chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Auditory hallucination; Psychosis; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 04Mar2021 12:00 (Batch/Lot Number: EL9269) as single dose for covid-19 immunisation. The first dose was received on 08Feb2021 (lot number: EL9262) on the left arm.  Medical history included post-traumatic stress disorder, and sleep deprivation for the last 4 years. The patient's concomitant medications were not reported. Patient reported having some weird symptoms the last month. Some of this, she has had but some of this she absolutely hasn't had until right around the second dose of Pfizer COVID-19 Vaccine. She had struggled with some mental health issues most of her life. This last month she reported experiencing auditory hallucinations on Mar2021. She had auditory hallucinations before around the time she gave birth to her son, it was stress induced. In the past like what she got with her son, she would get a song stuck in her head, more like an OCD thing and it was stress induced. This time she would hear really critical things. Patient stated the auditory hallucinations she was experiencing in the last month were different. This last week on 2021, patient reported hearing her neighbors yelling and screaming and actually called the cops on them. She never in her life has she experienced this, these are more paranoia thing. The doctors don't think it was schizophrenia because that usually starts in the 20s. She does not have a family history of this. She has PTSD from her son's rare heart condition, like pretty severely and just had major medical appointment where they gave her bad news. The auditory hallucination could be stress related, but she was trying to turn over every rock. They're trying to monitor it over the next 6 months. Patient thought it was highly unlikely that it was related to the Pfizer COVID-19 Vaccine but could be stress induced. Patient stated that the auditory hallucination she was having currently doesn't fit the normal type that schizophrenia usually does, like it's normally specific people, other people have different experiences, it could also be sleep deprivation or stress induced, but she has been having sleep deprivation for the last 4 years, so it just starting now is odd. The event was getting worse until she sought help for it and now it was slowly getting better. Patient went to Emergency Department three times, third time on 28Mar2021 when she was hospitalized and stated doctors diagnosed her with psychosis. It was all a blur. She was discharged April Fool's Day. She went into the Emergency Department on Friday 26Mar2021, before that it was either the 24Mar2021 or 25Mar2021. The first 2 Emergency Department visits they did not want to admit her, they said they thought she was just really stressed and really sleep deprived. Outcome of the events was recovering.
Received vaccine at 8am. Began feeling achy at 2pm. Fever reached 102F at around 4pm and was hard to control with Tylenol/Advil. 10/10 pain in the form of a  full, throbbing headache that also didn?t subside with Tylenol or Advil. My headache is now down to 6/10 pain 28 hours later but is worse when lying down. Fever is down to  100.6 without medication.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 12/22/2022 Discharge Date: Jan 2, 2023 COVID positive date: 12/22/2022  PRESENTING PROBLEM: Confusion [R41.0] Generalized weakness [R53.1] Community acquired pneumonia of right lower lobe of lung [J18.9]   HOSPITAL COURSE: Patient is an 85-year-old male with past medical history significant for colon cancer, tobacco use, emphysema, hypertension, hyperlipidemia, larynx cancer who presented to the hospital with weakness.  Family  gave the patient Norco and patient has been more sleepy and hard to arouse with constricted pupils.  They brought him in for evaluation.    He was diagnosed with COVID-19 and acute hypoxic respiratory failure.  Imaging shows small bilateral pleural effusions likely secondary to COVID versus malignancy.  It is unclear how long the patient was exhibiting symptoms.  He was treated with Remdesivir and Decadron and supportive care with improvement.  He was weaned to room air.  Also he complained of severe back pain.  MRI of the thoracic and lumbar spine was obtained which showed suspicion for sclerotic metastasis.  This was discussed with the patient and family.  The patient is scheduled to have an outpatient biopsy.  Patient states he wanted to pursue biopsy to confirm malignancy prior to enrolling in hospice. He reports that if confirmed to be cancer, he does NOT want to pursue chemotherapy nor radiation therapy.  IR consulted who recommended outpatient follow up for LLL nodule biopsy given COVID infection.His back pain improved while on decadron. He is otherwise not actively receiving treatment for cancer.     PT and OT recommends SAR. SLP recommends mechanical soft thin liquids.   He was discharged to senior home after he is out of COVID isolation on 1/2/23
Headache & NauseaVomiting  Narrative:  Other Relevant History:
if thrush is also a side-effect from / since I've had both shots; This case was reported by a consumer and described the occurrence of thrush in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of candida infection (1st dose received on an unknown date.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced thrush. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the thrush was unknown.   It was unknown if the reporter considered the thrush to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving 1st dose of Shingrix, the patient experienced thrush. The patient said I was wondering if thrush is also a side effect from Shingrix. The reporter did not consent to follow up. This case has been linked with US2020AMR245365, reported by same reporter and same patient.
