chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling of arm from shoulder to elbow which started the morning after the vaccine was given. Pt contacted doctor and no treatment was given. 10 days later patient is still experiencing redness and subcutaneous fluid buildup in bicep region of arm.
he received his first dose, tested positive; Fever; fatigue; congestion; This is a spontaneous report from a contactable received consumer (reporting on himself). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient was asking for guidance on timing of the second vaccine dose after testing positive for COVID following the first dose. Patient received his first dose, tested positive but had more severe symptoms with congestion, fever and fatigue and he was also supposed to go for his second dose on 26Apr2021. Patient asking the longest amount of time allowed between dose 1 and dose 2. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Mild Fever onset at 11:30pm, about ten hours after the vaccine. Poor sleep followed, chills, and extreme muscle aches. Woke up the following day with brain fog and head pressure. This subsided a bit by early afternoon.
10/28 at 0700: patient awoke with red, hot, swollen, and itchy left arm from shoulder (injection site) to elbow. As the morning progressed, sores in mouth and on tongue began to erupt. The redness and swelling in left arm lasted approximately 4 days and resolved spontaneously by 11/2. The patient took doxycycline 100mg PO BID for 4 days until it cleared. The apthous ulcers in the mouth spontaneously resolved at 14 days (11/10).
1st 30 sec. 2nd 10 sec.  Pt. was sitting in 15 min wait area when he had 2 seizures witnessed by EMS personel. Care was immidiatly given and he was transported to ER No hx of epilepsy declared on pre screening form
leg cramps; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious) with onset Jul2021, outcome "unknown", described as "leg cramps".  Additional Information: Patient called to report side effects after getting the first dose, she mentioned leg cramps which was a side effect after she got the first dose on 03Jul2021. As per the patient, she doesn't have a schedule for the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red at site, warm to touch, slightly swollen, itchiness. Worsening over the last three days.
pt recvd vax 7NOV95 & the same day 4PM pt's mom reported that pt had t103.5;overnoc temp reached 105.7 & ibuprofen was used to treat the fever;by 330PM the following day temp was down to 103.5;10NO95 pt was seen by MD & enlarged tonsils
Client was inadvertently given a Tdap along with MENACTRA. Was already given Tdap on 4/26/06. Spoke to VFC and talked to parent about high risk of local reaction.
approximately 12 hours after vaccine administration, I became cold with bone rattling and teeth chattering chills with severe shivering.  I had no fever when I checked my temperature orally.  I developed 3 small urticaria with one on my abdomen and one on each thigh.    I treated with 50mg of benadryl and 800 mg of Motrin.  It appeared to be a euthermic cytokine storm to me ( I am an ICU physician).   The symptoms resolved without issue.
04:00 in the morning, had chest discomfort - from the middle of my chest straight to the middle of my back. I couldn't sit up or lay down. It was very uncomfortable. I had to wake up my husband. I couldn't lay back. If I stood up I was okay. I thought I was maybe having an anxiety attack or something. They ruled out a heart attack. My EKG was a little abnormal but not really bad. Abdominal CT scan, EKG  - they said I had coronary artery stenosis - and also abdominal stenosis and said to see a doctor and a cardiologist. I have seen the doctor and am going to Cardiologist tomorrow. They admitted me overnight - ran IV fluids and some medication. They ordered an echocardiogram - the cardiologist at the hospital said they would discharge me if that came back okay and it did. Said to stay on Crestor and baby aspirin. They said I'm pre-diabetic and that  I need to change my diet and exercise more. I have stenosis but I don't have the chest pressure. That was a one time thing, don't know where that came from.  Had my flu shot on September 27th, 2021
pt presented to clinic p/a few hr inj, c/o severe h/a, nausea & severe chills;delayed systemic rxn;
Swollen lymph nodes in armpit of arm that received the shot.  Pain and swelling started 23 hours after booster and continued for 2 weeks with decreasing pain and swelling.  Pain and swelling noticed in contralateral armpit 3 days after booster and continued for 2 weeks  with decreasing pain  and swelling.  Sporadic pain continues through today around the tricep and shoulder of arm contralateral to shot.
Auditory hallucinations, paranoid, anhedonia, confusion, panic attacks, thoughts of suicide, anxiety irritability, enhanced sensory perceptions.
