chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported feeling lightheaded. No shortness of breath or difficulty breathing. Patient advised to lie flat and to stay hydrated. Patient instructed to notify medical staff or worsening symptoms. patient left site with resolved symptoms after a few minutes.
Self-attestation on site allowed patient to sign up for Moderna, despite being younger than 18 when administered.
This spontaneous report was received from a physician via company representative referring to an unspecified numbers of patients that on an unknown date, were vaccinated with a dose of PNEUMOVAX23 (lot # not reported). The physician mentioned that the patients developed red rash at the injection site after receiving PNEUMOVAX23. At the time of this report all patients outcome were unknown. Additional information has been requested.
Pt presented in office on 7/05/05 with a rash. Pt was diagnosed with chickenpox. Treatment-supportive.
No additional AE; a 14 month old who was mistakenly given PNEUMOVAX 23 instead of Prevnar 13; a 14 month old who was mistakenly given PNEUMOVAX 23 instead of Prevnar 13; This spontaneous report was received from an office manager referring to a 14-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 26-JUL-2021, the patient was mistakenly vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ml, lot # T035379 with expiration date 31-MAY-2022, for prophylaxis (strength and route of administration were not reported) instead of pneumococcal vaccine conj 13v (crm197)(PREVNAR 13). No additional adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Redness at injection site ~2-3 cm diameter and rash on back first noted by parent 10 days after vaccination. Evaluated by MD on same day. No significant induration. Rash on back consisting of many diffuse very fine pustules with surrounding erythema, no vesicles.
Had a knot the first two days and soreness.  It got better, but last Monday, it started to get red and warm.  Each day the redness grew.  Went to an urgent care on day 6 when arm above elbow was very red and warm. Doctor said it was cellulitis and prescribed Bactrim for 7 days, and ice 3/4 times daily.  Go to PCP if in a couple of days the issues have not improved. Am starting the first dose of the Bactrim shortly (twice a day)
Information has been received from a nurse concerning a female patient who on an unspecified date, was vaccinated with the first dose of GARDASIL vaccine. On an unspecified date, was vaccinated with the second dose of GARDASIL vaccine 0.5 ml, IM. A day after vaccine was received, the patient experienced sores in her mouth after second dose. The patient's sores in her mouth persisted. The patient sought unspecified medical attention. Additional information has been requested.
Headache, Nausea, Night sweats, Body aches, Tinnitus
Joint pain, stomach ache, loss of appetite, difficulty sleeping, flushed cheeks, malaise.
Punctured Janssen COVID 19 vaccine vial was left at room temperature for 2 hours longer the manufacture recommended time. First punctured was at 11:45a, and vaccine was given at 3:42pm. Patient has headache and sore arm and a little joints pain the next day but no other symptoms.
HEADACHE; SHORTNESS OF BREATH; WHEEZING; COUGHING; SWOLLEN THROAT; DIZZINESS; FLU LIKE SYMPTOMS; PALENESS; REACTIONS BEGAN WITHIN 30 MINUTES OF VACCINE.  FLU LIKE SYMPTOMS LASTED 2 DAYS.  OTHER SYMPTOMS ARE STILL PRESENT.  TWO DAYS AFTER RECEIVING THE SHOT, PATIENT CALLED DOCTORS OFFICE AND LEFT MESSAGE ABOUT REACTION. AT THE END OF THE DAY (AFTER 5PM) DOCTOR RETURNED CALL. DOCTOR ADVISED PATIENT TO GO TO URGENT CARE.  SHE WAS ALSO TOLD 'NOT' TO TELL URGENT CARE PHYSICIAN SHE HAD RECEIVED A VACCINE, BECAUSE SHE WOULD GET NO TREATMENT IF SHE DID.  PATIENT WENT TO URGENT CARE.  PATIENT DID TELL DOCTOR ON CALL AT URGENT CARE ABOUT GETTING THE VACCINE, BECAUSE SHE WAS AFRAID IF SHE DIDN'T, THE DOCTOR MIGHT GIVE HER SOMETHING THAT COULD REACTION WITH IT.  DOCTOR AT URGENT CARE DIDN'T WANT TO DISCUSS PATIENT HAVING A PNEUMONIA VACCINE, SAID HER SYMPTOMS WERE NOT A REACTION TO VACCINE.  DOCTOR LISTENED TO PATIENTS CHEST, AND TOLD HER SHE WAS HAVING AN ASTHMA ATTACK.  PATIENT TOLD DOCTOR SHE HAS HAD ASTHMA SINCE SHE WAS 6 WEEKS OLD, AND THIS WAS NOT AN ASTHMA ATTACK.  DOCTOR DID NO TESTING. DOCTOR DID NOT EVEN TAKE A CHEST X-RAY.  PATIENT WAS GIVEN A BREATHING TREATMENT AND RELEASED.
