chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain
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 dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced pain, with outcome of unknown. Therapeutic measures were taken as a result of pain. The patient took Tylenol 4 and tramadol. She wanted to know if it's ok to take pain medications. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Muscle spasms, Restlessness, Tremor, Vomiting
Clinical narrative: Tossing; Shaky; Flu-like; Threw up; Cramps; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A female patient received BNT162B2 (BNT162B2), administration date 17Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RESTLESSNESS (non-serious) with onset 19Apr2021 02:00, outcome "recovering", described as "Tossing"; TREMOR (non-serious) with onset 19Apr2021 02:00, outcome "recovering", described as "Shaky"; INFLUENZA LIKE ILLNESS (non-serious) with onset 19Apr2021 02:00, outcome "recovering", described as "Flu-like"; VOMITING (non-serious) with onset 19Apr2021 02:00, outcome "recovering", described as "Threw up"; MUSCLE SPASMS (non-serious) with onset 19Apr2021 02:00, outcome "recovering", described as "Cramps".  Additional Information: The patient was calling about the Pfizer BioNTech COVID-19 vaccine. The patient had the vaccine on Saturday (17Apr2021) and she was feeling fine until last night around 2:00 AM (19Apr2021). The patient was tossing, got shaky, and flu-like. Then the patient had to go to the bathroom and then she threw up. Ever since then, the patient has stayed in bed and has cramps, right now she feels a little bit better. The patient wanted to make sure she is okay.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site soreness; intermittent soreness; This is a spontaneous report received from a contactable pharmacist. The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date 24Mar2021 09:30 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021, outcome "recovering", described as "Injection site soreness; intermittent soreness". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The most recent vaccine was administered in a public health clinic or Veteran's administration facility. Injection site soreness started on the same day of the vaccine and lasted for two days, then intermittent soreness for 3 to 4 days afterward. The patient has not been tested for COVID-19 post vaccination.   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-2021439827 Same patient and product; different events and dose
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very sore arm; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date Mar2021 (Lot number: ER8733) at the age of 56 years as dose 1, single for COVID-19 immunization. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "Very sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. Other medications in two weeks included unspecified vitamins. No other vaccine was administered in four weeks. The first dose was administered at 01:00 PM. The patient has not been tested for COVID-19 post vaccination.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021439215 Same patient and product; different events and dose
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic
Clinical narrative: On 04Apr2021 she had a topical allergic reaction; The initial and follow up 1 case was missing the following minimum criteria: [specify criteria (no adverse event)]. Upon receipt of follow-up information on [26Apr2021], this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021465423.  A female patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (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: DERMATITIS ALLERGIC (non-serious) with onset 04Apr2021, outcome "unknown", described as "On 04Apr2021 she had a topical allergic reaction". Therapeutic measures were taken as a result of dermatitis allergic.  Additional information: A female patient age reported as 62 (unit not provided). Patient received the first dose of the Pfizer BioNtech Covid-19 vaccine on 21Mar2021,on 04Apr2021 she had a topical allergic reaction (she doesn't think it's related to the vaccine) to the formaldehyde in the paper mask she was wearing. Her doctor put her on oral steroids until 09Apr2021, her second dose was going to be that weekend and no-one could tell her if she should take it or not, she missed her second dose. She was still on topical steroids, she would like to know if it was safe for her to get the second dose of the vaccine. Reporter reschedule for second dose on 11Apr2021 possible reaction on steroids. Can she still get her second dose. She did not state what the reaction(s) were.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated the narrative and deleted the age from field and capture in narrative additional information.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Sleep disorder
Clinical narrative: feels really weird; cannot sleep and would wake up every hour; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "feels really weird"; SLEEP DISORDER (non-serious), outcome "unknown", described as "cannot sleep and would wake up every hour".  Additional information: The patient wanted to know the vaccine's side effects. This was because 4 days after her vaccine shot, she felt really weird. She cannot sleep and would wake up every hour. She wanted to know if this was a possible side effect of the 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: Full blood count, Full blood count decreased
