chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was administered undiluted dose of pfizer vaccine (0.3 ml). Upon discovery, we called the patient and notified the error. We consulted him about the side effects of high dose of vaccine (headache, flu like symptoms, fever, chills). Pt was notified half an hour after the administration of vaccine. He did not report any signs of stress during that time. Pt was advised to seek medical help if he experience any severe symptoms or feeling unwell.
Sibling had break-through dx of varicella (VAERS submitted 4/24/08).  Patient given Varivax #2 4/23/08, had onset of pox...5 days later - only 5 pox.
the first vaccine i was just with a headache and a bit tired , after the second vaccine , i felt it coming on 3 hours , by 6 hours later i was getting achy , by 12 midnight which was 12 hours later i had sort of like flu symptoms , then shaking and teeth chattering uncontrollably ,i had a fever not sure how high it went . i took extra strength tylenol. i was feeling crumby still on day 3 but was much better then prior 12 to 24 hours. also  very sore shoulder on both vaccinations. last night which was july 1 i woke and for a brief moment my teeth were chattering ,then it stopped. i have no sign of fever even tho i have a uti . i am on day five of antibiotics.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Lot number: ER8734), in left arm, on 18Apr2021 as dose 2, single (Lot number: EW0170), in left arm, on 18Nov2021 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 25Apr2022 as dose 4 (booster), single (Lot number: FP4564), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: GABAPENTIN; DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergies. Other medication in 2 weeks product: Gabapentin, Dorzolamide hydrochloride Timolol maleate. Anti viral details for COVID 19 Treatment included Paxlovid (lot number: GA6260) from 09Jul2022 to 13Jul2022.  No follow-up attempts are possible. No further information is expected.
Drew up the vaccine, inserted needle in left delt, the barrel separated from the needed.  did not touch plunger, vaccine ran down her arm. there was bleeding (normal bleeding). it puffed almost immediately.  she still wanted flu vaccine and in the left arm so we proceeded with another syringe and dose of vaccine.  she called next day. said arm was swollen in area as big as baseball.  she sent picture. could not see swelling from photo. will call her Thursday pm to check on her arm.
Pt reports started with spots on 2/14, now today 2/15, 10-15 on torso and about that many between both legs. Low grade fever.
17NOV93 t102.5, poor appetite; temp x 2 days; unable to reach parents until 10DEC93;
Pt had a tonic clonic seizure approximately 2 minutes long.  Was post ectal-had se other wise well.
Gastrointestinal issues; Had occasional zaps of pain in toes and tiredness; Had occasional zaps of pain in toes and tiredness; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318) via an unspecified route of administration on 02Feb2021 at 16:00 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included pancreatic cancer. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included levothyroxine; pancreatin (CREON); famotidine; latanaprost; and calcium carbonate, vitamin b12, vitamin D (CALCE) from unknown dates for unspecified indications. The patient did not have any known allergies. On 03Feb2021 at 18:00 around dinner time, the patient started with gastrointestinal issues and also had occasional "zaps" of pain in toes and tiredness. These lasted into Saturday night (06Feb2021). The patient did not receive any treatment for the events. The outcome of gastrointestinal issues, zaps of pain in toes, and tiredness was recovering. It was also reported that the patient had not been tested for COVID-19 after the vaccination.   No follow-up attempts are needed. No further information is expected.
Shivering/chills, muscle aches, nausea, fatigue - lasted about 24 hours, pain at injection site - lasted 36+ hours.
Spotty rash at injection site which was itchy. Lasted a couple of days and then went away.
Pt presented with dizziness approx 10 minutes after vaccination. Pt was given water. 5 mins later, pt presented with a pounding heart and headache. Pt was assessed by RN. Approx 15 mins after initial encounter, pt stated that she felt her hand was shaky. Pt ate some food and drank more water, and was reassessed. Pt felt better and left the vaccination site accompanied by a competent adult.
