chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 14 year old, female patient with no pertinent medical history reported. On 15-OCT-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Concomitant medications included hepatitis A vaccine (manufacturer unknown) administered on 15-OCT-2012 (intramuscular in the left arm, dose not reported). On 21-FEB-2013 the patient was vaccinated with the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Symptoms began on (Sunday) about 6 hours after vaccine was received. They started fairly mild, with a sore arm, mild headache and fatigue.  When I woke up the next morning (Monday) and I felt very ill.  I could not move my arm without severe pain, I had shaking chills, I was weak, I was achy and I had a fever.  My temperature went as high as 100.5.  The next day (Tuesday) I woke up feeling better than I felt the previous day, but still felt weak, and achy I had no temperature when I woke up but by 10:00am my temp was up to 99.4.  It is now 7:00 pm (Tuesday) my temp is 99.8.  I feel much better than I  have for the past two days, but I do still feel very tired. (my normal daily temperature runs low... 96.5 - 97.5)
Pt passed out right afte giving 3 injection-eyes rolled, legs stiff, hands shaking, skin pale and wet-called for dr and crashcart-upon Dr entering the room, Pt coming to and answering questions-elevated legs, soda, crackers given and monitored Pt for 1hr-Pt complained of headache and itching all over-Pt left at noon with no symptoms.
Approx 1hr after vaccinations developed general redness with whelps and itching on face, ears, trunk. No resp symptoms. Responded well to tx with antihistamine and steroids discharged.
My daughter started with a fever in the am (Day 8 from vaccine), at 5pm received a text that my daughter's temp had returned and was 101.9 and TYLENOL was going to be given. No other symptoms with fever. At around 6 pm daughter started seizing. It presented as a seizure to start but then my daughter lost consciousness, stopped breathing and was turning blue around her mouth and chin. At that point I was unsure if it was a seizure or choking or what so began first response measures (check airway, back blows, rescue breaths) and 911 was called. She was unresponsive and not breathing for 2-4 minutes but by the time the paramedics arrived she had started breathing on her own. She still was unresponsive and limp. Ended up taking a ride to the hospital via ambulance and upon arrival she started to respond to stimulus. During the ride oxygen was given. Ran a number of test at the ER, Simple Febrile Seizure was diagnosis and we were discharged that evening. Fever continued through the next day, seemed to break for 12 hours and then returned. Finally ending day 11. She did have some diarrhea after the fever started (after ER) but assuming it was then related to higher temps. Was not runs multiple times a day but loose stool when she went regularly.
Dizziness, fatigue, nausea, numbness and tingling in all extremities. This has been occurring roughly a week after the initial vaccination.
9FEB89 to ER p/brief generalized tonic/clonic sz; T101; Seen by MD felt to be febrile sz; Sent home; Later returned to ER w/similiar event; Had otitis; given ATB;
Pfizer-BioTech COVID-19 Vaccine EUA child had ache in armpit of shot that received shot.  pain medicine was given to help relieve as well as warm compress.  pain medicine was needed for several days after pain started
Vaccine was administered to patient 2 days past the 30-day time in refrigerator; Dose/volume 0.5 ml/Patient received Moderna vaccine Booster on 04/08/2022; Vaccine was given beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was administered to patient 2 days past the 30-day time in refrigerator), ACCIDENTAL OVERDOSE (Dose/volume 0.5 ml/Patient received Moderna vaccine Booster on 04/08/2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine was given beyond use date) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     The patient had no known drug allergy. Acute illnesses at the time of vaccination and up to one month before was reported as none. Chronic or long-standing health conditions were reported as unknown.     On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Apr-2022, the patient experienced ACCIDENTAL OVERDOSE (Dose/volume 0.5 ml/Patient received Moderna vaccine Booster on 04/08/2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine was given beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered to patient 2 days past the 30-day time in refrigerator). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was administered to patient 2 days past the 30-day time in refrigerator), ACCIDENTAL OVERDOSE (Dose/volume 0.5 ml/Patient received Moderna vaccine Booster on 04/08/2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine was given beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine was given beyond use date) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Vaccine was administered to patient 2 days past the 30-day time in refrigerator) and ACCIDENTAL OVERDOSE (Dose/volume 0.5 ml/Patient received Moderna vaccine Booster on 04/08/2022).    Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event was reported as unknown. The patient received Moderna vaccine booster on 08-Apr-2022. Vaccine was given beyond use date. Vaccine was received in refrigerator on 07-Mar-2022 in appropriate temperature (2-8 Celsius). Vaccine was administered to patient 2 days past the 30-day time in refrigerator. The vial did not undergo any temperature excursion. The event did not cause the patient to seek medical care. There were no any other potential causes. No treatment medications were reported.
