chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: In Sep2021 I noticed a small quarter-sized bald patch on the back of my head.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Apr2021 (Lot number: FW0170) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Behavioral health" (unspecified if ongoing), notes: other medical history: Behavioral health; "asthma" (unspecified if ongoing), notes: other medical history: asthma. Concomitant medication(s) included: LAMICTAL; CITALOPRAM. Past drug history included: Augmentin, reaction(s): "Allergy: Augmentin", notes: known allergies: Augmentin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733), administration date: 01Apr2021, when the patient was 28 years old, for Covid-19 Immunization. The following information was reported: ALOPECIA (non-serious) with onset Sep2021, outcome "not recovered", described as "In Sep2021 I noticed a small quarter-sized bald patch on the back of my head.". The event "in sep2021 i noticed a small quarter-sized bald patch on the back of my head." was evaluated at the physician office visit. Therapeutic measures were taken as a result of alopecia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient treated with corticosteroid injections and topical treatments. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort
Clinical narrative: Chest tightness; burning feeling in her chest; like heart burn thing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: CHEST DISCOMFORT (non-serious), outcome "unknown", described as "Chest tightness"; BURNING SENSATION (non-serious), outcome "unknown", described as "burning feeling in her chest; like heart burn thing". Therapeutic measures were taken as a result of chest discomfort, burning sensation.  Additional information: Reporter stated that his wife was vaccinated and like 9 days from now and since last Thursday she had been experiencing chest tightness, and kind of like burning feeling in her chest and so she thought may be it would be like heart burn thing but she was trying to take some heart burn medicines but that had not helped her. Reporter was informed about the role of the Pfizer Drug Safety and Pfizer Medical Information Department.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis atopic, Rash
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). Other case identifier: 2022SA006650. A 60-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient developed a rash (spread all over her body) and atopic dermatitis (after the COVID-19 shot, a flare broke-out on hips, stomach and chest), with outcome of unknown. Therapeutic measures were taken as a result of rash and atopic dermatitis. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: lymph nodes under both my arms are swollen, sore. Hurting bad; lymph nodes under both my arms are swollen, sore. Hurting bad; This is a spontaneous report received from a contactable Consumer for a Pfizer sponsored program (005570). The reporter is the patient.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE),  (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: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "lymph nodes under both my arms are swollen, sore. Hurting bad".  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Sex: U
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. A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had pain/body pain (big problem; 7 months), with outcome of unknown. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I got vaccinated I had bad rash all over my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). 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: RASH (non-serious), outcome "unknown", described as "I got vaccinated I had bad rash all over my body".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoglycaemia, Postural orthostatic tachycardia syndrome, SARS-CoV-2 test
Clinical narrative: right sided weakness; prolonged hypoglycemia; developed POTS (diagnosed by clinician); This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "ehlers danlos" (unspecified if ongoing), notes: Ehlers danlos; "inflammatory bowel disease" (unspecified if ongoing), notes: Inflammatory bowel disease. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Batch lot number unknown.), for Covid-19 immunization, reaction(s): "severe dizziness with 1st dose of vaccine". The following information was reported: ASTHENIA (non-serious), outcome "not recovered", described as "right sided weakness"; HYPOGLYCAEMIA (non-serious), outcome "not recovered", described as "prolonged hypoglycemia"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "not recovered", described as "developed POTS (diagnosed by clinician)". The events "right sided weakness", "prolonged hypoglycemia" and "developed pots (diagnosed by clinician)" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of asthenia, hypoglycaemia, postural orthostatic tachycardia syndrome.  Additional information: The patient had no Covid-19 prior vaccination. The patient has tested covid post vaccination. If the patient had any Known allergies was unknown. It was unknown if the patient had any other vaccine in four weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint effusion, Joint swelling, X-ray
