chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Firmness Lt arm - T-97.2. Pt received Pneumo vaccine LT deltoid IM on 11-30-10 10:35. At bedtime unable to lie on left arm due to pain. Called nurse 12-2-10. Advised to come in. No redness no fever. Area tender. Advised ice packs and Ibuprofen, move arm. Doctor PAC notified.
This case was reported by a lawyer and described the occurrence of lupus-like reaction in a 19 year old female patient who received Lyme disease vaccine recombinant injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the patient received LYMErix. At an unknown time after receiving LYMErix, the patient experienced severe angioedema, pleurisy, pericarditis, and diffuse polyarticular arthritis resulting in lupus like reaction requiring intensive care hospitalization and ongoing rheumatologic treatment. Time to onset, treatment, and outcome were not reported. Per follow up report received on 03/21/2005:  Legal case, no further information.
10/14/09 15:15: Received seasonal flu shot - never took before 16:00: Coughing, hotflash, eyes bloodshot, swollen lips and eyes, hoarse voice, nose running, pounding H/A. 19:00: Took BENADRYL 25mg po. No trouble breathing. Did not to to ED as instructed. BENADRYL 50mg po q4 hr x24 hr. 10/16/09: To dr, Rx for ATARAX, steroids. 10/17 s/s resolved.
COVID 19 Treatment; COVID 19 Treatment; Finished Paxlovid 25Aug. Developed "rebound symptoms" including flushed face, fatigue, muscle aches on 30Aug; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 74-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "dyslipidemia" (unspecified if ongoing); "thrombocytopenia" (unspecified if ongoing); "HTN" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Fentanyl, reaction(s): "Known allergies: Fentanyl"; Keflex, reaction(s): "Known allergies: Keflex"; Omeprazole, reaction(s): "Known allergies: Omeprazole"; Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DISEASE RECURRENCE (medically significant) with onset 30Aug2022, outcome "recovering", described as "Finished Paxlovid 25Aug. Developed "rebound symptoms" including flushed face, fatigue, muscle aches on 30Aug"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering", and all described as "COVID 19 Treatment". 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. Clinical Course: It was reported that patient received COVID 19 Treatment with Paxlovid from 21Aug2022 to 25Aug2022. Finished Paxlovid 25Aug2022. Developed "rebound symptoms" including flushed face, fatigue, muscle aches on 30Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Information has been received from a licensed registered nurse concerning a 50 year old female with sulfonamide allergy and a history of shingles multiple times in the past, who on 16-SEP-2009 was inadvertently vaccinated with a dose of VARIVAX (Merck) (lot # 664327/0778Y). ZOSTAVAX (Merck) was the intended vaccine. On 12-MAR-2010 the patient had another outbreak of shingles. The reporter stated that this was not a product confusion, but staff error. Relevant test included varicella titer, result not reported. The patient had visited office. At the time of the report, the patient's status was unknown. Additional information has been requested.
Vomiting, stomach, cramps, diarrhea, itching, red swollen at injection site.
brought back 2 weeks after the first Varicella and received a dose of MMR-II; This spontaneous report was received from a nurse referring to a 15-month-old female patient whose medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2022 (also reported as at 12 months old), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX); then, on an unspecified day in June 2022 (also reported as 2 weeks after, and as about 3 months ago), the patient received the vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). Both vaccines were subcutaneous injection formulations and were administered as prophylaxis (strengths, lot numbers, expiration dates, routes of administration, anatomical locations, and vaccine scheme were not reported). It was reported that the parents wanted to separate the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) instead of getting them together at one time; also, the reporter stated she knew it makes it invalid because the two live vaccines should have been separated by at least 4 weeks (inappropriate schedule of product administration). The nurse would like to know if the patient can get the measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) when she comes back since they were out of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) by itself therefore would result in giving the patient an extra dose of varicella virus vaccine live (oka/merck) (VARIVAX).
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 08-SEP-2016, the patient was vaccinated with ZOSTAVAX (lot number, dosage, site and route of administration not provided) for its intended purpose of prevention of shingles. Shortly thereafter, the patient suffered double vision, constant headaches, and blurry vision. In or around September 2016, the patient presented to his physician for this injury and was diagnosed with sixth nerve palsy. The treatment and outcome of sixth nerve palsy was unknown. Causality assessment was related. Upon internal review, sixth nerve palsy was determined to be a medically significant event. Additional information has been requested.
rash under arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH (rash under arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-128314 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Non significant follow up received on 14-JUN-2021, no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128314:
Tested positive for covid; Tested positive for covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP6955), in left arm and on 15Apr2021 as dose 2, single (Lot number: EW0162) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: 017F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Dose 1, 2: Pfizer/ Dose 3: Moderna" (unspecified if ongoing), notes: Dose 1, 2: Pfizer/ Dose 3: Moderna. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022, outcome "unknown" and all described as "Tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive; (07May2022) Negative; (08May2022) Negative; (12May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Tested positive for covid on 29Apr2022. Took Paxlovid 02May - 07May2022. Tested negative for covid on 07May2022, and tested negative for covid on 08May2022. Started coughing and sneezing, again on 09May2022 or 09May2022 or 10May2022. Also was very tired. Tested positive for covid on 12May2022.
