chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHILLS, NIGHT SWEATS. Chills, no fever, began about 12 hours following the injection and continued periodically for 2 days. Night sweats began on 2/17/2021, 7-days following the injection, for 17 consecutive nights and then gradually less frequently until 4/11/2021. Experienced 28-night sweating episodes of varying intensity from full-body drenching/soaking the bedding to light sweating wetting the clothing. Took no additional medication or dietary supplements other than that reported in item 9. Dramatically altered eating habits, i.e., no evening meal, believing that diet could be source of night sweating episodes. The dietary changes had no apparent effect. Did not observe any physical changes such as itching, rashes, swelling, etc. In May 2021, a sleep therapist reviewing my sleep history suggested submitting a VAERS report to report the night sweating as possible COVID-19 vaccine side effects. I am a non-smoker, non-drinker, and rarely get sick. Have a history of infrequent (a few episodes annually) of night sweating but do not recall ever having consecutive night sweating episodes. In April 2019, to determine possible causes of the night sweating, primary care provider referral testing for HIV1, chest x-rays, and TB were negative. Received only COVID-19 test on 6/4/2020 which was reported as negative. Frequent dental visits and screening and never experienced nor reported any possible COVID-19 related symptoms. On 1/13/2021, received the 1st dose, Moderna lot number 011J20A, at a county public health COVID-19 drive-thru clinic, intramuscular right arm with only mild shoulder discomfort. Routinely receive the annual flu immunization which occurred on 9/2/2020, FLUAD INJ 2020-21, intramuscular right army with no side effects. Periodic blood donor with last donation on 10/9/2020. Last medical surgical procedure was dental implant oral surgery on 12/15/2020. As a retired member of service received many immunizations during period of service 1968-1988 and some afterwards for overseas travel as a government civilian.
No adverse medical reaction.  The patient is 12 years old, too young for the Moderna vaccine We have contacted the health department and moderna
Markedly increased need to urinate, heart palpatations, aches, headache, severe dizziness, and violent and severe vomiting...This occured in this order starting with the need to urinate, then the palpatations, rested for several hours to no avail, then the severe dizziness (vertigo-like) ensued... severe nausea and finally agressive and prolonged vomitting...  Consulted doctor, I'm not normally a health alarmist, but I was terrified...             Felt somewhat better on 4/9, but still, on 4/10, no energy, headache and loss of appetite.
had the flu shot twice and both times/ got the flu; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious case from a patient via Digital Media.  This case involves a patient with unknown demographics who had the flu shot twice and both times/ got the flu (influenza), while being treated with vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a Dose  dose of suspect INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose and frequency via unknown route and unknown site for prophylactic vaccination.  On an unknown date (unknown latency), after starting the suspect vaccine therapy, the patient had the flu shot twice and both times got the flu (influenza).  No laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
Rt arm has a red swollen area at site of injection, and a bruise. C/O pain at site.
