chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. received only yellow fever vaccine on 7/5/07. Forty minutes later developed reddened raised are on one side of face red area faded after 24 hrs-but pt had itching all over body for 48 hrs-Resolved with medical intervention
Received phone call fro friend of pt about 4:45 pm. Stating pt began with rash/itching on stomach and neck; c/o heartburn and throat closing up and hurting. Symptoms began 2 hrs ago was given 2 Benadryl and taken to ER. Better and being released from ER.
Moderna vaccine booster received within an hour after the flu vaccine (flu in left arm, Moderna in right) on Friday afternoon. Not sure which of the vaccines was the cause, or if it was the combination.  Friday Evening through Sunday Morning - arm sore at the injection site. Took Motrin Saturday morning - diarrhea. Took Imodium AD Saturday afternoon - chills - wore sweats, a thermal shirt, and a fleece bathrobe/blanket in 60+deg weather, and was still cold Saturday and Sunday - headache (mild, nowhere near migraine level). Took Motrin Saturday and Sunday - tired. Took a few naps
headache; Red at the injection site which is gradually going all the way upto the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and VACCINATION SITE ERYTHEMA (Red at the injection site which is gradually going all the way upto the shoulder) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (headache) and VACCINATION SITE ERYTHEMA (Red at the injection site which is gradually going all the way upto the shoulder). The patient was treated with IBUPROFEN (ADVIL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, HEADACHE (headache) and VACCINATION SITE ERYTHEMA (Red at the injection site which is gradually going all the way upto the shoulder) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medication information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Mar-2021: NNI
Heart palpitations causing me to feel the need to stop and wait for the palpitations to cease. These effects lasted for 6 days following the COVID booster shot.
Itching in hands, head and back of neck, dizziness. Benadryl 25mg given and taken to ED for further tx.
This spontaneous case reported by an other healthcare professional, describes the occurrence of product dose omission issue (has been more than 42 days since the first dose) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. April 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced product dose omission issue (has been more than 42 days since the first dose). At the time of the report, product dose omission issue (has been more than 42 days since the first dose)  resolved. The reporter did not provide any causality assessments, concomitant medications or treatment information. Most recent follow-up information incorporated: On Sep 6, 2021: Follow-up information received included no new information.
Fever, nausea, HA, sore throat, rhinorrhea, + cough.  Sx started hours after typhoid vaccine given.  Given Augmentin 875mg BID x 10d.
Teniviac expired on 08-Mar-2020 and was given to a patient on 09-Mar-2020; Initial information received on 09-Mar-2020 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2020SA065407.  This case involves a 71 year old male patient who received 0.5 ml expired dose of vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number- U5882AA, Expiration date- 08-MAR-2020) via an unknown route at an unknown administration site for prophylactic vaccination on 09-Mar-2020.  Medical history, medical treatment, concomitant therapy, vaccination and family history were not provided.  It is a case of actual medication error due to expired vaccine used. It was reported that an expired dose of Tenivac was administered to a 71 year old male patient on 09-Mar-2020.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
This spontaneous report as received from a register nurse refers to a 27 year old patient. Pertinent medical history, allergies or drug reactions were not reported. On 15-SEP-2013 the patient was vaccinated with the first dose of GARDASIL, the second dose of GARDASIL was applied on 15-JAN-2009 and the third dose of GARDASIL was applied on 15-SEP-2013. Concentration, route of administration, dose and duration were not reported for all doses. Concomitant medications were not reported. No adverse events were mentioned. Additional information has been requested.
I woke up on 06/03 and felt really tired and had sinus issues and sore throat. I attributed that to my recent travel. But I took a home Covid test which was negative. Later that day I went ahead and went to a local clinic to take a PCR test. I received positive results the next morning on 06/04. Before I received my results, I was informed that some of the family I was traveling had turned up positive for Covid. I was experiencing head cold like symptoms like congestion and headache which lasted through till Monday. I was treating symptoms with over the counter medications until Monday morning when I called my doctor, who prescribed Paxlovid which I began on Monday evening, and by Tuesday, my symptoms had greatly improved and have continued to improve each day.
Fever; Arthralgia - Information has been received from a registered nurse concerning a 2 year old caucasin male who was vaccinated with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation subcutaneously.  Concomitant vaccination that same day included a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid manufacturer unknown and a dose of poliovirus vaccine inactivated manufacturer unknown.  Sebsequently 11 days later, the patient experienced temperature of 101F and joint tenderness.  It was reported that the child was in Mexico after vaccination during this period and was treated with ibuprofen motrin.  The patient's symptoms subsided after five days.  In follow up it was reported that the patient's sysmptoms lasted for 3 days.  Unspecified medial attention was sought.  No further information is expected.