This spontaneous report as received from a pharmacy technician refers to a 5 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 23-MAR-2018, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The Oka/Merck VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Information has been received from a nurse concerning a 57 year old patient who on 08-OCT-2009 was vaccinated with PNEUMOVAX 23 (662874/1125Y). Concomitant therapy vaccine include a flu vaccine was given in a different arm on 08-OCT-2009. One hour after the PNEUMOVAX 23 was given, the patient "felt bad". The nurse stated that on 09-OCT-2009, the patient had a red and swollen arm at the injection site and fever. The patient sought medical attention via office visit. At the time of the report, the patient had not recovered. Additional information has been requested.
Patient was given wrong vaccine, patient received pediatric hep a vaccine when he needed adult hep. Clinic pharmacist was informed, and she stated patient is able to receive the full dose 1 ml of the adult hep a vaccine at his next visit, Patient and provider are both understanding about this information.
Woke up following morning with fever of 101 and upset stomach. By 2:30 that afternoon fever spiked to 103.6. Child was severely sweaty and lethargic. (Tylenol administered at 1:00 PM). 3:30 PM temp came down with cold compress.  Child was alert and feeling better by 6:00 PM. Temperature was completely normal by the following morning.
rash and fever.  Treatment: benadryl, ibuprofen, tylenol, cold compress
Woke up 7-29-22 with sore calf. Woke up Saturday 7-30-22 and went to urgent care. No ppler ultrasound was done and Xarelto was started due to dot.
Pt devel inc sleep, gray/pale most of day p/vax; cried quite strongly on day of vax, but consolably;
I26.99 ACUTE PULMONARY EMBOLISM 11/22/2021 CANCER METASTATIC TO UNSPECIFIED LUNG I26.99 ACUTE PULMONARY EMBOLISM 11/22/2021 SHORTNESS OF BREATH
BODY ACHES; ARM HURT FOR A WHOLE WEEK; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, arm hurt for a whole week, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body aches and arm hurt for a whole week was not reported. This report was non-serious.
pt recvd vax & began to swell, ecchymosis-L upper arm, sl induration, erythema & warmth area measures 14x14 cm & extend down to elbow;
patient received 4th dose for immune compromised condition.  She received a full dose instead of a booster dose.
Acute onset of rapid heart rate, chest pain, and shortness of breath around 11:00 pm on 10/15/21. Went to ER and found to be in SVT with resting HR of 215 - given dose of adenosine. With further testing, additionally diagnosed with pericarditis. Admitted to the hospital from morning of 10/16/21 until night of 10/18/21.
Per history, patient had not felt well since day of vaccination.  11/25/10 had episode of chest pain.  MI ruled out.  On admission, patient with CHF exacerbation.  No history of frequent exacerbations in this patient. INR supratherapeutic
Injection site pain 8 days after injection, The area is red, warm and you can feel a lump where the shot was given.
pt recvd vax 26JUN95 & LMP 01JUN95;pt became pregnant;pt elected to terminate the pregnancy in the first trimester;
Really tired but planned to lay low; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-APR-2022 Reporter's comment: This case was reported by patient via interactive digital media. The patient received second dose of Shingles vaccine and patient was really tired, but patient planned to lay low. Additional Supportive Information: This case is linked with case US2022AMR066730 reported by same reporter. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR066730:Same reporter.
Received flu shot at pharmacy because hospital had ran out. 3 hours later became short of breath and started wheezing. Called 911 and was taken to Medical Center ER. Given BENADRYL, SOLU-MEDROL IV and nebulizer treatments.
42 yo f presents to clinic to receive booster. Within 20 minutes of observation pt started to c/o of chest tightness, SOB, and dizziness. Pt stated she had anaphalaxis reaction to primary series when she returned home and receiving the vaccine. She stated she did end up going to the ER. Pt states she has a hx of asthma and MS. VS @ 1354 HR 104, BP 147/89, RR 18,O2 100, PAIN 0; @ 1402 HR 96, 138/85, RR 18, O2 100, PAIN 0. We continued to monitor the patient for 30-45 minutes. Pt states she was feeling better after using her inhaler and refused ER transport.