Clinical narrative: pain and swelling of left knee with an effusion; pain and swelling of left knee with an effusion; pain and swelling of left knee with an effusion; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "fibromyalgia" (unspecified if ongoing), notes: A 70 year old female with fibromyalgia received 2 doses of Pfizer COVID vaccine. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization. The following information was reported: JOINT EFFUSION (non-serious), ARTHRALGIA (non-serious), JOINT SWELLING (non-serious), outcome "unknown" and all described as "pain and swelling of left knee with an effusion". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of joint effusion, arthralgia, joint swelling.  Additional information: It was reported that A 70 year old female with fibromyalgia received 2 doses of Pfizer COVID vaccine. 6 months later she received a booster. Within 7-10 days she noted pain and swelling of left knee with an effusion. No change in X-ray findings and no relief with steroid injection after 2 months. What further treatment is indicated and should she ever receive another booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: a little rash and itchiness; a little rash and itchiness; This is a spontaneous report received from contactable reporters (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Lot number: 331308A or 331308H; as reported) at the age of 35 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "Parity 2" (unspecified if ongoing), notes: two daughters (5-year-old and 2-year-old). There were no concomitant medications. The following information was reported: RASH (non-serious), PRURITUS (non-serious) all with onset Jan2022, outcome "recovered" (Jan2022) and all described as "a little rash and itchiness". The event "a little rash and itchiness" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, pruritus. Additional information: The patient stated she was vaccinated with the Pfizer vaccine on 22Dec2021 for her first dose, and the second dose was on 31Jan2022. The patient stated after the first dose, she had a little rash so she was checking with her primary care physician (PCP) and he said it would be okay to move forward with the second one, that was why the second one was a little bit later. The patient stated she was supposed to go for her second dose on 13Jan2022, but the rash started a few days before. The patient felt itchiness also, and it started about a week and a half later. The patient stated that was why she was thinking twice before getting the second one. The patient's doctor gave her a steroid cream. The rash lasted almost 2 weeks. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any additional vaccines on the same date of the Pfizer suspect. There were no relevant tests. There were no adverse events following prior vaccinations.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Headache, Insomnia
Clinical narrative: This is a spontaneous report received from contactable pharmacist, consumer or other non-HCP. A 56-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FD7218, expiration date: Feb 28, 2022), at the age of 56, in left arm, on Jan 19, 2022, single dose, for COVID-19 immunisation. Medical history included migraines (unspecified if ongoing), notes: patient usually suffers from migraines before the vaccine. Concomitant medications not reported. The  patient had gait disturbance (needed a cane to walk for more than 2 weeks), arthralgia (arthritis pain, worse after the vaccine/knee pain), onset 2022, outcome of unknown; headache (bad headache; couldn't fall asleep until 4 am) and insomnia, onset Feb 5, 2022, with outcome of recovered (Feb 5, 2022). No follow-up attempts possible. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Influenza like illness, Neck pain, Pain
Clinical narrative: terrible headache; neck pain; hurt everywhere; freezing all night; Flu like symptoms; i had arm pain with all three shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Dec2021 11:00 (Lot number: 331308A) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "endometriosis", start date: 1969 (unspecified if ongoing); "Hysterectomy", start date: 2001 (unspecified if ongoing); "Gallbladder" (unspecified if ongoing); "Gallbladder removal", start date: Nov2019 (unspecified if ongoing); "menopause" (ongoing); "Hypothyroidism" (ongoing); "muscular pain" (ongoing); "fibromyalgia" (ongoing). Concomitant medication(s) included: ESTRADIOL taken for menopause (ongoing); SYNTHROID taken for hypothyroidism (ongoing); LIOTHYRONINE taken for hypothyroidism (ongoing); CYCLOBENZAPRINE taken for myalgia (ongoing); NAPROXEN taken for fibromyalgia (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Date: 08Mar2021, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: EN6205), administration date: 08Mar2021, when the patient was 63 years old, for Covid-19 immunization, reaction(s): "Itching for 2 months", "arm pain"; Bnt162b2 (Dose: 2nd, Date: 29Mar2021, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: ER8733), administration date: 29Mar2021, when the patient was 63 years old, for Covid-19 immunization, reaction(s): "plantar fasciitis", "foot pain", "arm pain". The following information was reported: HEADACHE (non-serious) with onset 30Dec2021 22:00, outcome "recovered", described as "terrible headache"; NECK PAIN (non-serious) with onset 30Dec2021 22:00, outcome "recovered", described as "neck pain"; PAIN (non-serious) with onset 30Dec2021 22:00, outcome "recovered", described as "hurt everywhere"; FEELING COLD (non-serious) with onset 30Dec2021 22:00, outcome "recovered", described as "freezing all night"; PAIN IN EXTREMITY (non-serious) with onset 30Dec2021, outcome "unknown", described as "i had arm pain with all three shots"; INFLUENZA LIKE ILLNESS (non-serious) with onset 30Dec2021 22:00, outcome "recovered", described as "Flu like symptoms". Therapeutic measures were not taken as a result of headache, neck pain, pain, feeling cold, influenza like illness.  Additional information: Patient had no prior vaccinations within 4 weeks. The night of the booster which patient got around 11AM. Patient got a terrible headache with neck pain. An hour later patient had hurt everywhere and patient was freezing all night. It eased up in the morning and was gone by that night. Patient had arm pain with all three shots but patient wasn't worried about that.