struggled to get out of bed and stayed in bed all day; no appetite; vaccination site pain; Felt miserable; Felt knocked out; Short term memory feels affected more once again; A spontaneous report was received from a consumer concerning 82 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt knocked out/ loss of consciousness, felt miserable/ feeling abnormal, struggled to get out of bed and stayed in bed all day / bedridden, short term memory feels affected more once again/ amnesia, no appetite/ decreased appetite.  The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient included lisinopril, levothyroxine sodium, omeprazole.  On 22 Feb 2021, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 001A21A) through intramuscular route at left arm for prophylaxis of COVID-19 infection.  On 23 Feb 2021, patient experienced arm sore for a few days. On 25 Feb 2021, patient had experienced hurting all over body and couldn't do anything for 5 days (very painful). Short term feels affected.  On 22 Mar 2021, prior to the onset of the event, the patient received second of their two planned doses of mRNA-1273 (Lot number: 037A21A) through unknown route at right arm for prophylaxis of COVID-19 infection.  On 22 Mar 2021 in the evening after second dose, patient felt knocked out and miserable and struggled to get out of bed. She had short term memory feels affected more once again. On 23 Mar 2021 patient stayed in bed all day and had no appetite. On 24 Mar 2021, patient was feeling a lot better.  The event patient felt knocked out was a medically significant condition.  Treatment activities for event was done with paracetamol.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event, felt knocked out, felt miserable, struggled to get out of bed and stayed in bed all day, short term memory feels affected more once again, no appetite was recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056390:Dose 1
Redness the size of a baseball, swollen knot as large as my hand, very sore, cramping
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 14-NOV-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, albumin status: recombinant human albumin (rHA)). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. ; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Case number PHHY2012US054996 is an initial literature report received on 25 Jun 2012. Authors presented the importance of clinicians alertness to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. This case refers to a patient (age and sex not specified). The patient's medical history included severe to profound neurologic and neurodevelopmental disabilities, including physical limitations, cerebral palsy and intellectual disability. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on an unspecified date during Oct 2010 to Nov 2010. On an unspecified date after vaccination, the patient developed influenza. On an unknown date the patient died due to multiple organ failure. No other information pertaining to this patient was available. Authors concluded that clinicians should be alert to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. Prompt testing and early empiric antiviral treatment in residents with respiratory symptoms in residential or long-term care facilities is important. Influenza prevention efforts should include vaccination of residents, health-care personnel, and others who might transmit influenza to residents, use of infection control precautions, and appropriate use of antiviral medications.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 1:58 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:17 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 45.48 for dose administered on 27-Mar-2021 and 45.37 for dose administered on 13-Feb-2021.  No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion on 27-Mar-2021 with temperature 35 and 35 degrees Fahrenheit from 09:00AM to 10:00 AM. This vial was moved to fridge 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Batch number  031L20A underwent temperature excursion on 13-Feb-2021 with temperature 32  degrees Fahrenheit at 09:00AM. This vial was moved to fridge 09-02-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported   This case was linked to MOD-2022-566976 (Patient Link).
Ringing in the ears; dizziness; vomiting; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for four patients. This is one of four reports. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0170) on 19Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced ringing in the ears and dizziness a few minutes after the vaccine and vomiting on 19Apr2021. The reporter also stated that within 2 hours the patient had ringing in the ear, dizziness, and vomiting. The reporter considered the events related to BNT162b2. Reporter stated that seriousness was unknown and did not know if it was significant or not.  Stated the patient did not have any medical treatment, she was just given some water. The pharmacist reported same events for four different patients and stated that one person (unspecified which one) had to lay on the ground. The outcome of the events was unknown.   No follow up attempts are needed; no further information is expected.
pt recv vax OCT or NOV96 & 24DEC96 pt exp tiredness;25DEC96 pt devel watery eyes & a runny nose;26DEC96 pt exp chest pain & SOB & went to the ER;@ ER an unspecified arrhythmia was noted which leveled out;pt told had flu
Patient received vaccines in the office sometime between 7:30 - 8:30 am. About 3pm there was a note in ER records expecting patients arm and in ER via EMS. Baby was in swing and mom heard him moan, she turned to look at him he vomited once, was short of breath, gasped before and after and stopped breathing for less than 5 secs, she called EMS, on her arrival baby had a temp of 99, in ER temp was 38.9. ER notes describes him as barely interactive on arrival, he was discharged home after that visit, same day.
Patient stood up a few minutes after receiving the vaccination and fell over. Patient got back up with assistance from pharmacist on duty and was advised to sit with head down for a few minutes. Pharmacy personnel called EMS to be safe. Patient recovered and started drinking some water given to him with no concerns. EMS walked out with patient after his 15 minute observation period was up, but he seemed stable at that time.
seizure; jaw-locked, tonic-clonic activity x 3-4 minutes, witnessed by EMS
I did not have an adverse reaction to the vaccine. On 06/17, I tested positive for COVID-19 with a home test and my doctor confirmed the diagnosis. I was given a prescription for benzonatate and it did not help. I was given a prescription for Z-PAK and a steroid but it didn't work either. I still have the cough and it is causing trouble with my breathing.
