chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site lump in a 16-year-old female patient who received BEXSERO. Concomitant products included Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. On 16th December 2015, the patient received the 1st dose of BEXSERO (intramuscular). On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site lump and injection site warmth. On an unknown date, the outcome of the injection site lump and injection site warmth were unknown. It was unknown if the reporter considered the injection site lump and injection site warmth to be related to BEXSERO. Additional details were received as follows: The patient received the 1st dose in the series of BEXSERO. She also received a meningococcal vaccine on the same day (she believed it might have been brand name MENVEO, but was unsure). The 2 vaccines were administered in different arms. The patient developed a golf-ball sized lump at the site of the BEXSERO vaccine. The lump was red, warm to the touch, and sore for 1 month. The muscle soreness was severe enough to prevent the patient from driving. The patient attempted applying heat and ice, but the pain did not resolve. The patient also took over-the-counter pain medications to relieve the pain. When the patient presented to the clinic for the second BEXSERO injection, the lump had decreased in size, but was still present at the site of the previous injection. The patient's mother requested that the second BEXSERO injection be administered slightly lower on the muscle and the patient did not have an adverse reaction to the second BEXSERO injection.
pt. c/o tingling and numbness of her toes up to her knee.  This was the 2nd dose of COVID vaccine.  it was resolved and patient went home.
Mild tenderness at the injection site; She felt nausea; Tiredness; Flu; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: slightly immunocompromised. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 01, first two doses where she and her husband both experienced side effects with the second dose being even stronger. She did report mild tenderness at the injection site.), for COVID-19 immunization, reaction(s): "mild tenderness at the injection site". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Mild tenderness at the injection site"; INFLUENZA (non-serious), outcome "recovered" (2021), described as "Flu"; NAUSEA (non-serious), outcome "unknown", described as "She felt nausea"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness".  Additional information: Caller reports no side effects (no body aches, fever, tiredness, nothing) after the booster dose as compared to the first two doses where she and her husband both experienced side effects with the second dose being even stronger. She did report mild tenderness at the injection site. Caller concerned that the vaccine may not be working or she could have gotten the wrong dose since she did not experience any side effects. after the second dose, they both had flu that lasted for 3 days. he felt nausea, tiredness similar to feeling under the weather like she was catching a cold or the beginning of a flu. Caller stated the second vaccine had stronger effects than the first one. she felt the side effects of the second vaccine every other day for 3 to 4 days.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain in left wrist that traveled up arm and into neck within less than an hour Upper arm where shot was administered very sore and painful Next day pain continued Pain gradually lessened over next 3 days
Information had been received from a registered nurse concerning a 12 month old male patient with no known allergies and a history of frequent otitis and upper respiratory infections who on May 23 2005 was vaccinated IM in the left thigh with a second dose of hepatitis B virus vaccine (+) Hib conj vaccine (lot 649286/0807P). Concomitantly administered on the same day May 23 2005, the patient was vaccinated SC in the left deltoid with a first dose of varicella virus vaccine live (lot 648558/0443P). The patient was not ill at the time of vaccination. The registered nurse reported that the onset of elevated temperature and a decreased appetite started in the afternoon on May 24 2005 and by 22:00pm, the patients temp reached 105.1. He was taken to the ER on May 25 2005 with a fever of 105.1 degrees F, a mild cough, runny nose, some wheezing, warmth, swelling and minimal induration of his anterior left thigh. Acetaminophen Tylenol) and ibuprofen (Advil) were prescribed and his fever dropped in two hours to 99.8 degrees F. A chest X ray was done in the ER and was normal. It was noted that the patient did not have any adverse events following prior vaccination. The patient recovered on Jun 6 2005. There was no product quality complaint reported. No additional information is expected.
Queasy feeling late afternoon, progressing into evening. Flushed and nauseated by 7pm. By 9pm, patient had severe nausea and vomiting for approx 20mins.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
11/20/2021 upper area of left arm started hurting and pain wrapped around arm continuous for 62 days, then continues to hurt occasionally throughout the day almost every day.
