chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician for the Pregnancy registry for GARDASIL, concerning a 26 year old female patient with a history of first trimester miscarriage in 2006 who on 25-JAN-2007 was vaccinated IM with a first dose of HPV. The physician reported that on 27-MAR-2007 the patient was vaccinated with second dose of HPV and had a positive pregnancy test the next day. The patient presented to the physician's office on 09-APR-2007 with vaginal bleeding and a pelvic ultrasound determined that she was suffering a spontaneous abortion. She was at 6 weeks gestation. The patient was admitted to the hospital on the night of 09-APR-2007 with severe vaginal hemorrhaging and  underwent an emergency dilation and curettage procedure. The patient was recovering without complication. The physician added that, on 27-MAR-2007, the patient was diagnosed with bacterial vaginosis but she did not take the prescribed treatment. The physician considered spontaneous abortion to be significantly disabling and life threatening. Additional information has been requested.
COVID-19 Treatment; COVID-19 Treatment; 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), on 26Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 16Apr2021 as dose 2, single (Lot number: ER8729), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic rhinitis" (unspecified if ongoing) ; "fibromyalgia" (unspecified if ongoing); "lyme" (unspecified if ongoing); "Sulfas" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE, start date: 15Jul2021; METHENAMINE, start date: 01Apr2021. Past drug history included: Metronidazole, reaction(s): "known allergies: metronidazole". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive, notes: I have yet to test negative since my diagnosis on 16May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.
1/5 vaccination later that evening; shakiness, heart palpitations, chills. Lasted for approximately an hour and then subsided.
Pt currently has Covid 19 Vaccine #1 given 02/25/2021 Moderna Lot # n/a
Headache, Myalgia, Fever, NauseaVomiting, nausea,dry heaves, body aches headache and  fever/sweating tmax 101.3 Narrative:
Went to outdoor wedding in Maine last September and got pneumonia from kids running around; Then had more, the 4th in Apr2022. A little fatigued and a little soreness at site; Then had more, the 4th in Apr2022. A little fatigued and a little soreness at site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (ongoing), notes: Osteoporosis, takes Prolia 60mg subcutaneous injection twice a year. diagnosed 7 years ago.; "Arthritis" (unspecified if ongoing); "Left branch bundle blockage" (unspecified if ongoing); "Post traumatic stress syndrome" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: XANAX taken for stress, anxiety, start date: 2004 (ongoing); ALBUTEROL HFA taken for asthma (ongoing). Vaccination history included: BNT162b2 (Dose 1, Lot No: ER2613), administration date: 19Mar2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot No: EW0153), administration date: 09Apr2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (Dose 3, Lot No: FH8020), administration date: 19Oct2021, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Apr2022, outcome "unknown" and all described as "Then had more, the 4th in Apr2022. A little fatigued and a little soreness at site"; PNEUMONIA (medically significant) with onset Sep2022, outcome "unknown", described as "Went to outdoor wedding last September and got pneumonia from kids running around". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: Negative covid. Therapeutic measures were taken as a result of pneumonia.  Clinical course details: The patient went to outdoor wedding last September and got pneumonia from kids running around. 6 other people at wedding got pneumonia in their 40's. Thought had Covid and went to hospital and did test. She was Negative covid but it was pneumonia and she was put on 2 types antibiotics and a steroid prednisone to help deal with it.
A nurse reported that a 26 month old male received Acel-Immune. Hib-Titer and Varivax vaccines on 03/27/00. On 04/04/00, the patient developed generalized hives. A copy of this report has been forwarded to Merck, manufacturer of Varivax.
Numbness and tingling in right arm (whole arm).....come and goes..since the 19th Next day 20th numbness moved to left arm and fingertips comes and goes.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in August 2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, (dose, lot# and expiration was not reported). On an unknown date in November 2017, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly, (dose, lot# and expiration was not reported). On 27-DEC-2017 the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly, (dose, lot# and expiration was not reported). No known adverse effects were reported. No causality assessment was provided.
