chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Contant headache; pain chest; high heartbeat; facial numbness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 17:30 (Lot number: FC3184) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Shirm lobster" (unspecified if ongoing), notes: known allergies Shirm lobster. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 11Sep2021, outcome "not recovered", described as "Contant headache"; CHEST PAIN (non-serious) with onset 11Sep2021, outcome "not recovered", described as "pain chest"; HEART RATE INCREASED (non-serious) with onset 11Sep2021, outcome "not recovered", described as "high heartbeat"; HYPOAESTHESIA (non-serious) with onset 11Sep2021, outcome "not recovered", described as "facial numbness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, chest pain, heart rate increased, hypoaesthesia.  Additional information: No other vaccine in four weeks. Multi vitamin was other medications in two weeks. No covid prior vaccination. Patient was not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Injection site redness, swelling, heat. Knot located around arm and traveled down arm closer to tricep area. Reaction started the night of the injection and was still present 24hours after injection. Pharmacist recommended patient to take APAP or NSAID over the counter and to apply cool compress.
my son received his 1st dose of the Pfizer COVID-19 vaccine today at his doctors office. After the shot was administered we were waiting our 15 minutes and the doctor came in to tell us there was an issue that they had administered a shot that was outside of the 12 hour window of dilution. She said there was a patient who should have received theirs in the prior afternoon, and did not show, and they did not discard the dose and instead administered it to my son in an administrative error.
Beginning 3/01/04 left eye red, clear discharge, nasal congestion, fever, 3/13/04 skin lesions scalp, neck and left wrist. Chickenpox diagnosed.
This spontaneous report as received from a nurse (who was an office manager) refers to a 16 year old male patient. No information regarding the patient's medical history or concurrent conditions was provided. On 31-JUL-2014, the patient was vaccinated with the first dose of GARDASIL injection (lot# J006850, expiry date 31-MAR-2016; dose and route of administration were not reported). He received his second dose of GARDASIL injection (lot# K011492, expiry date 22-JUN-2016) on 16-OCT-2014, and the patient's third dose was GARDASIL 9 injection (lot# L007495, expiry date 24-FEB-2017; dose and route of administration were not reported), received on 06-AUG-2015. There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
CHEST TIGHTNESS, TACHYPNEA, ABDOMINAL PAIN, PAIN AT INJECTION SITE, DIAPHORESIS
Sore arm only for 24 hours.  Given shot 6 days prior to 18th birthday
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2012, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster (onset date was not provided). On an unknown date in 2012, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-OCT-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot number K016322, with expiration date of 24-DEC-2015) (dose, administration route an anatomical location were not reported). Additionally, no adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Just after vaccine, patient lightheaded and passed out, patient laid down given some juice.  Pt was nauseated and lightheaded especially with sitting or standing.
Moderna on 2/2 and 3/4. Positive on 11/28
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 31-MAR-2014, the patient was vaccinated with an unspecified improperly stored dose of PNEUMOVAX 23 with lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported), which was stored at 33 Fahrenheit (F) Degrees (0.555555556 Celsius) (lowest recorded temperature) for a total of 72 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported nor was product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Information has been received from a LPN concerning a 30 year old male who, as a child, was vaccinated with a series of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently, the pt was found to have negative titer levels for measles and rubella. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
arm bled heavily; bruised from shoulder to elbow; arm swelling; soreness in arm; This case was reported by a consumer via call center representative and described the occurrence of hemorrhage in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th May 2019, immediately after receiving Shingrix, the patient experienced hemorrhage (serious criteria GSK medically significant), bruising of arm, swelling arm and pain in arm. On an unknown date, the outcome of the hemorrhage, swelling arm and pain in arm were recovered/resolved and the outcome of the bruising of arm was recovering/resolving.   It was unknown if the reporter considered the hemorrhage, bruising of arm, swelling arm and pain in arm to be related to Shingrix.  Additional details were provided as follows: At the time of the injection the patient's arm bled heavily. Afterwards her arm was very sore, swollen and bruised from shoulder to elbow.  The swelling and soreness resolved after a few weeks, but her arm was still bruised. The bruise was fading and was in the general area of the injection site at the time of reporting. She has never bled like this with previous vaccines.  The reporter did not consent to follow up.