gums hurt after second shot; tastes blood in the mouth; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (gums hurt after second shot) and TASTE DISORDER (tastes blood in the mouth) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GINGIVAL PAIN (gums hurt after second shot) and TASTE DISORDER (tastes blood in the mouth). At the time of the report, GINGIVAL PAIN (gums hurt after second shot) and TASTE DISORDER (tastes blood in the mouth) outcome was unknown.            No concomitant medications were reported. No treatment information was provided by the reporter.    Reporter did not allow further contact
99-100 temp, tired, sore at site, rash below inj site and slight bruise, resolving by day 3.  Then day 4, 5 PM mother noted rash, heat at site.  ER physician did not treat but advised to use Benadryl prn for next few days and not ever get another tetanus booster. By day 7-8 patient still getting red and rashy at site, increasing with physical use of affected arm for softball practice. By day 10, mom was still giving Benadryl in the evening, but each day she stated the area affected by rash and redness was less than previous day (resolving).
administered an expired Fluzone QIV-HD to a patient (expiry date: 30 June 2023) with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who was administered an expired fluzone qiv-hd to a patient (expiry date: 30 june 2023) with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Aug-2023, 0.7 ml dose of suspect influenza quadrival A-B high dose HV vaccine expiry date: 30-Jun-2023 via unknown route in unknown administration site for immunization (strength, formulation, batch: unknown), patient administered an expired fluzone qiv-hd to a patient (expiry date: 30 june 2023) with no reported adverse event (expired product administered) (latency same day). Information on the batch number was requested  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient reports headache,total body neuralgia and "toothache pain" down arm-symptoms resolved in 24 hours
4/3 vaccination. Six hours later, slight fever. Horrible body aches, HA. Aches lasted for a couple days. Nausea lasted almost till presently. Week after, started to experience increase stomach pain. 'Empty stomach feeling'; hurt, sharp pain, if drank liquids it was sharp pains between lower chest and above belly button, like ulcer. Tele health - prescribed anti-acid medications; no relief, not immediate. Second week, hard eating solids. The ulcer pain started really hurting. Only really eating milk, bread, very bland foods. Saturday, I woke up legs were  numb. Thru the day, my lower back hurt more and more. The pain interchanged between the back pain and leg numbness; sciatica. MRI of lower back; neg.  *Stomach still not 100%; still tender *I have been getting better but not watching what I eat, not eating normal things. I have lost 6-7lbs.  *I have appt with PCP for opinion and get referred as my stomach is still tender, sore.
Very sore arm 3 days 101.3 temp 2 days Body aches/chills 2 days Headache 1 day
Swelling behind knee; Arm is sore at the site of injection; Arm is sore at the site of injection; Fever; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE PAIN (Arm is sore at the site of injection), SWELLING (Swelling behind knee), PYREXIA (Fever) and the second episode of VACCINATION SITE PAIN (Arm is sore at the site of injection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 02-Mar-2021, the patient experienced the first episode of VACCINATION SITE PAIN (Arm is sore at the site of injection) and PYREXIA (Fever). On 31-Mar-2021, the patient experienced SWELLING (Swelling behind knee) and the second episode of VACCINATION SITE PAIN (Arm is sore at the site of injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SWELLING (Swelling behind knee), PYREXIA (Fever) and the last episode of VACCINATION SITE PAIN (Arm is sore at the site of injection) outcome was unknown.            This case was linked to MOD-2021-065268 (Patient Link).
A report has been received from a Health Professional concerning a 3 year old, Male subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on 23-Dec-2013. The patient was administered expired FLUMIST which started on 23-Dec-2013. The outcome of the event of administration of expired FLUMIST is unknown. The report was considered to be non-serious.
patient was given monovalent Pfizer 6mo-<5yr for the 3rd dose instead of Pfizer bivalent 6mo-<5yr.  No treatment needed Parents notified that monovalent was given instead of bivalent
Fever, hot/cold sweats, rapid pulse, headache. Severe reaction to flu vaccine, i.e. jerking movements, spasms over entire body, head, shoulder chest, arm, hands, hips, thighs, knees, calves, ankles, feet and elbows. Still continuing but less present since flu shot on 12/31/2001.
I woke up and I started having severe diahrrea and it lasted over 5 days. So i went to Urgent care and was told to just let things happen naturally. It eventually went away after about 2 weeks.
Hypotonic hyporesponsive event during sleep lasting 1-2 hours in duration before his mentation returned to baseline. Each time we found him crying with his body limp in his crib. His first event began on 4/15/20 within 2 months of receiving his third Pentacel dose in addition to prevnar, and rotavirus vaccines on 2/19/20 . We brought him to the local hospital for evaluation including neurological and EEG evaluation all of which was negative. Between the months of April and May 2020 he experienced a total of 4 hypotonic events the last event I am reporting to VAERS occurring the evening of the third hepatitis B vaccine series. Fortunately he hasn't had another event but with thoughtful discussion with our pediatrician began a modified vaccine schedule giving each separately since February 2020.
After Administering the vaccine to the patient, one of our technician was pushing safety cap on needle and it slipped our and she scratched needle on left arm finger. Pt is fine and no major reaction happened but she is going thru our companies standard process after needlestick.
Reports a delayed allergic reaction at home, Patient called clinic hours later, patient is in distress, crying, due to allergic reaction c/o throat pain