chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FELL BACKWARDS 4 MINUES AFTER ADMIN. DTAP. IPV, HEP A, VARICELLA AND MMR. HIT HEAD ON FLOOR.  EYES CLOSED. ROUSED SLOWLY.  COLOR PINK-RESP EASY AT 12.  ICE PACK TO HEAD.  OBSERVED 1 0 P-96 R-12 WILL SEE PHYSICIAN 1 PM TODAY
pt recv vax 14MAY97 & 18MAY97 pt devel h/a which seemed to be more nocturnal;h/a occurred daily for @ least 4 wk;
1:15PM-vaccine given and patient sent to waiting room for 15 minute waiting period. 1:25PM-patients wife alerted staff that he was "passing out". Staff assisted patient in waiting room, instructed to remain seated, patient had LOC for <10 seconds and then regained consciousness immediately after. Patient instructed to remain in the clinic until 1:50PM, provided apple juice, crackers and ice pack. 1:50PM patient left with his wife, said that a friend drove them to appointment so they would not be driving. 6/30/2021 2:00PM- call to patient for follow-up, he is feeling much better today, has slight headache and body aches but no other complaints.
The first 2-3 days and had maybe one or two clots; My periods have been extremely heavy and extremely clotty; My periods have been extremely heavy and extremely clotty; Im also experiencing more cramping.; This is a spontaneous report from a non-contactable consumer (patient). A 38-years-old non-pregnant female patient (not pregnant at time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 22Apr2021 (at the age of 38-years-old) as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other medications within 2 weeks of vaccination. 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 the vaccination, the patient hadn't been tested for COVID-19. On 28Apr2021, after first dose her periods had been extremely heavy and extremely clotty. She was on her 3rd cycle at the time of reporting and no improvements. She was also experiencing more cramping. She had to change a super-sized tampon every 2 hours for the first 2-3 days of period. Her period was never like this before. Prior to being vaccinated she did change a super tampon every 6-8 hours for the first 2-3 days and had maybe one or two clots. The patient did not receive any treatments for the events. Reporter considered events as non-serious. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
fever-APAP, crying, irritable; didn't sleep all noc; afternoon of day immun given pt taken to MD for cold-was told to take pt to ER; called MD-Dimetapp; eyes were also swollen; cried Friday noc but not as bad;
second dose had not been given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (1st dose received on 5th January 2021, lot number:2A3Z9, expiry date: 14th October 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The reporter called for recommendations regarding the next dose of Shingirx for a patient. Till the time of reporting, the patient did not receive second dose of vaccine, which led to incomplete course of vaccination.  The reporter consented to follow up by email.
pt recv vax 21APR99 & c/o swollen rt arm that is painful to touch;pt states that sx began approx 4hr p/vax;upon exam of rt arm, noticed presentation of redness around site approx 4in long x 2 1/2in wide;area warm to touch w/sl pain
Redness/pain/hard swelling at injection site from 22 hours post to present with gradual lessening on symptoms. Low grade fever/chills from 22 hours post to 28 hours post. Thoracic muscle spasms at 48 hours post. Lumbar muscle spasms from 72 hours to 100 hours post.
Rubella vax recvd 20MAY; approx 15 days later pt began to exp diffuse arthralgias, burning, pains in arms & hands, & paresthesias in hands;
This spontaneous report was received from a pharmacist concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 24-APR-2017, the patient was vaccinated with ZOSTAVAX 19400 pfu, subcutaneosly, lot number M037013, expiration date 22-NOV-2017 (dose and anatomical location were not reported) for prophylaxis, and with PNEUMOVAX 23 lot number M032635, expiration date 05-MAY-2018 (dose, route and anatomical location were not reported) for prophylaxis. The patient's concomitant medication included sterile diluent (STERILE DILUENT), lot number reported as M013218 and expiration date 08-NOV-2018. No adverse effects were reported. Additional information has been requested.
pt adm to hosp for dehydration p/fever, cough & vomiting for 4 days; MD exam revealed t40C,resp rate 28/min, orthostatic hypotens, enlarged uterus; devel bilateral conjunctivitis, patchy erythematous, nonpruritic rash, exudative pharyngitis
Painful arm, very sore muscle pain in arm with injection, swollen, pinkish and red. Tired and fatigued. Pulsating Headache that extended in to right shoulder, ringing ear. One instance of diarrhea. Diarrhea Self resolved He was told to apply ice to swollen, red arm. Recommened to take TYLENOL or Ibuprofen. When he called back his headache was improving and was starting to feel better. He was also told to check with his primary care prescriber in 1-2 days if symptoms still persisted.
