chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a company representative referring to her father, a 75 year old male patient. The patient did not have a pertinent medical history; he was not using any concomitant therapies and did not have any past drug reactions/allergies. The patient's concurrent conditions were not reported. On 07-OCT-2017 the patient was vaccinated with a dose of PNEUMOVAX 23 in the arm (not specified) (strength, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date in October 2017, also reported as "shortly after receiving the dose of PNEUMOVAX 23", the patient experienced a local injection site reaction. The reporter stated that her father experienced a red, raised, and hard rash around his arm and elbow. The patient reported the incident to his physician who suggested to put ice on it. The reporter stated that after a few days of putting ice on the area the reaction subsided. The outcome of rash papular, injection site reaction and rash erythematous was recovered on an unknown date in 2017. The reporter did not assess a causal relationship between the aforementioned events and PNEUMOVAX 23.
About 15 hours after receiving the vaccine I woke up with nerve pain under my left arm. It went under my arm into the back of my shoulder blade. I felt itchy under my arm. When I looked in the mirror I had red blisters that traveled up my back and towards my neck. They were red, raised, and circular. Then they became blisters during that daytime. I called the doctor and they had me come in. On 12/6/2021 the doctor confirmed that I had shingles. I was prescribed acyclovir pills, acyclovir ointment, and gabapentin. The nerve pain lasted for about 3 weeks, and the rash crusted and dried up within 2 weeks, but I still have the red marks.
headache started at approx 3pm, debilitating chills with uncontrolled shaking started at 4pm with low grade fever that began to climb.  Fever peaked at 104.8 and stayed there for approx 6 hours.  Vomiting started around 7pm. Rapid hear rate for approx 4 hours.  Pulse was over 120 beats for approx 2 hours with chest pain.
Per mom pt had swelling and redness with multiple blister/bullae (has picture taken) on (R) upper arm at vaccination site the day after vaccination. ++ fever. Seen by MD at another facility and Rx PO KEFLEX, BENADRYL and prednisolone. Today pt doing well, has scar on (R) arm.
Reports pain in left arm since second shot, pain progressed 2-3 days after injection.  Unable to use his arm at his  doctor visit on 5/4/21.  Diagnosed with shoulder injury related to vaccine administration.  F/U appointment on 6/7/21 reports able to use his left arm, still has pain off/on .  Has been going to PT for three weeks and has shown increased range of motion.  Improved but still not back to normal, still unable to sleep on left side.  Continuing PT.
Admit 6/23, vaccine 3/11, 4/13. Admit for acute chest pain, dyspnea, chills. Multiple comorbidities CAD, COPD, HTN, OSA.  CXR shows opacities, COVID PNA or aspirate PNA. Treated with abx, steroids. Remained on RA, no remdesivir given. DC'd home.
Itching, urticarial rash, mild shortness of breath, headache, mild nausea.
Headache, Arthralgia, NauseaVomiting, FATIGUE, UNEASY STOMACH, POOR APPETITE, PAIN INJ SITE, TENDER LOCAL LYMPH NODE ON SIDE OF INJ(SUBMANDIBULAR JOINT Narrative:
one of 4 pt to devel fever of 101 to 102 deg F. , uncontrollable irritability and a local rxn post vax
persistent inconsolable crying >8 hrs p/vax; had fever 39C (@ 2 days p/vax); devel bronchiolitis 2 days p/vax;
Headache and dizzy within 2 hours of injection,   8 hours later body aches, teeth chattering chills, headache, dizzy, nausea and diarrhea and left eye pain. Was in bed fully clothed from head to foot covered completely with covers to stay warm all day and night Thursday the 24th, Friday the 25th all the same as Thursday eye pain increasing and fever blisters (cold sores) starting in left nostril and on bottom lip, took Tylenol and Ibuprofen, didn't work. Saturday the 26th, eye pain worse, went back to clinic, was told she saw bleeding in my left eye. Sunday 27th eye pain even worse and travelling to right eye, and headache is only getting worse, called eye doctor, scheduled appointment with him for Monday 28th at 8:10 a.m., says no bleeding in eye(s), but there appears to be a virus most likely from the COVID vaccine that has caused not only the virus in the eyes but flare up of fever blisters (cold sores) prescribed antibiotic and steroid drops  for eyes, and extra Acyclovir for fever blisters (cold sores).
