chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax; pt cried inconsolably for 3-4 hr starting several hr p/ vax;
3 days after second vaccine started with headaches which got worse on day 5 after vaccine; I went to ER for migraine and high blood pressure of 163/113; I went to ER for migraine and high blood pressure of 163/113; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318) via unknown route of administration on 27Jan2021 14:00 at right arm as a single dose for Covid-19 immunization. The patients medical history included Gastrooesophageal reflux disease (GERD), irritable bowel syndrome (IBS) and anxiety. No Known allergies were reported. Concomitant medications included famotidine (PEPCID), calcium, multivitamin and Birth control pills. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 on 06Jan2021 14:00 (Lot Number: EL0142) at right arm as a single dose for Covid-19 immunization. It was stated that 3 days after second vaccine started with headaches on 30Jan2021 12:00 PM which got worse on day 5 after vaccine I went to ER for migraine and high blood pressure of 163/113 on an unknown date in 2021. Was given IV meds for migraine and help Bp come down to 144/98 on an unknown date in 2021. The patient had taken covid test post vaccination, test type was reported as Nasal Swab and covid test name post vaccination was reported as Rapid with covid test result as negative on 01Feb2021. The outcome of headache was not recovered and for other events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Arm soreness around injection site that lasted 6 days.  Small, raised, itchy hive at injection site that spread down and across arm to an area about 3" by 8" which lasted 6 days.  Treated with anti-itch lotion and ice pack.
Redness, one large (1/2 inch ball) blister surrounded by small blisters.
9x11cm slightly raised erythematous macule on the upper left arm. Pain to palpation. ALLEGRA and MOTRIN given. BENADRYL 25mg, cool compress.
10/10 8:45 am recieved Twinrix. Several hours after vaccine felt some pain. Hour later pain down arm, in armpit,and going down right side of back. Approximately 2:30 pm went to MC quick care recieved flexaril, prednisone ultram. 10/11/2007 States has quarter size red welt at shoulder site, continues to be swollen and painful States not any better not any worse.
Information has been received from a physician concerning a 6 year old female who on 21-JUL-2008 was vaccinated with GARDASIL vaccine (yeast) 0.5 mL IM. Subsequently the patient inadvertently received GARDASIL vaccine (yeast) instead of hepatitis A vaccine and no symptoms were reported. No other information was available.
Case number PHEH2011US07814 is an initial spontaneous report received from a pharmacist on 24 Oct 2011. This case refers to a 12-year-old male patient. He was vaccinated with MENVEO (batch number: M10129) at a dose of 0.5ml subcutaneously on 24 Oct 2011. No adverse event had occurred following this administration error.
9/25/02 DTaP given. That evening pt awoke screaming and crying and inconsolable for ~ 30 mins. She subsequently had rhythmic movement at her head to one side. No other T-C activity. She was relaxed throughout the episode. Eyes were swollen from crying so parents were unable to comment on eye deviation. Subsequently silent through night, well the next day.
At 10 minutes, tongue irritation. At 25 minutes, hives on palm of hand which resolved after 10 minutes. At 90 minutes, drop in blood pressure, dizziness, weakness, severe stomach cramps, nausea, vomiting, diarrhea, tightness in chest and head. Took Benadryl, Albuterol and Pepcid. One hour later, 103 fever, severe pain in all joints. Stayed on Benadryl for 24 hours. Once Benadryl was stopped, developed hives all over chest, various spots on arms and stomach, continued dizziness, swollen lymph node in arm pit. Eyes were swollen and itchy. and red.  Resumed Benadryl x5 days, every time Benadryl stopped, hives resumed. . Periodic hives still surface as of this date but mostly improved. My MD suggested I report event.
