chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Illness, Lethargy, Pain, Rash
Clinical narrative: burning pain at night; stabbing pain at night/ like a hot poker; rash on left arm; rash across chest; ongoing left arm pain/nonstop left arm pain/24/7 left arm pain/underside of the arm to elbow and around arm pit/left arm soreness; medical issue/side effects (booster dose); sick to stomach; lethargy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (medical issue/side effects (booster dose)), BURNING SENSATION (burning pain at night), PAIN (stabbing pain at night/ like a hot poker), ILLNESS (sick to stomach) and LETHARGY (lethargy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004FHA, 025A21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCITRIOL (ROCALTROL) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced VACCINATION COMPLICATION (medical issue/side effects (booster dose)), ILLNESS (sick to stomach) and LETHARGY (lethargy). On an unknown date, the patient experienced BURNING SENSATION (burning pain at night), PAIN (stabbing pain at night/ like a hot poker), VACCINATION SITE RASH (rash on left arm), RASH (rash across chest) and VACCINATION SITE PAIN (ongoing left arm pain/nonstop left arm pain/24/7 left arm pain/underside of the arm to elbow and around arm pit/left arm soreness). On 07-Nov-2021, ILLNESS (sick to stomach) and LETHARGY (lethargy) had resolved. At the time of the report, VACCINATION COMPLICATION (medical issue/side effects (booster dose)), BURNING SENSATION (burning pain at night), PAIN (stabbing pain at night/ like a hot poker), VACCINATION SITE RASH (rash on left arm) and RASH (rash across chest) outcome was unknown and VACCINATION SITE PAIN (ongoing left arm pain/nonstop left arm pain/24/7 left arm pain/underside of the arm to elbow and around arm pit/left arm soreness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported.   This case was linked to MOD-2021-435238 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain, Vaccination site rash
Clinical narrative: burning pain at night; stabbing pain at night/ like a hot poker; rash on left arm; rash across chest; ongoing left arm pain/nonstop left arm pain/24/7 left arm pain/underside of the arm to elbow and around arm pit/left arm soreness; medical issue/side effects (booster dose); sick to stomach; lethargy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (medical issue/side effects (booster dose)), BURNING SENSATION (burning pain at night), PAIN (stabbing pain at night/ like a hot poker), ILLNESS (sick to stomach) and LETHARGY (lethargy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004FHA, 025A21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCITRIOL (ROCALTROL) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced VACCINATION COMPLICATION (medical issue/side effects (booster dose)), ILLNESS (sick to stomach) and LETHARGY (lethargy). On an unknown date, the patient experienced BURNING SENSATION (burning pain at night), PAIN (stabbing pain at night/ like a hot poker), VACCINATION SITE RASH (rash on left arm), RASH (rash across chest) and VACCINATION SITE PAIN (ongoing left arm pain/nonstop left arm pain/24/7 left arm pain/underside of the arm to elbow and around arm pit/left arm soreness). On 07-Nov-2021, ILLNESS (sick to stomach) and LETHARGY (lethargy) had resolved. At the time of the report, VACCINATION COMPLICATION (medical issue/side effects (booster dose)), BURNING SENSATION (burning pain at night), PAIN (stabbing pain at night/ like a hot poker), VACCINATION SITE RASH (rash on left arm) and RASH (rash across chest) outcome was unknown and VACCINATION SITE PAIN (ongoing left arm pain/nonstop left arm pain/24/7 left arm pain/underside of the arm to elbow and around arm pit/left arm soreness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported.   This case was linked to MOD-2021-435238 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Muscle spasms, Pain
Clinical narrative: Spotting between period; Extended period circle from 3 days to 7 days; Excruciating pain; cramps; This is a spontaneous report from a contactable consumer. The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Apr2021 17:30 (Lot number: EW0162) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious) with onset May2021, outcome "not recovered", described as "Spotting between period"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset May2021, outcome "not recovered", described as "Extended period circle from 3 days to 7 days"; PAIN (non-serious) with onset May2021, outcome "not recovered", described as "Excruciating pain"; MUSCLE SPASMS (non-serious) with onset May2021, outcome "not recovered", described as "cramps". Therapeutic measures were not taken as a result of intermenstrual bleeding, heavy menstrual bleeding, pain, muscle spasms.  Additional Information: Facility where the most recent COVID-19 vaccine was administered reported as Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The other medications the patient received within 2 weeks of vaccination reported as Nil. