chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NO ADVERSE EFFECT; expired dose administered; This spontaneous report was received from a medical assistant regarding a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-SEP-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant human albumin) (M-M-R II) lot # N025892, expiration date: 19-SEP-2019 (exact dose, strength, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with a sterile diluent (lot number: N030846, expiration date: 26-APR-2020). No product quality complaints were involved.
Extremely sore arm to the point where it hurt to lift it.  Then shivers, chills and upset gastric system.
Patient underwent surgical debridement of necrotizing faciitis at the site of immunizations.  Discharge to home today on oral antibiotics.
sore left arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The patient reported that he experienced a sore arm which was not going away after receiving Shingrix. The reporter consented to follow up.  No information was available. The outcome reported for AE in the structured field is recovering instead of not resolved (outcome uploaded).
Pt cried non stop- uncosolable for 4 hours gave Tylenol and held but no relief
Information has been received from a licensed practical nurse concerning a female patient who was vaccianted with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649695/0512P) and within 72 hours she developed cellulitis at the injection site. The patient sought medical attention and was treated with antibiotics. The patient recovered. There was no product quality complaint reported. The reporter considered cellulitis at injection site to be an other important medical event (OMIC) and disabling. Additional information has been requested.
Pt called office and c/o L upper arm still being sore 2 weeks after injection.  Received GARDASIL 12/30/08- Called office 1/14/09.
w/in 1hr of vax pt became edematous w/redness & itching present;edema & redness extended to elbow;pt also had fever >100;APAP taken;p/several days arm still sl reddened;sl edema present;suggested pt take DPH, PRN
The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the State Department of Health recommends being revaccinated at their earliest convenience.
Client c/o soreness, itching and edema at left deltoid 3 days post vaccine pt stated she rubbed and scratched area until it became more swollen. She went to her PCP- he ordered Cortisone cream and left arm healed in 2 days according to pt.
Nausea x 4 days post vaccine - needed visit to MD for prescription anti-nausea meds to relieve symptoms. 1/27/10 PM - TC from mother of client who has had nausea/dizziness/headache since received Hep A immunization on 1/25/10 (also rec'd PPD test). Vomited once today. Instructed to take to PMD as not typical reaction to immunization. 1/28/10 TC to mother. Took client to doctor. C/o nausea as being worst symptom and was given 2 pills (to take 1 pill q8h). Cl. felt fine for approx 4 1/2 hrs after taking pill and then nausea started again. Took the other pill. Cl. c/o nausea yet today - some headache. Went to work today. Only had some tea. Did eat a sandwich with "hot peppers". Cl. later showed for TB reading. Did call doctor  and got 4 more pills for nausea. Plans to eat something. Discussed more bland foods to eat. Will f/u with client tomorrow. 1/29/10 Called client. Feeling better today. Stomach still "a bit sore". Ate sushi today." Instructed to F/U with doctor if need arises. Will send VAERS.
Arm is very sore and hurts to move; This is a spontaneous report received from a non-contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is very sore and hurts to move".  No follow-up attempts are possible. No further information is expected.
This case was reported by a pharmacist and described the occurrence of nodule injection site in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 16 August 2012 the subject received a dose of BOOSTRIX (details unknown). On 17 August 2012, 1 day after vaccination with BOOSTRIX, the subject experienced injection site soreness, 3 days after vaccination with BOOSTRIX, the subject experienced injection site pruritus and less than a week after vaccination with BOOSTRIX, the subject experienced nodule injection site. The subject developed a "knot under the skin" (nodule injection site) at the BOOSTRIX injection site. The subject had injection site soreness the day after the injection, but it was resolved at the time of the report. The pharmacist stated that the knot was not painful, but was not going away. The pharmacist stated the knot did not develop on the dame day at the injection, but some time later. According to the pharmacist, the knot itched yesterday [19 August 2012], but that had resolved. At the time of the report, the nodule injection site was resolved and the injection site soreness and injection site pruritus were resolved in August 2012.
Vaccine administered 6/16 @ 10am then on 6/17 in late afternoon, pt noticed L head tenderness in hair and tender glands in neck on L side. This occurred again on 6/18. Pt treated with Aleve and Vicks rub on neck. On 6/19, reports almost 100% back to normal. No injection site reaction.
3rd cranial nerve palsy to L eye. Drooping lid. Burning eye, socket pain - severe. Watery eye. Seen by 5 ophthalmologist no treatment. Prognosis 3-6 months with 100% return of eye function & sight. Also have distorted vision that causes nausea.