10 minutes after vaccine administration patient developed BL upper extremeties weakness. Vitals: 180/83 mmHg, HR 88, Pulse O2 98%. Gave oral fluid hydration. Repeat Vitals BP 171/85 mmHg, HR 92, Pulse O2 99%. He has a Hx of HTN and took all his BP medications earlier today. Patient is alert and oriented x3 and is not in distress. He continues to reports B/L upper extremity weakness. Advised hospitalizations; he is agreeable. EMS was called. Patient went local ER s/p Pfizer Covid-19 injection - reported that he was observed in the hospital then discharged with anxiety. Symptoms resolved shortly afterwards, self-limited without intervention and was discharged in stable condition. Wife at bedside. Patient feels fine and wants 2nd dose.
Vaccination given 5/24/2021, no adverse event (fatigue), patient has taken tylenol for sore arm.  Mother reports patient is fine with expected side effects.
Within three hours I had a crazy headache and I was so dizzy I could not even stand up. For the rest of that day I felt that way it was not until I went to bed and got up the next morning that the dizziness was away. On that day when I woke up which was the day after my shot I was achy, tired(slept a lot) and still have the headache. As of today I still have all three symptoms but I would say not as severe.
In the beginning, I had lower-grade fever and a headache.  Then a week ago, I had rashes all over my body.  On Saturday night, I went to care.  I was referred to meet with an allergist.  I meet with the allergist 2 days ago.  She said it is common that I was having a reaction to the vaccine.  And the diagnosed with hives.
warm injection site; swelling injection site; redness injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (warm injection site), VACCINATION SITE SWELLING (swelling injection site) and VACCINATION SITE ERYTHEMA (redness injection site) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm injection site), VACCINATION SITE SWELLING (swelling injection site) and VACCINATION SITE ERYTHEMA (redness injection site). At the time of the report, VACCINATION SITE WARMTH (warm injection site), VACCINATION SITE SWELLING (swelling injection site) and VACCINATION SITE ERYTHEMA (redness injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Pt developed irritability about 8 to 12 hours, post vax. No fever. Brought to my attention on the 4th day, post vax. She was given Tylenol.
This spontaneous report was received from a nurse via company representative and refers to a 14 month old patient of unknown gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 23-AUG-2018, the patient was vaccinated with expired dose of Oka/Merck VARIVAX expiration date 10-AUG-2018(exact dose, route of administration and lot # were not reported), for prophylaxis. Concomitant therapies included sterile diluent. No adverse effect reported.
Constant headache, fever, shakes, disoriented, dry mouth, watery/itchy eyes. Started 2  days after shot.
2 DAYS AFTER THE DONOR RECIEVED THE VACCINE HE REPORTED HE EXPERIENCE ITCHING AND HIVES TO UPPER BODY.
Arm painful and red one day following vaccine. Went away and re-appeared 8 days later worse
Patient was given MMR vaccine on 3/16/09. Route IM the right lower thigh, Mom noticed reaction next day. Swollen. Warm to touch. Large ring around the injection site. Tx, cold compress. TYLENOL for pain.
SYMPTOMS: REDNESS AND WARMTH TO TOUCH AT RIGHT DELTOID. TREATMENT: SUPPORTIVE CARE, ICE AND TYLENOL PRN.
Patient was started COVID vaccine series and was administered a 1st dose of Moderna on 4/20/2021. The patient returned  today for his "2nd dose" without his vaccination record stating he was here for 2nd dose of Pfizer. Patient was given dose of Pfizer 5/18/2021 and upon checking out it was discovered the he should have received a moderna 2nd dose. Patient was notified of error and was monitored for 30 minutes for any adverse reactions. Patient reported feeling well when he checked out. LVN advised the patient to continue to monitor for any signs or symptoms of adverse reactions and seek emergency care immediately if any necessary. Patient verbalized understanding.
