chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a adult female patient who received FLUARIX (batch number D3AF5, expiry date 9th June 2016). On 21st September 2015, the patient received FLUARIX .5 ml. On an unknown date, less than a week after receiving FLUARIX, the patient experienced injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever to be related to FLUARIX. Additional details were received as follows: Patient's age range went from around 25-55 years of age. In September 2015, less than a week after receiving FLUARIX, the patient experienced injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever. On 25th September 2015, the patient adverse events were noted. The date of birth and information on adverse events experienced by individual patients were unknown. Reporter just explained that the most common adverse event experienced was induration at the injection site. Also the patient experienced redness, swelling and tenderness at the injection site. Less commonly reported event was itching throughout the body. The least common reported event was fever. This case was one of the 9 cases reported by same reporter.
painful chills; fever (101.7 f); body aches; headache; some tenderness at injection site; This is a spontaneous report from a non-contactable nurse.  A 45-year-old female patient received BNT162B2 vaccine (Lot number EK5730) intramuscular in the left arm on 16Dec2020 at 18:30 at single dose for immunisation. Relevant medical history included high blood pressure and seasonal allergy. Concomitant medications included lisinopril and over the counter allergy pill. On 17Dec2020 at 10:00, the patient experienced painful chills, fever (101.7 F), body aches, headache and some tenderness at injection site. Corrective treatments taken as a result of the events included paracetamol (TYLENOL). The patient was not pregnant. Facility type vaccine: Hospital. The patient did not receive other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination, and she was not tested post vaccination. At the time of the report, the patient had not recovered from the events.
Pain in left arm at surrounding area, shot given. ADE reported 10/18/10, pain when lifting arm (has decreased over time but still painful).
Patient is reporting pain in shoulder and elbow. Reports pain when lifting arm and tenderness at elbow. No numbness reported. No diagnosis from doctor, patient has made an appointment to follow up with primary care physican.
Weakness, dry mouth, chills, body aches, achy headache, fatigue, dizziness with position changes started about 17 hours ago.
Received lower than recommended dose of moderna bivalent vaccine. Patient should have received 25 mcg, but instead received 10 mcg.
02/18/2021 10:20:50 MST Subject: Covid vaccine side effect   Pt is receiving her initial vaccine today.   Pt stated she had felt a warm flush and developed elevated heart rate at  141 bpm per her watch. She denied chest pain, shortness of breath or other concerns at that time.  Lung sounds clear and heart rate elevated at 110 bpm per auscultation. Pulse ox shows HR at 102 with o2 saturation of 98% room air.  Pt instructed to wait additional 15 (total 30min) for monitoring purposes. February 18, 2021 10:38 MST (Verified)  Updated HR 103 and O2 saturation 98%. Pt states she felt better but was concerned about continued elevated HR. SHe continued to deny chest pain, shortness of breath or light headedness. Provided ER precautions to Pt and recommend she contact her PCP with further questions or go to the ER if symptoms worsen.
Chills, fatigue, headache March 14, 2021- March  16, 2021
I started out feeling like I was getting a cold with coughing, sore throat, and achy on 11/24/2022 evening.  By Friday morning I felt achy and tired.  I took a home test that Friday and it was positive.  Saturday morning I went to the walk in clinic and they confirmed I was positive and prescribed Paxlovid.  I never got really really sick just the diabetic side my numbers were very high.  My numbers were in the 300's.  That was the worse part for me.  I continued to test positive until the 15th day when I tested negative.
Vaccine administered was 2 days outside of the 31 day approved window after vaccine is thawed. Patient was informed and able to decide to receive booster again but patient declined.
After my second dose on 1-30-21 Vaccine lot# 030l20A I experienced normal side effects 10 hours after which including, low grade fever, chills, body pains, and headache lasting 12 hours. Residual headache lasted 3 days after the vaccine. Around the 6th day I started to feel pressure in my inner ear making noises and even my own speech sounding muffled. I still currently have ear pain and now added dizziness which started on 2/23/21. Seen by a Dr. on 2/16/21 stated my lymph nodes are swollen which is causing the pressure and fluid build up in my ears. Seen again  on 2/23/21 in office due to symptoms getting worse even with an antibiotic and steriod prescribed the week before. On 2/23/21 symptoms worsened including  added dizziness, stated my lymph nodes are still swollen and increased amount of fluid in both ears.
Pt. states that after receiving the 2nd dose of Moderna 08/06/2021, started experiencing symptoms that evening of face swelling, severe headache, weakness, and rash throughout the body. Swelling subsided within 24hrs, and vertigo set in. Still continuing to experience headaches. No primary visit noted.
2 hours post-injection, I experienced an episode of nearly fainting (all over body heat, sweat, hearing and vision lessening). I made sure my feet were planted and put my head down between my knees. After 10-15 minutes, I started to return to normal. I never fully fainted. I was sitting at home on the couch.
