chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; severe left ear pain; "Pimple" on the inside of the ear; nonpruitic vesicular lesion in her ear with surrounding erythema; Erythema; This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th December 2019, the patient received the 1st dose of Shingrix. On 27th December 2019, 7 days after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced shingles, ear pain, pimples, vesicular eruption and erythema. The patient was treated with acyclovir, prednisone and analgesic, nos (Analgesics). On an unknown date, the outcome of the shingles was unknown and the outcome of the ear pain and erythema were not recovered/not resolved and the outcome of the pimples and vesicular eruption were recovering/resolving.   It was unknown if the reporter considered the shingles, ear pain, pimples, vesicular eruption and erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient presented to the emergency room with 24 hours of severe left ear pain. She reported developed a pimple on the inside of her ear that she unsuccessfully tried to pop using a sterilized needle. The patient experienced a nonpruitic vesicular lesion in her ear with surrounding erythema but no purulence. On 30th December 2019 reported that her ear was about 65 percent better but continued pain and erythema. The patient experienced Shingles within a week after vaccination.  The reporter said that since Shingrix was an inactivated vaccination, she could not have developed shingles from the vaccine, recommended that since the only contraindication for Shingrix was an allergic reaction, and this was not, that he recommend she receive the 2nd dose when she was  due for it. It be possible that the process of her immune system responding to the vaccine could have reactivated a latent zoster infection. The reporter said that it seems like a crazy coincidence that she just happened to have shingles a week after the vaccination, if they were totally unrelated.
Moderna booster shot 08-Nov-2021, which expired on 06-Nov-2021; Vaccine side affects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Vaccine side affects) and EXPIRED PRODUCT ADMINISTERED (Moderna booster shot 08-Nov-2021, which expired on 06-Nov-2021) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna booster shot 08-Nov-2021, which expired on 06-Nov-2021). In November 2021, the patient experienced VACCINATION COMPLICATION (Vaccine side affects). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Moderna booster shot 08-Nov-2021, which expired on 06-Nov-2021) had resolved. At the time of the report, VACCINATION COMPLICATION (Vaccine side affects) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment drugs were reported  Vaccine was kept in refrigerator on 07-Nov-2021 at 39.0 of temperature.  Patient was doing well and was having the normal vaccine side effects, feels like it felt the last two times.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow-up received: Patient demographic details (ethnicity and race), product anatomical location and new event with outcome was added.
woke up had a mild fever of 99.9 degrees; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old male patient received second dose of bnt162b2 (BNT162B2; Solution for injection; Lot Number: UNKNOWN), via an unspecified route of administration, administered in left arm as dose 2, single on 25Feb2021 11:45 AM (at the age of 53-year-old) for covid-19 immunisation. Patient had no known allergies and medical history. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (COMIRNATY; Solution for injection; Lot Number: UNKNOWN), via unspecified route of administration, administered in left arm as dose 1, single on 04Feb2021 10:30 AM (at the age of 53-year-old) for covid-19 immunisation. Both doses were taken at workplace clinic. No other vaccine in four weeks administered and no other medications took in two weeks. The patient experienced woke up had a mild fever of 99.9 degrees on 26Feb2021 05:30 AM in the morning. Lab tests and procedures which included body temperature: 99.9 centigrade on 26Feb2021. Patient received no treatment for the event. Patient had no COVID prior to vaccination and post vaccination not tested for COVID. At the time of this report, outcome of the events was recovered on 26Feb2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Substantial lower back pain making mobility difficult. No prior hx of back issues or injuries. Started 2nd day after vaccination.
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. As reported, the patient had it all and now has Covid. The patient also told: '' keep your stupid shots.''  Company comment: This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred on an unknown date after the a dose of mRNA-1273. As reported, the patient had all shots and now has Covid. No exact administration dates or dose number was provided. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred on an unknown date after the a dose of mRNA-1273. As reported, the patient had all shots and now has Covid. No exact administration dates or dose number was provided. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Vaccine Hep B #3 administered about 12 noon 12/09/2002. About 02:00 pm, child developed rash on hands (top0, neck, and on mouth area (lips). Child taken to ER, MD said child had dermatitis allergy. Child given a dose of Prelone and Atarax in ER. Sent home with Prescription for same meds.
12 hours after shot severe body aches, sore throat, chills, sweating, fever, headaches, delirium. Felt as if bones were disintegrating/breaking, extreme overall body pain and temperature fluctuation. 24 hours after vaccine persistent sore throat, chills, sweating with rushes of extreme heat, extreme dizziness/light headedness. 48 hours after vaccine I fainted and continued to have episodes of near fainting with sweating through clothes. Primary care would not see me due to sore throat, advised to go to urgent care. Primary care was very concerned about severe reaction to booster. I was not able to get into Urgent care as they have shut down walk ins and appointments. Eventually had telemedicine appointment with MD who advised me to go to emergency room due to left sided chest pain, pressure, dizziness, weakness, and fainting episode. Went to ED on 12/15/21 where my EKG was normal, did not see any medical professionals due to overloaded ED and was advised by staff to leave due to high covid cases. I returned home where I continued to have dizzy spells along with forgetfulness, and sweating. On 12/16 I did not improve and was seen at an urgent care location where I tested negative for flu and strep throat, currently waiting for covid PCR results. I was told by MD that my symptoms  are due to booster and there is nothing that can be done. It is currently 12/17 and I am still experiencing dizziness/light headedness, headaches, hot and cold sweats.
