chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had shingles twice after I received the Shingrix vaccines/ suspected vaccination failure; shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced once before vaccination which was all across the waistband and back and was really bad).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-Jul-2022 Reporter's comment: The patient self-reported this case. The patient received a dose of Shingrix and experienced shingles twice. The patient stated that the 2 bouts that she had after the Shingrix was not as bad as the first time. The second episode was down at crotch and third episode was between butt cheeks which the patient described as really nasty. The patient wondered if there was any study about people who have shingles after the vaccines. The patient was wailing to participate in a study if they were going to study shingles after the vaccine. The consent to follow up was requested. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Night after vaccination I began to experience Illness to include fever, aches and pains on first night. For next five days had significant back pain, as if entire back was in vise to the point it woke me up multiple times each night. Bouts of Dizziness/vertigo were also experienced for two days. Also saw tremors pronounced in left hand that still haven't gone away. Have had tremors in hands since 2010 when the they lost my shot records and vaccinated me twice within a short period of time. Recent vaccinations instigated more pronounced tremors that are slowly beginning to normalize again. I reported this reaction to the PA two days after the vaccination located at clinic.
SARS COVID-19 INFECTION.  COUGH, CONGESTION, RUNNY NOSE, DIARRHEA, HEADACHE, SORE THROAT, FATIGUE, CHILLS, MUSCLE ACHES.
15MAY98 6PM fine pink rash chest;no fever;fussy , restless;16MAY98 8AM red rash chest, legs, arms, face, trunk, restless-dec appetite;16MAY98 12noon to RN allergies rx-gave calamine lotion;16MAY98 12MN rash gone pt sleeps well;
Chills, body shaking feeling very cold in hands, feet and shoulders /neck from 8pm til 11pm and then very warm. Restless due to pain throughout body and poor sleep Vs unable to sleep. Woke at 2:30 am to call into work. Checked temp at 101,6 (temps throughout Covid no higher than 98.5). Very tired and weak throughout 1/5/21 with lying in bed except to use bathroom abs brush teeth at 6pm.
sharp passing pain near my heart; Almost fainted; woozyiness; disorientation; weakness in arm; Pain going across shoulders and across upper back; Pain going across shoulders and across upper back, lasted through part of the night; Fever started after I came home. I usually get fevers when I have an allergic response.; This is a spontaneous report from a contactable consumer (patient). This 50-years-old female (not pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 04May2021 15:00 (Lot Number: EW0172) as single dose for covid-19 immunisation. Medical history included penicillin and latex (allergy). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included echinacea purpurea root, olea europaea leaf, sambucus nigra fruit (ELDERBERRY ECHINACEA & OLIVE LEAF). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8729) administered in left arm on 13Apr2021 02:45 pm (at 50-year-old) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04May2021 at 15:15, patient experienced almost fainted, woozyiness, disorientation and weakness in arm, could feel the loss of control of arm, pain going across shoulders and across upper back, lasted through part of the night. Fever started after patient came home, she usually get fevers when had an allergic response. Patient experienced discomfort as drug initially moved through the body, she had a sharp passing pain near heart, this subsided after a few minutes on 04May2021. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the events. Outcome of the event sharp passing pain near heart was recovered on 04May2021, other events was recovered in May2021.  No follow-up attempts are needed. No further information is expected.
Information was received from a pharmacist regarding a 56 year old male patient with "cholesterol" and a prior history of shingles. On 26-OCT-2013, the patient was vaccinated with ZOSTAVAX lot # J003483 (exp. 29-JUN-2014), subcutaneously in the arm. Concomitant therapies included ZOCOR. On 27-OCT-2013, the patient came back to the pharmacy with a 5mm by 1 inch rash next to the ZOSTAVAX injection site. The outcome of the 5 mm by 1 inch rash next to injection site is unknown. Additional information has been requested.
Tingling in face, then numbness sensation on lips, numbness sensation on tongueminutes after injection. Later sensation of palate and tongue having been burned by hot liquid or hot food. Slightly feeling of swollen throat. Altered sense of taste (example coffee did not taste the same as usual) slight loss of smell Feeling winded when breathing. Pain on let side of neck on Sunday. Still numbness and feeling burnt on Sunday
pt recv vax 1OCT97 & 14OCT97 pt devel a rash & a 2nd rash appeared 30 days post vax;
Frontal of right armpit (same side as vaccine), swelled up ,the size of a baseball.  It was very prominent the first two days, then has slowly decreased in size everyday since then.  The swollen area was very very sore for two days.  Assuming it was the lymph node.  I am sure it will self resolve, but we wanted make sure  you have it noted for your side effects tracking.  Also, as expected, the injection site was sore for a few days.
Myalgia, pain a injection site, chills Narrative: Per nursing report: "took 2nd Moderna vaccine on Monday April 5th. C/o headache, swelling and soreness to left arm at site of injection, chills and flu-like symptoms. States was not able to come to work on Tuesday [4/6] and today [4/7]."
Starting the day after injection, the area was "beet red" for about 2 days. Today there is no redness, but a "lump" and hot to the touch. Will observe for further symptoms or resolution.
