out it was 100.6 degree F. The outcome of the events of fever and chills unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache since taking the second dose of the Pfizer Covid vaccine; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for covid-19 immunization. Patient had a headache since taking the second dose of the Pfizer Covid vaccine and wanted to know if he could take Tylenol or Ibuprofen, he read somewhere that he was not supposed to take one them. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Dyspnoea, Fatigue, Flatulence, Oropharyngeal discomfort
Clinical narrative: has reflux, gas and bloating/gas and acid reflux is worse; has reflux, gas and bloating/gas and acid reflux is worse; has reflux, gas and bloating; he is so tired; hard time breathing from gas/ had a hard time breathing last night; hives on his face on both sides of his cheeks; disturbance on his throat; felt like something was blocking his throat; This is the spontaneous report from a contactable consumer (patient wife). A 63-year-old male (patient) received BNT162B2 (lot number: EW0158) first dose on 14Apr2021 16 15 PM on left arm at single dose for COVID-19 immunisation. Medical history included allergic to milk and beef, gives him hives on his face. Concomitant medications included nasal spray (he doesn't take any other medication). No Prior Vaccinations (within 4 weeks). Consumer asked if her husband can take benadryl before the vaccine. Consumer stated her husband has no known allergies to medications. Caller stated that her husband had the first dose of the Pfizer covid 19 vaccine on 14Apr2021 at about 4:00 pm. Caller stated he ate dinner and then around 8;00 or 8:30 he felt like a disturbance on his throat. Caller stated he could swallow but felt like something was blocking his throat. Caller stated that 1/2 hour later it went away. Caller reported the next day (15Apr2021) he had hives on his face on both sides of his cheeks. He is so tired. Caller stated her husband has reflux, gas and bloating. Hard time breathing from gas. Caller stated her husband had a hard time breathing from gas last night (20Apr2021). Gas and acid reflux is worse on 20Apr2021. Vaccine Administered at Military Facility was no. No event require a visit to: Emergency Room or physician office. The outcome of event disturbance on his throat was recovered on 14Apr2021, hives on his face on both sides of his cheeks recovered on 15Apr2021, gas and acid reflux is worse recovered on 21Apr2021, hard time breathing from gas/ had a hard time breathing last night was recovered on 21Apr2021. The outcome of other event was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Reflux gastritis, Throat tightness, Urticaria
Clinical narrative: has reflux, gas and bloating/gas and acid reflux is worse; has reflux, gas and bloating/gas and acid reflux is worse; has reflux, gas and bloating; he is so tired; hard time breathing from gas/ had a hard time breathing last night; hives on his face on both sides of his cheeks; disturbance on his throat; felt like something was blocking his throat; This is the spontaneous report from a contactable consumer (patient wife). A 63-year-old male (patient) received BNT162B2 (lot number: EW0158) first dose on 14Apr2021 16 15 PM on left arm at single dose for COVID-19 immunisation. Medical history included allergic to milk and beef, gives him hives on his face. Concomitant medications included nasal spray (he doesn't take any other medication). No Prior Vaccinations (within 4 weeks). Consumer asked if her husband can take benadryl before the vaccine. Consumer stated her husband has no known allergies to medications. Caller stated that her husband had the first dose of the Pfizer covid 19 vaccine on 14Apr2021 at about 4:00 pm. Caller stated he ate dinner and then around 8;00 or 8:30 he felt like a disturbance on his throat. Caller stated he could swallow but felt like something was blocking his throat. Caller stated that 1/2 hour later it went away. Caller reported the next day (15Apr2021) he had hives on his face on both sides of his cheeks. He is so tired. Caller stated her husband has reflux, gas and bloating. Hard time breathing from gas. Caller stated her husband had a hard time breathing from gas last night (20Apr2021). Gas and acid reflux is worse on 20Apr2021. Vaccine Administered at Military Facility was no. No event require a visit to: Emergency Room or physician office. The outcome of event disturbance on his throat was recovered on 14Apr2021, hives on his face on both sides of his cheeks recovered on 15Apr2021, gas and acid reflux is worse recovered on 21Apr2021, hard time breathing from gas/ had a hard time breathing last night was recovered on 21Apr2021. The outcome of other event was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Dizziness, Feeling abnormal, Heart rate decreased