A physician reported the occurrence of a seizure in an 18-month-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history included gastroesophageal reflux disease (GERD) and failure to thrive. He had no known allergies, received no concurrent medications and had experienced no adverse events following previous immunizations. The pt received his 4th injection of Infanrix on 11/04/2002 (lot DTAP575A2; expiry 04/09/2004). Later that day, the pt experienced a seizure. He was seen in the ER and treated with phenobarbital. Unspecified laboratory tests were performed. Computed tomography was "fine". The seizure resolved and the infant was sent home that evening. He was seen by his physician on 11/05/2002; at that time, his temperature was 104.2 degrees F. As of 11/11/2002, the outcome of the fever was unknown. The Infanrix immunization series was discontinued. Seizure is considered GSK medically serious.
Client received her flu shot in left deltoid at approx 9am. At 730 pm same night she experienced painin her hip joint, sweating, lethargy-in waves.  Her parents took her to the ER. No dx
stomach upset; diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset) and DIARRHOEA (diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach upset) and DIARRHOEA (diarrhea). At the time of the report, ABDOMINAL DISCOMFORT (stomach upset) and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was not provided.
No additional AE/PQC.; inadvertent administration of expired PNEUMOVAX 23 to a patient.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On 23-OCT-2023, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # W007035 has been verified to be a valid lot number, expiration date: 20-OCT-2023; strength, dose and route of administration were not reported), administered by a health professional for prophylaxis (expired product administered). No additional adverse event (AE)/product quality complaint (PQC) was reported.
Shingrix in the subcutaneous area of my arm; This case was reported by a consumer via interactive digital media and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The reporter was the patient. The reporter stated that, received shingrix vaccine via subcutaneous route, which led to intramuscular formulation administered by other route.
Serve  headache started  after shot and game continued for almost 48 hours little relief with ibuprofen.
Itching; Developed rash on her arm, chest and stomach; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and RASH (Developed rash on her arm, chest and stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching) and RASH (Developed rash on her arm, chest and stomach). At the time of the report, PRURITUS (Itching) and RASH (Developed rash on her arm, chest and stomach) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
At injection site: very swollen and hard; Very red; very sore and itchy. Did not have any adverse reaction at all yo the first dose
This case was reported by a other health professional via sales rep and described the occurrence of pain in a patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced pain, blister and erythema. On an unknown date, the outcome of the pain, blister and erythema were recovered/resolved. It was unknown if the reporter considered the pain, blister and erythema to be related to BEXSERO. Additional details were provided as follows: This case was reported by a medical assistant. The age at vaccination was not reported. The size of erythema and blister was explained as the size of a silver dollar. The Medical Science Liaison (MSL) did not have the reporter's telephone number and was unable to provide any further details regarding the adverse events described.
9 x 7.5 cm erythematous induration area on upper arm. Received DTaP A/ DTap reaction.
Broken blood vessels (veins), bruising, and ruptured blood vessels under skin of palmar surface of left gand at palm and 2nd finger.
Patient began to shake and tremble after needle withdrew from administration site. Patient stated he was afraid of needles. 5 minutes later patient was back to normal. VS normal.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients who were vaccinated on unknown dates with unspecified doses of ROTATEQ that were improperly stored. No adverse effects reported. No further information provided. Additional information has been requested.
No additional adverse event.; the patient was inadvertently administered a dose of Rotateq on 22-JUN-2020 that had been improperly stored.; This spontaneous report was received from a physician referring to a 9-week-old patient of unknown gender. Information about medical history, drug reactions/allergies and concomitant therapies was not provided.  On 22-JUN-2020, the patient was inadvertently administered a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S028768, expiration date 11-APR-2021) (strength, dose, frequency and route were not reported) that had been improperly stored for prophylaxis (product storage error). The vaccines were exposed to temperature 72 Fahrenheit degrees (F) for 47 hours. No previous excursion was reported. The data logger was involved. No additional adverse event was reported.
Sicker than a dog; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date refer case- US2022AMR131402).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR131402   Additional Information: GSK Receipt Date:11-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that was one set of shots he/she got.  They made patient sicker than a dog.  The patient hope and pray they were much more effective than the phony Covid shots that had not worked for anyone. Additional supportive information: The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR131402:Same reporter