chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CDC reports: 10 mo infant developed fever to 103.6 & convls, duration of illness 5 days.
mild or small pustule; the area started as a small white center/on his left thigh; it does itch.; red inflamed tissue on his left thigh; red inflamed tissue / little red spot with a white spot / looked like a bug bite / continued to grow; something bothering him on his back; second dose of Shingrix on 8/6/2020 / diagnosed with shingles / case of shingles; having a chill; he may have had fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart transplant (heart transplant in February 2016) and shingles (Family History) (the patient's father had shingles). Previously administered products included Zostavax (received on an unknown date in 2015).   On 6th August 2020, the patient received the 2nd dose of Shingrix. On 6th August 2020, less than a day after receiving Shingrix, the patient experienced chills and fever. On 7th August 2020, the patient experienced pustule, skin discoloration, pruritus, shingles, soft tissue inflammation and erythema. In August 2020, the patient experienced back discomfort. The patient was treated with acetylsalicylic acid (Aspirin). On 6th August 2020, the outcome of the chills and fever were recovered/resolved. On an unknown date, the outcome of the pustule, skin discoloration, pruritus, soft tissue inflammation, erythema and back discomfort were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the chills, fever and back discomfort to be related to Shingrix. The reporter considered the pustule, skin discoloration, pruritus, shingles, soft tissue inflammation and erythema to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix at 8:30 or 9:00 AM, and later that day experienced chill. As per reporter, the patient might had a fever but he could not confirm because he did not take his temperature. The patient took one Aspirin and the incident resolved. On Friday, he noticed a a mild or small pustule, little red spot with a white spot in the middle on his left calf which was surrounded by red inflamed tissue. It was about the size of a dime and looked like a bug bite. Saturday it was the size of a nickel so he went to ER where he was told that it was a side effect of the Shingrix vaccine and that he had a mild case of shingles. He was released and they did not provide any treatment for him because he was a heart transplant patient. The patient says it does not hurt but it does itch. The patient also felt something bothering him on his back but he had not been able to look at it yet. The reporter consented to follow up.
Immediate pain in arm injected in. Left hand hurt rest of day. In evening starting getting a headache and body felt uncomfortable, kinda like I needed to puke. About an hour later started to get cold chills. Then, that turned in full blown fever like reaction. I was super hot but I way covered by 4 blankets. I also had full body soreness during this time. Couple hours later the chills stopped and I was just extremely warm. After that,  another hour or so I started sweating from how hot I was. My house is between 65-75 anytime so it was my body. The next day I just had a headache and slight body aches and my arm with the injection still hurts alot. At the moment my head still aches, slightly. Body no very achy and my injection arm still hurts.
Fever chills; Fever chills; This is a spontaneous report from a non-Contactable Consumer (patient sister). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration on unspecified date at a single dose (1st dose and 2nd dose) for covid-19 immunization.  Relevant medical history included virus before she got the vaccine.  On an unspecified date, patient got the vaccine and had fever chills after it. Patient received 2nd dose took Tylenol and Zyrtec before the dose. The reporter asked if that was not recommended and if could affect the efficacy. The outcome of the events was unknown.   No follow up attempts are possible. Information on Lot/Batch number could not be obtained.
A report was received from a health care professional on 1/21/04 concerning a 45 year old male vaccinee who developed low frequency tinnitus lasting several months, 2 weeks after he received Fluvirin on 10/14/02. On 10/14/02 the vaccinee received Fluvirin. About 2 weeks later in November 2002 he developed a low frequency tinnitus that lasted several months and resolved by late summer 2003. In fall 2003, the vaccinee received Fluzone and the tinnitus returned. According to the vaccinee at the time of reporting the symptoms had mostly resolved, but are not 100% resolved. There was insufficient information to determine the reporter's causality assessment. Follow up pending
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot#J016188, expiration date:02-OCT-2016 and lot# J015437, expiration date: 09-OCT-2016.  The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 16 months old child patient of unknown gender. On 13-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route not reported, lot # J011121, expiration date 04-JUN-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Pt states she received the influenza vaccine at pharmacy at approx. mid-day on 9/17.  Pt states by that afternoon she was unable to lift her right arm due to pain.  Patient presented to her PCP's  office on 10/17/2019 where she was instructed to increase fluids, take Ibuprofen, and use warm compresses.  As of 10/28/2019 patient states her arm is feeling much better.
