chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizziness; headache; tiredness; slight fever; stomach ache; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), DIZZINESS (dizziness), VACCINATION SITE PAIN (soreness at injection site), HEADACHE (headache) and FATIGUE (tiredness) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 13-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), HEADACHE (headache), FATIGUE (tiredness) and PYREXIA (slight fever). On 14-Apr-2021, the patient experienced DIZZINESS (dizziness). At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), DIZZINESS (dizziness), VACCINATION SITE PAIN (soreness at injection site), HEADACHE (headache), FATIGUE (tiredness) and PYREXIA (slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  No treatment information was provided.   This case was linked to MODERNATX, INC.-MOD-2021-107185 (E2B Linked Report); Sender's Comments:  MODERNATX, INC.-MOD-2021-107185:
This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 61-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6202; Expiration Date: Jun2021), via an intramuscular route of administration (at the age of 61-years), administered in arm left on 02Mar2021 at 14:00 as dose 2, single for COVID-19 immunization. Medical history included, none from an unknown date and unknown if ongoing. The patient had no family history. The patient concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EM9809; Expiration Date: Jun2021), via an intramuscular route of administration (at the age of 61-years), administered in arm left on 11Feb2021 as dose 1, single for COVID-19 immunization. No prior vaccinations (within 4 weeks) aside from first dose of covid vaccine. The vaccination facility type was reported as hospital. The patient did not receive any other products. On 03Mar2021, the patient experienced high fever, severe body aches, headache. It was further stated that She was calling about the covid vaccine. She received second Pfizer covid vaccine on 02Mar2021. 12 hours later she got a high fever of 101.7, which is a high fever for her. She had severe body aches and a headache. She still has symptoms and her doctor suggested to call. She was asking what she should do. She had a low-grade fever as of now, her severe body aches recovered within in 24 hours. Her headache is not as bad. She will let her doctor know that she called to report this. The treatment was received for all the adverse events. The duration of event severe body aches was reported as 1 day. The adverse events did not result in emergency room visit or physician office visit. The patient underwent lab tests and procedures which included body temperature: 101.7 on 03Mar2021 high fever of 101.7. The patient was taking the Covid vaccine as a preventative. The clinical outcome of the event severe body aches was reported as recovered on 04Mar2021 while for the events high fever, headache was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Systemic Reaction  o 7/10 pain, cramping both legs described as moderate interrupting sleep, started 7hrs post vaccine. Improved by next day. o Migraine with nausea, worse with bending over, however has chronic daily migraines, improved next morning. o 3/10 abdominal pain, resolved next morning.
Fever; Headache; Chills; This a spontaneous report from a Pfizer-sponsored program by a contactable consumer (patient). A 77-years-old female patient received first dose of bnt162b2 (Covid-19 vaccine, Batch/lot number: EL3246), via an unspecified route of administration on 07Jan2021 at SINGLE DOSE on left arm for covid-19 immunisation. Medical history included ongoing blood pressure. Concomitant medication included amlodipine (AMLODIPINE), bisoprolol fumarate/hydrochlorothiazide (BISOPROLOL/HYDROCHLOROTHIAZID), both since 2015 and ongoing for blood pressure. The patient experienced fever, headache, chills on 08Jan2021. Everything happened at night time. Her temperatures have been 100.4 and 100.5 degrees. The headache only lasted for a couple of days. It was also only at night. The patient underwent lab tests and procedures which included blood pressure measurement: fine on 12Jan2021, body temperature: 100.4 and 100.5 degrees on an unknown date. The event outcome of fever, headache was not recovered; outcome of chills was recovering.