Fever reached 105 within 30 minutes of administration of vaccine. I was unaware and incoherent. Went to work and passed put. Fell asleep and went to er once I woke up again on Friday night.  Went medical whereon was prescribed valium, licoderm patches and tramadol, and valium for severe pain because I had already taken enough tylenol and ibuprofen to break the fever. I was sent home. Got up the next day to  fill the prescriptions but was still to incoherent to realize what was going on, no fever and didn't understand that I was sick. Filled prescriptions and was in pain but thought I could make it to work. Pulled over at a gas station because I became disoriented where Iproceeded to have a seizure. I have no history of seizures. I am now unable to drive or work for three months and Agency instructed me not to report these reactions when I called to ask if I was possibly having a reaction to the vaccine on Friday afternoon.
Pt experienced redness, warmth at injection site, knot at injection site, peeling of the skin around site.
Patient's husband described that the patient's arm at the site of the injection had signs of bruising (black and blue coloration), and swelling. Slightly below the injection site there was also a 1 inch diameter red area.  The following day, this had grown to a 5 inch diameter red area.  Tenderness of the entire arm was seen, and the patient also experienced heat and swelling from the injection site.  The patient has been prescribed antibiotics, opioids, and antiemetics.  Currently the patient is resting at home.
I feel super tired all the time, shortness of breath even walking around the house, I think it started now with my appetite and I have lost about 20 LBS.
Continuous headache , fatigue, muscle aches, episodes of shooting pains in legs >6 weeks  Loss of taste, appetite > 3 momths
Headache, nausea, diarrhea, severe pain in injection area, swelling, redness at injection site, fever, chills, ache in joints, lump under arm, excessive swelling, dizziness, redness under arm and around arm, pain in shoulder and neck, swelling of arm.
Pt's IZ records were not complete in our practice. Later mom brought full IZ records and we found that the vaccines above listed were duplicates.
Patient presented as highly anxious during the administration of the flu shot. Flu shot was given. Patient subsequently stood from the chair and walked toward the front of the room. Staff and writer heard a noise and observed the patient on the ground toward the front of the room. No witness fully observed the action. Patient was conscious when writer intervened. Patient reported he "blacked out". Patient was pallor, lethargic, and somewhat confused about the events that had transpired. Patient became more alert as writer probed several health assessment questions. Writer lifted the patients legs up in the air for several moments and patient was educated about the intervention. The school nurse was called and further assessment was completed. After some time, patient stood on his own accord and care was fully transferred to the school nurse where he remained for some time. After the clinic had concluded, writer observed the patient in the school nurse's office without being in distress.
Tens days after vaccination, my arm became red, swollen, and warm with fever. I called my doctor?s office. The conclusion was that I have commonly termed as COVID Arm.
The pt experienced a measles rash over entire body on 4/6/01. The pt had an MMR on 3/27/01.
flu like symptoms; Freezing phenomenon; Chills; Nauseous; Injection site swelling; Injection site erythema; Injection site warmth; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site warmth), INFLUENZA LIKE ILLNESS (flu like symptoms), FREEZING PHENOMENON (Freezing phenomenon), CHILLS (Chills) and NAUSEA (Nauseous) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced INJECTION SITE WARMTH (Injection site warmth), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (Injection site erythema). 26-Mar-2021, the patient experienced NAUSEA (Nauseous). On 27-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), FREEZING PHENOMENON (Freezing phenomenon) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 09-Apr-2021, NAUSEA (Nauseous) had resolved. At the time of the report, INJECTION SITE WARMTH (Injection site warmth), INFLUENZA LIKE ILLNESS (flu like symptoms), FREEZING PHENOMENON (Freezing phenomenon), CHILLS (Chills), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (Injection site erythema) outcome was unknown.            The patient reported concomitant medication use of female hormones and cholesterol medication both for unknown indications since unknown start dates. Action taken for Moderna COVID-19 Vaccine was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-075275 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075275:CROSSLINKED WITH DOSE 1
Information has been received from a health professional referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, these patients were vaccinated with doses of improperly stored oral, ROTATEQ (lot # reported as 1020859, expiration date: 19-JAN-2017, strength and dose unknown) orally. There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pain - sore to touch and movement with arm Swelling Redness about 2 inches below injection site.  Fever of 104.3f
Developed prickly feeling and slight rash...perhaps some mild hives about 11 hours after the vaccine.  I also felt like I had a bit of a lump in my throat. I called the Doctor's office and spoke with a nurse who suggested I take Benadryl.  I did so at around midnight and that seemed to take care of things.  Went to bed and woke up the next morning feeling ok (though groggy from the Benadryl).
No reaction. Patient received 0.25mL of Moderna Bivalent Booster dose. Patient notified.