a patient was given powdered component of the Pentacel vaccine, diluted with sterile water; Initial information received on 18-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7-months old (also reported as 8 months old) female patient who was given powdered component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5) /HIB(PRP/T) VACCINE [PENTACEL], diluted with sterile water (lot UJ134AAA,dose: 0.5ml expiration date: 04-Oct-2020) via intramuscular route in the left thigh on 18-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.   It was an actual medication error due to wrong solution used in drug reconstitution. The Hib lyophilized component administered separately will count as a valid dose only if it was reconstituted with the proper diluent, i.e. 0.4% NaCl saline solution.  At the time of reporting, no adverse event was reported.  The outcome was reported as unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  List of documents held by sender: none.
10 days after first vaccination, itching, burning rash on forearms and hives/itching around knees, ankles, and hands. Lasted 7-10 days then cleared. Recurred in same areas within 24 hours of second vaccine dose.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 78-year-old female patient who received SHINGRIX (batch number 4X733, expiry date 8th March 2021) for prophylaxis. On 9th April 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 10th April 2019, 1 days after receiving SHINGRIX, the patient experienced injection site rash and injection site erythema. On an unknown date, the outcome of the injection site rash and injection site erythema were recovering/resolving. It was unknown if the reporter considered the injection site rash and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX at 9:50 am. Either the next day or the day after, the patient experienced a red rash that forms a band around the injection site. It had improved but had not resolved.
When administering first dose, the needle retracted mid-vaccination and part of the dose went on the patient's arm (using a retractable needle).  The amount injected into the patient's arm was estimated to be about 1.5mL. The patient then received another 1.5mL of Pfizer. The patient did not experience an adverse event.
Discomfort; Had severe pain all over her body; pain on head; pain on scalp; pain in ear; redness in left eye; difficulty seeing; sensitive to light (photosensitive); blisters on face; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 9ZJ25, expiry date 23rd January 2023) for prophylaxis.   Concurrent medical conditions included multiple sclerosis and rheumatoid arthritis (which treated with Methotrexate).   On 20th August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2021, less than 3 weeks after receiving Shingrix, the patient experienced blister. On 20th August 2021, the patient experienced general body pain, headache, scalp pain, ear pain, eye red, visual impairment and photosensitivity. On 23rd August 2021, the patient experienced discomfort. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Ice Pack (No Medication)). On 21st August 2021, the outcome of the eye red was recovered/resolved. On 27th August 2021, the outcome of the general body pain was recovered/resolved. On an unknown date, the outcome of the headache, scalp pain, ear pain, visual impairment, photosensitivity and blister were recovered/resolved and the outcome of the discomfort was recovering/resolving.   It was unknown if the reporter considered the general body pain, headache, scalp pain, ear pain, eye red, visual impairment, photosensitivity, blister and discomfort to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient herself. The patient had reported these adverse events to the CDC, her pharmacy, her doctor, State Health Department, County Health Department and the Immunization Division for her state. The patient received a dose of Shingrix and she felt fine for first hours after the vaccine then she had severe pain all over her body for approximately 7 days, the pain on her head and scalp was all over head and scalp but also, a plum sized circle of pain over her left ear, like a circle of gunshots that moved from over her ear to the top of her head to the back of her head, had redness in her left eye and went away on the first night, had difficulty seeing for a couple days, was sensitive to light which resolved within 4 days and had blisters on the lower part of her face which resolved within 5 days. The patient called an Urgent Care office about 3 days after the vaccine and they recommended Tylenol by mouth and Ice packs for her discomfort, which she said did help. Medicine of doctor had cancelled the 2nd dose of her vaccine. The reporter consented to follow-up with herself and with her doctor.
