chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of systemic lupus erythematosus in a 55-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included systemic lupus erythematosus. In July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 21st September 2018, less than a week after receiving SHINGRIX, the patient experienced cold. On an unknown date, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant), muscle pain, sleepiness, joint pain, bone pain and arthritis. The patient was treated with Aspirin. On an unknown date, the outcome of the systemic lupus erythematosus, muscle pain, sleepiness, joint pain, bone pain and arthritis were recovered/resolved and the outcome of the cold was unknown. It was unknown if the reporter considered the systemic lupus erythematosus, muscle pain, cold, sleepiness, joint pain, bone pain and arthritis to be related to SHINGRIX. Additional information was reported as follows: The patient experienced muscle aches, sore bones, sore joints and slept for a period of 2 days after vaccination with the first dose of SHINGRIX. The patient stated that the pain experienced by her was so bad that taking Aspirin did not help. The pain experienced by the patient was similar to when she had lupus flare up, which typically manifested as arthritis like pain. The events resolved 2 days post vaccination with SHINGRIX.
He starts to get sick in the middle afternoon; Migraine; chills and fever on and off has happened 4 times in total by 7 pm he has fever 101 fever all night; 3 pm starts chills by 5 pm  he has chills; headache this morning; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (He starts to get sick in the middle afternoon), MIGRAINE (Migraine), PYREXIA (chills and fever on and off has happened 4 times in total by 7 pm he has fever 101 fever all night), CHILLS (3 pm starts chills by 5 pm  he has chills) and HEADACHE (headache this morning) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A, 041LC0A and 045C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included Adverse event with Flu shot.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-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 ILLNESS (He starts to get sick in the middle afternoon), MIGRAINE (Migraine), PYREXIA (chills and fever on and off has happened 4 times in total by 7 pm he has fever 101 fever all night), CHILLS (3 pm starts chills by 5 pm  he has chills) and HEADACHE (headache this morning). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] (oral) for Migraine, at an unspecified dose and frequency. At the time of the report, ILLNESS (He starts to get sick in the middle afternoon), MIGRAINE (Migraine), PYREXIA (chills and fever on and off has happened 4 times in total by 7 pm he has fever 101 fever all night), CHILLS (3 pm starts chills by 5 pm  he has chills) and HEADACHE (headache this morning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101 fever.         No concomitant medications were reported. Patient had no actual side effects from the vaccines themselves and reported he took lots of medications daily but unspecified and stated he took the 3rd dose and he mentioned he wasn't supposed to.
Pt called office stating she received an H1N1 shot she thinks the last week of December. She does not know which clinic. We have records seasonal flu on 9/23/09 but not H1N1. She received shot at a clinic and her arm from the elbow down to fingers swollen and red. There is a small red spot @ the site but no other reaction @the site. She has not been to a doctor yet.
Pfizer-BioNTech COVID-19 vaccine EUA  - Client reports "after 45 minutes post injection, started having mild itching in my trunk, arms and left Hand. itching increased so took Benadryl 50 mg PO, stayed for 15 minutes then left work to go home. Once home itching increased, eyes started swelling and started losing my voice. Husband took me to the ER at Hospital, arrived approx. 6.10 pm. Treated with Benadryl, Solu medrol and Pepcid, all thru IV. Condition improved and client sent home with script for Pepcid, Medrol dose pack and Atarax.
dizziness , Fainting, loss of consciousness , shaking ,chills,  may be seizure
On July the 14 I had an elevated temperature , headache , running nose and coughing  after I also started to have diarrhea. I took acetaminophen to help with the symptoms. I took a home COVID-19 test and it was positive, I then called my doctor  and he prescribed me molnupiravir  . Everyday I started to feel better, I can say I feel 85% better .
Left ear sounds muffled/ right ear has definite less hearing than left; Right ear mild ringing; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old, male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 23Apr2021 at 14:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to avocados. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 16:00, the patient experienced right ear mild ringing after 2 hours of injection. On 24Apr2021, the left ear sounded muffled like he had water in there. This started when he woke up the morning. The patient tried to get his ear to pop by driving up a high mountain and coming down (12,000 feet elevation) however he could feel it trying to pop but did not. The right ear had definite less hearing than left and was extremely noticeable. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of right ear mild ringing and left ear sounds muffled, right ear has definite less hearing than left was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
The vaccine was administered, and the client left the room with his dad. At approximately 1650 the Lead RN was walked past and noticed client was pale, lethargic, and diaphoretic in the father?s arms. RN had Parent place child on the floor and put his feet up on the chair. The RN started talking to the patient and sent another staff member to get another RN, ice packs, juice/gummies, and the BP cuff. Client was lethargic but conscious while the nurse was present. Parent stated that he did pass out. He wasn?t worried because this was common in their family (Dad and sister both commonly had moments like this with shots). Ice was placed on the clients neck and under the arms. Unable to get BP. Juice and a high carb snack was administered. Client?s legs were lowered to the floor and the client slowly sat up. RN continued to monitor and assess for signs of syncope. Parents declined any Rescue measures. Client stated an extra 20 minutes after the episode and left without further incident.