Pt recv vax on 3/14/99; on 3/15/99 pt exp abdominal cramps, migraines, nausea, fatigue, insomnia, dizzy, memory loss, confusion & shortness of breath. A follow up report received 6/12/2000 adds: This was her 4th Anthrax vaccine that preceded the symptoms - she was seen by rheumatologist (military) who gave no diagnosis or Tx - told her not to take 5th shot in series. She is now in another workplace - will be able to see a rheumatologist after her med ins starts (5/5/00). Consent form sent so that we can get access to rheumatologist record.
This solicited report has been received from a physician concerning to an 48 years old female patient with multiple sclerosis. Information about medical history and concomitant medication were not provided. On an unspecified date, the patient was vaccinated with PNEUMOVAX  23 (concentration, dose, lot number and expiration date were not reported). On an unknown date, the patient experienced multiple sclerosis relapse and was hospitalized. The outcome of multiple sclerosis relapse was unknown. The causality between the therapy with PNEUMOVAX  23 and the event was reported as related. Upon internal review, the event multiple sclerosis relapse was considered to be medically significant. Additional information has been requested.
Called into the clinic on 12/20/2017. The patient had been running fevers for 2 days and fussy. Little stuffy nose. Very fussy and hard to console. Was seen in this clinic on 12/20/17-mom reports high pitched screams. Fevers up to 101.0.
Patient got light headed and started having blurry vision. Pharmacist gave Benadryl and called EMTs. EMT's came and checked him out and his vitals were fine and he was feeling better.
Prior Covid patient prior to getting the vaccination Dose 1, anaphylaxis situation, vomiting for six hours, off work for few days; then recommended to have second dose by workplace. Three days after the Dose 2, chest pains, called primary care right away advised to wait, then she made office appointment appointment was not able to be seen until one month later and scheduled currently still waiting for ECHOcardiogram due to community COVID this delayed.
This case was reported by a nurse (subject herself) and described the occurrence of paresthesia in a 39-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 15 July 2014, the subject received unspecified dose of FLUARIX (unknown route, injection site and batch number not reported). On 18 July 2014, 3 days after vaccination with FLUARIX, the subject experienced prickling, tingling in both feet. The subject also experienced numbness in both feet along with muscle weakness, severe muscle pain and muscle twitching. The subject visited doctor and reported that she still had the tingling sensation, pins and needles, along with muscle weakness and muscle pain. The subject also visited a neurologist and was currently querying for Guillain-Barre syndrome. At the time of reporting, the events were unresolved. Follow-up information received by a physician on 26 September 2014: The case was considered as serious (clinically significant) by the reporter. The batch number for FLUARIX was reported as AFLUA825AB but expiry date was not provided. Co-suspect products included AVAXIM (batch number H0227-03, expiry date unknown). Concurrent medical conditions included penicillin allergy and allergic reaction to antibiotics (Cephalexin). Regarding her alcohol abuse, the subject used to drink very little and seldom. The reporter considered the paresthesia, numbness in feet, muscle cramp, muscle twitching, muscle weakness and muscle pain to be possibly related to FLUARIX. Few lab tests were done (MRI, nerve conduction test, EMG, blood tests) and nothing abnormal was detected. Guillain Barre syndrome was not suspected.
got COVID; got COVID; heart attack due to a 100% blockage; long COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2 (COMIRNATY), as dose 1, 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 "got COVID"; MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack due to a 100% blockage"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long COVID". Clinical course: After initial dose patient got COVID and during long COVID he had a heart attack due to a 100% blockage that is has left him suspicious though not positive of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client was given adult pfizer dose by nurse . Child was fine next day with no extreme side effects.  Complaints included sore arm and mild headache. Father aware of situation.
