chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; Moderna Vaccine dose 5, BNT162B2 dose 1,2,3,4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 75 years, on 20Oct2021 as dose 3 (booster), single (Lot number: 30155BA), on 09Feb2021 as dose 2, single (Lot number: EL3247), on 19Jan2021 as dose 1, single (Lot number: EK9231) and (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Sep2022 at 15:45 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; vitamin d3 (VITAMIN D3), since Jan2000 (Batch/Lot number: unknown). The patient's relevant medical history included: "mild emphysema" (unspecified if ongoing), notes: mild emphysema; "mild glaucoma" (unspecified if ongoing), notes: mild glaucoma; "osteopenia" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Sep2022, outcome "unknown", described as "Moderna Vaccine dose 5, BNT162B2 dose 1,2,3,4"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Patient stated that Rebound, I guess and had felt great after 5 days of Paxlovid. Felt a little worse 2 days later, did home antigen test, was positive. She also Continued to feel worse each day for several more days. Today it has been a week since finishing Paxlovid and finally I'm starting to feel better, though I'm still testing positive on home antigen tests.It's been all the typical COVID symptoms, enough to make me want to stay home and sleep a lot but not serious enough to seek medical care.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient developed ongoing chronic migraine, dizziness, neuropathic scalp and neck pain since the time of vaccination April 2021.
Inconsolable crying, slight rash on back and trunk. Seen by private physician, treated for ear infection 9/13/06. On 9/15/06 temp of 102 with Tylenol for 4-5 hrs on afternoon. Seizure activity for 2 hrs, life flighted to Hospital. admitted 9/15/06 discharged 9/17/06. DOS 09/15-09/17/06 DC DX: status epilepticus, probably complexed febrile seizure. Seizure activity felt to be a febrile event.  HX of present illness: treated for otitis media continued to run low grade fevers getting higher on day of admission followed subsequently by three to four short bursts of seizures this evening prior to admission, over a two hour period. Temp 37.0
Patient seen here in office on 6/26/02 with complaints of frequent falls. Diagnosed with coordination disorder. Seen by MD (Pediatric neurologist). Diagnosis of cerebellar ataxia.
Immediately after injection patient received a 2cm hematoma with no known leakage of vaccine.
As of 8/25/02 pt in ICU. Dx: Guillain Barr syndrome. The 60 day follow up states pt is in ICU last I knew 11/19/02. A follow up report received 9/5/2002 adds: As of 8/25/2002, pt is in ICU. Dx Guillain-Barre Syndrome. The discharge summary received on 1/28/04 states bowel impaction, acute respiratory insufficiency, hypoxemia, change in mental status, atelectasis,  and cough.
Fever, lethargy, sleeping/not eating at immediate onset of vaccines, and second occurrence of a spontaneous, double ear drum rupture (blood pouring from his ears), 48 hours after the vaccines were administered... The first time was 48 hours after his 18 month vaccines.
Arm swollen/sore night of vaccination, swelling increased after exercise next day - red/inflamed. Warm to touch. Seen in clinic 8-12-2016; swelling into elbow, tender to touch. Prescribed Cephalexin and ZYRTEC.
Currently pregnant 12 weeks, date of delivery 23-Sep-2021. Shortly after injection, facial tingling and tongue numbness occurred and lasted about 10 minutes. It presented again the 2nd day with facial tingling and tongue numbness and lasted a few hours; also had a moment of hot flashes (which i dont have in general); face was flush.  Tightness in neck muscles as well, but do have a previous herniated disk which seemed to be inflamed after injection. 3rd day numbness in  roof of mouth behind front upper teeth and tingling in tongue lasted several hours.
Rigors; Hives; Rash; This is a spontaneous report from a contactable nurse via a sales representative. This nurse reported for a 55-year-old male patient that who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization; started to receive immunoglobulin human normal (PANZYGA) via an unspecified route administration, from 21May2021 at unknown dose and frequency, then on 11Oct2021 at 08:45 am (lot number: L043A8251) at 10 g, for an unspecified indication. Medical history included CIDP. Concomitant medications were not reported. The patient previously received first single dose of BNT162B2 on an unspecified date for COVID-19 immunization. It was reported that patient had been receiving PANZYGA since 21May2021. Patient did not have any allergies to other IVIGs and had received other brands in the past. Patient received dosage this morning, 11Oct2021, approximately 08:45 am. Had a reaction, with rigors, hives and rash. It was at the tai end of his infusion (-95%). He was instructed to administer his epi-pen and then when RN got back to his home he was sent to Emergency Department via ambulance at 12:00 and discharged home at 14:30. The action taken to the events for immunoglobulin human normal was unknown. Outcome of the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Chills, Urticaria and Rash" and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt. has had an adverse reaction the hepatitis B shot in the past that consisted of a rash with an onset of 10 minutes after administration. Pt. received HPV shot and meningoccal today.  I waited 15 minutes between adminstration of each vaccine to check for reactions.  The meningococcal vaccine was adminstered first with no reaction. After 15 minutes the HPV vaccine was adminstered and patient had some localized itching at the injection site and some slight itching on her face but did not report any problems swallowing or breathing.  After 15 minutes the patient left the office with instructions to call if itching increased. After one hour the patient's mother called in complaining of increased itching by the patient.  The patient was informed to come in and per Dr. a 4mg/ml 1 ml dose of dexamethasone sodium phospate was injected in the gluteus muscle. The patient was held at the office for one hour and reported feeling better with less itching.  The patient was sent home with instructions to go to the ER if any signs of trouble breathing or swallowing were found.
Took my own blood pressure and it was up to 200. I went to the doctor and he said I needed to go to the ER. They admitted me and kept me overnight for observation. They had trouble getting my blood pressure down so they gave me Heparin I think and that is what finally worked. Since receiving the vaccine I have many more AFIB attacks than I ever did before
Patient said he bled after receiving the SHINGRIX vaccine. He had a sweater on, and pulled the sweater down to expose the deltoid. Patient said he has had a sore left shoulder and limited range of shoulder movement  ever since he received the vaccine.
Nausea, chills, headache, body aches, low-grade fever. Symptoms started 18-20 hours after receiving vaccine dose. Symptoms lasted about 6 hours and then subsided. Took 2 Tylenol.
2 inch diameter red, hard, tender lump at injection site lasting for 2+ days. 1 day post injection, feeling of mild body achiness and headache, that was relieved with 400mg ibuprofen.
Swollen arm; Red arm; This case was reported by a nurse via sales rep and described the occurrence of swelling arm in a female 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 swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comments: After vaccination patient developed a swollen and red arm for 10 days.
dizziness; This case was reported by a nurse via sales rep and described the occurrence of dizziness in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Bexsero .5 ml. On an unknown date, unknown after receiving Bexsero, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported dizziness that prompted her to miss work after receiving both doses of Bexsero. The reporter consented to follow up.
Tingling, soreness, blisters and itching on (R) side of chest and back. Some blisters have broke open and have scabbed over and some have not. Feels better than it did last week per patient. Recvd shingles shot on 10/16/12 at 2:37pm. Stated he felt these symptoms the following Saturday. No MD visit at time of my conversation with patient.
Swelling, hard lump, red triangle on and around injection site.  COVID arm or vaccine arm. Started as as a moderate itch right next to injection site 7 days after injection.  The next morning, it continued to itch and then swelled.  The red patch showed up later on day 8.  The red patch was in the shape of a triangle, with the injection site at the center.
Employee dizzy, SOB, diaphoretic, nauseous, "feels weird", light-headed, hands tingly.
Pt recv vax on 2/26/99; immediately post vax pt exp burn feeling at vax site, bump on rt arm, red & warm vax site; tx=cold compress, Duracef
Pt became febrile after receiving vaccinations very irritable that PM increased Temp continued x 48 hours decreased appetite and irritability continued for some time span.