Vaccines received 8/22/12 per mother. Called made to advise nurse on 8/23/12 at 7:46 PM with complaint that patient could not keep formula down. Mom states that it was not projectile vomiting. Dr. discontinued ROTATEQ vaccine today. (Contraindicated because of vomiting).
swelling & erythema lt upper arm from shoulder to elbow-both conditions persisted until mid MAY swelling slowly subsiding; (hard knot in arm);
C/O pain at injection site for 3 days, then about 1 month later developed approx. 25 pox that appear to look like chicken pox.
Received vaccination at 12:20pm on 6/8/19, patient experienced arm aching pain around 8pm 6/8/19 in which she stated on 6/9/19 that she took two tablets of Tylenol 500mg then again every 4 hours. Patient called RPh at 10:12am on 6/9/19 once pharmacy opened to report aching pain in arm and minor difficulty swallowing food. She did not have a fever, or rash, or trouble breathing. RPh recommended seeking medical care first. Patient refused stating she rather try a medication to help her first. Therefore, RPh recommended Benadryl and continue every 4 to 6 hours as needed. RPh pager her primary doctor at 10:20pm, however no call back to the pharmacy. RPh checked on patient by calling her at 10:51am 6/9/19, patient stated she was feeling a lot better and reufsed going to the ER and stated she will take her second dose of Benadryl in 4 hours. RPh called patient again at 2:23pm in which pt stated she was able to swallow and eat solid food properly and felt completely better. RPh stated to follow up with her doctor in the morning.
Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023; No adverse event; Moderna COVID-19 Vaccine Bivalent were administered on 24MAR2023 BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine Bivalent were administered on 24MAR2023 BUD), PRODUCT STORAGE ERROR (Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     The patient had no known conditions.     On 24-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 24-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine Bivalent were administered on 24MAR2023 BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine Bivalent were administered on 24MAR2023 BUD), PRODUCT STORAGE ERROR (Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine Bivalent were administered on 24MAR2023 BUD) and PRODUCT STORAGE ERROR (Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023).    Concomitant medications were not reported.  The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  HCP stated 2 doses of Moderna COVID-19 Vaccine Bivalent were administered on 24-Mar-2023 BUD. Vials were moved from freezer to refrigerator fridge since 22-Feb-2023 with a use by 23-Mar-2024. Caller mentioned no AEs were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-717193 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Mar-2023: Live follow up received. Updated reporter details, suspect dosage details, event verbatim and narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717193:Master case
no adverse event; Medical assistant reported a temperature excursion which was administered to the patient; This spontaneous report was received from a medical assistant concerning, a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.     On 03-APR-2021, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) thimerosal-free (RECOMBIVAX HB), 1 dosage form (lot number T033149 which was verified to be a valid lot number, expiration date reported and upon internal validation established as 19-NOV-2022), as prophylaxis (frequency, route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion above 9 degree Celsius (°C) (9.3C) during a time frame of 0 hours 46 minutes and 0 seconds, as recorded by data logger. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033149; expirationdate: 19-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA001384: US-009507513-2104USA001383: US-009507513-2104USA001382: US-009507513-2104USA001375: US-009507513-2104USA001385:
On day 7 post injection have  itchy bump at injection site and swelling mad redness in circle around injection site. No other symptoms or concerns present.
Frozen shoulder in the receptive arm, ROM limited above and below shoulder beginning a few days after vaccine. Now in PT.
7/20/13 headaches, joint pain, bloating, gas, stomach pain. Continues to present.
Arm soreness started 2-3 hours after injection. Intense body aches down spine and legs started 12 hours post-vaccine injection along with fever, chills, and headache. Body aches lasted for 24 hours. Fatigue lasted 3 days and had a strong headache that got worst with change of position 4 days after injection that lasted 18 hours. Returned to normal 5 days post injection.
This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 21-SEP-2015, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX lot # K011804, expiration date: 21-AUG-2016 and lot# L016126, expiration date: 06-MAY-2017 (dose and route were not reported). No adverse effects reported and there was no Product Quality Complaints (PQC) involved. Additional information has been requested.
Information has been received from a health professional concerning a 1 year old female who on 08-Nov-2007 received a dose of PROQUAD (lot #658032/0985U).  It was reported that while receiving the dose of vaccine the child jerked and may have received less than the recommended dose.  Medical attention sought and current patient status was not reported.  Additional information has been requested.
following the vaccination shot on same day 2/6/21 complaints of injection site pain and headache she was found deceased in her residence 2/8/21 8:00 am
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2014, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2014, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Patient waited his recommended 15 minutes after receiving the vaccine. Upon getting out of the chair to exit the building, the patient passed out and fell onto his face. EMT's were immediately called, and pharmacy staff also immediately attended to the patient.