Approximately one minute following the vaccine the child began to slump forward as if she was reaching down to pick something up. When I saw that her hands were not reaching and she was going head first I reached down prevent the fall. Upon lifting the child she was limp and her eyes were closed and color of her skin was pale. She regained consciousness in approximately 2-3 seconds. I lifted her on to mother's lap and immediately provided a Sprite to sip on. Mom stated child hadn't eaten anything since the morning. Child remained on mom's lap for several minutes while we ensured safety of child.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on unknown dates, the patients were vaccinated with improperly stored doses ROTATEQ lot # M040270 with expiration date of 29-APR-2018 and lot# M041184 with expiration date of 31-MAY-2018, for prophylaxis (dose, route and frequency were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 8 hours and 20 minutes (worst case). Previous temperature excursion was reported as 47 to 77 degrees Fahrenheit for 40 minutes. The call was because of a "data logger". This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA008789: US-009507513-1707USA000697: US-009507513-1707USA000699:
Information has been received from a registered nurse concerning unspecified number of patients of unknown age and gender. The nurse reported that multiple unspecified patients were administered improperly stored VARIVAX (Merck) (lot # L001331, expired date 13-JAN-2017, dose and route not reported) on multiple unspecified dates following an excursion on 22-DEC-2015. The temperature and time frame was reported as -12.3 Centigrade for 1 hour and 6 minutes; -13.6 Centigrade for 48 minutes. There was no previous temperature excursion. At the time of report, the status of patients was unknown. Additional information is not expected as reporter refused additional contact.
Patient notified pharmacy today (03/22/2021) that Janssen Covid-19 Vaccine that she received on 03/03/2021 caused Pneumonia. Patient says that on 03/11/2021 went to hospital for treatment and MD told her that Pneumonia was caused by Janssen Vaccine she had received. Patient says was treated at hospital with 2 kind of IV antibiotics.
Swelling and redness 4" x 3 1/2" at site of vaccine injection of DTAP. She was prescribed on 7-12-2010 ELOCON cream and Prednisone 15 mg BID x 5days
Redness, elevated skin temp 24 hrs after vaccination, fever, Benadryl and Keflex.
his tinnitus has been "bothering me more than usual" and "seems like it's getting louder".; This is a spontaneous report from a contactable consumer (patient). This 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (reported as "last Saturday") at single dose for COVID-19 immunization. Medical history included tinnitus. Concomitant medications were unknown. The patient's tinnitus had been "bothering me more than usual" and "seems like it's getting louder". The patient asked if this was a reported side effect after receiving the vaccine. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
DIZZINESS, DISORIENTATION, UNSTEADY GAIT, SEVERE HEADACHE, NAUSEA WITHIN 10 MINUTES OF VACCINE; THESE SIDE EFFECTS CONTINUED ALONG WITH EXTREME FATIGUE, NO APPETITE,  LOSS OF 6 LBS IN 6 DAYS, WEAKNESS.  SYMPTOMS STILL PERSISTING ON DAY 8.
Reporting on behalf of patient. He self reported to the Medication Safety Coordinator, that he was woken up from his sleep the night after receiving the vaccination, with his jaw moving side to side uncontrollably. This lasted for a couple seconds, would stop, and then would happen again. This occurred about 3 times total. He also felt twitching in his forehead a couple times. These episodes self resolved and did not happen again.
Patient had nausea, vomiting, headache, felt cold and chilly. Still feels nauseated 2 days after vaccination. Still has headache 10 days after receiving vaccine.
no additional adverse events reported; adult dose of Vaqta was given to patient when he was still 17 years old; This spontaneous report was received from an office manager, referring to a 17-year-old male patient. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported.      On 25-AUG-2020, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA), lot number S017741, expiration date 26-AUG-2020, as prophylaxis; a few weeks prior to his 18th birthday (incorrect dose administered) (strength, exact dose, route of administration, and anatomical vaccination site were not provided). No additional adverse events, no product quality complaint (PQC) or product confusion were reported. The outcome of incorrect dose administered was unknown. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S017741; expirationdate: 26-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This 34 year old female received the Covid shot on  4/2/21    and went to the ED on  4/7/21   with the following diagnoses listed below. U07.1 - COVID-19
cutaneous reaction started immediately as golf ball increased to size of tennis ball, 3 days later became red and today; 11 days later has localized cellulitis
Information has been received from a physician concerning a 10-year-old male with asthma and no history of varicella who on 12-OCT-1998 was vaccinated subcutaneous in the right thigh with his first dose of varicella virus vaccine live (Oka/Merck) (lot # 625477/0653H). There were no illnesses at the time of vaccination. In June 2007, the patient developed "10-12 vesicles on his left anterior thigh". The physician states that she did not see the above vesicles, therefore, she does not know if they were varicella-like (the patient was not examined by the physician). There were no diagnostic labs performed. On 12-DEC-2007 at 15:00 the patient was vaccinated subcutaneous in the left thigh with a second dose of varicella virus vaccine live (Oka/Merck) (lot # 658411/1023U) without any reaction. The physician also states that the patient is immunocompetent. On an unspecified date the patient recovered. A product quality complaint was not involved. Additional information is not expected.
