chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Chills, Ear pain, Headache
Clinical narrative: Severe chills; Throat pain; Fever over 102 degrees; Muscle and bone pain that feels like my bones are trying to escape my body; Muscle and bone pain that feels like my bones are trying to escape my body; Headache/migraine; Headache/migraine; Frequent and urgent urination; Frequent and urgent urination; Left ear pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 17:15 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: Covid prior vaccination. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Administration time: 05:15 PM, Anatomical Location :  Arm Left), administration date: 31Aug2021, when the patient was 41 years old, for COVID-19 immunization.  The following information was reported: CHILLS (non-serious) with onset 22Sep2021 02:00, outcome "not recovered", described as "Severe chills"; OROPHARYNGEAL PAIN (non-serious) with onset 22Sep2021 02:00, outcome "not recovered", described as "Throat pain"; PYREXIA (non-serious) with onset 22Sep2021 02:00, outcome "not recovered", described as "Fever over 102 degrees"; BONE PAIN (non-serious), MYALGIA (non-serious) all with onset 22Sep2021 02:00, outcome "not recovered" and all described as "Muscle and bone pain that feels like my bones are trying to escape my body"; HEADACHE (non-serious), MIGRAINE (non-serious) all with onset 22Sep2021 02:00, outcome "not recovered" and all described as "Headache/migraine"; MICTURITION URGENCY (non-serious), POLLAKIURIA (non-serious) all with onset 22Sep2021 02:00, outcome "not recovered" and all described as "Frequent and urgent urination"; EAR PAIN (non-serious) with onset 22Sep2021 02:00, outcome "not recovered", described as "Left ear pain". The events "severe chills", "throat pain", "fever over 102 degrees", "muscle and bone pain that feels like my bones are trying to escape my body", "muscle and bone pain that feels like my bones are trying to escape my body", "headache/migraine", "frequent and urgent urination", "frequent and urgent urination" and "left ear pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, oropharyngeal pain, pyrexia, bone pain, myalgia, headache, migraine, micturition urgency, pollakiuria, ear pain.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 with Nasal Swab test on 19Sep2021 and result was negative. Device Date reported as 22Sep2021.  Follow-up attempts completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Severe chills; Throat pain; Fever over 102 degrees; Muscle and bone pain that feels like my bones are trying to escape my body; Muscle and bone pain that feels like my bones are trying to escape my body; Headache/migraine; Headache/migraine; Frequent and urgent urination; Frequent and urgent urination; Left ear pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 17:15 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: Covid prior vaccination. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Administration time: 05:15 PM, Anatomical Location :  Arm Left), administration date: 31Aug2021, when the patient was 41 years old, for COVID-19 immunization.  The following information was reported: CHILLS (non-serious) with onset 22Sep2021 02:00, outcome "not recovered", described as "Severe chills"; OROPHARYNGEAL PAIN (non-serious) with onset 22Sep2021 02:00, outcome "not recovered", described as "Throat pain"; PYREXIA (non-serious) with onset 22Sep2021 02:00, outcome "not recovered", described as "Fever over 102 degrees"; BONE PAIN (non-serious), MYALGIA (non-serious) all with onset 22Sep2021 02:00, outcome "not recovered" and all described as "Muscle and bone pain that feels like my bones are trying to escape my body"; HEADACHE (non-serious), MIGRAINE (non-serious) all with onset 22Sep2021 02:00, outcome "not recovered" and all described as "Headache/migraine"; MICTURITION URGENCY (non-serious), POLLAKIURIA (non-serious) all with onset 22Sep2021 02:00, outcome "not recovered" and all described as "Frequent and urgent urination"; EAR PAIN (non-serious) with onset 22Sep2021 02:00, outcome "not recovered", described as "Left ear pain". The events "severe chills", "throat pain", "fever over 102 degrees", "muscle and bone pain that feels like my bones are trying to escape my body", "muscle and bone pain that feels like my bones are trying to escape my body", "headache/migraine", "frequent and urgent urination", "frequent and urgent urination" and "left ear pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, oropharyngeal pain, pyrexia, bone pain, myalgia, headache, migraine, micturition urgency, pollakiuria, ear pain.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 with Nasal Swab test on 19Sep2021 and result was negative. Device Date reported as 22Sep2021.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: slight sore arm; slight low-grade fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine janssen (DOSE 1), administration date: Mar2021, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "slight sore arm"; PYREXIA (non-serious), outcome "unknown", described as "slight low-grade fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient received first dose of Pfizer COVID-19 vaccine one week ago. she had a slight sore arm and very slight low-grade fever. No problem with the shot. The symptoms were not significant.  she just want to know if she can get the second shot of the Pfizer COVID-19 vaccine to complete the full vaccination regimen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Cyst, Rash
