chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had pain in extremity (little arm pain), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Follow-up (Aug 23, 2021): A contactable female consumer (patient) reported: Patient information. Follow-up (Oct 4, 2021): This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: left arm pain; Chills; extremely tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 21Aug2021 13:30 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, lot number=FA7484, brand=Pfizer lot unknown=False, administration date=31Jul2021, administration time=06:45 PM, vaccine location=Left arm,, dose number=1), administration date: 31Jul2021, when the patient was 12 years old, for covid-19 immunization, reaction(s): "1st dose sore left arm and sore right arm per patient (muscle aches) only", "muscle aches"; Tdap (Other vaccine 4weeks details , Other vaccine 4weeks product=Tdap, Other vaccine 4weeks vaccine date=12Jul2021,, Other vaccine 4weeks vaccine location=Left Arm), administration date: 12Jul2021, when the patient was 12 years old. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Aug2021 20:00, outcome "recovering", described as "left arm pain"; CHILLS (non-serious) with onset 21Aug2021 20:00, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 21Aug2021 20:00, outcome "recovering", described as "extremely tired". Therapeutic measures were not taken as a result of pain in extremity, chills, fatigue.  Additional information: Facility type vaccine was Pharmacy or Drug Store. No known allergies. No other vaccine in four weeks. Other medications in two weeks were reported as none. AE resulted in none of the above. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fall, Full blood count, Malaise, Product administered at inappropriate site
Clinical narrative: Today morning when she woke up, she started feeling unwell and she fell down in the bathroom; Today morning when she woke up, she started feeling unwell and she fell down in the bathroom; Anatomical site of  vaccine administration: Reporter stated, ''Left hand."; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13 year-old female patient received bnt162b2 (BNT162B2), administered in hand left, administration date 21Aug2021 (Lot number: FC3181) at the age of 13 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 21Aug2021, outcome "unknown", described as "Anatomical site of  vaccine administration: Reporter stated, ''Left hand.""; MALAISE (non-serious), FALL (non-serious) all with onset 22Aug2021, outcome "unknown" and all described as "Today morning when she woke up, she started feeling unwell and she fell down in the bathroom". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reported told actually her (Reporter) child 13 years old has took a Pfizer vaccine COVID19 second dose. It was yesterday and today morning when her daughter (patient) woke up, her daughter started feeling unwell and fell down in the bathroom. So reporter didn't knew what happened. Reporter asked why would that happen. When probed for if reporter wanted to report the side effects, reporter stated, ''Yes she wanted to report the side effects. reporter didn't knew whether it was the side effect or what it was, reporter was not sure, it looked like from the COVID vaccine. When asked about expiration date reporter told there was no expiration in the card. It just says the LOTP # Pfizer LOT # but no date.  When asked about Lab test, reporter told it was a normal test like blood test, Blood count and all those things. Patient History and Other Products were reported as no.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: he lost feelings in legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "he lost feelings in legs".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Felt like absolute crap for 3 to 4 weeks after the first vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 30Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt like absolute crap for 3 to 4 weeks after the first vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: She suffers from depression but after the both doses of the Covid Vaccine, she has a lot of energy and generally happier; She suffers from depression but after the both doses of the Covid Vaccine, she has a lot of energy and generally happier; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRE-EXISTING CONDITION IMPROVED (non-serious), THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown" and all described as "She suffers from depression but after the both doses of the Covid Vaccine, she has a lot of energy and generally happier".  Additional information: She suffers from depression but after the both doses of the Covid Vaccine, she has a lot of energy and generally happier.   Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Smelling smoke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 17:15 (Batch/Lot number: unknown) at the age of 55 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Shellfish" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAROSMIA (non-serious) with onset 22Aug2021 18:00, outcome "not recovered", described as "Smelling smoke". Therapeutic measures were not taken as a result of parosmia.  