A 53 y.o. female with a history of TMJ dysfunction, depression who presented to Observation 11/22/2021 with fatigue, poor PO intake, and HA x 2 days after COVID-19 booster shot and an episode of syncope while sitting. Hospital course complicated by progressive polyarthropathy.   1. Syncope: presented as above, occurred sitting in hair salon but had not yet had hair washed, denied positional changes; preceded by lightheadedness. In setting of fatigue, poor PO intake, and HA since COVID-19 booster shot 11/20/21. Tachycardic, BP soft 100s/50s. Baseline labs and troponin wnl. Low suspicion for cardiac etiology, CSRS 0 (low risk). Likely related to dehydration/hypotension. Resolved with IVF, supportive care. 2. Polyarthropathy: Bilateral hands, wrists, with edema and warmth. Also pruritis and rash. Received COVID vaccine 11/20/21, concern for inflammatory reaction. D-dimer 11, ESR 20, CRP 54. ANA, RF, ds-DNA, antiphospholipid pending at discharge. Discussed with ID, inflammatory arthropathic has been reported, reported to VAERS. Trial NSAIDs and steroid burst with expectant resolution. F/u with PCP, consider Rheumatology referral if symptoms fail to improve. 3. Depression: per hx, mood stable on exam. Continued home Prozac.  Medications started: hydroxyzine, naproxen, prednisone  follow up phone call on 11/26/21:Call to patient, she states she is still itchy in some places, but overall doing well.  States has some SOB when lying down.  Encouraged her to call PCP if worsens or does not improve.  Reviewed including meds and f/u appts.  No questions or concerns.   follow up with pcp scheduled on 12/01/21
Numbness of fingers, ER on 12/16/09, - stroke, numbness "wooden feeling of legs" fell and could not get up. Admitted 12/21/09 for 9 days ICU.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jul2021 as dose 1, single (Lot number: EW0191), in left arm and on 20Aug2021 as dose 2, single (Lot number: EW0186) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Kidney transplant patient" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Gentamycin, reaction(s): "Known allergies: Gentamycin"; Cefazolin, reaction(s): "Known allergies: Cefazolin".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result, notes: Product: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid started on 20Jul2022 and stop date 24Jul2022.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Cough, SOB starting on 1/9. Loss of taste and smell starting 1/10 and still hasn?t returned. Dizziness and fatigue on 1/10 as well
Information has been received from a registered nurse concerning a 15 month old female patient with no pertinent medical history or illness at the time of vaccination, who on 03-SEP-2009 was vaccinated in the left thigh with the first dose of VARIVAX (lot # 664905/0865Y). The same day the patient was vaccinated in the right thigh with the first dose of MMR II (lot number 664607/0609Y) (MSD) (WAES0910USA00806). The nurse reported that the patient developed a wheal at the injection site immediately after administration of VARIVAX. The patient was treated with BENADRYL. After 15 minutes the wheal was gone but the area was still red. The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. Follow up information has been received from the registered nurse who reported that on 03-SEP-2009 (same day of VARIVAX) the male patient (previously reported as female) was vaccinated in the left thigh with the third dose of influenza virus vaccine (unspecified) (lot number UT31736A). The reporter stated that immediately post-vaccination, the patient developed a wheal at the injection sites from VARIVAX and MMR II and that patient recovered the same day with BENADRYL. The patient had no other symptoms. This is one of several reports received from the same source. No further information is available.
Patient fainted 10 minutes after getting the vaccine, he felt light headed and had seizure like symptoms, and his body was rigid and shaking . He wasn't able to breathe, patient was put on his back and CPR was performed for 20 seconds, and 911 was called. Patient was able to breathe again and felt okay. Patient stated that he didn't eat or drink anything prior, he was given a sports drink and sat back in a chair for 20 minutes after. EMTs showed up and took his vital signs, patient refused to go to the hospital.
No adverse event; 5 doses administered after expiration date. Doses administered today. Bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.   It was reported that error had not been discussed with patients.  Treatment information was not provided.  This case contains information about patient 5th out of 5 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729599 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729599:Master case
My Limbs and hands/feet are weak and throbbing on and off. My limbs/hands/feet tire very quickly.
She got the vaccine, did had a little sore arm, but nothing else.  She went to bed and when she woke up that her eye was watering and bump like under it, and when she wiped her eye she noticed it.  It is still there, and it's only at the corner of the right eye.  Every once in a while it starts to water and drain.  She has to be careful to wipe he eye as when she touched it it hurts.  She does not think that it's the eye, and has never had watery eyes.  No other reactions other than the eye and the soreness of the arm.  She has not taken anything or put anything in her eye.
Patient was administered with vaccine that had undergone temperature excursion issue; No symptoms were reported after administration of vaccine; Patient was administered with vaccine that had undergone temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion issue), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion issue) and NO ADVERSE EVENT (No symptoms were reported after administration of vaccine) in an 8-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion issue). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion issue) and NO ADVERSE EVENT (No symptoms were reported after administration of vaccine). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion issue), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion issue) and NO ADVERSE EVENT (No symptoms were reported after administration of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No symptoms were reported after administration of vaccine) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion issue).    Patient age was reported as 8 years 3 months.  No concomitant medications were reported.  It was reported that excursion happened on 18-Jul-2022 for two and half hours and the, maximum temperature reached was 8.76 degree celsius and minimum temperature reached was -4.5 degree celsius. The vials were still frozen after excursion.  It was determined even though there was a temperature excursion one time that the vaccines was still viable and can be used until the end of the expiration day on 17-Aug-2022.  No treatment medications were reported.
