chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the day of the 1st dose, I tasted heavy metals in my mouth and some aches throughout my body. 2nd dose, I will be fine until the following day, I felt like I got hit by a semi-truck. Every bone in my body hurt. It lasts about 24 hrs. But I really felt off for months after. On December 24 I felt really flush and my hips hurt like I was getting a sinus infection. 25th same thing but when I woke up on the 26th I could not open and close my hand it hurt so bad. My hips and feet hurt. Then my whole body felt like I got hit by a semi-truck. I did a home test and tested positive for Covid.
Pediatric dose was administered to patient instead of the adult dose recommended.  Family and charge nurse notified of incident. LPN
Narrative: Patient received Moderna vaccine dose #1 on 03/19/2021 and dose #2 on 04/19/2021. He presented to the ED on 12/7/2021 with chief complaint of chest pain, shortness of breath, and fever. O2 saturation as low as 87% and he was admitted to the hospital and treated with remdesivir and dexamethasone.
received an expired dose of tenivac with no reported adverse event; Initial information received on 13-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age male patient who had received an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Oct-2023, the patient received an expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot number, strength, dosage- not reported) (expiry date- 24-SEP-2023) via unknown route in unknown administration site for lacerations (Skin laceration) with no reported adverse event (expired product administered) (latency- same day). Information on the batch number was requested.  Reportedly, Caller wanted to know about what to do next. Caller received the TENIVAC on 12Oct2023, due to consumer having some lacerations.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Customer experienced swelling on lower left side of face. Doctor had her to take Benadryl otc.
Experienced double vision for 5 minutes on 11/26/22 and again for 2 minutes on 11/28/22--no pain, no loss of vision, only present with both eyes open. No other neurologic symptoms such as dizziness, headache, weakness, numbness/tingling. It resolved on its own, no treatment was needed to stop the double vision. I did see my primary care office on 12/1/22 for an physical evaluation with a normal neurologic exam and a recommendation to see ophthalmology for an eye exam. If there is no findings with the eye exam, PCP office is planning brain imaging and blood work.
None--pt was given vaccine that had been stored at conventional freezer temp > than 14 days.  Pt was offered another dose.
A report has been received from a health professional concerning a 4 year old female subject, who had been receiving nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 17-Dec-2013. The health professional reported that they inadvertently gave three doses of expired FLUMIST (preferred term: expired drug administered) on 17-Dec-2013. The outcome of the event of administration of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Patient voiced she was anxious and asked for water.  Patient voiced she felt warm then became unconscious for few seconds. Her head was protected from injury.  911 called. No medication given. Ice pack given for cooling measures. Patient said she felt fine and refused further treatments and hospitalization. O2 saturation 99% room air. Heart rate 90bpm. No shortness of breath and no other abnormal findings noted.
After receiving injection a large bluish, red, purple lump formed on the surface of the skin.  It came to a head, pussed, scabbed and would get smaller, but didn't disappear.  A biopsy was taken and was found to be necrobiotic collagen with palisading granulomatous features.
Patient received incorrect second dose COVID-19 immunization. First dose COVID-19 was Moderna
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On an unknown date, the patient was vaccinated with ZOSTAVAX refrigerated vial (lot#, expiration date, strength, dose, anatomical location and route of administration were not reported). On an unknown date, about a week after getting the vaccine, the patient experienced injection site reaction. The patient was treated with hydrocortisone and the event was considered as not serious. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Moderna COVID-19 Vaccine EUA dose given 54 days after BUD for refrigeration
Vaccine administered 5-13-08. 5-15-08 Soreness in right shoulder, supralateral aspect then more pronounced. On 5-19-08 reported cannot lift above horizontal. No paresthesia, weakness or fever.
Redness at injection site getting bigger; Redness at injection site lasting longer; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Redness at injection site getting bigger), CONDITION AGGRAVATED (Redness at injection site lasting longer) and INJECTION SITE ERYTHEMA (Redness at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at the injection site). On 24-Feb-2021, the patient experienced CONDITION AGGRAVATED (Redness at injection site getting bigger) and CONDITION AGGRAVATED (Redness at injection site lasting longer). At the time of the report, CONDITION AGGRAVATED (Redness at injection site getting bigger), CONDITION AGGRAVATED (Redness at injection site lasting longer) and INJECTION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO CONCOMITANT AND TREATMENT MEDICATIONS WERE NOT USED   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non significant follow up appended
Had all the described symptoms in literature (sore arm, swelling, headache, flu-like symptoms continued for 2 1/2  weeks (body aches, sinus congestion, sweating, fatigue, (fever?), then receded to "just" chronic left arm pain (pain waking me at night), limited arm movement, can't reach behind back or lift up without pain. Continues still to this day, 12-14-17. On a follow-up visit with Dr. (date unknown: a few months later), I complained of the prolonged symptoms following PREVNAR-13 shot and continuing arm pain awakening me in middle of night. She said I probably had an allergic reaction to the tetanus serum in Tdap and shouldn't have that shot in future. I've had at least 2 tetanus shots in my life and never had adverse reaction. For arm pain she ordered x-ray which I wasn't allowed to see but was told it was arthritis and to take ALEVE or other NSAID and most recent visit to take melatonin 10 mg to help with sleep. None of this is helping the arm pain which I believe is caused by taking a PREVNAR-13 injection to prevent pneumonia, which at this time I would rather take my chances with pneumonia than live with chronic shoulder pain/insomnia. Side note: at time I was given injection, the nurse (don't remember name) said at first try at arm jab, the needle tip "broke", so started over, but can't be related to serum side effects, right? It's now almost 1 1/2 years since I made the big mistake of agreeing to be an old guinea pig for a supposedly "safe" vaccine. Will I receive an acknowledgement of receipt of this form?
