chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-OCT-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician 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. On 01-OCT-2015, the patient was treated by a physician for a persistent vesicular rash, 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.
Also had dizziness while sitting down. Felt like I would have fallen if I stood up so I sat for 20mins.; Mental confusion; couldn't gather my thoughts or write what I wanted to say; mental 'fog'; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 34-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm, on 28Dec2020 13:15 at single dose for COVID-19 immunization. Medical history allergy to penicillin. The patient is not pregnant during the time of vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin and cefalexin (KEFLEX) and experienced allergies to both. The patient experienced mental confusion, mental 'fog', "couldn't gather my thoughts or write what I wanted to say", also had dizziness while sitting down (felt like I would have fallen if I stood up so I sat for 20mins) all on 28Dec2020 at 13:15. The patient did not receive treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 28Dec2020 at 13:45 (reported as events subsided after 30 minutes). The reporter assessed the case as non-serious.
Started with itchy hands and feet progressed to stomach pain vomiting nausea. Fever 103. Drowsiness weight loss. Liver enzymes escalated severely.  Blood in urine.
No additional AE reported; Patient was administered improperly stored, seprate PNEUMOVAX 23; This spontaneous report has been received from a office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 23-DEC-2022, the patient was vaccinated with a improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, see event description, lot number W007035 verified as valid, expiration date reported as 23-OCT-2023, and upon internal review established as 20-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided) at a temperature of 55.0 degree Fahrenheit for 153 hours (product storage error).  This is one of several reports from the same reporter.
FEVER @ 103 FOR THE PAST THREE (3) DAY'S PER MOTHER.
I noticed swelling on my cheek that was getting bigger. I started to feel some tingling on my jaw on the left side and my arm, and I got concerned. I did a phone visit with a doctor, whose name I do not know unfortunately right now, and he said that I should go to the ER and that it seemed to be a carbuncle, and prescribed Cephalexin.   I went to the ER, and the doctor there had to try to open the area in my cheek and it was like an abysses and he was trying to drain it.
Tinnitus, clogged ears, head pressure starting twenty hours after vaccine and lasting 48 hour. Head ache lasting greater than 36hours.
patients being administered expired ACTHIB with no reported adverse event; Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA046771.  This case involves a 15 months old male patient who being administered expired haemophilus type B (HIB) vaccine (ACT-HIB) HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Influenza  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Immunisation.  On 01-Nov-2022, the patient received a dose 4 at dosage 0.5 mL of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection, (lot number: UJ594AAA and expiry date: 26-Oct-2022 via intramuscular route in the left vastus lateralis for immunization with no reported adverse event (expired product administered) (latency: same day).  No lab data was reporte.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 guidelines. 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.
Onset 6-8 hrs after MMR vaccine: dizziness, body aches, N/V, fatigue - ? fever, "felt warm" (did not take temp). Symptoms above lasted 24 hrs. Denied local skin reaction.
pt exp MS vs Transverse myelitis; AUG92 rec hept vaccine; 1 wk later, paresthesias below waist, LE weak; Rx w/Prednisone;
This is a spontaneous report from a contactable physician received via Pfizer sales representative. This physician reported that a consumer (patient's mother) referred that a 7-month-old male patient received PREVNAR 13 (lot S58703, expiry date 31Oct2019), PENTACEL, hepatitis B vaccine (unknown Manufacturer), influenza vaccine (unknown Manufacturer) and ROTATEQ, all on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not reported. On vaccination evening the patient developed a fever and had a seizure. Patient's mother called 2 days later to report to office and that she did not seek medical attention for the patient. The patient had only one seizure and recovered on an unspecified date. The outcome of fever was unknown. Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of "seizure" cannot be fully excluded considering the known adverse event profile of PREVNAR 13.
Rash locally on both anterolateral aspect of the thigh - on 6/1/2011, gradually getting better. Mother gave only TYLENOL for fever.
