chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from nurse referring that "lots of patients" had developed shingles after vaccination with ZOSTAVAX (lot # and expiration date not reported) but no specific patient information was available. At the time of the report, the patients outcome was unknown. Additional information has been requested.
5/15: Two days after vaccine: feelings of paranoia, unable to complete work, up all night, had to miss two days work.  6/18: Feelings of numbness on right side (hand, foot) while going through security at Airport. Weakness in right leg.  6/23: Went to urgent care facility. Was told it sounded like a stroke, sent to hospital for treatment. After imaging at hospital patient was told he had a minor stroke.
improperly stored vaccine administration; This spontaneous report was received from an unspecified reporter referring to a currently 1-year-old patient of an unknown gender. Information regarding the patient's pertinent medical history, concomitant medication and drug reactions/allergies was not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (lot # S038702, expiration date 01-DEC-2021; strength, vaccination scheme, route and anatomical location not reported) for prophylaxis.   The vaccine administered experienced a temperature excursion of -9.5 degrees Celsius (C) for 8 hours and 53 minutes; and -10.1C for 6 hours and 40 minutes, as recorded by a data logger. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA008353: US-009507513-2009USA008397: US-009507513-2009USA008398: US-009507513-2009USA008449: US-009507513-2009USA008475: US-009507513-2009USA008486: US-009507513-2009USA008520: US-009507513-2009USA008533: US-009507513-2009USA008553: US-009507513-2009USA008555: US-009507513-2009USA008557: US-009507513-2009USA008746: US-009507513-2009USA008761: US-009507513-2009USA008804: US-009507513-2009USA008870:
Patient had previously received MRNa Moderna Vaccine and experienced allergic reaction of hives, after discussing revaccination with primary MD, patient was advised by MD to received Janseen,  Patient received Janssen vaccine as recommended by MD and mixed prior to completing primary dose vaccine.
His covid tested was positive; Fever; Chills; Headache; Body aches; A cough; Feeling really sick; This is a spontaneous report from a contactable pharmacist (parent) via medical information team. A 20-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 15May2021 (age at vaccination 20-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 17May2021, patient had fever, chills, headache, body aches and a cough. patient had fever and chills for I believe she said about 5 days. So she took him to the doctor and he ended up being positive for COVID. He was also "feeling really sick on 17May2021 but hesitated to get tested" for Covid-19, for fear of "being hospitalized. The son had the side effects for 6 days and "got tested for Covid on Thursday, 20May2021, his covid tested was positive." patient has completed his isolation period at home and has "been fine for 4 days." "Because he was Covid -19 positive, how long should he wait for his 2nd dose?" The outcome of events was unknown.  Information about lot/batch number has been requested
This spontaneous report as received from the mother of a consumer refers to a 15 year old male patient. The patient did not have a pertinent medical history or drug reactions/allergies. On an unknown dates the patient was vaccinated with the complete series of GARDASIL (intramuscular injection). There were no concomitant medications. After receiving the complete series the patient began experiencing fatigue and was sleeping longer than usual. The patient's breasts were "about a C cup in size, which is too large for a boy". The outcome was reported as not recovered. No treatment for the events was given. No lab diagnostics were performed. The patient did not seek medical attention. Additional information has been requested.
her muscles and joints hurt like hell/Muscles and joints hurt; her muscles and joints hurt like hell/ Muscles and joints hurt; head pounding, later confirmed as headache/Heading pounding, headache; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received second dose of bnt162b2 (PFIZER-BIOINTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EN6205) via unknown route of administration on 16Mar2021 (at the age of 75 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included arthritis (from unknown date and ongoing), pain, anxiety and depression (from unknown date and unknown if ongoing). The concomitant medication included clonazepam (KLONOPIN) 1 mg at night once a day and fluoxetine hydrochloride (PROZAC) 20 mg at night once a day with ongoing for anxiety and depression and ongoing diclofenac (VOLTAREN) apply on legs and bottom of feet for pain. The patient historical vaccine included first dose of bnt162b2 PFIZER-BIOINTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EN6205, Expiration Date: 30Jun2021) via unknown route of administration in Left top of shoulder on 23Feb2021 (at the age of 75 years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient received B12 shots every month prior Vaccinations within 4 weeks. No additional vaccines administered on same date of the Pfizer vaccine. She got her second dose yesterday (16Mar2021) and on 17Mar2021, this morning she woke up with her head pounding, later confirmed as headache, and her muscles and joints hurt like hell. The patient did not visit emergency room and physician office due to the events. At the time of this report the outcome of the event was not recovered.  No follow-up attempts were possible. No further information was expected.
Local pain (Injection site pain, injecton site pain)(Pain inject site) - recovered/resolved Local swelling (Injection site inflammation, injection site inflammation)(Inflam inject site) - recovered/resolved Local redness (Injection site reaction, injection site reaction)(Inject site react) - recovered/resolved A report was received from a health professional on 05 November 2003, concerning 44 vaccinees who all experienced local reactions at the injection site a day after receiving Fluvirin on 03 November 2003. On 04 November 2003, the vaccinees experienced local reactions at the injection site. No other information was available. There was insufficient information to determine the reporter's causality assessment. Update 1, 20 January 2004. A follow-up report was received from a health care professional concerning 20 to 30 vaccinees who developed local pain, local swelling and local redness after they received Fluvirin. The reporter indicated that all symtoms had resolved within 48 hours and there are no ongoing complaints.
