chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had itching at the site of the injection/Injection site itching; This case has been upgraded to valid as there was new event has been reported after receiving the second dose of Product BNT162B2. Follow-up (16Feb2021): The initial case was missing the following minimum criteria: Upon receipt of follow-up information on 16Feb2021, this case now contains all required information to be considered valid.  This is a follow-up spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported herself. A 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown Expiration date: unknown), second dose via an unspecified route of administration on 11Feb2021 as a single dose for COVID-19 immunisation. Patients' medical history included high blood pressure, cancer surgery in 1985. Patient concomitant medications were not reported. Patient stated that she guesses she received her first injection on 18Jan2021. It was reported that she was just aching with the first injection and she was alarmed when she started having itching with the second dose. Patient experienced itching at the site of the injection on 12Feb2021. The patient underwent unspecified lab test and procedures on 05Feb2021. The outcome of the event recovered in Feb2021.   Information on the lot/ batch number has been requested.
UrticariaPruritus 9X7 cm induration Narrative: 9X7 cm pruritic, erythematous , warm induration 7d after Vaccination.
Per mom swelling and redness injection site L thigh on exam Sl swelling, 0 erythema, increased warmth, or ecchymosis L thigh.
pt recvd vax;w/in 12-24hrs pt devel inflam at inject site, & a knot below the inject site;
Flu vaccine provided 1330 pm 10-15-13; Pt phoned for appt by daughter 10-16-13. Pt reports fine until 10pm 10-15-13 then felt chilling and had to take shallow breaths for 4 hrs. Neck and throat swelled shut. Denied noticing wheezing or chest pain. Didn't take any OTC rx nor did he go to ER. Woke up fine this am. Even able to smoke cigarette today without problem 10-16-13 Evaluated in clinic stable O2 sat no rest distress. Provided IM DEPO MEDROL dexamethasone pt reports he is back to normal.
Soreness in armpit area, redness at site of injection. Also soreness and pain in the shoulder area on arm of injection. Symptoms appeared on the morning after getting the vaccine. Symptoms are still present 3 days later taking TYLENOL to relieve pain.
(L) upper arm red, swollen, fever at injection site. Pt reported having highest temp (oral) at 101.3. (Mom stated always has fever with vaccinations). Site 5 1/2 inch x 6 1/2 inch. Giving BENADRYL PO q6h. Drew border/margin lines with marker. Told mom should shrink in size, if gets bigger to call office back. No pain with flexion/extension of elbow or rotation of shoulder.
Chest pain (sharp/stabbing). Evaluated by EMS-Transported to Emergency room/department or urgent care.
12-14 hours after getting injection woke up with headache, slight trouble swallowing, dizzy, temp 98.3.  Mom gave BENADRYL.
Information has been received from a nurse concerning a 4 year old patient who on 31-MAR-2009 was vaccinated with the first dose of VARIVAX (Merck) (lot# 662201/1544X). The nurse mentioned that on 15-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. On 07-JUN-2012 the patient was vaccinated with a second dose of VARIVAX (Merck) (lot# 671474/1381AA). A lot check has been initiated. Additional information has been requested.
The patient experienced COVID on an unspecified date.; The patient experienced COVID on an unspecified date.; This is a spontaneous report from a contactable consumer via Pfizer sponsored program Topical LCM US Quant & Qual Follow-Up Study. A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246, Expiry Date: Unknown), via intramuscular in upper arm on 08Jan2021 in AM as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9263, Expiry Date: Unknown), via intramuscular in upper arm on 29Jan2021 in AM as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were none. Prior vaccination was reported as none. Relevant Test was reported as none. Reporter stated that 9 players and the coaches of the baseball team all came down with COVID. The patient experienced COVID on an unspecified date. The outcome of event was unknown.  Follow up (07Jul2021): This is a follow up-spontaneous report from a contactable consumer. This consumer reported for patient in response to consumer letter sent via follow-up letter which included that: Added dose details (1st and 2nd dose: date, time, route of administration, anatomical site of injection) medical history, relevant test, concomitant drugs and prior vaccination updated as none.
