chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching in throat, slight dizziness.  Next day, flu like symptoms--aches, fatigue, dizziness, large red itching whelp at injection site. Became more severe on the 25th.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Patient became lightheaded about 10 minutes after immunization. He presented as pale, shaky, and almost ready to faint. Patient was given pedialyte, ice, and chocolate after vomiting one time. EMS was contacted, they arrived and assessed the patient. He was cognizant and able to stand on his own. Mother refused transport to the hospital and the family left about 45 min after immunization was given.
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Almonds and walnuts" (unspecified if ongoing), notes: known allergies: Almonds and walnuts. Concomitant medication(s) included: ZINC; VITAMIN D [COLECALCIFEROL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive, notes: Positive test two days after a negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid,19May2022 to 24May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient stated she started having asthma attacks after receiving the vaccine. She stated she rarely has asthma attacks but it started flaring after receiving the vaccine. She stated she felt pressure in her chest (like an elephant sitting on chest) but that is common with her asthma attacks. She denied any swelling, rashes, chest pains or fast beating/pounding heart.
Expired VAQTA was given to patient; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 13-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 1 ml, lot # S007265, with expiration date of 07-JUL-2020, by intramuscular route (strength, dose, frequency, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007265; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report was received from a Nurse refers to a 16 yeare old patient. On 20-MAR-2014, the patient was vaccinated with improperly stored VARIVAX Lot # H014074 (dose, route and frequency were not reported). The nurse reported that the on 24-OCT-2013, VARIVAX was stored for -13.9 C for 8 hours. On 29-OCT-2013, the VARIVAX was stored for -12.8 C for 4 hours. On 14-NOV-2013, the VARIVAX was stored for -11.4 C for 1.5 hours. On 26-MAR-2014, the VARIVAX was stored for -14.7 C for 1.5 hours. On 14-MAY-2014, the VARIVAX was stored for -13.8 C for a total of 5 hours. Since the overall average for VARIVAX was below -15 C, these cumulative excursions of -11.4C for 20 hours is supported. No adverse effect has been reported. No further information was provided. This case is linked to the case 1405USA015833, 1405USA015834, 1405USA015835, 1405USA015837, 1405USA015838, 1405USA015839, 1405USA015840, 1405USA015841, 1405USA015842 and 1405USA008798 (same reporter link). Additional information has been requested.
Flu vaccine administered into left deltoid muscle on 10/12/11.  Met resistance when pushing plunger in.  Had to pull needle out.  Unable to deliver full vaccine (approximately 75% of vaccine was wasted).  No redness or swelling noted at the injection site.  Pt indicated he had had shoulder surgery to both arms several years ago and had recently begun weight training--said his shoulders had been more tight and sore lately, but that he had no limitations or severe pain).  I advised Pt to check with his PCP regarding the injection.  I called Pt back in 1-2 days to check his status and to let him know that according to our consulting physician that it should be OK to get another flu shot d/t not receiving the full vaccine amount should he wish to do so.  Pt did call his family physician who advised no further intervention and that soreness should reside in a few days.  On 11/7/11 Pt called to say that he weakness and discomfort in left arm and that he can barely move his arm above his head.  There is no numbness, tingling, bruising, redness or swelling.  He denies acute pain at rest.
Pt developed erythematous papules on face, trunk 9 days after she received MMR/varicella/PENTACEL, hepatitis A, PCV 13, influenza vaccines.
Headache and facial pain began after 20 minutes, ongoing at 3 weeks (responded minimally to tylenol and no response to advil).  Pain in jaw, spine, and hands began next day, fading at 3 weeks.  Rash on shoulder and upper arm from bra strap to elbow began at 2 weeks, lasted 1 week (with allegra and topic clobetesol).  Symptoms lessened at 3 weeks but not yet resolved.
Gait disturbance. a mother reported that her child received 1st dose of Prevnar on 3/29/01. Within 3 hrs the child developed a limp in the leg in which Prevnar was administered. Follow-up info was received from the physician on 06/25/2001. The reporter indicated that the child developed slight swelling at the injection site. He recovered approximately 3 days later.
6 months after having the vaccine, I was checking my BP and noticed I had an irregular heartbeat. So, I went to an emergency room, and they determined I had a PVC. They referred me to see a cardiologist and it was confirmed I had a PVC. There is no treatment at this time and will continue to be monitored. Occasionally I get dizzy, but unsure if related to PVC. Also, sometimes get "phantom pain" on top of head which I never had before.