Clinical narrative: drop in blood count; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 84 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: FULL BLOOD COUNT DECREASED (non-serious), outcome "unknown", described as "drop in blood count". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient has received Covid vaccine 2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This is a spontaneous report received from a contactable nurse. The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), intramuscular, administered in arm left, administration date 27Dec2020 14:00 (Lot number: EH9899) at the age of 27 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "Birth control" (unspecified if ongoing). Concomitant medication(s) included: JUNEL FE taken for contraception, start date: 2012 (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 28Dec2020 03:00, outcome "recovered" (28Dec2020 15:00), described as "Injection site pain". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: The patient provided information regarding the reported adverse event with the use of the product. The patient considered that the Pfizer product had a causal effect to the adverse event. The only reaction to the first shot was injection site pain for about 12 hours.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122919 Same patient and product; different events and dose
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: tiredness; sore arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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: FATIGUE (non-serious), outcome "unknown", described as "tiredness"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "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: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP/patient's friend) from a Pfizer sales representative.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: TINNITUS (non-serious), outcome "unknown", described as "tinnitus".  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-2021443460 same reporter, drug and event/ different patient
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from a non-contactable reporter (Consumer) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: TINNITUS (non-serious), outcome "unknown", described as "tinnitus".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Hypoaesthesia, Malaise
Clinical narrative: Headache; Feels weak; Doesn't feel good; Numbness in her legs; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (BNT162B2), administration date 17Apr2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "Headache"; ASTHENIA (non-serious) with onset Apr2021, outcome "unknown", described as "Feels weak"; MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "Doesn't feel good"; HYPOAESTHESIA (non-serious) with onset Apr2021, outcome "unknown", described as "Numbness in her legs".  Additional information: The patient received first dose yesterday. The patient had a headache. The patient felt weak, doesn't feel good, and numbness in her legs. The patient wanted to know if she can take acetylsalicylic acid (ASPIRIN). She is concerned about blood clots.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Apr 14, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had peripheral swelling (swollen arm after first vaccination shot), with outcome of unknown. The event occurred 3 days after vaccination. 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: headache; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 18Apr2021 (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) with onset 18Apr2021, outcome "unknown", described as "headache".  Additional Information: The patient asked if he could take acetaminophen (TYLENOL) or ibuprofen (ADVIL) for headache because he was experiencing it after taking the first dose of COVID-19 vaccine last 18Apr2021. He could not remember his second dose schedule because his vaccination card was with his wife. .   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt tired after receiving his second dose; This is a spontaneous report received from a contactable reporter (Consumer).  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "felt tired after receiving his second dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Colonoscopy, Headache, Pain in extremity
Clinical narrative: sore arm, but not sore enough that patient could not sleep on her left side; brief headache; extremely short lived drop in body temperature; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 02Feb2021 (Lot number: EL 3249) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Chronic kidney disease", start date: 2012 (unspecified if ongoing), notes: stage 2a chronic kidney disease; "Ringing in ears" (unspecified if ongoing); "allergic grass" (unspecified if ongoing); "animal dander allergy" (unspecified if ongoing); "mold allergy" (unspecified if ongoing); "fabrics allergy" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; STOOL SOFTENER; CALCIUM;VITAMIN D NOS. Past drug history included: Sulfa, reaction(s): "tongue enlarged to enormous proportions". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "sore arm, but not sore enough that patient could not sleep on her left side"; HEADACHE (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "brief headache"; BODY TEMPERATURE DECREASED (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "extremely short lived drop in body temperature". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Patient feel so much safer after having the vaccine. Patient got tested twice for nasal swabs, once before patient visited her son for the first time and once when patient started to experience a ringing in her ears, both tests were negative. Patient has been good about social distancing and using safety protocols, although patient does her own grocery shopping. Patient is taking unspecified multivitamin. Patient doesn't know if she had an allergic to any ingredient in the vaccine but just wanted to report her experience. Patient stated if she needs a booster shot in the future, she is not sure if she will be willing to get it or if she really need to get the booster hopefully it is less of a dose for her and may be just as effective.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021444925 same patient/drug, different dose and event