Evening after vaccine, complaint of stiff neck and malaise. Two days after vaccine still complaining of stiff neck, malaise & sore throat. Denies fever.
At 8 hours post vaccination headaches, muscle pain in L arm proceeding to fever and chills...chills progressed in severity for almost 3 hours until relieved with ibuprofen.
Sore arm; Fluad was given to under the age of 65; This is a non-serious spontaneous case, initially received from a pharmacist on 05-Dec-2018, concerning a 43-year-old adult female patient.  On 25-Oct-2018, the patient (under 65 years) was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250794 and expiry date: 30-Apr-2019] (explicitly coded as inappropriate age at vaccine administration) for active immunization against influenza.  On the same day, after vaccination, the patient experienced sore arm for 2 days. It was reported that no treatment was required for the event.  The outcome of the event was recovered on 27-Oct-2018.  This case is linked to 201804954 (same reporter).  Non-significant follow up report received from the pharmacist on 07-Jan-2019: The county of the reporter was updated in general tab. Pharmacist confirmed that the reporter had not given permission to contact the patient; hence no patient information was obtained. Added reference number (Med-info number: SEQ19-00119) in the additional information tab. No changes were made in the narrative.; Reporter's Comments: A 43-year-old female (under 65 years) patient was administered Fluad (TIV) (inappropriate age at vaccine administration) and developed painful arm on the same day after vaccination. The company assessed the causality of the event (painful arm) as related to the suspect vaccine due to plausible temporal relationship between the event and suspect vaccine and the causality of the event (inappropriate age at vaccine administration) as not related to suspect vaccine due to accidental nature of the event.
No adverse events reported from dose. Dose of Moderna Bivalent (0.5mL) given on 10/13/22 was accidentally given 2 weeks prior to recommended dose range of 2 months from previous Moderna Monovalent dose. CDC recommended us give a second dose of Bivalent 8 weeks from previous Bivalent dose to ensure adequate coverage.
Within 5-10 of receiving vaccinations client c/o itching feet and eyes, eyes became puffy after 5 mins-client given 25mg diphenhydramine SQ-itching subsided within 20 mins
NDC# 59267-1055-04  - lot # FL2757 with manufacturer's expiration date of Sept 30, 22. Information has been received from the manufacturer indicating that stability an
Information has been received from a female registered nurse with a history of hives who on an unspecified date was vaccinating a patient SC with a dose Zostavax. While administering the vaccination, some of the vaccine got into a cut that was on her finger. As a result, her finger became "real red". The nurse recovered on an unspecified date. It was noted that the vaccinee was given the full dose with no issue. A product quality complaint was not involved. No further information is available.
10 minutes after administration employee developed red hives on neck, chest, injection site and down left arm, back, abdomen, thighs and buttocks - completely generalized. Itching profusely. Benadryl given by mouth for treatment.
Information has been received from a licensed practical nurse concerning a 3 month old patient who on an unspecified date was vaccinated with RECOMBIVAX HB. Subsequently, the patient developed erythema multiforme "from RECOMBIVAX HB". Unspecified medical attention was sought. At the time of this report the patient's status was not reported. No further information was provided. There was no product quality complaint involved. Follow up information indicated that another doctor's office called the primary reporter of this report for advice about this case. This was not a patient of their office. They had no information about the patient or physician. Additional informtion is not expected.
She states every joint hurts and had trouble getting out of bed. Slight headache in the night. She has arthritis and was exacerbated by the shot takes pain meds anyway did use heating pad stayed on it all day.
deep joint pain in a shoulder; two separate patients that received the Pneumovax 23 from the same lot, and they both had intense arm pain beyond what we expect from vaccines; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T016159, expiration date not reported but after lot validation established as: 28-FEB-2022 (dose and route of administration were not reported), administered in deltoid, for prophylaxis.  On an unknown date, the patient experienced intense arm pain beyond what was expected from vaccines and deep joint pain in the shoulder. She was treated with antibiotics but was still complaining of deep joint pain.  The outcome of the event of deep joint pain in shoulder was not recovered/not resolved. The outcome of the event of intense arm pain beyond what was expected from vaccines was unknown. The causal relationship between the events and vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was related.  This is one of two cases received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.;  devicelotnumber: T016159; expirationdate: 28-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2011USA010012:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 2:02 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:02 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 68.81 for dose administered on 20-Mar-2021.  No concomitant medications were reported.  Vial was moved to fridge on 09-Mar-2021. Product moved to clinic on 20-Mar-2021. Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 degrees Fahrenheit from 09:00 AM to 10:00 AM. Beyond use date for the vial was reported as 08-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 traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Fever above 101 degrees, headache, body aches, lethargy, dry cough, stomach pain. All symptoms still present at this time. Treating as flu with rest, liquids, Motrin/Tylenol, etc. Will probably require a dr visit.