Suspected Vaccination Failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure and shingles were unknown.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and experienced shingles. Consent to follow up was not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not provided. This case was linked to US2022AMR022236 from  same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR022236:Same reporter.
p/vax pt exp burning @ the inj site;p/pt presented w/an inj site rash up to neck, swelling, tenderness of the inj site;f/u info indicated that w/in 3 days of onset pt recovered;
Extremely heavy and painful menstrual cycle; Extremely heavy and painful menstrual cycle; Pins and needles/numbness in left leg through foot; numbness in left leg through foot/ Hands and feet "fall asleep"/go numb very frequently; Extreme muscle tightness in left calf; muscle weakness; muscle weakness/fatigue; muscle spasms; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198) via an unspecified route of administration at left arm on 02Mar2021 08:30 (24-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications that the patient received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) via an unspecified route of administration at left arm on 09Feb2021 08:30 (24-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Pins and needles/numbness in left leg through foot began about 3 hours after 2nd dose (from 02Mar2021 12:00). Extreme muscle tightness in left calf. Ultrasound done on calf came back negative. Full brain/spinal cord scan done to detect demyelination of nerves - MRI came back normal. EMG done on left leg to check for peripheral nerve damage - EMG came back normal. Almost 8 weeks post 2nd dose and still experiencing muscle weakness/fatigue and muscle spasms, specifically in legs through feet. Hands and feet "fall asleep"/go numb very frequently, even when the extremities are not restricted in any way. No medication or other treatment given for symptoms. Extremely heavy and painful menstrual cycle this month (1 month after 2nd vaccine, Apr2021), which is extremely abnormal for patient. Events were assessed as serious with criteria of Disabling/Incapacitating. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The outcome of muscle weakness/fatigue and muscle spasms was not recovered; outcome of other events was unknown.
Malaise, HA, nausea that started same day that vaccine given. At 14 days post vaccination sxs, intermittently and getting better
This spontaneous report as received from a other health professional refers to a 11 year old female patient. On 14-MAY-2013 the patient was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscularly. On 15-AUG-2013, 93 days after vaccination the second dose of GARDASIL, the patient experienced headache and rhinorrhea. The outcome of rhinorrhea and headache were unknown. Action taken with GARDASIL due to events were not provided. Additional information has been requested.
Left sided facial numbness and tingling. Left eyelid drooping. Ataxic gate. "Feels drunk"
arrhythmia; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 25 years old and unknown gender patient who experienced arrhythmia while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a serious arrhythmia (unknown latency) following the administration of Influenza Vaccine.  It was reported that ? It goes on and on, and on. It's happening everywhere, and is not normal. 25 years old, operation on the heart after an arrhythmia.  Action taken : not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event outcome : Unknown for the event.  Seriousness criteria : This event(arrhythmia) was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 07-Feb-2022. This case involves a 25 years old and unknown gender patient who experienced arrhythmia while receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses, and concomitant medications. The role of the vaccine cannot be assessed this.
After immunization, approximately 10-15 minutes after. Patient received PNEUMOVAX 23 vaccine for the first time in the exam per protocol. Patient walked half-way down the hall following injection and stopped, leaned forward a bit and looked unsteady. Writer called out to patient asking if she was okay and moved toward her. Saw patient stop and moved toward her also. Patient moved herself to chair sitting in the hallway and said she didn't feel well (we reached right after she sat down). Writer noted that her face and arms were bright red. Dr. notified of reaction and she assessed patient right away.  BP became elevated. Patient was wheezing, very flushed, Oxygen started per N/C.  After about 3-4 minutes patient started to look not quite as flushed, but respirations tight.  Patient transferred to ED for further assistance, patient was discharged from ED without further incident.
Received a dose from a punctured vial after the 12 hour timeframe in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose from a punctured vial after the 12 hour timeframe in the refrigerator) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose from a punctured vial after the 12 hour timeframe in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a dose from a punctured vial after the 12 hour timeframe in the refrigerator) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter. Consent given for Safety to follow up. Email provided for contact.   This case was linked to MOD-2021-208074, MOD-2021-207584, MOD-2021-258552, MOD-2021-258572, MOD-2021-258587, MOD-2021-258599, MOD-2021-258615, MOD-2021-258632, MOD-2021-258644, MOD-2021-258660, MOD-2021-258672, MOD-2021-258682, MOD-2021-258689, MOD-2021-258691, MOD-2021-258693, MOD-2021-258697, MOD-2021-258699, MOD-2021-258700, MOD-2021-258702, MOD-2021-258704, MOD-2021-258706 (Patient Link).