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: terrible headache; neck pain; hurt everywhere; freezing all night; Flu like symptoms; i had arm pain with all three shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Dec2021 11:00 (Lot number: 331308A) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "endometriosis", start date: 1969 (unspecified if ongoing); "Hysterectomy", start date: 2001 (unspecified if ongoing); "Gallbladder" (unspecified if ongoing); "Gallbladder removal", start date: Nov2019 (unspecified if ongoing); "menopause" (ongoing); "Hypothyroidism" (ongoing); "muscular pain" (ongoing); "fibromyalgia" (ongoing). Concomitant medication(s) included: ESTRADIOL taken for menopause (ongoing); SYNTHROID taken for hypothyroidism (ongoing); LIOTHYRONINE taken for hypothyroidism (ongoing); CYCLOBENZAPRINE taken for myalgia (ongoing); NAPROXEN taken for fibromyalgia (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Date: 08Mar2021, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: EN6205), administration date: 08Mar2021, when the patient was 63 years old, for Covid-19 immunization, reaction(s): "Itching for 2 months", "arm pain"; Bnt162b2 (Dose: 2nd, Date: 29Mar2021, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: ER8733), administration date: 29Mar2021, when the patient was 63 years old, for Covid-19 immunization, reaction(s): "plantar fasciitis", "foot pain", "arm pain". The following information was reported: HEADACHE (non-serious) with onset 30Dec2021 22:00, outcome "recovered", described as "terrible headache"; NECK PAIN (non-serious) with onset 30Dec2021 22:00, outcome "recovered", described as "neck pain"; PAIN (non-serious) with onset 30Dec2021 22:00, outcome "recovered", described as "hurt everywhere"; FEELING COLD (non-serious) with onset 30Dec2021 22:00, outcome "recovered", described as "freezing all night"; PAIN IN EXTREMITY (non-serious) with onset 30Dec2021, outcome "unknown", described as "i had arm pain with all three shots"; INFLUENZA LIKE ILLNESS (non-serious) with onset 30Dec2021 22:00, outcome "recovered", described as "Flu like symptoms". Therapeutic measures were not taken as a result of headache, neck pain, pain, feeling cold, influenza like illness.  Additional information: Patient had no prior vaccinations within 4 weeks. The night of the booster which patient got around 11AM. Patient got a terrible headache with neck pain. An hour later patient had hurt everywhere and patient was freezing all night. It eased up in the morning and was gone by that night. Patient had arm pain with all three shots but patient wasn't worried about that.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Fatigue; Body aches; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Jan2022 09:37 (Lot number: FJ1620) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), administration date: 29Apr2021, for COVID-19 Immunization; Bnt162b2 (DOSE: 2), administration date: 20May2021, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 05Jan2022, outcome "unknown", described as "fatigue"; PAIN (non-serious) with onset 05Jan2022, outcome "unknown", described as "body aches". Therapeutic measures were not taken as a result of fatigue, pain.  Additional Information: The patient provided information to regarding the reported adverse events with the use of the product to the physician when she presented to the office for her daughter's routine visit. Possible normal expected side effect is from expired vaccine. The Pfizer product had a causal effect to the adverse event. The patient was not willing to be contacted again by Pfizer on the reported adverse event. The patient had no prior Vaccinations within 4 weeks. The vaccines reconstituted and stored in syringe on 31Dec2021. The nurse did not read label on syringe that showed the date and administered the dose on 04Jan2022. She said she did not recall a label on it and thought it was just drawn up. The nurse did not see expiry date and has been reminded to never administer a vaccine without a label. The patient's mother both experienced fever, fatigue and body aches that they did not experience with previous doses both recovered without a need to seen medical attention.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Inflammation, Limb discomfort, Pain
Clinical narrative: pain; inflammation; In her right leg, she now has constant pain; she felt something "different", a sensation throughout her body./she didn't feel comfortable walking in market; she is sick; foot kept slipping off of it; swelling; 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 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Pain" (unspecified if ongoing), notes: pain over the past 35 years. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization complete , MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), outcome "not recovered", described as "pain"; INFLAMMATION (non-serious), outcome "not recovered", described as "inflammation"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "In her right leg, she now has constant pain"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she felt something "different", a sensation throughout her body./she didn't feel comfortable walking in market"; ILLNESS (non-serious), outcome "unknown", described as "she is sick"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "foot kept slipping off of it"; SWELLING (non-serious), outcome "not recovered", described as "swelling".  