chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Metallic taste in mouth; Hives all over; Flare in inflammation or pudendal nerve; Spike in hormone level; Vaginal inflammation; Vaginal infection; Change in vision; This is a spontaneous report received from a contactable other healthcare professional (patient). A 49-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 23Aug2021 as dose 1, single and a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 23Aug2021 10:00 (both doses at the age of 49-years-old) as dose 2, single for COVID-19 immunisation. Medical history included pudendal neuralgia, lichen sclerosis, pelvic congestion, covid-19 from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The most recent COVID-19 vaccine facility was administered in workplace clinic. The patient experienced metallic taste in mouth, hives all over, flare in inflammation or pudendal nerve, spike in hormone level, vaginal inflammation, vaginal infection, change in vision on 23Aug2021 10:00. Treatment was received for the events (prescription for infection). Patient visited Doctor or other healthcare professional office/clinic visit. The outcome of the events was reported as not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
About six weeks after the second dose I started to have a stuffy nose. I then got a cough which would not go away. I went to Urgent Care 07/02/2021. I was prescribed Azithromycin and Steroids. It was dry mostly and very hard to control the coughing spells. I had the cough for about six weeks and it improved after the medication. Currently it is still improving but I still get bouts of coughing.
Information has been received from a physician concerning a 14 year old "N" male student with a history of asthma but non since 1999 who on 02/27/03 was vaccinated in the left arm with a first dose of varicella virus vaccine live (Lot # 644086/0974M).  It was reported that the pt received the vaccine because of a negative antibody titer. There was no illness at the time of the vaccination.  On 02/10/03 the pt was vaccinated with a dose of hepatitis B vaccine recombinant (manufacturer unknown) that was "given elsewhere" and on 02/19/03 the pt was vaccinated in the left arm with an adult dose of TD toxoid (Lot # 90820AA).  There were no other concomitant medications. The pt had no adverse events following prior vaccinations.  On 03/12/03 the pt was seen at a medical center ER with a "few/several" generalized varicella-like, vesicular lesions of his arms, face and trunk. It was reported that he was treated and released.  On 04/01/03, the pt was seen in follow up by a pediatrician. A varicella antibody titer was ordered and the reported noted that he had seen the report and that it "must be IgG (no IgM identified)-- the titer was positive (0.99)".  On 04/04/03 the pt recovered. No further information is expected.
Sore arm then severe headache with nausea and light sensitivity. Pain medication PRN headache.
patient fainted/lost consciousness and started to convulse 1-2 minutes after injection for about 1-2 minute pt was disoriented when regain consciousness.
Temperature of 101.5-103.5 elevated pulse of 140 over a period of about 7 hours was prescribed Tylenol as needed after. Temperature went back to normal after a few hours. 120 - 130 BPM for Tachycardia episodes.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (Lot #, dose and route not reported) on 08-AUG-2011. On 27-JUL-2012 the patient received the second dose. No adverse event reported. Additional information is not expected.
Rash and urticaria, pruritus. Acyclovir 1200 mg tid, Triamcinolone bid.
Red itchy 2x2 inches area . Dr. Told me put hot towels on it . Put Benadryl cream. I took one Benadryl pill.  Today is date 12 still itching, but much better
Extreme pain/inflammation in joints of arm that vaccine was administered into. Pain in elbow, wrist and fingers lasted for 2 days. Treated with Naproxen.  Went away for 3 days and then came back. Comes & goes.
On April 11th, woke up with a swollen left eye and upper cheek, with redness. On April 12th, woke up with left eye nearly swollen shut, and entire left side of face red and puffy. As the day progressed, blisters appeared and began weeping. Which does sound like it could be a poison weed, right? I had zero contact with any poison ivy, sumac, oak, etc. I had not changed my diet, changed any soaps/detergents, etc. Contacted primary care provider who diagnosed issue as poison ivy and prescribed 40 mg of prednisone for 3 days, 20 mg for 2 days. By Thursday April 14th, issue was not improving and my entire face was swollen, red, hot and itchy.  Went to the urgent care clinic who conferred with my primary doctor and they decided to increase my prednisone treatment to 60 mg for 3 days, 20 for 3 days. As of today, April 16th, the prednisone treatment does not appear to be helping, as face is still red, swollen, hot and itchy. This has also spread to my neck area, but not any where else on my body.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In December 2019, between 2 and 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The patient received their first Shingrix in September and was diagnosed with Shingles in December. The patient did not receive the vaccine at the reporting pharmacy. The reporter consented to follow up.
