chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MOC reports that pt t104 R on 12MAR92 continuing through evening of 13MAR92; pt "irritable" during this time; APAP & a tub bath were used to lower pts temp to 101; mom also reported pt rubbed knees & fussed on 5MAR92;
Rash, dizziness, feeling lightheaded, drunk. Later hives, itching, severe itching, flushing. Stated tongue feels bigger. Stated some difficulty swallowing. After BENADRYL and later afternoon slurred speech, some confusion.
came for his booster vaccine and the 0.25ml dose was administered.  After his 15 minute waiting period when the staff was drawing up a dose for a subsequent patient it was discovered that the vial had been kept at room temperature for greater than 12 hours
BODY ACHES; CHILLS; FATIGUE; HEADACHE; RELATIVELY MILD FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced body aches, chills, fatigue, headache, and relatively mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, headache, body aches, chills and relatively mild fever was not reported. This report was non-serious. This case, involving the same patient is linked to 20211150118.
pt to ER 8FEB97 p/couldn't wake pt up-step mother went in & found pt half-awoke & jerking-was about 45min p/this pt was completely awake @ ER;pt took unk pill for pain from hx of sz as child;
PT recd series of 3 Engerix-B vaxs (20mcg) on 3AUG90, 15SEP90, & 5FEB91 & was a non-responder;
postherpetic polyneuropathy; This spontaneous report has been received from a layer regarding a case in litigation, concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 02-DEC-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and rote of administration ere not reported), as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to vaccination, the patient was treated by a physician for postherpetic polyneuropathy (PHN). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, he patient had and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome for postherpetic polyneuropathy was not provided. The lawyer considered postherpetic polyneuropathy to be related to zoster vaccine live (ZOSTAVAX).
Serum sickness, headache, weakness. Onset of symptoms, 4 to 6 hours after IMZ administration.  Symptoms lasted 24 hours. Patient missed worked the day after IMZ.
A week after my first dose, I had loss of vision for about 20-30 minutes. I also saw floating spots/bright light float from my right eye to my left eye.   Four days after my second dose, I experience the same side effect, however the loss of vision occurred for only 10 minutes this time.   For both times, I called the neurologist I have been seeing. I had Lasik eye correction so I know I have perfect vision. I have not experienced these side effects ever since.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It is unknown if the doses are first, second or third doses for the  patients. The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions. No concomitant product was provided by the reporter. No treatment medication was provided.
Complex febrile seizure; fever. Discharge Summary received on 1/3/2005 states lethargy. Medical Record received on 1/3/2005 states viral inflammatory process.
At time of treatment, adverse side effects were severe, but normal.  Yesterday, almost 4 months after second vaccine, arm and hand pain similar to that experienced after first and second vaccine recurred and seems to stem from site of injection where there is a bump that is new, too.  Pain is sharp and radiates from shoulder to hand, leaving thumb/wrist in debilitating pain.  This started suddenly and is not typical for me, but is the same as side effect from first vaccine.  Pain area when iced feels hot, and when treated with heat feels cold.
I developed a restriction in my throat, suffered from involuntary heart contractions, still experiencing throat and esophagus restrictions.
Patient had discoloration of knuckles and cold hands. Given oral diphenhydramine 25 mg x 1 dose
Fainting, possible seizure, vomiting  5 hours after vaccine patient felt faint. Passed out for a few seconds, L lateral gaze, arms stiff, + shaking. No post-ictal state.  Patient was taken to to the ED.
Patient received Pfizer Covid-19 vaccination 28 days before his 16th birthday. Vaccinator failed to subtract patients birthday from current date correctly. Someone spoke to dad on 4-2-21 all 3 family member will come back 5-3-21 for 2nd Pfizer dose when son is 16 years old.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021 at 11:37 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 66.96 for dose administered on 03-Mar-2021 and 67.03 for dose administered on 31-Mar-2021. No concomitant medications were reported. Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit from 12:00 PM to 01:00 PM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021. Batch number 014M20A underwent temperature excursion on 03-Mar-2021 with temperature 35 degrees Fahrenheit from 01:00 PM to 02:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-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 Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported.