Fever; Dizziness; Inability to Walk; This case was reported by a consumer via call center representative and described the occurrence of fever in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number FZ7Z4, expiry date 27th January 2023) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 30th August 2021, less than a day after receiving Shingrix, the patient experienced fever, dizziness and unable to walk. The patient was treated with paracetamol (Tylenol). On 1st September 2021, the outcome of the fever, dizziness and unable to walk were recovered/resolved.   It was unknown if the reporter considered the fever, dizziness and unable to walk to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received first dose of Shingrix vaccine in left deltoid muscle.   For the 24 hours following vaccine patient stated she had high fever, dizziness, and inability to walk.   The patient stated she then took Tylenol and was fine.   The patient had been advised by her health care provider she should not receive second dose. The reporter consented to follow up. The patient gave permission to contact pharmacy for follow up information.
First case of shingles after ZOSTAVAX; the second case after SHINGRIX; This spontaneous report has been received from a female patient of unknown age via Glaxosmithkline, referring to herself. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was unknown.  In 2017 (reported as about 4 years ago), the patient had varicella zoster vaccine rge (cho) (SHINGRIX) vaccine (and completed the series) (indication unknow). On unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis. The dose, strength, route, lot number and expiration date were unknown.  Then, on unknown date, she had a mild case of shingles. The patient had cases of shingles twice. First case of shingles after zoster vaccine live (ZOSTAVAX) and the second case after varicella zoster vaccine rge (cho) (SHINGRIX). The outcome of the events was unknown. The causality assessment between the events and suspect vaccines was not reported.  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2109USA005810:
Red spot on arm; Sore; Itchy; This is a spontaneous report from a contactable consumer (patient herself). A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number and Expiry date were not reported) via an unspecified route of administration in the right arm on an unspecified date in 15:45 and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number and Expiry date were not reported) via an unspecified route of administration in the right arm on 17Jun2021 14:45 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history included meniers disease, obesity. The patient concomitant medications were not reported. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took morphine (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 17May2021 at 15:45, the patient had experienced red spot-on arm, sore and itchy and stayed that way for 2 weeks. The patient receive treatment for the adverse event Spot still on arm, but soreness and itchiness gone with the first dose used cortisone cream. Got the second dose on 17Jun2021 same thing happened but much more intense. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events which included cortisone cream but not helping on second dose. The outcome of the events was not recovered.  Information on Lot/Batch number was not available. Additional information has been requested.
sore arm; swollen tongue; rash at injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (sore arm), SWOLLEN TONGUE (swollen tongue) and VACCINATION SITE RASH (rash at injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), SWOLLEN TONGUE (swollen tongue) and VACCINATION SITE RASH (rash at injection site). At the time of the report, PAIN IN EXTREMITY (sore arm), SWOLLEN TONGUE (swollen tongue) and VACCINATION SITE RASH (rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
high pitch cry, irritable, inconsolable low grade fever 100-100.5 R;
Within 15 minutes of receiving the vaccine, the patient began having conjunctival suffusion, lacrimation, nasal stuffiness, and tachycardia. The patient was treated with epinephrine and Benadryl.
About 26 hours after receiving the Pfizer Covid Vaccine, I experienced about half an hour of extreme dizziness, starting about 6:00 pm.  It lasted so long that I decided to just go to bed. I have never experienced such intense dizziness before.  Also, I felt tired the next day, and just stayed home and rested. So far, I have not had any more dizzy spells.
VARIVAX has been administered with an inappropiate storage; No additional AE details; This spontaneous report was received from a consumer referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On an unknown date, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX)  for prophylaxis (lot # U039949 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 16-DEC-2023) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were -14° Celsius (C) up to -10°C for 2 hours and 5 minutes and -10°C up to 8°C for 1 hour and 25 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines experienced a previous temperature excursion of -14°C up to -10°C for 0 hours 50 minutes.  No adverse event reported.
