chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Four hours after injection pt started with redness, swelling & knot at injection site.  Seen in office 48 hrs after injection Dx'd with mild cellulitis.  Pt presented again 72 hrs after injection with redness spreading.  Redness measured 6 inches wide and 7 inches in length.  Pt being treated with KEFLEX 250 mg.
Lt arm red and swollen at vaccine site. Benadryl every 6hrs and dose at bedtime.
Upon receiving shot pain shot down arm to left hand.  When standing up felt faint.  Remained in store for 20min until fainting feeling subsided.  That night got fever, chills, muscle aching, joint pain, abdominal pain and nausea,  diarrhea severe headache.  The fever and chills stopped next morning.  Continued having moderate muscle aching, nausea and severe headache for 3 days.  On the line of severe migraine.  It has been 6 days and I still have mild muscle aching, joint pain, nausea, headache, fatigue, and faint.
I had a flu shot on October 26, 2015 at my local public health department. I am a county employee and the county was offering a free shot through our health insurance. The shot was given to me in my upper arm; however, the prick/insert was rather high on my upper arm. Ever since that day, my right upper arm has been sore. It is now almost April, 2016, and my arm is still sore. I can't raise it high and I feel a discomfort when I'm changing shirts. I also can't sleep on my right side, due to discomfort in my upper arm.
blurred vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series, unknown manufacturer), for Covid-19 immunization. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "blurred vision".  Additional information: Reprter asked was blurred vision a side effect of the new Covid vaccine and stated patient received Pfizer Bival Covid (12Y+) VACC MDV yesterday and today they had blurry vision. They appreciate response.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Child was crying and states he itches- had hives. Given Benadryl 7.5cc PO
The day after my vaccination, the rash flared up; This is a spontaneous report from a contactable other hcp. A 48-year-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 12Mar2021 12:00 (at the age of 48-year-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing dermatitis contact, seasonal allergy. Patient did not receive any other vaccine in four weeks. There were no concomitant medications. On 13Mar2021 08:00, the patient experienced the day after my vaccination, the rash flared up. Patient received her first Pfizer covid vaccination while she had an active case of contact dermatitis due to poison ivy. The day after vaccination, the rash flared up. Upon the flare-up, she started taking oral prednisone 20 mg with limited relief. It appears to be resolving slowly now. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Lower extremity weakness noticed on 12/05/15, 6 days following 6 month immunizations including flu. Diagnosed with longitudinal transverse myelitis from C4-T2. Infectious etiologies mostly ruled out at time of report. NMO and oligoclonal bands still pending. Responding quite well symptomatically on day 3 of steroid burst. Considering IVIG.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment start date reported as 29Jun2023 and Treatment stop date reported as 04Jul2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250325 Same patient, different drug, different event;
This case was reported by a nurse via call center representative and described the occurrence of injection site induration in a patient who received MENVEO. On an unknown date, the patient received MENVEO. On an unknown date, unknown after receiving MENVEO, the patient experienced injection site induration, injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site induration, injection site swelling, injection site warmth and injection site erythema were unknown. It was unknown if the reporter considered the injection site induration, injection site swelling, injection site warmth and injection site erythema to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient in the practice had received MENVEO, and then experienced a localized reaction, described as induration, redness, swelling and warmth to touch, at the injection site. No patient or product information was available, but might be available upon follow up by fax. This was 1 of the 8 cases, reported by the same reporter.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included denosumab (Prolia). On 5th October 2018 10:30, the patient received the 1st dose of SHINGRIX (subcutaneous). On 5th October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site tenderness and intramuscular formulation administered by other route. On 6th October 2018, the patient experienced injection site erythema, shivering, injection site warmth and extensive swelling of vaccinated limb. On 7th October 2018, the patient experienced injection site itching. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)) and medication unknown (Anti-Itch Medication). On an unknown date, the outcome of the injection site erythema, injection site itching, injection site warmth and extensive swelling of vaccinated limb were not recovered/not resolved and the outcome of the shivering and injection site tenderness were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema, injection site itching, shivering, injection site tenderness, injection site warmth and extensive swelling of vaccinated limb to be related to SHINGRIX. Additional details were provided as follows: The reporter reported that, she got SHINGRIX and it was administered subcutaneously, which led to Inappropriate route of vaccination. The injection site was tender on same day of vaccination. One day after receiving SHINGRIX (next morning), the patient woke up with an egg size area that was red, swollen and hot to the touch. It continued to grow that day and she also experienced some shivering. On 6th October 2018, she felt like she was coming down with a cold. On 7th October 2018, 2 days after receiving SHINGRIX, when patient woke up she felt fine except for the redness and swelling at the injection site which was the size of a baseball. On 7th October 2018,  2 days after receiving SHINGRIX, the patient started getting itching at the injection site as well. On 8th October 2018, she saw her doctor and the redness and swelling was about 6 inches long by 4 inches wide. The patient had been prescribed an antibiotic and anti-itch medication.