About 5 to 10 minutes after the shot was given. Patient stated that her heart was racing and she was hot. When we helped her to the immunization room to sit on the bench seat she said she felt dizzy and was also shaky. At one point she said it was a bit difficult to breathe, but stated it may have just been her mask. She was given 10mls (25mgs) of liquid Benadryl initially and then the paramedics were contacted she had red marks on her arm but she stated it was from hand sanitizer. Also, she had some red marks on her neck as well, which we notified the paramedics of Another dose of Benadryl (25mgs) was given when the paramedics arrived. She walked out of the store with the help of the paramedics &
Dose Number 1/Date of start of drug: 16-MAR-2021/ Dose Number 2/Date of start of drug: 29-DEC-2021; symptoms of sharp pains and numbness in my head; symptoms of sharp pains and numbness in my head; right arm felt dead, listless; left hand tingling and legs are worse; left hand tingling and legs are worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 17:30 (Lot number: FD7218) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Arthritis" (unspecified if ongoing), notes: knees; "high cholesterol" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: From the mass behind my left optic nerve.; "Morbidly Obese" (unspecified if ongoing); "bulging discs in neck and back" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "allergy"; Ampicillin, reaction(s): "Allergy"; Chemicals, reaction(s): "Allergy", notes: Some perfumes,peanuts. Vaccination history included: Bnt162b2 (Dose Number: 1,(11:45 am), Batch/Lot No: EN6205, Location of injection: Arm left), administration date: 16Mar2021, when the patient was 58 years old, for COVID-19 immunization.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Dec2021 17:30, outcome "unknown", described as "Dose Number 1/Date of start of drug: 16-MAR-2021/ Dose Number 2/Date of start of drug: 29-DEC-2021"; HEADACHE (non-serious), HYPOAESTHESIA (non-serious) all with onset 29Dec2021, outcome "unknown" and all described as "symptoms of sharp pains and numbness in my head"; LIMB DISCOMFORT (non-serious) with onset 29Dec2021, outcome "unknown", described as "right arm felt dead, listless"; PARAESTHESIA (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 29Dec2021, outcome "unknown" and all described as "left hand tingling and legs are worse". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional Information:No other vaccines were received within 4 weeks prior to the COVID vaccine. Patient received some medications in two weeks. Prior to vaccination,patient was not diagnosed with COVID-19.After the vaccination, patient tested negative for COVID-19.  Follow-up attempts are completed. No further information is expected.
Fever, headache, body aches, light headedness and nausea causing me to pass out while trying to walk to the bathroom. Upon standing up from the laying down position, I got lightheaded, started profusely sweating, became nauseous and ultimately lost consciousness. When I regained my consciousness, there was a loud ringing in my ears and my hands were numb. I took some Tylenol, laid down and it subsided shortly after. I did not experience any symptoms as severe as this at any point again.
About 13 hours after receiving vaccine I awoke close to midnight feeling ill. I spent the next 3 hours having bouts of diarrhea every 5 to 10 minutes along with chills and feeling hot and abdominal pain. This morning on the 16 of March I feel okay with some fatigue and sore right shoulder at injection site.
Upon completion of HPV vaccine to right arm (last vaccine given) RN was talking with patient assessing how he was feeling as RN was completing documentation.  Patient stating he was feeling well and was ready to leave clinic.  After appx 2-3 minutes of talking, patient started to stand up and became pale and dizzy and fell to his left into the wall and slid down onto the floor.  He was completely passed out and RN yelled for help as she rolled patient onto his back.  He awoke immediate upon rolling into supine position.  His feet were elevated and a cool compress applied.  It took appx 5-10 minutes for dizziness to completely resolve.  Patient was monitored for appx 20 minutes total before being allowed to leave clinic with his mother.
PIMPLES ON TONGUE; SKIN RASH ON BODY; 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 received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-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 MAY-2021, the subject experienced pimples on tongue. On MAY-2021, the subject experienced skin rash on body. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from pimples on tongue, and skin rash on body. This report was non-serious.
Insomnia after 12am, 2/26 Exhaustion full day 2/26 Body aches after 4am, 2/26 Fever exceeding 102F  5am-3pm, 2/26 Migraine 11am-4pm 2/26
Pt stated had arm pain from vaccine received on 10/20/14. She went to PCP and said deltoid may have been bruised.
Immediately after administration of #1 Hep B and Tdap,client had generalized seizure,including all extremeties.Seizure activity lasted approx.one to two minutes.Witnessed by three RNs.Client's mother denies hx.of seizures.Transported to ER by EMT.Mother telephoned office to report ER advised he did not have seizure,just afraid of shots.