Patient developed a heavy rash over the entire upper body Dermatologist identified as a Hypersensitivity Reaction Prescribed topical lotion and mosturizer
3-27-21 Arm stared getting sore 2-3 hours after shot and increased though out the day.   Was very sore until 3-29-21. 3-30-21 Noticed in the afternoon that left arm around injection site and below very red and blotchy.  Does not itch but a little warm and feels like a bruise.   Have put ice on it and some of symptoms have gone away.
Patient stated he developed rash on arm and chest 4 hours after injection on 3/16/22.  on 3/17/22 he stated he had a "candle wick like"substance come out of the injection site.  He said it does not appear infected at the time of report.
this is one of four pt from this site to devel a lump at the inject site after recv vax
they only gave the liquid portion. She was referred to the Pentacel Reconstitution with no adverse event; Initial information regarding an unsolicited valid non-serious case received on 30-Dec-2020 from a other health professional.  This case involves a patient (unknown demographics) who received the liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], while she was referred to the pentacel reconstitution (product preparation issue).  Medical history, medical treatment, vaccination, family history and concomitant medications were not provided.  On 29-Dec-2020 (reported as yesterday), the patient received a partial dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number, expiry date and other dosing details were not reported] via unknown route at an unknown administration site for prophylactic vaccination as advised by nurse.  It was reported that the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) was only one of the 2 vials that came in the pack was given and they only gave the liquid portion (Product preparation issue). They wanted to know if they should re-administered the vaccine with the correct dose.  At the time of report, no adverse event was reported.  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 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.  There will be no information available on the batch number for this case.
Headache, migraine, nausea, vomiting, vertigo, perithecia, left-sided weakness, numbness, tingling, slurred speech, muscle weakness, fatigue, balance issues, concentration issues, light sensitivity, sleep disruption, dehydration, diarrhea, vision problems.
I had no difficulties with the first two Moderna vaccines given in April and May of 2021 - minor myalgia for which I didn't need any medication.  However with this booster dose, I had a severe response that evening with very bad myalgia, shaking chills, with some nausea and headache.  The reaction was so severe that I could not sleep, and could barely get around. Finally at 1:00 AM I took a Tylenol with only minimal relief.  In the morning, I still felt like I had been "hit by a truck", to the point of tears because I had work to do.  I took one more Tylenol at noon, trying to minimize analgesics.   This was quite unexpected, as I had no anxiety about getting the booster shot, and on-line information reports that the reaction to the Moderna booster had been  about the same or better than to the primary vaccinations.   I actually double-checked with the pharmacist this morning that the booster dose is reduced to .25 ml, and they say that it is. I am writing about this adverse response because the booster shot is being so strongly advised, and required in some circumstances.    While I have been very pro-vaccine, I would be loath to have another booster if this is going to happen routinely - the reaction has been honestly frightening.  I wonder if there needs to be a closer look taken at the interval time and dose for this first booster.  While the first vaccinations were administered with lots of paperwork for reports of side effects, I received no such paperwork from the pharmacy.  I'm not at all comfortable that adverse reactions are being adequately monitored.
Widespread >30 papules/macules, vesicles. Dx: Varicella Tx: Symptomatic
PATIENT WAS BROUGHT IN BY EMS AND GIVEN AN ADULT EPIPEN IN ROUTE. COMPLAINED OF SEVERE ITCHING AND FELT LIKE THROAT WAS GETTING TIGHT. ALSO COMPLAINTS OF INCREASE SOB. UPON ARRIVAL TO ER, WAS GIVEN SOLUMEDROL 125 MG AND BENADRYL 50MG . ALSO TREATED FOR HTN IN THIS VISIT. PATIENT WAS GIVEN A PRESCRIPTION FOR A MEDROL DOSE PACK AND TOLD TO CONTINUE BENADRYL Q6-8H FOR NEXT 48 HOURS. GIVEN FAMOTIDINE
The patient developed a red, warm, rash/bruise in upper 1/2 of right arm that was painful and warm to touch even 6 days post vaccine
Redness to right deltoid. Patient states "I've been scratching, it itches"! 5" l x--> Tdap x 3" w. MENACTRA.
I am post menopause over 3 years with no period.  I started my period after vaccine.
This case was reported by a nurse and described the occurrence of inappropriate preparation of medication in a unk patient who received ROTARIX (batch number A41CB4464, expiry date 30th January 2016). On 14th October 2014, the patient received ROTARIX (oral). On 14th October 2014, an unknown time after receiving ROTARIX, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication was unknown. Additional information received: RN reported to Account Manager that 5 patients had inadvertently received only the diluent portion of the ROTARIX vaccine. All five patients returned to the physician office that day to receive the vaccine and diluent product. No AE's were reported. It is thought that one child may have been 2 months old, it is unknown if any had received ROTATEQ previously as the office was changing over vaccine manufacturers.
