chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 19 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On 10-AUG-2018, the patient was inadvertently vaccinated with PROQUAD (therapy type rHA) (lot # N025924 with expiry date of 18-MAR-2019) for prophylaxis (drug administered to patient of inappropriate age), after an unspecified "blood test" was performed and the results showed "low titre levels".  The patient sought medical attention. The outcome of viral titre decreased was reported as recovered. The causality assessment was not provided by the reporter. No product quality complaint was filed.
Approximately 3-5 hours after vaccines administered, generalized tonic clonic seizure lasting 40 minutes, with fever. Resolved in hospital after Ativan given. Kept in PICU 3 days.
pt exp inconsolable screaming for 4-6hrs following vax;seen by MD p/4hrs;fully recovered;
Disseminated zoster infection, MRSA infection--sepsis and pneumonia, acute respiratory failure, altered mental status.
Muscle aches throughout entire body within 10-12 hours post vax. Onset of flu-like symptoms(congestion, runny nose, sore throat, fever) within 24 hours post vax. Symptoms lasted 5-7 days.  Follow up 06/05/2000: "Patient recovered from adverse event. Patient received further anthrax shots with events: similar to 1st shot-flu like symptoms to include congestion, headache-symptoms also included prolonged tiredness."
Pt recvd vax on 21FEB91 & later that day devel hives; Seen in office the next day; tx included DPH;
A consumer report has been received concerning a female patient. No medical history of the patient was reported. No concomitant medication of the patient was reported. The patient (mother) was exposed to her son, being in close proximity, who had been receiving nasal FLUMIST which was started on 16-Nov-2012. The patient's mother reported that she had a secondary transmission and developed flu like symptoms on 19-Nov-2012 and then had a flu. Action taken with suspect drug was unknown. At the time of reporting, the outcome of the event of secondary transmission and flu/flu like symptoms was unknown. The company physician assessed the events of secondary transmission and flu/flu like symptoms to be non-serious.
Red, swollen, hardened area on (L) upper extremity. Completed series - 2nd booster 48 hrs ago.
Pt received a flu shot (Fluzone,lot # U1147AA, 0.5ml/IM/Rt. Deltoid) at approximately 07:45am.  Client had reported receiving previous flu shots and denied allergies at time of administration.  Approximately 2hrs later, at 09:50am, presented at the Health Dept., stating his co-worker noticed his lip was swollen.  Client's supervisor sent him the the HD for follow-up.  Client was in no discernable distress, and apart from a swollen lower lip, showed no other allergic signs or symptoms.  The above-named MD examined pt and ordered Benadryl 50mg, IM, which was given at approximately 09:55am.  Client was instructed to remain at HD for 30 min. for further observation, and left without further incident at 10:25am.
very very sore arm.; Headache; chills; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing), notes: other medical history: Psoriatic arthritis. Concomitant medication(s) included: LOSARTAN; ATORVASTATIN; VITAMIN D3; COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE]. The following information was reported: HEADACHE (non-serious) with onset 19May2022 at 17:00, outcome "recovered" (May2022); PAIN (non-serious) with onset 19May2022 at 17:00, outcome "recovered" (May2022), described as "body aches"; CHILLS (non-serious) with onset 19May2022 at 17:00, outcome "recovered" (May2022); PAIN IN EXTREMITY (non-serious) with onset 19May2022 at 17:00, outcome "recovered" (May2022), described as "very very sore arm.". Therapeutic measures were not taken as a result of pain in extremity, headache, chills, pain.  Additional information:  No covid was reported prior to vaccination. Not tested to covid post vaccination. No Known allergies were reported. No other vaccine in four weeks. Age group: Adult (18-64 Years). Sore arm and headaches lasted a bit longer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The day I got the vaccine I noticed a lot of muscle stiffness and joint pain especially in the shoulder, my ROM in the shoulder was limited. I had like really tense muscles in my lower back and pretty much most of my extremities. I remember taking Ibuprofen that night to go to sleep because I had a head ache. The next day I still kind of felt like recovering from a cold like still having the achiness and dizziness like your head is kind of heavy. Its been pretty persistent of those symptoms since then. On 03/23/2021 I had a doctor?s appt and they assured me that we lost our baby and they were worried about my blood pressure, it was 149/106 with pulse of 88. They told me that I should be worried about my blood pressure because that is extremely high and to take caution and monitor it. That is when I started doing the weekly reports. We do not know if the blood pressure was related to the pregnancy but it has come down since then. Since then I still have the occasional head ache and dizziness, right now I am actually sick with cough and mucus and I am schedule to take a Covid test. I had high blood pressure during pregnancy before.
Ten days after the vaccine I woke up in the morning with little lumps on my ankles and the top of my feet. By the end of the day ,they were pointy hard lumps with heads on them. They spread to other parts of my body. They would rupture and they were huge. They were very itchy and painful. They were on my thighs, arms, back but they were worst on my feet ankles and calves. I took Benadryl and Epsom Salt baths which helped but they were there for a week. The first three days were the worst. They were popping up a few at a time for another month. They later ones were mostly on my thighs and I never had any on my arms. I have never had hives that ruptured so easily and were so big.