Clinical narrative: my arm looked like it had a rash; I got a cyst on my left shoulder near my shot; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Sep2021 14:45 (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: RASH (non-serious) with onset 08Sep2021 20:00, outcome "not recovered", described as "my arm looked like it had a rash"; CYST (non-serious) with onset 08Sep2021 20:00, outcome "not recovered", described as "I got a cyst on my left shoulder near my shot". Therapeutic measures were not taken as a result of rash, cyst.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient not been tested for COVID-19. The patient had gotten a shot for a physical for any other medications the patient received within 2 weeks of vaccination. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (25Oct2021): 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dehydration, Dyspnoea, Headache
Clinical narrative: 102.5 fever; can''t stay awake; throbbing headache; chills; body aches/body cramping; body aches/body cramping; arm feels very heavy; very sore at injection site; Pain in fingers; Shortness of breath; dehydrated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 16:00 (Batch/Lot number: unknown) at the age of 40 years 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, Arm Left, at 10:00 AM), administration date: 04Sep2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "102.5 fever"; SOMNOLENCE (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "can''t stay awake"; HEADACHE (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "throbbing headache"; CHILLS (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "chills"; PAIN (non-serious), MUSCLE SPASMS (non-serious) all with onset 22Sep2021 19:00, outcome "not recovered" and all described as "body aches/body cramping"; LIMB DISCOMFORT (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "arm feels very heavy"; VACCINATION SITE PAIN (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "very sore at injection site"; PAIN IN EXTREMITY (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "Pain in fingers"; DYSPNOEA (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "Shortness of breath"; DEHYDRATION (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "dehydrated". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, somnolence, headache, chills, pain, muscle spasms, limb discomfort, vaccination site pain, pain in extremity, dyspnoea, dehydration.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscle spasms, Pain, Pain in extremity, Pyrexia
Clinical narrative: 102.5 fever; can''t stay awake; throbbing headache; chills; body aches/body cramping; body aches/body cramping; arm feels very heavy; very sore at injection site; Pain in fingers; Shortness of breath; dehydrated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 16:00 (Batch/Lot number: unknown) at the age of 40 years 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, Arm Left, at 10:00 AM), administration date: 04Sep2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "102.5 fever"; SOMNOLENCE (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "can''t stay awake"; HEADACHE (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "throbbing headache"; CHILLS (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "chills"; PAIN (non-serious), MUSCLE SPASMS (non-serious) all with onset 22Sep2021 19:00, outcome "not recovered" and all described as "body aches/body cramping"; LIMB DISCOMFORT (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "arm feels very heavy"; VACCINATION SITE PAIN (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "very sore at injection site"; PAIN IN EXTREMITY (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "Pain in fingers"; DYSPNOEA (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "Shortness of breath"; DEHYDRATION (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "dehydrated". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, somnolence, headache, chills, pain, muscle spasms, limb discomfort, vaccination site pain, pain in extremity, dyspnoea, dehydration.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: 102.5 fever; can''t stay awake; throbbing headache; chills; body aches/body cramping; body aches/body cramping; arm feels very heavy; very sore at injection site; Pain in fingers; Shortness of breath; dehydrated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 16:00 (Batch/Lot number: unknown) at the age of 40 years 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, Arm Left, at 10:00 AM), administration date: 04Sep2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "102.5 fever"; SOMNOLENCE (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "can''t stay awake"; HEADACHE (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "throbbing headache"; CHILLS (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "chills"; PAIN (non-serious), MUSCLE SPASMS (non-serious) all with onset 22Sep2021 19:00, outcome "not recovered" and all described as "body aches/body cramping"; LIMB DISCOMFORT (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "arm feels very heavy"; VACCINATION SITE PAIN (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "very sore at injection site"; PAIN IN EXTREMITY (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "Pain in fingers"; DYSPNOEA (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "Shortness of breath"; DEHYDRATION (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "dehydrated". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, somnolence, headache, chills, pain, muscle spasms, limb discomfort, vaccination site pain, pain in extremity, dyspnoea, dehydration.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Rash pruritic, SARS-CoV-2 test