This spontaneous report as received from a consumer refers to a 68 years old male patient with aspirin allergy. Drug reactions/allergies included aspirin. On 28-DEC-2012, the patient received a dose of ZOSTAVAX (Subcutaneous Injection) (lot # and dose not reported0. No other co-suspects were reported. Concomitant therapy included albuterol sulfate, COMBIVENT and ASMANEX TWISTHALER. On 10-JAN-2013, the patient experienced flu-like symptoms after receiving ZOSTAVAX. The patient also reported that ZOSTAVAX was administered in his stomach, rather than in the arm as the prescribing information indicated. No treatment was given. The outcome of the event was recovering. The relatedness of the event with ZOSTAVAX was not provided. Additional information is not expected.
Guillain-Barre syndrome. Starting 1 week after 2nd dose of Pfizer COVID-19 mRNA vaccination, patient developed numbness and tingling in hands and feet. Over the next month, patient developed ascending numbness spreading proximally up all 4 extremities and ascending paralysis of all 4 extremities, became unable to walk, admitted to hospital 3/17/2021 to 3/28/2021, diagnostic workup including lumbar puncture for CSF analysis consistent with Guillain-Barre syndrome.  CSF Glucose 88 mg/dL, CSF Protein 140.5 mg/dL, CSF RBC count 24 Cell/mm3, CSF WBC count 0 Cell/mm3. Received 5 days of IVIg. Discharged to skilled nursing facility. Over next 8 months, gradually regained strength, initially could only crawl, then could transfer to wheelchair, then could walk with walker, now can walk with cane, still with residual ataxia (gait imbalance).
About 24 hours after Trihibit vaccine given, he developed purpuric/petechial rash.
Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE and NAUSEA in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE and NAUSEA. At the time of the report, HEADACHE and NAUSEA outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.
Heart racing, shortness of breath which leads to mild headache; noticed approximately Monday, May 24 Miscarriage symptoms began on Tuesday May 25th
Within minutes after influenza and Pediarix vaccines in his thighs, he developed erythematous patches/mild hives on bilateral thighs.  No systemic symptoms.  He was given one dose of Benadryl and rash improved within 10 minutes.
Developed itching a few hours later, then an increasing area of redness and discomfort, pain, chills, headache, neck pain, shoulder pain.
August 24 side effects: Extreme tiredness, achy all over body, injection site pain, tinnitus (ringing of ears), headache, nausea, muscle pain, joint pain and chills. These were throughout the day. August 25 side effects: Diarrhea in morning. It seemed like I had more severe side effects with 4th shot.
Possible varicella, erythematous, papular eruptions - majority to anterior trunk, arms and left thigh.
1st dose 2018, 2nd in 2022; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose around 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 2018, 2nd in 2022). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 20-Apr-2023 The nurse called to inform that a patient received the 2nd dose in 2022. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
8NOV w/in 24hrs of inj lt arm swelling (2x normal) occured from shoulder & upper back to wrist;T100.4, site of inj 4 inches of red, warm, tender area;9NOV95 sx same x/no fever
Sick process; Slip disc; Back ache; This is a spontaneous report from a contactable consumer (patient). This male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in Mar2021, reported as between 01Mar2021 and 10Mar2021, as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were unknown. The patient reported he had a slipped disc and was taking pain relievers for backache which helped him sleep better at night. He reported he received the first dose of BNT162B2 somewhere in between 01Mar2021 and 10Mar2021; his second dose was due on 31Mar2021. The patient inquired if he could take ibuprofen after vaccination with BNT162B2 and if he could drink alcohol after vaccination. The patient reported he had been going through a sick process ever since vaccination, inquiring if that was normal. The clinical outcome of sick process was not recovered, the outcome of slipped disc and backache were unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
4MAR92 office visit had diarrhea & vomiting x 2 days; 5MAR92 office visit still vomit, diarrhea, no temp, well hydrated; 10MAR92 phone f/u fine since 8MAR;
Gave patient the wrong dosage of the peds Pfizer vaccine due not diluting the vaccine. Gave a dose equivalent to an adult dose.
Received flu shot today (11/15) in my left arm. Approximately 10 minutes after receiving the shot I had swelling on the right side of my face just lateral to my cheekbone. The area was red, warm, and approximately 2 inches in length (roundish). I also am experiencing a frontal headache. There is no swelling in the left arm where I received the flu shot. No issues with breathing. Event reported to Occupational Health immediately and documented in my employee record.