chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered to patient after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after 30-day Use By Date) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after 30-day Use By Date). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  No treatment medications were provided.   This case was linked to MOD-2021-366127 (Patient Link).
HEREDITARY PERIPHERAL NEUROPATHY 2/21/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Tinnitus ... ringing in my ears was immediately noticeable when I woke up the next morning and it has never stopped.
An hour later I got chills that lasted for about 40 minutes. I felt fine. Then I woke up about 3 or 4 in the morning, and I was really burning hot. I went outside because it was winter at that time to cool off. I came in then I felt like I was freezing cold. I was nauseated and didn't hardly eat anything for 2 days. I also felt achy.
Mild muscular pain (at rest) with moderate pain on movement days 2-4 following flu shot. Resolved on day 4. One week post flu shot, following light workout, left arm with moderate to severe pain radiating to socket and occasionally down left arm. Left arm pain subsided over next 4 days. Pain somewhat relieved by 400 mg ibuprofen. Resolved 12/11/05
p/vax T100, arm was somewhat swollen, red;had rash, itching;hurt more than 1wk;given APAP & ice packs;mom reports next morning had convuls & stopped breathing;to ER. 60 day follow up: Pt had similar reaction to DTaP as a infant, mother states. She received DT after that. Suggested they speak to family Dr about what she should received in the future. Pt had swelling and rash at site x 1 mo.
felt bad p/shots given or 6MAY92 w/no appetite-slept most of day &MAY92 drank plenty of liquids; 8MAY92 temp 101.2; fever 106, WBC elevated; was given @ ER:
Symptoms started 32 hours after injection. Nausea and vomit for 12 hours, vomit each hour. Temperature 100.8, migraine, facial hives, maculopapular rash on torso, extreme fatique. Muscle soreness at injection site for first 24 hours, but no other onsite reaction or rash to vaccine. Symptoms lasted 52 hours.   Previous 2 vaccines produced NO symptoms. All symptoms reported above occured for booster only.
Neck pain started on 7/17/15 in the evening. On 7/18/15 the patient woke up w/left face paralysis which was continued to be Bell's Palsy. The patient is pregnant and has ITP.
Expired Flulaval administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 10-year-old patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 93Z32, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 15th September 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra 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: 19-Sept-2022 Reporter's comment: The reporter consented to follow-up. The case was linked with cases US2022134437, US2022134439 and US2022134440 reported by same reporter for different patients. Additional supportive information: The patient received an expired dose of Flulaval quadrivalent, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022134437:Same reporter US-GSK-US2022134439:Same reporter US-GSK-US2022134440:Same reporter
Severe pain in the neck that travels in to the right arm. The pain is so severe that nothing I have tried is releaving it and it's just getting worse.; a crippling pain was reported as worsened; Pain started in left arm and moved up to neck; Can't do anything, it hurts so bad; This is a spontaneous report from a contactable consumer (patient). A 30-years-old non pregnant female patient received first dose of bnt162b2 (Solution injection, Batch/Lot Number: FF2588), via an unspecified route of administration, administered in Arm Left on 14Sep2021 at 16:45 (at the age of 30-years-old) single dose for covid-19 immunisation. Medical history was none. Concomitant medications included bupropion and buspirone. The patient previously took codeine. 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. On 15Sep2021 at 19:00, patient experienced severe pain in the neck that travels into the right arm. She stated it was not so bad at first, and she thought it would go away. The pain was so severe that nothing she had tried was relieving it and it's just getting worse. A crippling pain was reported as worsened. Pain started in left arm and moved up to neck. She can't do anything, it hurts so bad. This resulted to emergency room visit at physician office. She stated that the doctors cannot figure out what is going on. She was treated with muscle relaxers and anti-inflammatory medication. She reported being twice at medical health center for these symptoms. Caller stated that she just had an X-Ray, but they refused to do any blood work on her. She stated she has an appointment tomorrow for an MRI. The patient underwent lab tests and procedures which included SARS-CoV-2 test which was negative on 18Sep2021. Therapeutic measures were taken as a result of severe pain in the neck that travels in to the right arm and the pain is so severe that nothing i have tried is relieving it and it's just getting worse and patient was treated with muscle relaxers and anti-inflammatory medication.  Information on Lot/Batch number was available. Additional information has been requested.
Face swelled up, her eye swelled shut down to throat (was able to breath w/o difficulty) she called ER nurse advised her to get BENADRYL. Pt was given BENADRYL x 24 hrs.
Received 0.5 ml for booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5 ml for booster dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 02-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 02-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Received 0.5 ml for booster dose). At the time of the report, ACCIDENTAL OVERDOSE (Received 0.5 ml for booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that an immunocompromised patient had received a total of four doses and each one of the doses had been 0.5 ml.  No treatment information was provided.
