chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stomach is not right (upset stomach; Chills; sore arm; feeling tired; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart valve replacement. Concomitant products included COVID 19 VACCINE.   On 20th April 2021, the patient received the 1st dose of Shingrix (intramuscular). In April 2021, less than a day after receiving Shingrix, the patient experienced upset stomach, chills, pain in arm and tiredness. On an unknown date, the outcome of the upset stomach, chills, pain in arm and tiredness were not recovered/not resolved.   The reporter considered the upset stomach, chills, pain in arm and tiredness to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's wife. The reporter mentioned that Shingrix was administered by a nurse practitioner to patient at around 1pm to 2pm and side effects started 5 am next day. Next morning, the patient woke up feeling tired, sore arm, chills, no fever and his stomach was not right (upset stomach). The reporter read these side effects online and asked how long does these reactions last. The reporter stated that the patient had his heart valve replacement done. She also mentioned that they both received their 2 doses of COVID vaccine a few weeks ago from reporting day. The reporter stated that they did not receive any information from the clinic, therefore did not have lot number, expiration date, or dosage. The reporter consented to follow up.
Day 1- sore throat, fatigue, cough, and chest pain following few hours after shot  Day 2- sore throat, runny nose, cough worsened, severe chest pain, difficulty breathing, loss of taste, fatigue, diarrhea, arm soreness  Day 3- sore throat, severe cough, severe chest pain, fatigue, diarrhea, arm soreness  Day 4- severe chest pain, severe cough, extreme difficulty breathing, severe sore throat , fatigue  Day 5- severe chest pain, cough, sore throat, fever, fatigue, headaches   Day 6- sore throat, fever, body aches, fatigue, headaches  Day 7- fever, body aches, fatigue, headaches  Day 8- fever, body aches, fatigue, headaches Day 9- body aches, fatigue  Day 10- body aches, fatigue  Day 11- body aches, fatigue
Child developed very bad blistering eczema, stopped rolling over, and developed very bad GERD. Developmental delays, eye problems, asthma. Treat included dermatologist visits, ER visits for asthma, medical treatment for GERD, occupational and physical therapy for low muscle tone.
Severe swelling of leg from upper thigh to knee, visibly larger and erythematous, hot to the touch.
Case number PHEH2016US029216, is an initial spontaneous report received from a physician on 04 Nov 2016. This report refers to a 13-months old male patient. Medical history and concomitant medication were not reported. This 13 months male patient was inadvertently vaccinated with FLUVIRIN (batch number: 1618621) at a dose of 0.5 ml intramuscularly, on 01 Nov 2016. No adverse event was reported following this administration error (drug administered to patient of inappropriate age). The case was assessed as non-serious by the physician.
Received the vaccine at 7 weeks pregnant with first child. Due date: Sept 17, 2021. Baby looks healthy as of now and I am receiving prenatal care.   Two days after the vaccine I noticed painful spots on my vulva. These turned into 3 large ulcerations which had me concerned, so I went to my OBGYN three days after the vaccine (Thursday) -- they tested me for several STDs including a culture of the ulcer and everything was negative by the following Monday. Within 2 weeks the ulcers completely healed with no occurrence since and no scarring. I've never had this happen before or since. I also had a mild fever, muscle and body aches, and fatigue for the two days after the vaccine.
Fever 101.9 degrees Fahrenheit at 2030 on 1/15/2022 Fever 102.5 degrees Fahrenheit  at 2130 on 1/15/2022 Runny nose all day and stuffy Says she has been cold all day
Inappropriate schedule of vaccine; paralyzed diaphragm; low right lung function; This case was reported by a consumer via call center representative and described the occurrence of diaphragmatic paralysis in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In July 2018, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced diaphragmatic paralysis (serious criteria GSK medically significant) and lung function decreased. On an unknown date, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the diaphragmatic paralysis, lung function decreased and inappropriate schedule of vaccine administered were unknown.   It was unknown if the reporter considered the diaphragmatic paralysis and lung function decreased to be related to Shingrix.  Additional details were provided a follows: The symptoms began around July 2018 and the patient was formally diagnosed in September 2018. The patient experienced paralyzed diaphragm on the right side as well as lowered lung function in the right lung. The reporter did not consent to follow-up. No lot number or specific dates were available. This case has been linked to case US2019105209, reported by same reporter.