Fever CHILLS, NAUSEA, INSOMNIA Narrative:  Other Relevant History:
Patient said her arm became swollen and she developed a rash along her entire arm where vaccine was administered. Developed hives on arm too. Put ice packs and took ibuprofen. (Lasted 3 days).
20APR93 mom reported pt has frequent blank stares, a shrill cry & a temp, no thermometer to check degree; stomach flu virus;
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 23-DEC-2014, the patient was vaccinated with an improperly stored GARDASIL (lot # H020901, expiry date 05-JUL-2015) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a licensed nurse practitioner refers to unspecified number patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose and route were not reported) lot # L042846 and expiry date: 15-SEP-2017. No concomitant medications and no adverse effects were reported. The call was due to a data logger. No further information was available. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
It was reported that a 39 year old female pt received a TD Adult vaccination on 08/04/2000. Reportedly the pt received the vaccination at noon on Friday, developed headache several hours after. The next day the pt developed dizziness, nausea, and vomiting and unrelieved headache. On Sunday the pt experienced dizziness, ringing in ears and fainted. The pt was not seen by a physician.
57 Y male with with history of hypertension, hyperlipidemia, diabetes mellitus type 2, received 2 doses of Pfizer COVID19 vaccines on 4/2021 presents on 8/21/21 with shortness of breath. Patient had URI symptoms with cough since 8/15/21 that progressed to fever, chills and body aches on 8/16/21 then was seen in clinic on 8/18/21 for fever of 102F and sore throat, tested positive for COVID-19 on 8/19/21. Patient had a follow up telephone appointment with his doctor on 8/20/21 for persistent fever, fatigue, body aches and headache, then another telephone appointment on 8/21/2021 where patient reported SpO2 90-93% at rest with mild shortness of breath and was advised to go to the emergency department if his SpO2 dropped to less than 90%. Patient noted SpO2 drop to 88% so he presented to the emergency department on 8/21/2021, was noted to have SpO2 89% with ambulation with tachypnea and increased work of breathing so hospital medicine was consulted. Patient was also found to be hyponatremia at 121, repeat was 123. Patient reports shortness of breath with exertion but not too bad when resting. Patient reports poor oral intake in the past 4 days due to poor appetite but drinking lots of water (10 bottles per day).  FAILURE (8/21/2021) Symptom onset on 8/15/21. COVID positive on 8/19/21. He completed a 5 day course of remdesivir. His O2 remains stable at 2L at rest and 4L with exertion. He will complete his decadron course at home with 4 more doses. He is referred to oxygen clinic as well as for sleep study due to his concern for OSA.   HYPERLIPIDEMIA (2/7/2011) He was continued on his PTA statin.    DM 2 (4/10/2012) Patient takes Glipizide and Metformin as outpatient which have been held.  He was on NPH 6u BID and ISS while admitted. His PTA meds were resumed at discharge.    HYPONATREMIA (8/21/2021) Etiology most likely secondary to poor oral intake; patient also reported drinking increased water prior to admission. On date of discharge Na was WNL at 136.  Reason for Hospital Admission (Admitting Diagnosis):  Acute hypoxemic respiratory failure  - Pt Discharged on 8/26/21
Patient reports taking Tylenol immediately after getting vaccination on 5/4/2021 at 8:36AM. Reports feeling "fine" until Thursday night when she developed pain at injection site, shoulder area, back of neck and left jaw. She states she has already reported this to vaers via email and received confirmation of her email. She continued to take Tylenol with no relief over the weekend. She was seen by Dr. yesterday at 1:15pm. Reports she was given pain medication and pain patch. Patient reports waking up this morning with worsening swelling and pain in her eyes and jaw area, notes that her speech is different, "like baby talk" and that her jaw "has shifted over". She states she "woke up looking like a monster today". She denies any numbness or tingling in her body. She called into Dr. and left him a message earlier this morning and is waiting for him to respond to her. She does report hx of brain tumor at the base of her head and believes it may be flaring up after her vaccination.
red, circular rash.   a little warm to the touch.  but that's it.  no other symptoms yet.