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: experiencing extremely heavy longer periods (monthly menstruations) with violent painful cramps/It is atrocious; experiencing extremely heavy longer periods (monthly menstruations) with violent painful cramps/It is atrocious; experiencing extremely heavy longer periods (monthly menstruations) with violent painful cramps/It is atrocious; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18May2021 (Lot number: ER8731) at the age of 30 years as dose 1, single and administration date 08Jun2021 14:30 (Lot number: ER8731) as dose 2, single for covid-19 immunisation. Relevant medical history included: "chipotle sauce/flavoring any brand" (unspecified if ongoing); "fever" (unspecified if ongoing). Concomitant medication(s) included: ALEVE taken for pyrexia. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), OLIGOMENORRHOEA (non-serious), DYSMENORRHOEA (non-serious) all with onset 18May2021 14:30, outcome "not recovered" and all described as "experiencing extremely heavy longer periods (monthly menstruations) with violent painful cramps/It is atrocious". Therapeutic measures were not taken as a result of heavy menstrual bleeding, oligomenorrhoea, dysmenorrhoea.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not diagnosed with COVID-19. The patient received other medications within two weeks was Aleve for fever after the vaccination. It was reported that ever since patient had the vaccinations. Patient was experiencing extremely heavy longer periods (monthly menstruations) with violent painful cramps that patient never had prior to the vaccinations. It is atrocious!!! Patient using two boxes 36 count ever since her cycle was that was not normal for her.    No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Mood altered, Premenstrual syndrome
Clinical narrative: For 3 consecutive months after my 2nd shot, I experienced immediate & unusually heavy periods, with painful cramping/excessive bleeding/mood changes/PMS.; For 3 consecutive months after my 2nd shot, I experienced immediate & unusually heavy periods, with painful cramping/excessive bleeding/mood changes/PMS.; For 3 consecutive months after my 2nd shot, I experienced immediate & unusually heavy periods, with painful cramping/excessive bleeding/mood changes/PMS.; For 3 consecutive months after my 2nd shot, I experienced immediate & unusually heavy periods, with painful cramping/excessive bleeding/mood changes/PMS.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Apr2021 (Lot number: EP2533) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Alpha Gal IgE" (unspecified if ongoing). Concomitant medication(s) included: XOLAIR. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number=EN6202,, lot unknown=False,, administration date=05Mar2021,, dose number=1,, vaccine_location=Left arm), administration date: 05Mar2021, when the patient was 45 years old, for Covid-19 Immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious), MOOD ALTERED (non-serious), PREMENSTRUAL SYNDROME (non-serious) all with onset 03Apr2021, outcome "recovered" and all described as "For 3 consecutive months after my 2nd shot, I experienced immediate & unusually heavy periods, with painful cramping/excessive bleeding/mood changes/PMS". Therapeutic measures were not taken as a result of heavy menstrual bleeding, dysmenorrhoea, mood altered, premenstrual syndrome.  Additional Information:  Facility type: Pharmacy or Drug Store. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested COVID post vaccination. The patient did not receive any treatment for the events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: started her menstrual cycle , which was about 5-6 days earlier than normal.; the beginning of her cycle was heavier than normal and she is currently still on her cycle.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 05Aug2021 (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: POLYMENORRHOEA (non-serious) with onset 11Aug2021, outcome "not recovered", described as "started her menstrual cycle, which was about 5-6 days earlier than normal."; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 11Aug2021, outcome "not recovered", described as "the beginning of her cycle was heavier than normal and she is currently still on her cycle.". Additional information: On 11Aug2021, the caller stated that she started her menstrual cycle, which was about 5-6 days earlier than normal. The patient stated that her menstrual cycle has been a very consistent pattern. She also states that the beginning of her cycle was heavier than normal and she was currently still on her cycle. The patient stated that she had heard other women saying that they have had menstrual changes after receiving COVID vaccines as well. Caller asked what information we have regarding menstrual changes after someone receives the Pfizer COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Menstruation irregular, Off label use, Product use issue, Suppressed lactation