I started with chills the night of 11/05.  By the time I went to bed, I was nauseated and achy.  I was chilling so badly that I couldn't stop shaking.  My arm where the injections were given was sore down to my elbow and sore under my arm.  It was so sore that between my other symptoms I was unable to sleep that night.  The next morning the symptoms continued and my fever broke.  My skin had red bloches all over.  I continued to take Ibuprofen and got enough relief to go to work the next day.  The same symptoms contined until 11/7.  My arm was no longer tender after 11/8.
pt recv vax 17DEC97 & 21DEC97 pt devel a mild rash w/less than five, dried (no fluid), small lesion on the rt antecubital area, rt upper arm & two on lt wrist;
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a adult 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 feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable. The reporter stated that her sister in law told her that a lot of people had a lot of reactions. The lot of people were not feeling well. The reporter provided this information regarding that statement. The reporter had denied permission to contact their physician. This case was linked with case US2018162463, reported by the same reporter.
No adverse event; Vaccine coordinator is reporting the administration of improperly stored vaccines to unknown patients after the temperature excursion on 20JAN202; This spontaneous report was received from an office manager referring to a patient of unspecified age and gender. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 20-JAN-2022, temperature excursion occurred. The vaccine varicella virus vaccine live (Oka/Merck) (VARIVAX) exposed at a temperature of -14 degrees Celsius for 7 hours. On an unspecified date in 2022 (reported as after temperature excursion), the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, dose reported as 1 (units not reported) (strength, frequency, and route of administration were not provided); which lot # U020244 has been verified to be a valid lot number with expiration date: 28-JUN-2023, administered as prophylaxis (product storage error). It was unknown whether there was previous temperature excursion. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA005084:02167789 US-009507513-2205USA004997:02167739 US-009507513-2205USA005067:02167784 US-009507513-2205USA005023:02167763 US-009507513-2205USA004990:02167746 US-009507513-2205USA005071:02167774 US-009507513-2205USA005002:02167802 US-009507513-2205USA005130:02167643 US-009507513-2205USA005126:02167756 US-009507513-2205USA005002:02167797 US-009507513-2205USA005023:
Received second dose 2/4/21 0830 hours. Left arm. At around 1300 hours in same day, developed fatigue and headache. Those persisted into evening where chills developed and headache worsened.  2/5/21 woke up to very sore arm. Tender to touch. Fatigue and nausea and headache persisted through day. End of day, more chills developed and into the night.  2/6/21: headache lingered in day. Developed itchy and painful warm to the touch/firm rash around injection site.
12/22/08 called to report rash on Abdomen , shoulders, c/o itching, pustule on shoulder. Fever 100 degrees to 101 degrees.
Itching at different parts of the body , started at the back of right hand, then at left side on the back, back of left leg, left upper arm with rashes, then rashes started to appear at back  of left leg as well.  By the time I got to be seen by the nurse practitioner, redness was observed by the nurse spreading from the back of right hand to right arm. Blood pressure was 126/86 which is high for me. After 15 min of being given Benadryl, itching stopped. BP rechecked, 107/73 and I was sent home.
This spontaneous report as received from a physician refers to a 62 years old female patient with no drug reactions or allergies. The patient's medical history included shingles. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) in August 2012. No other co-suspects were reported. There were no concomitant medications. The physician reported that three weeks ago (approximately on 26-OCT-2012) the patient developed painful shingles on the same spot on right buttock after receiving ZOSTAVAX. The patient saw the physician and acyclovir was given as treatment. No lab diagnostic tests were performed. The outcome of painful shingles on the same spot on right buttock was unknown. The relatedness for the reported event was not provided for ZOSTAVAX. Additional information has been requested.