Clinical narrative: very weak and dizzy; dizzy; extremely dizzy I thought I was going to faint; I thought I was going to pass out; pulse get very low it got so slow; I felt really bad; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150, expiration date: 31Jul2021), via unspecified route of administration on 20Apr2021 at single dose for COVID-19 immunisation. The relevant medical history included allergies to preservatives, additives, soy, corn starch, anything, even olive oil; immune system was compromised; blood clot. Concomitant medications included warfarin sodium for blood clot. The patient received first dose of Pfizer COVID-19 vaccine and was very weak and dizzy, she got dizzy for 10 minutes and decided to stay there an additional 30 minutes, just sat there and got better, like her pulse got really really low, she felt it in her neck, very slow. Second dose is scheduled for 11May2021. The decision to receive the second dose for any other reason cannot be made. The patient was referred to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Consumer stated she had vaccine first dose yesterday and she asked them for the paper work because she did have allergies 10 years ago and she now realize from reading the list here of the reaction that she did have reaction to the vaccine. The patient stated that the adverse event was not persisting, it was within the first 10 minutes and she stayed there for an hour because she was scared but it went away. Well the reaction she had was that she got extremely dizzy, she thought she was going to faint, that's the reaction she had after the vaccine. She thought she was going to pass out, and she saw her pulse get very low it got so slow. It was not just a quick feeling she felt really bad for 10 minutes. The patient underwent blood test with unknown results on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: very weak and dizzy; dizzy; extremely dizzy I thought I was going to faint; I thought I was going to pass out; pulse get very low it got so slow; I felt really bad; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150, expiration date: 31Jul2021), via unspecified route of administration on 20Apr2021 at single dose for COVID-19 immunisation. The relevant medical history included allergies to preservatives, additives, soy, corn starch, anything, even olive oil; immune system was compromised; blood clot. Concomitant medications included warfarin sodium for blood clot. The patient received first dose of Pfizer COVID-19 vaccine and was very weak and dizzy, she got dizzy for 10 minutes and decided to stay there an additional 30 minutes, just sat there and got better, like her pulse got really really low, she felt it in her neck, very slow. Second dose is scheduled for 11May2021. The decision to receive the second dose for any other reason cannot be made. The patient was referred to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Consumer stated she had vaccine first dose yesterday and she asked them for the paper work because she did have allergies 10 years ago and she now realize from reading the list here of the reaction that she did have reaction to the vaccine. The patient stated that the adverse event was not persisting, it was within the first 10 minutes and she stayed there for an hour because she was scared but it went away. Well the reaction she had was that she got extremely dizzy, she thought she was going to faint, that's the reaction she had after the vaccine. She thought she was going to pass out, and she saw her pulse get very low it got so slow. It was not just a quick feeling she felt really bad for 10 minutes. The patient underwent blood test with unknown results on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Sore shoulder; Pain at injection site; This is a spontaneous report from a contactable consumer (patient). This consumer reported 2 reports for same patient and different dose, this is the second of 2 reports. A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via intramuscular, administered in right arm (reported as right shoulder) on 26Jan2021 15:30 (Batch/Lot Number: EN5318; Expiration Date: 31May2021) as SINGLE DOSE for covid-19 immunisation at Workplace clinical. Patient's medical history reported as none. No prior vaccinations. No concomitant drugs. There were no concomitant medications. The patient experienced pain at injection site (seriousness criteria: not serious) on 26Jan2021 15:30 with outcome of recovered on an unspecified date, this event did not require the initiation of new medication/ other treatment/ procedure, sore shoulder on an unspecified date with outcome of unknown. No relevant test. First Dose resulted in a sore shoulder.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021169816 Same patient, same product, different dose, similar events.