He passed out twice, vision changes prior to passing out. HR remained elevated for 12 hours after passing out, between 88-127 as we monitored it. Shivering and headache after passing out. Laying down didn't bring him out of the passed out state. He didn't come to until his feet were elevated a few seconds. BP afterward when laying down was 110/55, HR 68. He had COVID back in Dec 2020 with very mild symptoms. Totally healthy and feeling good when he got the vaccine yesterday and he is a very healthy 19/yo male.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction to the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Bad reaction to the Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (Bad reaction to the Moderna vaccine) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not  reported.
Booster; I had a MI after the third vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, After the first one, he wound up in the ER and hospitalized for angina. IV nitrates. False positive, ended up in the covid unit. Antigens taken, never had Covid. That was a disaster), administration date: 2021, for COVID-19 immunization, reaction(s): "Angina"; Comirnaty (Dose 2), administration date: 2021, for COVID-19 immunization, reaction(s): "The second I was fine". The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; MYOCARDIAL INFARCTION (medically significant) with onset 2021, outcome "unknown", described as "I had a MI after the third vaccine". It was the first ever. The patient wanted to know what they were finding with cardiac effects on patients and if it was anything on coagulation. The patient did not know what needs to be done in the future as it keeps mutating and will be additional vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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
Drug dose administration interval too long; Injection site reaction; redness from her shoulder to her elbow; Deep cough in chest; Flu-like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 99D9F, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site reaction (received 1st dose on 8th October 2018, refer case US2019107209).   On 4th June 2019, the patient received the 2nd dose of Shingrix. On 4th June 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In June 2019, the patient experienced injection site pain, erythema, cough and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, erythema, cough, influenza-like symptoms and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site pain, erythema, cough and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in left arm. The pharmacist stated that the patient experienced injection site reactions. The reaction was worse with redness from her shoulder to her elbow; the redness was still ongoing at the site and developed a deep cough in her chest and flu-like symptoms.  The pharmacist notes the injection was given by a rotating pharmacist.  She states the patient gives permission for GlaxoSmithKline to reach out to her.  The patient provided the pharmacist with a phone number if safety needs to follow up directly. The pharmacist also consents to follow up.
tinnitus; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for male patient (reporter's husband). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/ batch number unknown), via an unspecified route of administration on unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that her husband has tinnitus and his started four days after the vaccine. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and requested during follow up.
No additional AE/PQC reported; Nurse calling to report administration of expired PROQUAD.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On 30-APR-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, albumin status has been verified as recombinant human albumin (rHa), lot #U R015744, expiration date was reported as 12-FEB-2019 (also reported as 30-APR-2023, discrepancy) (expired product administered) for prophylaxis (strength, dose, anatomical location, and route of administration were not provided). The reporter was unaware if there were any temperature excursions in the products lifetime. No additional adverse event (AE) was reported (no adverse event).
Rash presented several days after 2nd dose of vaccine. Seen in urgent care on 4/28 for this.  On 5/8/21, patient had left weakness and numbness, dizziness, and loss of balance. Alteplase given,. Transferred to Medical Center, medical intensive care unit. Transferred to medical/surgical unit 5/9/21. Intermittently Febrile - T-max 39.5. CT for mild lethargy 5/9/21. 5/11 - mild respiratory distress and minimally responsive. Continued decline. TOD 1644 5/13
Patient fainted after about 5 to 10 minutes never stopped breathing emt checked patient out and he left of his own accord stating he was fine now
Rash on trunk and local swelling, pain, itching at vaccination site. Antihistamines Prescribed.
Tinnitus onset with headache and nausea lasting 36 hours. Tinnitus unresolved as of 03/06/2021.
75 y.o. M w PMHx of Stage 4 CKD, T2DM, amputations of L toes 1-3, HTN and anemia who presented initially to clinic today w/ L foot pain. He had noticed it for about a week or so. Monday he was able to remove a piece of tissue and the foot began draining. The clinic doc was concerned about osteomyelitis and he was sent to the ED. XR there confirmed osteo of the 5th ray w/ possible metallic foreign body adjacent. He was hemodynamically stable in their ED. Pertinent labs include: Cr 2.65 (stable), PCT 0.11, Hgb 9.8 (12.0 in January, denies any bleeding issues), CRP 1.8, ESR 110. A COVID test did return positive (again, not hypoxic).