Clinical narrative: Off label use; Drug use in unapproved population; Breakthrough period while breastfeeding 4 months postpartum; anxiety; Decreased milk supply 2 weeks; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jun2021 14:00 (Lot number: Ew0187) at the age of 36 years as dose 2, single and administered in arm left, administration date 03Jun2021 12:00 (Lot number: Ew0178) as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "Off label use"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "Drug use in unapproved population"; MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "Breakthrough period while breastfeeding 4 months postpartum"; SUPPRESSED LACTATION (non-serious) with onset 27Jun2021 14:00, outcome "unknown", described as "Decreased milk supply 2 weeks"; ANXIETY (non-serious), outcome "unknown", described as "anxiety". It was unknown if therapeutic measures were taken as a result of off label use, product use issue, menstruation irregular, suppressed lactation, anxiety.  Additional information: Patient never had a period before on 3 other children. Patient Still having anxiety and no more bleeding. 3 days after second vaccine decreased milk supply. Patient did not tested for covid prior and post vaccination and also not had allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101084130 mother-child cases
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Heavy menstrual bleeding, Menstruation delayed, Menstruation irregular, Oligomenorrhoea
Clinical narrative: after getting second COVID vaccine had an early period followed by a late period followed by a missed period followed by an extremely heavy 11-day long period followed by another late heavy period; after getting second COVID vaccine had an early period followed by a late period followed by a missed period followed by an extremely heavy 11-day long period followed by another late heavy period; after getting second COVID vaccine had an early period followed by a late period followed by a missed period followed by an extremely heavy 11-day long period followed by another late heavy period; after getting second COVID vaccine had an early period followed by a late period followed by a missed period followed by an extremely heavy 11-day long period followed by another late heavy period; after getting second COVID vaccine had an early period followed by a late period followed by a missed period followed by an extremely heavy 11-day long period followed by another late heavy period; after getting second COVID vaccine had an early period followed by a late period followed by a missed period followed by an extremely heavy 11-day long period followed by another late heavy period; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Feb2021 09:00 (Lot number: EM9810) at the age of 46 years as dose 2 , single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; LDNIL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3246, administration time: 08:30 AM, vaccine location: Left arm), administration date: 20Jan2021, for Covid-19 Immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious), POLYMENORRHOEA (non-serious), MENSTRUATION DELAYED (non-serious), AMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), OLIGOMENORRHOEA (non-serious) all with onset 06Mar2021 08:00, outcome "not recovered" and all described as "after getting second COVID vaccine had an early period followed by a late period followed by a missed period followed by an extremely heavy 11-day long period followed by another late heavy period". Therapeutic measures were not taken as a result of menstruation irregular, polymenorrhoea, menstruation delayed, amenorrhoea, heavy menstrual bleeding, oligomenorrhoea.  Additional information: Patient's periods were always regular, light, short, and on time before the second COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: after getting second COVID vaccine had an early period followed by a late period followed by a missed period followed by an extremely heavy 11-day long period followed by another late heavy period; after getting second COVID vaccine had an early period followed by a late period followed by a missed period followed by an extremely heavy 11-day long period followed by another late heavy period; after getting second COVID vaccine had an early period followed by a late period followed by a missed period followed by an extremely heavy 11-day long period followed by another late heavy period; after getting second COVID vaccine had an early period followed by a late period followed by a missed period followed by an extremely heavy 11-day long period followed by another late heavy period; after getting second COVID vaccine had an early period followed by a late period followed by a missed period followed by an extremely heavy 11-day long period followed by another late heavy period; after getting second COVID vaccine had an early period followed by a late period followed by a missed period followed by an extremely heavy 11-day long period followed by another late heavy period; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Feb2021 09:00 (Lot number: EM9810) at the age of 46 years as dose 2 , single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; LDNIL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3246, administration time: 08:30 AM, vaccine location: Left arm), administration date: 20Jan2021, for Covid-19 Immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious), POLYMENORRHOEA (non-serious), MENSTRUATION DELAYED (non-serious), AMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), OLIGOMENORRHOEA (non-serious) all with onset 06Mar2021 08:00, outcome "not recovered" and all described as "after getting second COVID vaccine had an early period followed by a late period followed by a missed period followed by an extremely heavy 11-day long period followed by another late heavy period". Therapeutic measures were not taken as a result of menstruation irregular, polymenorrhoea, menstruation delayed, amenorrhoea, heavy menstrual bleeding, oligomenorrhoea.  Additional information: Patient's periods were always regular, light, short, and on time before the second COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dysmenorrhoea, Heavy menstrual bleeding, Menstruation delayed, Migraine
