chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable Physician. A currently 12-year-old male patient had received 2 doses of PREVNAR 13 when he was a baby. Relevant medical history and concomitant medications were not reported. He had lobar Pneumonia 3 times, the last time was when he was 9 years old. The outcome of the event was unknown. Information on the batch number has been requested. Sender's Comments: A possible contributory role of the suspect product cannot be excluded for the reported events drug ineffective and lobar Pneumonia.
the patient reported on 10/24 having felt weak and tired and staying in bed the previous day (10/23) and having swelling and pain at injection site causing difficulty sleeping on that side.  The patient had tried ice pack which did help with the discomfort and tylenol which did not.  She called as she was concerned about how she was feeling 4 days later, but did acknowledge she was better than the day before and would continue to use ice pack which helped and try ibuprofen to see if it would help more with the pain.  She would call with any increase symptoms
Fever 103*...Tylenol or Motrin, fluids....fever broke 10/31/2009 around 2:00 PM...fever very consistent 102.7*-103* entire time.
I also had a strong local soreness/swelling reaction in the PNEUMOVAX (right) arm, which isn't that common. It is still a little red, sore and swollen 8 days later. On 1/31 in the evening, I started to get a headache, slept poorly and noticed nasal dryness overnight with my BiPap that I thought was from new meds from my neurologist (cyclobenzaprine or maybe propranolol). Both arms really sore, red and swollen, right arm (Pneum) worse than left (Shingles). I had a mild fever the morning of 2/1 around 99F and headaches, weakness, body aches progressed all day with a fever around 100.5F by bedtime. Again, dry sinus and almost no sleep Monday night. Fever 101-102F, nausea, intense chills/headache/body aches all day 2/2 & 2/3, only got out of bed a few hours in evening to eat a little. Stayed hydrated throughout 10-12 glasses of water per day but almost every glass produced chills even though water tepid. Slept a little Wed night, fever down to 99-101 2/4, able to sit at computer most of day and did some work but still very weak and headache/stiff neck/nausea. Slept a little better Thursday night. Friday 2/5 left arm almost normal, just a little tender, right arm still very inflamed, red, painful - size of baseball (Monday was size of softball). Still weak but able to leave apartment for short walk for first time since Sunday. Fever 99-100, head/neckache late afternoon/evening. Progressively better sleep and less pain over the weekend. Today, right arm pain/redness/swelling size of golf ball. Temps around 98.5 (lately had typically been between 97.1 - 97.5. Still afternoon neck pain/headache.
pt recv vax 14AUg97 & pt devel lesions in the mouth;
This spontaneous report as received from a pharmacist refers to a patient who was vaccinated with ZOSTAVAX on an unknown date. On an unknown date the patient experienced redness around injection site after receiving ZOSTAVAX. The outcome of the event was unknown. The relatedness for redness around injection site was unknown for ZOSTAVAX. Additional information has been requested.
Pt became unconscious and quickly recovered w/ pale, sweaty symptoms. Pt also started to hyperventilate for a minute before catching his breath. A medical team responded and provided oxygen/labwork. No epi required. Pt fully recovered.
A spontaneous report (United States) was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, fever of 101.9F/pyrexia, headache, eyes are burning/ Eye irritation.  The patient's medical history reported included anxiety and  allergy to meperidine and venlafaxine . Concomitant medications reported were Ativan(lorazepam), trazodone, lorazepam for drug use for unknown indication.  On 18 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 011M20A) in the right arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the events chills, fever of 101.9F, headache, eyes are burning.   Treatment information provided was took paracetamol 2 hours prior to this report . Laboratory details were not provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, chills, fever of 101.9F, headache, eyes are burning were unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient called 1/22/14 to tell me she had a reaction and went to Dr. with a rash and burning sensation around her breast. Dr. diagnosed with shingles. She waited until 1/21/14 to go to MD office. Dr. gave VALTREX 1gm tid x 7d.
she has an infection; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 19Jan2020, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified) via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced an infection. It was reported that the patient was scheduled for minor surgery next week. She was going to be given antibiotics and she wants to make sure that one won't interfere with the vaccination. She was going to be on two or three antibiotics because she has an infection. She wanted to make sure no issue. Patient clarified that she was looking for information about COVID vaccine and antibiotics and just wanted the medical information to pass along to her doctor. Outcome of event was unknown.  Information on the lot/batch number has been requested.
Day after administration: myalgias, subjective fever. Starting the second day after administration: muscle soreness in the forearms with weakness and paresthesis in the hands. mild weakness in the legs and upper arms.