Approximately 30 minutes after the dose, I suddenly had a severe crushing headache that was primarily on the right side of my head. Accompanied by numbness of my right jaw and jaw pain which also radiated to only my teeth on that side . My face was a little swollen along that side also. I took Advil.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756494A, A0756496A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Pt received vaccine 11/18/13, noticed pimple-like rash on torse where waistband of pants & bra sits (per pt).  Pt states rask started 11/28/13 & is itchy.  Per pt, as of 12/5/13, rash is resolving.
Patient was given 0.2mL of the Regular 12+ year pediatric vaccine. Patient's mother states the child had a fever for 2 days, but is now currently feeling well. Patient's mother states the child was not hospitalized nor had other complications.
Vertigo started suddenly on Day 3 - it felt like my chair dropped 1 foot, out of the blue.   After that,  any movement of my head was too much for my brain to keep up with.  Vertigo/dizziness has continued for the last 4 hours (is still ongoing).
L Deltoid has a firm knot at the injection site.  Area is reddened.  She complains of arm pain.
Within 24 hours became dizzy, fever, lower ext -> weakness; pain in legs, nausea
Polyarthralgia significant enough to require ED evaluation for pain management (received Toradol and discharged)
Patient reported intense pain in muscle surrounding right arm injection site. Pain was getting worse overnight, she had difficulty raising arm above chest level, and might not be able to go to work. FLUVIRIN given in other arm but that arm was fine. PNEUMOVAX arm was the problem.
flushed, hot, itchy Benadryl 50mg IM given in car observed in medical tent for 30-60 minutes patient left in POV feeling much better
No adverse effects reported; that were improperly stored./ excursion occurred; This spontaneous report was received from a vaccine coordinator regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 21-JUL-2019, the patients were vaccinated with improperly doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product storage error) for prophylaxis, lot number N022727, expiration date 12-JUN-2020 (strength, dosage, frequency, and route of administration was not reported). However, no adverse effects reported.   The administered dose of vaccine experienced the temperature excursion on 25-AUG-2018 with 30 Celsius for 3 hours. Data logger was involved. There were no previous excursions reported.  This is one of four reports, received from the same reporter.; Sender's Comments:  US-009507513-1907USA015535: US-009507513-1907USA016724: US-009507513-1907USA016723:
Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)    Patient is a 69 year old male with significant smoking history, who recently had CT which showed RIGHT lung nodule concerning for cancer. Repeat scan showed the nodule was decreased in size significantly, however did show large LEFT pleural effusion, causing patient chest pain and dyspnea. Patient admitted for further workup and management   COVID positive by PCR, also reports that he was positive at home in late March, son had moderate symptoms and tested positive; patient tested after this result. He had minimal symptoms at onset. Was noted to be slightly hypoxic on room air, to 89%. Was placed on 2L oxygen, and was weaned off. During home O2 eval patient did desat to 89% on day of discharge, but had no symptoms of dyspnea or chest pain. Discharged home without O2 (88% cutoff used).   Thoracentesis performed, positive Light's criteria. No malignant cells seen, potentially parapneumonic effusion based on COVID infection. However with recent imaging, unable to rule out malignant effusion. Given loculated nature of effusion prescribed antibiotics for three weeks. Gram stain with bacteria but culture did not result with anything. Recommend repeat imaging with PCP, for effusion as well as for lung nodule.   Chronic issues including hypertension, hyperlipidemia, GERD treated with home medications. Stable on discharge   Issues Requiring Follow Up: (Who, what, when, and how communicated?)  Right lung nodule on CT imaging Loculated effusion may require follow up imaging as well to ensure resolution
Patient reports that at about 30 minutes after she received her vaccine, her lips began feeling numb and tingling, mouth dry.  She reports her face starting itching and developed a red rash, her face felt like it was "on fire".  She denied any shortness of breath or difficulty breathing.  She walked back into the clinic office at 1240, a set of vitals were taken and at 1250 25mg of PO benadryl was administered.  Patient was held for observation and at 1325 she reported that the itching had improved.  She did have an itching sensation in her through but no feelins of constriction or difficulty breathing.  She stated that she did not feel drowsy and was okay to drive herself home.  Her husband would be at home with her for the remainder of the day and she was told that if she developed any new or worsening symptoms to report to the ED immediatley.
