chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient experienced a migraine; This is a spontaneous report from a non-contactable consumer. A female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 23Apr2021, the next day after receiving the second dose of the vaccine the patient experienced a migraine. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.The clinical outcome of the event migraine  was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 10 minutes after administration patient reported her throat felt slightly swollen or tight. She stated it was not enough to cause any difficulty breathing and that it wasn't itchy.  She took 25mg of liquid benadryl at this time.  She reported no other symptoms but could still feel swelling  (not improving and not getting worse) and her voice was slightly hoarse.  She did not want us to administer EpiPen and she did not want us to call EMS as she stated the swelling was not getting worse. She was able to speak, drink water and swallow.  We continued to monitor.  She took another 25mg of benadryl and reported no changes.  She was feeling well enough to leave with her husband at 55 minutes after administration and we advised her to follow up with a visit to urgent care if no improvement. She did follow up with a visit to the local urgent care where she states she was given IV medrol and more benadryl.
Took shot about 3:45p.m. 11-12-09. Started running fever 9:30p.m. 11-12-09. Had chills and joint and muscle pain for 3 days. Fever broke 11-15-09. Had one big hive just above elbow. Couldn't raise arm. Fever was 101.6, down to 100.
Chills and shaking from around 12:15 AM - 4 AM, sweating, feeling feverish, horrible headache from around 4 AM - 7 AM, feeling feverish, sweating, headache remainder of day (7AM - 9 PM)
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 31-OCT-2012 17:40, 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.
Developed subjective fevers and night sweats the night after receiving the second dose. Upon waking, I had significant chills, muscle and body aches, and fatigue. These symptoms lasted between 12-24 hours.
Patient reported trouble breathing.  Epinephrine was administered and within 1 minute, patient was breathing normally.  Patient had previously received flu shot at another pharmacy without our knowledge and came in requesting flu vaccine here.  EMT was called to the scene. Patient did not want to go to the ER. Patient was seen and released on site.  Followed up with patient at home and she reported no other side effects
"erythematous urticarial rash on R upper arm immediately after 2nd Moderna COVID shot. worsening."
Gas and intestinal upset and gas started approx 1-2 days after the 1st vaccination (01/07) and on 01/13,  diarrhea started at 02:30 (am) and proceeded throughout the day.
2 days p/vax pt awoke covered w/fine red rash, sl raised; no itching; no fever; seemed to feel well; rash subsided p/3-4 days then devel sx of URI-runny nose, cough, puffy eyes, no fever; has cold;
Pt developed polymorphic morbilliform rash on upper torso, upper back and upper extremities where vaccines were given in 5 minutes. After a dose of Benadryl, rash faded away and pt was asymptomatic.
Patient presented to ED with reports of weakness stating that he was lightheaded and felt like he was going to pass out. Also stated that he had nausea. Patient lowered himself to the ground and called his son to help and take him to the hospital. Stated that he frequently has dizziness in the mornings (for the past 5 years) and that they have increasing in frequency. On arrival to the ED, he continued to have generalized weakness and was unable to sit up.
Patient complains felt bad right away, but did not complain. Main complaint now is claims to have arthritis pain in knees, hips and shoulders since shot and has not got any better. Doctor told her to monitor symptoms and follow up with him. Does not want to get second shot for fear symptoms with worsen. Also said felt like had flu like symptoms for couple of days but they went away after a couple days.
Left sided chest pain began about 1-2 weeks after second dose of Moderna vaccine. Chest X-ray showed pleurisy and possible pericarditis. Labs showed new onset of drug induced lupus. Chest pain has not subsided 1 year after vaccine dose.
.  He felt fine for one hour then stated that his lips swelled a bit more from the interior of his mouth.  He kept biting on his cheeks. He felt a scratchy throat too but it did not swell as far as he knew.  His lips and tongue felt tingly for 2 hours after. He took benydril and a clarting.  He has no known allergies.  No hives no rashes
This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (little soreness in the arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the third dose prior to 6 months of receiving the primary dose series of vaccine) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. The patient's past medical history included Cancer (cancer free at this time) and Heart disorder (Heart condition).Concurrent medical conditions included Depression and Anxiety.On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 11-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the third dose prior to 6 months of receiving the primary dose series of vaccine). On an unknown date, the patient experienced PAIN IN EXTREMITY (little soreness in the arm). On 11-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the third dose prior to 6 months of receiving the primary dose series of vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (little soreness in the arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (little soreness in the arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the third dose prior to 6 months of receiving the primary dose series of vaccine) to be possibly related. No concomitant medication reported. The patient did not receive any additional treatments.This is a case of inappropriate schedule of product administration for this 43-year-old, female patient with a medical history of unspecified cancer (currently in remission) and unspecified heart condition, who experienced the unexpected, non-serious event of pain in extremity after administration of the booster dose of the Moderna mRNA-1273. The start date of the event pain in extremity was not provided. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report. Sender's Comments: This is a case of inappropriate schedule of product administration for this 43-year-old, female patient with a medical history of unspecified cancer (currently in remission) and unspecified heart condition, who experienced the unexpected, non-serious event of pain in extremity after administration of the booster dose of the Moderna mRNA-1273. The start date of the event pain in extremity was not provided. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.
