chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she cut her thumb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 28Aug2021 as dose 3 (booster), single (Lot number: FC3182) at the age of 65 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1; SINGLE), administration date: 28Dec2020, when the patient was 64-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2; SINGLE. Lot number: EL3248), administration date: 18Jan2021, when the patient was 64-year-old, for COVID-19 immunization; Flu vaccine (Has gotten the flu vaccine and no reactions that she can remember, nothing extreme); Pneumonia vaccine (Has gotten the pneumonia vaccine and no reactions that she can remember, nothing extreme). The following information was reported: SKIN LACERATION (non-serious), outcome "unknown", described as "she cut her thumb". Therapeutic measures were taken as a result of skin laceration.  Additional Information: The patient had tetanus shot, because she cut her thumb.
went into CHF exacerbation and atrial fibrillation, both new to patient; required hospitalization
Night of to day one: Chills, Fever 101.3, Headache, Joint Pains, Muscle spasms, Muscle aches, Fatigue, Nausea, Vomiting, Diarrhea, Swollen Glands, Stomach cramps, Difficulty breathing, Blurred vision.  On the 2nd day 14th February: Headache, Swollen glands, Bruising and redness at site, Fatigue, Stomach cramps, extreme thirst and skin dryness.
DID NOT SLEEP WELL; ACHES AND PAINS FOR 5 DAYS; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On 16-MAR-2021, the subject experienced did not sleep well. On 16-MAR-2021, the subject experienced aches and pains for 5 days. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not sleep well on 17-MAR-2021, aches and pains for 5 days, and chills on 21-MAR-2021, and fever on 18-MAR-2021. This report was non-serious.
FACIAL NUMBNESS. PT TOOK BENADRYL AND FELT BETTER.  WENT TO THE EMERGENCY ROOM.  THEY SAID SHE IS FINE.
This spontaneous report as received from a nurse refers to a unspecified amount of patients of unknown age and gender. On an unknown dates between 07-AUG-2017 and 19-SEP-2017, the patients were vaccinated with impropely stored doses of VARIVAX (doses, route of administration and indication were not reported, lot# M049126 exp 15-DEC-2018; M028551 exp 07-JUN-2018). Concomitant therapies included properly stored sterile diluent (STERILE DILUENT). No adverse effects were reported. Data logger involved ( 6°F to 14°F for 16 hours). Previous temperature excursion reported ( 6°F to 14°F for 16 hours). This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1709USA010341:
thrombocytopenia/platelets were only 1; a petechial purple pin point areas covering entire body.; This is a spontaneous report was received from a contactable consumer or other non hcp (patient). A 51-years-old Caucasian non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0172) via an unspecified route of administration, in arm left on 22Apr2021 14:00 as single dose for covid-19 immunisation. Medical history included multiple sclerosis. The patient's concomitant medications were not reported.  The patient previously took first dose of bnt162b2 (batch/lot number: ER8733) for covid-19 immunisation on 01Apr2021 at 9:00AM. The patient had experienced hypersensitivity with betadine, compazine, dilaudid and morphine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Apr2021, the patient had started with a petechial purple pinpoint areas covering entire body had blood drawn and admitted for thrombocytopenia and given IVIG 2united Platelets and IV steroids because platelets were only 1. The patient was hospitalized for 3 days. The patient had received treatment with immunoglobulin and platelets. The patient underwent lab tests and procedures which included nasal swab and sars-cov-2 test was negative on 15Jan2021. Case was considered serious as it was reported life threatening. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
No additional AE,; temperature excursion, caller disclosed that multiple doses of MMRlI were administered to multiple patients; This spontaneous report as received from an office administrator refers to a 12-month-old male patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.    On 08-NOV-2020, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status rHA) 0.5 ml injection,"once", lot # S012944 was confirmed to be valid, expiration date 28-APR-2021 (route and site of administration were not reported) for prophylaxis. There were previous excursions reported. The digital data logger was involved. No additional adverse events were reported.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2101USA000853: US-009507513-2012USA012763: US-009507513-2101USA000852:
After leaving pharmacy, patient experienced a seizure while riding as a passenger in a vehicle.  Patient was hospitalized and diagnosed with a "Brain Bleed" according to mother.
Fever over 103 degrees - measured by rectal thermometer.  Temperature went on for 3-4 days.  Even after fever ceased, it has been 5 days now, her temperament has not returned to what it was.  Patient will scream and cry randomly which is not at all typical behavior for her.  She has not been sleeping well as she wakes constantly and is very difficult to put back down.  Again, this is all new since she received her vaccinations.  She will only take fluids if she is nursed and is still does not have much of an appetite, although it has increased slightly.  She has not been around anyone with a virus.
