chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is 4-5 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Patient is 4-5 weeks pregnant) 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 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 05-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient is 4-5 weeks pregnant). On 05-Feb-2021, EXPOSURE DURING PREGNANCY (Patient is 4-5 weeks pregnant) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPOSURE DURING PREGNANCY (Patient is 4-5 weeks pregnant) to be not related.
A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 27-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half of the dose was discarded by the person administering the vaccine. There was no adverse event associated with this vaccine underdose; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
This spontaneous report as received from a Registered Nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of PEDVAXHIB with lot number M046134 and expiration date of 27-SEP-2019 (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was stored from 47 Fahrenheit degrees (°F) to 77°F for 18 minutes and reconstituted with properly stored sterile diluent with lot number reported as N007550 and expiration date of 03-MAY-2018. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA010584. US-009507513-1705USA009159:
Patient experienced troubles breathing and throat closing 7 minutes after receiving first dose of Pfizer Covid-19.   An Epipen was administered and patient started breathing better immediately after administration.  Patient was monitored an extra 1/2 hour,  and told we were going to call EMS for further evaluation and patient did not want us to do that because she was feeling better.  Patient also has a peanut allergy.  She left a message for her PCP for follow up.
This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). A 55-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (death), outcome "fatal", described as "Cause he's got diabetes and even though he got the vaccine"; IMMUNE SYSTEM DISORDER (death), outcome "fatal", described as "his immune system is done"; COVID-19 (death), outcome "fatal", described as "died of COVID after being vaccinated". The patient date of death was unknown. Reported cause of death: "Cause he's got diabetes and even though he got the vaccine", "his immune system is done". It was not reported if an autopsy was performed. Clinical course: Dr. reports another Patient died of COVID after being vaccinated. We just lost a fifty-five-year-old. A grandpa and I'm a grandpa. Cause he's got diabetes and even though he got the vaccine, his immune system is done because he has to get part of a liver and he didn't make it. Reports his daughter required surgery after taking Celebrex. She became allergic to Tylenol, Motrin, we had to do Celebrex and then she had to have three hundred thousand dollars' worth of sinus surgery. It came out of nowhere. Reports another Patient experienced side effects while taking Eucrisa and it's an oral pill and there can be some stomach, the Dupixent has worked so well I would only use that, and I used it on two college students. They're beautiful girls. But it gets on their face despite Dupixent and their neck. This is a sensitive area. So, and the Eucrisa was burning her all the time. And girls, they like to look good. They don't like to look yucky, right. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on limited information in the case, a possible causal association between  the reported fatal events Diabetes mellitus, Immune system disorder, COVID-19 and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. Reported Cause(s) of Death: his immune system is done; Cause he's got diabetes and even though he got the vaccine.
The next day he was left paralyzed in the back and fell.   The back has since resolved, but there are ongoing urological symptoms including burning while peeing, frequency of urination and pain in the abdomin
This case was considered medically important. Information regarding PREVNAR 13 was received from a nurse, the mother of the patient, regarding a 3-year-old male patient who experienced warm, itchy, swelling at injection site on left arm and golf ball sized lump - possibly cellulitis. At 3 years of age, the patient received a dose on 16-Sep-2010. The patient experienced warm, itchy swelling at injection site on left arm on 16-Sep-2010. On 17-Sep-2010, the swelling had developed into a golf ball sized lump - possible cellulitis on 17-Sep-2010. The reporter stated that the physician suspected possible cellulitis. The patient was treated with topical mometasone and an antihistamine. Laboratory testing was done, but the results were not reported. The events have not resolved. No additional information was available at the time of this report.
4AM LA-painful, no redness, swollen @ site; 615PM vomited 4-5x; 320PM last vomiting episode; no sx or LOC, no elevated temp;
Patient states she felt fine in afternoon after receiving shot.  She was awakened in the middle of the night by a pounding, racing heartbeat.  She almost woke up her husband to take her to the ER.  It lasted for several hours, then resolved and she felt fine the next morning
Per store manager, patient felt dizzy and mother had to grab her. Mother disclosed that patient has recently been having problems with fainting. Patient is being monitored by per pcp.
Dry patches initially formed around thighs, then to the arms forming bumps, redness, and itching.