Narrative:  76 year old male received first dose of COVID-19 vaccine (Pfizer) on 2/16/2021. Patient was admitted to emergency room on 2/11/2021 from rehab, skilled nursing facility with pneumonia and CHF. He was on treatment for bacteremia and presented with dyspnea on exertion & leg swelling. Patient had symptoms for 2 weeks prior, worsening and associated with non-productive cough. Patient tested positive for COVID-19 on 3/11/2021, never received second dose of COVID-19 vaccine and expired 3/22/2021.
AKI (acute kidney injury) NSTEMI (non-ST elevated myocardial infarction)
A non-serious, spontaneous report of administered expired products was received from a nurse concerning a six-year-old female. Subsequent to FLUMIST. The patient received FLUMIST on 20-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information received on 31-Mar-2009: included Product Complaint Investigative results.
The decedent received first Covid vaccine, 12/2020 and second vaccine 01/07/2021.  The decedent experienced no known side effects.
Pt had received Td vaccine LD/IM, and was receiving Menomune LA/SQ when he lost consciousness, became diaphoretic, became tremotous and had tonic-clonic like movements while seated in chair. Very slow to respond to ammonia, seemed post ictal, all called and taken to ER for eval.
severe h/a & severe pain in back of neck, aching in entire body so bad unable to walk, unable to sleep entire noc of 23FEB93; didn't know any of family & hallucinating & posturing of hands, suspected brain & brain stem swelling; t100-102;
got very ill; Initial information was received on 02-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social Media.  This case involves a patient (unknown demography) who got very ill (illness), while the patient received INFLUENZA VACCINE.  The patient's past vaccination(s) included Flu shot [Influenza vaccine] from which got sick.  Medical history, medical treatments, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient who got very ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
I received  Moderna Covid vaccine #2  on 1/28/2021.  1/29/2021  I developed left sided neck and left arm pit lymph adenopathy diagnosed by ER at MFSH on 1/31/2021.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown demographics. On an unknown date, the patients received improperly stored oral, ROTATEQ (lot # K016261, expiry date: 23-JUN-2016, one dose). No adverse effects were reported. Outcome was unknown. This case is also related to 1509USA006820, 1509USA006365, 1509USA006822, 1509USA006823, 1509USA006821 and 1509USA006825 (same reporter link).
Information has been received from a nurse at the health care department who received a faxed report from a registered nurse, concerning a case of breakthrough chickenpox from a 21 month old male who on 03-DEC-2007 was vaccinated with a single dose of VARIVAX (Merck). On 20-AUG-2008, the patient developed lesions. The distribution of character of the lesions was not provided but was described as "less than 50 lesions". The case was reported to the pediatric office by the child's mother by phone. No additional information is available.
Patient reported swelling and warmness but no bruising or redness. This lasted 6 days and is now better.
vial was thawed directly from the freezer each time they needed to administer a dose; No adverse event; HCP stated they accidentally administered the dose of Moderna COVID-19 Vaccine Bivalent after the expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered the dose of Moderna COVID-19 Vaccine Bivalent after the expiration date), PRODUCT STORAGE ERROR (vial was thawed directly from the freezer each time they needed to administer a dose) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma.    On 26-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered the dose of Moderna COVID-19 Vaccine Bivalent after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was thawed directly from the freezer each time they needed to administer a dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered the dose of Moderna COVID-19 Vaccine Bivalent after the expiration date), PRODUCT STORAGE ERROR (vial was thawed directly from the freezer each time they needed to administer a dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered the dose of Moderna COVID-19 Vaccine Bivalent after the expiration date) and PRODUCT STORAGE ERROR (vial was thawed directly from the freezer each time they needed to administer a dose).    It was unknown if the patient received any other vaccines in the 4 weeks prior to Covid-19 vaccine. Concomitant product use was not provided by the reporter. The dosage text of the suspect product was reported as unknown.   Vial size was reported as 2.5 ml. Vial did not undergo any temperature excursions. Treatment information was not provided.  This case contains information about patient 3rd out of 9 patients.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729345:master case
The vial was expired on 24-Mar-2022 and removed from freezer just prior to administration time on 05-Apr-2022 at 08:45; Administered with an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) and PRODUCT STORAGE ERROR (The vial was expired on 24-Mar-2022 and removed from freezer just prior to administration time on 05-Apr-2022 at 08:45) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022 at 8:45 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was expired on 24-Mar-2022 and removed from freezer just prior to administration time on 05-Apr-2022 at 08:45). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) and PRODUCT STORAGE ERROR (The vial was expired on 24-Mar-2022 and removed from freezer just prior to administration time on 05-Apr-2022 at 08:45) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported from a pharmacist of a hospital that recently found out the patient was administered with an expired vaccine. There was no information on date of the vial that was initially stored in the refrigerator. The vial had not undergone any temperature excursions. The vial was removed from freezer just prior to administration time. No treatment medications were reported.   This case was linked to MOD-2022-570968, MOD-2022-570980, MOD-2022-571139 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Follow up received includes batch number was added, start time was added for suspect vaccine and product storage error event was added.
