chrisvoncsefalvay/vaers-outcomes huggingface dataset:
IMMUNE THROMBOCYTOPENIC PURPURA; This spontaneous report received from a pharmacist concerned a 27 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported,1 total, administered on JUL-2021 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 after the vaccination, the patient was diagnosed with immune thrombocytopenic purpura (ITP) and patient received the courses of Intravenous immune globulin (IVIG) and steroids. The patient recently started on Eltrombopag. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from immune thrombocytopenic purpura. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20211028342-COVID-19 VACCINE AD26.COV2.S-. This event(s) immune thrombocytopenic purpura is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
pt recv vax & broke out w/ chicken pox; dad said about 70% of body covered;
20 second post-administration of vaccine, patient stated he felt nauseous, and like he was going to pass out. He was lowered to the floor and did not lose consciousness. Vital signs were WNL other than a BP of 158/109. Patient was able to stand and left without any issues after a 30 minute observation period.
first dose of TWINRIX on the 4th January, 2021 / second dose was not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 24-year-old female patient who received HAB (Twinrix) 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.   Previously administered products included TWINRIX (1st dose received in 4th January 2021 with lot number: 75C72, exp irydate 13th June 2022.).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Twinrix vaccine at primary reporter's facility. The pharmacist reported that the patient was known out of schedule to get the 2nd dose of the Twinrix vaccine and till the time of reporting, the 2nd dose was not administered which led to incomplete course of vaccination. No further details or events were reported at the time of the call. The reporter consented to follow up by email.
Red knot at the injection site; red at injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE INDURATION (Red knot at the injection site) and VACCINATION SITE ERYTHEMA (red at injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 21-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Red knot at the injection site) and VACCINATION SITE ERYTHEMA (red at injection site). On 16-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE INDURATION (Red knot at the injection site) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Email added
Localized pain/swelling at injection site. Complained of pain with lifting arm at injection site (right). Patient also complained of numbness infect/hot flashes/weakness. Temp 100 deg F after injection (next day).
Swollen and painful lymph node in left armpit starting approximately 24 hours after vaccination and lasting approximately 4-5 days.  Low grade fever with chills approximately 48 hours after vaccination (99 degrees F).  Fever was gone the following morning and responded appropriately to medication.    Technically pregnant at time of vaccination according to hCG level; however, miscarriage had already been confirmed prior to vaccination via ultrasound and lowering hCG levels.  Due date was June 12; however, pregnancy was determined to be a miscarriage prior to vaccination.
IPV and DTAP given in L arm. Pt developed pain at site of injection Friday 11/13/09. Arm swollen, red, hot and itchy from shoulder to elbow on 11/14/09-Advised to give BENADRYL. By 11/16/09-swelling remained over upper half of upper arm. No pain, redness.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 23-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022). No concomitant product use was reported. Patient received half dose. The vial had not undergone any temperature excursions. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2022: Follow up information received includes non significant information. On 03-Aug-2022: Follow up received: Case report type, reporter details updated, patient details were added, suspect vaccine information was added, new events were added and narrative updated.
elevated fever & taken by parent to ER in afternoon p/receiving vax; said by ER to be otitis but questioned by MD;
Bruise, swelling, pain at injection site immediately following administration.  Fatigue starting 12 hours after  Muscle aches and joint pain 24 hours after
Felt fine after shot, but woke up @ 2am with some mild pain in arm at injection site and physically felt like I got run over by a medium size truck. Just now (@3:30 pm) I took some Tylenol.
He started to have sore the day after the vaccine, two days later had body aches and chills. No sure of fever. Severe pain in  throat, did not go to work. Rapid strep test was negative. Asked to take advil for pain, warm water gargle.
Cellulitic appearance to injection site, extended from shoulder to wrist. Severe swelling, pain. Began the day if injection, resolved over next 7 days. Given antibiotic.