Unsure  if patient got full dose, Needle broke and some dose leaked; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number YA29D, expiry date 6th October 2023) for prophylaxis.   On 15th November 2022, the patient received the 2nd dose of Shingrix. On 15th November 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Linked case(s) involving the same patient:  US2022169285   Additional Information: GSK Receipt Date: 15-Nov-2022 Reporter's Comment: The patient had received the second dose of the shingrix vaccine, but during the application, the needle broke off and some of the dose leaked.  They relayed information that referred to the vaccine and basic patient information for report, but while medical information was being disclosed, she asked if help was actually going to be given before hanging up.  Consented to follow up. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: the patient received Shingrix vaccine and some of dose leaked, which led to incomplete dose administered.; Sender's Comments:  US-GSK-US2022169285:Same reporter
pt devel t101 6 days p/vax recvd; pt then devel hives on back & around mouth; while talking to mom reported hives are disappearing on back & turning into pimples; seen by MD like blisters now; lips were violet; runny nose;
allergic reaction; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program .  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Mar2021 at single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced allergic reaction on Mar2021. The outcome of event was unknown.  Information on the lot/batch number has been requested.
His left face is drooping; Numbness to right face; Numbness to right eye; Headache pain behind his left ear; This spontaneous case was reported by a nurse and describes the occurrence of FACIAL PARALYSIS (His left face is drooping) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness to right face), EYELID SENSORY DISORDER (Numbness to right eye) and HEADACHE (Headache pain behind his left ear). On 07-Mar-2021, the patient experienced FACIAL PARALYSIS (His left face is drooping) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (His left face is drooping), HYPOAESTHESIA (Numbness to right face), EYELID SENSORY DISORDER (Numbness to right eye) and HEADACHE (Headache pain behind his left ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Positive.     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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
No Adverse Event; The patient received his second dose of the Moderna Covid-19 vaccine on January 6, 2023More than 36 days in between doses of primary series Moderna Covid-19 vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his second dose of the Moderna Covid-19 vaccine on January 6, 2023More than 36 days in between doses of primary series Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No Adverse Event) in a 13-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Nov-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his second dose of the Moderna Covid-19 vaccine on January 6, 2023More than 36 days in between doses of primary series Moderna Covid-19 vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his second dose of the Moderna Covid-19 vaccine on January 6, 2023More than 36 days in between doses of primary series Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his second dose of the Moderna Covid-19 vaccine on January 6, 2023More than 36 days in between doses of primary series Moderna Covid-19 vaccine.).    No concomitant information was reported. No treatment information was provided.   Reporter did not allow further contact
The event was a vaccine error, double dose of polio vaccine pentacel and IPV  was given.  There was no adverse reaction.
No adverse event; Patient 6 months-5 years of age received a Moderna Covid19 bivalent Vaccine from the pink cap (10 mcg) instead of blue cap (25 mcg); This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient 6 months-5 years of age received a Moderna Covid19 bivalent Vaccine from the pink cap (10 mcg) instead of blue cap (25 mcg)) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 17-Jun-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 10 microgram. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient 6 months-5 years of age received a Moderna Covid19 bivalent Vaccine from the pink cap (10 mcg) instead of blue cap (25 mcg)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient 6 months-5 years of age received a Moderna Covid19 bivalent Vaccine from the pink cap (10 mcg) instead of blue cap (25 mcg)) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 WRONG PRODUCT ADMINISTERED (Patient 6 months-5 years of age received a Moderna Covid19 bivalent Vaccine from the pink cap (10 mcg) instead of blue cap (25 mcg)).    The route of administration of suspect Moderna bivalent dose 1 and 2 was reported.  Concomitant medication was not reported.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:same reporter
Patient went to five different free Flu shot providers and got the flu shot; Initial information received on 08-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via social media.   This case involves a patient (unknown age and gender patient) who went to five different free flu shot providers and got the INFLUENZA VACCINE (extra dose administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received five doses of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to extra dose administered (same day latency).  It was reported "I went to five different free Flu shot providers yesterday and got the shot. My doctor told me NOT to get more than one shot but also told me it was 100% safe. So 5 is better than 1. 5 times the protection."   At time of reporting, the no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
On 09/23/21 my ears became painful, like they needed to "pop". this slight went away, but  9/26/21 my head felt like it was in a bubble, difficult to hear, ringing/humming in my left ear. By 09/29/21 I was not able to hear at all, I had dizziness and nausea at times.  Unable to see my own provider I went to an urgent care as I was not able to perform the duties of my job. Informed that I had Eustachian tube dysfunction .