My arm was super sore I couldn't move it, had a huge lump under my injection,  a really big red rash bigger then a baseball and was super hot to the touch, a low grade fever, headache,  nasuea, really tired and no energy.  Still having some issues.
Approximately 24 hours after receiving the vaccine, patient developed a swollen rash on her face. No difficulty breathing, no swelling of the tongue or lips. Some swelling of the eyes. Parent gave Benadryl and hydrocortisone. Hydrocortisone helped and rash was gone by morning. The next evening, patient developed same exact reaction. Hydrocortisone applied and rash was gone by the next morning.
Patient was given a dose of a Pfizer pediatric vaccine that was not reconstituted. Patient experienced severe side effects the next morning at 4:30am that included high fever, arms and head hurting, and vomiting. Patient was taken to ER and was given zofran and ibuprofen. Patient returned home later that morning and fever subsided.
Pt received immunization around 11:30 am. Slept for awhile after getting home. Then started screaming at 3:35 pm and would not be comforted. Nurse spoke to mother around 5pm. Pt afebrile T 97.2. Baby does not want to take feedings.
11/22 2021: swollen axillary lymph nodes & nausea through 12/6/2021 12/6/2021: head congestion with persistent cough 12/7/2021: home test for Covid - Negative 12/11/2021: severe coughing, visit to urgent treatment clinic, Covid negative. Diagnosis exacerbation of allergies. Treatment: prednisone injection, Augmentin, Rx for Augmentin, loratadine, fluticasone nasal spray 12/13/2021: severe coughing, SOB, visit to Emergency Room, Covid negative. Diagnosis exacerbation of COPD. Treatment: prednisone injection, albuterol by nebulizer, IV ceftriaxone, Rx for doxycycline 12/15/2021: follow up with pulmonary specialist, Diagnosis pneumonia, Treatment prednisone injection, Rx levofloxacin, albuterol inhaler
This spontaneous report as received from a nurse refers to an adult female patient of unknown age, who worked in a nursing home. On approximately 08-MAY-2014 (also reported as last week), the patient was vaccinated with her first dose of M-M-R II injection, dose (unknown) and route of administration (unknown). No concomitant medications were reported. In approximately MAY 2014 (also reported as on an unspecified date), the patient developed cervical lymphadenopathy. Patient sought medical attention (unknown type). Action taken with respect to M-M-R II was not applicable. No product quality complaint was involved. The outcome of cervical lymphadenopathy was not resolved. Causality was not reported. No further information provided. Additional information has been requested.
Pt was given an expired dose of vaccine; this lot # expired 10/31/2022. Pt called and updated; aware she should be re-dosed. No adverse effects reported.
Patient had severe right arm pain that significantly limited her ability to use her arm and had a very large bruise at the site of injection that took about 3 weeks to resolve.
13DEC95 a little irritable, went to sleep, woke @ 130AM & temp 104 R, hands face flush, cool bath given;APAP given also;PC 14DEC95 from mom pt's t102 R instructed to call MD take pt to be seen;
Patient discharged from clinic at 6:07pm.  He returned at 6:55pm complaining of muscle jerking.  He sat in a chair and began to seize.  He was assisted to the floor and had a grand mal seizure that lasted approximately 1 minute.  His VS remained stable.  He was confused after seizure, but responded to name and had garbled speech.  He was able to focus and follow simple commands.  EMS arrived and his speech clear and he was oriented X 3 at that time.  Patient transported to Emergency Department.
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 PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 65-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 16-Nov-2021 at 4:56 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021, 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, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (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 Products were reported. No Treatment information was reported.
CHILLS; NAUSEA; RAN A TEMP OF 102°F; FEELING TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced chills, nausea, ran a temp of 102°f, and feeling tired.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine  was not applicable. The outcome of the chills, nausea, ran a temp of 102°f and feeling tired was not reported. This report was non-serious.
