chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 68-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that patient's facility was unable to download the database, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter also stated that no adverse reactions were reported by any patients.  Treatment information was not provided.
From faxed correspondence received at Aventis Pasteur Inc. on 08/01/2002, it was reported that a 4-month-old male received a dose of ACTHIB, Tripedia, IPOL, and Prevnar on 07/12/2002. Pt developed redness and swelling at injection site and was irritable on 07/15/2002. This reporter has 2 more patients who experienced similar reactions after receiving these vaccines. Linked with cases U2002-00607 and U2002-00525. From additional correspondence received at Aventis Pasteur Inc. on 11/26/2002, the lot #'s and administration sites for the vaccinations were provided. The pt received ACTHIB, lot #UA708AA, in the right leg as dose #2, IPOL, lot #U0425, in the left leg as dose #2, TRIPEDIA, lot #U0544CA, in the right leg as dose #2 and PREVNAR (manufacturer Lederle), lot #484-210, in the left leg as dose #2. The pt recovered. From additional correspondence received at Aventis Pasteur Inc. on 12/18/2002, it was reported that the pt had no pre-existing diagnosis and no illnesses at time of vaccination. The pt had no previous adverse reactions following prior vaccinations. No further info was reported. Case is closed.
patient requested a shingrix vaccine yesterday on 1/8/23 / That would be a third dose from yesterday 1/8/2023; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in June 2018) and Shingrix (2nd dose received in January 2019).   On 8th January 2023, the patient received the 3rd dose of Shingrix. On 8th January 2023, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's Comments: The pharmacist inquired any contraindication or any problems about Shingrix vaccine. The RPH (registered pharmacist) reported an over 50 year old patient requested a Shingrix vaccine yesterday (from the reporting date). They administered the vaccine but RPH later found out the patient received a first dose and second dose of Shingrix and that would be a third dose from yesterday (from the reporting date). The RPH declined to provide any patient or vaccine details.  The reporter did not consent to follow-up. Additional supportive information: The patient received additional 3rd dose of Shingrix, which led to extra dose administered.
Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Oct2021 at 15:30 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroparesis, depression, anxiety and COVID-19, which was diagnosed prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received isopropanol/chlorhexidine gluconate (CHLORAPREP) and experienced drug allergy. On 02Oct2021 at 04:00, about 12 hours after injection, the patient experienced vomiting and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vomiting and diarrhea was resolved on an unknown date in Oct2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This is a spontaneous report from a contactable physician (father of patient). A 6-weeks-old female patient of unknown ethnicity received PREVNAR 13 (lot number G57197, Exp date Sep2014) at 0.5 ml single dose and PEDIARIX at 1 DF single dose, both intramuscular on 16Oct2014. Medical history included sensorineural hearing loss and a treatment with Valacyclovir. Concomitant medications included Flu vaccine on unknown date. The patient was administered with an expired dose of PREVNAR 13. On an unspecified date in Oct2014, the patient experienced also localized redness and swelling that is painful to the touch. A treatment for the event was performed. The patient repeated vaccination on 14Nov2014 since the previously received product was expired. Outcome of the events was recovered. Follow-up (17Nov2014): New information from the same contactable physician included medical history, outcome of the events, concomitant medication. Follow-up (14Jan2015): Follow-up attempts completed. No further information expected.
Client came to facility on 4/28/21 for her second COVID Moderna vaccine.  She was seen by Dr.  She complained of nausea, head heaviness and lightheadedness.  Her heart rate was 73 and 67.  Her oxygen sat was 96%.  Her lungs were clear.  She was monitored for 30 minutes and then sent home with her mom.  No additional intervention.
On 12/31/00, pt began "feeling funny". On 1/1/01, pt started feeling tingling in hands, food tasted funny. Weakness in arms and legs on 1/3/01 and taste gone. Seen by MD on 1/2/01 with headache and congestion. No fever, no ST. MD thought it was ? allergic reaction to Prilosec. Seen by MD on 1/3/01 with ptosis and weakness. Currently recovering. Subsequently, dx'd with atypical GBS involving cranial nerves in particular. Per doc 210316, patient almost completely recovered, but still with occasional extremely tingling and scalp pain.  Follow up 07/06/2001: "Patient did not experience any illness with in 4 weeks prior to onset of GBS.  Possible URI 2 weeks prior to onset.  A final diagnosis of GBS has been made as : Demyelinating polyneuropathy poss atypical GBS."
Rash on arm with main large red hot welt at injection site on day 1-6, no rash on day 7-8 and welt was no longer red raised or hot, rash returned on day 9. Large raised red hot itchy welt on day 9.
Felt awful the 2nd week after shot, sweats, achy joints, very difficult to get out of bed. 11/30 I developed this pain in my ribs on the left side. I thought I had turned the wrong way or something. Iced it 5/1-5/3. On the afternoon of 5/3 I noticed a poison ivy type rash on torso close to left breast. Had a similar rash along the same line on the back. Called my doctor and we decided it was Shingles. Started taking 1gm of Valacyclovir HCL Evening of 5/3. Confirmed diagnosis with in office Dr. visit on 5/4.