Information has been received from a consumer concerning her 21 year old son, with a history of acne and no known allergies, who on either 05/11/2001 or 05/18/2001 and either 06/11/2001 or 06/18/2001 was vaccinated with the first and second doses of hep b vaccine recombinant, respectively. Concomitant therapy included minocycline. Following the second dose, the pt went home and lifted weights for 45 mins. The next day, he developed forearm, hand, and shoulder swelling, "three times the normal size." It was reported tat the arm returned to normal within 5-7 days. The pt did not seek medical attention. Additional info has been requested.
Well child received immunization 5/11/01. On 5/13 temp of 101. On 5/14 had febrile seizure with T 105 in ER. WBC 8.3, cultures neg. No sigh of infection. Erupted 1 tooth on 5/16/01.
A man called and identified himself as the father on 5/23/23 and stated that had to take the child to the ER for vomiting / diarrhea and decreased PO intake.  Was concerned that the immunizations may of caused the s/s.  He was a poor historian on the phone, was unsure of the discharge instructions from the ED, states had no MD to take the child to.  Reviewed needed to take the child to the nearest pediatric clinic for follow up after ED visit.  Obtained ED visit, Medical decision making:  Vital signs were reviewed and were acceptable.  Patient was seen in ED, had taken a few sips of Pedialtye while in the ED.  Child was treated for for an ear infection and given an IM injection of IM antibiotic per family request.  Was given Rocephin and was recommended to follow up with pediatritrician.  The child was suspected to have adenoviral gastroenteritis and told to follow up in ED for significant worsening of symptoms.  Patient was discharged home in good stable condition.  Sent home with amoxicillin, Q 12 hrs.
administration of three months expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA648A, expiry date 31st March 2022) for prophylaxis.   On 20th June 2022, the patient received Menveo. On 20th June 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 23-June-2022 Reporter's comment: A nurse reported a maladministration of Menveo as a patient received a three months expired dose of Menveo. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Menveo, which led to expired vaccine used.
pt recvd flu vax 26OCT93 & 27OCT93 c/o throat felt scratchy; pt devel a sinus infection, a burning feeling in lungs & throbbing pain in the arm that inject was given; arm throbbed 4 days p/vax; pt took advil but discont when stomach pain
Pt called to report rash on arms and legs on day 3 after receiving the vaccine.
This spontaneous report was received from a consumer referring to her mother, a 70 year old female patient The patient had no pertinent medical history, drug reactions/allergies or concomitant medication. On 07-OCT-2017 the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (route, strength, dose schedule and lot number were not reported). In October 2017, shortly after receiving PNEUMOVAX 23 the patient experienced local injection site reaction and a red flat rash around her arm and elbow. The patient reported the incident to her physician but no treatment was given for the adverse events. No studies or laboratory tests were performed. The reporter stated that the reaction subsided after a few days (October 2017). Causality assessment was not provided.
2 days of body aches and pain. Pt advised to follow-up with outside PCP.
Hives; Rash; Itching; Allergic reaction; I received the 3rd shot for the Pfizer, the booster; I received the 3rd shot for the Pfizer, the booster; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported, Expiration date: unknown), via an unspecified route of administration on 16Sep2021 as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Lot number and expiration date not reported) as dose 1, single and second dose of bnt162b2 (Lot number and expiration date not reported) as dose 2, single, both via an unspecified route of administration on an unknown date for COVID-19 immunization. On 05Oct2021, the patient got an allergic reaction, a rash, hives, and itching. Patient wanted to know if that was possible that after three weeks, he gets a reaction. The outcome of events was unknown.  QR comment: Reporter type was not available over the call, hence reporter type was captured as consumer or non-healthcare professional by default.  No follow-up attempts are possible. No further information is expected.