Increase heart rate; This is a spontaneous report from a contactable physician  received via a sales representative.     A 13-years-old female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization.  Relevant medical history and concomitant medications were not reported. On an unspecified date the patient experienced increase heart rate serious for hospitalization with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client presented for second dose Moderna.  Nurse drew up 0.5 mL dose.  As dose was being injected, the needle separated from the hub and more than 50% of dose ran down arm.  Client revaccinated per his consent without incident.  Needle used was Easy Touch Fliplock Safety Syringe; 3 mL, 23 Gauge Lot number 52378
Fatigue; Burning with last injection; Sore arm; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), INJECTION SITE PAIN (Burning with last injection), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade fever) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), INJECTION SITE PAIN (Burning with last injection), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade fever). At the time of the report, FATIGUE (Fatigue), INJECTION SITE PAIN (Burning with last injection), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade fever) had resolved.            No concomitant medication was reported. No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of fatigue, sore arm and low-grade fever was not provided. The reporter's causality for the event of burning with last injection with Humira (adalimumab) was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
PT EXPIRED OF COVID-19 ON 9/5/2021; BREAKTHROUGH CASE
received both Shingrix shots/ get shingles/ suspected vaccination failure; Shingles; Post-herpetic neuralgia pain; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On 4th July 2019, the patient received the 2nd dose of Shingrix. In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. The patient was treated with valaciclovir (Valacyclovir) and gabapentin. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and post herpetic neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received both Shingrix shots in 2019, 3 months apart. Since getting the Shingrix vaccine series, the patient has continued to get shingles (twice) and suffers from the post-herpetic neuralgia pain. The patient received Gabapentin and Valacyclovir for pain and to treat the shingles. Spoke per content in terms of her inquiry about getting a 3rd shot of Shingrix and supplied her with  number for her health care professional.  The reporter did not consent to follow up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
4/21/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, he experienced an adverse reaction with the following symptoms:  nausea and tingling and numbness to cheeks and tongue/ c/o of tiredness.   Assessment : Time of assessment *1634. Alert and oriented, Tachycardia, Pallor, Diaphoretic, Clammy and Nausea.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN. Water x 2 and 1 juice, VS taken at 1634- BP- 141/89, P- 110, O2- 98%, 1642, BP- 139/88, P- 102, O2- 100 %, 455pm, BP- 123/78, P- 97, O2- 100%, 514pm, BP- 123/81, P- 100, O2- 100%       Medications administered: Loratadine (Claritin) 10 mg  by mouth. Time: 1645. Administered by RN. Famotidine (Pepcid) 10 mg by mouth. Time: 1645. Administered by RN. Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: x 2 doses at 1634 and 1645. Administered by RN.   Disposition: Reports no further symptoms of adverse reaction after observation for 60 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.  Wife with patient.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/21/2021  4:16 PM 0.3 mL 2/25/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER8735   NDC: 59267-1000-2          Electronically signed at 4/21/2021  5:33 PM  Immunization on 4/21/2021   Detailed Report  Note shared with patient
Arthralgia, UrticariaPruritus, SWELLING, WARMTH AND HARDNESS WITH INCREASED PAIN AT SITE OF INJECTION; Narrative:
A week later I stated having fluttering in my chest.  I finally called my doctor on 4/29/2021 and he sent me to the hospital to be checked out to make sure I was not having a heart attack. After being checked out at the hospital they assured me the fluttering was not a heart attack but it was Palpitations. I was referred to a heart doctor who gave me instruction for my diet and gave me medication to take if the palpitations continued.  My doctor did not believe the palpitations were caused by the Vaccine.
Subsequent to receiving varicella virus vaccine live the pt developed breakthrough chickenpox. An additional pt had a similar experience following exposure to varicella virus vaccine live.
At 8pm noticed difficulty getting up from sitting and left thigh pain. Developed headache, nausea, numbness and tingling both feet, left greater then right. Weakness left leg. On exam had severe limp, absent DTR except right knee. Also had headache, fever, cough on 10/1/09 one day after seasonal flu vaccine.
pain in her left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 02Dec2021 (Batch/Lot number: unknown) as dose 3, (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization; Bnt162b2 (Dose: 2), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "pain in her left arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Agent stated caller was a consumer who received the Pfizer COVID vaccine primary series and the booster dose. Agent stated the caller stated she received the booster dose on 02Dec2021 and starting late Dec she began having noticeable pain in her left arm.  Agent stated caller has sought no treatment. Agent stated caller would like to know how long the pain will last.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information regarding Hib-Titer was received from a healthcare professional regarding a 5-year-old female patient who experienced antibody test negative. The patient received a dose on an unspecified date. The patient experienced antibody test negative on an unspecified date. No further information was provided. Blood immunoglobulin G (results: normal) was done on an unspecified date. See related case (s): HQWYE565230JAN06 (adverse event, expedited) in which the same reporter revealed this patient experienced pneumococcal meningitis after receiving 3 doses of Prevnar.
pt recvd vax & exp tenderness & firmness in rt deltoid; tx w/ heat & ice; inflamation;
Fever reaching 100.4°F  from apx. 18:00 on day of vaccination until some time after 11:00 (AM) of the following day. Skin was hot to the touch. Fever responded to oral paracetamol. Whole body pain and muscular weakness that developed by 18:00 on the day of vaccination and lasted for the two days following vaccination.  Severe ocular headache persisting from development of other noted effects for apx. 2 days following. Headache sensitivity to light and auditory stimuli. Fatigue from onset of adverse effects for apx. 2 days.
Small fiber neuropathy & postural orthostatic tachycardia syndrome (POTS) Numbness in my extremities (left arm first, then both arms, that continued to my feet and legs) & face (first on one side, then the other, and then traveling numbness), electric-shock like nerve pain, tachycardia, dizziness, migraine headaches, nausea, chest pain, blurred vision, brain fog, GI problems, tightness in throat and itching tongue when eating/drinking on and off, and shakiness.