A lump in her lower left arm; This spontaneous case was reported by a consumer and describes the occurrence of MASS (A lump in her lower left arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy bilateral. Concurrent medical conditions included Blood pressure high. Concomitant products included ANASTROZOLE and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S) for Lupus erythematosus.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced MASS (A lump in her lower left arm). At the time of the report, MASS (A lump in her lower left arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
fatigue; headache; injection site soreness; This is a spontaneous report from a contactable other health care professional. A 36-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0140), via an unspecified route of administration on 12Jan2021 16:00 at SINGLE DOSE at left arm for COVID-19 immunization.  Medical history included Idiopathic intracranial hypertension. On 12Jan2021 20:00, the patient experienced Fatigue, Headache, Injection site soreness. The patient did not receive treatment for the events. The outcome of the events was recovering.
Pt with PMH schizophrenia and homelessness. Pt showed up at paper only mobile mass vax site. He had reported to staff he had no prior immunization for Covid-19?. Pt received dose 1 on 7/31/21. No ADRs were described during this immunization. Following manual entry of immunization into patients chart, it was discovered patient had previously received Pfizer on 3/1/21 (lot# EN6198; right arm) and 6/3/2021 (Lot#EW0173; left arm).
swollen arm; red and itchy arm; Injection site pruritus; Injection site swelling; injectio site redness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), RASH (red and itchy arm), INJECTION SITE PRURITUS (Injection site pruritus), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (injectio site redness) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 001M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), RASH (red and itchy arm), INJECTION SITE PRURITUS (Injection site pruritus), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (injectio site redness). At the time of the report, PERIPHERAL SWELLING (swollen arm), RASH (red and itchy arm), INJECTION SITE PRURITUS (Injection site pruritus), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (injectio site redness) outcome was unknown.            No concomitant and treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR uploaded requested call back number updated
On the 2nd day I was extremely fatigued. The following day I started with a headache and cough.  On that Sunday had an extremely bad headache with chills. On Monday was having  trouble breathing and Tuesday had to sign in at the emergency and they diagnosed me with Covid Vaccine Reaction
Barely even sore injection site after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Barely even sore injection site after first shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included Stomach function disorder (little stomach issue) and Irritable bowel syndrome (about 20 years ago. Has not had IBS since 20 years ago.).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Barely even sore injection site after first shot). On 09-Apr-2021, VACCINATION SITE PAIN (Barely even sore injection site after first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2022-452386, MOD-2022-452389 (Patient Link).
experienced big, hot, red, itchy at the injected area; experienced big, hot, red, itchy at the injected area; experienced big, hot, red, itchy at the injected area; experienced big, hot, red, itchy at the injected area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (experienced big, hot, red, itchy at the injected area), VACCINATION SITE PRURITUS (experienced big, hot, red, itchy at the injected area), VACCINATION SITE ERYTHEMA (experienced big, hot, red, itchy at the injected area) and VACCINATION SITE SWELLING (experienced big, hot, red, itchy at the injected area) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concomitant products included HYDROCORTISONE for Itching, CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) for Symptomatic treatment.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE WARMTH (experienced big, hot, red, itchy at the injected area), VACCINATION SITE PRURITUS (experienced big, hot, red, itchy at the injected area), VACCINATION SITE ERYTHEMA (experienced big, hot, red, itchy at the injected area) and VACCINATION SITE SWELLING (experienced big, hot, red, itchy at the injected area). At the time of the report, VACCINATION SITE WARMTH (experienced big, hot, red, itchy at the injected area), VACCINATION SITE PRURITUS (experienced big, hot, red, itchy at the injected area), VACCINATION SITE ERYTHEMA (experienced big, hot, red, itchy at the injected area) and VACCINATION SITE SWELLING (experienced big, hot, red, itchy at the injected area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
I am a nurse practitioner and received the vaccine at the office where I practice, which is also my primary care physician.  I have had flu vaccines yearly since childhood but I have never had any reaction.  In less than 12 hours after the vaccine, I developed SEVERE and UNRELENTING total-body muscle and joint aches that did not improve with NSAID or narcotic medication.  I had a severe headache, profound fatigue, fever up to 101, sweats, chills, sore thoat, cough, and nasal congestion.   I was sick for over 8 days, spent 6 days fully confined to bed, and missed 2 days of work.  I had not been sick prior to the vaccine.  I treated myself with NSAIDs, fluids, rest, and antibiotics, but nothing improved my situation except time.
Pt received Tdap & varicella on 7/11/11. Mom reported that pt began having swelling in LUA on date of injections, pt came to clinic on 7/13/11. Had 5cm red, raised lump in LUA at site of varicella injection. Advised to apply ice & OTC cortisone.