had her complete vaccination of SHINGRIX got Shingles/suspected vaccination failure; got Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and COVID-19 VACCINE UNKNOWN. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. Pharmacist reported that female patient who had completed her vaccination of Shingrix got Shingles. Patient's physician told her that it might be due to the COVID vaccination.  The pharmacist called to see if Glaxosmithkline had information regarding that topic. The reporter did not have any vaccine information at the time of the call (lot number, expiration date of the doses). This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting. No further events were reported at the time of the call. The reporter consented to follow up by email.
HEART RATE OF 110; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-SEP-2021 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 30-SEP-2021, the patient experienced heart rate of 110. Laboratory data included: Heart rate (NR: not provided) 110. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate of 110 on 30-SEP-2021. This report was non-serious.
The day following my 2nd vaccine I had joint pain in my fingers and hands.  Low grade fever and chills.  I was very tired.  This continued for several days.  I developed red spot that was swollen and hot to touch on my arm where I received the vaccine this lasted a little over a week.  It's now been several weeks and I waking up every night with joint pain in my fingers.  My hands are stuck open and takes like a minute to slowly get my joint to relax and close my fingers.
Arm pain, swelling at site. Sick feeling for 4-5 days, malice, flu symptoms aches/pains for weeks, now. Swelling on right side= arm, legs, breast pain still continues, also.. no treatment other than aspirin and or Tylenol initially.. swollen right side has still persisted as well as painful breast nipple area.
PT RECEIVED VACCINE, 30 MINUTES LATER EXPERIENCED LIGHT HEADEDNESS AND FAINTED AT CHECKSTAND. DID NOT HIT HEAD
Under arm  pit  and by breast burning itchy sensation. Numbness and tingling down the  arm into the left fingers. Area where shot was give  swollen, hot and painful to raise the arm. Using ice under the arm for pain and relief of itching.
PT STATED SHE HAD ITCHING, A LITTLE PAIN, SWELLING AND BRUISING AROUND INJECTION SITE ON LEFT DELTOID. PT STATED THAT IT STOPPED HURTING UNLESS SHE PRESSES ON IT.
Shortness of breath for 2 weeks or so leading up to the event. On day of event, serious shortness of breath during activity that shouldn't have caused it. Elevated pulse rate. Normal blood pressure. Elevated breathing rate. No chest pain. No heart strain. Seasonal flu vaccine received same day (10/27/2021 as COVID-19 booster. Manufacturer unknown.
Awoke shivering at 11:30 pm with chills; injection site was very sore. Took ibuprofen and fell asleep. Awoke 2 hours later feeling better with no chills. Writing this at 7:30 am, 8 hours after awaking with chills, and still feel better. Injection site not as tender. Pulse oximeter just now  (after shower) reports 95% O2 and a pulse rate of 111.
pt recv vax 22OCT96 or 23OCT96 pt devel vomiting & diarrhea w/o fever p/inj;pharmacist related there were other pt that exp v,d who did not recv flu vax;this is one of 25 cases reported to a pharmacist;
Information has been received from a physician concerning a 15 year old female who on 8/2/03 was vaccinated with a dose of hep A virus vaccine. There was no concomitant medication. On 8/5/03 the pt developed an "increase in LFT's"; "alt-146" and "AST" was "normal" twice. It was noted that the pt was not pregnant and was not hospitalized. Unspecified medial attention was sought. There was no product quality complaint involved. Upon internal medical review an "increase in LFT's" was considered an other important medical event (OMIC). Additional info has been requested.