No adverse effect reported; were inadvertently administered doses of MMR II, that had been improperly stored; Information has been received from a registered nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. The patient's pertinent medical history, drug reactions/allergies and concurrent condition were not provided.      On 01-JUL-2019 the patient were inadvertently administered doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: recombinant human albumin(rHA); lot # R028224, expiration date reported as 04-OCT-2020, but upon internal validation established as 02-OCT-2020; strength, dose and route were not reported) for prophylaxis (product storage error). The administered doses experienced a temperature excursion of 15.9 degree Celsius for 5 hour and 15 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effect was reported.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA002125: US-009507513-1907USA003024: US-009507513-1907USA003023: US-009507513-1907USA002218:
c/o lt arm aching 28AUg97 evening wake up 29AUg97 w/lt arm red, swollen & warm to touch from elbow to top of lt shoulder;fever <101 that evening 29AUg97;rx of ATB from child MD;2SEP97 arm still sore, appears buried per child mom;
He only had a sore arm the next day with the 1st dose; This is a spontaneous report from a Pfizer sponsored program  from a non contactable male consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included spinal cord injury from an unknown date and unknown if ongoing (3-4 years he's been doing acupuncture for a spinal injury).  The patient's concomitant medications were not reported. The patient reported he only had a sore arm the next day with the 1st dose, on an unspecified date. He believes he had no side effects because for 3-4 years he's been doing acupuncture for a spinal injury. He had no side effects with the 2nd dose that he got last Thursday (unknown date). The outcome of the event, sore arm the next day was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
About 8 PM I noticed a scaly patch on the middle finger left hand and some other small areas. It was itchy. About 2 hours later my back left shoulder was itchy and I felt another scaly area. 20 minutes later it occurred on my right side in the same general area. I had my partner take a picture because I'm a nurse and I noticed the same thing on my upper back and left lower quadrant of my back and I recognized it as a systemic reaction and went to the ER for treatment. I was given prednisone and BENADRYL and waited an hour and the rash had substantially subsided. I was sent home with a prednisone script for 5 days and triamcinolone cream.
Myalgia, NauseaVomiting, back pain, sore left arm,  Narrative:
Chill; aches; This is a spontaneous report from a contactable consumer (patient herself). This 80-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EN5318), via unspecified route of administration on the left arm on 10Feb2021 at 11:00 AM (at the age of 80-year old) at single dose for COVID-19 immunization. The patient received her first dose of the same vaccine (Lot number EL1283) on 20Jan2021 at 11:00 AM on the left arm. Relevant medical history included COVID in Oct2020. Concomitant medications were not reported. On 10Feb2021 at 05:00 PM the patient experienced chill and aches. No treatment was required and the patient recovered from the events.
swelling on face around eye, shingles-like rash, Persistent, intense itch on other areas including genitals but no visible rash.
Patient stated she started having tingling in her tongue as soon as she received the injection and she had not been experiencing it prior to being vaccinated.
most people getting lethargic; pain going across their back; Patient also states they had Charly horse that were visible all over their body; They could not even walk; They felt electricity going through their body to their fingers; car accident; whiplash on their neck; tired after the first dose,They get very tired, it hurts so they cannot move; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (most people getting lethargic), BACK PAIN (pain going across their back), MUSCLE SPASMS (Patient also states they had Charly horse that were visible all over their body), GAIT DISTURBANCE (They could not even walk) and PARAESTHESIA (They felt electricity going through their body to their fingers) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (at the age of 10) and Nervous system neoplasm surgery (had 2 months ago and put a titanium plaque on their back. patient had their vocal cord snip during surgery). Concurrent medical conditions included Osteoarthritis, Arthritis and Disability (since 33 year ago).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (most people getting lethargic), BACK PAIN (pain going across their back), MUSCLE SPASMS (Patient also states they had Charly horse that were visible all over their body), GAIT DISTURBANCE (They could not even walk), PARAESTHESIA (They felt electricity going through their body to their fingers), ROAD TRAFFIC ACCIDENT (car accident), POST-TRAUMATIC NECK SYNDROME (whiplash on their neck) and FATIGUE (tired after the first dose,They get very tired, it hurts so they cannot move). At the time of the report, LETHARGY (most people getting lethargic), BACK PAIN (pain going across their back), MUSCLE SPASMS (Patient also states they had Charly horse that were visible all over their body), GAIT DISTURBANCE (They could not even walk), PARAESTHESIA (They felt electricity going through their body to their fingers), ROAD TRAFFIC ACCIDENT (car accident), POST-TRAUMATIC NECK SYNDROME (whiplash on their neck) and FATIGUE (tired after the first dose,They get very tired, it hurts so they cannot move) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient also reported that they felt electricity going through their body to their fingers. They had a lot of nerve problems since affecting their legs and arms. Patient also mentioned getting zap when touching a socket. Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-389035 (Patient Link).