Clinical narrative: Redness; Rash around my neck; Itching rash above my buttocks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 12:00 (Batch/Lot number: unknown) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Known allergies: Milk products" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Administration time: 06: 00 AM, Vaccine location: Right arm), administration date: 09Mar2021, when the patient was 62 years old, for COVID-19 Immunization. The following information was reported: ERYTHEMA (non-serious) with onset Aug2021, outcome "not recovered", described as "Redness"; RASH (non-serious) with onset Aug2021, outcome "not recovered", described as "Rash around my neck"; RASH PRURITIC (non-serious) with onset Aug2021, outcome "not recovered", described as "Itching rash above my buttocks". The events "redness", "rash around my neck" and "itching rash above my buttocks" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of erythema, rash, rash pruritic.  Additional Information: It was reported that facility type vaccine was at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received list of any other medications within 2 weeks of vaccination. Treatment received for the adverse event as Triamcinolone Acetonide ointment USP, 0.1%. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Malaise, Pain, Pyrexia
Clinical narrative: fever; chills; aches; I felt really crappy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "ovarian cancer", start date: 2014 (ongoing), notes: cancer for seven years.; "irregular heartbeat" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "chemo" (unspecified if ongoing), notes: She said she was having her chemo before the 1st dose. She had her chemo 2 days before having the 2nd dose. Concomitant medication(s) included: TAXOL; DOXIL [DICLOXACILLIN SODIUM MONOHYDRATE]; METOPROLOL TARTRATE taken for hypertension. Vaccination history included: Covid-19 (1st dose), administration date: Mar2021. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "aches"; MALAISE (non-serious), outcome "unknown", described as "I felt really crappy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller undergoing chemotherapy. I have been on chemo about a year and a half. No information. She said she was having her chemo before the 1st dose. She had her chemo 2 days before having the 2nd dose. I am concerned via the media pullback for safety reasons. Safety of third dose but it was ok to give to immunocompromised. What is the safety issue of not letting anyone have the third dose. That one I was getting Doxil, monthly. Totally off during the first vaccine. Second dose I had Doxil on a Monday and vaccine on a Wednesday. I do take a blood thinner. Two weeks of chemotherapy in a row. Most of my blood work is pretty solid, I am in the normal range.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Scan
Clinical narrative: fever; chills; aches; I felt really crappy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "ovarian cancer", start date: 2014 (ongoing), notes: cancer for seven years.; "irregular heartbeat" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "chemo" (unspecified if ongoing), notes: She said she was having her chemo before the 1st dose. She had her chemo 2 days before having the 2nd dose. Concomitant medication(s) included: TAXOL; DOXIL [DICLOXACILLIN SODIUM MONOHYDRATE]; METOPROLOL TARTRATE taken for hypertension. Vaccination history included: Covid-19 (1st dose), administration date: Mar2021. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "aches"; MALAISE (non-serious), outcome "unknown", described as "I felt really crappy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller undergoing chemotherapy. I have been on chemo about a year and a half. No information. She said she was having her chemo before the 1st dose. She had her chemo 2 days before having the 2nd dose. I am concerned via the media pullback for safety reasons. Safety of third dose but it was ok to give to immunocompromised. What is the safety issue of not letting anyone have the third dose. That one I was getting Doxil, monthly. Totally off during the first vaccine. Second dose I had Doxil on a Monday and vaccine on a Wednesday. I do take a blood thinner. Two weeks of chemotherapy in a row. Most of my blood work is pretty solid, I am in the normal range.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mass, Peripheral swelling, Rash pruritic
Clinical narrative: itchy rashes and bumps; itchy rashes and bumps; recurrent pain in left deltoid and shoulder joint; swelling in hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Jul2021 12:00 (Lot number: 11345) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Low back pain" (unspecified if ongoing); "Muscle relax" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism, start date: 1994 (ongoing); VIT. E, start date: 2015 (ongoing); MAGNESIUM taken for muscle relaxant therapy, start date: 1995 (ongoing); IBUPROFEN taken for back pain, start date: 1993 (ongoing); SUMATRIPTAN taken for migraine, start date: 1994 (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, Time: Approx. 12:00 PM, Lot no: 16161, Anatomical location: Left arm, Parent route of administration: intramuscular), administration date: 05Jul2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: RASH PRURITIC (non-serious), MASS (non-serious) all with onset 26Jul2021 12:00, outcome "not recovered" and all described as "itchy rashes and bumps"; ARTHRALGIA (non-serious) with onset 26Jul2021 12:00, outcome "not recovered", described as "recurrent pain in left deltoid and shoulder joint"; PERIPHERAL SWELLING (non-serious) with onset 26Jul2021, outcome "not recovered", described as "swelling in hands". Therapeutic measures were not taken as a result of rash pruritic, mass, arthralgia, peripheral swelling.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. The patient has not been tested for COVID-19, Since the vaccination. No known allergies were reported. Clinical course includes Patient didn't see a doctor and is still breaking out with itchy bumps. She has started a low glycaemic/ anti-inflammatory diet in hope to resolving this.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Migraine, Pyrexia, Rash