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Allergy to vaccine, Erythema, Urticaria
Clinical narrative: Hives; His body was red; Allergic reaction to Covid vaccine ingredient; This is a spontaneous report from a contactable consumer(patient's mother). A 23-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 28Mar2021 (Lot Number: ER8732) as single dose for covid-19 immunization. The patient's medical history and concomitant medications reported as none. On 29Mar2021, the patient had an allergic reaction to the first vaccination of the Covid vaccine Pfizer (Couple of hours after), he broke out with hives, his body was red, so he went to an allergist, they did confirm that he was allergic to one of those ingredient (Covid vaccine) and allergist said he should not get his second vaccine, so he was not able to do that (second vaccine). No doctor prescribed the vaccine, he just found it online. Events lasted 2-4 days. He was recovered at the time of the report but he was scheduled to get his second shot this but the allergist told him, he should not get the second shot. The patient did an allergy test determined to see he was allergic to ingredient of Pfizer vaccine, just one test two days before. The patient had not taken any treatment for the allergy (event). The outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Head discomfort, Headache, Pain in extremity
Clinical narrative: Sore arms; Some heart palpitations; Very sensitive to light one side of head; chills; felt like she has been hit by a truck. It liked knock her out.; Headache on one side of head/ serious headache; Feel a lot of pressure on one side of head; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EL9261, expiration date unknown) on 22Mar2021 at age of 49-year-old via an unspecified route of administration on the left arm at single dose for COVID-19 immunisation. Patient previously received 1st dose of BNT162B2 (Lot number: EL9266) via an unspecified route of administration on the left arm on 25Feb2021 at age of 49-year-old at a school for COVID-19 immunisation. Medical history and concomitant medication was reported as no. The patient stated she was not sure if someone else has been reported it. She was having headache. She was having headache on one side of head, also one week has been down. She was having serious headache and she just wanted to know if this was something that has been reported. Patient stated after the vaccine, she was having sore arms, noticed some heart palpitations, also didn't feel any nausea, chills and pulse (pending clarification). But she did feel like she has been hit by a truck. It liked knock her out. She was out for like two days. She had recently been having headache on one side of head. When she bend down, she felt a lot of pressure on one side of head and also light. She was very sensitive to light one side of head. Patient was receiving ongoing Tylenol 500mg, 2 tablet, twice a day as treatment. Onset date of "headache on one side of head/ serious headache" and "feel a lot of pressure on one side of head" was 04Apr2021. Outcome of event "headache on one side of head/ serious headache" and "feel a lot of pressure on one side of head" was not recovered, of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Photophobia
Clinical narrative: Sore arms; Some heart palpitations; Very sensitive to light one side of head; chills; felt like she has been hit by a truck. It liked knock her out.; Headache on one side of head/ serious headache; Feel a lot of pressure on one side of head; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EL9261, expiration date unknown) on 22Mar2021 at age of 49-year-old via an unspecified route of administration on the left arm at single dose for COVID-19 immunisation. Patient previously received 1st dose of BNT162B2 (Lot number: EL9266) via an unspecified route of administration on the left arm on 25Feb2021 at age of 49-year-old at a school for COVID-19 immunisation. Medical history and concomitant medication was reported as no. The patient stated she was not sure if someone else has been reported it. She was having headache. She was having headache on one side of head, also one week has been down. She was having serious headache and she just wanted to know if this was something that has been reported. Patient stated after the vaccine, she was having sore arms, noticed some heart palpitations, also didn't feel any nausea, chills and pulse (pending clarification). But she did feel like she has been hit by a truck. It liked knock her out. She was out for like two days. She had recently been having headache on one side of head. When she bend down, she felt a lot of pressure on one side of head and also light. She was very sensitive to light one side of head. Patient was receiving ongoing Tylenol 500mg, 2 tablet, twice a day as treatment. Onset date of "headache on one side of head/ serious headache" and "feel a lot of pressure on one side of head" was 04Apr2021. Outcome of event "headache on one side of head/ serious headache" and "feel a lot of pressure on one side of head" was not recovered, of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Ear pain, Pain, Pain in extremity, Stress