her son has been dealing with runny stool for quite a long time; pediatrician gave my son the ROTATEQ vaccine and only gave 1 dose and then they gave ROTARIX / He was supposed to get 3 doses of ROTATEQ; pediatrician gave my son the ROTATEQ vaccine and only gave 1 dose and then they gave ROTARIX / He was supposed to get 3 doses of ROTATEQ; This spontaneous report was received from a patient's mother and refers to a currently 9-month-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 10-FEB-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose (exact dose, dose number, vaccination site, route of administration, lot # and expiration date were not provided) for prophylaxis. On 12-APR-2020, the patient was vaccinated with rotavirus g1 p1 vaccine live (89-12) (ROTARIX).  The patient's mother stated that she was in panic that her pediatrician gave her son rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and only gave 1 dose and then they gave rotavirus g1 p1 vaccine live (89-12) (ROTARIX). She wanted to know if there were any adverse reactions that could happen by doing that. The patient was supposed to get 3 doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  Since an unknown date (reported as for quite a long time), the patient has been dealing with runny stool. The outcome of the event was unknown.  The causal relationship between the event and the suspect vaccines was not reported.
About two weeks after receiving my 2nd booster, I started showing systems of Autoimmune Hemolytic Anemia; however, was not tried for this disease until July 14, 2022.
On 4-19-2021 I had the second dose at 9am. At 10 am I had a headache on the right side which is abnormal for me. I took a sumatriptin and slept for 30 minutes. I got up and felt fine. At 4:30 pm I had an uncomfortable feeling on the left abdomen. I ate supper and then at bedtime around 9 pm I was vomiting. I could not keep water down. I took 2 ibuprofen  On 4-20-2021 I called Dr. to report I was not feeling well as I felt I was lipping away. This was at noon. At approximately 2pm I called Dr. office and asked for help. I was advised everyone was with patients. I advised them I was going to the hospital. I went to the hospital with feelings of slipping away and left abdominal pain. I received two bags of hydration via IV and a CT scan. I was told there was a "mass in the sift tissue" on the left side. They tried to do a transvaginal ultrasound but it was too uncomfortable. ON 4-21-2021 I saw Dr for a check up after leaving the ER. He ordered the MRI of the abdomen per suggestion of the ER doctor, On 4-22-2021 I returned to Dr. as my left upper arm was very swollen, red and hot. He advised it was a side effect and to take benadryl and ibuprofen.. On 4-23-2021 the pain on the left side of the abdomen was very severe and it took me,in the am, more than 30 minutes to get up from the couch due to the severe pain in the abdomen. The MRI was denied by insurance and I called my GYN who referred me to Dr. I told Dr. the pain finally went away on 5-24 when I woke up that morning. A CT scan with dye was ordered and that has caused the pain and feeling of swelling on the left side of the abdomen to come back. I am now waiting to have the MRI on 7-16-2021. I had my annual check up with my GYN approximately 3 weeks before the second shot and I had no complaints and no pain on either side. A physical exam was performed by the GYN and there was no problems. .
Fever, extreme body aches, difficulty breathing and dizzy. All started the night after I was vaccinated and continued the entire next day. Symptoms became more mild on the second day.
painful blistering rash, which was diagnosed as herpes zoster; Information has been received from a lawyer, regarding a case in litigation, and refers to a currently approximately 83-year-old patient (pt) of an unknown gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 24-JUL-2011, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a "provider" for painful blistering rash, which was diagnosed as herpes zoster and resulted from the pt's use of zoster vaccine live (ZOSTAVAX). The outcome of the event was not provided. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Red, raised, hive like rash that was hot and itchy. Pt took Benadryl and applied anti-itch spray to the area.
Was observed for at least 15 minutes. Arrived at home and had a seizure, was rushed to the hospital. Mother claimed patient is in ICU.
Back hurts; arm is sore; she is nauseous; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back hurts), VACCINATION SITE PAIN (arm is sore) and NAUSEA (she is nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back hurts), VACCINATION SITE PAIN (arm is sore) and NAUSEA (she is nauseous). At the time of the report, BACK PAIN (Back hurts), VACCINATION SITE PAIN (arm is sore) and NAUSEA (she is nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.
dry throat, dizziness, felt like bp was high. Evaluated by EMS-Refusal to transport.
ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME
it was given me the flu every time; Initial information received on 19-Oct-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer).  This case involved a patient of an unknown demographic who had the flu every time (flu), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown), it was reported that patient had flu every time (flu).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown for flu.  There will be no information available on the batch number for this case.
Maculopapular Rash beginning not long after vaccine, began with hives and itching on hands, did not speculate vaccine relation until following day, hives appeared on hands and continued non-uniform across forearms, armpits, chest, abdomen, pelvic/thigh crease, buttocks, and behind knees, approx 50-60% of body experienced hives and maculopapular rash within 0-4 days after vaccine, minor swelling occurred where rash was present and was most prevalent 3 days post injection.