During simultaneous IM injects infant held breath for appr. 6 seconds, got some air & again held breath, another appr. 6 secs turned very dusky, then mild cry & became very pale ashen color;
Pt stated that after receiving his second dose of Pfizer on 04/16/2021, with in a couple of days he started with bad Headache's that lasted about a week.  He started with fatigue that was greater than normal and that has not gone away and he continue with Fatigue and gets tired easily doing everyday tasks.    He  has received three Pfizer monovalent and one Pfizer Bivalent vaccine.     First Dose = 03/26/2021, Second on 04/16/2021, Third 12/10/2021 and Fourth dose on 08/15/2022.  Only the last dose was given at our clinic. First two doses were from the Health Dept and third dose given at a pharmacy.   Report requested by Provider.
Persistent severe left shoulder/upper arm pain.  Has not yet seen physician, but plans to.
The pt developed itching approx 58 hours after TD vaccine along with swelling of tongue, eyes, difficulty breathing, followed by rash over entire body.
t102, anorexia, diaphoresis, vomiting, malaise x 1wk;
I started having palpitations, my heart rate felt like a hiccup with my heart. That was in the beginning of April. It kept happening for like 10 days. I scheduled a visit with a doctor. My visit was on 04/19/2021 and they did blood work, which came back normal. I usually track my water intake and I was not dehydrated. Also, I did not over exercise. The week before the palpitations started, I had a cold.  On 04/22/2021 I stopped having the palpitations.
RA,presumed site of varicella vaccine administration 11/03/2008, shows erythematous  area, sl textured, warm to touch, 60mm high X 50 mm across, noted last evening initially.  Guardian states it was firmer, and more swollen last pm.  Child is afebrile, normal activity level.  Incidental is 15 mm bruise noted in R deltoid area:  dtap and influenza vaccine were administered to RD on same day.
Presented with AMS, vaginal bleeding; + Covid and PNA in ED; hemorrhagic cystitis; no sepsis; CRP 4.77; Ferritin 1255; Tx: zithromax, maxipime, Vit C, Rocephin, Decadron, ; initially on room air, up to 3 LPM NC and then back to room air
patient reported site pain 24 hrs from vaccine administration with some bursa (redness and pain). Told patient to ice and rest the arm and closely monitor within the next week,  if the adverse does not resolve then go seek medical attention immediately.
4 days after vaccine arm left arm became red and difficult to move up the arm. Looked like a cellulitus, although sed rate CBC ok. Placed on Bactrim and NSAID and resolved after a week. Then 6/29/15 had redness again and unable to move arm, xray showed some pseudogout.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age. On an unspecified date the patients were vaccinated with VARIVAX (Merck) which was improperly stored at various temperatures. No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patients had sought medical attention. No adverse reaction reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source.
Pt recvd 3 doses of Hep V vax on 14JUN90, 12JUL90, & 13DEC90 following 3rd dose pt donated blood & the red cross reported that lab eval on 12JUN91 revealed pos anti-HBc; pt remains pos anti-HBs;
C/O sweats, chills, fever T: 100. degrees F, left upper lateral arm (+) edema, erythema, warmth, measured apprx. 15 x 8 cm. Also small central area with blistering/vesicles and scant amt. of clear fluid drainage. Tx with Cephalexin 500mg BID x 10 day, TYLENOL PRN.
has an autoimmune disease/Myasthenia gravis and was given bnt162b2 vaccine; has an autoimmune disease/Myasthenia gravis and was given bnt162b2 vaccine; General feeling of malaise; Prickly feeling through body; General Flu-type feeling; Fever of 101 degrees; This is a spontaneous report from a contactable other healthcare professional (patient). A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9251), via an unspecified route of administration on 20Jan2021 07:00 at 0.3 mL, single on left arm to prevent COVID virus (COVID-19 immunization). Medical history included myasthenia gravis, and an ongoing autoimmune disorder. Patient has no family medical history. There were no concomitant medications. The patient did not receive any other vaccines 4 weeks prior to COVID vaccination. The patient did not receive additional vaccines on the same date as Pfizer suspect. On 20Jan2021, the patient experienced general feeling of malaise, prickly feeling through his body, which lasted a few hours and fever of 101 degrees. On the same day (20Jan2021), patient had general flu-type feeling that lasted the whole day. He was fine the next morning (21Jan2021), when he woke up. The events were considered serious and medically significant by the reporter. The events did not require a visit to a physician or to an emergency room. The patient underwent Gammunoglobulin blood test with unknown results on an unspecified date. The patient recovered from general malaise, prickly feeling through the body, general flu-type feeling, and fever of 101 degrees on 21Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation.  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 RAs, Ethics Committees, and Investigators, as appropriate.