Projectile vomiting, diarrhea and flu like symptoms.  Less than 2 months after taking the vaccine she was admitted to the hospital for heart problems. She has heart failure. All this came after taking the 2nd vaccine.
Pt developed small umbilicated papules on both thighs, 1 day after vaccine administration - no pain - pt eating & drinking well.
Patient has had 3 menstral cycles in 1 month following the covid vaccine. She has been regular up to the point of vaccination. This should be noted;
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Feb-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Raised, redness, warm to touch 2-50 cent pieces.Treatment-water and check at clinic. ER if worse.
Patient received vaccine on 9/24 and woke up on 9/25 with severe rash. Rash has persisted over the last 10 days. Will resolve for a few hours with Benadryl and cold compress but then reappears. Has presented on wrist, back, neck, inside of thighs. Does not report any difficulty breathing or swelling of tongue. Pharmacist encouraged patient to follow-up with PCP and report back to pharmacy. Pharmacist reported reaction to vaccine as soon as she was notified on 10/4/21.
Felt normal for the rest of the day after the shot. Woke up profusely sweating at 3 am the following morning. Chills, body aches, and moderate headache all day on the 11th of January. This morning, on the 12th... Headache worsened considerably... With nausea and light and noise sensitivity and added upper neck pain.
Vaccine expired 10/13/2021, vaccine given 10/14/2021.
No additional adverse effect reported; on 3/5/2020 patient received a dose of improperly stored ROTATEQ; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 05-MAR-2020, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660942, expiration date 06-FEB-2021 (exact dose and route of administration were not reported) for prophylaxis. No additional adverse effect reported. No product quality complaint. The vaccine experienced multiple temperature excursions below 2 degrees Celsius (1.28C) for 2 hours and 30 hours. There was no previous temperature excursion. There was data logger involved.
Severe aches, fever, chills, joint & muscle pain, headache started coming on about 8 hours after 2nd vaccine & got worse through the night. Couldn?t sleep, left arm & left side of neck were sore & hurting in the beginning, then spread to my entire body. (1st vaccine 3 weeks before, no problems except my left arm was sore for a day.) Took ibuprofen & alprazolam before getting in bed & it seemed to help for a short time. My nerves felt like they were on top of my skin. Didn?t sleep much at all, maybe couple hours. Now, 3pm the next day, I?m still very sore, tender all over my body.
On 07/20/2000 the patient was exposed to a child who had developed typical chickenpox spots following vaccination with varicella virus vaccine live. On 07/26/2000 the patient had a secondary transmission and developed chickenpox which was described as a rash and 10-12 little pox spots on his head, forehead, face, neck, ears and trunk in different stages and had a low grade fever, 99.8F. The patient ran a fever for a week. On 08/02/2000 the patient was seen in the physician's office and it was noted the rash was resolved but the fever returned with irritability and poor intake. On 08/02/2000 the patient was noted to be teething. On 08/05/2000 the patient developed some drainage from the eyes, a low grade fever and an upper respiratory infection. The patient was treated with a topical decongestant. On 08/17/2000 the patient's temperature was 101.7F. On 08/18/2001 the patient had a cold, cough, nasal congestion, profuse purulent nasal discharge, a poor appetite and a fever of 99.2F. The physician diagnosed a fairly severe upper respiratory infection with a history of otitis media. The patient was treated with Amoxil, Tylenol and fluids. It was noted that during the time the patient had his spots he was around an adult white male who was diagnosed the second week of September, 2000 with shingles. No further information is available. Per F/U 6/17/02; on 8/2/00, the pt was vaccinated with a 2nd dose of Hib (lot 601063A) in the right thigh, a 2nd dose of Triedia (lot U00566A) in the left thigh, the 2nd dose of Engerix-B (lot 3300B2) in the right thigh and the 2nd dose of IPOL (lot P1232) in the left thigh. On 8/28/00, the pt had nasal congestion. The physician's impression was that the pt had bilateral otitis media, upper respiratory infection and reflux. The pt received treatment with Augmentin, Rondec drops, Tylenol as needed and saline nose drops. The pt stopped taking Rondec drops and started taking Otrivin pediatric nose drops, Zantac and Reglan. It was noted that in 8/00, the pt recovered. On 9/7/00, the pt's resipratory illness was much improved but continued to spit up after feeding. On 9/8/00, the pt was noted to have congestion, spitting up, not drinking well, refusing to drink his bottle and low-grade fever. It was noted that his congestion was doing much better. The physician's impression was that the pt had GERD and resolved otitis. The pt continued on Reglan and Zantac with a pediatric Gastroenterology referral considered if symptoms do not improve. No further info is available.