Additional information: Patient did not receive any other vaccine in four weeks. Patient received other Medications in Two weeks. Smelling smoke. started Sunday evening and was intermitten all day yesterday. Not as much during the day today but pretty constant all this wvening. Patient did not tested covid prior vaccination and post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: headaches; sore arms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arms".  Additional information: Was speaking to my sister today and learned that she and my brother-in-law both recently were vaccinated for COVID-19. She mentioned they both received the Pfizer vaccine at their doctors office. She said that on their first shots they both experienced headaches the next day but not that bad and that they both had sort of sore arms where the injection had taken place. They both received 1st shots on same day a few weeks ago  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 14:00 (Lot number: FC3182) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, injection in left arm, Lot Number: EW0176), administration date: 02Aug2021, when the patient was 57 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 24Aug2021, outcome "not recovered", described as "Headache".  Additional information:The caller is reporting on her husband. They had the second dose of the Pfizer covid shot yesterday. She is asking what can be taken for a headache and fever. Clarifies her husband is experiencing a headache that started this morning. There are no relevant test.Prior Vaccinations (within 4 weeks) was none.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101098022 same reporter/product/event, different patient
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: sudden onset of hair loss within two weeks of this dose. This hair loss included the hair on my head, eyebrows, and other body hair.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18May2021 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number:EW0164,, administration time:10:00 AM, dose number:1, vaccine location:Right arm}]), administration date: 23Apr2021, when the patient was 52 years old, for COVID-19 immunization.  The following information was reported: ALOPECIA (non-serious) with onset 31May2021 16:00, outcome "recovered with sequelae", described as "sudden onset of hair loss within two weeks of this dose. This hair loss included the hair on my head, eyebrows, and other body hair.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia.  Additional information: No other vaccine in four weeks. No covid prior to vaccination. Covid tested post vaccination. No Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact
Clinical narrative: Poison Ivy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12May2021 09:00 (Lot number: EW1164) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATITIS CONTACT (non-serious) with onset 29May2021, outcome "recovered" (06Jun2021), described as "Poison Ivy".   Additional information: Patient had no side effects from his 2nd dose until 5 days after the dose. He woke up Sunday morning (06Jun) with his torso covered in hives. He have never had hives before and they were very itching. He had a bad case of poison ivy when he got the 2nd dose so thought his immune system may have been over stimulated. The next day the hives were from the bottom of his feet to the top of his hand. He went to the urgent care and they gave him a steroid injection and taper pack that helped but 1 week after the steroids were done. He still had hives between his fingers and toes. He took another taper pack, they mostly went away. Then another week later patient went swimming and the something in the pool must have aggrevated his skin and he got hives again. Patient was taking loratidine and famotidine in double dose for the past 5 weeks. 2 weeks into that regimine the hives went away.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Condition aggravated, Spinal pain
Clinical narrative: She is having back and spine pain; She is having back and spine pain; Bone pain/feels like her bone hurts; And that it is worse today than yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 19 year-old female patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) at the age of 19 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "back sprain" (unspecified if ongoing), notes: she sprained her back, like she did 2 years ago when she was tubing behind a boat. . The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), SPINAL PAIN (non-serious) all with onset Aug2021, outcome "unknown" and all described as "She is having back and spine pain"; BONE PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "Bone pain/feels like her bone hurts"; CONDITION AGGRAVATED (non-serious) with onset Aug2021, outcome "not recovered", described as "And that it is worse today than yesterday". Therapeutic measures were taken as a result of back pain, spinal pain.  Additional information: Reporter was calling about an effect her daughter was having. age 19 years. Asked if anyone has reported bone pain.  She was having back and spine pain, but feels like her bone hurts.  Declined filing safety report.  Stated to agent that she was contact HCP at some point.  