chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered Pentacel to a patient, after giving shot nurse realized she was not able to reconstitute Hib component of vaccine, patient only received DTaP-IPV component with no reported adverse event; Initial information received on 07-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional (nurse).  This case involves a 4 months old male patient who was administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] to a patient and after giving shot nurse realized she was not able to reconstitute Hib component of vaccine, patient only received DTAP-IPV component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. There were no concomitant vaccines administered.  On 07-Jul-2023, the patient only received DTAP-IPV component at a dose of 0.5ml (dose 2) of suspect Diphtheria/Tetanus/5 HYBRID AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of lot UJ843AB and expiry: 24-Feb-2024 (strength: standard and frequency: once) via unknown route in the thigh NOS for immunization and after giving shot nurse realized she was not able to reconstitute HIB component of vaccine, patient only received DTAP-IPV component with no reported adverse event (single component of a two-component product administered) (Latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event single component of a two-component product administered.   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.
10/08/2021 around 9:30 pm started to experience pain in the heart, felt like someone was poking my heart with a needle and it was gone immediately. Happened every few minutes for 15 minutes or so, then would abate, pick back up again after various intervals. This went on until 10/09/2021 at 3:00am. Experienced this needle through heart on and off until 2:00 pm. Started back up again about 6:30 pm until about 10:00 pm. On 10/10/2021, experienced once instance after 10:30 am. It is 11:30 am as of this writing.
Syncope. She was in the waiting room and passed out. She woke up within seconds but seemed lethargic. She was brought to a room. Vitals were obtained and wnl except for a low BP of 60/40.  She had not had anything to drink yet today, and we gave her water. Within 10 minutes, BP was repeated and up to 92/50. She felt much better, and mom brought her home via her car.
neck and face, and her face was warm, swollen, she didn't experience any fever  spoke to the pharmacist who expressed they are side effects to the vaccine it could have been an allergic reaction
Patient had a Moderna COVID-19 booster on 12/23/21.  Patient developed flu-like symptoms the next day.  The following day, pt developed on and off chest pain which eventually became constant.  In the ER, vital signs normal & stable except tachy ~100, BP 80s/60s
Expired dose was given to an adult patient; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received HAB (Twinrix adult) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th August 2022 12:00, the patient received Twinrix adult (intramuscular). On 24th August 2022, the patient started Twinrix Pre-Filled Syringe Device. On 24th August 2022 12:00, unknown after receiving Twinrix adult and Twinrix 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 Information: GSK Receipt Date: 24-Aug-2022:  Reporter's comments: The healthcare professional reported that an adult patient received expired dose of Twinrix, on the day of reporting at noon on left deltoid.  The patient did not report any side effects.  The reporter did not consent to follow-up. Additional Supportive Information: The patient was administered an expired dose of Twinrix, which led to expired vaccine used.
Seizure lasting thirty seconds, followed by unresponsiveness lasting for thirty seconds.  He was also hypotensive for about five minutes.  He was treated by lying him down and elevating his legs until his blood pressure normalized.
Patient reports feeling warm.  Injection site is not red, swollen, or irritated looking.  Had patient sit and apply an ice pack to the injection site.  Patient also reported pain in the ring & pinky finger of his right arm.  Patient was advised to sit and hold ice pack for 15min - patient got up at 12:18 and reported that he felt fine.  I visibly checked the injection site prior to his getting up, and again at approx 12:50p - no reaction, swelling, or redness visible.
This spontaneous report as received from a Registered Nurse refers to an unspecified multiple patients of unknown gender and unknown age. On an unknown date, the unspecified multiple patients were vaccinated with doses of PROQUAD (lot/batch number, expiration date, dose, route and indication not reported) that were improperly stored. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Got the shot at 9:20am on Saturday (April 10th). By the time I sat down to do the 15min waiting period before I could leave. My arm from the back of my shoulder all the way down to around my thumb joint in my hand ached so bad. By around 3pm on the same day, I started to feel really tired and had a pounding migraine. By 4:30p I started to get really cold and everything started to ache. By 6p I was feeling hot but at the same time cold and shivering. My head was pounding. Every muscle ached all over my body, and by every muscle I mean even my eye muscles and pelvic floor muscles. My face had so much sinus pressure that it felt like it could explode. My skin, all over my body, was so sensitive that it hurt to the touch. On top of my skin being sensitive to the touch, off and on my skin would tingle, including the inside of my mouth and tongue. My lymph nodes were swollen enough in my neck that my throat ached.  I was mentally confused and shaking. Everything got bad enough I started crying and hyperventilating. I felt sick to my stomach and felt digestive pain. My entire body felt so heavy. By the time it got to around 8p, my mom finally took my temperature, which at that point I had already been taking Tylenol all day and was no longer shivering, and I had a temperature of 101 degrees F. I finally went to bed around 9p. I was thirsty but my stomach felt sick. I still ached and woke up around 10 times throughout the night either feeling too hot or cold or hurting so bad. At 4am I took a Tylenol because it everything hurt bad enough to able to fall asleep. The next day. I mostly better. I was still tired and a little achy and my lymph nodes under my arm pits were swollen. At this point my lungs felt strange. Harder to breathe than normal.  I was starting to cough. The day after that (today) I have felt fairly normal except I?m coughing and my lungs still feel a little strained. No more aches or fever or anything like that though.
general malaise 9/25/2021 a few hours after receiving the 2nd shot, starting at 4:00 am 9/26/2021 Fever of 101.4 lasting all day, lethargic, passed out most of the day.  It is 4:00 at night now and I still have the fever. With the first shot, I went home and 15 minutes later passed out on the front porch and was not able to get up for 20 hours.
No additional adverse events reported.; a 5 year old patient received 2 pediatrie doses of VAQTA on one visit; This spontaneous report was received from an office manager and refers to a 5 years old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 11-DEC-2020, the patient was vaccinated with two pediatric doses of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, 25/0.5 (units not provided) lot # S037576, expiration date 10-APR-2021 (exact dose, route of administration and anatomical location were not reported) for prophylaxis at one visit (inappropriate schedule of product administration). It was just human error and not product confusion. No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S037576; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
arm sore for wk or 2 w/redness site & shooting pains; seen by MD 14JAN94 dx as serum sickness type react w/arthralgia;
Information has been received from a physician concerning a 16 year old female patient who on 26-JUN-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included hepatitis virus vaccine (unspecified). On 26-JUN-2007 the reporter that "the patient fainted immediately after receiving her first dose of Gardasil. She recovered completely quickly. Patient's mother reported that she had a similar episode when she received hepatitis injection a few years ago." Unspecified medical attention was sought by patient. The patient recovered. Additional information has been requested.
no adverse effect; patient was administered an expired dose of MMRII; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 12-SEP-2019, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) via subcutaneous route, lot # N023142, expiration date 24-AUG-2019 (exact dose and injection site were not reported) for prophylaxis. The suspected vaccine was reconstituted with properly stored and non-expired sterile diluent. There was no adverse effect reported.
more side effect; She is been in a circle of pain and not getting better; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (more side effect) and PAIN (She is been in a circle of pain and not getting better) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Autoimmune disorder. Concomitant products included METHOTREXATE SODIUM (METHOTREXATE [METHOTREXATE SODIUM]) for RA.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (more side effect) and PAIN (She is been in a circle of pain and not getting better). At the time of the report, ADVERSE DRUG REACTION (more side effect) and PAIN (She is been in a circle of pain and not getting better) was resolving. Not Provided          Concomitant medication include methotrexate for RA (stopped 5 days before the vaccination)and blood pressure medicine, No treatment medication reported. The patient reported that she restarted the rheumatoid arthritis medications again. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow- up information received on 17 May 2021. Events outcome were updated.
Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 29-Mar-2022; patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 29-Mar-2022) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Acute illness at the time of vaccination and up to one month before was reported as unknown. Chronic or long-standing health conditions was reported as unknown.     On 29-Mar-2022 at 6:46 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Mar-2022 at 6:46 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 29-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 29-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination  or at the time of the adverse event were reported as unknown. Other vaccines given on the same day as Moderna COVID-19 vaccine and other vaccines received within one month prior to any dose of Moderna COVID-19 vaccine were reported as unknown. It was reported that the vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and the patient received booster dose on 29-Mar-2022 at 06:46:17. No treatment information was reported.   This case was linked to MOD-2022-542869 (Patient Link).
Child developed chickenpox. Child had varivax vaccine on 3/9/1996.
Patient presented to provider office visit 2 days after 2nd dose of Moderna vaccine with testicular pain for last 2 days, bluish color on tips of left fingers.  Was prescribed levofloxacin x 7 days to cover for possible epididymitis and was told to monitor the finger discoloration and return to PCP next week for recheck.  The following day (7/17), he presented to the Emergency Department for evaluation of the fingertip discoloration.  He reported that the testicular pain had improved.   ED provider noted: Fingertips on 2 or 3 fingers of a few small thin lines that are purplish in color almost as if discoloration of the fingerprint itself.  But it is no more than 1 or 2 lines to 2 or 3 fingertips.  There is no erythema no swelling no tenderness.  There is no muscle soreness.  No axillary lymphadenopathy.  No ascending lymphangitis.  ED Course Differential Dx: Adverse reaction to Covid vaccine, DVT, electrolyte imbalance, coagulopathy, electrolyte imbalance, localized trauma   Lab normal white count hemoglobin platelet count mildly elevated hematocrit of 51.3.  CMP showed a low CO2 22 I suspect this is due to prior elevated respiratory rate he does admit that he slightly anxious.  Glucose was elevated 142 BUN was 6.  Liver function studies normal.  Coags normal   Did do ultrasound of his arm since he recently was vaccinated there is no evidence of DVT or any occlusion.   Patient's fingers are warm he has intact sensation I am not sure if this is an adverse reaction to the recent vaccine, some sort of unknown localized trauma.  I suggested patient follow-up closely with primary care for reeval this week if no improvement and return if any acute worsening symptoms or problems.
Patient received PNEUMOVAX 23 vaccine and reported major pain in arm the next day. She said pain from 1-10 was a 29 and excruciating.
24 hours almost exactly after the first dose, my husband's top lip swelled up massively.  He was able to get some benadryl around noon and took that then took more when he returned home.  The swelling went down as he continued the benadryl for several days every 4 hours during the day and then before bed.   It has now been almost a week (Feb. 1, Monday) and the lip is still a little swollen and is tender and sore.
Directly aver receiving the vaccine, pt c/o HA and jaw pain.  Observation only with VS and gave pt juice box. No medications or other interventions required, symptoms resolved within 20 minutes. Observation for 30 minutes prior to leaving with parent. no s/s distress on leaving.
Sore arm at site of injection; leg pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 13:30 (Lot number: EW0167) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (dose number=1, lot number=ER8733,, administration time=13:30 PM,, vaccine_location=Left arm}]), administration date: 01Apr2021, when the patient was 47 years old, for Covid-19 Immunization; Bnt162b2 (Covid vaccine details:, Product: COVID 19, Brand: Pfizer, Lot number: ER8733, Administration time: 01:30 PM, Dose number: 1, Vaccine location: Left arm), administration date: 01Apr2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Apr2021 13:30, outcome "not recovered", described as "Sore arm at site of injection"; PAIN IN EXTREMITY (non-serious) with onset 26Apr2021 13:30, outcome "not recovered", described as "leg pain". The events "sore arm at site of injection" and "leg pain" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity.  Additional Information: A 47-year-old non-pregnant female patient received second single dose of bnt162b2 (BNT162B2), on 26Apr2021 13:30 PM as dose 1, Single for covid -19 immunisation. The patient had no known allergies. Historical vaccine included the patient previously received first single dose of bnt162b2 (BNT162B2) on 01Apr2021 at 01:30 PM as dose 1, Single for covid -19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for Covid-19. The patient received within 2 weeks of vaccination. On 26Apr2021 at 01:30 PM, the patient had experienced adverse events. The patient was not received treatment with medication. The seriousness of the events was not provided.   No follow-up attempts are possible. No further information is expected.