Patient was fully vaccinated with the Moderna COVID-19 vaccine, on 3/1/2021 and 3/31/2021 respectively.  On 9/4/2021, pt tested positive for COVID-19.  Pt subsequently hospitalized for COVID-19 infection which resulted in asthma exacerbation and steroid induced hyperglycemia.  Admitted 9/16/2021,  discharged 9/18/2021.
Could not lift her arm; So dizzy they could not stand up; Chest pain for 31 hours; nausea; headache; Muscle pain; Joint pain; Chills; Tired; fever; Really bad lower back pain on left and right side/Like something was ripping out kidneys; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Really bad lower back pain on left and right side/Like something was ripping out kidneys), LIMB DISCOMFORT (Could not lift her arm), DIZZINESS (So dizzy they could not stand up), CHEST PAIN (Chest pain for 31 hours) and NAUSEA (nausea) in a 47-year-old female patient 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 Cancer and Cardiomyopathy. Concomitant products included METOPROLOL and GABAPENTIN for an unknown indication.    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced BACK PAIN (Really bad lower back pain on left and right side/Like something was ripping out kidneys), DIZZINESS (So dizzy they could not stand up), CHEST PAIN (Chest pain for 31 hours), NAUSEA (nausea), HEADACHE (headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Tired) and PYREXIA (fever). On an unknown date, the patient experienced LIMB DISCOMFORT (Could not lift her arm). At the time of the report, BACK PAIN (Really bad lower back pain on left and right side/Like something was ripping out kidneys), LIMB DISCOMFORT (Could not lift her arm), DIZZINESS (So dizzy they could not stand up), CHEST PAIN (Chest pain for 31 hours), NAUSEA (nausea), HEADACHE (headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Tired) and PYREXIA (fever) outcome was unknown. Not Provided
I received the flu vaccine after a normal prenatal appointment in the office. Later that evening, I laid down, to be awakened by the sensation of needing to make a bowel movement. I went to the bathroom and bared down as if to pass stool and expelled my 14 week -4 day fetus, which began the spontaneous incomplete abortion, requiring hospitalization. I nearly lost uterus due to uncontrolled bleeding. At admission, my H&H was 12 and 35%, but decreased to 9.25 and 28%, due to hemorrhage.  Pregnancy history: 4 pregnancies with 3 deliberate abortions. EDT: April 4, 2017
A FEW HOURS AFTER RECEIVING VACCINES PATIENT EXPERIENCED SHORTNESS OF BREATH AND NOT FEELING WELL.  PARTENT TOOK HER TO ER. NO TREATMENT GIVEN AT VISIT ONLY OBSERVATION.  EPISODE ONLY LAST LESS THAN ONE HOUR.  SENT HOME.  NO FURTHER PROBLEMS.
Patient experienced coldness in arm then felt it become numb and swollen within 30 minutes of vaccine administration.
got the vaccine and it gave me/Suspected Vaccination Failure; it gave me; painful; itchy; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the vaccine and it gave me/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: it gave me), pain (Verbatim: painful) and pruritus (Verbatim: itchy). The outcome of the vaccination failure, shingles, pain and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-APR-2023 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine and it gave him/her shingles, less strong but still so painful and very itchy. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  The follow up would not possible as no contact details were available.
I received Botox injections on 1/21/21 to both jaw muscles. On the evening of 1/29/21, the left side of my face became swollen and felt tingly, numb, and painful. My lips also became swollen when I woke up the morning of  1/30/21.
intermittent-99-100 onset 21NOV93; lower legs red & sore to touch, hot touch, h/a 2-3 days not responsive to pain killers; knee joint pain, weakness noc sweat;
Swelling in the face and neck on left side. Tender and warm to touch. Swelling lasted Friday to Sunday after vaccine. Patient used OTC ibuprofen and ice to treat.
