chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY ACHES; STIFF NECK; FEVER OF 101; POUNDING HEADACHE; This spontaneous report received from a parent via a company representative concerned a female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-DEC-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 30-DEC-2021, the patient experienced body aches, stiff neck, fever of 101, and pounding headache. Laboratory data included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 101, body aches, stiff neck and pounding headache was not reported. This report was non-serious.
Localized induration, with tingling sensation of vaccinated site the night after. Also stomach cramp and generalized malaise.
Headache, body aches, low-grade fever, nausea and vomiting, exhaustion.
Fever; chills; body aches; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613), via an unspecified route of administration in the right arm on 21Mar2021 at 15:00 (at the age of 17-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient had a history of lactose intolerance. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW6203), via an unspecified route of administration in the right arm on 28Feb2021 at 14:00 (at the age of 17-years-old), as a first single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 at 14:30, the patient had experienced fever, chills and body aches. The patient did not receive any treatment for the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, chills and body aches were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a Registered Nurse regarding a 12 year old Adolescent patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 03-DEC-2018, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error). Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA001085.
This spontaneous report was received from a physician via a company representative concerning an unspecified patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL intramuscularly (dose, frequency, lot number and expiration date were not reported) for prevention of human papillomavirus (prophylaxis). The physician reported that he was hearing that somebody in a town close, on an unknown date, experienced an unspecified disabling effect (adverse event). At the time of reporting, the outcome of the event was not reported. The causal relationship between the event and GARDASIL was not reported. The reporter considered the adverse event as a disabling event. Additional information is not expected as there are no contact details available.
Vaccine given at 2pm 01/13/19, at 6pm had facial flushing and swelling, resolved with benadryl. At 1am 01/14/1, woke with facial flushing and swelling again, this time with shortness of breath, went to ED.
Reports fainted in the car. When clinical staff arrived, the patient is alert and oriented. Reports fainting, nausea, and weak. HR 48-50 and BP 90/60 initially. Improved in a few minutes to HR 60 and BP 120/60 and remained stable, symptoms eventually resolved before leaving the site. The patient is the driver today and here alone. Advised her to have someone drive her to her second appointment and tell the vaccinator that she had a reaction to the first dose so she will be directed to 30 minutes observation line.
103 degrees fever, seizures, As per mom, patient was  brought to ER, Urine test done, T= 101 degrees F & sent home. Patient on Tylenol.  Follow up: no site reaction.
A few days after first vaccine I began to experience loose stools. I also began to experience stomach pains. This continued until I got my second vaccine and at that point my stool was now diarrhea and the stomach pains came and went. I also had bouts of nausea and lost around 10 pounds. I still have diarrhea daily and  have not had a regular bowel movement since my first vaccine. I've seen a gastroenterologist who ran a stool specimen which shows I have lots of inflammation in my colon and he  has put me on Align in the meantime and I am now scheduled for a colonoscopy. I never had issues of this sort so I strongly believe this was caused from the vaccinations. It's the only thing different that I had done.
Since receiving immunization over 2 weeks ago, the patient has been experiencing on and off soreness and swelling in arm. Patient has been directed to contact doctor for treatment.
Patient was given Menveo vaccine ON 07/26/2011 Lot# A10059 was mixed with the wrong sterile diluent (Merck lot # g00151 ep 3/12) instead of the correct conjugate component for the Menveo vaccine.
25OCT94 neck, shoulder pain;28OCT94 flu-like sx-fatigue, h/a, neck & shoulder pain;31OCT94 returned to hosp-shoulder & neck pain, fatigue-put on Darvocet N-100 & Amoxicillin; 1NOV94 to ER for tingling & parasthesias in upper extremities
During the Covid vaccine observation period the patient complained of hoarseness, itching and throat swelling.   The patient had  history of chronic urticaria and prior to receiving her vaccine had taken benadryl, ranitidine as well as an OTC antihistamine at home.  She was escorted via wheelchair to the ED, BP 151/102 and pulse 101 in ED, pt noted to have blanching hive-like rash on her chest as well.   Received Epinephrine 0.3mg, prednisone 60mg PO x 1.   Pt was monitored for 3 hours and discharged to home.
10 AM - Vaccines given. 11 AM - Mother reports itching and rash on stomach. Goes to hospital ER. MD reports red itchy rash on body. Child given BENADRYL, DECADRON and DUO NEB. Child back in school and doing "OK" on 10/25/11 according to mother.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. A 80 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Mar2021 (Lot number: ER2613) at the age of 80 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ELIQUIS taken for atrial fibrillation; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "On a blood thinner and got the vaccine"; HEADACHE (non-serious), outcome "unknown", described as "headache". The patient currently on blood thinners and failed to mention that on the HCP who administered her 1st vaccine shot on 21Mar2021. Now, the patient wants to know if this had any interactions and complications with the vaccine and on her upcoming 2nd dose schedule. No follow-up attempts are possible. No further information is expected.