pt devel poss brachial plexus neuropathy, causing pain in both arms p/recvd flu vax; pain began w/in hrs in lt arm (inject site) followed by pain in the rt arm 2 wks later; approx 1 month p/vax;
Significant pain in left shoulder upon certain movements. It does not hurt unless I move my shoulder. Reaching, lifting, and moving my arm cross body all illicit a sharp pain. I took 800mg Ibuprofen 2 to 3 times a day for a few weeks with mild relief. I reached out to my Primary Care Physician on 11/4 and received a prescription for Ketorolac 10mg 1 tablet every 6 hours as needed for pain for up to 5 days. This did help with the pain but the pain fully return after finishing Ketorolac therapy.
Patient is a 16-year-old female who presents today with mother. The patient states she was with her mom earlier getting her prom dress fitted when she blacked out. Her mom states her face when pale and her lips turned blue in color. The patient was out for about 2 minutes. She did not fall to the floor, because her mom was able to hold her up. The patient did stated that she had her knees locked while she was standing. She did say everything went black. When she woke up she did remember where she was at. She was very tired upon waking up and is still very lethargic. She did receive a GARDASIL shot in her right shoulder yesterday and meningitis shot in her left shoulder yesterday. Patient did have a similar episode back in November, the day after her first GARDASIL shot was given. The patient denies any vision changes, headache, nausea, chest pain, shortness of breath, bladder or bowel changes. She states she is still very tired and her legs feel very heavy.  4/10/09 ER record received for DOS 3/13-14/2009 with D/C DX:  Syncopal event 2' to Gardasil. Depression. Pt presented after episode where pt had episode of pallor then LOC with lip cyanosis.  Similar event after receiving 1st Gardasil vax. PE (+) for pallor and leg heaviness with difficulty lifting legs. Admitted for observation. D/C'd in am after ambulating.
(L) deltoid area red, itchy, warm and painful to touch. Giving BENADRYL and MOTRIN.
Reported side effects of fever, chills and headache that began within 24 hours, also reports burning in throat. Was evaluated by a specialist after 1 week due to continued burning and pain in throat. Reports was diagnosed with edema around vocal chords. Approximately 2 weeks after vaccination developed swelling  in left arm. She was seen by her physician who sent her for an ultrasound and they found a blood clot. Patient called  to report these symptoms.
Redness, rash, warm feeling from injection site. Prickly feeling. No energy for a few days. Less appetite.
Pt c/o "lump" were vaccine was placed that  never went away and painful to touch.  Pt received 3 Moderna vaccines in the same arm. Vaccines given at a clinic.
This spontaneous report as received from a medical assistant (also reported as administrator) refers to a patient of unknown age and gender. On 02-JUN-2016, unspecified dose of improperly stored PROQUAD (lot# L050907, expiry date: 14-JUN-2017/M004895, expiry date: 26-JUN-2017) was administered to the patient. No adverse events were reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative:  He has history of asthma since childhood. ASTHMA IS UNCONTROLLED BASED ON CHART REVIEW. He also has anaphylaxis to multiple tree nuts and was intubated once. Onset of sx after COVID19 Pfizer vaccine was at 5hrs, used EpiPen b/c he felt SOB and wheezing. Sx thought likely due to uncontrolled asthma rather than the vaccine.