3-5 minutes post vax, the pt fell hit his nose on the counter, had mild jerking motion, unresponsive for several seconds. Swelling to the nose, complained of neck pain when sitting up. Ice was applied to nose. The pt was transported via spinal board to ER by EMS.
fever x 3 days 7 days p/vax;red rash (macules over entire body x 24hr);
This spontaneous report was received from a healthcare professional and refers to a 19 year old female patient. The patient's medical history and concurrent conditions were not reported. On 14-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
patient was administered expired tenivac with no reported adverse event; Initial information was received on 08-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 58 years old male patient who was received expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  Concomitant medications included tozinameran (Pfizer biontech covid-19 vaccine) for Immunisation.  On 08-Feb-2023, the patient was received expired suspect of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (strength: standard, formulation: Unknown) at dose of 0.5 ml once (lot: U6922AA, expiry date: 22-Jan-2023) via intramuscular route in the right deltoid for Immunisation with no reported adverse event (expired product administered) (latency: same day)  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event patient was administered expired tenivac with no reported adverse event.  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 guidelines. 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.
Brachial Plexopathy and possibly a specific form called Parsonage Turner Syndrome
Fine first day - body aches the second day. Nothing serious - just achy on arm and all over.
Started experiencing lower back pain which intensified each day to the point it was excruciating and I went to ER. MRI showed herniated disc at L4L5 on exiting L5 nerve root. Doctor at the time said I needed to learn to live with it. Nothing has helped. Epidurals, PT, acupuncture, decompression. I am absolutely  convinced this is from the vaccine. I did not receive what I consider proper care, Changed insurance and doctors and am now going to get to see an neuroorthpedic specialist. I am greatly debilitated and limited in daily functioning. I can't sleep well, waking every couple of hours. Before this, I was walking 3 miles a day and doing pilates reformer 2-3 times a week and very, very fit - all muscles. I feel my life has been entirely ruined and am really struggling with how to manage this.
Information has been received from a physician concerning a female with asthma and no drug reactions/ allergies who on an unspecified date was vaccinated with the first dose of PNEUMOVAX 23. It was reported that the patient's titers were low, that was why the patient decided to administer a second dose. On 26-MAY-2009, the patient was vaccinated with the second dose of PNEUMOVAX 23. Concomitant medications included asthma medications. On 27-MAY-2009, a day later, the patient developed fever that had continued to persist. It was also reported that it was "now" nine days that the patient had had the fever. It was not specified if the patient had similar adverse effect the first time. The patient visit the office for medical attention. Additional information has been requested.
Pt recvd 2nd dose of Engerix-B on 25JAN91 & 3-4 hrs later devel a rash; Visited ER & was treated w/DPH & Decadron;
This spontaneous report as received from an office administrator and a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot # reported as L040053, expiration date 10-MAY-2017 or lot # reported as M018624, expiration date 28-MAY-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced a temperature excursion of 72.5 degrees Fahrenheit for 5 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Symptoms first reported 4/21/2015 Headaches-onset 4/18. "Feverish"-4/19 onset. Redness at and around injection site-4/19. Large swelling at and around injection site-onset 4/19.
Redness, swelling, itching, pain at the site of injection. Pain and itching subside within 72 hrs.
About 30-40 minutes, post vax, pt's legs hurt and "felt weak". About 1-2 hours, post vax, had "bumps" on face and neck". About 18-20 hours, post vax, he had left side of face and left eyelid swollen. About 24-27 hours, post vax, both sides of face and both eyelids were swollen. RN called pt's doctor and symptoms reported on 7/28/00 at 13:45. Pt's parent called MD, also.
SHINGLES; RASH; This spontaneous report received from a patient concerned a 62 year old of unspecified 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: 1802072, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced rash. On 30-MAR-2021, the subject experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash, and shingles. This report was non-serious.
2 areas on face are reddened and/or very sensitive to touch on arm following administration.
Patient was in office for MCV4 vaccine, vaccine was diluted with sterile diluent and administered to patient. Patient was notified in office.
Extreme pain in injected upper arm. Presented to ED @ 1226 on 10/06/2015. No redness or warmth @ injection site after receiving Flu and Prevnar.
Narrative: No information known other than that patient's daughter reported his death which occurred the day after the patient received the COVID-19 and influenza vaccine.
Cellulitis/localized allergic reaction left deltoid x 5 days - self limiting.
the patient was administered an improperly stored dose of ROTATEQ; This spontaneous report was received from a registered nurse referring to a patient of unknown demographics. The patient's concurrent conditions and medical history was not repoted. There was no concomitant medication reported.   On 26-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # 1660704, expiration date: 20-MAR-2021) oral for prophylaxis. It was reported that the vaccine had a temperature excursion of 12.1 celcius degrees for a time frame of 16 hours and 11 minutes. There was no previous temperature excursions. The call was because of a digital data logger.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300227899 same patient different drug/event;
4 weeks after receiving Janssen vaccine, patient's thumb and pointer fingers on her right hand became necrotic. She has no feeling, they are turning black and they are cold. Ultrasound and Cat Scan were done. Patient had blood clot in in her right arm that the doctors told her had broken apart and ended up in her fingers, causing them to lose circulation. Patient was recently told by hand surgeon that fingers will need to be amputated.
Initial misuse report received from a healthcare professional on 24 May 2013. A patient (No information was provided regarding the patient) was inadvertently administered expired dose MENACTRA vaccine. No adverse event was reported. List of documents held by sender: none.