Clinical narrative: after the first vaccine my menstrual cycle was late two weeks; had horrible cramps which never happens/ horrible menstrual cramps; migraines; lower back pain; menstrual cycle changed to heavy flows after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: EP7534) as dose 1,single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 27Mar2021, outcome "unknown", described as "after the first vaccine my menstrual cycle was late two weeks"; DYSMENORRHOEA (non-serious) with onset 27Mar2021, outcome "unknown", described as "had horrible cramps which never happens/ horrible menstrual cramps"; MIGRAINE (non-serious) with onset 27Mar2021, outcome "unknown", described as "migraines"; BACK PAIN (non-serious) with onset 27Mar2021, outcome "unknown", described as "lower back pain"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 27Mar2021, outcome "unknown", described as "menstrual cycle changed to heavy flows after the vaccine". Therapeutic measures were not taken as a result of menstruation delayed, dysmenorrhoea, migraine, back pain, heavy menstrual bleeding.  Additional Information- After the first vaccine my menstrual cycle was late two weeks and had horrible cramps which never happens. Although I was on birth control pill and I always get my period on time. This did not happen. After my second dose, my menstrual cycle was two weeks earlier and same thing as before heavy bleeding, horrible menstrual cramps, lower back pain and migraines. This never happens with me usually its none to mild back aches. But my menstrual cycle changed to heavy flows after the vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Heavy menstrual bleeding, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: Started mental two days after shot and never stopped bleeding. Bruising for no apparent reasonHeadaches; Started mental two days after shot and never stopped bleeding.  Bruising for no apparent reasonHeadaches; Started mental two days after shot and never stopped bleeding.  Bruising for no apparent reasonHeadaches; Started mental two days after shot and never stopped bleeding.  Bruising for no apparent reasonHeadaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jul2021 12:00 (Lot number: ew0196) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUAL DISORDER (non-serious), CONTUSION (non-serious), HEADACHE (non-serious) all with onset 23Jul2021 12:00, outcome "unknown" and all described as "Started mental two days after shot and never stopped bleeding.  Bruising for no apparent reasonHeadaches". The event "started mental two days after shot and never stopped bleeding.  bruising for no apparent reasonheadaches", "started mental two days after shot and never stopped bleeding.  bruising for no apparent reasonheadaches", "started mental two days after shot and never stopped bleeding.  bruising for no apparent reasonheadaches" and "started mental two days after shot and never stopped bleeding.  bruising for no apparent reasonheadaches" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of heavy menstrual bleeding, menstrual disorder, contusion, headache.  Additional information: On 02Sep2021 Follow-up report received from contactable reporter. No other vaccine in four weeks. No other medications in two weeks. No Covid infection prior vaccination. Covid was tested post vaccination. Covid test post vaccination: covid test type post vaccination was Nasal Swab. Covid test date 28Jul2021. Covid test result was Negative.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: Early period, extended period, spotting, unusual intense cramping. Happened to myself and daughter at the same time after vaccine; Early period, extended period, spotting, unusual intense cramping. Happened to myself and daughter at the same time after vaccine; Early period, extended period, spotting, unusual intense cramping. Happened to myself and daughter at the same time after vaccine; Early period, extended period, spotting, unusual intense cramping. Happened to myself and daughter at the same time after vaccine; This is a spontaneous report received from a non-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 02Aug2021 12:00 (Lot number: ewo183) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gastrooesophageal reflux disease" (unspecified if ongoing); "penicillin" (unspecified if ongoing). Concomitant medication(s) included: NEXUS [AMLODIPINE]; VITAMIN D COMPLEX; IRON. The following information was reported: DYSMENORRHOEA (non-serious), MENSTRUATION IRREGULAR (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), INTERMENSTRUAL BLEEDING (non-serious) all with onset 24Aug2021, outcome "unknown" and all described as "Early period, extended period, spotting, unusual intense cramping. Happened to myself and daughter at the same time after vaccine". Therapeutic measures were not taken as a result of dysmenorrhoea, menstruation irregular, heavy menstrual bleeding, intermenstrual bleeding.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient dose not received treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101112243 Same Vaccine/event, different  patient