Sciatica was getting worse; Covid; Covid/Covid vaccine made ill; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4136583.  An 84-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 84 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1165533), subcutaneous for psoriasis. The patient's relevant medical history included: "sciatica", start date: 2010 (ongoing), notes: On 2010, the patient experienced Sciatica was getting worse. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "recovered" (2022), described as "Covid"; SUSPECTED COVID-19 (medically significant) with onset Jul2022, outcome "recovered" (2022), described as "Covid/Covid vaccine made ill"; SCIATICA (non-serious), outcome "not recovered", described as "Sciatica was getting worse". The action taken for adalimumab was unknown.  Additional information: The reporter's causality for the event of Covid vaccine made ill and Sciatica was getting worse with Adalimumab Solution for Injection was No Reasonable Possibility. The reporter's causality for the event of Covid with Adalimumab Solution for Injection was Not Provided. The reporter's causality for the event of Covid vaccine made ill with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. The reporter's causality for the event(s) of Covid and Sciatica was getting worse with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Opinion was that the causality for the event(s) of Covid, Covid vaccine made ill and Sciatica was getting worse with Adalimumab Solution for Injection was Not Provided. opinion was that the causality for the event(s) of Covid, Covid vaccine made ill and Sciatica was getting worse with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Assessment Results were Humira: Illness, Non-Health Care Professional, Introspection, Not Related. Humira: Sciatica aggravated, Non-Health Care Professional, Introspection, Not Related. Pfizer BioNTech COVID-19 vaccine: Illness, Non-Health Care Professional, Introspection, Probable.  The reporter's assessment of the causal relationship of "covid", "covid/covid vaccine made ill" and "sciatica was getting worse" 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 information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the events drug ineffective,Suspected COVID-19 and sciatica are possibly related to the suspect BNT162b2.
Soreness when moving arm for about 2 weeks now worse at night and when lifting arm to move the muscle.
11/25/22  I started with a little cough, it wasn?t bad at all. It progressively worsened. I was feeling tired with not much energy by the end of the week. I had postnasal drip that continued to get worse.  On 12/9/2022 I saw my physician and was diagnosed with pneumonia. I was given a breathing treatment in the office and was sent home with a prescription for albuterol and an antibiotic. It took about 4-5 days to start feeling better.  The cough was getting less and less. All the symptoms I had started to diminish. It took at least 10 days for me to start to feel better.
Redness and warm area noted on right thigh, mom stated when she (pt) woke up from nap pt started itching thigh and complained of pain 6/4/10. 6/4/10 redness, warm and swelling on (R) upper thigh.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 04-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 16 hours with the lowest recorded temperature of 29 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, injection site pain, chills, weakness Narrative:  The day after receiving the second dose of the vaccine, the patient reported pain in her left (injection) arm, a fever of 101 (F), headache, nausea, generalized body aches and weakness. She took three doses each of acetaminophen 650mg and ibuprofen 400mg that day.
1st dose 20Nov2019, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 20th November 2019, batch number PR5B2 and expiry date 15th November 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-JAN-2023 Reporter's Comments:  The reporter asked if the patient could get the second dose of Shingrix or need to restart the series. The patient received the first dose of Shingrix back on 20th November 2019 and never got the second dose. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
severe joint aching the day after the injection that lasted for 3 days. Also fever x 5 days still ongoing
Information has been received from a nurse concerning an 18 year old female patient who did not develop an adequate titer response following vaccination with an unknown manufacturer's Hepatitis B vaccine. The patient was revaccinated with a second series of RECOMBIVAX HB, receiving the first dose of on 06-MAY-2010, the second dose on 09-JUN-2010. They were planning to vaccinate the patient (who was present in the office) with the third dose at the time of call. The patient's outcome was unknown. The patient sought medical attention by office visit. Additional information has been requested.
Pt called on 11/01/2004 to c/o redness, swelling, pain and tenderness at injection site. Also notes blister at the center of the redness and c/o difficulty lifting arm. Onset of symptoms approximately one week post vaccination. Seen in office on 11/01/2004 and treated with Allegra 60mg b.i.d. and Hytone 1% cream to affected area t.i.d. Spoke with patient today in follow-up phone conversation. States that she has noted improvement but it has not completely resolved. The blister noted a week ago is gone and she can now move her arm. The redness has become three smaller areas, 1/8", 3/8", 3/4" approximately. I will follow-up with patient next week.
BLOOD CLOTS; This spontaneous report received from a patient via social media via a company representative concerned an 80 year old male of unspecified race and ethnicity. 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, batch number and expiry were not reported) dose, start therapy date were not reported administered 1 in total for covid-19 prophylaxis. 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, the patient experienced blood clots. Reported that "My 80+ year old husband got blood clots after getting J&J shot! My brother and I did not get blood clots! The medication cost has taken a toll on our budget as well as his health! And we have excellent insurance." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220802964-covid-19 vaccine ad26.cov2.s- Blood clots. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Alcohol-induced acute pancreatitis - He was treated with the CIWA protocol, provided IV fluids, electrolyte replacement, and TPN/lipids for 48 hours. PT/OT was consulted for ongoing rehabilitation. His diet was gradually re-instituted, the TPN was stopped, and his pancreatitis symptoms resolved. He was restarted on his home anxiety regimen, his home pain regimen for chronic low back pain, and returned to his baseline functional strength status prior to discharge. He tolerated a regular diet and fluids well and was discharged to home. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.