A report has been received from health professional via MHRA concerning, a 10 month old, female patient. The reporter was also received from consumer via spontaneous source. The patient's medical history was not provided. The patient's concomitant medications were not reported. The patient received influenza virus vaccine, 1 df started on an unknown date. The route of administration and formulation information was unknown. It was reported that the patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal Influenza vaccine) on an unknown date. One to two weeks post vaccination the patient had high fever. Doctors concluded that she had neutropenia. Her neutrophil counts were so low that she was hospitalized for a couple of days. It took five months for her count to return to normal range. She had not had an event since then. The doctors thought it was autoimmune neutropenia. Her mother refused to administer a second dose of vaccine. The patient recovered from the events of autoimmune neutropenia, fever and neutrophil count decreased on an unspecified date. The reporter assessed the events of autoimmune neutropenia, fever and neutrophil count decreased to be serious with the criteria of hospitalization.
This is a prospective pregnancy case. This 31-year-old female subject who was enrolled in an open label study. The subject received BOOSTRIX .5 ml on 2nd January 2015. The subject's estimated date of delivery was 19th February 2015. The subject received BOOSTRIX at week 33 of the pregnancy and during the third trimester of pregnancy. On 2nd January 2015, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: Reporter is the patient. She works at Pharmacy. Another pharmacist gave her the BOOSTRIX while being pregnant. No symptoms reported.
24-28 hours later swelling, redness, tenderness, and warmth half way around my arm where I received the vaccine. Looks like a bad sunburn. 24-28 hours later- GI cramps, bloating, nausea, stomach pain, flares. GI symptoms are still ongoing over 48 hours after the vaccine.
Approx. 8-10 hours following the injections I experienced muscle pain, fever, chills and ringing in my ears (tinnitus).  24-36 hours after all symptoms subsided with the exception of the tinnitus. Tinnitus has been a constant high frequency ringing non stop since onset. I have become hyper sensitive to loud noises and loud background noise. I assumed it would go away and determined I would wait a week before calling Dr. I contacted my Dr. yesterday and have an appointment tomorrow (June 9, 2022).
Fever and swelling that is moving down arm. Hot to touch.  Continued to break out in rash. Arm is very sore. Two full days have passed
Numbness in legs and numbness in hands. Blood pressure reading has increasedSlurring of speech, decrease visibility/vision , increased blood sugar readings, increased authentic pain
Headache Fatigue Narrative: 24 hours after vaccine administration onset of headache, malaise, feeling poorly - subsequently missed work 12/22 in order to rest; resolved by 12/23
Extremely Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Extremely Nauseated) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced NAUSEA (Extremely Nauseated). At the time of the report, NAUSEA (Extremely Nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Mild soreness at Injection site; This is a spontaneous report from a non-contactable consumer for himself.   A 24-years-old male patient received bnt162b2 (BNT162B2; Lot # EL 3247) vaccine , via an unspecified route of administration in the left arm on  21Jan2021 at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced mild soreness at injection site  on 22Jan2021 with outcome of recovering.  Follow up not possible. Lot number already received.
hand itches; Face became numb; She was not feeling good; Fever 104.9F; She was tired; she was Cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (she was Cold), PRURITUS (hand itches), HYPOAESTHESIA (Face became numb), FEELING ABNORMAL (She was not feeling good) and PYREXIA (Fever 104.9F) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A, 011L20A and 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Epstein Barr virus positive mucocutaneous ulcer (Epstein Barr Virus). Concurrent medical conditions included Drug allergy (If she takes Valtrex 1 gram twice a day her hand itches). Concomitant products included VITAMIN D NOS for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced NASOPHARYNGITIS (she was Cold), PYREXIA (Fever 104.9F) and FATIGUE (She was tired). On an unknown date, the patient experienced PRURITUS (hand itches), HYPOAESTHESIA (Face became numb) and FEELING ABNORMAL (She was not feeling good). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency; VALACICLOVIR HYDROCHLORIDE (VALTREX) at a dose of 1 gram and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. On 14-Feb-2021, NASOPHARYNGITIS (she was Cold) and PYREXIA (Fever 104.9F) had resolved. On 15-Feb-2021, FATIGUE (She was tired) had resolved. At the time of the report, PRURITUS (hand itches), HYPOAESTHESIA (Face became numb) and FEELING ABNORMAL (She was not feeling good) had resolved.            Treatment medication included Tylenol and Advil and Fluids, Valtrex, (A-Eb-H6)  All side effects  lasted for 48 hours. She was tired for a day after fever went away.  She now is taking Valtrex 1gram daily. If she takes Valtrex 1 gram twice a day her hand itches.  She tried a Natural supplement: (A-Eb-H6)  for  two days before started Valtrex. This supplement was stopped.  On an unknown date in Feb-2021, the patient was positive for Epstein Barr Virus test after second shot      This case was linked to MOD-2021-289692, MOD-2021-290616 (Patient Link).