Large red itchy hard welt appeared at injection site   Four weeks pregnant estimated delivery day Nov 1st
-arm felt immediately warm after receiving vaccine (has felt similar after previous vaccines) -within one hour, arm was red and swollen -within two hours, left arm broke out in rash -over the next few hours, the rash spread down left arm and onto right leg -rash persisted for two+ weeks
Pt has vasicular rash to both hands and going up arms that is itchy and raised. Symptoms started hours after the 8 vaccines were given. Pt was treated with Decadron and sent home with a script for steroids and itch cream. Pt left with the rash still intact.
HYPOTENSION 2/25/2023  &  2/12/2023   --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
patient fainted; light headed, dizzy, sweaty and nauseous for about 5 minutes watched patient closely, used ice pack, gave water .patient was fine after
rash under arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH (rash under arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced RASH (rash under arm). At the time of the report, RASH (rash under arm) outcome was unknown.            Concomitant medication was not reported.  Treatment medication was not reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
On the evening of 02/16/2023, I took my temperature, and it was at 99.4. I began coughing a lot and felt slight shortness of breath. I went to bed and didn't sleep great because I was coughing so much. I got up the next morning and wasn't worse, but I didn't feel well enough to go to work. They symptoms continued through that day. When I woke up Saturday morning, my fever was closer to 100 and I was coughing more, so I found an urgent care clinic. They took my temperature, and it was at 102.4. They tested me for COVID-19, Flu, and RSV. It took around 20-25 minutes for the positive COVID-19 results to come back. The doctor offered a prescription for Paxlovid and Teflon Perles. I was able to get the Paxlovid filled, but the pharmacist told me that I could not take Seroquel while taking the Paxlovid and that it would make the Lamictal less effective. She also advised that I may get a rebound case of COVID-19. So, I decided not to take the Paxlovid. I treated they symptoms with Tylenol and the cough medicine. 02/20/2023 was the last day I had a fever. I stayed home from work for 10 days on the advice of my doctor and regulations. I returned to work on 02/28/2023.
Swelling, induration and erythema of right thigh with fever. Admitted to hospital and treated for possible cellulitis.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LIOTHYRONINE; CELEXA [CITALOPRAM HYDROBROMIDE]; WELLBUTRIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, 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, notes: After a positive covid test, I took paxlovid for 5 days; (Jul2022) Negative, notes: My symptoms went away and I tested negative; (Jul2022) Positive, notes: One week later, covid symptoms returned and I am testing positive for covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received anti viral treatment with PAXLOVID from 09Jul2022 to 13Jul2022 for COVID-19. After a positive covid test, patient took Paxlovid for 5 days. Her symptoms went away and she tested negative. One week later, covid symptoms returned and she was now testing positive for covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Adult dosage (0.3ml) was administered incorrectly to a Pediatric patient. The patient should have received a Pediatric dose ( 0.2ml).  No adverse effects were reported at time of administration.  Doctor informed of error and patient was asked to report to doctor's office.
I received the vaccine March 15 and just shy of 2 months later; May 10th, 2021 I woke up at 8am with a severe headache.  I had a fever as well as the chills.  I was nauseous and dizzy all throughout the day.  The same symptoms continued on for 1 week.  Then they eased up. I didn't think too much about it, but then the headaches have continued.  As well as the nausea and dizziness.  The symptoms are erratic.  They last for 2 days at a time.  Then they disappear for a few days.  Then the cycle repeats.  This has been on going since May 10th.
Very naushia , diarehha, tingle in both hands and arm 2 days headaches  Vomitting and could not eat or drink and felt fatigue.