RAISED RED PAPULAR RASH 24 HOUR ONSET AFTER INJECTION ITCHY RED.
Received Flu vaccine on 10/18/2020, and had no issues until late Saturday, 10/27. Pt is having extreme pain on arm and it radiates up neck. Pt reports that it is excruciating to move her arm. 10/15-10/19 symptoms worsened. She is taking Tylenol every 4-5 hours and gets some relief but it is very painful and she can only raise arm to about eye level. Pt notes no swelling or redness.
I began having chills and shakiness  at about 7 PM.  I could not warm up. Took a hot bath still could not get warm. Turned up my electric blank in bed and still could not warm up. Finally about 1 Am I got up and took an oral dose of Thera Warming Flu. It knocked out the chills immediately and I was finally able to sleep. I had no arm pain.
At 205 pm tingling & numbness in tongue. Tightness in jaw and lightheadedness. Gave 50 mg of BENADRYL took vital signs 118/70 at 2:10. At 2:20 pm 98/66. At 2:35 96/64. 250 96/66. Pt states tongue is better. Went back to work.
With the third dose I was really exhausted and had body aches. I just slept a lot and that was it for that dose. With the second dose I had body aches, headaches, exhaustion, I did have some chilis where I was just shivering uncontrollable. I had abdominal pains, my heart rate had drop, and I had some chest pains. With the first dose I just had soreness in my arm at the injection site and exhaustion.
Right upper arm in vaccination injection area sore for 3 days then  tender to touch, 2.5 cm hard red  palpable swollen area and itchy started 3 days after injection and then redness and soreness for 4 days, today redness starting to diffuse and becoming less red and tender but still a bit swollen. No other side effects noted.
This case was reported by a consumer and described the occurrence of benign hepatic neoplasm in a 58 year old female subject who was vaccinated with hepatitis A vaccine inactivated Havrix, for prophylaxis. The reported is the subject. A physician or other health care professional has not verified this report. The subject's medical history included allergy to contrast dye, breast cancer, chemotherapy, radiation therapy, hypertension and hypothyroidism. Concurrent medications included thyroxine sodium Synthroid to treat hypothyroidism, Metoprolol succinate Toprol XL to treat hypertension, Anastrozole (Arimidex) to treat breast cancer, and nutritional supplementation with calcium sale and Linseed (Flax seed oil). On 4/22/2005 the subject received the 1st dose of Havrix (AHAVB043BA). On 4/22/2005, the subject was also vaccinated with yellow fever vaccine (YF Vax). On an unspecified date in July 2005, 2 months after vaccination with Havrix, the subject experienced rib pain. The subject was seen at a physicians office. The consumer reported that , a PET scan and ultrasound showed a 1.7cm mass in the liver, A biopsy showed that it was not cancerous. The events were ongoing at the time of initial reporting, 8/19/2005. On 8/31/2005, the consumer sent the pathology report from the liver biopsy. The biopsy was performed on 8/5/2005 and showed Hepatic parenchyma with focally dense lymphoid infiltrate, predominantly periportal, no evidence of metastatic mammary carcinoma, immunohistochemical staining for B and T cells (CD20 and CD3) showed a mixed infiltrate, most consistent with a reactive process. No further follow up information will be available.
tingling in fingers, toes, gen weakness & paralysis presently hosp;dx GBS;tx plasmapheresis
Shingles; Information has been received regarding a case in litigation concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) by a pharmacist, for the long-term prevention of shingles and zoster related conditions (strength, dose, anatomical location, route of administration, lot number and expiration date were not provided). Subsequently, the pt was treated by a physician for the following injuries resulting from vaccination: shingles (herpes zoster). The outcome of shingles was not provided and the causality assessment between shingles and zoster vaccine live (ZOSTAVAX) was reported as related.
ED visit for abnormal pulse oximetry. admitted due to suspected COPD exacerbation secondary to coronavirus OC43 (not SARS-CoV-2) and suspected superimposed bacterial pneumonia. She received steroid, antibiotics and  Bronchodilators. She also received IV Lasix 20 mg x1 due to concern for pulmonary edema. Symptoms have improved and patient insists on going home day 2. She is clinically stable for discharge at this time. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
New guidelines were implemented yesterday where peds 6 month-5 yrs now receive Moderna Bivalent "Dark Blue Cap" for 1st & 2nd dose of vaccine. I was confused and thought peds 6 months-5 years only got Moderna Bivalent "Pink Cap".  I administered 0.25mL of Moderna Bivalent "Pink Cap" to patient as first dose. No adverse reaction noted during 15 minute wait period.