Localized redness at injection site, palpable knot which measures 3cm X 2cm, red but no warmth to touch and no induration or streaks. Outline drawn and to observe.
Patient found at home not breathing, CPR started. EMS continued CPR & brought patient to our ED. Patient still in full cardiopulmonary arrest. Patient never recovered heart rate.
Red, erythematous rash on left arm (site of vaccine).  Per articles I've read, it is now called "COVID Arm".  The rash appeared 7 days post vaccine & lasted approx 5 days.  It was itchy for only 6-8 hrs on the first day.  No other redness.  No pain.
Plantar wart disappeared (burned off before, kept coming back); This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included plantar warts (have had plantar wart which was between her 4th and 5th toe on her right foot ).   On 27th April 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingrix.     Additional Information: GSK receipt date: 19-Sept-2022 Reporter's comment: The patient stated that she had previously had it burned off multiple times before but it kept coming back. Did not consent to follow-up. This case is for 1 of 2 linked patients. Additional supportive information: After receiving the first dose of Shingrix, the patient's plantar wart which was between her 4th and 5th toe on her right foot disappeared, which led to unexpected therapeutic benefit; Sender's Comments:  US-GSK-US2022134443:Same reporter
Myalgia, Fever, chills Myalgias chills low grade temp for 24 hrs. Returned to work and symptoms resolved
Numbness of the left arm, mainly fingertips within the first 10 min. after vaccine was given.
Pneumonia twice in the years of 2009-2014; This spontaneous report was received from a consumer regarding himself a 78-year-old male. The patient's medical history and concurrent conditions were not reported.  On an unknown dates in 2006 and 2009, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, lot #, expiry date, and route of administration were not provided) for prophylaxis. On an unknown date in 2014, the patient was vaccinated with pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13).  On an unspecified dates in 2009 and 2014, the patient experienced pneumonia twice. The patient received antibiotics (unspecified) as treatment for the event. At the time of reporting, the patient recovered for the event.   The causal relationship between pneumonia and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.     Upon internal review, pneumonia was determined to be medically significant.
Within 15-30 minutes, post vax, pt vomited several times and then had dry heaves. Pt became very lethargic and pale. Pt would open eyes with stimulation but otherwise, would not respond. Lethargy improved after 2-2 1/2 hours.
Given High dose instead of regular dose. Aches, vomiting, headache, fever, fatigue
runny nose; sniffles; arm soreness; sore throat; Feeling bad; This is a spontaneous report received from Pfizer-sponsored program, received from a contactable consumer (patient's mother). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. In Mar2021, the patient experienced feeling bad after that with runny nose, sniffles, arm soreness, and sore throat. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
States received immunization 8/16/07 pm.  Last night started feeling bad, achy all over, clammy, temperature (no thermometer).  Father is EMT, said she was okay.  Mother wants to take to hospital.  I asked if she felt that bad and she said yes.  I told her to go ahead and I would check with her tomorrow.
Fainting in the shower with white out vision; Uncontrollable shaking and convulsions; Fever of 103.3 degrees F.; Uncontrollable shaking and convulsions; Body Aches; Chills/Teeth Chattering; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 11:30 (Lot number: FF2587) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Prior to vaccination, was the patient did not diagnose with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8737, Location of injection: Arm Left, Vaccine Administration Time: 07:00 AM), administration date: 30Mar2021, when the patient was 33 years old, for COVID-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Right, Vaccine Administration Time: 07:00 AM), administration date: 09Mar2021, when the patient was 33 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021 11:30, outcome "unknown", described as "Booster"; SYNCOPE (medically significant) with onset 18Nov2021 17:00, outcome "recovered" (2021), described as "Fainting in the shower with white out vision"; SEIZURE (medically significant) with onset 18Nov2021 17:00, outcome "recovered" (Nov2021), PYREXIA (non-serious) with onset 18Nov2021 17:00, outcome "recovered" (2021) and all described as "Fever of 103.3 degrees F."; TREMOR (non-serious) with onset 18Nov2021 17:00, outcome "recovered" (2021), described as "Uncontrollable shaking and convulsions"; PAIN (non-serious) with onset 18Nov2021 17:00, outcome "recovered" (2021), described as "Body Aches"; CHILLS (non-serious) with onset 18Nov2021 17:00, outcome "recovered" (2021), described as "Chills/Teeth Chattering". The patient underwent the following laboratory tests and procedures: body temperature: (18Nov2021) 103.3 Fahrenheit, notes: 17:00. Since the vaccination, has the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Patient stated that he had some lip tingling after first time dose after leaving from observation. That did diminish on its own.    3:00pm  Tongue tingling. 25mg of Benadryl given. BP, P, 02  through out observation. VS WNL normal and all symptoms resolved prior to leaving at 3:35pm. Patient verbalized feeling comfortable to leave. Director of Nursing and PCP will be notified.