Patient states she had an extreme headache the day following vaccination. She is now stating  on a phone call on 8/12/2022 nearly 8 months after vaccination that she has an enhanced sense of smell, a loss of taste, short term memory loss and she is complaining she now hates many foods that she used to  love. Specifically, she stated eggs as a food she used to love but now she can taste the albumin in them and disgusted by said food.
Information has been received concerning a pt who had been vaccinated with varicella vaccine and 2 years the pt developed chickenpox that consisted of approximately 10 lesions and no fever. It was not known if the pt was exposed to wild type varicella virus. It was reported that the pt sought unspecified  medical attention. Follow up information from the mother indicated that her daughter broke out into a fluid filled rash all over her body. The pt was never seen in physician's office but the pt did recover.
Surgery after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (Surgery after 1st dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SURGERY (Surgery after 1st dose). At the time of the report, SURGERY (Surgery after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. No treatment medications were reported.  Patient had a surgery after first vaccination so patient wanted to reschedule the second dose of vaccine  Company Comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
The infant was given Hepatitis A vaccine instead of his first Hepatitis B vaccine. No symptoms reported thus far. Family notified.
Urinary retention; A spontaneous report was received from a female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed urinary retention.   The patient's medical history was not provided. Concomitant product use was not provided.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   The patient reports that two days after receiving the vaccine, she developed urinary retention. Treatment for the event included cephalexin.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, urinary retention, was considered unknown.; Reporter's Comments: This case concerns a female patient, who experienced event of urinary retention. The event occurred 2 days after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
Dizziness, HEADACHE, Myalgia, CHILLS/FATIGUE Narrative:
patient has rash over arms and throat, has shortness of breath, needs go to hospital for assistance.
This spontaneous report was received from a pharmacist refers to a 70 year old male patient. The patient's current condition included diabetes, hypertension and hypercholesterolemia. The patient did not have any drug reactions or allergies. On an unknown date in 2012 (reported as 2 years ago) the patient was vaccinated with ZOSTAVAX (strength, dose, route of administration and lot number were not reported). Concomitant therapies included LIPITOR, niacin, TRICOR, metformin, hydrochlorothiazide (manufacturer unknown), lisinopril (manufacturer unknown), REQUIP and PLAVIX. On an unknown date the patient was diagnosed with shingles by his unspecified physician. The patient was treated with acyclovir. The patient had sought medical attention by office visit. There was no product quality complaint (PQC) involved. The outcome of shingles was reported as not recovered. Causality of the event was not provided. Additional information has been requested.
Part of Mass vaccination event , pt was screened several times , and age was over looked at time of vaccination, Patient was not age eligible at tiome of vaccination
Information has been received from a nurse practitioner concerning a 21 year old female who had a biopsy on 08-MAY-2007 (reason not reported) and was also vaccinated with Gardasil at 8:00 pm. Concomitant therapy included ethinyl estradiol (+) norethindrone acetate (LOESTRIN). On 09-MAY-2007 the patient became paralyzed from the neck down while at school and was taken to the emergency room by ambulance. Upon internal review, paralyzed from the neck down was considered to be an other important medical event. Additional information has been requested.