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: sore arm, but not sore enough that patient could not sleep on her left side; brief headache; extremely short lived drop in body temperature; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 02Feb2021 (Lot number: EL 3249) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Chronic kidney disease", start date: 2012 (unspecified if ongoing), notes: stage 2a chronic kidney disease; "Ringing in ears" (unspecified if ongoing); "allergic grass" (unspecified if ongoing); "animal dander allergy" (unspecified if ongoing); "mold allergy" (unspecified if ongoing); "fabrics allergy" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; STOOL SOFTENER; CALCIUM;VITAMIN D NOS. Past drug history included: Sulfa, reaction(s): "tongue enlarged to enormous proportions". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "sore arm, but not sore enough that patient could not sleep on her left side"; HEADACHE (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "brief headache"; BODY TEMPERATURE DECREASED (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "extremely short lived drop in body temperature". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Patient feel so much safer after having the vaccine. Patient got tested twice for nasal swabs, once before patient visited her son for the first time and once when patient started to experience a ringing in her ears, both tests were negative. Patient has been good about social distancing and using safety protocols, although patient does her own grocery shopping. Patient is taking unspecified multivitamin. Patient doesn't know if she had an allergic to any ingredient in the vaccine but just wanted to report her experience. Patient stated if she needs a booster shot in the future, she is not sure if she will be willing to get it or if she really need to get the booster hopefully it is less of a dose for her and may be just as effective.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021444925 same patient/drug, different dose and event
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, 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: MALAISE (non-serious), outcome "unknown", described as "not feeling well".  Additional information: The reported mentioned that her parents were scheduled to receive their second dose but they would not be able to get it since they were not feeling well.   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-2021444923 same suspect drug and similar event on different patients
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, 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: MALAISE (non-serious), outcome "unknown", described as "not feeling well".  Additional information: The reporter mentioned that her parents were scheduled to receive their second dose but they would not be able to get it since they were not feeling well.  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-2021444910 same suspect drug and similar event on different patients
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: suffered from pain in the vaccine area; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (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 "suffered from pain in the vaccine area". Additional information: The reporter was reporting on AE/medical inquiry after the COVID vaccine and was reporting product complaints on other products. When the reporter had called the patient (daughter) this morning, patient said that she had experienced pain but just in the vaccine area.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: experienced a Sore arm on previous date after receiving the First and second PFIZER COVID 19 Vaccine doses; This is a spontaneous report received from contactable reporters (Consumer and Physician). Other Case identifier: 01907850 (Merck).  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, 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), outcome "unknown", described as "experienced a Sore arm on previous date after receiving the First and second PFIZER COVID 19 Vaccine doses".  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-2021446577 Same reporter/drug/ event for different patients
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain in extremity
Clinical narrative: arm pain; stomach cramps; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 17Apr2021 15:00 (lot number ER8731) at the age of 38-years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, lot number ER8730, administration time 14:30), administration date: 27Mar2021, when the patient was 38-years old, for Covid-19 immunization, reactions: "arm pain for 48 hours", "early menstrual cycle (came 4 days early)". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "arm pain"; ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "recovering", described as "stomach cramps". Therapeutic measures were not taken as a result of pain in extremity, abdominal pain upper.  Additional Information: The vaccine was given in a pharmacy or drug store. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. The patient was not tested for covid-19 post-vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: She states that the covax gave her a  boost energy, she felt great; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 73 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "fatique", start date: 2005 (unspecified if ongoing), notes: came down with something of fatigue, fever, muscle weakness; "fever", start date: 2005 (unspecified if ongoing), notes: came down with something of fatigue, fever, muscle weakness; "muscle weakness", start date: 2005 (unspecified if ongoing), notes: came down with something of fatigue, fever, muscle weakness. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "She states that the covax gave her a  boost energy, she felt great".  Additional information: Patient got covax series and had positive results. 