Swelling and numbness around right eye and cheek; hives. Lasted for about 2 hours maximum. Took Claritin and showered.
chills and fever after the second dose; chills and fever after the second dose; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 30  year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 07Apr2021 15:18(Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient also has Downs syndrome being treated with Besponsa for leukemia and bridging until patient can have CAR T-cell therapy. Patient has low blood cell counts, low neutrophils, but no signs of infection. The patient previously took bnt162b2 for covid-19 immunisation. The patient experienced chills and fever after the second dose on an unspecified date with outcome of unknown.  No follow-up attempts are needed. No further information is expected.
BECAME SYMPTOMATIC AND TESTED POSITIVE FOR COVID19 ON 8/13/21. DIED 9/1/21
tired; This is a spontaneous report from a non-contactable consumer.   A 96-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient was consistently tired. The outcome of the event was unknown.  No follow up attempts are possible. Information about lot/batch number could not be requested.  No further information is expected.
Developed severe back pain, lower extremity weakness, and loss of bowel and bladder control 16 days after receiving flu vaccine.  1/4/08 Reviewed hospital D/C summary which reveals patient experienced  lower back pain &  LE weakness x 2 mo which became acute on 11/3/07 w/sudden onset of weakness in bilat LEs w/progression, multiple falls, urinary incontinence.  Seen in ER but sent home when spine & MRI were WNL.  Continued to deteriorate & admitted 11/6-11/21/2007.  Neurology & neurosurgery consults done.  Transferred to inpatient rehab upon d/c. FINAL DX: myelitis w/lower extremity weakness & bowel/bladder dysfunction, etiology unclear, thought to be most likely postvaccination.
30 mins p/vax pt became limp & unresponsive, color pale for about 30 seconds; roused sl gradually woke up color & muscle tone returned totally in 15 mins; became lethargic for 15 mins again;
On 9-7-10 received flu vaccine (L) thigh and DTAP in (R) thigh. Mom reported that on 9-9-10 noted 2-3" of redness around injection site (R) thigh. On 9-10 noted hardness. Office visit on 9-17-10, no redness less than 1 cm induration & hyperpigmentation medially less than 1 inch to injection point.
SEVERE BREAST PAIN; A BIT MORE JOINT PAIN; This spontaneous report received from a patient via social media  via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune disorder. The patient experienced joint pain when treated with influenza vaccine for prophylactic vaccination.  The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported administered for covid-19 prophylaxis. On an unspecified date, the patient experienced severe breast pain following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The outcome of severe breast pain was not reported. The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced severe breast pain, and a bit more joint pain (Dose number in series 2). It was reported that, "I did take the J and J vector vaccine and I do have autoimmune. I can say I did have a bit more joint pain but then it subsided. I also have the same reaction after the flu shot. I did report this as well to J and J along with sever breast pain that occurred after both J and J shots. Overall no other challenges. Will not mix J and J vector with Pfizer or Moderna MRNA. Hoping J and J gets approval for their booster". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from a bit more joint pain, and the outcome of severe breast pain was not reported. This report was non-serious. This case, involving the same patient is linked to 20221258086.
Treatment of COVID-19; Treatment of COVID-19; Yellow stool; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 06Apr2021 as dose 1, single (Lot number: 036B21A), in right arm and on 06May2021 as dose 2, single (Lot number: 025C21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Known allergies: Sulfites" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D2, start date: 01Jan2021; FAMOTIDINE, start date: 01Jan2021; B12-VITAMIIN, start date: 12Jan2022; FOLIC ACID, start date: 01Jan2021; NORETHINDRONE [NORETHISTERONE], start date: 01Jan2021, stop date: 20May2022. The following information was reported: FAECES DISCOLOURED (non-serious) with onset 23May2022 at 11:00, outcome "unknown", described as "Yellow stool"; DIARRHOEA (non-serious) with onset 23May2022 at 11:00, outcome "unknown", described as "diarrhea"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 with Paxlovid (Lot number FY9918) from 21May2022 to 23May2022. Therapeutic measures were not taken as a result of faeces discoloured, diarrhoea.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot FH8020 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FH8020, fill lot FG3521, and the bulk formulated drug product lot FH0137. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Patient came in presenting with tight nodules on palms of both hands.  She indicated to be in pain and unable to straighten.  Her tendons appear to be very tight, causing her ring fingers to be bent inward, and she can't open her palms fully.