Runny nose, sore throat, cough, chest pain, headache, sinusitis
Non-ST elevation (NSTEMI) myocardial infarction Facial weakness NSTEMI (non-ST elevated myocardial infarction) CHEST PAIN CEREBROVASCULAR ACCIDENT
Pt recv vax on 10/15/98; on same day pt exp chills & fever(100.5), achy feeling, hives/itching at night-back, stomach &nape of neck, swollen&numb lips; dx=pneumonia&allergies; tx=cough syrup,Augmentin-Erythromycin,Benadryl;seen by allergist
5 days after first dose,  extreme groin and kidney pain, gross hematuria, was diagnosed with multiple kidney stones.  After second visit, another bout of gross hematuria, developed long term GI issues including bloating and constipation.  CT scans show a enlarged spleen.
tested positive for COVID; A spontaneous report was received from a consumer concerning a 27-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive for covid.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event tested positive for covid.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event tested positive for covid was unknown.
fever; chills; muscle aches; scratchy throat; can't taste or smell; can't taste or smell; sinus infection/sinus infection off and on; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 15Sep2021 (Batch/Lot number was not reported) as dose 2, single (age at vaccination 39-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on an unknown date in 2021 for COVID-immunization for no events reported. The patient experienced fever, chills, muscle aches, scratchy throat, can't taste or smell on Sep2021 and sinus infection/sinus infection off and on an unknown date 2021. Caller reports she had her second Pfizer Covid 19 dose on Wednesday. Wants to know if someone can tell her some of the side effects and how long they last. Has had a sinus infection off and on and on Wednesday was fine when she got the shot, now since then she has had a scratchy throat. She told the pharmacist this and was told to go ahead and get the vaccine and she called her doctor. She has had fever, chills, and muscles aches and saw that they were common, but now she could not taste or smell right. Therapeutic measures were taken as a result of events. The outcome for event fever and chills was recovered on an 16Sep2021 while muscle aches and scratchy throat was unknown and rest was not recovered.   The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
In the summer of 2021 my irregular heart beats were getting more frequent and stronger. As time went on I was getting worse from seated to standing I would want to pass out. I would get the black out feeling. As time passed my chest pains got worse and the intensity of the irregular beats got worse. The chest pain felt like a sudden my heart would stop for a minute and then it starts again it was if someone would kick me in the chest. It is as if an elephant is sitting on my chest - pressure. I went to cardiologist but nothing was found so I changed physicians. I was able to get a new cardiologist. New ECHO showed 4 valves were leaking. I was feeling a different type of fatigue than my regular Lupus fatigue. I visited the ER twice in 2021-early 2022 because I knew something just wasn't right. I was treated with a bag of fluid but never truly resolved the palpitations. I wore a monitor twice for 2-3 weeks at a time.
Had shot on 1/20/10 Wednesday on Friday 1/22/10 I broke out in hives, so bad they turned to welts. I had to go to ER at the hospital. They gave me more Benadryl and some Prednisone.
This spontaneous report as received from a physician refers to an unknown number of patients. Case 3 of 6 of the same reporter (related cases 1211USA005695, 1211USA005837, 1211USA005839, 1211USA005840 and 1211USA005841). The patient was vaccinated with haemophilus B conjugate vaccine in 2012. No other co-suspects were reported. No concomitant medications were reported. The patients were administered vaccines that had been improperly stored for the last six months. No treatment information was reported. No adverse event was reported. Additional information has been requested.
reports development of right arm redness and swellling related to covid vaccine administration. On 1/16/21, he reports having fatigue and body aches. On 1/17/21, he reported right arm redness, swelling, and warmth which increased throughout the day. He took 800 mg of Ibuprofen and ultimately sought care at a local emergency department, and was prescribed two oral antibiotics. stated the emergency room provider diagnosed the condition as cellulitis and informed patient the condition is a known side effect of vaccines. As of this writing, patient reports a decrease in redness/tenderness and no pain.
Red/swollen arm, fevers, body aches, chest pain, increased heart rate continuing/worsening into day 4 after vaccine. Started 1 day after the vaccine.
sore throat, lost my voice, runny nose, headache, body aches, sweats, chills.
Within 15 minutes, left arm got got really cold -  like ice. Lasted about 2 hours. The arm to the touch was warm but it felt like it was in ice bucket. They kept me for 2 hours. Started to resolve in those two hours but didn't go away completely. By evening it was mostly returned to normal. Next day, I woke up with flu-like symptoms - felt like I had the flu. Every hair on my head hurt; wanted to sleep; no appetite. Three in afternoon - I felt much better. As quickly as it came on, it went away quickly.
no additional AE details are available; inadvertently gave a dose of Proquad to a 14 year old patient; This spontaneous report was received from a medical assistant and refers to a 14-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 01-JUL-2021, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: recombinant Human albumin (rHA)) (PROQUAD) lot # T034823, expiration date 11-APR-2022, at a dose of 0.5 milliliter for prophylaxis (dose #, route and anatomical location were not reported).
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 11-month-old male patient who received FLUARIX (batch number X9HM3, expiry date 15th June 2015). On an unknown date, the patient received FLUARIX .5 ml. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.