A report was received form a health care professional on 11/22/2002 concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/2002-onwards. From 11/07/2002 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporters causality assessment. Update1. 12/10/2002: A follow up report was received from a health professional indicating that a 4 year old male vaccinee was inadvertently administered Fluvirin intramuscularly on 11/14/2002. Cross Reference with: PJP-2002-00848, PJP-2002-00849, PJP-2002-00850, PJP-2002-00851, PJP-2002-00852, PJP-2002-00854, PJP-2002-00805, PJP-2002-00855, PJP-2002-00856, PJP-2002-00857, PJP-2002-00858, PJP-2002-00859, PJP-2002-00860, PJP-2002-00861, PJP-2002-00862, PJP-2002-00863, PJP-2002-00864, PJP-2002-00865, PJP-2002-00866, PJP-2002-00867, PJP-2002-00868, PJP-2002-00869, PJP-2002-00870, PJP-2002-00871, PJP-2002-00872, PJP-2002-00873, PJP-2002-00874, PJP-2002-00875, PJP-2002-00876, PJP-2002-00877.
Information has been received from a registered nurse concerning a 7 year old female with no known drug allergies who on 02/10/1998 was vaccinated SC in the left arm with a first dose of varicella vaccine. There were no concomitant medications or illnesses at the time of vaccination. there were no adverse events following prior vaccinations for both the pt and her siblings. It was noted that a rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. On 11/10/2000, at 21:00pm, the child's mother noticed a rash at bedtime. On 11/11/2000 the child presented to the physician's office with a rash that started at the left elbow and extended to the fingers. It was noted that the fingers were swollen, and that the inside and one spot on the hand were painful. The child was diagnosed as having shingles. It was noted that the child was afebrile. Lab results yielded a positive test for strep. It was noted that there was no history of, recent exposure to chicken pox or herpes zoster and that a specimen was not obtained for PCR analysis. It was reported that the child recovered from the shingles on 11/14/2000. No further info is available.
Patient said her arm where the flu shot was administered has been sore since. In the daytime it's comfortable but at night it keeps her up occasionally. She told her doctor but he didn't do anything.
The patient's arm was slightly red in color and swollen. When felt, there seemed to be a lump where the vaccine was given after 5 days.
Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka-Merck) PROQUAD (dose and route were unknown) lot # M015698 with expiration date 26-SEP-2017, lot # M000998 (and invalid lot number) with expiration date 07-JAN-2018 and lot # M006724 (an invalid lot number) with expiration date 08-FEB-2018. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Member with 26cm X 13cm erythematous induration extending below elbow on left arm, tenderness and warmth. Reports pain with movement.
Case number PHEH2014US003591 is an initial spontaneous report received from a pharmacist on 20 Feb 2014. This report refers to a 13 year old adolescent male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 010021A) intramuscularly on 27 Nov 2013. No adverse event was reported following this medication error (inappropriate age at vaccine administration). Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 20 Feb 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as Drug use in unapproved population.
Patient reported dizziness approximately 30 minutes after receiving vaccine. ED was called at 1:36 pm  as per protocol.   She was seated in the Pharmacy waiting area and were monitored by Pharmacist for blood pressure and oxygenation. Once Emergency team came (arrived at 1:52pm), she was monitored for blood sugar levels and they were normal. She was offered to be transported to the nearest hospital for a checkup and she agreed. Patient transported from pharmacy at 2:02pm.