Initial Report Received: 07-Sep-2018 and 13-Sep-2018 Follow-up Report Received on 26-Oct-2016 included dates of administration of Engerix-B, dates of administration of HEPLISAV-B, and dates of titers. Patient is a 73-year-old female (race not provided) who was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. A nurse reported that the patient's titer result did not show immunity after completing the HEPLISAV-B series. Relevant medical history included Crohn's disease and a history of being a non-responder following 8 to 10 ENGERIX-B. ENGERIX-B was administered on 06-Feb- 2016, 02-Mar-2016, 02-Sep-2016, 20-Oct-2016, 22-Nov-2016, 28-Dec-2016, 07-Feb-2017, and 26-Jul-2017. Concomitant medications included Entyvio (vedolizumab). The patient received the first injection of HEPLISAV-B (Lot # 032912, expiration 15-Mar-2019) on 03-Jul-2018.   The patient received the second injection of HEPLISAV-B (same lot #/expiration as first dose) on 06-Aug-2018. On 04-Sep-2018, one month after the second HEPLISAV-B injection, a titer was drawn and the result was 9.2 (not immune).  A minimum of 9.9 was required to indicate immunity.  Of note, a previous titer was drawn on 19-Oct-2016 which was < 3.1. No other information was provided and the patient did not agree to being contacted. At the time of the report, the outcome of the event was not reported. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the event of therapy non-responder as non-serious. The event of therapy non-responder is listed per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of therapy non-responder as non-serious. The event of therapy non-responder is listed per HEPLISAV-B USPI.
mom reports 1DEC92 330PM t105.8, convuls lasting 3-4 mins, hospitalized; t101-104; 4DEC92 d/c from hosp; rx Phenobarb;
Narrative:  Patient previously used to receive yearly flu vaccinations up until 2019. in 2020, he had a diagnosis of GBS and has not been able to receive the flu vaccine.
Shaking chills on 12/8/21 and low grade temp of 99.7 headache and body aches on 12/9/21 body aches and fatigue on 12/10/21 local arm tenderness that started on 12/9/21
The same night post vax, both my right and left arm ached. I had redness, my last tetnus was 20 years ago, with tetnus injections I would have a red, hard deltoid for many days, hardness may have lasted weeks, fever for at least two days. For two weeks post vax pt noticed right arm ached more, pt left arm was aggravated with exercise. Pt also started having hot and cold feelings in different areas of both arms and tenderness on touching different areas of my arms at different times. Pt also experienced sharp pain at times in both arms. Two 1/2 weeks post injections pt had flu-like feeling. During this time I would awake at night with tightness across both shoulders in the back, tenderness on touching the areas. At the end of September I would wake up with the tightness also going up my neck a feeling in my head. One night I felt like my throat was swollen and I had pain feelings under my chin. My MD told me to go to ER. ER felt it was anxiety, depression. The pt felt it was something more serious. That afternoon I experienced a low grade fever 99.5 - 99.8. MD I then went to see another MD, hand she felt I may have bronchial neuritis from the shot. I saw Neurologist, he felt I probably had reaction to the tetnus that crossed over the nerve into both arms. The head symptoms deminished in October. Arm symptoms started to lessen the end of October, lessened more in December, but didn't deminish until March. I still have a rare tightness across my shoulder and cervical spine. Pt question is if this is a reaction should I ever have another shot?
Rash/hives from head to toe; lip swelling/tingling/numbness Rash worsened over the next couple of days after receiving the vaccination
Reported supraclavicular lymph node swelling and severe pain in left deltoid.  Took 2 courses of oral antibiotics with minimal relief of symptoms.  MRI showed possible abscess.  4/30/10 Was admitted for IV antibiotics and on 5/1/2010 incision/drainage performed in the operating room.  Hospitalizion of 2 days.
CHILLS; HEADACHES; MUSCLE ACHES; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included several well-controlled autoimmune issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the patient experienced chills. On 24-MAR-2021, the patient experienced headaches. On 24-MAR-2021, the patient experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headaches, and muscle aches on 25-MAR-2021. This report was non-serious.
Body ache chills fever at 2:00 on 1/22/2021 that lasted until 6 pm with itching numbness mouth.  The itch mouth and numbness of upper lip has not resolved as of today 1/24/2021 at 1530
This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates the unspecified number of unspecified patients were vaccinated with unspecified doses of improperly stored GARDASIL (lot number not provided) injection (strength, dose, frequency and route not provided). No adverse effect was reported. The outcome of event was not reported. This one of several reports received from the same source. Additional information has been requested.
5 cm in diameter area of redness and swelling to left deltoid area observed. Patient reports tingling and itching at site.