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Sore Breasts; heavy, painful menstruation; heavy, painful menstruation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 20:00 (Lot number: fe 3183) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing), notes: other medical history: PCOS, Endometriosis; "Endometriosis" (unspecified if ongoing), notes: other medical history: PCOS, Endometriosis; "Latex" (unspecified if ongoing), notes: known allergies: Latex, coconut; "coconut" (unspecified if ongoing), notes: known allergies: Latex, coconut. There were no concomitant medications. The following information was reported: BREAST PAIN (non-serious) with onset 26Aug2021, outcome "unknown", described as "Sore Breasts"; HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious) all with onset 26Aug2021, outcome "unknown" and all described as "heavy, painful menstruation". Therapeutic measures were not taken as a result of breast pain, heavy menstrual bleeding, dysmenorrhoea. No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Allergy test negative, Blood immunoglobulin M increased, C-reactive protein normal, Full blood count normal, Mechanical urticaria
Clinical narrative: Severe itchy hives and rashes, dermatographia
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash, Thyroid function test normal, Urticaria
Clinical narrative: Severe itchy hives and rashes, dermatographia
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: My symptoms started 11 days after the shot. I had non stop hives and red rashes all over my body and not just at the injection site. I have changed nothing in my routine or been exposed to any new food or detergents. I have been able to treat it with over the counter allergy medicine and Pepcid. As soon as the allergy medicine wears off all of the hives come back and continue. The hives are still there during the day, but more itchy at night.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Full body rash that still persists.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: 9 month old is running 102 fever.  Ran fever with first one as well as now after second dose.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pain
Clinical narrative: 12 hours after shoot temp of  102.4. Severe body aches, chill.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives all over my body not responding to antihistamine
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Pain, Pain in extremity
Clinical narrative: Sore arm & sore body with extreme exhaustion for about 24 hours.  He?s fine & back to normal today.   Only a sore armpit continued today.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immediate post-injection reaction, Injection site erythema
Clinical narrative: burning at injection. immediate pain at the injection site soon after the shot.  had headache start day of injection that was controlled with pain reliever.  injection site became red and very tender/ with a knot. The next day Dec 30 2021 in the later afternoon started having worsening headaches that were controlled with alternating pain relievers. Was nauseous,  has chills and fever. The next day Dec 31th 2021 symptoms subsided, still was mildly fatigued and  had mild headache.  But started feeling better.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site nodule, Injection site pain, Nausea, Pyrexia
Clinical narrative: burning at injection. immediate pain at the injection site soon after the shot.  had headache start day of injection that was controlled with pain reliever.  injection site became red and very tender/ with a knot. The next day Dec 30 2021 in the later afternoon started having worsening headaches that were controlled with alternating pain relievers. Was nauseous,  has chills and fever. The next day Dec 31th 2021 symptoms subsided, still was mildly fatigued and  had mild headache.  But started feeling better.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Began hives 12/27 eve escalated thought night, by 10:00am headed to ER (epi injection, Benadryl, Pepcid, steroids) next morning woke up hives again mild, following day flare like first day back to ER added steroids. Managing daily morning flare ups at home w steroids, Benadryl, Allegra, Pepcid?watchful eye for anaphylaxis.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Pyrexia, Skin discolouration
Clinical narrative: 102.2 fever, severe migraine, chills, discoloration to fingers
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Erythema, Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: About 2 weeks post-immunization, I developed severe dermatographia. My skin becomes red and inflamed at the slightest scratch or rub. Even wearing tight clothing triggers a flare. It has impacted my entire body, but is worst on my arms, neck, and back, particularly my left shoulder. These areas develop the largest and longest lasting welts. Additionally, my skin has been persistently itchy. All other environmental factors have been eliminated as possible causes (food, animals, plants, fabrics, skincare products, etc.)