Reported to the vaccination clinic by county EMS: Pt expired at his home following a call to 911 for a cardiac event for which resuscitation efforts were unsuccessful. This occured on the same day as his last dose of the Moderna vaccine.
Did not feel right; Headache; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Did not feel right), HEADACHE (Headache) and CONDITION AGGRAVATED (Condition aggravated) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Ulcerative colitis.    No Medical History information was reported.   On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 17-Dec-2021, the patient experienced CONDITION AGGRAVATED (Condition aggravated). On an unknown date, the patient experienced FEELING ABNORMAL (Did not feel right) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Did not feel right), HEADACHE (Headache) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product reported by reporter. No treatment medication reported by reporter.  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.
Starting 09/20/2022, I had body aches and head cold symptoms. I tested myself 2 times at home for COVID-19 and both were positive. I contacted my PCP and she started me on PAXLOVID the same day. By Friday, I tested myself again, and I was negative. I had symptoms for about 3 days: Congestion, sore throat and upper respiratory symptoms. On 09/30/2022, I started getting a scratchy throat and by 10/01/2022 I was testing positive for COVID-19 again. At this time, I developed diarrhea and vomiting. I had symptoms for about 9 days and still tested positive at that time. I would not test negative until 10 days into the rebound infection. I felt tired and still had cold symptoms until I tested negative again. 9 days after testing negative, I developed stomachache issues again: Diarrhea and vomiting. I would experience that again 9 days later. Then, about 8 days after that, I developed head cold symptoms that led to a sinus infection and the need for antibiotics and a MEDROL DOSEPAK. After I finished the 10 days of antibiotics, about 5 days later, I would develop afib which I have never experienced before. They did an EKG and an echo which showed no abnormalities. They said it could have either been due to sleep apnea or the consecutive illnesses I experienced. They treated me with medicine: CARDIZEM, magnesium and ELIQUIS.
Redness, swelling, warmth & pain at site of PCV-13 injection. Pt "jumped and was poked twice for shot" per mom. Possible Sub Q injection unintentionally?
Arm soreness; This is a spontaneous report from a contactable physician. A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number EK9231), via an unspecified route of administration on 19Dec2020 08:00 at single dose at right arm for COVID-19 immunization. Medical history included asthma. Concomitant medications included budesonide (PULMICORT), mometasone furoate (NASONEX), ibuprofen, and paracetamol (TYLENOL). On 20Dec2020, the patient experienced arm soreness. The patient did not receive treatment for the event. The outcome of the event was recovered.
8.5cmx4.5cm area of erythema - tenderness. Rx Augmentin.
Heart rate has been over a hundred; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender started to receive BNT162B2 (lot number and expiry date unknown), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "I got the COVID vaccine yesterday. I am just a little concerned because my heart rate has been over a hundred for an hour now". It has been over 24 hours since the vaccine was administered. The patient was requested to visit nearest emergency room or contact a health care provider. The outcome of the event was unknown.  The following information on the batch number has been requested.
receive ROTATEQ via nasogastric tube; It is unknown at time of call if patient will receive product via NG tube.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, strength, frequency, lot# and expiration date were unknown) for prophylaxis via nasogastric tube (NG) (incorrect route of product administration and circumstance or information capable of leading to medication error). It was unknown at time of call if patient would receive product via NG tube.
General Achiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Dec2022 at 01:45 as dose 4 (booster), single (Lot number: GJ6742) at the age of 31 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 14Dec2022 at 23:00, outcome "recovering", described as "General Achiness". Therapeutic measures were not taken as a result of pain.  Additional information: General Achiness starting at night through the next day. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive other vaccines within 4 weeks prior to the vaccination. The patient did not have any known allergies or any other medical history.  No follow-up attempts are possible. No further information is expected.
CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced chills, and fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, and fever. This report was non-serious.
