chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm where vaccine was injected,; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in left arm on 06Mar2021 at 00:00 (at the age of 64-years-old), as a single dose, for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 06Mar2021, at 12.00am the patient experienced sore arm where vaccine was injected which lasted about 7days. No therapeutic measures were taken as a result of adverse event. The clinical outcome of the event vaccination site pain was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Myalgia, Arthralgia, Fever, NauseaVomiting, photophobia/ "red, tender, chapped lips" Narrative:  Other Relevant History:
Pt fainted after injection. Pt was pale and weak. Pt was brought to medical area and laid down with feet elevated. Pt vital signs were taken and hr was 49-40, bp was 104/72, resp 18, spo2 was 98% ra. Pt rested with feet elevated for 20mins. Pt felt better vs improved. Hr increased to 71. No was increased to 113/77. Resp 18. Spo2 98% ra. Pt felt better and was released to observation area. Pt checked herself out w/o incident.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (Date of vaccination, lot number, dosage, and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated at a clinic (by an unspecified healthcare professional) for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving 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 (h)as suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
02/28/2006 Started to feel bad, 03/01/2006 lips began to swell, had fever, tongue feeling thick.  03/03/2006 woke up with swelling on views with tenderness under jaw line.
Information has been received from a physician who heard from another physician concerning a female patient, "about 16 or 17 years old", who had received two doses of Gardasil (lot numbers not reported), went to a gynecologist with a problem, and it was diagnosed as a genital wart. It is unknown if the wart was present prior to receiving Gardasil. No product quality complaint was involved. The patient
Extreme chest pain, shortness of breath, elevated heart rate, increased d-dmmer results in blood test, swollen lymph nodes on injection site, acid reflux/GERD-like symptoms
Slept for 19 hours; Heartburn; headache; muscle ache; Extreme fatigue; Nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept for 19 hours), DYSPEPSIA (Heartburn), HEADACHE (headache), MYALGIA (muscle ache) and FATIGUE (Extreme fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 032M20A) 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 medical history reported).   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced HYPERSOMNIA (Slept for 19 hours), DYSPEPSIA (Heartburn), HEADACHE (headache), MYALGIA (muscle ache), FATIGUE (Extreme fatigue), NAUSEA (Nausea) and CHILLS (chills). On 01-Apr-2021, HYPERSOMNIA (Slept for 19 hours), DYSPEPSIA (Heartburn), HEADACHE (headache), MYALGIA (muscle ache), FATIGUE (Extreme fatigue), NAUSEA (Nausea) and CHILLS (chills) had resolved.            No concomitant medication reported  Treatment using  ibuprofen 400mg was reported
dizziness  nausea  muscle weakness  headache  heart pains difficulty breathing injection site pain shoulder to fingertips fatique fever
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced HEADACHE (Headache). On 02-Feb-2021, HEADACHE (Headache) had resolved. Not Provided          No concomitant medications and treatment information were reported.   This case was linked to MODERNATX, INC.-MOD-2021-069947 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-069947:1st dose case
given of Kinrix instead of Boostrix; 11 year old given a dose of Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd September 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd September 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 8-Sept-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Kinrix instead of Boostrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 17Apr2021 at 11:00 as dose 2, single (Lot number: EW0158) at the age of 35 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, 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 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: After completing five days of treatment, symptoms returned. On 06Jul2022, she started Paxlovid for covid19 treatment and stopped on 11Jul2022. On 12Jul2022 at 07:30 AM, she had symptoms. After completing five days of treatment, symptoms returned. No treatment received. It was unknown if event recovered or not.   No follow-up attempts are possible. No further information is expected.
Blister-like lesion to right thigh area, 3-4mm with surrounding erythema. No fluctuance, not increasing in size X2 weeks.
I received the second Pfizer-BioNTech Coronavirus Vaccination on February 18th and on February 20th i started to experience and currently am experiencing Bilateral Tinnitus ringing in both ears for the last 14 days. The Tinnitus is shifting in quality at times. Doing some head tapping on the lower back of the head with my fingers does temporarily help with the symptoms.
Around noon the following day I started feeling achy and tired.  My eyes burn and I have chills.  Just feel like I'm coming down with something.
