chrisvoncsefalvay/vaers-outcomes huggingface dataset:
herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67 year old patient (pt) of unspecified gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On approximately 21-OCT-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for long term prevention of shingles and zoster-related conditions.               On an unknown date, the pt was treated for herpes zoster as a result of zoster vaccine live (ZOSTAVAX) use. At the time of the report, the pt's outcome was unknown.
Today he had little bit of fever 99.5; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: FF2589) via an unspecified route of administration on 05Sep2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose on unspecified date (Lot number: FC3181) for covid-19 immunisation. On 06Sep2021, the patient had little bit of fever 99.5. The outcome of the event was unknown.
BRIEF OVERVIEW: Admission Date: 9/8/2023 Discharge Date: 9/9/23 Discharge Disposition:  Home without services DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM:f Weakness [R53.1] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 70 y.o. female with medical history significant for ischemic cardiomyopathy, coronary artery disease, hypertension, type 2 diabetes who presents today with weakness. Patient endorses subjective fever and chills short, shortness of breath, cough, headaches, nausea, 1 episode of vomiting at home, poor appetite and body aches.  Patient  was diagnosed with COVID 9/5/23, patient went to hospital with similar complaints. Taking Tylenol at home has not been helping, lives with her daughter who has been helping take care of her.  Patient is experiencing increasing fatigue and weakness and is unable to take care of herself.  Patient continues to smoke 3 cigarettes a day, denies alcohol or using illicit drugs.   In emergency department, complete blood count CMP unremarkable, lactic acid mildly elevated 2.2, chest x-ray significant for right-sided pneumonia.  Due to her weakness and COVID pneumonia patient will be admitted. She was seen by PT/OT who determined no need for services.She had improvement in her symptoms and was discharged home in stable conditions
Pt received HPV and pt. and mother remained in office and during the stay she fainted. Pt. c/o nausea. Dr. and clinical assistant remained with and reassessed pt's stauts.  Staff offered sips of liquid and she refainted 3 - 5 minutes later and remained with c/o nauesa. Pt. remained assessed at office.  Once discard pt went home and remained with c/o nausea throughout the day.
Red knot on arm, sore arm, chills, nausea, fatigue, body aches   Started 4/29/2021 night and last until the night of 4/30/2021
headache; fever; This is a spontaneous report from a contactable consumer.A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and  concomitant medications were not reported. Patient previously received  the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunization. The patient experienced headache, fever on an unspecified date.  Outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
I started having shortness of breath and rapid heart beat with chest pain around July 2021 . EKG showed Atrial Flutter.  Further EKGs were clean. On and off chest pain  July 2022 blood test at ER for chest pain shortness of breath show high D Dimer no blood clots in chest/lung November 2022 test positive ANA speckled pattern also high D Dimer again.  All blood work ran again. Negative with all labs clean for auto immune disease but unexplained D Dimer still  Joint and muscle pain and stiffness
Patient stated she developed full body red, itchy rash which began 3 days after first COVID vaccine.
pain in knee; achy; tired; temperature 99.0F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), FATIGUE (tired), PYREXIA (temperature 99.0F) and ARTHRALGIA (pain in knee) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Knee pain.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN (achy), FATIGUE (tired) and PYREXIA (temperature 99.0F). On an unknown date, the patient experienced ARTHRALGIA (pain in knee). At the time of the report, PAIN (achy), FATIGUE (tired), PYREXIA (temperature 99.0F) and ARTHRALGIA (pain in knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter states Lot# 023m20a, but the patient is unsure if this is the lot number for 1st 0r 2nd dose.  Concomitant medications include antidepressants and BP for unknown indication
Information has been received from a physician concerning his 5 month old male son who was vaccinated with Rotateq PO (LOT # 656194/0024U). The physician reported that after receiving Rotateq PO, the patient was experiencing irritability and stomach cramping for about 24 hours. "The patient had the same reaction to both doses of Rotateq PO," but he will still have the third dose". Subsequently, the patient recovered from irritability and stomach cramping. Additional information has been requested.
7 days p/vax pt rpt rash, fever of 104 then c/o screaming, kicking, wouldn't open eyes for 45 min. states ``we couldn't get pt to respond to anything we did.
Per Mom, pt. was feeling fine earlier but after stated pt. feeling dizzy and felt like fainting, elbow area of the arm where HPV was given very itchy and rash that looks like mosquito bites.
My arm started to feel sore again after a week. ESP when lift up high. It is getting better. But was very sore a week after vaccination.
Patient reported dizziness, nauseous and had syncope. EMS was called, vitals were checked, patient refused hospital services and was stable after 10 minutes. Patient received hydration and left at 1pm.