Expired Kinrix administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 1st February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details reported were as follows: The medical assistant reported about the administration of expired Kinrix to the patient, which led to expired vaccine used. Therefore a repeat dose of Kinrix was administered on 15th March 2022 (Lot number H9FM5 and Expiry date 7th May 2023). The reporter consented to follow up.
Pt received second dose of Pfizer on 5/11/21 was in observation for 20 minutes and c/o itching, no rash visible.  Benadryl 50mg IM given with good results.  Pt stable.
Patient received vaccine on October 13, 2018, and hours later has severe pain in upper left shoulder, dismissed the pain as part of the flu shot and it has never gotten any better. Patient took ibuprofen multiple times with some relief. Patient presents to pharmacy counter with first encounter since flu shot stating she has had pain in left shoulder where you received your flu shot and has daily pain in arm. She states it is hurting now. She has not reported to a doctor, no swelling or nodules, she presses on arm and says it may be a tight feeling there, she thought it would go away. Patient has had no relief with use of ibuprofen. At time of injections, adverse events are told may have redness, soreness or swelling, can last up to 2-3 days, can take TYLENOL and apply cold compresses every 20 minutes. Patient is now referred to doctor since she reports these symptoms now and have lasted longer than 7 days.
2 hours after vaccine pt started to feel like inside and outside of mouth burned and tingled. No facial swelling, throat or mouth swelling, sob, chest pain, or any other symptoms.  Benadryl 25mg given upon rearrival to clinic (6 hours after vaccine)- pt noted improvement of symptoms after about 20 minutes. Stayed additional 40 minutes still feeling better, then went home.
Mother called provider office @ 3pm and reported baby had been crying uncontrollably for 2 1/2 hr. Office staff spoke with parent at "3:23pm", still crying; they advised giving baby Tylenol and to call back if continues to cry; No call back.
pt recv vax & 1 1/2yr later pt exp chickenpox w/approx 5 to 6 lesions form which pt recovered
Patient received Moderna vaccine on 05/05/2021 at 1:54PM. Roughly, 3-5  minutes after her injection, the patient began having symptoms of increased heart rate (140's). Patient was re-checked with office pulse oximetry. Heart rate then dropped to 110's and oximetry reading was 99%. Patient began shaking uncontrollably and with slight chest pain. Heart rate began fluctuating between 60's-150. Patients was evaluated by on site MD. Electrocardiogram was performed on the patient. Full set of vital and glucose finger stick performed on the patient. 50mg of Benadryl was administered to the patient. MD made the decision to send the patient to local ER for evaluation. ER was called and patient was transferred to local ED by ER.
Patient was given vaccine by mistake; she was supposed to get Gardasil 9 shot 3. She experienced nausea on Sunday which was did not suspect was caused by the vaccines.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 4:53 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 4:53 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions were reported.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
Headache; tired; arm was sore; This is a spontaneous report from a contactable consumer (patient) reporting for different event under the same suspect product for herself. This is one of two reports.  A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 04Mar2021 at 09:05 (at age of 67 years old, Lot Number: EN6206) as single dose for covid-19 immunization. Medical history included ongoing allergy and hypothyroid; Inflammatory arthritis, diagnosed at least 5 years before; stated that was when they really found out she had the spondylosis and she got the CRPS, Complex regional pain syndrome, with nerve damage in her right foot from surgery. Adds she doesn't take anything for it. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for allergy from an unspecified start date and ongoing; levothyroxine sodium (LEVOTHYROXINE) taken for hypothyroid from an unspecified start date and ongoing. The patient experienced headache, tired and arm was sore on 04Mar2021. she had the first dose of Pfizer on 4Mar2021 and initially she had a headache within about 15 minutes; she felt tired and her arm was sore. The outcome of the event headache was recovered on 25Mar2021, event tiredness was recovered on 31Mar2021 and outcome for event pain in arm was not recovered.  No follow-up attempts are needed. No further information is expected.