Since having the vaccine though, the patient is reporting that she sleeps all through the day, wakes up and then goes back to sleep; This is a spontaneous report from a contactable consumer (patient herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of ad-ministration on an unspecified date in 2021 as dose 1, single for covid-19 immunisation. Patient medical history included insomnia from an unspecified date and unknown if ongoing. Concomitant medications were not reported. Caller reported after having the Pfizer COVID-19 Vaccine she was having a harder time with her sleep schedule. She stated she previously, after the first dose had insomnia on an unspecified date in 2021 and took sleeping medications. The outcome of the events was not recovered.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
pt states exp arrhythmia @ home;it was not intense but lengthy (45-50 min);pt also stated arm was sore x 3 days;felt like a golf ball was in arm;tx pt prayed;
20OCT94 father woke up @ 830AM & found deceased; immed prior to event, pt had no apparent signs of sx;
I couldn?t talk or walk, and the left side of my face was so swollen that I was unrecognizable.  I was very weak and felt like I was dying. Healthcare facility admitted me and gave me Benadryl.  Hospital had to place a Cather inside of me because I couldn?t go to the restroom. This happen after the second  Merderma shot. Hi
Patient started getting chills that evening, fever spiked 10/6/23 7pm 102.9, red swollen bump on left arm about 2.5inches to 4 inches and there are 4 red splotches under bigger swollen bump
her husband and she had COVID in June; her husband and she had COVID in June; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "her husband and she had COVID in June".  The reporter stated that she and her husband received the first 2 doses and 1 booster dose last February. The reporter wanted to know if they should receive a fourth and fifth dose of this vaccine. The reporter mentioned that her husband and she had COVID in Jun2022. She declined to be transferred.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201324375 same reporter/product/AE, different patient;
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-JUN-2017, the patient was inadvertently vaccinated with an expired dose of VAQTA injection, lot # L002717, expiration date: 02-JUN-2017 (strength, dose and route of administration were not provided). There were no adverse effects reported. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Allergy".The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rash on his head; This spontaneous report was received from an unspecified reporter and refers to a 4 month old male patient. . No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (strength, dose, frequency, lot # and expiration date were not reported) for prophylaxis.  On an unknown date the patient experienced presented with a rash on his head but it did go away.      Causality was not provided.
Started about 5 a.m. this morning.  My left upper arm is very swollen at the injection site.  No redness.  Very sore.  I am tired and achy.  I had a stuffy nose at around 5 a.m. today that appears to be getting better.  I feel lethargic and unwell.
Patient received first COVID vaccine on 2/6/2021 and second vaccine on 3/6/2021. Patient presented to Hospital on 4/09/2021 for persistent nausea and vomiting, diarrhea, hematuria and jaundice. Patient reported a 1 month history of intermittent nausea and vomiting, generalized abdominal pain, feeling dizzy and weak, poor appetite. Patient had a colonoscopy ~2 weeks prior admission to hospital for cancer screening purposes which was unremarkable and labs done by his primary care at that time were all normal (per admitting physician's note). At hospital, patient was found to have evidence of hemolytic anemia thought to be autoimmune in nature with a positive direct antiglobulin. Patient was subsequently transferred to hospital on 4/11/2021 for further workup. Patient is still currently admitted to hospital. Oncology was consulted for workup of pancytopenia and suspected warm autoimmune hemolytic anemia. Throughout admission, the patient's platelets have ranged between 59-154 k/µL and hemoglobin has ranged 4.5-8.6 g/dL with no documented history of thrombocytopenia or anemia. Patient received methylprednisolone 125 mg x9 doses, prednisone 80 mg daily (1 mg/kg) x5 doses, prednisone 60 mg x1 dose, rituximab 740 mg (375 mg/m2)  x3 doses, and immune globulin 40 g x3 doses. Patient has also received 4 units of packed red blood cells. Given the timing of anemia and thrombocytopenia and unknown etiology, immune response to his COVID vaccine is on the differential.
Had intense headache for 72 hours straight where I could not withstand any light - the best way I could describe it is my migraine had a migraine. Would get dizzy when I stood up. Nauseous and extreme fatigue for 3 days. Slept for 16 hours within 24 hours of receiving the vaccine, day 2 slept for 12 hours but then was up due to vomiting/diarrhea (for 6 hours) about 56 hours after injection and then slept another 12 hours on day 3 after injection. Had a slight sore throat as well. By day 4 all symptoms had resolved.
CONTINUED PAIN LIFTING UP LEFT ARM ABOVE SHOULDER HEIGHT SINCE OCTOBER 2022.
pt recv vax 30OCT95 & 1NOV95 devel an inj site rxn characterized by a papular,erythematous rash