PCV 13 (4th Pneumococcal vaccine) injected (L) thigh on 4/18/11. Pt was seen on 4/21/11 - swelling and tenderness (L) thigh - 1/2 the circumference with mild redness.
I contracted COVID-19 on 07/10/2022 with symptoms of sore throat, cough, congestion, fever up to 99.7, and body aches. I was prescribed Paxlovid on 07/11/2022. My temperature is back to normal, and the body aches have resolved as of my 3rd day of illness. I am not fully recovered yet.
1 days after vaccine red and swollen warm to touch. Afebrile x 3 days.
Initial unsolicited report received from other non-health care professional on 13 April 2016. This case is linked with case 2016SA074938 (same reporter, same lot number) and case 2016SA074966 (same reporter). This case involves a 51-year-old female patient who was vaccinated with a dose of ADACEL (Batch number: U5288BA, expiration date: 30 March 2018, dose number, route and site of administration were not reported) on 08 April 2016. Patient's medical history and concomitant medication were not reported. On 09 April 2016, one day post vaccination, the patient had experienced sore arm that she could not lift it and was swollen and red. Laboratory investigations and corrective treatment were not reported. The outcome of the events were not reported. List of documents held by sender: none.
suffers from stage 4 chronic kidney disease; chills and shivering on her whole body; This is a spontaneous report from a contactable consumer (reporting for his wife) from a Pfizer-sponsored program. A female patient of an unspecified age received the second dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown), via an unspecified route of administration on 09Apr2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 19Mar2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient was experiencing chills and shivering on her whole body for 3 and half hours now (Apr2021). She also suffered from stage 4 chronic kidney disease. The outcome of the events was not recovered.   Information on lot/batch number has been requested.
Stiff neck, headache, numbness in right cheek, holds mouth differently.  Went to a chiropractor twice with no relief. On 9/21/15 she came to Public Health office with no relief of symptoms. Advised to see a physician, given info on National Vaccine Injury Compensation Program.  On 9/29/2015 she again came to Public Health, stated that she is "getting worse", C/O pain "in my clavicles", still holding mouth as if she cannot open it fully, stated she is going to the ER.
fast heartbeat/episode of rapid heartbeat; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced fast heartbeat/episode of rapid heartbeat after the second dose on an unspecified date. The outcome of event was unknown.  Information on the lot/ batch number has been requested.
I went into A-fib with RVR. I was at stroke level. I had to be given stomach injections to avoid a stroke. I was admitted into the hospital for 3 days and was given meds to take if symptoms came back.
Pain, tenderness in lymph node of left arm, middle of the armpit. This began on day 4. Swelling, itchiness, hardness and redness of the left arm close to the vaccine site. It appears as a raised red rash.
Fever, rash, swollen neck glands, after 2-3 days of injections. Referred to VNC MD for evaluation. Rapid Strep negative, throat culture pending. Sent home with instructions to take Tylenol and Benadryl. Reportedly somewhat better by 03/23/2005, decreased rash, fever, but still has itching and swollen glands.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 29-OCT-2015 06:44, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 8.4 (10 mins) and 2.3 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
swelling in the nose; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (swelling in the nose) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On an unknown date, the patient experienced SWELLING (swelling in the nose). At the time of the report, SWELLING (swelling in the nose) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
PURPLISH BRUISE ON FOREARM; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart surgery, and concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On 08-MAR-2021, the subject experienced purplish bruise on forearm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from purplish bruise on forearm on MAR-2021. This report was non-serious.
After only a couple days post-vaccine, patient was unable to sit up, walk or feed herself. Taken to ER via EMS on 2/7/21.  Nothing remarkable discovered.  Slight dehydration, scant UTI bacteria.  She is now in the Hospice contracted bed at the hospital returning to hospice care at home with 24/7 aides to feed and car for her.
This is a spontaneous report from a contactable consumer (daughter) on behalf of father via Pfizer sales representative. A male patient of an unspecified age reported as (Age: 67; Unit: Unknown) and unspecified ethnicity started to receive PREVENAR 13, via an unspecified route of administration on an unknown date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously took influenza vaccine "flu shot" via an unspecified route of administration on an unknown date at a single dose for immunization. Four days after receiving pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) the area of the arm where the vaccine was administer become red, hot, swelled and fatigue. The clinical outcome of the events, vaccine was administer become red, hot, swelled and fatigue, was unknown.
