chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chronic induration and scaling at site 2 days after injection till now approx 1 mth later - monitor.
Within a day, redness and swelling approximately 1 inch to the left (medial) of injection site. No pain directly at injection site. Affected area approximately 1in x 1 in. Area has slowly increased in size. On 4/11 (4 days after vaccination), redness , soreness and swelling persist with affected area increasing to approximately 2in x 3 in.
Two days after receiving immunization, injection site red, hot & larger in size.  On exam:  Right anterior thigh injection site is firm, slightly warm, & tender.  Pinkish blue color, about 4x4cms.  Tx- CEFZIL 250mg/5ml, 8ml BID x 10 days.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP6955), on 09Apr2021 as dose 2, single (Lot number: EW0150) and on 22Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FF2593) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension." (ongoing). Concomitant medication(s) included: LOSARTAN; AMLODIPINE; ALEVE; TYLENOL.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; negative, notes: previously tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies. The patient received Paxlovid for COVID 19 treatment from 23Apr2022 to 27Apr2022.
Each day I'm more fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Each day I'm more fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Each day I'm more fatigue). At the time of the report, FATIGUE (Each day I'm more fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was given by reporter.  No treatment medication was given by reporter
In mid-July 2021, after second Shingrix dose  (4/20/21) and second Moderna Covid dose (3/31/21), I broke out in a terrible poison ivy-like rash all over my back, abdomen, under my breasts on my arms, legs and scalp. Went to dermatologist on 8/23/21. Was given 10 day oral prednisone dose.  Prednisone did not resolve rash. Rash continued over next several weeks. Went to dermatologist again on 9/21/21. Was prescribed 20 day oral prednisone which did resolve rash until last few days of regiment when rash came back with vengeance. Four (4) biopsies were taken on 9/21/21 that confirmed Grover's Disease. Also visited primary care physicians on 10/26/21 and on 11/8/21. Disease continues to be terrible and untreatable.
felt good in afternoon @ 6 or 7PM became nauseated, vomitting, diff breathing last noc, rash this AM (big bumps that itch on back, arms); temp last noc took APAP; h/a this AM (took APAP; also bumps on face; might have measles;
SHAKING; BODY ACHES; SEVERE CHILLS; SORENESS IN ARM AT INJECTION SITE; BAD HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight was 125 pounds, and height was 65 inches. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included patient had no past medical history. patient had no known allergies patient had no drug abuse or illicit drug usage. patient received multivitamin as past drug. The patient was previously treated with betamethasone dipropionate for psoriasis, citalopram for anxiety, depression, ergocalciferol, and ascorbic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 28-JUL-2021 17:15 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the subject experienced shaking. On 29-JUL-2021, the subject experienced body aches. On 29-JUL-2021, the subject experienced severe chills. On 29-JUL-2021, the subject experienced soreness in arm at injection site. On 29-JUL-2021, the subject experienced bad headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, and severe chills on 29-JUL-2021, and had not recovered from bad headache, body aches, and soreness in arm at injection site. This report was non-serious.
Hands and feet went numb and painful, fever, pain very sharp moved through my body, to all points of weakness from formal problems, left lung then kidneys and abdomen , lasted till next morning.
Clerk voiced pt's uncle called that pt felt sick, her eyes were swelling, clerk spoke to pt and voiced pt sound like she was wheezing. Pt was told to go to hospital. On 10/22/14 RN called pt unable to speak to pt uncle-in-law voiced pt was treated at hospital and felt much better.
Approximately six weeks after vaccination, patient developed multiple small vesicles at her vaccination site that remained for two weeks.  She had no pruritus, induration, swelling, or drainage at this area.  No treatment was needed other than a dressing over the vesicles until they resolved. In the 8 weeks post-vaccination, patient experience five migraine headaches.  Normally she only has about one migraine per year. She self-treated the headaches and has not had any further.
On 5/11/00, pt got a pneumovax instead of tetanus which was ordered. Had had pneumovax more than 2 years before. He had edema and redness on left arm on 5/12/00 and he got Keflex.
fever, chills, muscle aches  recommended tylenol or ibuprofen to relieve symptoms. If symptoms worsen referred her to see primary provider.
No additional AE reported; PROQUAD that had undergone temperature excursion was administered to patients; This spontaneous report has been received from a medical assistant and refers to a 4-year-old male patient.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 05-DEC-2023, a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number W019628 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported and established as 19-DEC-2023) suffered a temperature excursion and was administered  intramuscularly to the patient on 08-DEC-2022 for prophylaxis (strength was not provided) (product storage error).
Started with papules on 8/21. No fever or severe itch. Lesions increased over several days.
Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On an unknown date, the patients received improperly stored (Oka/Merck) VARIVAX (lot # L034370 with expire date 08-SEP-2017) (dosage and route not reported) which was reconstituted with improperly stored sterile diluent (sterile water diluent) (confirmed Lot # L015076 and expire date 04-MAR-2018). The conditions storage of (Oka/Merck) VARIVAX was 40 F for 100 hours then was back in range. The conditions storage of sterile diluent was: maximum temperature 47 F for 21 hours and minimum temperature 29 F for 273 hours (multiple cycles, more than 3). There was no previous temperature excursion. No adverse effects were reported. This is one of three reported received from the same reporter. Additional information has been requested.
Red, swollen, itchy, lump about size of half dollar at injection site. 4 days later began with itchy rash. It continued to spread for the next 3 days all over my body! Taking 50mg of Benadryl every 6 hours. Very uncomfortable!!!
given an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA57AA, expiry date 30th September 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th January 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 14th January 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient received an expired dose of Bexsero, which led to expired vaccine used. At the time of reporting, the patient had not been re-dosed. The reporter consented to follow up.
Cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On 04-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In July 2023, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   She had been taking a cold and flu thing. She had also been taking zycan. Never had covid in the past.
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No information about medical history, concurrent conditions was reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, dose, frequency, route not reported). No concomitant medications were reported. On an unknown date the patient developed a "little" redness and swelling at the injection site as well as "what looks like" a shingles rash at an unspecified location after receiving ZOSTAVAX. The outcome of the events is unknown. The causality of the events was not specified. Additional information is not expected as the pharmacist declined to provide any further information and there were no contact details available.
Patient received Covid Vaccine and followed process (15 minute monitored time). Patient was walking out of center and fell hitting his head. 12 lead EKG, CBC, Chemistry, Portable chest x-ray, CT Brain/Head w/o contrast, CT maxillofacial w/o contrast, CT Spine Cervical w/o contrast. Transferred by  helicopter to trauma.
2 inch area erythema @ site of VARIVAX injection. 1 inch area induration warm to touch. Dx: Local vaccine reaction. Treated with BENADRYL po & ice.
Developed a lump a little bit bigger than golf ball size under his left arm in his armpit where he got shot; Uncomfortable and irritable to put his left arm down; Area painful to the touch under his left arm and armpit where he got shot; This is a spontaneous report from a Contactable consumer (reporting himself). This is the second of 2 reports. This 43-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0150), via an unspecified route of administration in left arm on 05Apr2021 as a single dose for COVID-19 immunization. The patients medical history (including any illness at time of vaccination) Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, genetic/ chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity which included asthma. The patients family medical history was none. The patient had no AEs following prior vaccination. On 05Apr2021, the patient experienced pain at the injection site of left arm and on 06Apr2021, the patient had onset of uncomfortableness under his left arm and armpit, area painful to the touch under his left arm and armpit and it was uncomfortable and irritable to put his left arm down. When the patient woke up on 07Apr2021, that the patient noticed the patient had developed a lump a little bit bigger than golf ball size under his left arm in his armpit which is painful to the touch. The patient thought it may have started to develop that lump on 06Apr2021 but did not notice the lump until morning of 07Apr2021. The patient was wondering what he should do. The patient needs to know if this was serious and the triage nurse couldn't tell him and his doctor hasn't called him back. Event was unusual because the patient has never had a bump like that lump he has at this time-caller stated bump as a descriptor of lump. The agent caller spoke to earlier advised patient that if the patient was uncomfortable or in pain to go to doctors office so patient called primary care provider who said to go in to have it checked. Caller reported the agent tells you about the symptoms and agent said that he had seen swelling of lymph nodes was one of the symptoms in his clinical trials information for the Pfizer-BioNTech COVID-19 Vaccine; and in those reports the swelling of lymph nodes usually goes away in about 10 days. Outcome of that event unable to be clarified as if recovered completely or with lasting effects-when queried caller reported that he did not notice any problems after that, did not have the pain at the injection site of left arm after that day or two.  No Follow-up attempts are needed. No further information is expected.
The patient got covid after both shots; The patient got covid after both shots; This is a spontaneous report from a contactable consumer. This consumer reported for a patient that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown, Expiration date : Unknown) via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical Vaccine reported as BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 Immunization. The report received as, caller states that the patient got covid after both shots. The patient underwent lab tests and procedures which included Covid-19: got covid after both shots (the patient got covid after both shots) on an unknown date. Outcome of the event was unknown.  Information on lot number/batch number has been requested.
GARDASIL vaccine administered and within 2 days right arm painful and weak. Pt did not have weakness or pain in any other extremities. No dark urine. Treated with OTC pain relievers, increased fluids.
swelling of my foot which persisted for several months until the swelling moved up my leg and thigh. Subsequent tests determined the swelling was due to blood clots and that they had entered my lungs. I am no being treated with blood thinner, Eliquis after anintravenous blood thinner, Anaxaparin
Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient stated that she experienced sore arm. The reporter consented to follow up. No further details were provided.  For tolerance to 2nd dose of Shingrix, refer case US2019134748.
Headache, nausea, diarrhea, local reaction at injection site next day after injection no tx except KENALOG 80 mg I (L) buttock.