16 yrs. ago patient visited city name withheld and came down with something of fatique, fever and muscle weakness. None of the HCP can figure out what it is. Patient states that the covax gave her a boost energy, patient felt great 24 hr. The best patient has felt in 16 yrs. Patient wanted to let Pfizer know this. Patient has no diagnosis for the condition as of yet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: I had just sore arm after shot 1; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 08:30 (Lot number: EL9266) at the age of 67 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Other medical history: no meds until this no disease or condition. No COVID prior vaccination. No known allergies. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "I had just sore arm after shot 1". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Apr2021) negative, notes: Covid test type post vaccination=Nasal Swab, Covid test name post vaccination=PCS, Covid test date=07Apr2021, Covid test result=Negative. Additional information: Facility type vaccine: Hospital. COVID was tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, administration time: 10:00 AM), administration date: 03Mar2021, for COVID-19 immunization, reaction(s): "Tenderness at injection site", "mild headache ". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness at injection site".  Additional information: Unknown if there was other vaccine in four weeks and if there were other medications in two weeks. No covid prior vaccination. Not covid tested post vaccination. Known allergies: unknown.  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-2021448778 Same reporter/patient/vaccine, different dose/events
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: tenderness at injection site after first dose and soreness at injection site after second dose; mild headache after first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date 24Mar2021 (Batch/Lot number: unknown) as dose 2, 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) with onset 03Mar2021, outcome "recovered" (2021), described as "tenderness at injection site after first dose and soreness at injection site after second dose"; HEADACHE (non-serious) with onset 03Mar2021, outcome "recovered" (2021), described as "mild headache after first dose". Therapeutic measures were taken as a result of vaccination site pain, headache.  Additional information: The events were treated with Tylenol. There was no covid prior to vaccination, and no covid was tested after vaccination.  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-2021448755 similar report from same reporter
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Pain in extremity
Clinical narrative: Pain in my arm; Dizzy; Anxiety; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 53 years 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: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Pain in my arm"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; ANXIETY (non-serious), outcome "unknown", described as "Anxiety". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient's arm is better now, it's just a little sore. The patient took ibuprofen 800 (unit unspecified) and drank water and took one.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia oral
Clinical narrative: very tip of tongue was tingly; little bit dizzy; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 39 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 19Apr2021 11:02 (Lot number: ER8729) at the age of 39 years as dose number unknown, single for covid-19 immunization. Relevant medical history included: "Scoliosis", start date: 2018 (ongoing), notes: Diagnosed around 2018; "slipped disk in her back" (unspecified if ongoing), notes: diagnosed around last year; "Allergic to Windex" (unspecified if ongoing), notes: Caller stated, what windows are cleaned with, and that it is very weird. Concomitant medication included: IBUPROFEN taken for back disorder (ongoing). The following information was reported: PARAESTHESIA ORAL (non-serious) with onset 19Apr2021, outcome "not recovered", described as "very tip of tongue was tingly"; DIZZINESS (non-serious) with onset 19Apr2021, outcome "not recovered", described as "little bit dizzy".  Additional information: Caller stated she was calling about the Pfizer-BioNTech COVID-19 Vaccine.  She received it this morning. A few minutes after she received her vaccine, the very tip of her tongue was tingly. She received the vaccination at 11:02 am and the tingling is not getting worse, but it has not gotten any better. This started a few minutes after receiving her vaccine, maybe 5 minutes after.  Caller added that she was a little bit dizzy.  It was not like the room was spinning and it started kind of around the time that she got home from getting the vaccine and was about the same as it was. Treatment received was none, except laying down. Caller also clarified that her vaccine was received in her right arm, like up by her shoulder. She had not received any other vaccine within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Neck pain; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 63-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 (Lot number: EW0158, Expiration Date: 31Jul2021) at the age of 63 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: NECK PAIN (non-serious) with onset 13Apr2021, outcome "not recovered", described as "Neck pain". Therapeutic measures were taken as a result of neck pain.  Additional Information: The patient received concomitant product which included eye drops. The patient got her first shot on the 10th of April and then on the 13th, she started getting like a little bit of neck pain. On the 14th, it's really bad. So her neck really hurt and it was still like that. So she had six days with neck ache. She had no fever or anything like that it's just her neck was really bad. She just looked up for symptoms, it didn't say that she guessed the neck lymph node got swollen or she did not see any swelling but it hurt really bad so she didn't know. She asked if that was normal and if that happens. The patient stated that the start date of event was 4 days after the shot. As per patient, the event was persisting, worse persisting. She took some ibuprofen as treatment for the event.