Reddened, hardened, sore to touch area to left outer thigh @ IPV injection site. Irregular area appx 5x4 noted by PA @ ER. Mom TC to Health Dept nurse, recommended ER/Dr visit. PA informed health dept nurse that allergic Rx to vaccine was dx. ATB given prophylactic.
couldn't sleep all night; palpitations; severe migraine; eye pain in left eye which radiates down to the ear; achiness; pain on arm; pain on lymph node; chills; fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep all night), PALPITATIONS (palpitations), MIGRAINE (severe migraine), EYE PAIN (eye pain in left eye which radiates down to the ear) and PAIN (achiness) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 022M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder (unknown).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced INSOMNIA (couldn't sleep all night), PALPITATIONS (palpitations), MIGRAINE (severe migraine), EYE PAIN (eye pain in left eye which radiates down to the ear), PAIN (achiness), PAIN IN EXTREMITY (pain on arm), LYMPH NODE PAIN (pain on lymph node), CHILLS (chills) and PYREXIA (fever of 101). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 17-Sep-2021, PYREXIA (fever of 101) had resolved. At the time of the report, INSOMNIA (couldn't sleep all night), PALPITATIONS (palpitations), MIGRAINE (severe migraine), EYE PAIN (eye pain in left eye which radiates down to the ear), PAIN (achiness), PAIN IN EXTREMITY (pain on arm), LYMPH NODE PAIN (pain on lymph node) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, Body temperature: 101 (High) fever of 101.. On 16-Sep-2021, Heart rate: 113 (High) 113 beats per minute for past 8-9 hours 95-102 beats per minute which is fluctuations.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Fever occuring the night following vax adm of 102-104, vomiting continuing into 1MAY91 AM; Whining, abd cramping, arm lt swollen, tender;
Since he received Anthrax vaccine, SM notes recurrent pruritic nodules at AVA vaccine site on left upper arm. Denies significant local reaction or related systemic symptoms. A nodule about the size of a marble appears at old vaccination site and is extremely itchy. It lasts a few days and resolves, and then recurs again in about 3 weeks.
Tested NAAT positive for COVID 10/22/21 after being fully vaccinated.
Information received regarding son who post 3rd vax (given 11/03/1997), experienced eosinophilic gastroenteritis with severe vomiting (in February 1998), and diagnosed with the eosinophilic gastroenteritis and H. pylori gastritis on 12/15/1998 which was post 4th vax (given 10/23/1998). The pt took steroids to alleviate the symptoms. Lab evaluation revealed a lack of response. The physician felt that the symptoms were related to hepatitis b vax recombinant. Follow-up was received from a physician. The pt partially recovered from the symptoms by January 1999. They physician noted "only questionable relationship to vax." Additional follow-up was received which indicated the physician had not seen the pt since March 1999. He reported information was "true as of last visit/report." No further information is available.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 11-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Approximately 10 hours after receiving my second COVID shot and right before I went to bed at 10pm I started getting chills.  My symptoms worsened as the night went on, I was shaking and could not get warm.  I also had a very bad headache and I had trouble lifting myself up.  At about 3am I started sweating and feeling feverish.  I got out of bed to take Tylenol and drink water, and had trouble walking and I was breathing heavy.   At 6am I decided to take a hot bath with Epsom salts to help with my aches and headache.  When I got out of the bath I felt very dizzy and fatigued and need assistance from my wife to get back in bed.  At about 9am I started feeling better.  I sat myself up and ate apples and salty tortilla chips and drank lots of water.  By 1pm I was able to walk without difficulty and I felt better with only a mild headache.
No symptoms reported. Patient was given a dose of Moderna on 8/27/2021, but also received dose of Janssen on 3/27/2021.
Fever of 100-102 that won't break with Motrin, can't lift arm where I received the shot, injection site really hot, resting pulse between 110-120, dizzy, no energy, increased respiratory rate, joint aches, burning sensation in chest wall.