CLIENT STATES THAT AFTER FLU INJ SHE BEGAN W/ C/O SHOULDER PAIN, BEING 'PARALYZED' AND 'NO FEELING ' IN l SHOULDER.  ALSO REPORTS THAT INJ SITE WAS RED AND WARM.  SAW PMD ON 11/01/06 AND REFERRED TO NEURO BUT ALL TESTING HAS BEEN NEGATIVE.  CONTINUES W/ C/O DIZZINESS AND SORENESS
Had bloody stools and vomiting on 1/8th night and 1/9th morning. He had intussusception which required surgical repair. I am not sure if this might be related to Rotavirus given on Dec. 9, 2006. 02/07/07-records received and reviewed for DOS 01/09-01/12/07 DC DX: Intussuception 3 mo old presented to hospital with BRBRP that began on 1/8/07-history of loose stool times 2 days. emesis began last night. Seen in ER and sent home. Returned with dec activity had 30 cc BRBPR in ED.  Underwent barium enema reduction attempt 3 times which reduced from sigmoid colon to ileocecal valve but not beyond valve. PMHX: none Underwent surgical correction for intussusception on 1/9/07- also performed appendectomy. On post op day 3 had mild abdominal distention but bowel sounds were present. BMs were normal. DC home.
Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            No concomitant medication were provided by reporter. No treatment was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Spoke to daughter by phone and she reports tonight the patient called stating she hit her head and evidently pretty hard on two closet doors knocking them off track.  She continues to have diarrhea in which the daughter did give her two immodium tablets today.  Patient resides in an assisted living facility.  Staff reports that they had to help her back to her room due to increased weakness. Pt reports she feels poorly. She complained of severe weakness, chills and rigor at times.   Reports confusion.  Patient's daughter brought patient to the ED due to worsening confusion.  Patient also reports that she was found on the floor her living room at assisted living and had no memory how she got there.  Workup in the ED tonight revealed electrolyte imbalance along with positive COVID-19 PCR.
1600: Received flu vaccine in clinic today.  Family exited building and getting into car.  1610:  Pt within a couple of minutes of receiving vaccine started having difficulty breathing. He said he felt like he couldn't breathe and he was having swelling in his neck.   Patient started to cough and turned very red.  Said he throat felt tight.  Complained of nausea.  Felt like this came over him like a "lighting bolt".  Stomach feels as if someone is pushing on it.   Tired appearing.  He denies dizziness. He has not had similar feelings in the past. He has no known allergies to egg.  1627:  Epi 0.3 mg given IM  with improved symptoms within 3-5 minutes.   1635:  EMS arrived and transported patient to Hospital.  observed for 3 hours.  Send home on Prednisone, Pepcid and Benadryl.  Given epi pen for home use, if needed.   09/23/2020  Mom reports the patient is doing well and has no concerns.
Pain to immunization site immediately with duration 7 days swelling to immunization site 8-10 hours to vaccine" no erythema or warmthness to touch, no other symptoms.
left arm became very red; itching from the injection site muscle; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: left arm became very red) and injection site itching (Verbatim: itching from the injection site muscle). The outcome of the injection site erythema was resolving and the outcome of the injection site itching was resolved (duration 10 days).   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.  It was unknown if the company considered the injection site erythema and injection site itching to be related to Shingrix.   Additional Information: GSK Receipt date: 23-JUN-2023 A reporter reported about him self he received the first dose of Shingrix at his left arm on end of Apr 2023. The reporter states that after his injection, his left arm became very red and was itching from the injection site muscle, down the top for 10 days, but the redness lasted a little longer and got lighter and lighter after 10 days. The reporter was consent to follow up.   Upon internal review the case was updated on 20-NOV-2023. This case was initially processed as invalid, however upon significant follow-up received on 23-JUN-2023, case became valid and it was missed to add appropriate significant follow-up tracking, due to which regulatory reports had not been scheduled. The case was amended for error correction. Summary of Changes: Significant amendment tracking added with description as error correction and narrative updated.
One week after COVID-19 vaccine, had to get a one week Rabies shot. Dr. decided to give an antibody treatment instead of PAXLOVID.
INTENSIVE CARE UNIT; This spontaneous report received via social media from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown) dose, start therapy date were not reported, 1 total, for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, after the vaccination, the patient was in the intensive care unit (ICU), and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of intensive care unit was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210420177-covid-19 vaccine ad26.cov2.s-Hospitalization. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Caller reported AE for expired Measles, Mumps, Rubella and Varicella, Virus Vaccine Live (PROQUAD) that was inadvertently administered to a patient.; No symptoms reported.; This spontaneous report was received from  a medical assistant concerning a patient of unspecified age and gender.   The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were (unknown or not provided) by reporter.  On 01-AUG-2023, the patient was invertedly vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) (PROQUAD), subcutaneous injection, albumin status recombinant human albumin (rHA), 0.5 milliliter, administered for prophylaxis (Lot No. U031562 has been verified to be a valid lot number, expiration date reported as 06-APR-2023 and confirmed upon internal validation) (strength, and route of administration were not provided) (Expired product administered). No symptoms (No adverse event) or temperature excursions (TE) were reported.