Clinical narrative: feeling a bit achy; her arms hurting; having a little cough; earache; she is stressed out; This is a spontaneous report received from a contactable nurse and a consumer (patient). An 81-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date at 81 years old (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included tofacitinib citrate (XELJANZ) from Feb2021 and ongoing. Patient reported feeling a bit achy and her arms hurting after taking her first dose of the covid-19 vaccine. Patient also reported having a little cough and ear ache. Patient stated this happened when she was stressed out. The adverse events were non-serious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: Severe flu like symptoms; Fever of 101.4; Headache; Nauseousness; Aches; Fatigue; Red; Itchy; Hot to touch; Swollen at injection site; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 15Apr2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient has no history of COVID and was not tested for it prior vaccination. The patient previously received the first dose of BNT162B2 on 24Mar2021 02:00PM, on left arm, for COVID-19 immunization, and experienced only slight swollen arm. On 15Apr2021 20:00, the patient experienced severe flu like symptoms including fever of 101.4, headache, nauseousness, aches, fatigue for about 24 hours, red, itchy, hot to touch; then swollen at injection site. The patient did not receive treatment for the events. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Pain, Pruritus, Pyrexia
Clinical narrative: Severe flu like symptoms; Fever of 101.4; Headache; Nauseousness; Aches; Fatigue; Red; Itchy; Hot to touch; Swollen at injection site; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 15Apr2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient has no history of COVID and was not tested for it prior vaccination. The patient previously received the first dose of BNT162B2 on 24Mar2021 02:00PM, on left arm, for COVID-19 immunization, and experienced only slight swollen arm. On 15Apr2021 20:00, the patient experienced severe flu like symptoms including fever of 101.4, headache, nauseousness, aches, fatigue for about 24 hours, red, itchy, hot to touch; then swollen at injection site. The patient did not receive treatment for the events. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Severe flu like symptoms; Fever of 101.4; Headache; Nauseousness; Aches; Fatigue; Red; Itchy; Hot to touch; Swollen at injection site; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 15Apr2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient has no history of COVID and was not tested for it prior vaccination. The patient previously received the first dose of BNT162B2 on 24Mar2021 02:00PM, on left arm, for COVID-19 immunization, and experienced only slight swollen arm. On 15Apr2021 20:00, the patient experienced severe flu like symptoms including fever of 101.4, headache, nauseousness, aches, fatigue for about 24 hours, red, itchy, hot to touch; then swollen at injection site. The patient did not receive treatment for the events. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a solicited report from consumer (patient) via Pfizer AbbVie Inc. (Mfr. Control No.21K-163-3855391-00). A 71-year-old female patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) intramuscular, administered at an unspecified anatomical location on an unknown date (age at vaccination was 71 years) at a single dose for Covid-19 immunisation. On 02Mar2021 (ongoing) patient started treatment with ibrutinib (IMBRUVICA), orally at 1x/day (420 mg,1 in 1) for chronic lymphocytic leukemia. Concomitant medication were not reported. There was no reported medical history. In 2021, the patient experienced Fever with IMBRUVICA (IBRUTINIB). COVID-19 VACCINE was also considered suspect. It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial. The causality for ibrutinib (IMBRUVICA) was not reported. The reporter's causality for the event of fever was not provided. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Blood test, Cough, Fatigue, Headache
Clinical narrative: Couldn't raise her left arm, the pain in her muscle; Couldn't raise her left arm, the pain in her muscle; Pain went up into her neck; Headache; Muscle pain; Cold-like symptoms; Lost her voice; Coughing non-stop; Not feeling well; She was just tired from all the probing and injection; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 12Apr2021 (Batch/Lot Number: EN6198) as single dose for Covid-19 immunisation. Medical history included joint injury from an unknown date (patient will have knee replacement on 26Apr2021). The patient's concomitant medications were not reported.  On the night of the same day of vaccination, patient stated she started not feeling well. She assumed she was just tired from all the probing and injection and all that stuff so she wasn't feeling well on 12Apr2021night, she just assumed she was tired and had a busy day. On the following day, 13Apr2021, patient couldn't raise her left arm, the pain in her muscle, then it went up into her neck, her neck still hurts, she also had headache, muscle pain, cold-like symptoms, and then she lost her voice, and has been coughing non-stop since 13Apr2021. Outcome of event couldn't raise her left arm, the pain in her muscle  was recovered on 16Apr2021, pain went up into her neck, cold-like symptoms, cough, lost her voice was not recovered, of headache, muscle pain was recovering, of other events was unknown. The patient underwent lab tests and procedures which included blood test normal on 12Apr2021. Patient states she is scheduled for the second dose on 13May2021 at her post-op visit.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Malaise, Myalgia, Nasopharyngitis, Neck pain