No adverse event. This was an administration error without adverse event. Expired Covid vaccine administered (expired open vial time)
administered the wrong influenza vaccine with no adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from a Patient.  This case is linked to case 2023SA312971 (CLUSTER).  This case involves a 58 years old female patient where reporter reported two years ago she was at the doctor's office to receive a dose of influenza quadrivalent recombinant vaccine [Flublok QIV], but was administered a different Influenza vaccine instead with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza quadrivalent recombinant vaccine and influenza vaccine lot number not reported via unknown route in unknown administration site (dose, frequency, route, formulation, strength and expiration date: not provided) for Immunisation (wrong product administered). Information on the batch number was requested.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED ---------------------------------------------------------------------------------------------------------------------------------  ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/2/2022 ATHEROSCLEROSIS OF AORTA  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/3/2022 ATHEROSCLEROSIS OF AORTA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/2/2022 CACHEXIA  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/3/2022 CACHEXIA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/2/2022 THROMBOSIS OF PORTAL VEIN  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/3/2022 THROMBOSIS OF PORTAL VEIN
This spontaneous report was received from a Registered Nurse and refers to a multiple patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX lot number M037642, expiration date 01-SEP-2018, (dose, dose number, route and anatomical location were not reported), for prophylaxis. The vaccines experienced a temperature excursion between 6 to 14 Fahrenheit Degrees ("6 Fahrenheit Degrees was the actual highest temperature of exposure"), during 30 minutes of time frame. No previous temperature excursions and no digital data logger was involved. No adverse effect were reported and no product quality complain was involved. No other suspect or concomitant therapies were reported. Additionally,  there was also reported that only "9 doses administered". This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012014:
Body aches for about 8 hours, fever for about an hour, chills off and on for 6 hours, nausea for about 9 hours - symptoms may have occurred for longer, but I went to sleep and they were gone when I woke up.
This spontaneous report as received from a medical assistant refers to an unspecified number of patient of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of an improperly stored ROTATEQ (lot #, expiration date and dose were not reported), orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pruritus and angioedema to face with redness as well as dizziness for 5 days
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
patient received a HD vaccination yesterday and come to find out the patient had received a HD vaccination 4 days ago as well, no AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves a unknown demographic patient who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] twice (lot number not reported via unknown route in unknown administration site) on an unknown date.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to extra dose administered.   It was reported that the patient received a HD vaccination yesterday and come to find out the patient had received a HD vaccination 4 days ago as well.  At the time of reporting, 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 holder's 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.  Information on the batch number was requested.
2 hours after receiving (PEDIARIX, HIB, PCV13, HEP A) Pt broke out with hives and itchiness all over body. Mother call oncologist and he informed her to give pt BENADRYL.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 7 years old child patient and unknown gender. On 29-AUG-2014 the patient was vaccinated with PROQUAD lot # K006771, expiration date 19-JUL-2015) (dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 9 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to 4 patients of an unknown age and gender. The patient's past medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with PROQUAD (dose, frequency route unknown) for prophylaxis. The vaccine PROQUAD was reconstituted with properly stored sterile water diluent (unknown lot, unknown expiration) with temperature of 15°F to 46°F for a time frame of 5 days. There was no previous temperature excursion. No digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA011845.
Parents of child lied about age, verbally and form was filled out indicating pt was born in an earlier year than patient's actual birth year. First dose of vaccine was administered at Health Department. Second dose recommended for 16 years old who have already received first dose.
Patient had reaction to Tdap (ADACEL) vaccine given 8/26/15. Hot to touch and red. Dr treated w/ antibiotics.
Pt with stage IV colon cancer with mets to lung died on 12/18/21
Developed COVID; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Developed COVID) and DRUG INEFFECTIVE (Lack of drug effect) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jun-2021, the patient experienced COVID-19 (Developed COVID) and DRUG INEFFECTIVE (Lack of drug effect). On 29-Jun-2021, DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. At the time of the report, COVID-19 (Developed COVID) outcome was unknown.            Treatment information was not provided. No concomitant medications were reported. No lab data was provided by the reporter. This is a case of lack of efficacy of the vaccine. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable.   This case was linked to MOD-2021-243061 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Up on internal review on 11-AUG-2021, an event LOE has been added to the case.; Sender's Comments: This is a case of lack of efficacy of the vaccine.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable.