chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; HCP advised the her office could not clarify if her pharmacy has administer correct vaccine vials to her patients in August of 2022 / HCP is unsure of if vaccine dose that were administered were bivalent booster of monovalent boosters; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (HCP advised the her office could not clarify if her pharmacy has administer correct vaccine vials to her patients in August of 2022 / HCP is unsure of if vaccine dose that were administered were bivalent booster of monovalent boosters) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In August 2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (HCP advised the her office could not clarify if her pharmacy has administer correct vaccine vials to her patients in August of 2022 / HCP is unsure of if vaccine dose that were administered were bivalent booster of monovalent boosters). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (HCP advised the her office could not clarify if her pharmacy has administer correct vaccine vials to her patients in August of 2022 / HCP is unsure of if vaccine dose that were administered were bivalent booster of monovalent boosters) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (HCP advised the her office could not clarify if her pharmacy has administer correct vaccine vials to her patients in August of 2022 / HCP is unsure of if vaccine dose that were administered were bivalent booster of monovalent boosters).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
After receiving 2nd dose severe body ache and severe fatigue, requiring bed rest. high doses of Advil barely worked
Friday morning at 4:30am I woke up to go workout and as I was brushing my teeth I passed/blacked out. I came to and I began sweating profusely.
Approx 20 minutes after 2nd Moderna vaccine my tongue had an intense pins & needles sensation. Within a few minutes my lips had the same sensation, & then inside my ears. An area of my scalp the began to itch, & then changed to tingling. I developed a headache & became dizzy(was sitting). The worst of the pins & needles sensation lasted approx. 1.5 hours.  The headache & dizziness were significant for 2 days. The tip of my tongue still has a mild pins & needles sensation.
After taking my second dose of the moderna shot my body did very well for the first few hours. However,  I woke up in the middle of the night and was hallucinating. It felt as if my body was floating but I wasn?t in my body and I could hear someone talking outside. I woke up from a vivid dream of someone telling me to breathe harder and not give up. Once I woke up I could feel myself breathing hard. I had an accident in the bed, and my whole sheets were drenched of sweat. I got up to the bathroom and I passed out on the floor. I woke up in my bed and checked my oxygen. It was at 83, and my pulse was at 155 (I have a pulse ox at home). My temperature was at 102, and I know that can happen with this vaccine. I sat up for a few hours to get my oxygen and temp to calm down.
After receiving the flu shot in December, within 4 to 5 days he developed a tic (throat/grunting). We notified our doctor's office, and within two months the tic cleared up on its own. On May 10th 2017 he received the MMR vaccine, and again within 4 to 5 days developed a tic (this time sniffing). We notified our doctor's office, and they said it was safe to continue with his next vaccine. On July 27th 2017 he received the DTaP and polio combo vaccine (KINRIX), and again within 4 to 5 days developed another tic, this time nose scrunching, along with the sniffing that never went away, and his throat/grunt returned. We are now seven weeks removed, and he still has all three tics. Obviously we cannot be sure that the vaccines caused these tics, but we have no history of tics or neurological issues in our family history. And he has shown no signs of these tics prior to these vaccines. All three times the tics showed up within 4 to 5 days of a shot.
Presented to office with c/c bumps all over body, sent home from school. S/S papular lesion with clear exuate on abdomen and face. Dx: Varicella.
has pain under his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (has pain under his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (has pain under his arm). At the time of the report, PAIN IN EXTREMITY (has pain under his arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.
Resident received two doses of the Moderna vaccine.  Received the Pfizer booster. Wife present at time and requested administration. No adverse reaction noted.
rash on her chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on her chest) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced RASH (rash on her chest). On 07-Feb-2021, RASH (rash on her chest) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This case was reported by a nurse and described the occurrence of incorrect storage in a patient who received HAVRIX. On an unknown date, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: HAVRIX, ENGERIX and TWINRIX were shipped to clinic by wholesaler, but wholesaler states they had a refrigerator failure of their own causing higher than recommended storage temps. Clinic administered 6 doses of HAVRIX and TWINRIX and 2 doses of ENGERIX-B to various patients. Follow-up information received on 8 December 2014: Lot number added. Additional information:This product has been exposed to temperature outside of the required temperature range and the efficacy of this product outside the temperature range has not been established. This product was administered to several patients, ages and genders are not known at this time. Once additional information regarding the ages and genders of the patients involved is received it will be submitted.
Pt felt like he was going to pass out  - seemed to go in and out of consciousness for a few minutes but then was fine
Hand went numb. Fingers felt like they were asleep. Now my ring and pinky fingers feel tingly and/or numb depending on how much movement of my hand I do.
A nurse reported that a pt received an injection of Pnu-Imune 23. The next day, the pt developed an injection site reaction characterized by tenderness, heat and swelling. The pt recovered. The reporter indicated that 6 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. Follow-up information received on 3/1/00, identified 1 of the pts. The reporter indicated that she could no identify the remaining pts. The pt remained recovered.
After giving vaccine, patient was in observation area and stated he felt light headed. He was nervous about the vaccine and feeling anxious. After speaking with him, he calmed down and stated he normally gets anxious regarding immunizations. He sat for 20 minutes and felt fine enough to go home.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 14-NOV-2012 at 12:45, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Blurred vision in right eye, spots as if I had looked into a bright light, double vision in a small spot of my eye, then headache began to occur above right eye and progressed to the base of my neck on the back right side of the skull. After about 45 minutes the blurred vision began to subside but the headache remains.
Anthrax vaccination administered via left deltoid.  Patient noticed increased pain and erythema over injection site approx. 1-2 days afterwards.  Area became erythematous with approx. 10 cm of induration.  No discharge noted over injection site.  Discussed case with Dermatologist and Allergist.  Elected to treat symptomatically and stressed return precautions.
approx. 19 mins after the injection my right arm began to feel a tingle sensation that radiated down to my hands and right side of my chest. Lips felt swollen but not visible to the eye. My right lower extremity had the same feeling as describe what happened to my right arm.  I went to the ED of the hospital where I worked. This my second dose and I had the same experience with the first dose but on my left side.
Fingers tingly and injection site was numb. To ER -  local reaction on 10/20/09.  11/4/09:  Emergency Department Records received for date of service 10/19/09. Dx:  Left hand numbness Assessment:  This 12 week pregnant female pesented the day after receiving the H1N1 vaccine in the left deltoid,  with left arm and hand pain and numbness.  No redness, swelling, SOB, rash or pain around the injection site.  Pt. discharged to home.
EXPIRED VACCINE ADMINISTERED; INCORRECT STORAGE OF DRUG; This spontaneous report received from a physician 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced incorrect storage of drug. On 28-MAY-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered and incorrect storage of drug was not reported. This report was non-serious.
Patient's daughter called to report that patient had received vaccine Friday morning,  by Friday night was in bed with tired, achy and flu like symptoms,  stayed in bed all Saturday and woke up feeling better on Sunday.  Sunday night arm began to itch at injection site.  Has continued to itch and has become red and swollen.  Reddened are extends from just below injection site to elbow.   She stated it begins at the back of the arm and wraps around the front.
itching of the skin; This is a spontaneous report from a contactable consumer (patient), from a Pfizer sponsored program.  A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on an unspecified date as Unknown, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.It was reported that, the patient received the Pfizer Covid 19 Vaccine three weeks ago.The last few days she has experienced itching of the skin, denied a rash.The outcome of the event was unknown.  Information on lot/batch number has been requested.
Wrongful death; Shingles; This initial spontaneous report was received from a lawyer and patient representative regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies. In 2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Shingles and she was treated by a physician for the event. On an unspecified date the patient died. It was unknown the cause of the death as well as whether an autopsy was performed. The outcome of the event herpes zoster was not reported. The reporter considered the events of shingles and wrongful death to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event of death was considered to be medically significant.  Additional information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Initial unsolicited report received from non-healthcare professional (media monitoring reports) on 28 May 2015. A 23-year-old female patient, whose concomitant medication was not reported, had received a dose of Influenza vaccine (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. Patient's medical history was reported as autoimmune disease known as acute disseminated encephalomyelitis. The condition had left her with lesions on her brain and spinal cord. On an unspecified date, three months after vaccination, patient had lapsed into a coma and never fully recovered. She was in a wheelchair and had difficulty moving the left side of her body as she was left paralyzed. Laboratory investigation and corrective treatment were not reported. At the time of this report, outcome of the event coma was not reported and patient was not recovered from the event of left sided paralysis. Upon medical review, company assessed the event of lapsed into a coma and paralyzed/difficulty moving the left side of her body as serious and important medical events. List of documents held by sender: none.
11/18/21 presents to EC ED for "unable to feel her legs and attempted to stand however had shooting pains in both legs and was unable to ambulate". PMHx of "asthma, Ehlers Danlos syndrome, gastroparesis, hypothyroidism, joint pain".