Joint pain - waking me up at night Swollen lymph nodes - groin, neck and under arms
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 15-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two separate temperature excursions (dates unspecified): one lasting from 72 hours, with the lowest recorded temperature of 28 degrees Fahrenheit (-2.222222222 degrees Celsius) and another lasting for 32 hours, with the highest recorded temperature of 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Increased bruising noted.  8/2013 greatly decreased menstrual bleeding noted after 3 years of regular periods.  Also noticed episodic dizziness and feeling faint, fatigue, generalized achiness, dilated pupils, HAs.  9/2013 Severe muscle spasm and episodic dizziness, HAs, dilated pupils continue.  Menstrual period very very light, again.  10/23/2013 HPV #2 given.  11/2013 amenorrhea.  Began to notice periods of facial and extremity duskiness and pallor along with above symptoms.  Numbness and tingling also noted.  12/2013 AMH (antimullerian hormone which indicates ovarian reserve) is found to be similar to perimenopausal woman.  Amenorrhea continues along with other symptoms.  6 through 8/2014 diagnosed with POTS/Dysautonomia.
DYSENTERY; NAUSEOUS; CHILLS; SORE ARM; HEADACHE; fever; MUSCLES CRAMPING; SWEATS; Got dizzy; slept a bunch; A spontaneous report was received from a consumer concerning a 58 year old, male patient who experienced dizziness, fever, sweats/hyperhidrosis, nausea, chills, dysentery, slept a bunch/fatigue, sore arm/injection site pain, headache, and muscles cramping/muscle spasm.  The patient's medical history included having COVID-19 in December 2020.  Concomitant product use not provided.  The patient received their first of two planned doses of mRNA-1273 (Batch number 016M20A) on 10-Feb-2021 intramuscularly for prophylaxis of COVID-19 infection.  On 11-Feb-2021, around 2 o'clock in the morning the patient got dizzy, got a fever, sweats, nauseous, had chills, he got dysentery and got sick to his stomach. He was sick about one day or so after that. He slept a bunch. He  looked bad and started sweating. He had a sore arm for a few days. He also had headaches and his muscles were cramping.  Treatment for the event none provided.  The outcome of the events were unknown.; Reporter's Comments: Based on the information provided, the event of dysentery is assessed as unlikely as it is infective etiology, the other events are temporarily association with mRNA-1273 administration, a causal association between the reported events and the product use cannot be excluded. Nausea, chills, injection site pain, headache, pyrexia, fatigue are consistent with the safety profile of the vaccine.
Dizziness, SOB, chest pressure. BPs 86/54 (pulse 70), 96/54. O2 sats 100%.
Patient was given expired vaccine- He was notified 8/18/22 and will return for repeat dose to be given per CDC recommendations- This was his 4th dose.
Case number PHEH2014US004070 is an initial spontaneous report received from a pharmacist on 26 FEB 2014. This report refers to a 15-year-old patient of unknown gender. The medical history and concomitant medication of the patient was not reported. On an unknown date in FEB 2014 (two weeks ago), the patient was vaccinated with FLUCELVAX (batch number 004011A) intramuscularly at a dose of 0.5 ml. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014 of the date received on 26 FEB 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Feeling of dizziness, lose of feeling and uncontrollable shaking in left leg.
Has not eaten; Felt nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Felt nauseous) and DECREASED APPETITE (Has not eaten) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included HYOSCINE HYDROBROMIDE (SCOPOLAMINE PCH), BETHANECHOL, ALPRAZOLAM (XANAX) and ESCITALOPRAM OXALATE (LEXAPRO).    On 21-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced NAUSEA (Felt nauseous). On an unknown date, the patient experienced DECREASED APPETITE (Has not eaten). At the time of the report, NAUSEA (Felt nauseous) and DECREASED APPETITE (Has not eaten) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information provided.
Patient stated an hour or 2 after receiving the vaccine she developed chills, itch eyes, headache, nausea and itching all over the body. She stated she did not have anything to eat or drink after the vaccine. No rash on body but she is constantly itching.
Left arm is swollen, hot, itching. Patient took Zyrtec and is now putting Hydrocortisone cream to help.