Approximatley 2 hours after injection, after arriving home and starting some housekeeping activities, vertigo started with nausea and sensitivity to light.   It is going on 2 hours while lying down with eyes covered and some improvement in that eye motion is no longer sensitive.
At the time of the vaccination, within approx. 5 minutes, my heart began to race for about 2 min. and then it stopped.  A week later, I wasn't feeling well, I  felt tired, I was sweating at night while sleeping and  my heart rate was elevated on and off, my blood pressure was elevated and I went to the hospital. I felt a lot of anxiety which is not something I have experienced previously. Throughout the following weeks, my heartrate has gotten much better and my blood pressure has been normalizing. I do feel tired from time to time.
Develop Pneumonia; Cannot get the second shot of the vaccine ( almost 60 days after first shot ); This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Develop Pneumonia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, INSULIN for Diabetes.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced PNEUMONIA (Develop Pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Cannot get the second shot of the vaccine ( almost 60 days after first shot )). At the time of the report, PNEUMONIA (Develop Pneumonia) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Cannot get the second shot of the vaccine ( almost 60 days after first shot )) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information was received on 30-JUN-2017 from a medical assistant who was reporting on multiple unspecified patients. No medical history or concomitant medications were reported. The medical assistant reported that multiple doses of improperly stored (31 degrees F or lower (29F) for 7 hours 55 minutes) GARDASIL 9 (lot L037554, expires 25-DEC-2017, Lot M040412, expires 30-AUG-2019 and lot M041990, expires 28-JUN-2018) were administered to multiple unspecified patients on unspecified dates. No previous temperature excursions. No adverse effects reported. No further details available. Additional information is not expected, no additional information is available. This is one of several reports from the same reporter.
1st dose 2 years ago, 2nd dose 15Jan2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number H2PE2, expiry date 19th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about 2 years ago from the day of reporting).   On 15th January 2022, the patient received Shingrix. On 15th January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The Healthcare professional did not have the exact date of the 1st dose (it was given at a different pharmacy).  The reporter consented to follow up via email.
She had lots of dizziness for 20 + minutes after getting her shot. The paramedics came and checked her out. The dizziness was worsened by her new glasses. She took them off and had someone come pick her up to take her home.
About 4 hours after getting my pneumovax, I experienced pain from the injection site to the tip of my fingers. I was unable to lift my arm because the pain was so severe. When I went to bed around 10 pm, I was awakened around 11:30 pm because I felt extremely cold, as if I the heat system in my house had failed. I got up an push my thermostat up, added two blankets to the bed, put on a robe over my flannel pj's and tried to sleep. The chills were uncontrollable and I felt my bones were aching due to the severe chills, I was unable to sleep. I got back up and took 2 TYLENOL to see if it would help, but I have been instructed by my cardiac physician not to take TYLENOL. I did it anyway to see if I could get some relief. Around approx. 4pm, I fell asleep. When I woke up this morning my arm still hurts quite a bit, but the chills are gone.