Clinical narrative: Couldn't raise her left arm, the pain in her muscle; Couldn't raise her left arm, the pain in her muscle; Pain went up into her neck; Headache; Muscle pain; Cold-like symptoms; Lost her voice; Coughing non-stop; Not feeling well; She was just tired from all the probing and injection; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 12Apr2021 (Batch/Lot Number: EN6198) as single dose for Covid-19 immunisation. Medical history included joint injury from an unknown date (patient will have knee replacement on 26Apr2021). The patient's concomitant medications were not reported.  On the night of the same day of vaccination, patient stated she started not feeling well. She assumed she was just tired from all the probing and injection and all that stuff so she wasn't feeling well on 12Apr2021night, she just assumed she was tired and had a busy day. On the following day, 13Apr2021, patient couldn't raise her left arm, the pain in her muscle, then it went up into her neck, her neck still hurts, she also had headache, muscle pain, cold-like symptoms, and then she lost her voice, and has been coughing non-stop since 13Apr2021. Outcome of event couldn't raise her left arm, the pain in her muscle  was recovered on 16Apr2021, pain went up into her neck, cold-like symptoms, cough, lost her voice was not recovered, of headache, muscle pain was recovering, of other events was unknown. The patient underwent lab tests and procedures which included blood test normal on 12Apr2021. Patient states she is scheduled for the second dose on 13May2021 at her post-op visit.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Couldn't raise her left arm, the pain in her muscle; Couldn't raise her left arm, the pain in her muscle; Pain went up into her neck; Headache; Muscle pain; Cold-like symptoms; Lost her voice; Coughing non-stop; Not feeling well; She was just tired from all the probing and injection; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 12Apr2021 (Batch/Lot Number: EN6198) as single dose for Covid-19 immunisation. Medical history included joint injury from an unknown date (patient will have knee replacement on 26Apr2021). The patient's concomitant medications were not reported.  On the night of the same day of vaccination, patient stated she started not feeling well. She assumed she was just tired from all the probing and injection and all that stuff so she wasn't feeling well on 12Apr2021night, she just assumed she was tired and had a busy day. On the following day, 13Apr2021, patient couldn't raise her left arm, the pain in her muscle, then it went up into her neck, her neck still hurts, she also had headache, muscle pain, cold-like symptoms, and then she lost her voice, and has been coughing non-stop since 13Apr2021. Outcome of event couldn't raise her left arm, the pain in her muscle  was recovered on 16Apr2021, pain went up into her neck, cold-like symptoms, cough, lost her voice was not recovered, of headache, muscle pain was recovering, of other events was unknown. The patient underwent lab tests and procedures which included blood test normal on 12Apr2021. Patient states she is scheduled for the second dose on 13May2021 at her post-op visit.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Positron emission tomogram, Vaccination site pain
Clinical narrative: slight pain in arm due to covid vaccine; This is a spontaneous report from a contactable consumer or other non HCP. A male patient of an unspecified age received first dose bnt162b2 (BNT162B2, Formulation: 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 immunisation; lenvatinib mesilate (LENVIMA, Batch/Lot number was not reported) via oral from 08Jan2021 and ongoing, at 14 mg, daily for thyroid cancer. Patient stopped taking Lenvima- 21Mar2021- 28Mar2021, to have a break from side effects, dry mouth wakes him up at night, certain liquids/foods burning tongue,", all resolved after patient stopped Lenvima. MD aware of missed doses. No side effects due to missed doses.  Medical history included arthralgia from an unknown date and unknown if ongoing has improved since MD added Percocet. The patient's concomitant medications were not reported. The patient experienced slight pain in arm due to covid vaccine. The patient underwent lab tests and procedures which included positron emission tomogram: everything is smaller, even the lump in your throat on. Since starting Lenvima- Recent positron emission test showed "everything is smaller, even the lump in your throat". The outcome of event was not recovered/not resolved.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration, Influenza like illness, Insomnia, Off label use