Area where she received the injection became red and swollen.  She said its on the whole back of her arm, and approximately 6 inches x 3 inches.  She also mentioned a sore throat since receiving the injection.
Rash and swelling at vaccination site (L ARM) the day after vaccine. Poison Ivy- like rash began 4/19. Bilateral upper and lower extremities. Itchy and painful, pustules, hot to touch. Unable to sleep. Spreading and worsening as of 4/28.
Has made me very unusually tired  my arm hurts a lot and is a little swollen at the puncture site  I been getting hot and cold flashes which I?ve never gotten before insomnia I wake up from it  gottA turn the AC on I get cold and it?s low I get freezing cold  and when it?s off like 20-30 minutes later then it back in that?s the whole night since the  vaccine. I also been waking up with Charlie horses in my legs it hurts so bad I jump out of bed and gotta walk around that never happen to me before the vaccine also my throat hurts and my neck hurts a lot and it?s very soar and i feel sluggish I can?t concentrate or think quickly like I usually would.  The headache is nonstop and at times feels like a migraine  Nothing I take helps I just lay down and try to rest  this has been like this for 2 days so far and I also have a bad backache  I did have surgery on my spine called spine infusion the back of my neck but i don?t think it has any affect on that but idk that?s why I?m telling u all!!
Treatment of COVID-19; Treatment of COVID-19; interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 11Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Beta thalassemia minor" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; ACETAMINOPHEN; PSEUDOEPHEDRINE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Sep2022, outcome "unknown"; 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.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. The other reported event (Interchange of vaccine products) is considered Related due to the nature of the event. ,Linked Report(s) : US-PFIZER INC-202300158002 same patient, different drug/event;
Pt given Hep B and pneumonia vax on 11/1/99.Sent to ER on 11/4/99 w/ red,raised, cellulitis-like injection site.Pt also had increased temp at home,diarrhea,cold chills beginning on 11/1/99.
developed hyperthyroidism; lost 62-63lb in 2 months; she can't swallow; Gallbladder turned green and disintegrated; Gallbladder turned green and disintegrated; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTHYROIDISM (developed hyperthyroidism), WEIGHT DECREASED (lost 62-63lb in 2 months), DYSPHAGIA (she can't swallow), GALLBLADDER DISORDER (Gallbladder turned green and disintegrated) and GALLBLADDER RUPTURE (Gallbladder turned green and disintegrated) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gallbladder removal (was hospitalized for 6 days). Concurrent medical conditions included Asthma (had been on same medications for severe asthma for last 5 years, did not provide medication list).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced GALLBLADDER DISORDER (Gallbladder turned green and disintegrated) (seriousness criterion hospitalization) and GALLBLADDER RUPTURE (Gallbladder turned green and disintegrated) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HYPERTHYROIDISM (developed hyperthyroidism) (seriousness criteria hospitalization and medically significant), WEIGHT DECREASED (lost 62-63lb in 2 months) (seriousness criterion hospitalization) and DYSPHAGIA (she can't swallow) (seriousness criterion hospitalization). The patient was hospitalized for 6 days due to GALLBLADDER DISORDER. The patient was treated with Surgery (surgery to remove the gallbladder and was hospitalized for 6 days) for Gallbladder disorder. At the time of the report, HYPERTHYROIDISM (developed hyperthyroidism), WEIGHT DECREASED (lost 62-63lb in 2 months), DYSPHAGIA (she can't swallow), GALLBLADDER DISORDER (Gallbladder turned green and disintegrated) and GALLBLADDER RUPTURE (Gallbladder turned green and disintegrated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood thyroid stimulating hormone: not detectable not detectable. On an unknown date, Thyroxine: 2.44 (Low) Her free T4 is 2.44.         Concomitant medication taken by the patient include medications for Asthma.  About two months after the second shot her gallbladder turned green and disintegrated upon removal. Around the same time, she developed hyperthyroidism and lost 62 to 63lb in two months. She said her thyroid stimulating hormone was not detectable and her free T4 was 2.44.  Company Comment: 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.; Sender'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.