Daughter stated that it feels like she sprained her back, like she did 2 years ago when she was tubing behind a boat. Caller was giving her ibuprofen and using heating pads. Stated she was in tears today, and that it is worse today than yesterday, and she has a high pain tolerance, and is not a "cry baby". Caller stated her daughter took her first vaccine on Monday. Caller stated her daughter is experiencing major back and spine pain. Caller stated her daughter used Ibuprofen, ice, and heating pads today, and they did not help very much. Caller stated that it feels like her daughter's bones hurt, like a back sprain. Caller stated she has the vaccine information sheet, and that side effect is not listed.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Very sore arm; generally sore muscles in entire body.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 16:45 (Batch/Lot number: unknown) at the age of 18 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Aug2021 05:15, outcome "recovered" (2021), described as "Very sore arm"; MYALGIA (non-serious) with onset 12Aug2021 05:15, outcome "recovered" (2021), described as "generally sore muscles in entire body.". Therapeutic measures were not taken as a result of pain in extremity, myalgia.  Additional information: The patient had not received any other vaccine and other medications in 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: scheduled for 2nd dose and wonders if she can receive that when she is taking pain pills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 04Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. Relevant medical history included: "surgery" (unspecified if ongoing), notes: The surgery she had was one that was prescheduled prior to her COVID vaccine. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "scheduled for 2nd dose and wonders if she can receive that when she is taking pain pills". Therapeutic measures were taken as a result of pain.  Additional Information:  Patient just had a couple of questions. She got her first dose of the COVID Pfizer vaccine she thinks on 04 Aug2021 and she was supposed to have her 2nd dose today but she had surgery on Friday so she was only about 4 days postop. She asks, would it be wise to go and get her second vaccine even though she was taking pain pills. she confirmed that the surgery she had was one that was prescheduled prior to her first COVID vaccine. When attempting to inform patient that (Privacy) may have resources to speak from her question she interrupts and states, well go ahead and transfer her over there, she had been trying to get in touch with someone for the last hour. Unable to obtain further details.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: she stated that se has a sore arm (pain at the injection site); she is experiencing body aches; sort of back pain; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 24Aug2021 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Jun2020 (unspecified if ongoing), notes: Caller also mentioned she had COVID-19 infection last year, in June. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "she stated that se has a sore arm (pain at the injection site)"; PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "she is experiencing body aches"; BACK PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "sort of back pain"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "sore arm". Therapeutic measures were taken as a result of vaccination site pain, pain, back pain, pain in extremity. Additional information: stated that she had a sore arm (pain at the injection site) and requested information on the use of ibuprofen for the treatment of her symptoms following vaccination with the Pfizer COVID-19 vaccine first dose received yesterday 24Aug2021. stated last night she took one Tylenol PM 500mg and today ibuprofen 800mg because she had body aches sort of back pain, and a sore arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After taking the vaccine two weeks ago, I have not had any episodes of Cataplexy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Narcolepsy" (unspecified if ongoing), notes: Narcolepsy with Cataplexy for more than 10 years; "Cataplexy" (unspecified if ongoing), notes: Narcolepsy with Cataplexy for more than 10 years. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "After taking the vaccine two weeks ago, I have not had any episodes of Cataplexy".  Additional information: The consumer reported that the reporter wanted to speak with someone regarding my experience after taking the Pfizer COVID vaccine, have/had narcolepsy with Cataplexy for more than 10 years. After taking the vaccine two weeks ago, not had any episodes of Cataplexy. vaccine has made a big difference in the patient's life. follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: hurts too bad to sit/has a bad back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 17Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Surgery" (unspecified if ongoing), notes: She had undergone 17 surgeries and has different diseases. clarified all the surgeries were years ago. The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 2021, outcome "unknown", described as "hurts too bad to sit/has a bad back".  