Patient presented with a silver dollar size red area surrounding injection site. She stated that there was no pain or tenderness associated with the inflamed area. Patient noticed the area this morning and came to the pharmacy seeking advice. I instructed her to take Benadryl. She will follow-up with us if the area worsens or remains multiple days. I will follow-up with a call on Wednesday 06/12/17.
Planned power outage occurred on Saturday, 8/12 from 12:00p-11:00p. Asked facilities if medications from refrigerators in medication room needed to be removed due to power outages on 8/10/23. Was informed that medication room items should be on backup power so our refrigerator/freezers should be okay. Did not move medications out of these areas. Prior to being notified that refrigerators were out of range over weekend, patient was given adacel vaccine at visit today 8/14/23. Vaccine was given appropriately but should not have been given due to range of medication being inappropriate. Staff was not aware of refrigerator issue at time medication was given to patient. Management informed after of the temperature values in the area and placed signage in area to not use. Met with pharmacy and facilities and was told to discard all medications due to range values.
Patient reports approximately 10pm 11/01 when went to bed developed wheezing, tightness in chest and throat lasting 30 minutes.  Did not seek medical care.  No problems since.
No adverse symptoms were reported.; patient moved during administration and some of the vaccine "got on the patient's leg"; some of the vaccine "got on the patient's leg"; she is unsure if the patient received the full dose of PROQUAD.; This spontaneous report was received from a medical assistant, referring to a 4-year-old female patient. The patient's concurrent conditions included seasonal allergies. The patient did not have any pertinent medical history or concomitant therapies.  On 07-MAY-2020, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (lot number S022917 was verified to be a valid lot number, expiration date reported and established as 19-JAN-2021), by subcutaneous route, on the left thigh as prophylaxis (dose and vaccination scheme frequency were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number S038147 was verified to be a valid lot number, expiration date reported and established as 05-JUL-2022).  On the same date, the medical assistant stated that the patient moved during the administration of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) and some of the vaccine got on the patient's leg (accidental exposure to product and exposure via skin contact). Also, she was unsure if the patient received the full dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (incorrect dose administered). She did not seek medical attention, as the exposure to product occurred at the office visit and was taken care immediately. There were no laboratory diagnostic or studies performed. No adverse symptoms were reported.
COVID-19 virus test positive; COVID-19 virus test positive; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4476265-00 (Agency).  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 2 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jul2022, outcome "recovered" (Jul2022) and all described as "COVID-19 virus test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter considered "covid-19 virus test positive" related to BNT162b2. The reporter's assessment of the causal relationship of "covid-19 virus test positive" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's causality for the event(s) of covid-19 virus test positive with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of covid-19 virus test positive with JANSSEN COVID-19 VACCINE was possible.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Large local reaction to MMRV approx. noticed 3 days ago (3-10-17). Left upper arm and on abdomen and hives on back. BENADRYL 4 times a day for 2 days.
Patient was administered a dose of MMR II via the intramuscular route; No adverse events; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, allergies/drug reactions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, frequency, lot # and expiration date were not reported) via intramuscular route (incorrect route of product administration) for prophylaxis. The reporter stated that she was not directly involved with the administration. There were no adverse effects (no adverse event) reported. No product quality complaints reported.
Beginning the evening of December 25th I had a scratchy throat and it felt like I constantly needed to clear my throat. Tested positive on at home COVID-19 test and it was positive. The next day I began feeling fatigued and could feel my temperature going up. Also began having postnasal drip. My temp got up to 100.9. The following day my symptoms continued and my fever got up to 101.4. I took TYLENOL for fever and it would help keep fever down around 99. Had decreased appetite but still ate. Have slept and been very lethargic. 12/27-12/28 developed congestion Temp has been down since 12/29. Still feeling tired but other symptoms have resolved. I am an incredibly careful.
Patient reports waking up Wednesday morning 2 days after her vaccine with a bloody nose that soaked her pillow case. Her nose continued bleeding for 2 hours after that then again later in the day. She also reported a lot of blood volume from the bloody nose. She also said that despite having a total hysterectomy years ago she has had vaginal bleeding along with the bloody nose. I recommended she seek medical treatment from her PCP since this may not be vaccine related and could develop into a more serious condition.
The patient presented with acute onset of lower > upper ext weakness and numbness started on February 1st, after he came back from a trip, preceded by fever and transient rash. On presentation exam noted signs of UMN injury localized in the thoracic spinal cord (weakness mainly in the lower ext, sensory level, hyperreflexia with B/L Babinski, urinary and bowel retention) MRI of spine showed patchy high signal areas mainly in the thoracic spine, with post contrast patchy enhancement of the pons and medulla which is representing an encephalomyelitis (pons, medulla, and spine, mainly thoracic). Patient was treated with IV steroid and showed significant improvement. 04/07/08-records received for DOS 2/8-2/18/08-DX: encephalomyelitis with urinary retention. Acute onset of lower >upper extremity weakness and numbness after returning from a trip abroad. Likely has encephalomyelitis secondary to possible yellow fever vaccination. Initial C/O severe frontal headache, fever, urinary and fecal retention cutaneous hyperesthesia and evidence of CNS inflammation on analysis of his spinal fluid. Mosquito bites. Fever and chills. 5/28/08-records received for DOS 2/23/08-presented with headache, nausea and vomiting and ataxia since day before. Suprapubic catheter.