This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose and lot# not reported) subcutaneously. On an unknown date the patient experienced shingles within a few days after vaccination of ZOSTAVAX. The patient sought medical attention with the physician and was treated with VALTREX. At the time of reporting, the outcome of shingles was unknown. The patient was not reintroduced. Additional information has been requested.
pt recvd vax 10JAN94 & returned to hlth dept 1115AM; 11JAN93 w/red rash over entire body; severe itching, face swollen; no resp idstress; sent to ER;
This spontaneous report was received from a medical assistant, concerning a multiple patients of an unknown gender and age. There were no concurrent conditions, medical history and concomitant medications reported. On unspecified dates, the multiple patients could had been vaccinated with improperly stored doses of GARDASIL (dose, frequency and route not reported) lot # M020103 with expiration date of 15-FEB-2018 and lot # reported as M031557 with expiration date of 07-APR-2019. The medical assistant had no details about the excursion regarding the time and temperature but just stated that "the vaccines went out of range once." No adverse effects were reported. No product quality complaint (PQC) and data logger were involved. This is one of three reports received from the same reporter. Lot # M031557 is an invalid lot number for Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recomb. Vaccine. Additional information has been requested.; Sender's Comments: US-009507513-1702USA001654: US-009507513-1702USA005697:
RHC 3/15/21.  No significant reaction from vaccine. Had sore arm.
pt recv vax 18APR97 & immed clinched arms & hands to chest;put head on desk & turned yellow;pt placed on floor w/legs raised
Pain in arm; Malaise; Fatigue; Nausea; Headache; This is a spontaneous report from a contactable consumer or other non-health care professional (patient Mother) reported for her 14-years-old daughter (Patient). This is Report 2 of 2.  A 14-years-old female patient received first dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Jun2021 as dose 1, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Mother reported that her older daughter got the first dose of the Covid-19 vaccine on Friday (18Jun2021) and she had experienced pain in her arm, malaise, nausea, headache, and fatigue beginning the evening of the shot. The next day, 19Jun2021, the patient kind of felt that way as well, but towards the end of that day started to feel better. The outcome for the events was reported as recovered on 19Jun2021.   Information about batch/ lot number has been requested.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no previous temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-month-old patient of unknown gender. On 23-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date: 31-JAN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 10:47 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 10:47 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Census Ethnicity of the patient was reported.  Concomitant medication of the patient was not reported.  The patient received second booster dose and vaccine administration time was given as 10:47:30.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
Information has been received from a medical assistant for GARDASIL, a Pregnancy registry product, concerning a 10 year old female who on 07-MAY-2010 was vaccinated with a dose of GARDASIL (lot no. 662529/0299Z, expir. 30-MAY-2011) 0.5 ml IM while pregnant. Subsequently the patient delivered a child in November or December 2010. There was no available information on the present medical status of either the mother or the child. Follow up information received from the medical assistant regarding the patient pregnancy outcome. She reported that the patient gave birth to a live healthy infant with no congenital anomalies. When asked, she had no other information regarding the delivery/pregnancy statistics to report on the newborn or the patient. She reported that the 12 year old (also reported as 10 years old when vaccine exposure) patient gave birth via C-section due to her age and that the mother gave the child up for adoption. At the time of this report, patient's status was unknown. Upon internal review, "patient gave birth via C-section due to her age" was determined to be an other important medical event. Additional information is not expected.
Night of vaccine, red raised itchy rash around injection site, foggy head feeling, left arm pain. All of these effects went away in 2 days.   8 days following administration of first Moderna dose (1/5/2020), the raised, red rash around injection site had returned (same size as before), with nausea and vomiting. Slight headache.
The next day after receiving my vaccine I felt extreme fatigue. I took a  two COVID-19 at home test that came back negative. I started to develop a cough a few days later and took another COVID-19 test that came back positive on 5/5/2022. I have since started to have a mild body aches, decreased appetite, low grade fever of 99/100, and lightheadedness. I was prescribed Paxlovid.
Pfizer-BioNTech Covid-19 Vaccine EUA Injection Site Pain  radiating down to hand -2 days - Advil first day - no relief - Tylenol  tiredness - 36 hours headache -72 hours - Tylenol day 2 and 3 muscle pain and aches in legs - 72 hours chills - first 48 hours Joint pain - 48 hours Fever  to 100.4 first 48 hours injection site swelling and hot to the touch 48 hours nausea - 72 hours dizzy - 72 hours feeling unwell 72 hours
Received Td, MMR and Tb skin test on 08/22/2005. After shots started getting sore throat, running fever, arm left got sore but no redness or swelling was off work for 2 days then started feeling better.