48 hours after vaccine, shoulder pain is gone; This is a spontaneous report from a contactable consumer (patient herself).  A 62-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration, administered in right arm as dose 1, single on 30Apr2021 at 14:30 (at the age of 62-year-old) for covid-19 immunisation at pharmacy or drug store. Medical history included osteoporosis and fairly healthy. Patient had known allergies to Penicillin, Codeine, Eggs and gluten. Concomitant medications included alendronate sodium (FOSAMAX) and vitamin d NOS (VITAMIN D NOS) both taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient reported that this was a positive. She had severe shoulder pain for months and diagnosed at Bursitis, x-rays, ultrasound showed nothing. Exercise and Celebrex have not helped. She have not had Covid that she was aware. On 02May2021 07:00 AM, 48 hours after vaccine, her shoulder pain was gone. No treatment was received. At the time of this report, the outcome of event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
first dose more than one month ago not administered with 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old male patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HBV (Engerix B).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable. The patient received first dose more than one month ago (batch number: N4GA4, expiry date: 28th February 2023). The patient did not receive 2nd dose which led to incomplete course of vaccination. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021179660:same reporter
This non-serious spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc vaccine underwent first temperature excursion with maximum temperature (Tmax) 8.2 degree centigrade for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree centigrade for 23 minutes. On an unspecified date, two temperature excursions were identified after an audit. On 07-Nov-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252672 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse events after the vaccination. This case is linked to 201805262 (same reporter).
administrated with Infanrix and Pediarix on the same day; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 18-month-old female patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number TN7S9, expiry date 29th May 2022) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th June 2021, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device. On 7th June 2021, unknown after receiving Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Nurse reported that a patient was administrated with Infanrix and Pediarix on the same day, which led to overdose. No adverse event was reported . The reporter consented to follow up.
5:30 pm on day of vaccine: chills 7 pm: temperature up to 99 (usually 96.4) 8:30 pm: more severe chills,  extremely achy in all areas of body (not just arm), could not get warm 12:20 took advil to deal with the aches 12:30 AM: could not fall asleep, started having stomach pains, vomited all of my last meal (eaten at 8:15) and continued to vomit with empty subject, temperature up to 100, severe chills.  Next 2 hours: alternating between chills and sweats  Aches have continued with residual nausea now 24 hours after shot
Patient experienced pain at injection site that evening, with resultant large inflammation on surrounding area for 4 days, fatigue for several days, chills on day 3, then localized inflammation migrated down her arm from days 4-8. Pt feels ok today and was ok after day 8 but was concerned about the response while it was occurring because her husband did not have as significant of a response.
7cm x 5.5 1/2 cm area over (R) deltoid of swelling , redness, tenderness and warmth up elevation over past 12 hours.
Patient had a flu vaccine at pharmacy. Came to clinic 30 min later. C/O feeling hot and red in face. Neck, arms and chest were red with a rash. Patient given IM epi and BENADRYL.
Vaccinator administered 0.1mL intradermal injection of Jynneos to patient's right forearm on 10/18/22 at 10:04am. However,  a wheel or induration was not observed. Per protocol, another dose must be administered.  Patient exhibited no adverse signs. Patient was calm and cooperative.
Presented with lower lip swelling and hives to inside of cheek within a few minutes of receiving the vaccine. No tongue swelling. No SOB or throat itchiness.  Offered Benadryl and transport to ED but she declined and went home.
Soreness at injection site, fever (103F), headache, joint aches, nausea.
Pfizer vaccine vial punctured at 08:25. Gave Pfizer vaccine to patient at 15:55. Vaccine expired upon administration. No symptoms seen and no treatment given at this time. Observation of 20 minutes.
About 8 hours after the vaccine shot, I started to experience joint aches, then strong chills where I could not get warm, then a splitting headache.  Then the injection spot hurt badly,   These symptoms lasted for approximately 36 hours
Got sick on 1-3-22, tested positive for Covid on home test the next day. Worst symptoms: brain fog, muscular aches and pains, sore throat, cough, total lethargy.  Acute symptoms lasted until 6th and 7th.  Fatigue another month.  Whole bunch of muscle issues till present, although most are abating: both hands, hamstring tendonosis, plantar fasciitis symptoms-both feet.  My belief that some existing problems were amplified
positive test, came down with the COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive test, came down with the COVID) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced COVID-19 (positive test, came down with the COVID). At the time of the report, COVID-19 (positive test, came down with the COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants or treatment medications were reported.
Pneumonia, unspecified organism Thrombocytopenia, unspecified Trigeminal neuralgia Unspecified convulsions
Client was given 1st dose of Covid Vaccine at 8:07 am. Client was sitting in chair on phone when she fell off chair and hit the floor at 8:15 am. Client hit her head and was lying prone on the floor. Client was unresponsive and was noted to be having a possible seizure as she was contracting. Client was placed on left side and head was secured . Client took approximately 2-3 minutes to respond and give name and date of birth. Vitals were taken WNL 132/83 HR 78, 0xygen 99. EMS was called and client was taken to hospital.