Intense itching on the underside of the arm that the injection was given and a lump felt in the armpit.  By Tuesday there was pain in the chest and continued itching.  1/18/13 went to ER thinking she was having a heart attack.  Did CT Scan and it showed no heart involvement or blood clots. She was told to stop taking her Provera.
caller might have taken the COVID-19 vaccine/she has COVID and and her whole family has COVID; caller might have taken the COVID-19 vaccine/she has COVID and and her whole family has COVID; The initial case was missing the following minimum criteria: no suspect drug was reported. Upon receipt of follow-up information on (19Dec2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "caller might have taken the COVID-19 vaccine/she has COVID and and her whole family has COVID".  Clinical course: Phone-Out 02:19 PM EST, 2nd attempt by phone to consumer to obtain mailing information. Phone answered by consumer who said that patient had the Pfizer covid vaccine and had three doses. Consumer did not want to provide mailing address, but agree to provide e-mail address instead.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
12-20-20, started with tingling around my left lower lip at night time and the next morning I had tingling  going up to the left eye and cheek. No rash noted and concerned I was getting shingles.  I saw a doctor and he did an eye exam to see if I had any shingles in my eye. My symptoms went away in few days.
Fever CHills headache stiff neck redness and swelling at injection site nasal congestions bone pain joint pain
After I got the vaccine I felt fine, I was able to go out that night. Then Saturday I woke up I had headache and fever. I was drinking lots of fluid and taking Tylenol. My headache was still pounding. Saturday evening I noticed pain traveling up to my armpit. The Sunday I woke up with a huge lump the size of an orange was painful and warm to touch and my chest started hurting so I went to ER, I noticed I was making more of an effort to breathe. The ER doctor just felt like it was related to booster let it run its course, the swelling should go down within 10 days.
pt recvd vax;20 days later pt tested pos for hep B;pt believes that hep B was contracted from vax;
I received dose 1 of the Moderna vaccine on the day of my missed period, around week 4 of pregnancy. I had a miscarriage at about 6.5 weeks. No previous history of miscarriage/adverse pregnancy outcomes for myself, or history of miscarriage/adverse pregnancy outcomes in my family.
Roughly 4 hours after injection, patient was sitting at her desk in front of the computer.  She reached for the mouse and noticed her left arm began hurting.  She decided to get up and go to her family room chair, as soon as she stood up she began feeling very dizzy and needed to guide herself along the wall to get to the other room.  She sat down and rested, as she felt extremely dizzy.  After about an hour of resting, she then suddenly began shaking, and her teeth were chattering.  This lasted about 20 min.  Her shaking was so intense her spouse was not able to feel a pulse.  She felt very cold at her extremities, but core body felt very warm.  Spouse gave her tylenol and water to drink.   Weakness lasted though for almost two full days.  Her arm was also slightly swollen at the injection site, but denied any redness.  She felt very weak with ambulation, or any form of exertion.  She was extremely tired.  She slept a lot over the course of the two days after the injection, which she reports is abnormal.  Her arm remained sore also.  Two days later, the overall body weakness resided, but the arm remains sore.  No reports of redness at the injection site, denied swelling at the injection site.
Within 12 hours of flu shot injection the injection site was red, swollen, and heated.  After 24 hours, the entire upper arm and shoulder were affected similarly.  Hives formed under around the injection site, under the injected arm, and spread down the torso from the underarm.  Hives were limited to the injected arm until 72 hours after injection, when they spread to the rest of the body.  A low-grade fever was present for a few hours the morning after injection.  96 hours after injection, the swelling and redness at the injection site has resolved.  The hives and itchiness remain.  Treatment has been limited to Benadryl and topcial cortisone cream for the hives.  The patient is allergic to amoxicillin and cephalosporins.  He has had prior flu injections in 10/05, 11/05, 11/06, and 11/08 with no reaction.
A report has been received from a literature source concerning an adult, subject of unknown gender, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. The patient experienced transient fevers and chills. The outcome of the event of transient fevers and chills is unknown. The report was considered to be non-serious.
Day after vaccine  shoulder and neck pain. Third day ringing and hearing loss in left ear. Progressively worse at 1 week and 2 weeks. Third week, went to er, shoulder treated for inflammatory process, migraine treated, never had a migraine before, referred to ENT. Saw ent 2 days later, diagnosed with sensorineural hearing loss and tinnitus. Received 2and dose of vaccine in right arm on May 20, 2021. Ringing started in right ear today, May 22,2021.