Very itchy rash on lower abdomen and upper abdomen (under breasts). Continued to spread to inside upper arms and upper abdomen and buttocks area. Rash is small bumps of itchy nodules. The reaction is now continuing into it's third week post shot. Treated with aloe vera at first, then hydrocortisone cream 1%, then took oral BENADRYL tablets which seemed to make it recede a bit but switched to topical BENADRYL gel (all OTC drugs/treatments).
headaches, stiff and aching joints and muscles, excessive tiredness, allergy like symptoms, insomnia
Shingrix series completed, no antibodies; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   Additional Information: GSK receipt date: 05-JAN-2022 Reporters comment: The pharmacist reported that patient completed the shingrix series over the summer of 2022 had lab work done and it showed she did not had any Shingrix antibodies so the doctor wants to repeat the series. No further information was shared on the call and specialist did not note potential adverse event during the conversation, so permission to follow up was not requested. Specialist attempted to clarify what lab work was done, but the pharmacist said she did not have any additional information, only that the patient shared she had been told she did not have antibodies after completion of the Shingrix series Additional Supportive information: The patient completed the shingrix series, had lab work done and it showed she did not had any Shingrix antibodies which led to therapy non responder Note-As per narrative patient gender captured as female
01-30-17 4PM Sudden, excruciating pain in Left arm from shoulder to elbow. Unable to raise arm. I called pharmacy and was told by the pharmacist to go immediately to the Emergency Dept. that I was having a reaction to the shot. Blood work and X-rays were taken. I was given ROBAXIN and MOBIC and icy sling.
I developed an enlarged, red, tender, supraclavicular lymph node on the same side as the injection (left mid clavicle).
8-10 red papule on trunk - few vesicle mild chickenpox 2 vaccine. Treat sx: TYLENOL, BENADRYL. Fever x 48 hrs - T max 102 degrees. Decreased appetite, diarrhea x3 Sat. No cough, congestion, noticed spots on back. VARIVAX x 3 days ago 9/27/10.
Improperly stored vaccine adminstration; shipment was received a day late; This spontaneous report was received from a an administrator via a field representative referring to a 61 years old female patient. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown.   On 22-OCT-2020, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shipment was received a day late (expected arrival date was 21-OCT-2020, product shipment delay) to the reporter's practice, they were not viable for use, and someone in the office mistakenly placed them in the vaccine fridge (confliction information: the box of vaccines got placed into a refrigerator at recommended storage range once received).   On 23-OCT-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # T020638, expiration date 26-FEB-2022; route was not reported) for prophylaxis (improper storage of product in use).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020638; expirationdate: 26-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2011USA015360: US-009507513-2011USA015361: US-009507513-2011USA015362: US-009507513-2011USA015359: US-009507513-2011USA015363: US-009507513-2010USA011251: US-009507513-2011USA015358:
Within 30 minutes, post vax, the palms of both hands became red and itchy. On 7/18/00, follow-up call, she took Benadryl and is doing better.
Fever 24 hours later. Red, swollen, hot at the injection site. Red blotchy skin spread to 4"x6". Painful still, after three days.
2 days after vaccines pt returned to pharmacy displaying redness at injection site, rx told her normal reaction to return to pharmacy if worsens. 4 days after vaccine, pt returned to pharmacy with increased area of redness at IM site, and dark Red, and black skin at subcutaneous site. Was told to return if worsens, or see MD.
A couple hours after recieving the varicella vaccine my son started breaking out with the chicken pox. He had a fever,got really tired and fussy.He is currently taking tylenol for the fever, benedryl to help relieve ichiness,and oatmeal baths to help dry out the rash.
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and medication information provided.  No treatment information provided   Reporter did not allow further contact
Narrative:  69 yo male with PMH tobacco use, TIA, cataract, OSA, HTN PUD,  HF with EF 20-25% reported having diarrhea for 4 days after his first dose of covid-19 Pfizer vaccine on 2/8/2021. Symptoms self-resolved after 4 days. Pt did not seek medical care per record. Patient reported this ADR on 3/1/2021 when he  came back for his second dose of vaccine. Both vaccines were administered without complications.
Information has been received from a nurse practitioner referring to an unspecified number of patients. Information about concurrent condition, concomitant medication and medical history was not provided. The nurse reported that an unknown number of doses of improperly stored VAQTA (lot# M039202, expiry date: 11-MAR-2018) were administered to unspecified number of patients. The vaccines experienced a temperature excursion between 32F and 36F for 17 hours 25 minutes. No adverse effects reported. Data logger was involved. This report is one of the reports from same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006086: US-009507513-1703USA006087: US-009507513-1703USA006085.
Pfizer-BioNTech COVID-19 Vaccine EUA  5 hrs after injection sore arm which subsided by 5pm the following day.   8hrs headache which lasted 12 hrs.  Nause began 30 hrs after, on and off through today.  100 hrs after I am experiencing diarrhea.
Developed a moderate to severe headache several hours after the vaccine and moderate fatigue noted later in the evening.