37 out of 89 pts did not respond to 3 hepta B.  Unsure if pts recd all 3 vax yet.
Initial information received on 01-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a one-day old patient (gender not reported) who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT instead of Hepatitis B Vaccine (lot number and Exp. Date not reported) via intramuscular route in unknown administration site on 01-Dec-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to inappropriate age at vaccine administration and wrong vaccine administered. There were no AE noted at the time. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient's wife came in and stated that patient experienced heavy nausea. It was affecting his equilibrium that he was not able to drive himself around and that she was needing to drive him to different places. Patient had the symptoms for a few days, but was relieved at the time of reporting the incident.
3 hours after injection arm began to experience pain at injection which became increasingly worse.  Radiated into shoulder area,  collarbone area and eventually was so severe arm was not able to move.  Screaming pain.  Used Advil, ice pak and bed rest.  This arm was useless - no range of motion until 3rd day .   Gradual return to ability to do normal use.  Note:  I have had shingles 3 times in my life  - age 60 1997, age 71 2008 and age 85 2022.  Waited 5 months to have this vaccine
Information has been received from a RN concerning her 4 year old son who in May 1999, was vaccinated with varicela virus vaccine live.  The mother reported that the patient broke out in chicken pox.  On 10/17/2001, the patient developed approximately 100 macular and papular lesions all over his body, including the "peri area."  The RN reported on her other 2 children (WAES # 01104874 & 01110667).  Additional information has been requested.
For the patients second dose, he received undiluted pediatric Pfizer vaccine (0.2 mL of undiluted vaccine). Patient's father, was first contacted on the morning of 2/11/22 which is when the incident was discovered, but was unable to be reached. Patient's father was reached on 2/15/22. When asked how the patient was feeling, the father reported he was "doing great" and that he "had a low-grade fever the first night" but was "doing fine." Patient's father appreciated the call and had no concerns at this time. Patient's father was instructed to contact pharmacy with any future questions or concerns related to systemic side effects.
fatigue, bodyaches, mild sore throat, numbness & tingling lt arm, inject site swelling, ecchymosis, papular scattered areas, vague dizziness, nausea sxs; started a few days p/inject; pt began taking Ibuprofen for severe discomfort;
Inflammation of spinal cord, unspecified cord compression, numbness and tingling of all limbs, primary hypertension, abnormal reflexes, and other symptoms and signs involving the musculoskeletal system, anemia, low B12 Vitamin levels- hospitalization at Hospital from 12/11/22-12/17/22 Received 5 days of Pretizone steroid, intramuscular injections of B-12 vitamins, recommended surgery to decompress spinal cord inflammation at neck.
This spontaneous report has been received from a licensed visited nurse concerning to a patient of unknown age and gender. Current conditions and medical history were not reported. On 23-JUL-2008, the patient was vaccinated with a first dose of hepatitis a vaccine, inactivated (manufacturer unknown), (dose, lot# and route not reported) administration at another facility. On 13-JAN-2009, the patient was vaccinated with a second dose of hepatitis a vaccine, inactivated (manufacturer unknown), (dose, lot# and route not reported) administered at another facility. Concomitant medication was not reported. No adverse event reported. It was unknown if the patient sought medical attention. Additional information is not expected.
Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 06-JAN-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Usual dose is  0.5mL. Pt was given 2.5 mL in each arm. Shot given by a pharmacist intern. 1st shot significant leakage. Supervising pharmacist assumed improper technique and agreed with patient and intern concerns that 1st doses may be insufficient. 2nd shot given to other arm. Dose not verified until after both shots given. Patient and facility both made aware same day. Patient displays no symptoms currently.
Small welt at injection site became large and red. The area has continued to get larger, is still red, but is flatter. It itches.
Patient was given dose of Janssen on 5/24 after reporting no previous vaccination.  CAIR records reveal patient had also received J&J on 3/11/21.  Post vaccination monitoring of client by medical personnel at facility reveals no symptoms or side effects.
pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). At the time of the report, PAIN IN EXTREMITY (pain in arm) 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 concomitant medications were reported.  No treatment information was reported.
This spontaneous report as received from a registered nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, an unspecified number of patients were vaccinated with improperly stored VAQTA lot # K018181, expiration date 04-JUN-2017 (dose, route and site of administration were not reported). There were no adverse symptoms reported. No product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.