The patient received dose from vial beyond 30-day use by date; The patient received dose from vial beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported. The date of refrigeration was reported as 07 May 2021. 318 patients received dose from vials beyond 30-day use by date
I had a little soreness on my arm after the vaccine and Monday the same. On Tuesday morning, I started bleeding and felt cramped and pain the whole day. I went to the clinic and they did a blood draw - on April 20th.  No medication.  I'm still bleeding today but it is much less. I don't have the pain.  Pregnancy history - I have had three pregnancies in the past - three abortions; fourth pregnancy - first one that I was trying to have full term. Estimated date of birth - December 20th, 2021.
fast palpitation, chest pain, shortness of breath, blacked out, irregular blood pressure, tired,  weakness
Patient felt dizzy immediately after administration of vaccine.  I had him stay in the chair and after about 1 minute he blacked out for 5 to 10 seconds then awoke.  He said he felt like he had been dreaming for an hour, he was no longer dizzy.  I had him sit for another 20 minutes.  He indicated he felt fine and he left.  A follow up call 3 days later he said he was ok and had no further issues.
This spontaneous report as received from nurse via company representative refers to a female patient of unknown age. Pertinent medical history was unknown. On an unknown date the patient was vaccinated with second dose of GARDASIL (dose/frequency was reported as "1 single shot", route of administration, anatomical location and lot number was unknown). Concomitant medications were unspecified by reporter. On an unknown date the patient fainted while she was in the office. IT was reported that no adverse effects were reported with the patient's first dose of GARDASIL (dose, route of administration and anatomical location was unknown) on an unknown date. The patient sought medical attention but no treatment was given for the event. The action taken with GARDASIL was not reported. The outcome of the event was reported as recovered/resolved on an unspecified date. The causality was unknown. No further adverse event information was provided.  Additional information has been requested.
oPulsating pains in the back of my right calf on Thursday (2-18-2021) evening (one or two every minute) to Friday morning and oPulsating pains in the left side of my head from Friday (2-19-2021) evening until Sunday (frequent at first and then lessening in number). oAlso had what I would call several blood pressure headaches after (usually across the top of my head).
Fever with generalized seizure lasting 17 minutes; Taken by paramedics to emergency department. Evaluation with blood, urine, CSF. Temp in ED 104.1
Soreness and swelling at the injection site 2-24 hours post-injection, Chills 12 hours post-injection
BACK PAIN; SHOULDER PAIN; This spontaneous report received from a patient via social media from a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26. cov2.s (form of admin, route of admin, and batch number were not reported), 1 in total, dose was not reported (dose number in series 1), for prophylactic vaccination. It was reported that the patient "did not have any problem nor any pain or flu " following covid-19 vaccine ad26. cov2. s. (Dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number was not reported) dose, start therapy date were not reported, 1 total administered (dose number in series 2) for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced back pain, and shoulder pain. (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shoulder pain and back pain was not reported. This report was non-serious.
6-10-10 well check and immz done upon visit mom states she thinks (R) pupil is larger than left. 6-14-10 mom put in and states she believed childs personality has changed and question if he has autism. 6-21-10 pt was taken to ER for seizures.
This case was reported by a other health professional via call center representative and described the occurrence of facial paralysis in a 50-year-old male patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis. On 10th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 5 days after receiving SHINGRIX, the patient experienced facial paralysis (serious criteria GSK medically significant), headache and muscle twitching. On an unknown date, the outcome of the facial paralysis was unchanged and the outcome of the headache and muscle twitching were unknown. It was unknown if the reporter considered the facial paralysis, headache and muscle twitching to be related to SHINGRIX. Additional details were provided as follows: This case was reported by certified medical assistant. No further information was reported regarding the event.
pt broke out w/rash; MD called it hives p/shots; approx 2-3 hrs MD gave Atarax syrup; pt was asymptomatic by next day 16JUL94;
Headache, earache, hot flashes, nausea, chest pain, fatigue, body aches. It's only been a day and I still have symptoms
extreme pain; myalgia; really boom sleep; headache; This is a spontaneous report from a contactable physician. This physician reported similar events for four patients. This is the fourth of four reports.   A 16-year-old male patient received meningococcal group b rlp2086 (TRUMENBA, Batch/lot number: CM1494), via an unspecified route of administration on 26Aug2020 at single dose for immunization. Medical history and concomitant medications were none. The patient experienced severe reaction, extreme pain, myalgia, really boom sleep, and headache on an unspecified date with outcome of unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020335485 Same reporter/event different patient
03/21/2003 Grandmother states client was admitted to hospital with heart problems.  60 day follow up on 11/03/2003: "It is unknown if the vaccine recipient recovered from the adverse event.  For additional information, contact her physician." Discharge summary states Short of breath, cough, cardiomyopathy, heart transplant. msv Medical records state nausea, vomiting. msv  Follow up on 09/09/04 states: "Vaccine receipient has recovered from the adverse events that were reported for this vaccination.  Spoke with health department on 09/03/04.  Pt had a history of heart disease when she received the Hep B vaccine. She ended up having a heart transplant and has recovered from that."