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Condition aggravated, Kidney infection, Laboratory test, Pyrexia
Clinical narrative: I had symptoms of  low level un-diagnosed kidney infection for about a month prior to getting the Covid booster vaccine.   About a day after getting the vaccine, the kidney infection significantly  increased, I started having spots of blood come out of my urine tract, had a fever of 102.6 F for a couple days before my wife convinced me to go the the clinic.   They diagnosed it , gave me antibiotics  and it quickly cleared up.  The booster seems to have triggered the infection to get significantly  worse.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: I had symptoms of  low level un-diagnosed kidney infection for about a month prior to getting the Covid booster vaccine.   About a day after getting the vaccine, the kidney infection significantly  increased, I started having spots of blood come out of my urine tract, had a fever of 102.6 F for a couple days before my wife convinced me to go the the clinic.   They diagnosed it , gave me antibiotics  and it quickly cleared up.  The booster seems to have triggered the infection to get significantly  worse.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: I got very bad eczema after first shot. Then it got worse with second shot and very bad after booster. Still bad months after shots.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Urticaria
Clinical narrative: Hives all over the body and swelling of the lips and eyes
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Acute left ventricular failure, Angiogram cerebral normal, Anticoagulant therapy, Aortic stenosis, Arthritis
Clinical narrative: She had a stroke on April 1st, 2021 while at the Nurse's office, according to my mom & symptoms. She died on April 23rd as a result. Facility does not have a lot of equipment. She had tests done at another facility.   Mom had a stroke on April 1st, 2021. My sister and I recognized it as a stroke on the phone, just talking to my mom. The nurses & medical personnel at the facility did not acknowledge or seem to recognize that she had had a stroke. It took them all the next day to get her transported to the Hospital. The Hospital did say she had a stroke (see 1st page of medical report). We believe the vaccine & shot stroke may be related. The Facility may be trying to cover up something (esp. the stroke).  All day at Nurses office was admitted to hospital at facility later in the day.  They dragged her around all day until she had a stroke while there. Did not transport her until late on April 2nd.  Discharge Diagnosis:  Stroke Acute GI Bleeding Acute diastolic heart failure Aortic stenosis Arthritis, on chronic prednisone HTN DM2 Hyperlipidemia, unspecified Urinary tract infection  Surgical Procedures: ESOPHAGOGASTRODUODENOSCOPY EGD W/ peg tube 04/14/2021 14:21 placement  Hospital Course: Patient is an 83-year-old female with past medical history of prior ischemic stroke and cerebral aneurysm w/p coiling, as well as HTN and DM2, who presented from an outside facility due to new stroke.  The patient began feeling poorly several days prior to her admission to the outside hospital.  She became increasingly short of breath and developed lower extremity swelling.  She was evaluated in the ED and found to have an elevated BNP of 1700.  She was admitted and started on scheduled IV Lasix diuresis.  Around 8:45 PM the evening of transfer to our facility, the patient developed new slurred speech, difficulty swallowing, and left facial droop.  A CT of the head was done, and showed evidence of old stroke and prior aneurysm coiling but no acute abnormality. The case was discussed with MD of neurology and the patient was transferred to another facility for a higher level of care.  On arrival here, an MRI of the brain was done, and showed right frontal and left cerebellar infarcts.  MRA of the head was unremarkable.  2D echocardiogram showed a preserved LVEF of 75-80% without evidence of PFO of clot.  Carotid Doppler showed no significant stenosis.  The patient was evaluated by speech therapy, who recommended strict n.p.o. status due to her high risk of aspiration.  She ultimately required placement of a PEG tube on 04/14/2021.  Her ischemic stroke was otherwise managed with Plavix and a statin.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebellar infarction, Cerebrovascular accident, Computerised tomogram head normal, Dysarthria, Dysphagia