HA after vaccine and pain injection site . Pt vitals 02 sat 98% HR89
This initial spontaneous report was received from a licensed practical nurse refers to a multiple patients of unknown ages and genders. Concurrent conditions and medical histories were not provided. On unspecified dates since 27-MAY-2015, the patients were vaccinated with improperly stored GARDASIL Lot# K007264, Expiration date: 03/02/2017 and Lot# K006117, Expiration date: 01/14/2017 (dose, strength and route not provided). There was no concomitant medication. No adverse events reported. This is one of two reports received from the same reporter. Additional information has been requested.
Information has been received from a male physician who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Subsequently the patient had an anaphylactic reaction after vaccination and had to be taken to the emergency room. It was noted that an allergist is following the patient. Additional information has been requested.
pt recv vax AUG96 & 1mo a/taking a trip;FEB97 pt came back from trip & liver enzymes were elevated & pt devel flu-like sx;ALT & other liver enzymes normalized a wk later w/o treatment;
This spontaneous report as received from a pharmacy technician refers to a 5 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 19-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
/p receiving vaccine developed headache, sorejoints, chills, sternal chest pain, low grade fever, low blood pressure & low heart rate, chills again, relief lasted about 2-2.5 hrs.  I have not found the low B/P & HR documented.
sore arm for a day or two; 1st dose. Date: 10May2021/2nd dose. Date: 29Jun2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MDCA22-00635 (Moderna).  A male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OCREVUS. Vaccination history included: Bnt162b2 (1st dose, Route: Intramuscular injection left arm), administration date: 10May2021, for COVID-19 Immunization, reaction(s): "Sore arm for a day ". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm for a day or two"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Jun2021, outcome "unknown", described as "1st dose. Date: 10May2021/2nd dose. Date: 29Jun2021".  Additional information: Concomitant/regular medication: Ocrevus once every 6 months. Last dose received in Oct. Wait 5 months. Next infusion is next month. Allergies (medications, food and other products). No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic rash, hives Started about 12 hrs after injections treated with Benadryl otc
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a 34 year old female of an unspecified race and ethnic origin. Initial information was processed with the additional information received on 27-JAN-2023. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, 1 in total, administered on 01-APR-2021 for covid-19 prophylaxis.  The drug was associated with Batch and lot tested and found within specifications.  Age at time of vaccination 4 decade old.  No concomitant medications were reported.  On an unspecified date in NOV-2021, the patient experienced covid-19 (Covid Delta variant), tested positive via rapid test and had symptoms (reported as mild symptoms) (coded as confirmed covid-19 infection and confirmed clinical vaccination failure).  Laboratory data included: COVID-19 rapid POC test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000263299. The suspected product quality complaint has been confirmed to be batch and lot tested and found within specifications. The reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20221229001, 20221228979, 20230211727, 20220100988 and 20220100666.; Sender's Comments: V0: 20230211704-confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
pt received hepatitis b vaccine due to student health services recommendation since his titers low/undetectable.  after vaccine was administer in his left arm (deltoid muscle), it was discovered vaccine expired on 09/14/23. mfg was called and the agent stated it still had same potency/efficacy 30 days past expiration date. however, pt received vaccine 9 days past that 30 day mark. (received 39 days expired). per mfg, redosing is up to provider. informed patient and he said he will speak to md since he is immunosuppressed and may want to readminister dose
I ended up with COVID arm right away. A big red mark and it itched and that lasted for a week and a half until the redness, swelling and itching to go away. Tiredness for three or four days. Injection site hurt for two days. Got lymph node pain started the next day after the vaccine, too. The pain underneath my armpit is still there. It felt like it was a thumb that jammed into my armpit and squeezed it all night long. It lasted like that for about a month pretty consistently and even now I'm aware of the pain. It is very uncomfortable. I didn't get treatment for the other symptoms except for Ibuprofen but with the lymph node I got an ultrasound on July 8th. The result of that was confirmation of inflamed lymph nodes but nothing that was so concerning that there was an extreme level of blood flow. Swelling and inflammation is happening but nothing crazy. I have a follow up ultrasound on October 15th. I had the ultrasound done at clinic.
On the evening of the booster vaccination (approx 8-9 hours post vaccination), the patient developed fever and chills that progressed over the next 24 hours.  On the morning of 1/19/22, the patient's family member discovered the patient had passed away during the overnite