During the night, I had chills.  This morning I had a slight fever, aprox 100, chills, and a headache.  Symptoms seem to be easing up this afternoon.  I called to a clinic and their patient navigator told me these are common side effects.  My first Pfizer shot at the Forum on March 3, 2021 EN 6199 got rid of the Vertigo I had been suffering for several weeks!  Still a bit chilled today and slight headache but not as bad.
Within 12 hours: Fever, chills, headache, racing pulse, labored breathing, and the following 6 days: periodic hot flashes, extreme fatigue, nausea, weakness, digestive troubles. I still have extreme fatigue today, day 8.
a little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced FATIGUE. On 31-Mar-2021, FATIGUE had resolved. Not Provided      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.
Patient qualified for Moderna Booster (0.25ml) dose but received Moderna Additional (0.5ml)  dose instead.
Chills, shaking temperature of 101.8F. Tylenol, Benadryl and RX NSAID for treatment.
immediate itching , rash and redness at site, redness and itching radiated to lower arm, shoulder, chest and face.  With hives forming 45 minutes later hives to upper lip.    Treated with Ice, Triamcinolone Acetonide Inj and diphenhydrAMINE Injection  denies throat swelling, or any type of respiratory distress
Thrombocytopenia purpura onset several wks p/inject of hepatitis B vax; refractory steroids-splenctomy done on 21SEP92;  Initial sx: petechial of extremities & mucosa bleeding from now & mouth;
Pt received first and second doses of vax. Approximately 3 months post second vax, the pt presented with flu-like symptoms, ankle pain and knee pain that began about one month prior to physician's visit. The pt's blood work was negative. Approximately 2-3 months post onset, the pt recovered. Additional information has been requested.
shingles; Information has been received on from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 11-NOV-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to inoculation with zoster vaccine live (ZOSTAVAX), the pt was treated by a physician for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
At around noon 2/11/21 i began getting a headache and took prescription strength Tylenol, by 730pm I started having chills and couldn?t get warm, eventually just going to bed. Through out the night I was sweating and experienced awful body aches and twitching. I woke up on 2/12/21 at 6:00am with a 100.4 temperature and slept until about noon at which time I had 101 temperature and then continued to sleep until 5p, still having a fever of about 100. I then slept until around 830am 2/13/21, still experiencing twitching, body aches and sweating. When I woke on 2/13/21 I had no fever, but still achy and in a ?fog?.
Per assessment of RN  Patient?s medical problem is:  Redness and swelling to L thigh on 8/7/23.since 8/7/23 S/P immunization  Symptoms:  Per mom: Patient has redness and swelling to the L thigh since 8/7, after she received her vaccine. Denies pain , redness or itching. Denies fever  or any other symptoms . Patient s able to walk Med: none
It was discovered on 05/13/23 that patient was given a second dose of Prevnar by mistake on 05/05/23. Per The Immunization System, patient has already gotten 1 dose of Prevnar 20 on 10/12/2022. Patient's record from pharmacy dispensing system also confirmed the aforementioned error. Patient was contacted regarding this incident and reported no adverse side effects since his 2nd dose of Prevnar 20.
stomach ache; constipation; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache) and CONSTIPATION (constipation) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache) and CONSTIPATION (constipation). At the time of the report, ABDOMINAL PAIN UPPER (stomach ache) and CONSTIPATION (constipation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.
48hr of nearly constant crying p/2nd DTAP;pt also recv Comvax & IPV on same day;
Pt vaccinated w/OPV/MMR/HBVC mother states on 13DEC90 PM - fever 101.6, dizzy - irritable taken to ER.
Cough, rhinorrhea and fever (Temp 104) x 5 days. Seen 12/2/04 (10 days after vaccine) and Dx'd with pneumonia PE significant for aspirators crackle at lt base.
Caller states she received her initial Pfizer vaccine  yesterday and immediately started  to feel swelling of the tongue and lips, however, she sees no swelling.  She states that these symptoms returned today about 9AM, she says still with no visible signs of swelling.  Instructed to go to ER for evaluation.