severe pain in the left breast along with some redness and irritation; severe pain in the left breast along with some redness and irritation; severe pain in the left breast along with some redness and irritation; an abscess but did not feel any lumps; This is a spontaneous report from a contactable nurse (patient). A 49-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 12Feb2021 at the age of 49-year-old as dose 1, single for covid-19 immunisation. Medical history included irritable bowel syndrome, seasonal allergies , allergies to sulfa drugs , patient have silicone breast implants. In the left breast I also have some silicone free floating due to a silicone implant rupture years ago and they could not remove it all. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. Concomitant medications included claritin, famotidine taken for an unspecified indication, start and stop date were not reported. On 23Feb2021,  patient woke up with severe pain in the left breast along with some redness and irritation, 11 days after the injection. Patient consult a doctor and they started on an antibiotics for an abscess but did not feel any lumps. Redness and pain improved greatly with antibiotics. Mammogram and ultrasound showed nothing that would have caused this. Patient 2nd dose schedule on 05Mar2021 will get in right arm. The outcome of the event was recovering.    No follow-up attempts are possible. No further information is expected
Healthy 33 year old male who exercises 5 days a week. Only diagnosed with anxiety in the past and on fluoxetine. Otherwise, healthy. On 3/9/21 was feeling fine when I woke up then around 7AM could not get pants buttoned, tingling left side of body, could not move left side of my face, very slurred speech. This lasted about 10 minutes. Went to the ER for evaluation.
This spontaneous report as received from a pharmacist refers to a 29 year old female patient. Patient's current conditions included psoriasis and also the patient was allergic to latex. On 19-SEP-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (Lot number was reported as J008229 and expiry date was 12-JUL-2015), 0.5 milliliter (ml), subcutaneously. Concomitant therapies included sertraline hydrochloride and LEVOXYL. On 08-OCT-2013 (reported as about 3 weeks later), the patient experienced chickenpox. The patient had called the pharmacist to report that she had noted small red itchy bumps on her bilateral legs, abdomen, bilateral hands and behind the ears. The patient was advised to follow up with her unspecified physician. The patient call the pharmacist today on 11-OCT-2013, to report that the small bumps were still present and as numerous and that she had an appointment with the Unspecified physician today 11-OCT-2013. Patient sought medical attention (was yet to see the physician). No treatment was provided. Lab Diagnostics Studies Performed was none. The outcome of the reported event was not recovered/not resolved. Additional information has been requested.
Throbbing muscle aches in my neck and down both arms for about 15-18 hours.  Cramping in right hand for about 12-15 hours.  Really tired for approximately 6 days.
This case was reported by a lawyer and described the occurrence of delayed speech in a 32 month old male patient who received Hepatitis B vaccine recombinant injection for prophylaxis. The patient's past medical history included adenoidectomy, bilateral tympanoplasty and recurrent ear infections. On previous exposure, Engerix B was well tolerated. On 2/15/00 the patient received the third dose of Engerix B. Approximately 24 months after receiving Engerix B, an attorney alleged that the patient experienced delayed speech and cognitive retardation. Other vaccinations given included Acel-Imune, Hib-TITER, IPOL, MMR II Vaccine, Varivax, and concurrent doses of Engerix B. The outcome of the events is unknown. Legal complaint received on 2/21/05 indicated that the child suffered mercury poisoning subsequent to receiving vaccinations. It was also noted that in addition, the patient was exposed to highly toxic emissions from a medical center and power company in the environmental zone of his residence which contributed to the total dose of poisonous mercury. The complaint stated that the patient suffers now, and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning. The event of mercury poisoning was considered to be medically significant (OMIC). Note: The lot numbers provided in the source documents for the 5/28/99 and 7/12/99 doses of Engerix B are not valid lot numbers.
Deep vein Thrombosis cot, followed 2 days later by multiple blood clots in her lungs.
Mild site irritation 1-3 days. Then increased pruritus with large area of induration, redness, warmth with slight Fever and some areas of purulent drainage. Hypokensive, palpitation, and dizziness, tx'd with IVF. IV dose of antibiotics and follow up in PMD office by few hrs. Continued oral antibx. Benadryl and Prednisone.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-MAR-2014, the patient was vaccinated with a dose of PNEUMOVAX23, batch # J002646, lot # H013039, with an expiration date of 12-MAR-2014 (dose and route not reported). No adverse effect was reported. Additional information has been requested.
Tingling of the tongue. Told her to stick around the store so I could monitor her but put said she was all right and that it may have been due to not eating breakfast and drinking coffee before coming.