Within 1 to 2 days client had edema of her fingers on both hands with stiffness. Especially noticed the stiffness at night and when she needs to remove her rings. When see saw her doctor for a physical she mentioned this to the doctor. The doctor ran blood work and it all returned normal.
Blood clot in the right eye; This is a spontaneous report from a contactable consumer(patient) based on information received by Pfizer, license party for apixaban (ELIQUIS).  This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMIC VEIN THROMBOSIS (Blood clot in the right eye) in male patient of an unknown age who received apixaban (Eliquis) for an unknown indication. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for an unknown indication. On an unknown date, the patient started Eliquis (unknown route). On 07-Jan-2021, the patient started Covid-19 Vaccine (unknown route). In April 2021, the patient experienced OPHTHALMIC VEIN THROMBOSIS (seriousness criterion medically significant). The action taken with Eliquis (Unknown) was unknown. At the time of the report, OPHTHALMIC VEIN THROMBOSIS outcome was unknown. The consumer received his first Pfizer covid 19 shot on 07-Jan-2021 and the second one on 28-Jan- 2021, and 10 days prior to this report he got a blood clot in his right eye. He takes a blood thinner and remarks this should keep him from getting blood clots, should not it. Blood thinner provided was Eliquis. The event was related to covid 19 vaccine and causality with Eliquis was not provided. For Eliquis (Unknown), the reporter did not provide any causality assessments. This case was received via pfizer.  BMS Medical Evaluation Comment: This patient had ophthalmic vein thrombosis while on therapy with apixaban and after taking covid 19 vaccine. Underlying thromboembolic risk as ascertained by the use of apixaban is a significant factor that likely predisposed the patient to develop ophthalmic vein thrombosis and considered not related to apixaban therapy.  Causality Assessment: For apixaban: the causal relationship of the event Ophthalmic vein thrombosis with the suspect product apixaban was not provided Per Reporter; the causal relationship of the event Ophthalmic vein thrombosis with the suspect product apixaban was Not Related Per Company (Bristol-Myers Squibb)
Sore arm Began around 1:30 PM. Around 8:45 PM: Began to feel fever kick in. Temp initially 100.4. Extreme chills. Extreme back pain and joint pain. Took 1000mg of Tylenol. Fell asleep. Around 1:30 AM woke up to fever like symptoms returning and extreme headache. Took 800mg of Ibuprofen.  Woke up around 6:00 AM and had extremely sweaty back.. felt as though fever had broke, but still had headache. Took another 1000mg of Tylenol.  Woke up around 8:30 feeling pretty good. Minimal appetite day after shot.
Severe pain in upper at, (delt): Knot at injection site; itching all over body occasionally; constant nausea; soreness all over body.
Patient developed a 5cm x 5cm annular, erythematous, indurated lesion at injection site.
Since 5/14 (the date of the 2nd dose) my skin has been extremely sensitive to touch, routinely breaking out in hives and rashes all over my body. It gets worse with heat, especially in sweaty areas. I've used soaps & detergents for sensitive skin for the last 10 years, but never experienced sensitivity like this until after receiving the second dose. I have not gone to the doctor because I don't have health insurance and it doesn't ruin everyday life.
Breakthrough COVID case on August 26th, 2022. Symptoms included cough, runny nose, mild fever (~100*), lethargic, trouble sleeping. Administered OTC infant's Ibuprofen 1x day. Symptoms lasted 6 full days including date of onset.
Pt. had ongoing exhaustion, body aches, chills & fever upon receiving the GARDASIL immunization. He missed several days of school/went in late due to exhaustion. These symptoms were most pronounced 1-3 wks after the shot. I took him to his doctor on 4/18/11 to request blood work and see if he was anemic.
This spontaneous report as received from a Nurse Practitioner refers to a patient of unknown age. The patient was vaccinated a dose of GARDASIL (lot number not reported) on 18-SEP-2012. Other suspect therapies included CERVARIX vaccinated on 25-MAY-2011. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Pfizer vaccine was administered outside of source - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------ I95.89 CHRONIC HYPOTENSION 3/10/2022 FEVER I95.9 HYPOTENSION 7/1/2022 FEVER J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/11/2022 FEVER R09.02 HYPOXIA 7/1/2022 FEVER
Patient is charted to have received a COVID vaccine on 4/8 with another company as well as two more doses with Embry Health on 4/11 and 5/10.
Moderate tenderness, redness, swelling and heat (warmth compared to non-injection site) at injection site. Started within 1 hour of injection and persisting for 24 hours so far. Couldn't sleep on that arm due to the tenderness.
This spontaneous report was received from a medical assistant concerning a 4 month old female patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 01-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ dose 1, lot # L029617, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA006956: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1701USA005974: US-009507513-1704USA007655: US-009507513-1704USA007664: US-009507513-1704USA007665: US-009507513-1704USA007666: US-009507513-1704USA007667: US-009507513-1704USA007668: US-009507513-1704USA007669: US-009507513-1704USA007671: US-009507513-1704USA007672: US-009507513-1704USA007673.