No additional adverse effects reported.; patients have been administered improperly stored vaccines; This spontaneous report was received from a registered nurse 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 22-JUN-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot # S016870, expiration date 26-FEB-2022 (exact dose and injection site were not reported) for prophylaxis.  Administered dose of vaccine experienced the temperature excursion of below 36 degrees Fahrenheit (29.5 degrees Fahrenheit) for 10 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No additional adverse effects were reported.; Sender's Comments:  US-009507513-2007USA001137: US-009507513-2007USA001782: US-009507513-2007USA001781: US-009507513-2007USA001780: US-009507513-2007USA001779: US-009507513-2007USA001778: US-009507513-2007USA001777:
fever, chills, muscle ache, fatigue, headache that lasted 12 hours. Negative covid test.
PT. HAD HEART PALPITATIONS AND FEVER FOR 24 HOURS. RESOLVED THEMSELVES WITHIN 24 HOURS.
10-20 maculopapular lesions, primarily on forehead and scalp, with a few being vesicular/pustular, starting about 12 hours after below vaccines. I suspect mild reaction to VARIVAX.
pt recvd 3 doses of Engerix-B & 1 month following the last dose & pt devel bell's palsy; treated w/steroids, now taking calan & advil;
Hands and toes feel on fire; Rash and blisters on hands and toes; Arm was sore; blisters on top of my right middle finger and right middle toe; slowly spread to other fingers and toes; first one was about an inch and a half in diameter and the outer edge is more raised; little bit red and pink; blisters appear only on top of both my fingers and toes; blisters got worst; A spontaneous report was received from a reporter (consumer) concerning a patient of unspecified age and gender , who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. Concomitant medications were also not provided by the reporter .   On an unspecified date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unspecified date, after receiving the vaccine, patient experienced events, hands and toes on fire and rash and blisters on hands and toes.  Laboratory details was not provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of report, outcome of events hands and toes on fire and rash and blisters on hands and toes were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
received a Moderna booster dose 1 day later since it was opened; re-vaccinated with booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a Moderna booster dose 1 day later since it was opened) and EXTRA DOSE ADMINISTERED (re-vaccinated with booster) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a Moderna booster dose 1 day later since it was opened) and EXTRA DOSE ADMINISTERED (re-vaccinated with booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a Moderna booster dose 1 day later since it was opened) and EXTRA DOSE ADMINISTERED (re-vaccinated with booster) outcome was unknown.            No concomitant medications reported. No treatment reported   Reporter did not allow further contact
7/20/17 Site red, warm, swelling around 8pm. 7/21/17 increased redness, swelling, itching. Reported to Employee Health.
Abnormal extreme tiredness that has continued 4 days after the vaccine.  Abnormal menstrual bleeding began three days after the vaccine.
Cold sweats, lightheaded after vitals noted heart rate was faster than usual. After eating a cracker, juice, cold pack and laying back patient felt better approx. 10 minutes later.
Lethargic   Energy drain Soreness at injection site Weakness in arms and legs Overall feeling of sickness
sore arm; maybe a mild fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (maybe a mild fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had a couple of stents in the heart.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (maybe a mild fever). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (maybe a mild fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that he was taking blood thinners and had a couple stents in his heart, so he can not take anything stronger than that.  Patient stated that he received all the Moderna doses and it was a big mistake to get three vaccines at once on 09-Oct-2022. The patient began, every single one he had side effects such as sore arm, maybe a mild fever.  The only thing he took was acetaminophen and no other treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-743089, US-MODERNATX, INC.-MOD-2023-743016 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743089:bivalent case US-MODERNATX, INC.-MOD-2023-743016:
Arm is red, slightly swollen, warm to the touch at the injection site. Almost appears to be a single large hive approximately 3 X 4 inches. Patient complaining of pain also and still has symptoms as of 9/8/16 even after oral Benadryl and ice application.
1)Very sore arm and fever of 100.5 for most of the day following the vaccination; felt miserable. 2)About 4 months following vaccination, my Graves disease reappeared, after about 10 years in remission.  I think that may have been due to the adverse reaction following the 2nd Shingrix shot. Wonder if those with auto immune diseases should be advised not to have this vaccination.
?Covid arm? rash developed on day 2 post vaccination. Seemed to be resolving/subsiding on day 5. Day 6 felt swollen lymph nodes and later in the day Covid arm rash began to be bothersome again. Day 7 Covid arm hot to touch, increased pain, burning and surface area of Covid arm. By evening it hurt to move and interfered with sleep. Day 8 and 9 post vaccination surface area of Covid arm continued to grow and there was an ?eye? in Center with even more pronounced redness. A heat type rash developed on the ?eye?/Center of covid arm, I believe due to heat/inflammation.