Clinical narrative: Had first pfizer covid vaccine 9 days prior and was informed that it was no good and to come back for another shot; became very sick; flu like symptoms; vomiting; extreme body aches and pains; fever; Was unable to sleep entire first night; Had first pfizer covid vaccine 9 days prior and was informed that it was no good and to come back for another shot; This is a spontaneous report from a contactable consumer. This consumer (patient's parent) reported for a 25-year-old son (patient).  A 25-year-old male patient received the second dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0153) via unspecified route on arm left at a single dose on 16Apr2021 14:45 for COVID-19 immunization. There was no history of allergies to medications, food, or other products allergy. The patient had no relevant medical history. Concomitant medication was not reported. The historical vaccine patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0164) via unspecified route on arm left at a single dose on 07Apr2021 14:45 for COVID-19 immunization. The patient receives first covid vaccine 9 days prior within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 07Apr2021 patient received first shot and was notified that the clinic mishandled vaccine and was advised by dep of health to get another shot and upon arrival informed staff he received bad dose on 7 April and they advised to get another shot on 16 April. On 16Apr2021 patient received second shot and within 8 hours became very sick with flu like symptoms including vomiting, extreme body aches and pains along with fever. Was unable to sleep entire first night and by 6AM started feeling better. The clinical outcome of the events reported as recovering.   No follow-up attempts are needed. No further information is expected.  Follow-up: (22Apr2021) This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of event onset date. Reporter received the information at 7:30 on 17April2021.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Had first pfizer covid vaccine 9 days prior and was informed that it was no good and to come back for another shot; became very sick; flu like symptoms; vomiting; extreme body aches and pains; fever; Was unable to sleep entire first night; Had first pfizer covid vaccine 9 days prior and was informed that it was no good and to come back for another shot; This is a spontaneous report from a contactable consumer. This consumer (patient's parent) reported for a 25-year-old son (patient).  A 25-year-old male patient received the second dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0153) via unspecified route on arm left at a single dose on 16Apr2021 14:45 for COVID-19 immunization. There was no history of allergies to medications, food, or other products allergy. The patient had no relevant medical history. Concomitant medication was not reported. The historical vaccine patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0164) via unspecified route on arm left at a single dose on 07Apr2021 14:45 for COVID-19 immunization. The patient receives first covid vaccine 9 days prior within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 07Apr2021 patient received first shot and was notified that the clinic mishandled vaccine and was advised by dep of health to get another shot and upon arrival informed staff he received bad dose on 7 April and they advised to get another shot on 16 April. On 16Apr2021 patient received second shot and within 8 hours became very sick with flu like symptoms including vomiting, extreme body aches and pains along with fever. Was unable to sleep entire first night and by 6AM started feeling better. The clinical outcome of the events reported as recovering.   No follow-up attempts are needed. No further information is expected.  Follow-up: (22Apr2021) This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of event onset date. Reporter received the information at 7:30 on 17April2021.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back was hurting; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration from an unknown date to an unknown date as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, it was reported that the patient was calling because the patient must schedule to get the second shot and do not know what to do, missed appointment because the patient didn't wake up early and didn't realize until woke up and missed appointment which was 12:20 today and want to know what will happen, what can be done to get second shot and do not know. The patient wants to know how to go back and reschedule, didn't know what to do, and missed schedule appointment for today. It was missed today because the patient's back was hurting, so did not realize after woke up. The patient added, "So there will be no harm to me if I get that after the schedule date, everything should be fine with me." When inquired about lot number, the patient stated, "Do you mean ER number because I do not see any other number, the ER number is 8733." The outcome of the event was unknown.  No Follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: fever 103.5; Vomiting; exhaustion; headache; severe chills; arm ache; This is a spontaneous report from a non-contactable consumer.   A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Right Arm on 06Apr2021 10:30 (Batch/Lot Number: EP6955) as SINGLE DOSE (at the age of 49 years) for covid-19 immunisation.  The patient had the first dose of BNT162 lot number EN6208 for Covid-19 immunization on 16Mar2021 10:30 in right arm at the age of 49 years.  Medical history included drug hypersensitivity from an unknown date (known allergies: Sulfa), drug hypersensitivity from an unknown date (known allergies: Penicillin).  The patient was not pregnant at the time of the vaccination. Patient did not have Covid-19 prior to vaccination.  The patient's concomitant medications were not reported.  No other vaccine taken in four weeks.  The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity (known allergies: Cipro).  The patient experienced fever 103.5 on 06Apr2021 23:00 with outcome of recovering, vomiting on 06Apr2021 23:00 with outcome of recovering, exhaustion on 06Apr2021 23:00 with outcome of recovering, headache on 06Apr2021 23:00 with outcome of recovering, severe chills on 06Apr2021 23:00 with outcome of recovering, arm ache on 06Apr2021 23:00 with outcome of recovering.  The patient was not Covid-19 tested post vaccination.  No treatment was required.  The patient underwent lab tests and procedures which included body temperature: 103.5 on 06Apr2021.    No follow-up attempts are possible. No further Information expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: fever 103.5; Vomiting; exhaustion; headache; severe chills; arm ache; This is a spontaneous report from a non-contactable consumer.   A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Right Arm on 06Apr2021 10:30 (Batch/Lot Number: EP6955) as SINGLE DOSE (at the age of 49 years) for covid-19 immunisation.  The patient had the first dose of BNT162 lot number EN6208 for Covid-19 immunization on 16Mar2021 10:30 in right arm at the age of 49 years.  Medical history included drug hypersensitivity from an unknown date (known allergies: Sulfa), drug hypersensitivity from an unknown date (known allergies: Penicillin).  The patient was not pregnant at the time of the vaccination. Patient did not have Covid-19 prior to vaccination.  The patient's concomitant medications were not reported.  No other vaccine taken in four weeks.  The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity (known allergies: Cipro).  The patient experienced fever 103.5 on 06Apr2021 23:00 with outcome of recovering, vomiting on 06Apr2021 23:00 with outcome of recovering, exhaustion on 06Apr2021 23:00 with outcome of recovering, headache on 06Apr2021 23:00 with outcome of recovering, severe chills on 06Apr2021 23:00 with outcome of recovering, arm ache on 06Apr2021 23:00 with outcome of recovering.  The patient was not Covid-19 tested post vaccination.  No treatment was required.  The patient underwent lab tests and procedures which included body temperature: 103.5 on 06Apr2021.    No follow-up attempts are possible. No further Information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Irritability
Clinical narrative: Dizzy and became unusually irritable; unusually irritable; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Apr2021 at 15:00 (Lot Number: FR8733) as SINGLE DOSE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included diabetes from an unknown date and dairy allergy from an unknown date. Concomitant medications included sertraline (SERTRALINE); metformin (METFORMIN); montelukast (MONTELUKAST) and unspecified medication for birth control.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 16:00, the patient felt dizzy and became unusually irritable. No corrective measures were taken by the patient for the reported events. The outcome was reported as recovered on an unspecified date for the reported events.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test; This is a spontaneous report received from a contactable consumer (patient's son) via medical information team. A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was unknown), via an unspecified route of administration on 22-Mar-2021 (at age of 50 years) as a single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Son reported that, his parents took first dose of Pfizer COVID vaccine and tested positive for COVID on 02Apr2021. His mother had tested negative, but father was currently testing positive. Reporter asked that, can they get their second dose. Outcome of the events was reported as unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021443011 same reporter/drug, different patients
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a sore arm; This is a spontaneous report from a non-contactable consumer. A male patient (reporter's husband) of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Mar2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient had a sore arm after his Pfizer vaccine on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.