Additional information: Patient would like to know if her symptoms can be correlated with the booster dose, and mentions that she had no significant side effects from the primary series, and that she had never experienced pain like this before the booster. Patient mentions that condition (RA and OA) has changed steadily in terms of mobility and pain over the past 35 years. Patient is still having issues with the accelerator and now the brakes. Patient reports that she functioned reasonably well until that point, and noticed an immediate difference in her right foot. Prior to the booster, no issues with her left lower extremity, but now has inflammation on the left side and is having issues. The swelling does not subside with elevation like it used to, and has pain when she reclines. 1st attempt by phone to non-HCP to obtain mailing information. Phone answered by the patient who provided mailing address.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: pain; inflammation; In her right leg, she now has constant pain; she felt something "different", a sensation throughout her body./she didn't feel comfortable walking in market; she is sick; foot kept slipping off of it; swelling; 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 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Pain" (unspecified if ongoing), notes: pain over the past 35 years. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization complete , MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), outcome "not recovered", described as "pain"; INFLAMMATION (non-serious), outcome "not recovered", described as "inflammation"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "In her right leg, she now has constant pain"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she felt something "different", a sensation throughout her body./she didn't feel comfortable walking in market"; ILLNESS (non-serious), outcome "unknown", described as "she is sick"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "foot kept slipping off of it"; SWELLING (non-serious), outcome "not recovered", described as "swelling".  Additional information: Patient would like to know if her symptoms can be correlated with the booster dose, and mentions that she had no significant side effects from the primary series, and that she had never experienced pain like this before the booster. Patient mentions that condition (RA and OA) has changed steadily in terms of mobility and pain over the past 35 years. Patient is still having issues with the accelerator and now the brakes. Patient reports that she functioned reasonably well until that point, and noticed an immediate difference in her right foot. Prior to the booster, no issues with her left lower extremity, but now has inflammation on the left side and is having issues. The swelling does not subside with elevation like it used to, and has pain when she reclines. 1st attempt by phone to non-HCP to obtain mailing information. Phone answered by the patient who provided mailing address.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: psoriasis covered entire scalp, lower back, 30% of face,  elbows and hands and patches on legs. / psoriasis appeared inside nose and ears. Partially covered eyelids; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Sep2021 (Lot number: FD0809) at the age of 61 years as dose 3 (booster), single and administered in arm right, administration date 01May2021 (Lot number: EW0179) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Had Plaque Psoriasis For 40 Years" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTIN; AMLODIPINE; LEVOTHYROXINE. Past drug history included: Losartin, reaction(s): "Known allergies: losartin"; Benazepril, reaction(s): "Known allergies: benezepril". Vaccination history included: Bnt162b2 (Prev Dose Product: COVID 19,, Prev Dose Brand: Pfizer,, Prev Dose Brand Unknown: False,, Prev Dose Lot Number: EW0162,, Prev Dose Lot Unknown: False,, Prev Dose Administration Date: 10Apr2021,,  Prev Dose Dose Number: 1,, Prev Dose Vaccine Location: Left Arm), administration date: 10Apr2021, when the patient was 60 years old, for COVID-19 Immunization. The following information was reported: PSORIASIS (non-serious) with onset 04May2021, outcome "recovering", described as "psoriasis covered entire scalp, lower back, 30% of face,  elbows and hands and patches on legs. / psoriasis appeared inside nose and ears. Partially covered eyelids". The event "psoriasis covered entire scalp, lower back, 30% of face,  elbows and hands and patches on legs. / psoriasis appeared inside nose and ears. partially covered eyelids" was evaluated at the physician office visit. Therapeutic measures were taken as a result of psoriasis.  Additional information: Facility Type Vaccine was Doctor's Office/Urgent Care. No other vaccine in four weeks. Other Medications In Two Weeks was Rosuvastin, Amlodipine, Levothyroxine, Hydrochlori. She had plaque psoriasis for 40 years. Never had it anywhere else but back of scalp. After 2nd pfizer does, 3 days later psoriasis covered entire scalp,lower back, 30% of face, elbows and hands and patches on legs. After boosters (3rd) dose, psoriasis appeared inside nose and ears. Partially covered eyelids. Still not resolved as of 09mar after being on tremfya for 6 months. Currently on skirizi and cyclosporin. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment received for AE which included laser, estilar, tremfy, skyrizi and cyclosporine . No covid prior vaccination. Not tested for covid for post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: he felt hurt, with pain; fever; 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 56 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (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: PAIN (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "he felt hurt, with pain"; PYREXIA (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "fever". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Fatigue, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: After taking the vaccine my periods are way more heavy, way more painful, and super irregular; After taking the vaccine my periods are way more heavy, way more painful, and super irregular; After taking the vaccine my periods are way more heavy, way more painful, and super irregular; dealing with extreme fatigue the week before my cycle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14May2021 (Lot number: EW0168) at the age of 42 years as dose 1, single and administered in arm left, administration date 04Jun2021 (Lot number: EW0168) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious), MENSTRUATION IRREGULAR (non-serious) all with onset 21May2021, outcome "unknown" and all described as "After taking the vaccine my periods are way more heavy, way more painful, and super irregular"; FATIGUE (non-serious) with onset 21May2021, outcome "unknown", described as "dealing with extreme fatigue the week before my cycle". Therapeutic measures were not taken as a result of heavy menstrual bleeding, dysmenorrhoea, menstruation irregular, fatigue.  Additional information: No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Patient had been taking levothyroxine for hypothyroidism for almost 3 years now. In her 43 years of life she would had rather suffered through COVID then to deal with this monthly. And it's not getting any better.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Migraine
Clinical narrative: Migraine; Illness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "Migraine"; ILLNESS (non-serious), outcome "unknown", described as "Illness".  Customer Verbatim: I did two shots of your vaccine and right now I am with migraine. It is not possible to live with this illness.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 42-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 42, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), at the age of 42, for COVID-19 immunization. The patient had tinnitus, with outcome of not recovered and anxiety, with outcome of unknown. After the second dose the patient had a lot of tinnitus, which caused him a lot of anxiety. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: U
Vaccine: PNC20, PNC, PPV
Symptoms: Injection site pain
Clinical narrative: felt that Prevnar 20 was more painful than receiving Pneumovax; This is a spontaneous report received from contactable Pharmacist from a sales representative. The reporter is the patient.  A patient of unspecified age and gender received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as single. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "felt that Prevnar 20 was more painful than receiving Pneumovax".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC20, PNC, PPV
Symptoms: Pain
Clinical narrative: felt that Prevnar 20 was more painful than receiving Pneumovax; This is a spontaneous report received from contactable Pharmacist from a sales representative. The reporter is the patient.  A patient of unspecified age and gender received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as single. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "felt that Prevnar 20 was more painful than receiving Pneumovax".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "breast cancer" (unspecified if ongoing), notes: :decreasing chemotherapy for breast cancer patients after pre-surgery chemo and targeted therapy. Concomitant medication(s) included: ARIMIDEX; CYTOXAN; TAXOTERE. Vaccination history included: Bnt162b2 (Dose: 1st), for COVID-19 immunization; Bnt162b2 (Dose: 2nd), for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "recovered" (2022), described as "Rash".  Additional information: Patent's past medical history included:; decreasing chemotherapy for breast cancer patients after pre-surgery chemo and targeted therapy. On Mar2021, patient started therapy with Adriamycin for Breast cancer Her2+, We have no further information  regarding the reported  event(s) described above Any additional material information  received will be forwarded to you in accordance with policies and procedures.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Influenza, Lethargy, Liver disorder
Clinical narrative: flu; stomach issues due to changes in my liver bile; stomach issues due to changes in my liver bile; lethargy; low-grade fever; a headache every day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 28Dec2021 (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. Vaccination history included: Bnt162b2 (Dose 1), administration date: Apr2021, for Covid-19 Immunization; Bnt162b2 (Dose 2), administration date: May2021, for Covid-19 Immunization. The following information was reported: INFLUENZA (non-serious) with onset Jan2022, outcome "unknown", described as "flu"; ABDOMINAL DISCOMFORT (non-serious), LIVER DISORDER (non-serious) all with onset Jan2022, outcome "unknown" and all described as "stomach issues due to changes in my liver bile"; LETHARGY (non-serious) with onset Jan2022, outcome "unknown", described as "lethargy"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "low-grade fever"; HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "a headache every day".  