Clinical narrative: Bad Migraine; fever get elevated, up and down; Chills; Rash; 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), administration date 23Sep2021 (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 immunization. The following information was reported: PYREXIA (non-serious) with onset 24Sep2021, outcome "unknown", described as "fever get elevated, up and down"; CHILLS (non-serious) with onset 24Sep2021, outcome "unknown", described as "Chills"; RASH (non-serious) with onset 24Sep2021, outcome "unknown", described as "Rash"; MIGRAINE (non-serious), outcome "unknown", described as "Bad Migraine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional Information: Patient said that she received the second dose last Thursday evening but experienced fever, chills and rash this Friday morning so the patient was asking is it normal that her fever goes up and down and also she mentioned that she took something (Further Clarifications Unknown). Patient experienced fever, chills and rash after the second dose and a bad migraine. Patient stated because, she woke up, it was better (voice not clear) but the fever came back and she took something (Further Clarifications Unknown) to gamble that was to bring the chills but the fever get elevated, up and down, up and down. She work with kids and they check you when you go to work she don't want the fever to come and then I have to go home you know, come like she don't want to. Saw a doctor tomorrow said they must have a day to make sure that her work with children because they don't want to work with children, because that it is all about, right.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Herpes simplex, Hypersensitivity, Oral herpes
Clinical narrative: cold sore on her top lip and on top of the pallet; Caller said like herpes simplex; allergic reaction; looks more red and extended out, nothing she now has 3 dots on her for head; 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 55 year-old female patient received bnt162b2 (BNT162B2), administration date 22Sep2021 (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, SINGLE), for COVID-19 Immunization. The following information was reported: ORAL HERPES (non-serious) with onset 25Sep2021, outcome "unknown", described as "cold sore on her top lip and on top of the pallet"; HERPES SIMPLEX (non-serious) with onset 25Sep2021, outcome "unknown", described as "Caller said like herpes simplex"; HYPERSENSITIVITY (non-serious) with onset Sep2021, outcome "unknown", described as "allergic reaction"; ERYTHEMA (non-serious) with onset Sep2021, outcome "not recovered", described as "looks more red and extended out, nothing she now has 3 dots on her for head". Additional information: The patient had the second dose of the Pfizer covid 19 vaccine this past Wednesday, 22Sep2021. Patient stated on Saturday, 3 days after the vaccine, began to have like a cold sore on her top lip and on top of the pallet. Patient said like herpes simplex noting she has never had this. It was bothersome. The patient stated that today it looks more red and extended out, noting she now has 3 dots on her forehead. Patient has had this for 2 to 3 days and asked could this be an allergic reaction to the vaccine. Also asked should she go to the hospital.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up: 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.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling hot, Hyperhidrosis, Illness
Clinical narrative: fever of 101.7; chills; sweating and got really hot; sweating and got really hot; really sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (086396). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic myeloid leukemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 Immunization; Bnt162b2 (Second Dose), for Covid-19 Immunization. PTs spouse reported PT had a terrible reaction from booster shot for COVID -19 vaccine. PT had a fever of 101.7 and would not allow spouse to reach out to his HCP. PT stated his HCP informed him having the chills was normal after booster shot. PT further shared he was okay the first day after the booster shot but then he was sweating and got really hot. PTs spouse stated he got really sick. When was describing lodging resources available through regulatory authority, PTs spouse reported being on Pfizer medication makes PT afraid. PTs spouse further clarified that PT was informed his feces could be harmful if others encountered it, so PT does not like to sleep at other peoples homes for fear of having an accident/bowel movement. Pt further stated he would not want to infect others. PT additionally informed CC he is overwhelmed with paying bills. [no further info provided]. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever of 101.7"; CHILLS (non-serious), outcome "unknown", described as "chills"; HYPERHIDROSIS (non-serious), FEELING HOT (non-serious), outcome "unknown" and all described as "sweating and got really hot"; ILLNESS (non-serious), outcome "unknown", described as "really sick". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever of 101.7; chills; sweating and got really hot; sweating and got really hot; really sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (086396). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic myeloid leukemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 Immunization; Bnt162b2 (Second Dose), for Covid-19 Immunization. PTs spouse reported PT had a terrible reaction from booster shot for COVID -19 vaccine. PT had a fever of 101.7 and would not allow spouse to reach out to his HCP. PT stated his HCP informed him having the chills was normal after booster shot. PT further shared he was okay the first day after the booster shot but then he was sweating and got really hot. PTs spouse stated he got really sick. When was describing lodging resources available through regulatory authority, PTs spouse reported being on Pfizer medication makes PT afraid. PTs spouse further clarified that PT was informed his feces could be harmful if others encountered it, so PT does not like to sleep at other peoples homes for fear of having an accident/bowel movement. Pt further stated he would not want to infect others. PT additionally informed CC he is overwhelmed with paying bills. [no further info provided]. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever of 101.7"; CHILLS (non-serious), outcome "unknown", described as "chills"; HYPERHIDROSIS (non-serious), FEELING HOT (non-serious), outcome "unknown" and all described as "sweating and got really hot"; ILLNESS (non-serious), outcome "unknown", described as "really sick". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Pyrexia, Somnolence, Vaccination site pain
Clinical narrative: Arm pain where the injection site is; Diarrhea; A little feverish; Felt really kind of sleepy /groggy; 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 55 year-old female patient received bnt162b2 (BNT162B2), administration date 30Sep2021 (Batch/Lot number: unknown) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing), notes: she takes thyroid medication. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 immunization; Bnt162b2 (Dose:02), administration date: Apr2021, for COVID-19 immunization, reaction(s): "varicose veins". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Sep2021, outcome "not recovered", described as "Arm pain where the injection site is"; DIARRHOEA (non-serious) with onset 30Sep2021, outcome "not recovered", described as "Diarrhea"; PYREXIA (non-serious) with onset 30Sep2021, outcome "not recovered", described as "A little feverish"; SOMNOLENCE (non-serious) with onset 30Sep2021, outcome "not recovered", described as "Felt really kind of sleepy /groggy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, pyrexia, somnolence.  Additional information: Consumer stated that she had diarrhea / watery stools, sleepy/groggy after the vaccine that she got yesterday afternoon around 3pm, patient was still groggy, still had some diarrhea, her arm hurts. Patients brother (49 years old, male) who's a doctor, he's a MD had some side effects from his second Pfizer vaccine and he had it go on for almost 2 weeks. Patients brother said 10 days or 12 days, he had to take time off from work he's fine now." Caller also mentioned that she noticed after second vaccine, all of a sudden within that same week she  ended up with varicose veins. Patient also stated her mother (84 years old, female) had her Pfizer booster vaccine and had some arm pain, she did feel groggy, but not bad. patient felt it more than she did. Then patients mom's brother (83 years old, male) felt nothing and neither did his wife.   Follow-up (13Oct2021): 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.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness
Clinical narrative: Chest pain; Dizziness; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (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: CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "Chest pain"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills".  Additional information: NDC and UPC number of COVID Vaccine: Unknown. Reason for no lot number: of COVID Vaccine: Other. LOT#: Consumer stated, You said LOT#, where can I find that? Mam, I am having chills right now and I want to know what should I do? I am having chest pain and dizziness? Should I go to emergency room? Consumer stated, I just got the Pfizer two days ago and I am having chest pain and dizziness. Like I wanted to know what should I do? Consumer confirmed the name of the product as Pfizer COVID Vaccine. Consumer was informed about the Medical Information Department for the concern and was provided with the contact# as, option 3 from 8am to 8pm, Monday to Friday as per. Consumer stated, So, I cannot call them now? and hung up the call abruptly. Thus, further probing could not be done. Hence, limited information available over the call. This consumer reported in response to Non-HCP letter sent to consumer via telephonic follow-up activity which included that: Phone-Out 14:17 PM, 1st attempt by phone to consumer to obtain follow-up information contained on consumer questionnaire. Phone answered by consumer who refused to provide information, consumer wishes to not be contacted again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Paraesthesia, Swelling face