Left arm swollen at site of injection.  Arm and finger swollen next morning.  Tingling in toes.  Tongue raw and sore and loss of taste. Very tired and achy.  Low grade fever and chills. Unable to put two sentences together.  Fill like my head is full of fog.
pt stated woke up 12AM & felt could not breath;pt was taken to the ER & was given epi & DPH;pt was sent home;c/o h/a x 24hr p/episode;
Flushed face, hot flashes, patient reports symptoms lasted for 10 minutes, patient was seen and cleared by EMS. Patient received vaccine left site and returned after 30 minutes of receiving vaccine. patient stated that she tested positive for covid-19 23 days ago, she reports her physician cleared her to receive vaccine
This spontaneous report was received from a medical assistant and refers to a currently 11 years old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant  medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L024993 with expiration date 17-SEP-2017, (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Pt experienced tendinitis of the biceps brachii of her arm 10 days /p receiving influenza virus vaccine.
Nausea the next day, exhaustion, constipation, weight loss of 15 lbs.
p/vax pt exp vomiting dark brown coffee grounds (blood) for 24 hr;no tx, resolved on its own;
This spontaneous report was received from a nurse of unknown age and gender, regarding him/herself. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient administered valacyclovir hydrochloride(VALTREX) concomitantly (concentration, dose, frequency and indication were not reported) less than 24 hours prior to administration of ZOSTAVAX 19400 PFU (dose, anatomical place of vaccination, route, lot# and expiration date were not provided), for prophylaxis and then, also in the days after administration of ZOSTAVAX.  No adverse effects were reported. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site irritation in a unspecified number of adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site irritation. On an unknown date, the outcome of the injection site irritation was recovered/resolved. The reporter considered the injection site irritation to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The health care professional reported that they administered about 20 SHINGRIX doses and out of those 20, 2 to 3 patients reported irritation at the injection site. The health care professional wasn't alarmed because this was expected and fully resolved. The health care professional was reporting this as a general adverse event. She did not provided specific information.
Narrative:  55 yo patient with many comorbidities was given his first covid vaccine on 3/18 and on his way home was taken directly to local ER with anaphylaxis. He was treated and discharged that day and given an epi-pen and Benadryl in case he flared up again.
Approximately 5 minutes after receiving her Covid Bivalent booster vaccine, patient became light-headed and appeared to have a vasovagal syncopal event and collapsed to the floor.  She appeared "dazed" for a few minutes but was able to respond to questioning within less than a minute.  She did not appear to have any head injury or other bodily injury due to the fall.  She did claim that she was on her period and was experiencing menstrual cramps and also had not eaten anything since she woke up.  After patient was assessed and vitals taken, she was assisted into a chair and given some crackers and water.  Within 15 minutes, she felt well enough to go home.
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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 at 16:00 as dose 4 (booster), single (Lot number: Fj6369) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. No other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Indication=Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. Paxlovid, treatment start date: 12May2022, treatment stop date: 16May2022. Additional Information: This is a notification generated from the system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in RA Q1215 and/or Q1252. Conclusion of Previously Completed Investigation: The complaint for "PFIZER BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FP FJ6369 (SF: FJ6287). A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. RA concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record. Follow-up attempts are completed. No further information is expected.
numbness and weakness in my legs; numbness and weakness in my legs; difficulty urinating; This is a spontaneous report from a contactable consumer (reporting for himself). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Leg Left on 11Mar2021 at 05:30 (Batch/Lot Number: EN6208) as single dose for COVID-19 immunization. Medical history included transverse myelitis. The patient's concomitant medications were not reported. The patient previously took acetylsalicylic acid (ASPIRIN) and terbinafine, both for unspecified indication and experienced allergies. On 11Mar2021 at 10:30, the patient experienced numbness and weakness in his legs and some difficulty urinating. The patient was hospitalized. The patient did not received treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Mar2021. The outcome of the events was recovering.  Information about Lot/Batch number has been requested.