Immediately after injection, I felt a warm feeling flow from the injection site and across my chest.  No shortness of breath or chest pain.   Felt slightly light-headed. Drank water and ate some food to closely monitor.  Very sore Left deltoid starting about 8 PM on 12/31/20 (same day as the vaccine administration).  It was so sore that it woke me up a few times at night and 1/1/21 I had to take Ibuprofen 400 mg to alleviate the pain. Had a dull headache all day 1/1/21 and very tired. Slept that night from 9 pm - 8 am next day.  No symptoms since 1/3/21.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 4/20/21 and 5/11/21. Presented to ED 2/21/22 in cardiac arrest and Covid+. Started to have congestion earlier in the day. Pt had 2 incidences of falling throughout evening but had no loss of consciousness. Wife was sleeping and felt pt move head to her shoulder. Wife stated he was breathing but shortly thereafter stopped breathing and she completed two rounds of CPR before EMS arrived. In the ED pt was found to be in PEA. CPR was continued and after 3 rounds pt achieved ROSC. Elevated creatinine, LFTs, multilobar PNA noted. Pt kept on having multiple episodes of arrest to ICU and was having v fib/ vtach  and the AICD shocked him a few times. Support was withdrawn and pt expired on 2/25/22. Treated with doxycycline, zosyn. cefepime, remdesivir, dexamethasone.
Black particles in vaccine vial; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Black particles in vaccine vial) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Black particles in vaccine vial). On 04-Mar-2021, POOR QUALITY PRODUCT ADMINISTERED (Black particles in vaccine vial) had resolved. 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.   No relevant concomitant medications were reported.   No treatment information was provided.      This case was linked to MOD-2021-036321 (Patient Link).
Initial medication error report received on 04-September-2013 from a health care professional. A 4 year old child patient, medical history and concomitant medications were not reported, received a 5th dose of ADACEL (lot number, route and site of vaccination was not reported) instead of DAPTACEL on an unspecified date. As of 04-September-2013. Patient did not have any adverse events. List of documents held by sender: none.
I started with a sore throat, and the next day I had fever, cough, runny nose, sneezing. I tested for COVID-19 on June 8th 2022 and I had most of the symptoms on that day and it was a PCR test done at Pharmacy. The Dr. prescribed on Paxlovid on 6/10/22 and that was for 5 days. I had rebound symptoms with chest tightness and a cough. I still have the same symptoms now.
Patient woke up following day with hives from head to toe, swelling of the eyes and mouth. Visited doctor and received prednisone.
After the vaccine was administered, 5-10 minutes later I began to feel a rapid heart rate. One of the nurses came to check on me, I described to her my symptoms, and she let me know if they get worse to inform her. In the next 5 minutes, my head began to hurt, as well as, some chest pain. She checked on me again, and said to let her know if things got worse. Within the next 5-10 minutes after, I had difficulty swallowing and speaking. I raised my hand, and the nurse came over, then proceeded to get help. They then took my blood pressure and heart rate. My blood pressure was 185/103 and I believe my pulse was 156 bpm. I was still having a hard time swallowing and speaking. They proceeded to get an epi pen and the doctor on site, as well as suggested to send me over the ER/ call 911. The doctor checked my lungs, and they noticed my blood pressure and heart rate was not decreasing to a normal level. I was then put in a wheel chair and transferred to the ER. At the ER, my blood pressure and heart rate was still elevated, as well as difficulty swallowing. The doctor ordered Benadryl via IV, steroids, and the epi pen. After having a reaction to the Benadryl, the epi pen was put on hold. After about 15 minutes, I began to feel better. I was put on IV fluids and observation. I was able to leave the ER around 12 pm 2/05/21. At this time,  7:22 pm, I am feeling better with mild muscle aches, and fatigue.
A spontaneous report was received from a  Consumer) concerning a 30-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling terrible with body ache, nausea, fever, chills and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.     On 21-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 043L20A ) intramuscularly in the left arm  for prophylaxis of COVID-19 infection.  On 21-JAN-2021, the patient experienced feeling terrible, body ache, nausea, fever, chills and headache.  No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Was supposed to give the Covid Pfizer Bivalent booster.  Administered the tris in error
Moderna monovalent peds dose administered in error.  Should have received Moderna bivalent booster dose.  Patient informed.
FEVER 101.6, VOMITING, REDNESS AND PAIN INJECTION SITE
Patient called health system call center on 5/2/21 to report episode of shingles in left forehead and eye brow 2 days after receiving dose 1 of covid vaccine. Per patient, he was seen by his outside provider who prescribed him shingles treatment and has follow-up with his PCP.
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a female patient who experienced diarrhea. The patient received the second dose on an unspecified date. Medical History: The patient previously experienced diarrhea while taking Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection).  Product Details: Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant Therapy: Concomitant medications were not reported. Event Details: The patient experience diarrhea (diarrhea NOS). Related Case(s): The patient experienced diarrhea following receipt of her first dose of Prevnar on an unspecified date and erythema multiforme following receipt of her third dose of Prevnar on 23-Oct-2003, at 10 months of age (see MCN HQWYE671231OCT03 and HQWYE613229OCT03). No additional information was available at the date of this report.