Information has been received from a nurse practitioner concerning a 10 yr old female who was vaccinated subcutaneously on an unk date (when she was younger) with 0.5mL of a dose of varicella virus vaccine live (lot unk). In early Mar 2005 the pt experienced breakthrough case of varicella with about 20 lesions on her chest and behind her ears. She also had a low grade fever. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Client was in for Hep B vaccine.  Hepatitis A was pulled, and administered to patient.
BlurredVision, Headache, Myalgia, Fever, NauseaVomiting, PHOTOPHOBIA Employee got the second dose covid vaccine 02/02/2021, 1pm she claimed that at 10pm same day, she had progressive fever, chills, headache, neck pain / stiffness, photophobia Employee missed work for 2 days, 02/03/21, 02/03/21 Employee stated that he felt some relief with Motrin and Tylenol Diagnostic Tests Discussed (if any):na
Within 24 hours had chills and fever (temperature not taken). Within 48 hours complained of right flank pain, swollen right breast, swollen lymph nodes under right breast, swollen supraclavicular, cervical and submandibular lymph nodes on the right and left. By 96 hours after immunization, all symptoms resolved. Patient was not seen by a physician during this time. All by parent report.
2/16/17 Child (R) deltoid erythema 6x8cm warm, swollen, st. tender-no d/c. DTP Vaccine reaction local.
No additional AE reported; VARIVAX was administered to one patient after a temperature excursion.; This spontaneous report was received from a licensed visiting nurse (L.V.N) concerning to a patient of unspecified age and gender. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 05-APR-2023, the patient was vaccinated with a varicella virus vaccine live (oka/merck) (VARIVAX) lot #W021743 (expiration date: 10-JUL-2024) 0.5 milliliter dose, administered for prophylaxis (strength, and route of administration were not provided) that had gone through a temperature excursion (Product storage error). No additional information or adverse events (AEs) were provided (No adverse event).
About 6.5 hours after vaccine my head hurt and I had body aches. No fever or chills.
TESTED POSITIVE FOR COVID-19; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to insect bites, and other pre-existing medical conditions included the patient has suspected lupus but not diagnosed. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072 and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced tested positive for covid-19. Laboratory data included: Blood pressure (NR: not provided) NORMAL, COVID-19 virus test positive (NR: not provided) POSITIVE, and Oxygen saturation (NR: not provided) NORMAL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tested positive for covid-19. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Onset of chills at around 10pm (normal temperature). Early morning around 4am on 1/3/2021 I was woken up by severe arm pain (arm injected) and generalized body aches. Around 7am 1/3/2021 my temp was 99.7. Around 10am my temp rose to 100 and all morning I had chills. Chills and fever subsided after Tylenol but then I started having chills again around 3pm with my temp raising once again to 99.8. The whole day I also had a headache, generalized body aches, looked flushed, had moderate arm pain on arm injected. When I woke up on 1/4/21 all symptoms were gone.
Approximately 12-15 hours after vaccination, patient developed erythema / induration at site. Left thigh); this became worse after treatment with Cephalexin and ultimately, resolved quickly after taking corticosteroid and changing ABV to Bacteria. (Cellulitis vs. vaccine reaction)
Initial unsolicited report received from a consumer on 12 November 2015. This case involves an 81-year-old female patient, who was vaccinated with a dose of FLUZONE HD (batch number: unknown, dose, dose in series, route and site of administration was not reported) on 04 November 2015 at 10:00 AM. The patient denied illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. On 04 November 2015, same day of vaccination, patient experienced shortness of breath and tachycardia in the evening. On 05 November 2015, patient presented to Emergency room in the morning and was admitted for three days (discharge date was not reported). Laboratory investigations was not reported and patient was treated with Metoprolol 25 mg daily. The outcome of the events was reported as unknown. Documents held by sender: none.
Fever up to 102.3 degrees, severe chills, body aches, headache, loss of taste & smell, fatigue, dizziness.  Most symptoms including fever lasting at least 36 hours.  Still experiencing fever, fatigue, dizziness.
Arm:  Sore, red and hot around injection spot (5 days after injection still experiencing this) Chills: Day 2 after injection Mild headaches: Day 3-5
High fever first night and second day. Unusual heat start from my toes all the way to my hand, sweating especially my face, fast heart beat, dizziness and weakness on the third day.