"A physician reported that her 2 month old daughter received her 1st dose of Prevnar, Comvax, IPV and DTAP vaccines in 1/01. On 2/20/01, she was treated and released from the ER for a seizure and high fever. As of 2/22/01, she continued to receive treatment with ceftriaxone. Seizures are considered "Medically Important". F/U was rec'd from a HCP. She was treated at the ER with ceftriaxone sodium (Rocephin). Lab work was done, a LP was offered but was refused by the parents. The pt was discharged form the ER. On 2/21/01 the pt was seen for follow up in the pediatrician's office. She was given ceftriaxone sodium (Rocephin) 700mg again. On 2/22/01 the pt was in the physician's office for another follow up visit, and it was documented that the pt was alert, active, and doing great. The blood cultures were normal with no growth. The pt's ears were red, and the final dx was a urinary tract infection. The last visit for the pt was 3/14/01, at which time she rec'd her second dose of haemophilus B conjugate vaccine(+) hepatitis B vaccine recombinant (yeast). The decision was made to not give the pt a second dose of Streptococcus pneumonia vaccine (Prevnar). F/U correspondence rec'g on 8/29/01 pt's lab data was provided. Very high fever.
Shot received approximately 11:00 AM. Symptoms: midnight: severe chills (4 blankets didn't help). Muscle aches in legs and rear end. Feeling like I was going to throw up; headache. The headache started in afternoon. I had a previous reaction approximately 7 years ago but never reported; only it happened within 1/2 hour of shot. I've had shots since then with no symptoms.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 Vaccine) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jun-2021 at 11:53 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 Vaccine). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug information was provided by the reporter. No treatment information was provided by the reporter. No lab data was provided by the reporter
Lymph nodes in left (opposite) armpit swelled and were very painful to the touch and and when raising or lowering arm on Friday 3/12/21.  Since then, the lymph nodes in the right armpit are now swollen and painful as well.
Severe lower back pain; This is a spontaneous report from a non-contactable consumer, the patient. A 21-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 left arm on 07Apr2021 at 14:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on unknown date 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. On 08Apr2021 the patient experienced severe lower back pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event severe lower back pain was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Complaints of a scratchy throat minutes after receiving Pfizer vaccine.; This is a spontaneous report from a contactable healthcare professional. A 22-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an intramuscular route of administration in the right arm on 14Mar2021 at 15:00 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The patient had an unspecified medical history and known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The concomitant medication included unspecified medications. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 14Mar2021 at 15:00, minutes after the vaccine, the patient experienced a scratchy throat. The event resulted in the emergency room/department or urgent care. Therapeutic measures were taken as a result of the event included treatment with diphenhydramine hydrochloride (BENADRYL) via the intravenous route. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event scratchy throat was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Body aches, fever (102 F), headache beginning night of 2nd inoculation, continuing through next day
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown), 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: "Crohns disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment). The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Got shingles after the shot/Suspected vaccination failure; Shingles/got shingles after the shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-Feb-2023 Reporter's Comments: The case was received from the consumer via interactive digital media. The reporter reported that his/her brother had the patient (neighbor) got the shot and got shingles after the shot. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding primary schedule, time to onset for event and laboratory confirmation of shingles were not provided. The follow-up could not be possible as no contact details were available. This 1 of 4 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GSK-US2023AMR028529:Same reporter US-GSK-US2023AMR028533:Same reporter US-GSK-US2023AMR028534:Same reporter
no adverse effect; expired dose administered; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 19-SEP-2019, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) via intramuscular route (exact dose, injection site, lot # and expiration date were not reported) for prophylaxis. There was no adverse event reported.
develop a rash between receiving the two doses of the Pfizer Covid 19 vaccine; This is a spontaneous report from a contactable physician. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiry date was not reported), dose 1 via an unspecified route of administration on 19Feb2021 as DOSE 1, SINGLE (at the age of 48-years-old) for COVID-19 immunisation. The patient's medical history included diabetic and osteomyelitis from an unknown date and unknown if ongoing. The patient had no prior vaccinations (within 4 weeks) of COVID-19 vaccination. On an unspecified date in 2021, the patient experienced develop a rash between receiving the two doses of the Pfizer COVID 19 vaccine. The patient was also on IV antibiotics for osteomyelitis of her toe at the time. The rash was treated with steroids and resolved when the antibiotics were stopped and changed. It was, therefore, the consensus, that the reaction was more likely than not due to the antibiotics, not the vaccine. And the patient has since received a third dose as a booster (being a high-risk insulin diabetic patient) without any incident. Therapeutic measures were taken as a result of the event. The patient had recovered from the event on an unspecified date in 2021.  The reporter did not consider that the Pfizer product had a causal effect to the adverse events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (08Oct2021) This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.