Began with headache at 3pm, progressively got more sore in joints until 5pm when my whole body was sore and it was difficult to move. Around 7pm i felt dizzy and chilly, at 1am i threw up and had very bad chills and was still sore, at 7am the next morning i realized my vaccine site was swollen and bruised and felt like a large lump, the skin was rough and very hot to the touch. over the next day i had rolling headaches and nausea and it was difficult to move without pain in my extremities, this started to lessen over the next days but my arm is still swollen, hot, lumped, and painful.
Fever (101 F) treated with acetaminophen and resolved within 12 hours.
Awoke with left upper arm swelling, erythema, and mild ecchymosis at the injection site (approximately 16 hours after the injection).
Severe shaking chills, muscle spasms, leg cramps, cold sweats & fatigue, fever for 2+ days. Fatigue & dizziness lasted 5 days.
Felt like I had a bad case of COVID-19.  I was sick with COVID-19 in February, and, this was worse.
Redness, swelling that responded to BENADRYL and ice packs/compresses. Pain noted as well.
When (L) arm is adducted, abducted, flexed, raised above shoulder, or crossed in front of body, she has sharp pain, 7-8 on pain scale.
Information has been received from a registered nurse concerning a 5 year old female who on 22-MAY-2007 was vaccinated with a 0.5mL subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot # 657191/0365U) in the right upper arm. The patient developed erythema at the right upper arm injection site 5 minutes after administration of varicella virus vaccine live (Oka/Merck). No therapy was recommended. The outcome is unknown. No laboratory or diagnostic testing was done. Unspecified medical attention was sought. No further information was available at the time of this report. No product quality complaint was involved This is patient 1 of 2. Additional information has been requested.
Erythema and induration 13 x 16 cm left lateral thigh, upper leg slightly swollen; induration within border of redness. BENADRYL and TYLENOL as needed started at 48 hr post vaccination. The patient is a 4 year old female who is brought to the office today by her mother for evaluation of a skin lesion that began 2 days ago. The skin lesion involves the left lower extremity and is characterized by redness. The rash developed suddenly and has been progressively worsening. She has had a recent history of having received a PROQUAD vaccine at the affected area. She does not attend daycare. There are no aggravating factors. The symptoms have improved with no know factors. The patient/caregiver reports no additional symptoms. The patient denies: fever, itching, night waking with the pain, and vomiting. The patient reports no ill contacts.
Pt received Imovax and Imogan IG in ER for possible rabies exposure. Aprox 6 1/2 hrs later pt returned to ER by family, diaphoretic, pallor, nausea, dry heaves, tremors, fixed eyes and drooling. No motor activity. Admitted and started on enteric coated ASA. Recoverred well, ambulated without difficulty and discharged the following day.
This spontaneous report was received from a currently 25 year old female patient. The patient's concurrent conditions and medical history were not reported. In approximately 2007 (reported as "when I was 17"), the patient was vaccinated with GARDASIL (lot #, expiration date, dose and route were not reported). Then she was vaccinated with the second and third dose of GARDASIL (lot #, expiration date, dose and route were not reported) on an unspecified date. She reported she had all three injections of GARDASIL in the right interval. No concomitant therapies were reported. On an unknown date, the patient experienced condyloma. The gynecologist told her that she could not explain to herself why it could be happen that the patient got human papilloma virus infection (HPV). She told her that GARDASIL injection was not just to prevent the girls from cervix cancer, but also from condyloma. The patient was not very happy about it and felt "kidded" (vaccination failure). The outcome of condyloma and human papilloma viral (HPV) infection was unknown. The causality between the adverse events and GARDASIL was not reported. Additional information has been requested.