Severe left arm pain. Placed ice packs on left arm. Took ibuprofen. Throughout the night was unable to move arm due to pain. Experienced warmth, muscle, joint aches, and swollen. Aching. Pain underneath left arm. Slight fever 99.2. Pain in ribs on left side.
sneezing; runny nose,clear nasal discharge; dry cough; A spontaneous report was received from a consumer concerning a 79 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sneezing, runny nose, clear nasal discharge/ rhinorrhea, dry cough/ cough.  The patient's medical history was not provided. Concomitant medications taken by the patient were not provided.  On an unknown date, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: unknown) through unknown route at unspecified site for prophylaxis of COVID-19 infection.  On 27 Feb 2021, prior to the onset of the event, the patient received second of their two planned doses of mRNA-1273 (Lot number: 011A21A) through intramuscular route at unspecified site for prophylaxis of COVID-19 infection.  On 27 Feb 2021, patient experienced sneezing, runny nose, dry cough, clear nasal discharge.  Treatment activities for event was unknown.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, sneezing, runny nose, dry cough, clear nasal discharge was unknown.; Sender's Comments:  MOD-2021-029946:cross link, husband's case
This spontaneous report as received from a registered nurse refers to an unknown number of patients of an unknown age. The nurse reported that an unknown number of doses of GARDASIL (0.5ml, intramuscularly) and RECOMBIVAX HB (Pediatric/Adolescent formulation) that were exposed to temperature blow 32F have been administered. No adverse effect was reported. It was unknown if the patients sought medical attention. At the time of report the status of patients was unknown. Additional information has been requested.
Has been taking the cholera vaccine up until age 73; Spontaneous report received on 14MAY2020.  A male consumer reported that he "has been taking the cholera vaccine up until age 73" (PT: Product use issue). The consumer was receiving Vaxchora for immunisation. On 14MAY2020, the patient was informed that the cholera vaccine would not be provided to him because centers for disease control and prevention (CDC) does not recommend it over the age of 62. Although, he was taking the cholera vaccine until age 73. Action taken with Vaxchora with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was reported that a consumer had been taking the cholera vaccine (Vaxchora) up until the age of 73 (Drug use in unapproved age group). Further details of the event is limited. Vaxchora is indicated for use in adults (18 to 64 years of age) who are traveling to cholera affected regions, and the causality of the event is assessed as not applicable to Vaxchora.; Sender's Comments: It was reported that a consumer had been taking the cholera vaccine (Vaxchora) up until the age of 73 (Drug use in unapproved age group). Further details of the event is limited. Vaxchora is indicated for use in adults (18 to 64 years of age) who are traveling to cholera affected regions, and the causality of the event is assessed as not applicable to Vaxchora.
Menstrual cycle began five days early. Experiencing a lot of cramping and a much heavier flow than normal. My menstrual cycle has never started early before.
sore in the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the 1st dose and experienced sore in the injection site.  The reporter did not consent to followup.  This case has been linked with US2020204752 and US2020AMR206445 reported by same reporter. For tolerance of 2nd dose refer case US2020AMR206625.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020204752:same reporter (reporter´s case)
High heart rate spikes; heart rate issues got significantly worse; Pins and needles in arms and legs; ocular migraines; anxiety; panic attacks; breathing issues; pressure in chests; fatigue; vertigo; POTS; diarrhea; nausea; ocasional dizziness; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 14:00 (2:00 PM) (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. No medical history included and patient's concomitant medications were not reported. The patient reported that: "High heart rate spikes started 9 days after first vaccine. They continued to go unnoticed until my symptoms peaked in July. This is where my heart rate issues got significantly worse and other issues occurred. Pins and needles in arms and legs, ocular migraines, anxiety, panic attacks, breathing issues, pressure in chests, fatigue, vertigo, POTS, diarrhea, nausea". The patient also stated that: "I'm still dealing with the cardiac issues, occasional dizziness, pins and needles and GI issues". The events reported to start on 12Mar2021 at 06:00 PM. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and hospitalization for 3 days. No treatment was noted. The patient had no Covid prior vaccination. The patient is covid tested post vaccination via Nasal Swab on 25Aug2021 with negative result. The outcome of the events was not recovered
Shortness of breath began 12/29/21, chest congestion and positive COVID19 test 12/31/21. Due date: 8/18/22
Client called and reported a rash all over her body on 12/24/08.  Went to ER on 12/29/08 - Urgent care at medical center.  Rx with Methylprednisolone and was told by MD - no further HEP B vaccine.  Client denies any more problems at this time.