chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe nausea and vomiting for about 15 hours. Started approximately 2.5 hours after receiving the vaccine. I had no problems with the first dose of the COVID Vaccine (no. 025J20A).
Got vaccine on Friday 9/25/09 (got one last yr 11/17/08) and on Tuesday 9/29/09 developed rash on arm - Spreading to entire body. Called MD - MD said not vaccine related.
Soreness at injection, immediate Soreness of left arm, onset at 12:00pm Fatigue, onset at 4:30pm Sore throat, onset at 5:30pm Flushed, onset at 5:00pm Lightheadedness, onset at 5:30pm
Approximately 5 days after my 1st dose, I have experienced extreme fatigue, rash, myalgia, and shortness of breath. It was very unusual for me, and it lasted overnight, I did not take any medication for treatment instead I just slept on it and felt normal the next day.
pt reports 1 day after Pfizer booster in L arm than she had L axillary tenderness and swelling that has now lasted 2 months. ultrasound negative. not consistent with an allergic reaction however pt very concerned about the timing of it.
Came into the clinic 4/19/17 to get travel vaccines. Got Typhoid pills. Started taking them 5/1/17. Then on 5/3/17 called to c/o severe stomach pains that started 5/2/17 and continued to be bad. Lower right abd pain and c/o very frequent urination. Instructed to call her doctor to be seen to rule out other cause. Next day, mother called back and said the doctor did not see her, over the phone he said it was related to the typhoid pills and instructed her to continue them. She took the second dose on 5/3/17. Then on 5/8/17 called--stopped oral typhoid after dose #2 due to severe symptoms as listed above. Symptoms resolved 5/6/17 evening. No treatment for symptoms.
Initial unsolicited report received from a nurse on 06-Nov-2017. This case involves a six patients (gender and age were not reported) who were vaccinated with a FLUZONE HIGH-DOSE (batch number, expiry date, dose, route and site of administration was not reported), on an unknown date. The patients' medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced parkinson's like shaking. Three or four of the patients had dialysis on the same day they received the flu vaccine. Lab data and corrective treatment was not reported. The outcome of the event was unknown. These patients received vaccination over the last 30 days. Details surrounding each situation were unclear. List of documents held by sender: none.
male pt recv vax & pt wife called MD & questioned if the vax could cause infertility;No further details were provided;
Febrile seizure. Taken by ambulance to hospital. Fever measured at 105.5 rectally at hospital.
Approximately 24 hours post dose experienced dizziness, low-blood pressure, chest tightness, almost fainting lasting ~30 minutes.  Taken to ER via ambulance. Diagnosis of Near Syncope, Vasovagal.
Information has been received from a 24 year old female patient, for the Pregnancy Registry for GARDASIL, who on 04-AUG-2009 was vaccinated with a first dose of GARDASIL (route and lot # unknown). On approximately 20-AUG-2009, the patient became pregnant after receiving GARDASIL. The LMP was on approximately 20-AUG-2009 and EDD was on approximately 27-MAY-2010. The patient sought unspecified medical attention. At the time of this report the patient's outcome was unknown and the patient had 7 weeks gestation. Follow up information has been received from the nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning the 24 year old female (patient 4 of 4) without pertinent medical history, no drug reactions or allergies reported, who on 04-AUG-2009 was vaccinated with a 0.5 mL first dose of GARDASIL, intramuscular route (lot # unknown) No concomitant medication. The patient elected to abort the pregnancy on 19-OCT-2009. There was no congenital anomaly known related to the baby. The patient also experienced anemia related to the abortion. The nurse practitioner reported that this was the second patient's abortion and it was determined that she was RH negative and she was treated with RHOGAM. The LMP was on 21-AUG-2009. Additional lab diagnostic studies performed were unspecified. The patient sought medical attention at the physician's office. At the time of the report the patient was fine. Upon internal review, the abortion was considered to be an other medical event of medical importance. Additional information has been requested.
Woke up in middle of the night shaking cold, my shoulder and neck tightened up and I had no control of my body, I threw up and kept getting chills and hot spells. After throwing up was gasping for air for a few seconds. The shaking was uncontrollable. Took an advil and it calmed the chills and shaking. Very weak, and fuzzy in the head.  Phizer vaccine, was my second dose.
Vaccine failure. Patient received Varivax on 2/7/03 and was diagnosed today with varicella.
tingling around the bottom lip, chin area; This case was reported by a consumer via interactive digital media and described the occurrence of tingling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tingling. On an unknown date, the outcome of the tingling was unknown.   It was unknown if the reporter considered the tingling to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-Aug-2022 Reporter's comment: This case was reported by the consumer via interactive digital media. The reporter stated that Shingrix first shot and asked whether it could cause tingling around the bottom lip, chin area. Additional Supportive Information: Follow-up would not possible as no contact details were available.
I took the Johnson and Johnson covid shot 11/18/21 and started having numbness and tingling in my leg. My left arm is hurting and tingling. I have lower back pain and having trouble walking and getting up. I'm dizzying and nauseous. My arm is red and swollen at the injection site and have minimal use of my arm due to pain.