Information has been received from a registered nurse concerning her 26 year old female daughter who on 14-NOV-2006 was vaccinated with the first dose of Gardasil, injection, 0.5 ml. Concomitant therapy included Ortho Tri-Cyclen. On 15-NOV-2006 the following day after receiving the first dose of Gardasil, the patient experienced nausea, vomiting and severe ovary aches. On 12-DEC-2006, the second dose of Gardasil, the patient experienced nausea, vomiting and severe ovary aches. The third dose of Gardasil was received on 13-APR-2007. On 14-APR-2007, the patient experienced nausea, vomiting and the patient has recovered from the events. Additional information has been requested.
Pt presented 8 days after MMR vaccine with fever, hives.  08/03/2007 MR received for DOS 7/24-25/2007 for c/o hives, fever, tonsilitis and L otitis media (DXd in MD's office).  Fevers and hives began 7/22/07.  Attempts to give Orapred and Benadryl PO resulted in vomiting, therefore child was hospitalized.  PE (+) for hives, L TM erythematous and bulging.  Eyes sunken.  Tonsils 3+ with exudate, shotty cervical lymphadenopathy, welted lesions all over torso.  DX: Fever. 2' to tonsillitis and ear infection or possibly MMR.  Hives-viral or 2' to MMR. LOM and Tonsillitis
SHINGRIX was administered approximately one month after the pt had Shingles of the left-side of the face and ear. Pt is under 50, but was prescribed the vaccine by Dr. as he had a severe case of shingles and his PCP wanted to prevent another occurrence. Pt recovered from Shingles last month, but noted that he had permanent facial neuropathy. Administered a SHINGRIX vaccine on 6/15. Pt noted on 6/19 that on 6/15/18 at 13:00 (approx. 3.5 hours after administration), he started to have trouble involuntarily blinking (he reported that he could voluntarily blink though). Pt reports that that particular AE has improved as time went on, but still hasn't fully resolved. He reports he also had sweats - flu-like symptoms on 6/16 and 6/17. I talked to the patient today, (it was initially reported yesterday, 6/18, to another pharmacist), and recommended that he notify his PCP, Dr., who had wrote the prescription and had treated his Shingles. He agreed to my request, and told me he'll contact her tomorrow (6/20). Lot # of Shingles powder: Z9RR4 (exp 11/15/20). Lot # of Shingles Adj. Diluent: 32PE4 (exp 1-23-21).
pt recvd vax & devel diarrhea; @ the time of this report diarrhea persisted; No further details were provided;
I have been having a lot of dizziness and leg weakness. I get some pressure in my head and I get dizzy and my legs start to shake and I have fallen a couple of times. I have had a couple of doctor visits. I was just prescribed Meclizine to help with the dizziness.
pt recv vax 10JUN97 about 3 days later pt lt upper arm became sore on 16JUN97;there was redness more pain;had difficulty using the arm;had been febrile;18JUN97 seen in ER dx w/cellulitis tx w/med;t97.8
Nauseated, Dizziness, racing heart rate, mild fever that comes and goes, weakness, mild chills
Chills, 6 hours,  body aches 24 hours, headache 24 hours, foggy brain 24 hours
A few weeks after getting 3rd dose I got a random freak period. I was already in menopause which was also confirmed thru blood testing. I hadn't had a period in 14 months prior to vaccine shot. I was checked for other issues like cancer or abnormal pap smear but was cleared. I Never got another period after the only random one in November. Then in mid January of 2022 my primary doctor recommended a complete routine blood workup because it hadn't been done since May of 2020. I wasn't sick and had zero symptoms. My results from blood test in mid January of 2022 showed a  very high blood platelet count. I was sent to a blood specialist and thru more blood testing and a bone marrow biopsy  was diagnosed with Chronic Myelogenous Leukemia stage 1 on February 17 2022.