HCP called in to report a temperature excursion on ROTATEQ; No AE/ PQC reported at this time.; This spontaneous report was received from a other health professional concerning to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, frequency, route of vaccination and indication were not provided) (lot # 1741376 and expiration date since it makes match with the autopopulated expiration date 06-MAR-2022).        It was reported, that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccine was stored at temperature excursion. The temperature excursion was between 36 and 48.2 degrees Fahrenheit for a time frame of cero hours and 15 minutes, as recorded by a data logger. There was 46.2 degrees Fahrenheit as previous temperature excursion. No further details available. No additional adverse event reported.   This is one of several cases reported from the same reporter.
expiration date of 05Jul2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 92-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   On 7th July 2022, the patient received Boostrix. On 7th July 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 08-JUL-2022 Reporter's comment: The pharmacist reported that the patient received dose of Boostrix which had expired on 5th July 2022. At the time of reporting, repeat dose had not been administered.  The vaccine administration facility was the same as primary reporter. The reporter did not have patient initials available at time of call. The reporter did not consent to follow-up. Additional Supportive Information:  The patient received a dose of Boostrix which was already expired, which led to expired vaccine used.
Pt received flu vaccine on 11/9/17 in the morning, by the afternoon pt went to school nurse because she was in a lot of pain, said she felt like she was getting a Charlie horse in her arm, tried icing it and it didn't help, is swollen and hot below injection site, painful to touch. Seen in office and diagnosis with allergic rxn, the next day pt came back in office: direct swelling at shot site and this has decreased. But swelling now more diffuse and redness slightly increased as well. Less pain but still sore and pain w/ mvt. No fever. No angioedema. No wheeze/cough. No abd pain. No n/v/d. No rash. No hx of vaccine reactions in past.  - Pt given abx for cellulitis.
Difficulty breathing, pain with inspiration, tight chest, heart palpitations, cough, headache, body aches, fatigue, brain fog. Symptoms ongoing to this day.
Patient called me this morning and reported that a day after she received the shingrix vaccine on 1/30/2020 the location on her left arm where the shot was given had swelled up an was a little itchy with tiny bumps and sore and warm and red to touch, but the swelling and itchiness and warmness and redness went away and subsided.  But she reported after the swelling and itchiness went away 3-5 days, but the tiny bumps still stayed till now but no itching and swelling or redness or warmness.  Told patient to get checked with doctor immediately.
Progressively got sicker and sicker. Vomit uncontrollably for a few days after. Dizziness. Tremors. Feels slightly off not sure if use to it or somethings changed.
Patient with small lump on left thigh noted 7/6/21 by mother; no apparent symptoms; child does not appear bothered by the lump.
(L) deltoid area was red, hot and sore to the touch since 11.9.11. Rx for cephalexin 500 mg 1 QID given.
Swollen left arm; sore left arm, but not a lot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen left arm) and PAIN IN EXTREMITY (sore left arm, but not a lot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 059D21A and 088D21A) for COVID-19 vaccination.     No  allergies (medications, food and other products) reported and no history of relating to mentioned AE and both Acute and Chronic illnesses at the time of  vaccination. Patient did not test positive COVID test or diagnosis.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.    On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, the patient experienced PERIPHERAL SWELLING (Swollen left arm) and PAIN IN EXTREMITY (sore left arm, but not a lot). At the time of the report, PERIPHERAL SWELLING (Swollen left arm) and PAIN IN EXTREMITY (sore left arm, but not a lot) was resolving.            The patient did not experience a similar event in the past.  She was not under any concomitant or regular medication.  After the 1st booster dose on 12 APR 2022, she experienced a swollen and sore left arm, but not a lot, still ongoing but was improving. Adverse event did not cause patient to seek medical care. It was reported adverse event outcome as ongoing arm swollen, slightly painful. Symptoms were improved, a bit better.    Patient did not take any treatment for her symptoms.   This case was linked to MOD-2022-541687 (Patient Link).
Child started with fever with a max temp of 103F. Child continued with fever, lethargy, weakness x 2 weeks. child was given MMRV AND Varicella vaccine same day. So child received extra Varicella vaccine.
Fatigue- within an hour and lasted for 2 days. Fever- within an hour and lasted for two days, 101.8, took aspirin. Rash- red welts on upper chest and neck, lasted 2 days. Chills- within 8 hours and lasted 2 days. Stiff pain-within 24 hours in left shoulder and neck, improving sleep disturbances.
Got shingles a year later.; Patient had one shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Got shingles a year later.) and incomplete course of vaccination (Verbatim: Patient had one shot). The outcome of the shingles was not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported by patient via interactive digital media. The patient received one Shingles vaccine and got shingles after one year. The patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The follow-up could not possible as no contact details were available.
Patient states that she woke two times during the night with her heart pounding and cold sweats. She reviewed the VIS which listed these symptoms as possible reactions. She took Benadryl and symptoms subsided. No issues since taking the Benadryl.