both top and bottom lips have small tiny bumps; lips were swollen; lips look burnt; fever blister; burning; cracked; bump on lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP DISORDER (bump on lips), ORAL HERPES (fever blister), BURNING SENSATION (burning), CHAPPED LIPS (cracked) and LIP SWELLING (lips were swollen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUOXETINE, CLONAZEPAM (KLONOPIN), ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) and OMEPRAZOLE.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 02-Apr-2021, the patient experienced LIP DISORDER (bump on lips). On 03-Apr-2021, the patient experienced ORAL HERPES (fever blister), BURNING SENSATION (burning) and CHAPPED LIPS (cracked). On 06-Apr-2021, the patient experienced LIP SWELLING (lips were swollen) and ORAL DISCOMFORT (lips look burnt). On 19-Apr-2021, the patient experienced LIP DISORDER (both top and bottom lips have small tiny bumps). At the time of the report, LIP DISORDER (bump on lips), ORAL HERPES (fever blister), BURNING SENSATION (burning), CHAPPED LIPS (cracked), LIP SWELLING (lips were swollen), ORAL DISCOMFORT (lips look burnt) and LIP DISORDER (both top and bottom lips have small tiny bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
had an adverse reaction to the FLUZONE vaccine; had an adverse reaction to the FLUZONE vaccine and it got worse each year; Initial information received on 29-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Global Media Information (under the reference 00835362).    This case involves an unknown age female patient who experienced had an adverse reaction to the vaccine (adverse event) and it got worse each year (condition aggravated) after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical treatment, concomitant medication, vaccination and family history were not provided.   At the time of the event, the patient had ongoing Hypersensitivity.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious had an adverse reaction to the vaccine (adverse event) and it got worse each year (condition aggravated) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome of events was reported as unknown.  There will be no information available on the batch number for this case.
Weakness and pain in left arm at injection site and with movement. Patient reports 3-4 pain on a scale of 1-10 (1 being no pain, 10 being the worst pain) since 11/27/2022.
Pain around shoulder/deltoid area. Discoloration/rash around shoulder and deltoid/upper pec area. Pain and rash that last for about almost 2 weeks.
This prospective pregnancy case was reported by a pharmacist and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject had no previous pregnancies. On 18 June 2014, the subject received unspecified dose of BOOSTRIX (intramuscular, unknown injection site). Her last menstrual period was on 14 October 2013 and estimate date of delivery was on 20 July 2014. The subject was exposed to the vaccine during the third trimester. At the time of reporting, the pregnancy was ongoing. Follow-up received on 13 January 2015 from pharmacist: On an unknown date, the subject gave birth to a neonate. The pregnancy resulted in a live neonate with no apparent congenital anomaly. At the time of reporting no information regarding the method of delivery, the gender, the weight or Apgar score for baby were available.
This spontaneous report received from a nurse prescriber via company representative referring to a currently 23-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies or medical history. Approximately in 2008, when the patient was 12 years old, she received the first two doses of GARDASIL, (dose, route, anatomical location unknown) and her last dose approximately in 2009 when she was 13 years old. On an unknown date, the patient experienced stage 1 cervical cancer. It was reported that the patient sought medical attention but was unknown if any labs diagnostics nor studies were performed. The outcome and the causal relationship between cervical cancer stage I and GARDASIL were unknown. Upon internal review cervical cancer stage I was considered to be a medically significant event.