12 hours after vaccination I was lightheaded, dizzy, with nausea, sweating, shaking and chills. I fainted when sitting, after episode of about 2-3 minutes I brushed my teeth. As I walked into bedroom, I fainted again with the same symptoms. Pinpoint vision, rapid heart rate. I did NOT seek medical care but I should have.
Pain in left arm, underside (posterior) of upper arm across arm down to top (anterior) of the elbow down forearm to wrist. Bruising from underside (posterior) of upper arm across arm down to top (anterior) of the elbow.
no additional AE has been reported; a 4 month old patient was administered MMR II and VARIVAX; This spontaneous report was received from a medical assistant and refers to a 4- month-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On 26-AUG-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # T041687, expiration date: 10-DEC-2022; 0.5 milliliter (strength, dosing schedule and route of administration were not provided) for prophylaxis. On the same day, the patient received 0.5 ml dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA))(M-M-R II) lot# T012806, expiration date: 14-APR-2022 (strength, dosing schedule and route of administration were not provided) for prophylaxis. Both vaccines were administered to a patient prior to recommended age indicated in prescribing information. No additional adverse event (AE) had been reported at time of call.
Patient received dose 2 of the Moderna COVID-19 vaccine 17 days early. Patient waited in the recovery area for 15 minutes. No adverse event was noted. Patient was notified within 15 minutes. Patient returned and spoke with a provider. Patient was educated on signs/symptoms of an adverse event. Patient verbalized intent to return if adverse event occurred.
C/O (R) arm, shoulder, neck pain since receiving flu shot on 10/10/08. Pt states reaction started aprx 1 month after recieving vaccine. No time given. 1-6-09 Pt states pain in sholder started within a few days of her flu shot but she cant remember exactly
large - 4 to 5 inch diameter - round, red and warm swelling with induration, treated with benadryl and ibuprofen
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 12-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 25-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left arm for prophylaxis (lot # 1621931, expiration date on 26-JAN-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; 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; Sender's Comments:  US-009507513-2009USA006106:
6"-8" red, raised, warm area 2 days post vaccine. No complaints of fever or pain or discharge. Area involved is where PNEUMOVAX was given.
EAR DOUBLED IN SIZE; This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. 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 subject experienced ear doubled in size. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of ear doubled in size was not reported. This report was non-serious.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report was received from a 62-year-old American Indian or Alaskan native, not Hispanic/Latino male patient. The patient's height, and weight were not reported. The patient drinks a glass of wine occasionally, and does not smoke. He had no known drug allergies and no drug abuse or illicit drug use. The patient had no health conditions and exercises regularly.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, 1 total, administered on left arm on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUN-2021, the patient got an antibody test done which showed no antibodies (suspected immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210608194-Covid 19 vaccine-Suspected immunological vaccine failure This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
12 month old received a Gardasil vaccine that is not indicated for this age group. No adverse reaction noted, seen in office 1/17/08 for recheck.
At about 9:45pm on 2/11/21 I started having body chills. Throughout the night I was freezing but my body was warm. At 3:30am my temperature was 101 degrees. I took one dose of Tylenol. At 10am on 2/12 I was fatigued, weak and had body chills. At 11am my temperature was 100 degrees. Throughout the day, I was tired and body chills on and off. I took two more doses of Tylenol throughout the day. At 4pm my temperature was 97 degrees. On 2/13 I woke up nauseated with no appetite for food up until 1pm. I took a nap and had an appetite for food at 3pm. On 2/14 I had NO symptoms.
no other AE reported; Nurse administered expired ROTATEQ vaccine; This spontaneous report was received from a nurse and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies details were not reported.  On 20-SEP-2022, the patient was vaccinated with third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1742462, expiration date: 19-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event or product quality complaint was reported.
Sweating, increased number of seizures from baseline starting 1 hour post administration. Typical seizure baseline is 6-10 a day. REports 30 seizures that day. With increased seizure frequency for 3 days post administration.
Facial Herpes Breakout in multiple spots. Patient has tested positive for herpes simplex type 1 and has experienced mild outbreaks (cold sores) around 1-2 times/year. Reports possible facial herpes outbreaks when young (4-7) however is unsure.
I had a very sore throat, slight fever, and a lot of congestion for 2 weeks. I tested for COVID-19 on the 12th, and it came back negative. I went to the doctor, and they tested me for flu, RSV, and COVID-19. All the tests came back negative. The doctors said it was just a virus going around.
She as administered the vaccine while sitting up and then the nurse left the room and my daughter said mom said it hurts, and it burns, hot, sweaty,  she said she felt her throat was closing, nausea, dizzy, headache, she said she could not breath and then she past out. I ran out and yell to the nurse that she passed out. They took blood pressure, the nurse said the BP was low, she was clammy, they had her laid down until she felt better. She was pretty tired, weak and pale for about a week.
Hypotension noticed 24 hours post injection.  Effect lasted for 48-72 hours while improving.  Lowest BP 85/60, with symptoms: lightheaded at rest.