Additional information: Caller on the line and stated she and her husband both completed the 1st and 2nd doses of the Pfizer COVID Vaccine on 11Mar2021 and is asking when she could receive the booster shot; caller mentioned prior to the 1st dose of the vaccine she had undergone 17 surgeries and has different diseases. Caller clarified the information provided by the transferring agent and states that their 1st doses of the vaccine was on 17Feb2021, and the 2nd doses of the vaccine were on 11Mar2021 and clarified all the surgeries were years ago and she had quite a few and will be age 77. Caller states she wanted to go back to the same place regarding the facility where she had the vaccine and is aware that Pfizer unable to schedule appointments and referred caller back to the facility. Reporter details: Caller provided a different address than was provided by the transferring agent and states she has a lot of different doctors there and she had the vaccine in. Caller states they have to wait 8 months after the 2nd dose for the booster which would be November 10th and then states she had the 2nd dose of the vaccine on 10Mar2021 despite stating earlier the 2nd dose was on 11Mar2021; captured as stated by the caller.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Pain, Pain in extremity
Clinical narrative: extremely tired; Chills; her arm is hurting and swollen; body is aching; doesn't feel well; her arm is hurting and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 15:53 (Lot number: EW0172) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sickle cell disease" (ongoing), notes: born with this condition; "Asthma" (ongoing), notes: she has had for about 25 years; "Sickle cell anaemia" (ongoing), notes: born with this condition. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "extremely tired"; CHILLS (non-serious), outcome "not recovered", described as "Chills"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "not recovered" and all described as "her arm is hurting and swollen"; PAIN (non-serious), outcome "not recovered", described as "body is aching"; MALAISE (non-serious), outcome "not recovered", described as "doesn't feel well". Therapeutic measures were taken as a result of fatigue, chills, peripheral swelling, pain, malaise, pain in extremity.  Additional information: History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Prior vaccinations (within 4 weeks) was reported as none. AE(s) following prior vaccinations were reported as none. It was reported that, caller, reporting on the Pfizer Covid 19 vaccine and who explained that, she got the first shot yesterday and was having really bad side effects. She reported that, she was extremely tired, has chills, her arm was hurting and swollen, her body was aching and she didn't feel well. Caller wanted to report this. The events did not require a visit to emergency room and physician office. Therapeutic measures included that, she was just staying hydrated and resting. Relevant tests were reported as none.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: extremely tired; Chills; her arm is hurting and swollen; body is aching; doesn't feel well; her arm is hurting and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 15:53 (Lot number: EW0172) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sickle cell disease" (ongoing), notes: born with this condition; "Asthma" (ongoing), notes: she has had for about 25 years; "Sickle cell anaemia" (ongoing), notes: born with this condition. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "extremely tired"; CHILLS (non-serious), outcome "not recovered", described as "Chills"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "not recovered" and all described as "her arm is hurting and swollen"; PAIN (non-serious), outcome "not recovered", described as "body is aching"; MALAISE (non-serious), outcome "not recovered", described as "doesn't feel well". Therapeutic measures were taken as a result of fatigue, chills, peripheral swelling, pain, malaise, pain in extremity.  Additional information: History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Prior vaccinations (within 4 weeks) was reported as none. AE(s) following prior vaccinations were reported as none. It was reported that, caller, reporting on the Pfizer Covid 19 vaccine and who explained that, she got the first shot yesterday and was having really bad side effects. She reported that, she was extremely tired, has chills, her arm was hurting and swollen, her body was aching and she didn't feel well. Caller wanted to report this. The events did not require a visit to emergency room and physician office. Therapeutic measures included that, she was just staying hydrated and resting. Relevant tests were reported as none.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Paraesthesia, SARS-CoV-2 test, Tremor