RAISED BUMPS ON ARM LOCATION OF VACCINE ADMINISTRATION.  DID NOT ITCH. REFERRED TO MD.
received liquid portion of Menveo; received liquid portion of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA768A, expiry date 31-OCT-2024) for prophylaxis.   On 19-JUN-2023, the patient received Menveo (unknown arm). On 19-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: received liquid portion of Menveo) and inappropriate dose of vaccine administered (Verbatim: received liquid portion of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-JUN-2023 The reporter reported that a patient received liquid portion of Menveo and after this error, patient was revaccinated with a full dose of Menveo on the same arm and on the same day (lot number: 2AMAA768A; expiration date: 31st December 2023). The reporter consented to follow up by email. The patient received liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
complaint 2 weeks after vaccine that she had 1 month of pressure on top of the head, on the back of the head, sinus cavity, pallet of her mouth, behind eyes, and forehead, stiff neck and shoulder
Patient experienced memory changes, facial pain, and cold extremities one week after vaccination. He underwent evaluation for guillan barre but results were not congruent with this diagnosis and ultimately was told it could be an autoimmune phenomenon. He is currently on treatment with steroids with improvement but not resolution. He was treated in an inpatient setting with a neurology team. Details are not currently available.
pt recvd vax;fever inc to 103 for 24 hrs, listless x 12-18 hrs; no tx sought by pt/par;rxn not reported till jan95;
15 minutes after vaccination, there was a burning sensation starting at the vaccination site and spreading up through the neck to the jaw. Following the burning, there was a numbing/tightening sensation where the burning was. Jaw muscles tightened and tongue swelled, restricting breathing. Placed under observation until symptoms subsided 2 hours later.
she is not able to eat; extremely sick; nausea; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (she is not able to eat), ILLNESS (extremely sick), NAUSEA (nausea) and HEADACHE (bad headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DECREASED APPETITE (she is not able to eat), ILLNESS (extremely sick), NAUSEA (nausea) and HEADACHE (bad headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, DECREASED APPETITE (she is not able to eat), ILLNESS (extremely sick), NAUSEA (nausea) and HEADACHE (bad headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
suspected case of measles following vax;onset 11 days p/inj;duration 6 days; day 11 to 14: h/a, noc sweats w/fever;day 14 to 17 erythematous rash on face & neck, mouth sore, sore glands
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old female patient received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3(booster), single (Lot number: FC3183) at the age of 73 years for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (First dose, Lot: EN6202 , Expiry: Jun2021), administration date: 04Mar2021, when the patient was 72-year-old, for Covid-19 immunization; Bnt162b2 (Second dose: Date administered: Mar2021, she can't read the second digit in the day of the month-the first digit is 2, but the second digit she can't tell, it might be 24Mar2021, but she can't be sure of that; this was from the vaccine record card. , Lot: She was trying to read what they wrote on the vaccine record card, thinks it may be EP6955. NDC/Expiry: Unknown, not on the vaccine record card.), administration date: Mar2021, when the patient was 72 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a little bit of a sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient also received fourth dose on 28Jun2022 (Lot number: FM0173) at the age of 73 years for covid-19 immunization. And the patient is in excellent health. The patient age at vaccine was retained as 73 Years as per DOB. Event COVID-19 was deleted with DOSE 1 and 2 as it was reported that the patient has never had COVID. She mentioned separately that her blood pressure can get a little high, so she takes the lowest dose of Lisinopril when it gets a little high which is 1 pill a day. No follow-up attempts are possible. No further information is expected.
A few days after I got a rash on my right butt check which was really itchy, stingy and painful.  My PCP advised benedryl and cortisone cream and thinks it may be shingles and a swab was sent for testing to see if in fact it is shingles but the results arent back yet. On the night after the vaccine I noticed my butt was sore on that same side but nothing appeared until 3/30. EDD-8/19/2021. I have an appointment with the dermatologist 4/12.
I tested positive for COVID 9 days after my booster vaccine. My son came to visit and we think he was a carrier of the virus.