Briefly, patient with history of asthma and food allergies, presenting with hives, nausea, and swelling, in setting of receiving Covid vaccine 36 hours ago. Family had given benadryl and zyrtec without improvement, and symptoms were worsening to presents for evaluation.     My exam (after Epipen) showed: Gen: nontoxic appearing; HEENT: no lip/tongue/uvular edema, PERRL, EOMI, normal conjunctiva, neck supple without LAN; Card: RRR, no murmur, good perfusion; Lungs: CTAB, good air entry, no increased WOB, no wheezing; Abd: soft, non-tender, non-distended, no masses; Ext: warm and well perfused, moving all extremities; Skin: hives over hands, arms, abdomen, and legs, including between fingers and on soles of feet     Patient presenting with allergic reaction after Covid vaccine, could be more benign allergic reaction such as urticaria multiforme, but given constellation of symptoms and history of severe allergic reaction in past, will treat as anaphylaxis. Therefore given Epipen, steroids, and will plan for observation.   Observed 4 hours and continued to be well appearing without symptoms of rebound anaphylaxis. Therefore, patient safe for discharge to home with supportive care and PCP follow up. Given Rx for benadryl and steroids, refilled Epipein. Family in agreement with plan and verbalize understanding of signs and symptoms to return to care.  Final Diagnosis  1. Anaphylaxis T80.52XA
Patient presented to office 3/19/18 with swelling of the left arm for the past 2-3 days. He received ADACEL and MENACTRA at this site on 3/16/18. Within 24 hours parent noticed some swelling to the area. The swelling continued to increase over the next 24-48 hours and he also reported having pain along with the swelling on 3/18/19. No fever, cough, runny nose, congestion. No tingling, numbness, weakness in the arm, no other rashes or difficulty breathing or wheezing. There is an area of erythema roughly 3x3", the central part of erythema has a form swelling, which is tender to palpation, hot. Good peripheral pulses and sensations in the arm. Patient advised to apply warm compresses and was started on Cephalexin 500mg twice a day for 7 days. Patient is to follow up in 2-3 days.
Patient arrived to observation area at 11:22am with complaints of urticaria to left upper extremity. Patient refused vital signs, but was given 25mg of Benadryl PO. Patient was encouraged to stay in observation area for 30 minutes, but patient refused to stay. Patient and wife were educated to report to his PCP for follow up and call EMS/go to the emergency department if condition worsens or if new symptoms develop (i.e. throat swelling, difficulty breathing, etc).
L septic hip requiring prolonged IV antibiotics and surgery.  5/4/09 Received hospital medical records of 11/11/-11/25/20007. FINAL DX: left hip septic arthritis & acute suppurative otitis media Records reveal patient experienced sudden left hip pain unable to bear weight, fever, facial flushing, decreased appetite.  Seen in outlying ER & transferred to higher level of care for peds ortho consult.  Tx w/IV antibiotics, NSAIDS & pain meds.  Taken to OR for open drainage of left hip on 11/11.  Intermittent fever while hospitalized & OM w/perforated eardrum dx on 11/25.  Improved & D/C to home on antibiotic ear drops.
Information has been received from a nurse practitioner concerning a 7 year old male who on 8/1/2002 was vaccinated with a dose of varicella virus vaccine live. On 3/29/2005 a titer indicated that the patient did no show seroconversion. No symptoms were noted. No other information was available. There was no product quality complaint. Additional information has been requested.