Patient received his 2nd dose of Moderna Covid-19 vaccine, and approximately 5-10 minutes after receiving, while in the observation area, he lost conciousness while sitting up on the bench.  Epi- Pen was administered and EMS arrived within 5 minutes, and transported him to the Clinic.   At the time of EMS arrival, the patient was conscious.
At 9am on 3/4/21 I development tachycardia. It lasted about 10 minutes. Around 5pm on 3/4/21 I developed tachycardia again it was continuous and  it lasted until 11pm. On 3/5/21 and 3/6/21 I experience two more episodes that lasted 10 minutes each time.   On 3/4/21 I started experiencing  episodes of my blood pressure suddenly rising. It would go from mid 130?s to 160?s for 10-15 minutes and then fall back down into the 130?s again. This did seem to correspond with the tachycardia episodes.   At 9am on 3/4/21 I developed ringing in my ears, it intensified during the day and seemed to peak from 5pm-11pm. I am still currently experiencing ringing in my ears. It is not continuous and does seem to be getting better each day.   On 3/4/21 I developed swelling in my body. I especially noticed it in my hands and face. It went away by 3/6/21.
This spontaneous report was received from a registered nurse. It was reported that M-M-R II had been administered to an unspecified number of patients between 23-AUG-2012 and 04-SEP-2012 when the temperature had not been recorded and stability might have been compromised. Lot# was not provided. It was unspecified if the patients sought medical attention. No adverse events had been reported. This is one of several reports received from the same source: 1209USA002392, 1210USA000958, 1210USA000960, 1210USA00961, 1210USA000962. Additional information has been requested.
hair was thinning; This is a spontaneous report from a contactable nurse.   This 53-year-old non-pregnant female nurse reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176), via an unspecified route of administration on 13Jan2021 14:30 (Age at vaccination is 53 year) on left arm at single dose for COVID-19 Immunization at workplace clinic. The patient also received second dose on 03Feb2021.Patient medical history included diabetes, hypertension, hypothyroid, obesity, allergies to Sulfa drugs. Concomitant medications included acyclovir, atorvastatin, amlodipine and levothyroxine (Other medications in two weeks). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. After the first dose of the COVID vaccine patient noticed that her hair was thinning. It was unknown at this time if the damage would be permanent. The outcome for the event was unknown.  No follow-up attempts are possible. No further information is expected.
At approximately 4:00 am the day after receiving my 2nd covid shot I felt fatigued, with swelling, pain and redness at the injection site.  I felt very chilled as though I were coming down with a bad case of the flu.  I didn't take my temperature, as I don't have a decent thermometer.  I stayed in bed almost the entire day and night on Friday and just got up to go to the bathroom and once to eat lunch.  I didn't want any dinner, just to sleep and stay warm since I was so cold.  On Saturday, I felt sharp pain in my right scapula every time I breathed deeply, coughed or sneezed, that was so severe that I've now made an appt. to see my PCP.  I do have degenerative disc disease and had a cortisone shot back in around Oct. 2020 but it had been working up until after this shot which is in the same arm that I needed the cortisone shot.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated at an urgent care for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the 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 and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
given Hiberix reconstituted with sterile water; given Hiberix reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 594CF, expiry date 13th July 2022) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. A nurse reported that, it was possible that, the patient was given Hiberix that might have been incorrectly reconstituted with sterile water instead of saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Healthcare professional did not have specific patient information or dates administered at the time of report.  The healthcare professional stated that, the specific lot was administered over a range of a couple of months.  The reporter consented to follow up. This was 1 of 9 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR024234:Same reporter US-GLAXOSMITHKLINE-US2022022662:Same reporter US-GLAXOSMITHKLINE-US2022AMR024235:Same reporter US-GLAXOSMITHKLINE-US2022AMR024237:Same reporter US-GLAXOSMITHKLINE-US2022AMR024238:Same reporter US-GLAXOSMITHKLINE-US2022AMR024239:Same reporter US-GLAXOSMITHKLINE-US2022AMR024240:Same reporter US-GLAXOSMITHKLINE-US2022AMR024241:Same reporter
SM presented to the Troop Medical Clinic on 8/14/07 with c/o swelling and pain to the hands, feet and elbows times 2 days. Was noted with papular lesions over hands and feet. Diagnosed as Adverse effect of drug therapy vaccines smallpox at time of visit. Given Benadryl 50mg prn
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, generalized aching and fatigue. On an unknown date, the outcome of the injection site pain, generalized aching and fatigue were unknown. It was unknown if the reporter considered the injection site pain, generalized aching and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient complained about local pain at the injection site, fatigue and overall achiness that lasted about 2 to 3 days and then resolved. No further information was provided.
FEVER, ACHES, VOMITING, DIARRHEA, STARTING THURSDAY AT 10 PM UNTIL WOKE UP MONDAY MORNING AT 6 AM AND ALL SYMPTOMS GONE
ARM SWOLLEN, SORE, RED, AND HOT TO TOUCH. RIGHT ARM.