Clinical narrative: She had a stroke on April 1st, 2021 while at the Nurse's office, according to my mom & symptoms. She died on April 23rd as a result. Facility does not have a lot of equipment. She had tests done at another facility.   Mom had a stroke on April 1st, 2021. My sister and I recognized it as a stroke on the phone, just talking to my mom. The nurses & medical personnel at the facility did not acknowledge or seem to recognize that she had had a stroke. It took them all the next day to get her transported to the Hospital. The Hospital did say she had a stroke (see 1st page of medical report). We believe the vaccine & shot stroke may be related. The Facility may be trying to cover up something (esp. the stroke).  All day at Nurses office was admitted to hospital at facility later in the day.  They dragged her around all day until she had a stroke while there. Did not transport her until late on April 2nd.  Discharge Diagnosis:  Stroke Acute GI Bleeding Acute diastolic heart failure Aortic stenosis Arthritis, on chronic prednisone HTN DM2 Hyperlipidemia, unspecified Urinary tract infection  Surgical Procedures: ESOPHAGOGASTRODUODENOSCOPY EGD W/ peg tube 04/14/2021 14:21 placement  Hospital Course: Patient is an 83-year-old female with past medical history of prior ischemic stroke and cerebral aneurysm w/p coiling, as well as HTN and DM2, who presented from an outside facility due to new stroke.  The patient began feeling poorly several days prior to her admission to the outside hospital.  She became increasingly short of breath and developed lower extremity swelling.  She was evaluated in the ED and found to have an elevated BNP of 1700.  She was admitted and started on scheduled IV Lasix diuresis.  Around 8:45 PM the evening of transfer to our facility, the patient developed new slurred speech, difficulty swallowing, and left facial droop.  A CT of the head was done, and showed evidence of old stroke and prior aneurysm coiling but no acute abnormality. The case was discussed with MD of neurology and the patient was transferred to another facility for a higher level of care.  On arrival here, an MRI of the brain was done, and showed right frontal and left cerebellar infarcts.  MRA of the head was unremarkable.  2D echocardiogram showed a preserved LVEF of 75-80% without evidence of PFO of clot.  Carotid Doppler showed no significant stenosis.  The patient was evaluated by speech therapy, who recommended strict n.p.o. status due to her high risk of aspiration.  She ultimately required placement of a PEG tube on 04/14/2021.  Her ischemic stroke was otherwise managed with Plavix and a statin.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram normal, Ejection fraction normal, Facial paralysis, Feeling abnormal
Clinical narrative: She had a stroke on April 1st, 2021 while at the Nurse's office, according to my mom & symptoms. She died on April 23rd as a result. Facility does not have a lot of equipment. She had tests done at another facility.   Mom had a stroke on April 1st, 2021. My sister and I recognized it as a stroke on the phone, just talking to my mom. The nurses & medical personnel at the facility did not acknowledge or seem to recognize that she had had a stroke. It took them all the next day to get her transported to the Hospital. The Hospital did say she had a stroke (see 1st page of medical report). We believe the vaccine & shot stroke may be related. The Facility may be trying to cover up something (esp. the stroke).  All day at Nurses office was admitted to hospital at facility later in the day.  They dragged her around all day until she had a stroke while there. Did not transport her until late on April 2nd.  Discharge Diagnosis:  Stroke Acute GI Bleeding Acute diastolic heart failure Aortic stenosis Arthritis, on chronic prednisone HTN DM2 Hyperlipidemia, unspecified Urinary tract infection  Surgical Procedures: ESOPHAGOGASTRODUODENOSCOPY EGD W/ peg tube 04/14/2021 14:21 placement  Hospital Course: Patient is an 83-year-old female with past medical history of prior ischemic stroke and cerebral aneurysm w/p coiling, as well as HTN and DM2, who presented from an outside facility due to new stroke.  