PATIENT LOST CONSCIOUSNESS FOR 10 SECONDS , 10 MINUTES AFTER RECEIVING VACCINATION.  AFTER HE REGAINED CONSCIOUSNESS HE SAID HE HAD NOT EATEN BREAKFAST AND HAD NICOTINE GUM 10 MINUTES BEFORE GETTING THE VACCINE. ALSO HE MENTIONED THAT IT HAD HAPPENED TO HIM BEFORE WHEN HE GOT A VACCINATION. HE FAINTED WHILE THE NEEDLE WAS STILL IN HIS ARM.  HIS BLOOD PRESSURE WAS 142/68. EMT ARRIVED AFTER 5 MINUTES AND TOOK HIM TO THE HOSPITAL
not sure if had COVID right now; not sure if had COVID right now; This is a spontaneous report from a contactable consumer (the patient). A patient of an unspecified gender and age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (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 received the first vaccine, and the second vaccine will be tomorrow. The patient was not sure if he/she had a COVID right now. The patient was not sure and wanted to tell how he/she felt. The patient was not sure if this was COVID and thought maybe not maybe yes. The patient needed to talk to somebody to know about it and about how he/she was feeling. The outcome of the event was unknown.    No follow-up attempts are possible, information about lot number cannot be obtained.
Information has been received from a physician concerning a 77 year old female patient who in February 2007, was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). On 22-NOV-2008 the patient visited the physician with shingles. The physician reported that it started with a pain in her right elbow and then the "blotches" appeared. The physician determined it was shingles. At he time of reporting the patient was not recovered. Additional information has been requested.
3:30pm chills/fever/aches/pain/ringing in ears/headache/shortness of breath.
This spontaneous report was received from a registered nurse referring to a 5 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 20-OCT-2017, the patient was inadvertently vaccinated with PROQUAD rHA lot number N016994 and expiration date of 29-NOV-2018 intramuscularly instead of the intended subcutaneous route for prophylaxis (dose was not reported). No adverse effects reported.
I entered the immunization room and while engaging with small talk with the patient and her spouse, administered a Moderna COVID-19 shot in her left deltoid muscle. I did not verbally confirm with the patient or spouse which vaccine they were to be receiving that day. After I immunized her spouse, they left and I went to complete the back of the VAR by filling in lot number and expiration dates and noticed the pre-printed volume in the immunization information section was 0.7ml, not 0.5ml (which is what Moderna is). I realized at that point I had given the wrong vaccine and checked the VAR -- she was supposed to receive the Fluzone HD for patients 65+ years old. She had already left the store at this point. Multiple hours elapsed between me discovering this and contacting the patient -- I was distraught and did not to end up crying while on the phone while trying to tell her; also I was seeking advice from my pharmacy manager on how to proceed as far as error reporting with company policy as well as how to explain the situation to her. Once I did call her, I got her voicemail and left a message requesting a call back at her earliest convenience so we could discuss her visit to the pharmacy earlier that day. I checked her profile in our software and saw that this was her third dose of Moderna and her most recent dose was back in March. When she called back later in the day we discussed what had happened and she was very understanding and not upset; she said she and her husband had been planning to try to come in for boosters/third doses of Moderna later in the week. We made a plan for them to return later this week for flu shots and to update their vaccine cards with the third Moderna dose. (I am filing a separate VAERS for the patient's spouse, who had the same administration error).
This case was reported by a consumer via call center representative and described the occurrence of hives in a 62-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of urticaria (received on 5th November 2018 and experienced chronic urticarial and itching, refer case US2019049309). On 15th March 2019, the patient received the 2nd dose of SHINGRIX. On 15th March 2019, less than a day after receiving SHINGRIX, the patient experienced hives and pruritus. On 16th March 2019, the patient experienced pain in arm, queasy and pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the hives and pruritus were not recovered/not resolved and the outcome of the pain in arm, queasy and pain were recovered/resolved. It was unknown if the reporter considered the hives, pruritus, pain in arm, queasy and pain to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for himself. The age at vaccination was not reported but it could be 61 years or 62 years. The patient received SHINGRIX in the left arm and he came home by the time his back was lit up like a Christmas tree with hives. The day after the vaccination, the patient had a sore arm, and felt a little queasy and achy, but those symptoms had resolved. In March 2019, the outcome of the pain in arm, queasy and pain were resolved. The patient had problems with hives and itching at the time of reporting. The patient visited the emergency room. The patient provided the consent to follow up.