The patient who received the shot was 16 years of age, under the approved age recommendation for the shot. The patient/parent who filled out the consent form online indicated a date of birth. We were not made aware of the error until 5/27/21 when the parent came in for their second shot and informed us the patient was actually 16 years old.
Patient experienced his gout flare up  within 1 week of getting SHINGRIX vaccine leading to treatment with colchicine.  He decided to skip the subsequent vaccinations in the series due to possible side effect.
Really bad stomach ache; Really bad chills/Can't stop shivering; Some vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Really bad stomach ache), CHILLS (Really bad chills/Can't stop shivering) and VOMITING (Some vomiting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by reporter.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Really bad stomach ache), CHILLS (Really bad chills/Can't stop shivering) and VOMITING (Some vomiting). At the time of the report, ABDOMINAL PAIN UPPER (Really bad stomach ache), CHILLS (Really bad chills/Can't stop shivering) and VOMITING (Some vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 (Inconclusive) 100.5.         No concomitant and treatment medications are provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-Jun-2021, No new information. Patient Denied to Consent to Follow up.
Inappropriate shcedule of Hepatitis B vaccine; This spontaneous report was received from a physician via an immunization record, from a case in litigation for zoster vaccine live (ZOSTAVAX) (Marrs # 2008USA012413), concerning a 9-week-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-OCT-2000, she was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as "Hepatitis B") dose 1 as prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On 19-DEC-2000, she received the second dose of hepatitis b vaccine (recombinant) (manufacturer unknown) and on 26-FEB-2001, the third dose of the vaccine was administered (inappropriate schedule of product administration). The outcome of inappropriate schedule of product administration was unknown.    This is one of several reports concerning the same patient.; Sender's Comments:  US-009507513-2008USA012413: US-009507513-2112USA004907:
Approximately one to two months following my receipt of the 2nd dose of the COVID-19 vaccine, I started experiencing swollen areas in various parts of my neck.  The lump (swelling) would surface, last for a few days, and then disappear.  From recollection, I experienced four different lumps over the course of about one and a half to two months, the last of which was on my thyroid gland itself.  This swelling was associated with pain, and I was also feeling "out of sorts" and not my typically energetic self.  I had suffered from subacute thyroiditis back in 1997 (diagnosed by my physician at that time) following a viral respiratory infection.  Prior to experiencing these most recent symptoms, I had no recurrence of this condition since that time, however, due to the symptoms mentioned above, I suspected that my thyroid was once again acting up and I decided to see my doctor.  I was subsequently diagnosed once again with subacute thyroiditis; however, this current diagnosis did not follow any type of recent viral infection.  My physician encouraged me to report this diagnosis to the CDC as a possible consequence of the COVID-19 vaccination, since the onset of this condition occurred one to two months or so after my receipt of the 2nd dose of the COVID-19 vaccine.  My physician has conjectured and suspects that my immune system was possibly stimulated with an antibody response to the vaccine, and this might have induced a recurrence.
Patient developed left upper eyelid edema with an erythematous papule in the lid margin.  Started approximately day 8 after vaccination with Small Pox.
Pt  came in with multiple family members.  Age missed and inadvertently given adult vaccine when based on age should have been pediatric.  No issues at this time as of this submission.  Talked to Dad
He presented to the ED on 8/24/2021 for fever, nausea, diarrhea and weakness for the two to three days prior to admission. He lives alone at home and was unable to take care of himself, so was admitted to hospital on 8/24 for weakness. Fully vaccinated for COVID-19, no prior infections.
CHOPPED MY LEG OFF TWICE; 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced chopped my leg off twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chopped my leg off twice was not reported. This report was non-serious.
Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients might have received doses of improperly stored VARIVAX (lot # M023382, expiration date 06-NOV-2017; dose and route were unknown), for prophylaxis. The vaccines were exposed under temperature of 11 degrees Fahrenheit for 44 hours. There were no previous temperature excursions. Data Logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Herpes Zoster outbreak, unusually severe. Sharp pains in the chest. As of the date of this report, some pain still at the injection site in the arm.
Left vaccination facility at 1:10PM, March 7th, 2021.  About 2 hours later, hives and rash appeared on my upper torso and top of both thighs.  When I woke up the next day, the hives and rash covered everywhere except my head.  I took a shower and it became hard to breath, my eyes were very light sensitive, nauseous, and very dizzy.  I tried to make it back to my bed, but fell twice.  The second time I fell I stayed on the ground for about 5 minutes.  When I got up, everything was back to normal.  I left soon after to the Hospital emergency room to get checked.
8 days post injection (Wed. 12/30/20), L arm became red, swollen and warm to touch. Saw internal medicine doctor (Thurs 12/31/20) recommended to take Zyrtec- took one and on Friday 1/1 the red (not raised area) was fading. By today 1/6/20 it has resolved.