This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a female patient of an unspecified age. It was reported that whenever flu vaccine was drawn up, it leaked out from the rubber stopper (explicitly coded as product leakage). One of the nurses noticed when they popped the secured lock off the vial the rubber stopper was dented in and off a little. The nurses advised when they removed the hard cap and stuck the needle in the middle, there was a corner on the top where the rubber stopper was dented in causing a hole (explicitly coded as product closure issue) where medication would leak. About 5 doses were drawn out of 10 doses in the vial. The vials leaked and only 4 vials were leaking so far. On 01-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, deltoid, batch number: 252234, expiry date: 30-Jun-2019] from the leaking vial (explicitly coded as drug administration error). No adverse events were reported after administration of the vaccine. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was 1034101. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 252234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. A follow-up revealed the complainant was adding air to the vial prior to extracting doses and was inverting the vial when drawing the needle from the stopper. It is unknown that the addition of air to the vial can over pressurize the vial and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase the potential for the vial to leak. The root cause for this investigation was found to be User-Improper Handling (explicitly coded as wrong technique in product usage process). The reporter assessed this case as non-serious. This case 201804824 was cross-linked with the original case 201804823 due to the same reporter. Follow up report received from QA department on 19-Nov-2018: The QA investigation report stated that, the root cause for the leaking FLUCELVAX MDV of Batch 252234 was due to user or improper handling. Added new event (wrong technique in product usage process) in the event tab. The narrative was amended accordingly.
pt had chills, fatigue, 100.9 fever, weakness, and scratchy throat.  Her arm is very sore and a little swollen around the injection site.  She took Tylenol for her symptoms and seem to be getting better.
9-3-09 Back of Lt arm red, > than golf ball in size, hot to touch & feels swollen inside. Per Dr. Ok to give BENADRYL & cool compress if tender or improved to go the ED or RTC. (9-8-09) spoke with mom & did get worse on 9-4-09 & went to ER. given PREDNISONE. Today 9-8-09 much better.
Information has been received from a nurse concerning a 61 year old male with no past medical history who on approximately 06-NOV-2006, "last week," was vaccinated IM with a 0.5 ml dose of Pneumovax 23 (lot #655289/0958F).  There was no concomitant medication.  Subsequently the patient developed a very red dermatologic area covering his deltoid region.  Unspecified medical attention was sought.  At the time of the report, the patient was recovering.  The reporting nurse has requested a lot check due to the patients have adverse experiences.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released by the regulatory agency.  Additional information has been requested.
24 HOURS AFTER RECEIVING THE VACCINE MY LEFT WRIST BECAME INCREDIBLY PAINFUL. IT IS THE SITE OF AN OLD INJURY AND ARTHRITIS. ADDITIONALLY, MANY OF MY OTHER JOINTS BECAME PAINFUL AND MADE IT DIFFICULT TO MOVE ABOUT. AS OF TODAY, JUNE 14. MY SYMPTOMS ARE A LITTLE IMPROVED.
Urticarial rash, entire body after eating one bite of peanut butter jelly sandwich, 24 hours after vaccine was administered.  Area around DTaP was red, warm, and swollen also, but area around Pedvax was not.  Hives were giant and over entire body.  Given epinephrine 1:1000 x 2 with prompt resolution of hives within 1.5 hours.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, chills/ fatigue Narrative:
FEVER, COUGH,  Fatigue, Muscle or body aches, Congestion or runny nose, and Diarrhea
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 30-SEP-2013 the patient was vaccinated with M-M-R II (reported batch # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures for 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter link). Additional information has been requested.
pt recvd vax; by early eve pt had t102;inject site swollen, hot red & remained sore x several days; pt had high pitched cry x 4 hrs; remained fussy rest of night; MD contacted by phone;
This is a spontaneous report from a contactable pharmacist reporting on behalf of his mother. A 68-year-old female patient received PREVNAR 13, intramuscular, in left arm, on 09Dec2016, at 0.5 ml single, for immunisation. The patient medical history and concomitant medications were none. The patient was very sick, experienced fever, chills, nausea, vomiting, cold sweat, arm was red, all on 09Dec2016 in the afternoon, with outcome of not recovered. The patient was treated for sickness, fever, chills, nausea, vomiting, cold sweat. Treatment included oral TYLENOL 325 mg tablet every 46 hours but the patient still had the same adverse reactions and it was the same (persisting). Doctor visit was required for all the reported adverse events. The reporter considered that red arm was related to the suspect vaccine.
Intracranial Hemorrhage 11 days post booster vaccine, brain swelling leading to DEATH