Aneurysm; Swelling face; Swelling of legs; Weight gain; Feels bad/ Felt Horrible; Shaking; Cold sweat; Gagging; Dehydration; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Dehydration), FEELING ABNORMAL (Feels bad/ Felt Horrible), SWELLING FACE (Swelling face), PERIPHERAL SWELLING (Swelling of legs) and WEIGHT INCREASED (Weight gain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   In 2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced DEHYDRATION (Dehydration). On 21-Nov-2021, the patient experienced FEELING ABNORMAL (Feels bad/ Felt Horrible), TREMOR (Shaking), COLD SWEAT (Cold sweat) and RETCHING (Gagging). On 22-Nov-2021, the patient experienced SWELLING FACE (Swelling face), PERIPHERAL SWELLING (Swelling of legs) and WEIGHT INCREASED (Weight gain). On an unknown date, the patient experienced ANEURYSM (Aneurysm). At the time of the report, DEHYDRATION (Dehydration) and ANEURYSM (Aneurysm) outcome was unknown and FEELING ABNORMAL (Feels bad/ Felt Horrible), SWELLING FACE (Swelling face), PERIPHERAL SWELLING (Swelling of legs), WEIGHT INCREASED (Weight gain), TREMOR (Shaking), COLD SWEAT (Cold sweat) and RETCHING (Gagging) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2021, Weight: 3 3 pounds.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was provided.  The reporter's causality for the event(s) of POSSIBLE REACTION TO COVID VACCINE/SHAKING/COLD SWEATS/GAGGING/FELT HORRIBLE onset 21 Nov 2021, FACE SWOLLEN, LEG SWOLLEN, WEIGHT GAIN, POSSIBLE REACTION TO COVID VACCINE/SHAKING/COLD SWEATS/GAGGING/FELT HORRIBLE onset 21 Nov 2021, POSSIBLE REACTION TO COVID VACCINE/SHAKING/COLD SWEATS/GAGGING/FELT HORRIBLE onset 21 Nov 2021 and POSSIBLE REACTION TO COVID VACCINE/SHAKING/COLD SWEATS/GAGGING/FELT HORRIBLE onset 21 Nov 2021 with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of POSSIBLE DEHYDRATION and SPENIC ANEURYSM was not provided.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Migraine headache, fever, chills, shooting pains down left side of body, cramps, dizziness, extreme fatigue, loss of appetite, nausea.  Longer term experienced abdominal pain near stomach/spleen and nerve pain in back and right upper thigh.  Also experienced vertigo and tinnitus for several months after the shot.
Information has been received from a registered nurse concerning a 9 year old female patient with no pertinent medical history, who on 09-JAN-2001, was vaccinated with a dose of VARIVAX (Merck) (lot # 635605/1151K) 0.5 ml subcutaneously.  The nurse reported that in approximately May 2009, the patient had a negative varicella titer.  The patient sought medical attention at the office.  This is one of two reports received from the same source.  Additional information has been requested.
By 12Noon: site of inoculation swollen, red,hot By 8PM: Flu like symptoms Persistent headache, Fever (highest temp, 102.8.   102.2 was the most consistent temperature till 1:00AM, 7/12  Fever broke at that time), deep muscle and joint aches/pains from head to toe, chills, sweats, nausea, vomiting, extreme drowsiness--had to fight to stay awake.
extreme ocular adverse event, with severe diminution in visual acuity in his right eye.; Vision was dimmer; visual field is extremely distorted; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Jan2022 13:30 (Lot number: FJ6369) at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history or known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: bnt162b2 (Dose Number: 2, Batch/Lot No: EW0173, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 10May2021, when the patient was 31 years old, for COVID-19 immunization; bnt162b2 (Dose Number: 1, Batch/Lot No: EW0169, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 19Apr2021, when the patient was 31 years old, for COVID-19 immunization. The day following the 3rd dose on 20Jan2022 at 08:00, the patient woke up suffering from an extreme ocular adverse event, with severe diminution in visual acuity in his right eye. Vision was dimmer, and visual field was extremely distorted. The events "extreme ocular adverse event, with severe diminution in visual acuity in his right eye.", "vision was dimmer" and "visual field is extremely distorted" were evaluated at the physician office visit and serious for being disabling. Therapeutic measures were not taken as a result of visual acuity reduced, visual impairment, visual field defect. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not resolved.
dry throat; numbness in her face; needles in her face; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (dry throat), HYPOAESTHESIA (numbness in her face) and PARAESTHESIA (needles in her face) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced DRY THROAT (dry throat), HYPOAESTHESIA (numbness in her face) and PARAESTHESIA (needles in her face). At the time of the report, DRY THROAT (dry throat), HYPOAESTHESIA (numbness in her face) and PARAESTHESIA (needles in her face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI
administered with the vaccine which has been stored in the refrigerator for more than 30 days; administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 19-Jul-2021, the patient experienced PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days). At the time of the report, PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     Reporter did not allow further contact
My heart started racing and then I went into a fib until Sunday February 7. No other reactions.
pt recv vax; echocardiogram revealed dilated cardiomyopathy 15feb96;