A report has been received from a Health Professional concerning a 4 year old, female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 22-Jan-2013. The expired vaccine was administered on 22-Jan-2013 by a nurse in a public health clinic. The outcome of the event of expired FLUMIST administered is unknown. The report was considered to be non-serious.
FACILITY BELIEVES THEY GAVE PRIMARY MONOVALENT VACCINE IN ERROR FOR BIVALENT VACCINE.  NURSING COULD NOT TELL THE DIFFERENCE BETWEEN THE BOTTLES AND REPORTED THE LOT # FP7137 WAS USED FOR VACCINATION WHICH IS PRIMARY MONOVALENT VACCINE.
7 hours after vaccine severe chills, high fever (104.1F), severe headache, severe joint pain in legs. After 12 hours and 400mg Ibuprofen every 4  hour, fever down to 101.8F headache less severe, leg pain still significant.
rt arm swollen up next day very painful;no strength in arm had to work around house;just swollen the first day then when swelling started to go down, arm became hot to the touch & itchy;17MAR97 arm still red, & hot to touch;
Information has been received from a 28 yr old female nurse practitioner who on 10Feb06 was vaccinated IM into the left deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651322/1044P). By the next day, 11Feb06, the pt developed hives, "swelling warmth" and "redness at the injection site". The nurse practitioner further reported that she had "decrease use of left limb for 1 day". The pt sought unspecified medical attention. It was reported that there was "no treatment". At the time of this report, the pt had recovered from the events (date unk). Additional information has been requested.
Apparently a woman he had sex with a few days after he received smallpox vaccination in his left upper arm subsequently developed vulvar vaccinia. See attached MMWR report of this incident.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 01-APR-2014 the patient was vaccinated with ZOSTAVAX (dose, strength, frequency, lot# and expiration date not reported) exposed to 19F for 30 minutes (date of exposition was unspecified). No adverse effect reported. Additional information has been requested.
Patient reported feeling under the weather, somewhat shaky and overall "icky" after getting vaccination for about 24 hours afterwards. Asked about fever and possibly chills and the patient reported unsure. The patient did not report seeking any medical treatment and appeared fine at time of reporting the event in person.
Chills, fever, headache, intense all-over body aches, unable to sit up or turn over in bed, loss of appetite.
At 430 pm, broke out in hives and itchy rash all over body, primarily stomach chest back buttocks upper thighs and arms.; At 430 pm, broke out in hives and itchy rash all over body, primarily stomach chest back buttocks upper thighs and arms.; Redness on both upper arms.; Skin warm at injection site and red; Skin warm at injection site and red; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 09:30 (Lot number: FK5618) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Slight peanut allergy" (unspecified if ongoing); "Flu" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for influenza. The following information was reported: URTICARIA (non-serious), RASH (non-serious) all with onset 12Nov2021 16:30, outcome "unknown" and all described as "At 430 pm, broke out in hives and itchy rash all over body, primarily stomach chest back buttocks upper thighs and arms."; ERYTHEMA (non-serious) with onset 12Nov2021 16:30, outcome "unknown", described as "Redness on both upper arms."; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 12Nov2021 16:30, outcome "unknown" and all described as "Skin warm at injection site and red". Therapeutic measures were taken as a result of urticaria, rash, erythema, vaccination site warmth, vaccination site erythema.  Additional information included: The patient received other vaccine in 4weeks details [{other vaccine 4weeks product=Flu shot}]. Adverse event: on 12Nov2021, at 4:30 pm, broke out in hives and itchy rash all over body, primarily stomach chest back buttocks upper thighs and arms. Redness on both upper arms. Skin warm at injection site and red. The patient received the treatment Benadryl for adverse events. The patient was not diagnosed with covid1-19 prior to vaccination. The patient was not tested for covid-19 post vaccination.  No follow-up attempts are possible. No further information is expected.