Next day - ~3" round, red. indurated area on upper arm around injection site. Skin was warm and tender to the touch. Used warm heat at the end of the day and was not noticeable by the next morning. I  have had a small area that itches which may be related to the vaccine or may be an insect bite that developed last week. I don't believe it to be related even though it's in the same area
DTaP #4 on leg; swelling, induration, redness to thigh about 8.5cmx10cm area.
Patient began to become sweating and ended up throwing up about 10 minutes after the vaccination. The patient pulse was high, but never lost consciousness
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unkonwn age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (Merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. There was no information about concomitant medication, pertinent medical history, drug reactions and allergies reported. On unknown date, the patients were vaccinated with improperly stored ROTATEQ orally (lot#, expiration date, dose, frequency, indication were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Tinnitus 18 hours after second dose. Loud high pitched ringing that gets louder during quiet, when trying to sleep. Sometimes too loud to sleep. Never suffered from tinnitus in my life, musician very careful about hearing protection. Haven't seen doctor yet but I will if it doesn't go away. Reading a lot of other people have dealt with this for weeks and months after vaccination.
Pfizer-BioNTech COVID-19 Vaccine EUA. Developed Shingles 1 week after receiving 1st Pfizer Covid-19 vaccine. Note: Vaccinator who filled out card had poor handwriting. Lot number could be either "ER8729" or "ER8725". Unable to tell due to poor penmanship.
Eyes rolled back, convulsions, stiff, stated he felt hot, over 1 minute duration then pt snapped out of it. No treatment. Rested for 20 minutes and had water. Father took pt to MD to get evaluated.
Four days following administration we were made aware that our refrigerator experienced a temperature excursion lower than the recommended storage conditions.  After contacting the drug manufacturer, the vaccine was deemed as "not viable at the time of administration."  The patient denies any adverse health conditions or side effects following the administration of said vaccine.
Swelling at injection site; Redness at injection site; Itching at injection site; Injection site Hot to Touch; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (Injection site pain after receiving 1st dose on February 2019, see case US2019127842).   On 11th July 2019, the patient received the 2nd dose of Shingrix. On 11th July 2019, less than an hour after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received first dose Shingrix in late February and second dose in 11th July 2019. Following vaccination of both doses, caller experienced swelling, redness, itching, pain, and hot to touch at the injection site however, after the 2nd dose. The reporter had same side effects have lasted longer and reports more swelling and larger area of redness. The reporter stated that following the second dose today it appears it was beginning to clear but not fully resolved. The reporter was consented to follow up.
under the age of 18 was administered moderna covid-19 vaccine as 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the age of 18 was administered moderna covid-19 vaccine as 1st dose) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the age of 18 was administered moderna covid-19 vaccine as 1st dose). On 07-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the age of 18 was administered moderna covid-19 vaccine as 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment medications was not provided.
I have had a rash that comes and goes that appeared the day after I recieved the 2nd dose of the Pfizer vaccine.  The bumps are mostly confined to my trunk (stomach, lower back, buttocks).  Most of the bumps resolve within 2-3 weeks, however the original bump on my left hip turned into a patch about the size of a quarter and lasted for about 5 months.  I have another similar patch that appeared on my left arm that has currently been there for about 2 months.  The rash is not itchy.  It has not responded to cortisone creams.  I have had 3 spots biopsied.  The most recent biospy suggested a possible connective tissue disorder such as lupus.  My doctor is sending me for an ANA blood test.
weakness; faint feeling within 5 minutes; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient 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 28Feb2021 at 09:00 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history included premature ventricular contractions heart beats. The patient had known food allergy to gluten. Concomitant medications included propranolol (MANUFACTURER UNKNOWN), clonazepam (CLONOPIN), estrogen nos (MANUFACTURER UNKNOWN), progesterone (MANUFACTURER UNKNOWN), and testosterone (TESTOSTERON); all were taken for an unknown indication on unknown dates within two weeks of the vaccination. 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 28Feb2021 at 09:00 the patient experienced weakness and faint feeling within 5 minutes. The patient was ok by laying down, persisted for about an hour, and then felt fine. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events weakness and faint feeling were recovered on 28Feb2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Administered it through the wrong route; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 10-Jan-2023 Reporter's comment: The reporter asked that any information on administering in the wrong route and what the next steps were or they should revaccinate or there were any adverse events they should be aware of. Additional supportive information; The patient received  dose of Tdap through the wrong route, which led to intramuscular formulation administered by other route. The follow-up could not be possible as no contact details were available. The suspect was coded as per reported information.
Contracted COVID. Symptoms began appearing 9/12/21 with cold symptoms. On 9/15/21, lost my sense of smell. Tested positive for COVID on 9/17/21.
Pins and needles/tingling and numbness feeling in hand immediately after getting shot. Experienced this in feet as well. Lasting about 2 weeks
Within 6 hours of vax, the pt developed pain at the injection site, spreading upward to neck, then nausea, headache, fever, malaise, anorexia, dizziness, facial flushing. Started to improve after 24 hours with residual headache and shoulder/neck pain.