Patient developed fever, rash, myalgias and arthralgia 48 hrs after vaccine. Symptoms persisted, including fever 2 wks. Pt had multiple visit and work up done. No definite Dx made but specialists felt most likely serum sickness.  07/01/2008 MR received for DOS 6/19-21/2008 with D/C DX:  Suspected Serum Sickness. Pt presented for eval after several PCP and ER visits for 12 day hx of fevers, rash, muscle weakness and joint pain which began after receiving Menactra on 6/6/08. Pt had injection site erythema. On ~6/10/08 pt developed abd pain. PCP noted petechiae on pt's abdomen. CT (+) for colitis. Developed sore throat on the folllowing day.  Pt then developed a diffuse itchy, macular erythematous rash on the upper extremities, legs and shoulders.  Fever persisted and pt developed severe L elbow and knee pain which caused walking difficulty. Lightheadedness also reported. Admission PE(+) for L knee effusion, tachycardia, 2/6 systolic murmur, a pericardial rub, decreased ROM in the L elbow, L wrist, R ankle and L knee with knee swelling,  injected conjunctiva and periorbital erythema and swelling. Rheum consult felt not rheumatologic etiology. ID felt etiology most c/w serum sickness. Cardiology felt pericardial rub associated with systemic inflammation. Tx with IVF and Naproxen.
On day 8, my arm became hot, swollen, itchy, and sore. After researching, it sounds like Covid arm. This lasted for another week.
Patient presented to clinic for booster dose of 12> Pfizer's covid-19. The patient received a pediatric dose of Pfizer's covid-19. Patient was offered an adult dose of vaccine according to CDC guidelines but decided to wait a few days before receiving the dose.
administered Infanrix instead of Boostrix; 11y/o administered Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 1st June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-Jun-2022 Reporter's Comments: Medical assistant reported 11 year old patient was administered Infanrix instead of Boostrix. The reporter consented to follow up. Additional Supportive: The patient was administered Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. This case had been linked with the case US2022088502, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022088502:Same reporter
Swelling about the diameter of a baseball. Itchiness and major swelling appeared a week after injection.
This case was reported by a healthcare professional and described the occurrence of hot feeling at injection site in a 4-year-old male subject who was vaccinated with KINRIX. On 25 February 2013 at 10:45 the subject received 4th dose of KINRIX (.5 unknown, unknown, right deltoid). On 25 February 2013, less than one day after vaccination with KINRIX, the subject received a KINRIX dose and experienced redness at injection site. The redness was confined to the upper arm area, and did not go below the elbow. The injection site also felt hot. No other events were reported. The subject was being monitored and told that if condition worsens, to come to the physician's office. At the time of reporting the outcome of the hot feeling at injection site redness were unspecified.
Accumulation of mucus; Cough; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Accumulation of mucus) and COUGH (Cough) in a 65-year-old male patient 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 PRODUCTIVE COUGH (Accumulation of mucus) and COUGH (Cough). At the time of the report, PRODUCTIVE COUGH (Accumulation of mucus) and COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment information was reported.  It was reported that patient had similar symptoms of accumulation of mucus and cough after receiving the Moderna vaccine.
In the 1st 24hr fever, redness & swelling in thigh;dx cellulitis; IV ATB given & po ATB
This case was reported by the mother of a consumer and described the occurrence of a 18-year-old male subject not responding to therapy following vaccination with Engerix B for prophylaxis.  A physician or other health care professional has not verified this report.  Concurrent medical conditions included asthma, decreased igg and plastic bronchitis.  Concurrent medications included Salbutamol sulphate (Albuterol).  In 1991 the subject completed the standard dosing schedule for vaccination with Engerix B (unknown).  A blood test for titer detection performed on 22 June 2007 revealed non-detectable titers for hepatitis B.  The subject was considered to have not responded to therapy.  At the time of reporting the event was unresolved.  No additional details expected.
Day after injection there was some swelling at the site. He went to the E.R. and was diagnosed with cellulitis of the right upper extremity.
Covid arm.  Hive-like rash beginning about inch below injection site.  Painful swelling, become itchy.  Headache, fatigue and nauseated. Treated with benedryl and rest initially.  Took Nyquil at bedtime and slept with ice bag on it.  Ibuprofen in the morning.