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 18-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): lasting for 56, 136 and 24 hours, with the lowest recorded temperature of 30, 31 and 34 degrees Fahrenheit, respectively. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pregnant at the time of first and second inoculation; This spontaneous retrospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant at the time of first and second inoculation) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A, 028L20A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant at the time of first and second inoculation). The delivery occurred  on 28-May-2021, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. On 28-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant at the time of first and second inoculation) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication is provided by reporter. No treatment was provided COMPANY COMMENT: This case concerns a 34 year old female, with no medical information reported, who experienced non-serious unexpected event of Maternal exposure during pregnancy. The age of gestation of the pregnancy  at the time of exposure of the 1st to 2nd dose is unknown since we do not have details of the LMP of the patient . The  re-challenge for this case is not applicable. The benefit-risk relationship of mRNA-1273 (Moderna ) is not affected by this report.   This case was linked to MOD-2021-360694 (Patient Link).; Sender's Comments: This case concerns a 34 year old female, with no medical information reported, who experienced non-serious unexpected event of Maternal exposure during pregnancy. The age of gestation of the pregnancy  at the time of exposure of the 1st to 2nd dose is unknown since we do not have details of the LMP of the patient . The  re-challenge for this case is not applicable. The benefit-risk relationship of mRNA-1273 (Moderna ) is not affected by this report.
Date of GARDASIL injection #1: 6/11/09.  Date of seizure: 7/10/09.  Correlation unclear:  See Neurologist visit note attached from 11/16/09. 12/03/09 Neurology Consult record received DOS 11/16/09. DX: Generalized seizure with aura of confusion 07/10/09; transient alteration of awareness mid-August 2009, duration 1-2 minutes.  Pt. to discontinue anti seizure meds since no seizure recurrence. 12/07/09  Neurology records received for DOS 11/17/09, 08/24/09, 10/05/09, 11/16/09. Pt. reports episode of dizziness, confusion, tongue biting, arm waving, loss of awareness on 07/10/09. Episode of eyes fluttering, staring off into space, loss of awareness on 08/10/09. Reports no further seizures, loss of awaremess on 10/05/09. Impression: generalized seizure with aura of confusion; transient alteration of awareness, seizure may have been provoked by gardasil.
I20.9 ANGINA, UNSPECIFIED 3/29/2023 ABNL CARDIOVASCULAR STRESS TEST
Pt reports pain, itching, H.A., warmth in right arm from shoulder to elbow 2 hours following injection of Pneumococcal vaccine. Later noticing swelling, redness. Pt notified her physician on 10/16/2001. He prescribed Benadryl 50 mg TID, cold packs, nurse advised Tylenol.
Chills, fatigue,  joint pain, headache.  Chills lasted a couple hours.  Sever headache lingered for 24 hours, along with fatigue, and minor joint pain.  After a day of rest, fluids, and ice I felt almost back to 100%.
abscessed tooth; This case was reported by a consumer via interactive digital media and described the occurrence of tooth abscess in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced tooth abscess. The patient was treated with antibiotics nos. On an unknown date, the outcome of the tooth abscess was not recovered/not resolved.   It was unknown if the reporter considered the tooth abscess to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-Jul-2022 Reporter's Comments: The patient self-reported this case. The patient was due for the 2nd dose of Shingrix vaccine but had developed an abscessed tooth, she had been on antibiotics for the treatment and asked about the ingredients in Shingrix and asked would there be any interference and if she should wait. The reporter did not consent to follow up.
Pt. presented to pharmacy with rash on face and thought she may be allergic to flu vaccine.
Persistent lower back pain x 3 days (so far).  OTC's taken for pain.
Information has been received concerning a male described as "fairly healthy" with no significant medial history with a birth twin and a history childhood illnesses such as colds and ear infections who on 24-Jul-2006 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  Subsequently the patient developed several "bumps" on back of neck for which he was seen in the emergency room.  These had not developed into anything more at present, however, they are continuing to monitor the patient closely.  At this point, there was no other case information or specimens available for this patient.  The patients twin sister (WAES#0608USA02545) experienced an adverse event after vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  Additional information has been requested.
30 min after injection, inection area started itching. 2 hrs later, noted large firm area, tender and warm to touch 2 inches in diameter around injection location. Took Claritin 10mg. 36 hours later, local area still very sore/tender and warm to touch.
The weekend post 2nd dose I felt fatigue, runny nose and cough from Saturday to Monday. However, Friday October 1st, I began having sore throat, nasal congestion and runny nose. These progressed Saturday and Sunday. On Monday I also felt fatigue and chills, no fever. On Tuesday and Wednesday I began to develop a productive cough in addition to all previously mentioned symptoms. On Thursday I began to feel a slight improvement in my energy but cough continued. Today is Friday and I still have cough and congestion headaches. It seems as though these must be related to a delayed response to my 2nd vaccine because I tested negative for Covid-19 and none of my immediate family members have "caught" anything from me.
From initial information received from a physician on Jun 20 2005 regarding an adverse event, it was reported that a cluster of three patients (no specific provided) received Tripedia, as well as other vaccinations on an unspecified date. The lot numbers, routes and sites of administration were not reported. An unspecified amount of time later, the patients developed fevers ranging from 101 to 102 degrees F. it was not reported whether the patients recovered from these events.