lethargy; headache; injection site pain; exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Jan2022 18:00 (Lot number: fj5682) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "neuropathy" (unspecified if ongoing); "ocd" (unspecified if ongoing); "narcolepsy" (unspecified if ongoing); "sulfa drugs allergy" (unspecified if ongoing). Concomitant medication(s) included: LUVOX CR; OMEPRAZOLE; NUVIGIL; XYREM. Past drug history included: Codeine, reaction(s): "allergy"; Ceclor, reaction(s): "allergy"; Hydrocodone, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: ew0196, Location of injection: Arm Left, Vaccine Administration Time: 07:00 PM, Route of Administration: Intramuscular), administration date: 25Jun2021, when the patient was 30 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Batch/Lot No: ew0180, Location of injection: Arm Left, Vaccine Administration Time: 07:00 PM, Route of Administration: Intramuscular), administration date: 04Jun2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: LETHARGY (non-serious) with onset 14Jan2022, outcome "recovering", described as "lethargy"; HEADACHE (non-serious) with onset 14Jan2022, outcome "recovering", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 14Jan2022, outcome "recovering", described as "injection site pain"; FATIGUE (non-serious) with onset 14Jan2022, outcome "recovering", described as "exhaustion". Therapeutic measures were not taken as a result of lethargy, headache, vaccination site pain, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  clinical course: The patient was not received other medication in 2weeks. Anti-viral details: treatment of COVID-19 included Paxlovid was started on 04Jun2022 and treatment stopped on 08Jun2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect BNT162B2 cannot be denied for the reported events.
Local erythema and induration around injection site immediately after injection. Erythema spread distally to approximately 12 cm. Benadryl 50 mg given orally.
Patient reported normal pain at injection site at the time of vaccine.  States pain spread over several weeks to a larger area. Also c/o tingling and numbness in fingers. Evaluated by a neurologist and recevied dx of focal ulnar neuropathy.  Had OT for dx of cubital tunnel.  Treated with exercise and soft splint.
During the night while sleeping, was awakened with a severe pain in my back that felt like a very bad brush burn around the area of my right shoulder blade.  Was unable to sleep on my back for the rest of the night.  It is still there this morning although it doesn't hurt so bad unless I lean back against something.
Fever, fatigue, loss of appetite, drowsiness, excessive crying when awake, pain red swollen injection spot, excessive sleep, irritable, mistrusted parents, mistrusted nurse, mistrusted doctor, withdrew from parents, tried to isolate self from adults.
Information has been received from a literature article concerning a 14 year old female patient developed uveitis and conjunctival hyperemia, following administration of GARDASIL. The patient had as a pre-existing conditions tubulointerstitial nephritis Wegener's. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476 days); time to onset was unknown in 1 case; the time to onset in this case was of 7 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. There was insufficient data in the case reports to determine whether co-morbid Wegener's granulomatosis and tubulointerstitial uveitis were excluded as the cause of uveitis in this case. According to the World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
pt recv vax 20NOV96 & 22MAY96 pt exp measles;mom also reported that child devel chickenpox p/varicella vax WAES97031975;
Hard red and itchy spot appeared, approx 3.5cm around the injection site. painful and warm to the touch, itcy. Appeared 2 days post injection. Did not occur on first injection, just second. No treatments, just icing. Still ongoing after 2 days.
Went grocery shopping after vaccine, then went home. Around 5 pm started feeling uncomfortable and tired. I went to bed around 7 pm thinking I was getting a fever. Fell asleep, woke up around 8:30. I had horrible fever, got cool wash cloth. Tried to ignore this and sleep. The fever was very high. I used to get 106 fever often when I was younger. I got cold water bottles and put them in my armpits as I dread taking a tepid bath. The water bottles did not hurt as much as tepid bath. I don't know how high my fever was, but I wasn't well. In the morning, my temperature reduced to 99.6. By the next night it was down to normal 97.5. Also found my underwear in the living room on a table. High fever can make me delirious.