Fever as high as 101.8, body and joint aches, nausea /vomiting, headaches,  dizziness, SOB, increased pulse, Oxygen sat to 90 with any activit.  9 hours after vaccine side effects woke me from sleep.  I was in bed for 2 days unable to function and complete daily ADL's.  Tylenol, ibuprofen and Toradol had little affect on symptoms.  I was sicker for those 2 days than I was when I had covid and was in bed for 7 days.
DAY OF VAX., PT BECAME LETHARGIC, DEVELOPED BLISTERS AND REDNESS(INFLAMMATION) OF MUCOUS MEMBRANE OF MOUTH. TREATED WITH BENADRYL. OUTCOME: NO INJURY.
RED, SWOLLEN, AND TENDER AREA AT SITE OF ADMINISTRATION. PATIENT STARTED TREATMENT OF ANTIHISTAMINE (BENADRYL)
The injection site is  swollen; The injection site is red; she couldn't hold herself up; she was weak; sick on her stomach; sleep all; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th March 2020, the patient received Shingrix. On 17th March 2020, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, difficulty in standing, weakness, stomach discomfort and sleepiness. On an unknown date, the outcome of the injection site swelling, injection site erythema, difficulty in standing, weakness, stomach discomfort and sleepiness were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, difficulty in standing, weakness, stomach discomfort and sleepiness to be related to Shingrix.  Additional details were reported as follows: The patient shingrix vaccine and next day she was unable to hold herself up, she was weak, and her stomach was upset and patient slept all. The patient also experienced injection site redness and injection site swelling after vaccination. No other information was reported.
I started having pains in the center of my back. Even when touching the center of my back it starts to hurt a lot more. I?ve never had pains in the center of my back before and it?s started since the second dat of me having getting the vaccine
Administered IM Typhoid vaccine by SQ route. No adverse reaction from patient although she did say it stung.
The usual arm soreness.  Then, 24 hours after shot began being nauseated, dizzy, headache, and with chills.  Then, 48 hours additionally had slight loss of taste (most things tasting very flat, but could taste salt well).  Third day still dizzy, especially upon standing (no blood pressure drop), and having some dyspnea.  Walked out of house to get something from car (hot & sunny), legs got weak, had shortness of breath, and pulse 104, but with 97% pulse ox.
He developed acute dyspnea with a drop in pulse ox to 90. Normally not dsyneic, on room air and sats in a good range. Symptoms progressed and he was seen at the ED and ruled out for a PE, MI and antibiotics stopped based on neg proclaimed, imaging, etc  Chest CT read as interval progression of ILD and he was seen in consultation by Pulmonary.  Additional cardiac workup with TTE with normal EF.  Autoimmune/rheum workup was initiated with result to date unremarkable except for positive ANA and mildly positive dsDNA. He was discharge home on continuous O2, not weanable in hospital with follow up with pulmonary and no clear trigger as of discharge for acute change in pulmonary status from usual baseline.
Pt states that beginning Friday she had body aches and was so sleepy that she could not get out of bed all day and a very tender arm. Then at 5 AM Saturday she had severe pain from her neck down through her spine. By 8 am Saturday severe effects were gone.
Heart rate of 110 to 125 while at rest and chest pain. It started at about 6pm the day of the vaccine. I hoped it would pass by morning but it had not ceased. I was monitoring my pulse via fitbit. I went to the Hospital ER at about 9am the next morning, 12/29/21. They did an EKG, ran labs and gave me fluids then sent me home and said to rest.