Immediately after receiving vaccine patient stated that her entire hand was tinging and numb feeling. This was the hand of the arm the vaccine was administered in. Patient said no other symptoms of syncope were present and it was just the left hand with this issue. 10-15 min later she said for  a short time it went up to elbow but did not last there. Had her stay an extra 15 min and by the time the patient left she said it was better.
At the time of vaccination, the patient expected to receive the Moderna vaccine for dose 1 of COVID-19 vaccination series. The technician administering the vaccine unknowingly mixed pre-filled syringes of both Pfizer and Moderna together in the same container to bring into the vaccination room.  The technician believed she was providing the Moderna vaccine but unknowingly administered 3 total vaccinations before the mix-up was discovered, and 2 doses of Pfizer vaccine were unaccounted when discovered by the pharmacist on duty. All 3 patients within this time frame of 3 vaccinations given were notified that they potentially received the Pfizer vaccine, as there was no way to confirm with certainty using store camera footage which syringe had definitely been used on each patient.
Breakthrough Covid-19 case after J&J vaccine and two Pfizer boosters. I had a low fever (<= 100.0), fatigue, runny nose, cough. The fever went down after 4-5 days, other symptoms also improved gradually. However, home antigen test still positive on day 12.
Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 18Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "Fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
01/29/2023 I started having nasal congestion coughing and feeling crappy. After testing positive for Covid-19 I was prescribed PAXLOVID and FLONASE. Symptoms lasted about 5-6 days.
child injected with Shingrix accidentally instead of with the Varicella vaccine; child injected with Shingrix; This case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a child patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 17-JUN-2022 Reporter's Comments: The patient was injected with Shingrix accidentally instead of with varicella (chickenpox) vaccine which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter wanted to know if there were any concerns as Shingrix was not tested in children.
experienced a wide range inflammatory response in all joints/experienced same side effects; it exacerbated her fibromyalgia/experienced same side effects; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: ARTHRITIS (non-serious) with onset 2022, outcome "unknown", described as "experienced a wide range inflammatory response in all joints/experienced same side effects"; FIBROMYALGIA (non-serious) with onset 2022, outcome "unknown", described as "it exacerbated her fibromyalgia/experienced same side effects".  Clinical information: Caller received the Pfizer COVID booster in Jan2022 and experienced a wide range inflammatory response in all joints. Caller said it exacerbated her fibromyalgia, which developed as a result of Lyme's disease she contracted several years ago. Caller mentioned spouse also received Pfizer COVID booster at the same time and experienced same side effects.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200132898 same reporter/drug/event, different patients;
CLIENT RECEIVED INCORRECT FORMULATION OF PFIZER VACCINE FOR THE AGE GROUP SHE IS IN. CLIENT RECEIVED 0.3ML FORMULATIONS FOR 12+. CLIENT WAS 11YO AT TIME OF VACCINATION AND SHOULD HAVE RECEIVED PEDIATRIC FORMULATION 5-11YO.
Pain, redness, swelling, rash at the injection site lasting 3 days (and continuing) Headache ( for 1 day) Body and muscle aches (severe for 1 day, 50% improvement on 2nd day, gone on 3rd day)  Feeling tired very for 2 days Nauseated and vomiting after meals on 2nd day Pins and needles in feet and hands (severe for 1 day, 50% improvement on 2nd day, continuing at 10% on 3rd day)
Patient with complaints of feeling flushed with slight areas on face, also with complaints of stomach hurting.  No vomiting noted. 1:00pm- B/P 146/105, HR 106, R 20 ,O2 sat 99%.  Offered water and tolerated it well. Patient states she  ate lunch about an hour before the vaccine was administered.1:10pm- B/P 149/98,  HR 89, R 20, O2 sat 98%.  1:12pm- Patient states she feels better, and had a similar reaction after first COVID-19 injection on 03/26/2021,  but recovered shortly afterwards. Patient was evaluated by this nurse and EMT.  1:15pm- Patient was feeling much better, as she stated and transported to her vehicle per wheelchair without incident.
ADMINISTRATION OF VACCINE 40-110 HOURS POST EXPIRY; This spontaneous report received from a physician concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 26-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-SEP-2021, the patient experienced administration of vaccine 40-110 hours post expiry. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from administration of vaccine 40-110 hours post expiry. This report was non-serious.
PATIENT HAS FEVER,  SERVERE BODY ACHE, NAUSEA AND HEADACHE 24 HOURS AFTER GETTING THE VACCINE.  PATIENT FEELS BETTER 4 DAYS AFTER.  BUT THEN 3 DAYS LATER PATIENT CAN NOT SLEEP.  PATIENT DOES NOT FEEL WELL THE WHOLE WEEK.