Doses administered after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion ) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021 at 11:35 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:35 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion ). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion ) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 51.41 for dose administered on 03-Apr-2021.  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
I started taking a medication, Escitalopram 5mg, anti-anxiety medication about 2.5 months ago. I stopped taking the medication a week before 05/01/2022. On 05/01/2022, is when I really noticed the light-headed feeling and the headaches. It is kind of a weird and hard to describe. It feels similar to a free-falling feeling or a shot of adrenaline. It is very brief, and it hits real fast. My pulse rate resting as low as 45 bpm. Since this started my resting heart rate is low to mid 50's. When I am standing and walking around it is pretty normal. Headaches, chest pain, feeling like I am going to faint, and light-headedness. On 05/03/2022, I went to see the doctor. They took blood and ran labs. The doctor does not believe that the symptoms are from stopping the medication. He scheduled me to get a heart monitor in the next day or 2.
No adverse effect; inadvertently administered a dose of VAQTA (Lot#R006341/Exp: 4/21/2019) on 5/29/2019, that was expired; This spontaneous report was received from a nurse regarding a patient of unknown demographics. Information on concurrent condition, past medical history and concomitant medications were not reported. On 29-MAY-2019, the patient was inadvertently administered with hepatitis A vaccine, inactivated (VAQTA) of lot # R006341 with an expiry date of 21-APR-2019 (strength, dose, anatomical location not reported) for prophylaxis (expired product administered). It was also reported that patient had no adverse events.
pt recv vax 16AUG96 & 30AUG96 pt exp erythematous papular rash w/vesicles on buttocks, back & scrotum;w/in 1 day rash spread to inner thighs;5SEP96 rash persisted;
shortly after receiving vaccine patient felt very faint and almost passed out, then vomited.  Felt very weak and after about 1/2 hour said she was having difficulty forming words in her head.  Her mother did want an ambulance called when I asked her, and they came out and took her vitals, which were normal. They felt anxiety was the reason she was having trouble thinking of the words she wanted to use, and felt that she was not having an anaphylactic reaction since there was no rash at injection site or anywhere else forming, and patient had stated that she had passed when she had blood drawn in the past. They asked if she wanted to go to the hospital and she said no and that she felt she could go home with her parents. She was still feeling weak, but the paramedic felt she was ok to go home also.
sore throat, runny nose, headache, shortness of breath. Stated started on January 5, 2021. Reported to staff 01/15/2021.
patient felt dizzy and nauseous then she vomited about 20 minutes after receiving the vaccine. Afterwards she was under observation for another 20 minutes and she decided to go to the urgent care
Patient developed progressive weakness starting in his legs leading to falls and then in his upper extremities as well. He also developed neuropathic pain. These symptoms began 2 days after vaccine administration. He was seen in the ED and admitted to the hospital on 3/29. He was diagnosed with acute inflammatory demyelinating polyneuropathy (AIDP) and started on PLEX and methylprednisolone. Patient continues to require inpatient hospitalization and significant assistance with his ADLs. He is also experiencing autonomic dysfunction with tachycardia, elevated BP, and diaphoresis.
Patient called & said he's been having intense headache/congestion pain (some pain also in neck/shoulders) & chest "tightness"/heaviness. He said his blood sugar was over 400 at 7 PM, so he used HUMULIN R. He said at 9 PM he had a reading over 400 again & again used HUMULIN R. He said he checked his temp. & has no fever. He said he had some congestion on 11/12/11 but today (11/13/11) felt worse & high blood sugar, etc. (advised to go to E.R.).
Anxiety; Uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety) and FEELING ABNORMAL (Uncomfortable) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03782LA) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 12-Mar-2021, the patient experienced ANXIETY (Anxiety) and FEELING ABNORMAL (Uncomfortable). The patient was treated with MELATONIN at a dose of UNK. At the time of the report, ANXIETY (Anxiety) and FEELING ABNORMAL (Uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Possible NNI
Initial report received on 03/Feb/2006 from a health care professional. A 33 year old female patient with a history of goiter and seizures, who had not been on anti-seizure medication since September 2005, but was taking Levoxyl at the time of the vaccination, had received an intramuscular injection of DECAVAC (lot number U1620AA) in the left deltoid on 23/Jan/2006 at 12:00. Two hours later at 14:00, she experienced a seizure. She was seen by a physician and blood work, brain MRI and EEG were completed (results not reported). Per the reporter, it was unknown when was the last patient's seizure episode before the one described. At the time of the initial report, the patient had recovered from this event.
blood pressure at 273; disoriented; weak; This is a spontaneous report from a Pfizer-sponsored program. A Non-contactable Consumer reported for a female patient. A female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided) via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunisation. Medical history included patient was diabetic. Concomitant medication was not reported. On an unspecified date, patient experienced blood pressure at 273, disoriented and weak. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.