44 year old female, who is otherwise healthy, required emergency medical care within 15-30 minutes after the administration of the MMR Vaccine. The patient noticed a lump/swollen feeling in her throat that progressively got worse. She developed swelling and numbness of her tongue and throat, along with chest tightness. The patient required 2 epinephrine doses initially as well as a third dose of epinephrine when symptoms relapsed. Then she received 125mg of Solu-Medrol, 20mg of famotidine, and 50mg of Benadryl intravenously. She was admitted to the hospital for observation overnight.
A mammogram on 02/17/2021 seems to have been the cause of a serious reaction to left knee and left leg.  Severe swelling and pain on 02/19/2021.  This condition continued for 7-10 days requiring use of a walker for mobility and confinement to house.
woke with the dry heavies; achy body; light headness; feel really bad today; Fever; tired; muscle pain; headache; This case was reported by a consumer via interactive digital media and described the occurrence of dry heaves in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pruritus (received 1st dose one nad half year ago from reporting date, refer case US2020AMR040791).   On 3rd March 2020, the patient received the 2nd dose of Shingrix. On 4th March 2020, 1 days after receiving Shingrix, the patient experienced dry heaves, general body pain, light headedness, feeling bad, fever, tiredness, muscle pain and headache. On an unknown date, the outcome of the dry heaves, general body pain, light headedness, feeling bad, fever, tiredness, muscle pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the dry heaves, general body pain, light headedness, feeling bad, fever, tiredness, muscle pain and headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 64 years or 65 years. The patient needed second shot but the patient was very nervous about getting it due to adverse events experienced after 1st dose, so the patient received 2nd dose late, a year and half after the 1st dose. On the day of reporting, the patient woke with the dry heavies, achy body and light headness. The patient felt very bad on the day of reporting, had fever, tired, muscle pain and headache. The patient wanted to know how long thses side effect might last.
Pt presented to clinic on 6/15/22 stating she had left shoulder pain, difficulty with range of motion of the left arm, weakness, and a pins and needles sensation in her left art that started 6/3/2022, the day after receiving the boostrix injection.  Pt states she was seen at ER on 6/8  where an xray was performed that showed no abnormalities.  Pt was prescribed lidocaine patches, toradol, and flexiril at the ER.  She reports full range of motion as long as she is taking the medications.  An MRI was ordered on 6/15 and scheduled on 7/26.
Pt states left arm became swollen, hot to the touch, a rash developed on the arm which went down to the forearm. Also pt states her underarm was swollen and painful. Furthermore, pt states that she experienced itching so took BENADRYL. Pt iced the arm and took pain relievers. Pt presented to the pharmacy on 2/7/2018 because she was out of town.
Breakthrough case after three vaccinations Moderna 4/9/21 Lot# 025B21A;  Moderna 5/7/21 Lot# 043B21A;  Moderna 1/27/22 Lot# 066H21A
Spontaneous report has been received from a Health professional concerning a 13 years 18 weeks 4 days old male patient. Patient relevant history, concurrent diseases and concomitant drugs were not reported. On an unspecified date, patient received FLUMIST, 0.2 millilitres, once/single administration. Reporter stated that after receiving FLUMIST vaccine, flu confirmed via nasal swab and rapid test to a patient. Patient became ill on 09-Mar-2016. The outcome of after receiving FLUMIST vaccine, flu confirmed via nasal swab and rapid test and became ill was unknown. Company physician considered after receiving FLUMIST vaccine, flu confirmed via nasal swab and rapid test and became ill to be non serious.
Parent reports adverse events occurring 2 days following the administration of the vaccination including intermittent shortness of breath, intermittent tingling and numbness of bilateral extremities, headache.  Pt has been seen on 3 different occasions in the ER since the initial symptoms.  At the first visit, mother reported that he was given IV fluids, at the second visit no treatment was deemed necessary and at the third visit, the patient was admitted to the hospital for an overnight stay and cardiac evaluation. All workup was found negative per mother.  These adverse reactions and treatment were reported to the facility (the site of vaccine administration) on 1/24/2012 AM.  Mother was advised to have patient f/u with PCP or immediate care again if symptoms worsen.
Patient received under diluted dose of covid 19 vaccine 5-11.  No adverse event reported by parent.
My shingles scar / still itch intermittently years later; area around it still itch intermittently years later; This case was reported by a consumer via interactive digital media and described the occurrence of itching scar in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced itching scar and pruritus. On an unknown date, the outcome of the itching scar and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the itching scar and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingles vaccine and the shingles scar and area around it was still itch intermittently years later.  The patient got shingles vaccine as the Doctor told that he/she could get another case of shingles.  The patient had a reaction to the vaccine, but it was far easier to tolerate than the shingles. The follow-up would not possible as no contact details were available.
Soldier was given smallpox on 1/15/08.  Pregnancy test on 1/15/08 negative.  Soldier was later positive on pregnancy test.  Unsure of date.  Soldier was referred back to home station.