19hrs p/vax pt found unresponsive, cold & blue;pt unable to be resuscitated
The first dose headaches after the second dose syncope sindrome , abcent seizures , auras , dropping seizures , allergies , sleep apnea , toncilitis.
Exactly one week from the vaccination date, my arm swelled very large at the injection site (very hard), red and warm to the touch. I took Motrin and applied heat and it slowly went down within 2-3 days.
LITTLE SORENESS IN ARM; ABOUT 24 HOURS OF MALAISE; This spontaneous report received from a patient via a company representative via social media concerned a 71 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose,1 total, start therapy date were not reported for covid-19 prophylaxis. 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 patient experienced little soreness in arm, and about 24 hours of malaise (dose number in series 1). It was reported that, " "I am 71 and wife is 79. We both were given J&J with only a little soreness in arm and about 24 hours of malaise. Second injection was without issue. Neither of us have had even a sniffle during the entire covid period. We have been takimg an extensive targeted supplement regiment for over 20 years. We feel that had a great impact on the outcome."  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose,1 total, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether the adverse event reported following to second dose of covid-29 vaccine (dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little soreness in arm and about 24 hours of malaise was not reported. This report was non-serious. This case, from the same reporter is linked to 20220939908.
fatigue; worse sore arm; This is a spontaneous report from a contactable consumer (patient's father). A 21-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration in the left arm on 07Jan2021 at 15:00 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date were unknown) on 17Dec2020 for COVID-19 immunization and experienced arm was kind of sore and she was pretty tired, for which no admission to the hospital was involved and the patient did not receive any treatment. The patient's medical history was not reported. There were no concomitant medications. There were no other products taken together with the vaccine. The patient experienced worse sore arm on 07Jan2021 at 20:00 and experienced fatigue the next day on 08Jan2021 at 08:00. The adverse events (AEs) did not require any visit to an emergency room or a physician office. The patient did not receive any treatment for the events. The patient recovered from the event "worse sore arm" on an unspecified date, while the outcome of the event "fatigue" was unknown.  Information on the batch/lot number has been requested.
Moderna vaccine inadvertantly administered to 16year old during community clinic. No signs or symptoms of event reported to agency. Error noted by Dept of Health when reviewing immunizations that were entered, made agency aware.
patient report swolloen armpit and pain at the site of injection. patient only reported those events on 01202020. patient states arm still hurts and feel weak at times.
Brought to ER with altered mental status and occult GI bleed with chronic positive hemoccult test. COVID + the day before. EKG showed second degree AV block Mobitz type 1 with mild bradycardia. CT abdomen shows cirrhosis with trace ascites with associated thombocytopenia and hypoalbuminemia. Intially responded to fluid resuscitation with improved mental status. Two days after admission developed worsening hypoxia with increacing lactic. Started on remdesivir and dexamethasone. EKG changes noted and cardiology consulted. Confirmed an interior wall MI. No PE.  Due to poor respiratory statsu and bleeding history elected not to procees with catherization.  Became hypotensive requiring pressors. Worsening kidney fucntion, starting diuretics without improvement. Reviewed status with family and trasnsitioned to comfort care.
This is a female with a history of breast cancer on tamoxifen, hypertension, asthma who apparently received her second dose of Covid Pfizer vaccine 10 to 15 minutes prior to presentation who presented in ED with complaints of shortness of breath and tingling sensation over her face and neck.  Apparently had rash over the first dose and now presented with shortness of breath.  She denies any fever chills.  No chest pain. EPINEPHrine (EPIPEN) injection syringe 0.3 mg (0.3 mg intramuscular Given 1/26/21 1547) sodium chloride 0.9 % bolus 1,000 mL (1,000 mL intravenous New Bag 1/26/21 1555) dexAMETHasone (DECADRON) vial 6 mg (6 mg intravenous Given 1/26/21 1548) diphenhydrAMINE (BENADRYL) injection 25 mg (25 mg intravenous Given 1/26/21 1548) famotidine (PEPCID) injection 20 mg (20 mg intravenous Given 1/26/21 1548)
Itching; rash; This is a spontaneous report from a contactable consumer. This consumer (patients mother) reported for a 15-year-old male patient (reporters son). The report is cross referenced to report ID: This is Report 2 of 2. A 15-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, in Left arm on 27Jul2021 15:00 (at the age of 15-year-old) as dose 1, single for covid-19 immunization. The patient medical history reported as none. The patients concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. AE(s) following prior vaccinations, patients medical history (including any illness at time of vaccination) and relevant tests all of these were reported as none. Reporter explained her youngest son, got his shot on 27Jul2021 and was having itching on belly and arm where got shot. The itching on arm and belly started at that night about 8:00. The patient did not visit to the emergency room or physician office. The clinical outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Two days after receiving shot pt reported the injection site was swollen, red, warm painful. Recommended pt take Ibuprofen and use a cold pack and see MD to follow up.