The patient began feeling poorly several days prior to her admission to the outside hospital.  She became increasingly short of breath and developed lower extremity swelling.  She was evaluated in the ED and found to have an elevated BNP of 1700.  She was admitted and started on scheduled IV Lasix diuresis.  Around 8:45 PM the evening of transfer to our facility, the patient developed new slurred speech, difficulty swallowing, and left facial droop.  A CT of the head was done, and showed evidence of old stroke and prior aneurysm coiling but no acute abnormality. The case was discussed with MD of neurology and the patient was transferred to another facility for a higher level of care.  On arrival here, an MRI of the brain was done, and showed right frontal and left cerebellar infarcts.  MRA of the head was unremarkable.  2D echocardiogram showed a preserved LVEF of 75-80% without evidence of PFO of clot.  Carotid Doppler showed no significant stenosis.  The patient was evaluated by speech therapy, who recommended strict n.p.o. status due to her high risk of aspiration.  She ultimately required placement of a PEG tube on 04/14/2021.  Her ischemic stroke was otherwise managed with Plavix and a statin.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal haemorrhage, Gastrostomy, Hyperlipidaemia, Hypertension, Laboratory test
Clinical narrative: She had a stroke on April 1st, 2021 while at the Nurse's office, according to my mom & symptoms. She died on April 23rd as a result. Facility does not have a lot of equipment. She had tests done at another facility.   Mom had a stroke on April 1st, 2021. My sister and I recognized it as a stroke on the phone, just talking to my mom. The nurses & medical personnel at the facility did not acknowledge or seem to recognize that she had had a stroke. It took them all the next day to get her transported to the Hospital. The Hospital did say she had a stroke (see 1st page of medical report). We believe the vaccine & shot stroke may be related. The Facility may be trying to cover up something (esp. the stroke).  All day at Nurses office was admitted to hospital at facility later in the day.  They dragged her around all day until she had a stroke while there. Did not transport her until late on April 2nd.  Discharge Diagnosis:  Stroke Acute GI Bleeding Acute diastolic heart failure Aortic stenosis Arthritis, on chronic prednisone HTN DM2 Hyperlipidemia, unspecified Urinary tract infection  Surgical Procedures: ESOPHAGOGASTRODUODENOSCOPY EGD W/ peg tube 04/14/2021 14:21 placement  Hospital Course: Patient is an 83-year-old female with past medical history of prior ischemic stroke and cerebral aneurysm w/p coiling, as well as HTN and DM2, who presented from an outside facility due to new stroke.  The patient began feeling poorly several days prior to her admission to the outside hospital.  She became increasingly short of breath and developed lower extremity swelling.  She was evaluated in the ED and found to have an elevated BNP of 1700.  She was admitted and started on scheduled IV Lasix diuresis.  Around 8:45 PM the evening of transfer to our facility, the patient developed new slurred speech, difficulty swallowing, and left facial droop.  A CT of the head was done, and showed evidence of old stroke and prior aneurysm coiling but no acute abnormality. The case was discussed with MD of neurology and the patient was transferred to another facility for a higher level of care.  On arrival here, an MRI of the brain was done, and showed right frontal and left cerebellar infarcts.  MRA of the head was unremarkable.  2D echocardiogram showed a preserved LVEF of 75-80% without evidence of PFO of clot.  Carotid Doppler showed no significant stenosis.  The patient was evaluated by speech therapy, who recommended strict n.p.o. status due to her high risk of aspiration.  She ultimately required placement of a PEG tube on 04/14/2021.  Her ischemic stroke was otherwise managed with Plavix and a statin.