Clinical narrative: Continuous headache; Tingle right cheek to mouth; Right hand tremor; Brain fog; Intermittent blurred vision; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Aug2021 18:00 (Lot number: Fc3181) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "latex Allergy" (unspecified if ongoing); "Known allergies: ct contrast on opaque" (unspecified if ongoing); "Known allergies: soy" (unspecified if ongoing); "Covid" (unspecified if ongoing). Concomitant medication(s) included: LIALDA; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLONASE [MOMETASONE FUROATE]; PROBIOTICS. Past drug history included: Keflex, reaction(s): "Known Allergies: Keflex"; Zithromax, reaction(s): "Known Allergies: Zithromax"; Doxycycline, reaction(s): "Known Allergies: doxycycline"; Bactrim, reaction(s): "Known Allergies: Bactrim"; Levaquin, reaction(s): "Known Allergies: levaquin"; Betadine, reaction(s): "Known Allergies: betadine". The following information was reported: HEADACHE (non-serious) with onset 10Aug2021 06:00, outcome "not recovered", described as "Continuous headache"; PARAESTHESIA (non-serious) with onset 10Aug2021 06:00, outcome "not recovered", described as "Tingle right cheek to mouth"; TREMOR (non-serious) with onset 10Aug2021 06:00, outcome "not recovered", described as "Right hand tremor"; FEELING ABNORMAL (non-serious) with onset 10Aug2021 06:00, outcome "not recovered", described as "Brain fog"; VISION BLURRED (non-serious) with onset 10Aug2021 06:00, outcome "not recovered", described as "Intermittent blurred vision". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, paraesthesia, tremor, feeling abnormal, vision blurred.  Additional information: Patient was not diagnosed with COVID prior to vaccination and not tested with COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Continuous headache; Tingle right cheek to mouth; Right hand tremor; Brain fog; Intermittent blurred vision; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Aug2021 18:00 (Lot number: Fc3181) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "latex Allergy" (unspecified if ongoing); "Known allergies: ct contrast on opaque" (unspecified if ongoing); "Known allergies: soy" (unspecified if ongoing); "Covid" (unspecified if ongoing). Concomitant medication(s) included: LIALDA; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLONASE [MOMETASONE FUROATE]; PROBIOTICS. Past drug history included: Keflex, reaction(s): "Known Allergies: Keflex"; Zithromax, reaction(s): "Known Allergies: Zithromax"; Doxycycline, reaction(s): "Known Allergies: doxycycline"; Bactrim, reaction(s): "Known Allergies: Bactrim"; Levaquin, reaction(s): "Known Allergies: levaquin"; Betadine, reaction(s): "Known Allergies: betadine". The following information was reported: HEADACHE (non-serious) with onset 10Aug2021 06:00, outcome "not recovered", described as "Continuous headache"; PARAESTHESIA (non-serious) with onset 10Aug2021 06:00, outcome "not recovered", described as "Tingle right cheek to mouth"; TREMOR (non-serious) with onset 10Aug2021 06:00, outcome "not recovered", described as "Right hand tremor"; FEELING ABNORMAL (non-serious) with onset 10Aug2021 06:00, outcome "not recovered", described as "Brain fog"; VISION BLURRED (non-serious) with onset 10Aug2021 06:00, outcome "not recovered", described as "Intermittent blurred vision". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, paraesthesia, tremor, feeling abnormal, vision blurred.  Additional information: Patient was not diagnosed with COVID prior to vaccination and not tested with COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: My son received the first dose on Sunday and he is being sick ever since; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date 22Aug2021 (Lot number: FC3184) at the age of 16 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MOTRIN. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "My son received the first dose on Sunday and he is being sick ever since".  Additional information:  Other medications and medical conditions: Reporter stated, "A cough syrup. I don't know it is generic a pharmacy generic. I don't even know if he is really taking it." (Further not clarified hence, not captured in tab and however yes was checked in tab). Reporter stated, "Can I ask how long should we expect side effect for last" Reporter was informed about Pfizer Medical Information and asked to provide the number. Reporter stated, "You know what, I will call back tomorrow."  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick a couple of times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick a couple of times".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation irregular
Clinical narrative: Caused hard changes in my period also in both my daughters periods age 12 and 13; Caused hard changes in my period also in both my daughters periods age 12 and 13; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious), MENSTRUAL DISORDER (non-serious), outcome "unknown" and all described as "Caused hard changes in my period also in both my daughters periods age 12 and 13".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received no other medications within 2 weeks of vaccination. The patient was not tested post the vaccination. The patient had no covid prior to vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.   Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101110519 Same reporter/SD/AE, Different patient;US-PFIZER INC-202101110602 Same reporter/SD/AE, Different patient;
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Pain