Chills, "COVID inferno" AKA hot all the time x 5 days, fatigue, dizziness, myalgias (full body), nausea
I was tired after getting the vaccine. Then in August 2021 I lost my taste and smell. I had a really terrible headache, and I felt like I had a sinus infection. I received the monoclonal antibody injection on August 30, 2021.
Mistakenly injected to 15 yr old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Mistakenly injected to 15 yr old) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Mistakenly injected to 15 yr old). On 07-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Mistakenly injected to 15 yr old) had resolved.        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.   No concomitant medications were reported.   No treatment information was provided.
cyst develop at the injection site seven days after administering GARDASIL 9; This spontaneous report was received from a physician and refers to a 31-year-old female patient.  The patient's medical history included sicca syndrome. The patient's concurrent conditions and concomitant therapies were not reported.  On 25-OCT-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, use as directed to prevent human papilloma virus infection (prophylaxis), lot #W011264, expiration date: 05-SEP-2024, administered intramuscularly (strength was not provided).  On 01-NOV-2022 (also reported as seven days after vaccination), the patient experienced a cyst develop at the injection site (Vaccination site cyst). The cyst became golf ball sized. She sought for medical attention. At the time of the report, the size of the cyst had decreased to the size of a quarter. No treatment was given for the event. The patient had not recovered from the event. No additional information was available regarding the adverse experience.   The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding vaccination site cyst was not applicable.   The causal relationship between vaccination site cyst and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. The physician did not feel that the Sicca syndrome contributed to the cyst formation in any way. ; Sender's Comments:  US-009507513-2212USA000647:
Acute redness/swelling of RUE (arm/forearm) following pneumonia vaccine 3/28/11. Sent to hosp.
8 days after injection I had a quarter-size welt. 9 days after injection the welt grew to the size of my shoulder muscle. It was red, itchy, and very hot to the touch. It was sore if touched, but did not affect my movement. I managed it with ice and tylenol.
still sore arm; feel chilly; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On 18th October 2021, the patient received the 2nd dose of Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm and chills. On an unknown date, the outcome of the pain in arm and chills were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and chills to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine yesterday (day before reporting) and still experienced sore arm and kinda felt chilly. The follow-up would not possible as no contact details were available.
Scratchy throat, fatigue, slight headache and a cough. Lasted about 2 weeks. I did test positive for Covid. The 3rd day was the worse, I could barely move and did not have a whole of energy. The doctor prescribed: benvonatate 200mg for the cough, Dexanthasone 6mg, Guaiatussin AC for the cough.  Steroids taken about 6 days, and cough lasted for about 2 weeks.
Patient was given Monovalent Covid 19 vaccine instead of Bivalent Covid 19 vaccine
No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 29-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA001345: US-009507513-2207USA004244: US-009507513-2207USA004679: US-009507513-2207USA004688: US-009507513-2207USA004690: US-009507513-2207USA004691: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
Information has been received from a pharmacist referring to a 66 year old female patient. The patient's medical history included gastritis and oesophagitis. The patient did not have drug reactions/allergies. On 08-SEP-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K012424, expiration date 05-JUN-2016, dose and route were unknown). Concomitant therapies included budesonide and an unspecified flu shot on 08-SEP-2015. On 09-SEP-2015, the patient developed redness, swelling and discomfort at the injection site of the PNEUMOVAX 23. The patient visited an unspecified physician on the same day and was diagnosed with cellulitis around the injection site of the PNEUMOVAX 23. None lab diagnostics studies were performed. The patient was prescribed an unspecified antibiotic and an unspecified medication for pain. The outcome of the event was reported as not recovered/not resolved. Causality was not provided. Additional information has been requested.
Headache, body ache, fever, chills, muscle spasms, leg cramps, nausea, loss of appetite x 48 hrs.
This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a 66-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date unknown). On 31st January 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 31st January 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. On an unknown date, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash, intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. A dose of SHINGRIX was inadvertently administered subcutaneously in the upper left arm of the patient, instead of the intended left deltoid, which led to inappropriate route of vaccination and vaccine administered at inappropriate site. In 2018, less than a week after receiving SHINGRIX, the patient developed a rash at the injection site. The expiration date was unknown. The patient did not require an emergency room visit or medical intervention. The healthcare professional did not believe the rash was life threatening, or disabling, and the patient did not require hospitalization.
BODY ACHES; LOW GRADE FEVER; This spontaneous report received from a patient: concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: UNKNOWN) start therapy date was not reported 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 09-MAR-2021, the patient experienced low grade fever. On 09-MAR-2021, the patient experienced body aches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, and body aches on 10-MAR-2021. This report was non-serious.
Took first oral typhoid capsule as directed and within several hours had vomiting, diarrhea, fever and fatigue.  Symptoms resolved by next day.  Advised not to finish vaccine.