Patient called to report previous reaction to vaccinations received on 10/31/07; patient states she developed "hot red blotches" (pneumococcal) injection site just a couple of hours after getting injections; blotches extended down to almost left wrist area on lateral aspect; later that afternoon the "blotches" were on inner aspect as well; at about 6pm she developed tightness in her throat and chest; she took 2 puffs of Maxair and Benadryl 50mg po and tightness resolved after 30-40 minutes; she stated that the pain in her upper arm was a 6-7 on a scale from 1-10, 10 being intense worst experienced) she used ice and later heat but did not take analgesics; on 11/3/2007 she states pain, redness and blotches had resolved; patient instructed to seek emergency care in the future if similar chest and throat tightness were to occur, instructed patient to discuss with doctor at her next visit to decide about vaccinations in the future; patient agreeable; will mark "alert" on Immunization record; VAERS report faxed.
Tightness R upper back, tightness in chest, radiating pain into R neck, jaw & ear.  Elevated blood pressure, diaphoresis.  Went to Emergency Room. Event lasted approximately 60 minutes.  Symptoms continued to come and go through evening and continued on 10/4/2023.
Patient developed urticaria 7 ds after receiving Hep A and MMR. Type III hypersensitivity reaction.) Had had pneumo and varicella 11 days prior. Child was in excellent health, not sick at the time of vaccine receipt. Without infectious symptoms he developed deep red slightly raised patches over his entire body. The concern was he was breaking out in hives, so taken in for acute appt. Given BENADRYL, ATARAX, and eventually placed on steroids to control lesions. Mother said he did not appear too uncomfortable, lethargic, in pain, or itchy. The individual rashes last longer than 24 hours, and leave a hyperpigmented area for approximately 24 hours before fading completely. Some lesions leave a "deep purple" bruise, that then resolve in the subsequent manner a bruise would resolve (color change to green/yellow as fades). He was placed a 4 day Prednisone taper at 20 mg(2mg/kg) which he has completed. He took the prednisone at nighttime, and the lesions would resolve almost completely by morning. He was up to date on this other immunizations. He has been teething, and his mother has been using a homeopathic herbal blend, one which contained belladonna. He was also taking vitamin C, DHA, Flax oil, and probiotics, which were stopped at the onset of this rash. Additionally he was prescribed hydroxyne, diphenhydramine, and topical hydrocortisone which did not help. Sxs all resolved by 6 Feb 10. Hives. Will formulate schedule for future vaccinations after reviewing all vaccines needed and their components.
Extreme swelling, itching, redness, and pain at injection site. Took BENADRYL and acetaminophen for 3 days. Lump at injection site remained approximately a month.
After getting Pneumovax 23, the patient became dizzy.  She said she had never had that happen after getting a vaccine.  I asked the patient to stay seated until she felt better.  I also asked her husband to escort her, supporting her while walking to their car, to minimize the risk of a fall.  I called the patient to check on her later in the day, but was unable to reach her.  I also notified the doctor who had prescribed the Rx for Pneumovax 23 of the adverse event.
I am assigned to do Pfizer clinic today (Adult and Peds). I was getting ready to start my day by drawing up the vaccines. I took adult Pfizer (grey Cap) out of the fridge first, so I could do one at a time. When I was getting ready to draw it, other MA came and asked me if I had a Pfizer peds available which I didn't. At that point I got a little confused since she wasn't assigned to do Pfizer peds today, but I just rapidly switched from drawing Pfizer adult to Pfizer peds and gave her the dose she needed. Since we don't need to dilute Pfizer grey cap (adult). I accidently did the same for the Pfizer orange cap (Peds)and drew up a dose without diluting. Which was wrong as Pfizer orange cap (peds) needs to be diluted with 1.3ml of 0.9% sodium chloride. When I realized this, I went to look for the MA but it was already too late as she had already administered the vaccine. I went to look for our charge nurse to informed her what had happened and we had to contact our support. We explained her what happened and she said the dose wouldn't hurt the patient but she might experience more severe reaction to it since the vaccine wasn't diluted, she asked us to notify the parents so they could be aware of the situation. Our charge nurse called the parents and informed them. We also discarded the whole vial since we weren't sure how much of the 0.9% sodium chloride was needed to dilute the remaining of the vial.
pt recvd vax;immed after polio shots ears started to ring;1 hr later,body ache & HA;fever of 101.8;severe v for 4 hrs;feeling better in 23 hrs;feels fine now x/ for occasional HA;
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # M016193 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information has been requested. Sender's Comments: US-009507513-1707USA000601: US-009507513-1707USA000599: US-009507513-1707USA000600.