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not feeling well; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 12Apr2021 (Lot number: EP7533) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown), for covid-19 immunization. The following information was reported: MALAISE (non-serious) with onset Apr2021, outcome "not recovered", described as "Not feeling well".  Additional information: The patient received the second dose of the Pfizer Vaccine last Monday, one week ago on 12Apr and was having some side effects and they have not gone away. Patient was not feeling well still and have some side effect going on.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Formication, Paraesthesia
Clinical narrative: he is got like a crawling feeling on his face and his head; He started having pins and needles in both his hands and feet; This is a spontaneous report received from a contactable reporter (Consumer).  A male patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (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: PARAESTHESIA (non-serious) with onset 18Apr2021, outcome "unknown", described as "He started having pins and needles in both his hands and feet"; FORMICATION (non-serious) with onset 19Apr2021, outcome "unknown", described as "he is got like a crawling feeling on his face and his head".  Additional Information: The patient got the Pfizer shot on Friday (16Apr2021). Yesterday (18Apr2021), he started having pins and needles in both his hands and feet and today (19Apr2021), he got like a crawling feeling on his face and his head. The patient asked if he should even get the second one though he was having this reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Migraine
Clinical narrative: After 1st vaccine on 1st day I had migraine; After 1st vaccine on 1st day I had migraine; This is a spontaneous report received from contactable reporter (other healthcare professional). The reporter is the patient.  A 64 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 24Mar2021 13:30 (Lot number: ER8733) at the age of 64 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Brown- Sequard ( cervical myelopathy)" (unspecified if ongoing); "CVID" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "CRPS" (unspecified if ongoing); "IC" (unspecified if ongoing); "Allergies:Cipro, Macrobid, Supra, Tetracycline" (unspecified if ongoing); "Allergies:Reglan" (unspecified if ongoing); "Flu Vaccine" (unspecified if ongoing); "Allergies:Sulfa" (unspecified if ongoing); "Allergies:IVIG" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CYTOMEL; NEURONTIN; LYRICA; MET 500. The following information was reported: MIGRAINE (non-serious), DISEASE RECURRENCE (non-serious) all with onset 24Mar2021, outcome "unknown" and all described as "After 1st vaccine on 1st day I had migraine". Therapeutic measures were not taken as a result of migraine, disease recurrence.  Additional information: The patient had not received any other vaccine within 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. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hypomenorrhoea
Clinical narrative: Decrease in amount of menstruation.; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date 14Apr2021 (Lot number: ew0164) at the age of 26 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: HYPOMENORRHOEA (non-serious), outcome "unknown", described as "Decrease in amount of menstruation.". Additional Information: The patient and three of her other female friends experienced decrease in amount of menstruation. The patient did not receive other vaccine in four weeks. The patient has not been diagnosed with COVID prior vaccination and has not been tested for COVID post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021452460 same reporter, drug, event/different patients;US-PFIZER INC-2021452459 same reporter, drug, event/different patients;US-PFIZER INC-2021452461 same reporter, drug, event/different patients
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter (Consumer). 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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Tinnitus".  Additional Information: The patient had tinnitus and wanted to know if this was one of the side effects of COVID-19 shot. The patient was wondering if anyone reported any side effect with COVID-19 one shot, mainly tinnitus.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Where I got my shot is still sore/arm still sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 11Apr2021 (Lot number: EW0161, Expiration Date: 11Apr2021) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 11Apr2021, outcome "not recovered", described as "Where I got my shot is still sore/arm still sore". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Patient was asking why her arm was still sore as it has been a couple of weeks. She stated it should not be sore after two weeks.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dizziness postural
Clinical narrative: Dizziness like being sitting down; if I stand up quickly I am really Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Lot number: ER8737) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing). Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 16Apr2021, outcome "not recovered", described as "Dizziness like being sitting down"; DIZZINESS POSTURAL (non-serious) with onset 16Apr2021, outcome "not recovered", described as "if I stand up quickly I am really Dizzy". Therapeutic measures were not taken as a result of dizziness, dizziness postural.  No follow-up attempts are possible. No further information is expected.