Additional information: Patient took the first two Pfizer shots in Apr2021/May2021 without incident. After Booster (3rd shot) on 28Dec. 3 days later, had the flu, a headache every day, low-grade fever, lethargy, plus stomach issues due to changes in liver bile. Patient lost the entire month of Jan to this shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: flu; stomach issues due to changes in my liver bile; stomach issues due to changes in my liver bile; lethargy; low-grade fever; a headache every day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 28Dec2021 (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. Vaccination history included: Bnt162b2 (Dose 1), administration date: Apr2021, for Covid-19 Immunization; Bnt162b2 (Dose 2), administration date: May2021, for Covid-19 Immunization. The following information was reported: INFLUENZA (non-serious) with onset Jan2022, outcome "unknown", described as "flu"; ABDOMINAL DISCOMFORT (non-serious), LIVER DISORDER (non-serious) all with onset Jan2022, outcome "unknown" and all described as "stomach issues due to changes in my liver bile"; LETHARGY (non-serious) with onset Jan2022, outcome "unknown", described as "lethargy"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "low-grade fever"; HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "a headache every day".  Additional information: Patient took the first two Pfizer shots in Apr2021/May2021 without incident. After Booster (3rd shot) on 28Dec. 3 days later, had the flu, a headache every day, low-grade fever, lethargy, plus stomach issues due to changes in liver bile. Patient lost the entire month of Jan to this shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: left overnight at room temperature; administered; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  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: PRODUCT STORAGE ERROR (non-serious), outcome "unknown", described as "left overnight at room temperature"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "administered". Additional information: Additional information: Reporter details confirmed with the patient. The patient confirms he is calling about the Pfizer Covid 19 vaccine, gray cap vial and Pfizer Covid 19 vaccine, pediatric vial. The patient stated the vaccines were left out at room temperature overnight, and administered to two patients the next day. The patient clarifies that one patient received one dose of the Covid 19 vaccine, gray cap, and another patient received one dose of the Covid 19 vaccine, pediatric, for a total of two patients. The patient asks if the patients need to be revaccinated and for any information that can be provided for this situation. The patient declines to complete a full report, as he has been on hold for 35 minutes and is presently driving in the car. The patient stated to his knowledge, there have been no issues with the patients.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200419219 same reporter/drug/event, different patients.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Dates for First Dose: Achy Arm/Second Dose: Achy Arm; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 60 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Mar2021 (Lot number: ER8730) at the age of 59 years as dose 1, single and administration date 20Apr2021 (Lot number: EP7533) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Mar2021, outcome "unknown", described as "Dates for First Dose: Achy Arm/Second Dose: Achy Arm". Therapeutic measures were taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200416195 similar report from same reporter
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Neuropathic pruritus
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An elderly male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Feb2021 13:00 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Enlarged Aorta" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin; "Minor itching" (unspecified if ongoing), notes: Minor itching on back was present prior to COVID vaccination. Concomitant medication(s) included: AMLODIPINE. Vaccination history included: Bnt162b2 (1st dose, vaccination time: 01:00 p.m. vaccine location: left arm), administration date: 02Feb2021, for Covid-19 immunization. The following information was reported: NEUROPATHIC PRURITUS (medically significant) with onset Feb2021, outcome "not recovered", described as "Severe neuropathic itching (back, forearms, shins)"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "not recovered", described as "About one month after the vaccination the itching increased in intensity and to other parts of my body". The events "severe neuropathic itching (back, forearms, shins)" and "about one month after the vaccination the itching increased in intensity and to other parts of my body" were evaluated at the physician office visit. Therapeutic measures were taken as a result of neuropathic pruritus, condition aggravated (Gabapentin). The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 (Lot number: FL3198) at the age of 49 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Relapsing Remitting Multiple Sclerosis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Droperidol, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171, Location of injection: Arm Left), administration date: 30Apr2021, when the patient was 48 years old, for COVID-19 immunization, reaction(s): "I developed Tinnitus after the first two doses"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Left), administration date: 08Apr2021, when the patient was 48 years old, for Covid-19 Immunization, reaction(s): "I developed Tinnitus after the first two doses". The following information was reported: TINNITUS (disability), CONDITION AGGRAVATED (disability), outcome "not recovered" and all described as "The tinnitus worsened after the 3rd dose". The event "the tinnitus worsened after the 3rd dose" and "the tinnitus worsened after the 3rd dose" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus, condition aggravated (course of high dose steroids).
Sex: F
Vaccine: COVID19
Symptoms: Anxiety disorder
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced anxiety disorder, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.