This literature-non-study case was reported in a literature article and describes the occurrence of PERICARDITIS (acute pericarditis) in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:  No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (acute pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (acute pericarditis) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered PERICARDITIS (acute pericarditis) to be related.    No concomitant and treatment medications were provided.  Patient had acute pericarditis, induced by second dose of the Moderna COVID-19 vaccine. The authors stated that although there are other potential etiologies that could explain myocarditis and pericarditis in this cases, it was important to consider the COVID-19 vaccine as a plausible cause.  Company comment: This literature-non-study case report concerns a 28-year-old male patient with no medical history available, who experienced serious (medically significant) expected event of Pericarditis which occurred after the second dose of the mRNA-1273-1273 vaccine. At the time of this report, very limited information is provided and the outcome and clinical course of the event remained unknown. Temporal relationship between vaccination and occurrence of the event remained also unknown since dates were not available. Further information is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this.; Sender's Comments: This literature-non-study case report concerns a 28-year-old male patient with no medical history available, who experienced serious (medically significant) expected event of Pericarditis which occurred after the second dose of the mRNA-1273-1273 vaccine. At the time of this report, very limited information is provided and the outcome and clinical course of the event remained unknown. Temporal relationship between vaccination and occurrence of the event remained also unknown since dates were not available. Further information is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this.
Complain of itching, no observations of rash or hives. Medical director present, administered one dose of Benadryl 25 mg tab, patient state a history of itching after vaccinations. Patient was monitored for 30 minutes, rode home with her husband.
Mother noticed patient breathing hard in his sleep. He was warm to the touch and his heart was racing. He was taken to the ER but no treatment was done. Patient had a temperature of 100.4 degrees. He was given 2 tsp of Tylenol by his mother. Both of the patient's arms were pink, he felt dizzy and vomited once. Patient had stated that he felt funny in the car after receiving the shot.
Joint pain, body aches, fatigue and vertigo spells. Started overnight after the 2nd dose and lasted almost till  day 4. Day 2 and 3 were debilitating.
Patient stated after vaccination that she has difficulty swallowing, "lump in throat," chest tightness, and dizziness. Vitals stable. MD at bedside. An RN gave Benadryl 50mg IM. Patient no longer having chest tightness or feeling of lump in throat.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 23Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 07Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
twitching in left arm and left back under shoulder blade.  Face hot and flushed like face had sun burn or fever.  Gastrointestinal cramping and gurgling in stomach resulting in diahrea and blood in stool and nausea.
Patient has not has an adverse event.  When logging data into reporting agency, we were made aware that our nurse had given a 16 year old the Moderna vaccine which is for >18 years.
Fever; Body aches; Fatigue; Flu like symptoms; Feel terrible; This case was reported by a nurse via call center representative and described the occurrence of fever in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, general body pain, fatigue, influenza-like symptoms and feeling bad. On an unknown date, the outcome of the fever, general body pain, fatigue, influenza-like symptoms and feeling bad were unknown.   It was unknown if the reporter considered the fever, general body pain, fatigue, influenza-like symptoms and feeling bad to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. The reporter stated all the patients she had been involved with feel terrible after getting their first Shingrix shot. Every other provider she worked with, said the same thing about their patients getting the first Shingrix. The reporter even heard people discuss it at a conference she went to.  The patients told me that they had flu like symptoms, after their first Shingrix vaccination. The reporter did not have specific patient or product information to provide at time of initial report. The reporter consent to follow up.
experienced arm soreness for the next couple of days; person who injected the needle (i.e., vaccine) did it "wrong" or "at an angle"; person who injected the needle (i.e., vaccine) did it "wrong" or "at an angle" and made the arm bleed slightly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (173415). The reporter is the patient.  A 37 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was unknown and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "experienced arm soreness for the next couple of days"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), outcome "unknown", described as "person who injected the needle (i.e., vaccine) did it "wrong" or "at an angle""; VACCINATION SITE HAEMORRHAGE (non-serious), outcome "unknown", described as "person who injected the needle (i.e., vaccine) did it "wrong" or "at an angle" and made the arm bleed slightly". Additional information: When receiving the first dose, the person who injected the needle (i.e., vaccine) did it "wrong" or "at an angle" and made the arm bleed slightly: "went it at an angle"/"stabbed me a little"; experienced arm soreness for the next couple of days. Other medications, family history, social history were unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.