joint ache; heacache; This is a spontaneous report from a contactable consumer. This 72-year-old consumer reported in response to non-HCP letter sent which included that who received bnt162b2 (BNT162B2) solution for injection dose 1 (Batch/Lot Number: EL3249) via intramuscular route of administration in upper arm on 19Jan2021 05:30 Patient (at the age of 72-year-old) as dose 1 single for covid-19 immunisation. The patient medical history and concomitant medication was not reported. On an unspecified date the patient experienced Minor headache, Joint Ache. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
8 yr old patient received pediarix vaccine, no symptoms reported at time of discharge, did asked pt to follow up  in 2-3 days
dose 1821286 hours later pain in lower back and upper thighs lasted thru the night and into the next day could not sit down or lay down I had to kick legs for some relief. So I could not sleep and had to walk around all night. This pain has dulled and now flares with menstruation. I was working out 6 days a week at the gym with high intensity workouts. Now I have pain in lower back and swelling in my neck. I have passed out once and wake up bent over in pain that dissapates in about 2 hrs each morning. I am concerned that my energy levels are low. I have attended Physical therapy trying to treat the lower back pain. It does not go away fully and comes back each morning.
A lot of pain at injection site.  Redness beside injection site.  Swelling and itching underarm same side as shot.  Itching underarm- head - upper body.  Achy in upper body. Stomach pain. Extreme tiredness.
Headache, stuffy nose, extremely sore throat difficult to swallow, sore arm injection site, nausea Taking Tylenol
Eleven days after booster shot of Moderna, hives and dermatographia began, spreading across both hips, inner thighs, up back onto neck and behind ears. Next day video consult with doctor who prescribes 40mg prednisone for four days. Symptoms begin to improve  on prednisone (2 days at 40mg, 4 days at 20mg), along with Cetrizine 10mg/day and one Benadryl each night. Today, day nine, second day without prednisone, symptoms are greatly improved, though small areas or red itchy skin appear periodically and dermatographia may still occur, depending upon pressure exerted on skin and part of body.
fever; pain and burning at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and VACCINATION SITE PAIN (pain and burning at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A, 004C21A and 031B21A) for COVID-19 vaccination.     The patient had never been tested positive or diagnosed with COVID-19. No other vaccine was given to the patient within 1 month prior to Moderna COVID-19 vaccination.  Concurrent medical conditions included Drug allergy (Sulfa allergy), Arthritis (Arthritis on left wrist) and Raynaud's syndrome.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and VACCINATION SITE PAIN (pain and burning at the injection site). The patient was treated with TRAZODONE at a dose of Only as needed. At the time of the report, PYREXIA (fever) had resolved and VACCINATION SITE PAIN (pain and burning at the injection site) had not resolved.            No concomitant medications were provided by the reporter.  On 22-Nov-2021, the patient received the first booster dose of Moderna vaccine.   This case was linked to MOD-2022-550270, MOD-2022-550322, MOD-2022-550346 (Patient Link).
Anxiety, depression, fatigue, cognitive dysfunction, cold hands, inability to regulate body temp, lightheaded, insomnia, light sensitivity and malar face rash. Initiated restrictive eating disorder.
This case was reported by a other health professional via call center representative and described the occurrence of needle injury in a patient who received RABAVERT (batch number 627011A, expiry date 31st March 2020) and (batch number 564011A, expiry date 31st May 2018). On an unknown date, the patient received RABAVERT. On an unknown date, the dose was an unknown dose. On an unknown date, immediately after receiving RABAVERT, the patient experienced needle injury. On an unknown date, the outcome of the needle injury was unknown. It was unknown if the reporter considered the needle injury to be related to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. Healthcare professional reported that, an employee had a needle stick injury after administering a dose of RABAVERT to the patient. The needle was recapped by the employee. The healthcare professional had limited information. No patient information was available.