Clinical narrative: feels tingling and swollen right face with tightness/ under her right eye, her upper cheek area she felt a tingling and it felt tight; feel some time a tightness in right side of my face around the cheek area and beneath the cheek; feels tingling and swollen right face with tightness; 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 35 year-old female patient received bnt162b2 (BNT162B2), administration date 24Aug2021 (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 24Aug2021, outcome "recovering", described as "feels tingling and swollen right face with tightness/ under her right eye, her upper cheek area she felt a tingling and it felt tight"; SWELLING FACE (non-serious) with onset 2021, outcome "recovered" (2021), described as "feels tingling and swollen right face with tightness"; FEELING ABNORMAL (non-serious) with onset 24Aug2021, outcome "recovering", described as "feel some time a tightness in right side of my face around the cheek area and beneath the cheek".  Additional Information: Reportedly, she received her first dose of Comirnaty on 24Aug2021 and within the first minute of getting the vaccine under her right eye, her upper cheek area she felt a tingling and it felt tight. There was nothing visual with her face that you could see just this feeling she had. It lasted 2 weeks and after the 2 weeks it drifted down to under her cheek bone and now about 4 weeks later it is mostly gone but some days can still feel it under her cheek and her upper jaw.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Fatigue, Pyrexia
Clinical narrative: extreme fatigue; she couldnt get out of bed for days; fever; chills; 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 63 year-old female patient received bnt162b2 (BNT162B2), administration date 17Sep2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "chronic fatigue" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Hepatitis vaccine, reaction(s): "Tiredness", notes: 5 doses of Hep vaccine to get titres at acceptable range/level; Typhoid shot, reaction(s): "sick for 3 months". The following information was reported: PYREXIA (non-serious) with onset 22Sep2021, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset 22Sep2021, outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "recovering", described as "extreme fatigue"; BEDRIDDEN (non-serious), outcome "unknown", described as "she couldnt get out of bed for days".  Additional information: The patient stated that she had a weird body when she gets vaccines. She experienced fever and chills lasting until 5th day after the first shot then extreme fatigue set in and she could not get out of bed for days. Extreme fatigue resolving however she still feels tired. She was given an appointment for 2nd shot 4 weeks later. It should be at 3 weeks. Six years ago however she was on no medications.   Information about lot/batch number cannot be obtained. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pruritus, Rash, Swelling
Clinical narrative: itching/itches; swelling; rashes; Covid arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), administration date 25Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cancer treatment, start date: 2015, stop date: 2015, for Cancer treatment, reaction(s): "Immunotherapy Colitis". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "itching/itches"; SWELLING (non-serious) with onset 2021, outcome "unknown", described as "swelling"; RASH (non-serious) with onset 2021, outcome "unknown", described as "rashes"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Covid arm".  Additional information: He sent a note to his PCP (Primary Care Physician) and is going to see him tomorrow. He was also looking at the CDC (Centers for Disease Control and Prevention) website and they mentioned dealing with problems he experienced, like Covid arm. He thought he would talk to Pfizer because he does not know what he can do and is looking for suggestions. He suspects they might not know all of the side effects, since this is a learning curve. He is looking to see what his options are and what he can do. Caller was advised to consult with his primary care physician for any medical advice and was advised to consult with the Medical Information department for any questions about the vaccine. He states that he does not have questions about the Pfizer vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Nausea
Clinical narrative: had weirdness in his chest; nauseous; 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 male patient 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, SINGLE), for COVID-19 immunization. The following information was reported: CHEST DISCOMFORT (non-serious), outcome "not recovered", described as "had weirdness in his chest"; NAUSEA (non-serious), outcome "not recovered", described as "nauseous". Additional information: after second shot, had a weirdness in his chest. Didn't know, if like the phlegm, the weirdness in his chest had nothing to do with the shot. He had a truck driver come in who stated his sister also had weirdness in her chest after the second shot. This sister did not have phlegm after her first shot. Caller does not know how to describe the weirdness in his chest. Stating it was across the chest and very strange. Wanted to know if the weirdness in his chest has been reported before. Maybe it was just him and this truck driver's sister who are experiencing this. Stated the weirdness in chest goes from left to right. It was just strange.  Follow-up attempts are completed. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101327679 same reporter/product/event, different patient