Information has been received from a pharmacist referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 20-MAR-2014, the patient was vaccinated with the first dose in the series of three of GARDASIL (lot#, expiration date, dose and route not reported). The second dose was vaccinated to the patient on 13-AUG-2015 (lot#, expiration date, dose and route not reported) (inappropriate schedule of drug administration). The reporter confirmed that the third dose of GARDASIL was not administered to the patient. No adverse effects were reported. Additional information has been requested.
A non-serious spontaneous report of inadvertent administration of expired H1N1 LAIV was received from a registered nurse/health professional concerning a six-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment  and reporter causality assessments were not applicable and the event was considered to be resolved.
Stomach ache. Developed SOB, mucosa edema, puffy eyelids erythema and abo pain within 5 mins. 0.15ml epi given immediately. 2 tsp benadryl. 30 mg ora pred give. Fully recovered 45 min after event
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 58 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In April 2016, the patient was administered ZOSTAVAX by a pharmacist at a pharmacy (dose, route, and lot # not provided). On an unspecified date, the patient was treated by her healthcare provider at a medical office for the following injuries resulting from her ZOSTAVAX use: shingles. The outcome of the event was unknown. Causality assessment was related. Additional information has been requested.
Approximately 4 hours after injection severe right arm aching into shoulder elbow wrist and fingers. Took 1000mg Tylenol and pain resolved
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 01-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10Pk 10mcg/1mL SD LLok Cap AD", lot # L001441 with expiration date 17-AUG-2016 (route of administration and anatomical location were not reported). There were no concomitant therapies and adverse effects reported. No product quality complain was involved. On an unspecified date, the RECOMBIVAX HB had six temperature excursion of 34 F (1.11 Celsius Degrees) for 160 hours, 32 F (0 Celsius Degrees) for 376 hours, 29 F (-1.6 Degrees) for 256 hours, 31 F (-0.5 Celsius Degrees) for 552 hours, 33 F (0.5 Celsius Degrees) for 168 hours and 30 F (-1.1 Celsius Degrees) for 288 hours, respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Scratchy throat; Fever; Upper Respiratory Congestion; cold symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of UPPER RESPIRATORY TRACT CONGESTION (Upper Respiratory Congestion), NASOPHARYNGITIS (cold symptoms), THROAT IRRITATION (Scratchy throat) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 037C21A, 029L20A and 026L21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Drug use for unknown indication: Sulpha and Penicillin. Past adverse reactions to the above products included Allergy with Penicillin and Sulpha. Concurrent medical conditions included Breast cancer and Blood pressure high. Concomitant products included NEBIVOLOL, CYANOCOBALAMIN (NATURE MADE VITAMIN B-12), RISEDRONATE SODIUM (ACTONEL), ALOE VERA and KRILL OIL for an unknown indication.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022 at 1:45 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 13-May-2022, the patient experienced THROAT IRRITATION (Scratchy throat) and PYREXIA (Fever). In May 2022, the patient experienced UPPER RESPIRATORY TRACT CONGESTION (Upper Respiratory Congestion) and NASOPHARYNGITIS (cold symptoms). On 15-May-2022, UPPER RESPIRATORY TRACT CONGESTION (Upper Respiratory Congestion) and PYREXIA (Fever) had resolved. At the time of the report, NASOPHARYNGITIS (cold symptoms) had not resolved and THROAT IRRITATION (Scratchy throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Had negative rapid test..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that after taking last dose of Paxlovid on May 9 and having Negative rapid test and being asymptomatic patient started to run a fever and scratchy throat on May 13th. The fever and upper respiratory congestion continued until May 15. On May 16 patient had only cold symptoms.  It was confirmed that the patient was taking other medications within 2 weeks of starting COVID-19 treatment.  Treatment medication was not reported.
8 days after receiving the vaccine, 3-4 inch rash appeared on upper shoulder quadrant of L-arm; over the week, rash has continued to expand, spreading along full outer area of upper L-arm; the rash is red, itchy, and has a visible parameter ** 1-18: started oral Benadryl bid,  topical hydrocortisone cream daily