Case number PHEH2015US020166, is an initial spontaneous report received from a healthcare professional on 07 Oct 2015. This report refers to an 85 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with expired FLUVIRIN (batch number: 1413901 and expiry date: not reported) at a dose of 0.5 ml intramuscularly on 06 Oct 2015. No adverse event was reported following this administration error.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore arm) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Sore arm). At the time of the report, INJECTION SITE PAIN (Sore arm) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided. Patient has had a sore arm after all the doses of the vaccine.   This case was linked to MOD-2021-393534, MOD-2021-393537 (Patient Link).
Injection given on 1/17/11. Patient called RP on 1/24 said she had developed a rash on 1/23 at the injection site. RP told her to start BENADRYL & call her doctor for documentation.
This spontaneous report was received from an other health professional refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of PEDVAXHIB (dosing regimen unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter considered events to be not related to PEDVAXHIB. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
sore arm; fatigue; This case has been considered invalid as there is no indication that the patient experienced an event.   This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 08Feb2021 08:00 (Lot number: EM9810) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 2015 (unspecified if ongoing); "Lichen sclerosus" (ongoing); "Cholesterol" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "high Blood pressure" (unspecified if ongoing); "Kidney stones" (unspecified if ongoing), notes: Various times; "Vitamin D low" (unspecified if ongoing); "Allergy" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Muscle relaxant" (unspecified if ongoing); "Hair loss" (unspecified if ongoing); "back pain", start date: 06Feb2021 (ongoing); "preseptal cellulitis eyelid", start date: 06Feb2021 (ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol (ongoing); JARDIANCE DUO taken for diabetes mellitus (ongoing); METFORMIN taken for diabetes mellitus, start date: 2020 (ongoing); VALSARTAN + HIDROCLOROTIAZIDA taken for blood pressure measurement (ongoing); UROCIT-K taken for nephrolithiasis (ongoing); VITAMIN D [COLECALCIFEROL] taken for vitamin d decreased (ongoing); ALLEGRA taken for hypersensitivity (ongoing); ARIMIDEX taken for depression (ongoing); CLOBETASOL PROPIONATE taken for lichen sclerosus (ongoing); CEPHALEXIN [CEFALEXIN] taken for periorbital cellulitis, start date: 06Feb2021, stop date: 11Feb2021; MELOXICAM taken for back pain, start date: 11Feb2021 (ongoing); CYCLOBENZAPRINE HCL taken for muscle relaxant therapy (ongoing); LIDOCAINE HCL taken for back pain, start date: 11Feb2021 (ongoing); TYLENOL taken for back pain, start date: 08Feb2021; ANASTROZOLE; CLOBETASOL PROPIONATE; UROCIT K; JARDIANCE; TRADJENTA. Vaccination history included: Bnt162b2 (1st dose Time: 14:00 in the right arm. Lot: EL9261, Anatomical location - Arm right, Time: Afternoon, Route of administration: Intramuscular), administration date: 20Jan2021, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:It was fine. Sore arm both times at a little fatigue.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning an approximately 11-week-old female who on an unspecified date was vaccinated orally with a first 2ml dose of ROTATEQ. After receiving ROTATEQ, the patient developed 2 black, seedy stools. She was seen by the physician. Subsequently, on an unspecified date, the patient recovered. Additional information has been requested.
The patient called his Dr complaining of should pain following the vaccination. Dr advised him to try OTC pain remedies as the pain is expected to resolve within 1 day. The patient stated that the pain did not resolve in one day.
Flu shot received 12/02 fever developed later on 12/02/2005 persisting through 12/05/2005.
Pt noticed a small amount of redness at injection site about 24 hours after administration. Within 48 hours post-injection, redness was about 3" in diameter with sporadic itching.