Clinical narrative: The bottom of my feet was numb and when I walked I felt a numbing sensation that spread through my legs; If I stood and walk it was almost painful.; I felt like my legs would give out.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Aug2021 09:45 (Lot number: Unknown) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy: Pork" (unspecified if ongoing); "Allergy: shrimp" (unspecified if ongoing); "Allergy: dust" (unspecified if ongoing); "grass" (unspecified if ongoing). Concomitant medication(s) included: BIOTIN. The following information was reported: HYPOAESTHESIA (non-serious) with onset 15Aug2021 12:00, outcome "unknown", described as "The bottom of my feet was numb and when I walked I felt a numbing sensation that spread through my legs"; PAIN (non-serious) with onset 15Aug2021 12:00, outcome "unknown", described as "If I stood and walk it was almost painful."; LIMB DISCOMFORT (non-serious) with onset 15Aug2021 12:00, outcome "unknown", described as "I felt like my legs would give out.". Therapeutic measures were not taken as a result of hypoaesthesia, pain, limb discomfort.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 10 days after receiving the vaccine. I was eating when I suddenly felt that the right side of my neck was numb. A few minutes later it spread to half of my face. I thought I was probably tired, so I took a nap (around noon) woke up an hour later and found that I was numb from my thighs down and both arms were numb starting at the shoulder. If I stood and walk it was almost painful. I felt like my legs would give out. Laying was painful too, but less painful than standing. The numbness would spread every so often to my neck and face. This lasted until 9pm when I decided to go to bed. The next day, my hands were numb from my elbows down. My legs were still numb but hurt less than the previous day. My walking was affected by it. On the third day my fingers were numb. The bottom of my feet was numb and when I walked, I felt a numbing sensation that spread through my legs. On the fourth day my hands were fine. My legs continue to experience a numbness sensation.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: This is a spontaneous report received from a noncontactable other HCP. A patient (no qualifiers provided) received unknown dose number of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot#), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had rhinorrhea (runny nose), and oropharyngeal pain (sore throat), with outcome of unknown. Additional information: The reporter's colleague developed symptoms on Saturday night. Symptoms included runny nose and sore throat. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Dull headache across front lobe forehead including right and left side temples; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Aug2021 10:45 (Lot number: FA7485) at the age of 66  as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SIMVASTATIN; VYTORIN. The following information was reported: HEADACHE (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Dull headache across front lobe forehead including right and left side temples". Therapeutic measures were not taken as a result of headache.  Additional Information: Patient did not used any covid prior vaccination. Patient was not tested covid post vaccination. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility type vaccine was Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Pain in extremity
Clinical narrative: Couldn't lift her left arm; Brain is foggy right now; can't afford, I am nauseous I need to go to the bathroom; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1 ,single for covid-19 immunisation. Relevant medical history included: "Chemo therapy" (unspecified if ongoing), notes: she is about to start her Chemo therapy next week but not given the date (History); "Allergies messed up" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Couldn't lift her left arm"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain is foggy right now"; NAUSEA (non-serious), outcome "unknown", described as "can't afford, I am nauseous I need to go to the bathroom".  Additional information: Consumer stated, "Yes, I just want to make sure that second one is worse than first, my brain is foggy right now. I just can't talk to you right now." Consumer stated, "I wanted to know if it is ok to be around my grand babies because (name withheld) just 4 months, (name withheld) turns 3 in Nov, my daughter told me her two friends "died" (further not clarified) from it, I wanted to make sure that if I am not contagious because second one is worse than the first. I can't afford following these step (File safety report), what did she transfer me that you could help me? I am nauseous I need to go to the bathroom."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101116881 Same reporter/drug, different patient;US-PFIZER INC-202101116861 Same reporter/drug, different patient
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Second dose is worse than the first dose; her husband have the same event like sucker punch at his injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient (reporter's husband) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Second dose is worse than the first dose; her husband have the same event like sucker punch at his injection". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101116868 Same reporter/drug, different patient;US-PFIZER INC-202101116861 Same reporter/drug, different patient