Tested positive for Covid-19; A temperature 99.1; A little 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 events a cough, fever, Covid-19 infection.  The patient's medical history was not provided. Concomitant medications reported were Toprolol XL, Amlodipine Valsartan, Losartan, Amaryl, Dexilant, Citrical plus D, Multivitamin, Vitamin D, Actonel, Zetia, Tricor, Metformin  for unknown indication.  On 12 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (unknown batch number) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 18 Jan 2021, the patient experienced the events a little cough and had fever of temperature 99.1. The patient was reported to be tested positive for Covid-19.  Treatment details included BAM Infusion, Z-Pak and another antibiotics and steroids and cough medicine.  Action taken with mRNA-1273 in response to the events was not reported.   On 29 Jan 2021 the outcome of events, cough, fever and Covid-19 infection was not reported.; Reporter's Comments: The event of Covid-19 infection is unlikely to be related to Moderna's Covid 19 vaccine. Based on the current available information and temporal association between the use of the product and the start date of the events of cough and fever, a causal relationship cannot be excluded.
Chilled and feverish, drowsy, all over body aches,  dizziness, nausea in the morning, injection site pain. Symptoms did not require a dr appointment.  Symptoms appeared morning after Vaccination and lasted only one day.
PT ACCOMPANIED BY MOTHER SHOWING GENERALIZED PAPULES WITH OCCASIONAL OPEN SCABS MAINLY ON TRUNK OF HER BODY WITH A FEW ON LIMBS AND BACK. SHE DIDN'T COMPLAIN OF ANY ITCHING OR DISCOMFORT. SEEN BY DR. WHEN MOTHER REPORTED THAT 8 DAYS AFTER RECEIVING VACCINATION ON 5/24/2017, PT HAD ITCHY RED RASH OVER HER BODY AND MOM TOOK PT TO A PHYSICIAN WHO TOLD HER THAT PT HAD CHICKEN POX.
Red rash on face, feels jittery, dizzy, faint, chest pain difficulty breathing, tightening of throat, difficulty swallowing.
I administered the vaccine and asked patient to move to the waiting area for his 15 minute observation period. He moved out to the chair and sat down about 2 minutes later his abdomen started to move back and forth a few times and then he started to have what appeared to be a seizure. It was very short (20 seconds), he remained in the chair. His mom and I moved him to the floor with his help. He then mentioned that he forgot to take his seizure medication last night and was feeling very nervous about the vaccine.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  23-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route of administration, anatomical location were not reported; lot number R021636 was confirmed to be valid, expiration date 12-MAY-2021) for prophylaxis. Administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. Data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Terrible headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 12:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included Rheumatoid Arthritis (RA) and posterior uveitis. The patient was allergic to penicillin. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN) and rosuvastatin calcium (CRESTOR) all were from unknown date and for unspecified indication. The patient previously took doxycycline (MANUFACTURER UNKNOWN), ciprofloxacin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Mar2021 at 12:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 09Apr2021 at 15:00, after the second dose of vaccination the patient experienced terrible headache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  Therapeutic measures were not taken as the result of adverse events.  The clinical outcome of the events terrible headache and fatigue were not recovered at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No additional AEs; 10NOV2021 MMRII was administered that expired on 07OCT2021; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On 10-NOV-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis, lot # S031482 with expiration date on 07-OCT-2021 (strength, dose number, anatomical location and route of administration were not reported). The sterile diluent that was used to reconstitute the vaccine had lot # S031276 with an expiration date on 06-JUN-2022.
Approximately 12 hours post vax the patient was shaking and vomiting. Patient was seen at the ER later that morning, was treated with Amoxicillin for 10 days, a throat culture was done and blood was drawn.
contracted COVID-19; contracted COVID-19; This is a spontaneous report from a non-contactable consumer (patient). A 52-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on Mar2021 (end of March) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date of 2021, patient contracted COVID-19. It had already been 4 months past her first dose, and she wanted to know if she can still take the second dose of the vaccine with this situation. Patient was concerned since one doctor told her that she should start the vaccination series all over again and the other doctor told her that it was okay to go ahead with the second dose. The outcome of both the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Increased extreme hyperactivity, inability to concentrate, inability to follow instructions, incontinence of bowel and bladder (was fully potty trained at 2 years old with no intermittent incontinent episodes), anger and aggression within a month of vax. All issues continue at this time.
Patient's first dose was Moderna.  Patient received a Pfizer vaccine on 5/12/21.  No adverse reaction or symptoms noted after 30 minutes of observation.
Shaking hands, arms, legs and feet; numbness; difficulty standing, walking-came about rather suddenly. Went to PCP; sent to ER and admitted. Diagnosed with Guillain-Barre. Received IVIG for five days in the hospital; transferred to acute rehabilitation center. To this day, eight years later, I am still receiving physical therapy to help strengthen my lower extremities.