This spontaneous report as received from a Health care worker pharmacy technician refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with VAQTA (lot # J012963 exp 21-SEP-2015) 1 pediatric dose (dose and route not provided). Health care worker (pharmacy technician) stated that one patient may have received vaccine (dose and dose in series unspecified) that were improperly stored on 28-FEB-2014 at 9.5C for 50 minutes. No adverse effects reported. The outcome of Incorrect product storage was unknown. This is one of several reports from same source. Additional information has been requested.
Pt's husband stated on 6-17-17 that since pt got immunization, her left arm has been extremely painful and sometimes not relieved by APAP, ibuprofen, or oxy/APAP. Advised pt to inform her doctor.
1/25/07 swelling to left leg began. Motrin, warm compress. 1/26/07 increase swelling - nurse from pediatric office stated "size of grapefruit". Patient treated with Keflex 250 mg TID x 7 days. Diagnosis with cellulitis. Doctor number given.
Headache; 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 HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt also recieved a flu shot from the doctor but failed to communicate that when asked if she wants her flu shot with prevnar 13 at the pharmacy
Numbness & tingling of hands & extremities immediately following injection. Shortness of breath shortly after but had continued to notice increased shortness of breath and then began to see bright lights intermittently.
Unsure if related to vaccine but approx 2 weeks after the booster on 12/6/2021 my menstrual period began as schedule, but it never ended. as of today 2/7/2022 I am still menstruating.
Patient called 5/17- 2 weeks post vaccine stating arm is still tender, swollen, and warm to the touch. Patient states it is not red
Redness and swelling in site of injection still present 10 days after shot.  My arm was sore for a couple of days as expected, no other symptoms following the shot. I began experiencing a headache January 24th and woke during the night sweating. No temperature last night or today.
About 4 or so hours after the Varicella vaccine, Patient had a high fever that quickly went up to 105.2 and stayed there for a bit while on children's motrin. The fever lingered between 104.0 and 105.2.  She also threw up and had the chills, couldn't sleep and felt horrible. Had a phone visit with a doctor prior to ending up in the ER who told us it was normal and to not be concerned unless it reached over 105.0 .  She said our daughter's fevers/reactions to vaccines were rare but normal. When it reached 105.2, we called nurse hotline and started driving toward the Facility. The nurse hotline called us back as we couldn't get through and stated we should definitely be seen at Urgent Care. We walked into urgent care, and they refused to see us and directed us to the Emergency Room if we felt it "necessary" Since our 4 yr old had a 105.2 fever and we were scared AND had been told to be concerned if it reached over 105.0, we ran over to ER. We were seen and axillary temperatures were taken about 3 different times which were around 102.0. I asked for a temperature under her tongue since I know that axillary temperatures aren't too accurate. By that time, her fever had come down to about 100.0 I think (we had been waiting there for an hour I believe so far) and were told by the doctor that it was normal and she was fine. I asked for a social worker or someone to help us navigate the process of somehow trying to get an exemption for the MMR vaccine to which she replied we didn't need a social worker and that that wasn't her department and I needed to follow up with my child's pediatrician.  The ER doctor's name who told us it was a "normal" reaction was  MD. I had a scheduled visit with my daughter's pediatrician on June 3rd already so I used that appt to also discuss my concerns with getting any more vaccines, especially the MMR. Dr stated that she would be fine and that her fever/reactions are extremely rare but that she should be fine. I'm terrified to continue with her vaccines and there is no possibility for an exemption.
Information has been received from a physician concerning a female patient "in her sixties" in 2010 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and Lot# not reported). The physician stated that the patient experienced "within the last couple a months" also reported "4 months after vaccination" a zoster like rash down her left lower extremity that occurred in the L3 and L4 dermatomes. It was reported that the patient on an unspecified date recovered from zoster like rash down her left lower extremity in the L3 and L4 dermatomes. The patient sought unspecified medical attention. Additional information has been requested.
Feeling weak, fatigue, gastric and intestinal disruption, some constipation, strong headaches last night (after injection)
This case was reported by a nurse and described the occurrence of tight feeling in arm in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. There were no concurrent medications. On an unspecified date on or before 24 April 2006, the subject received a dose of Infanrix in an unspecified arm (dose number not provided). The nurse reported that the lot number of Infanrix was "either lot AC14A007BA or lot AC14A008AA." At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 24 April 2006, the subject experienced "tightness in th arm," injection site redness and swelling injection site. The subject was seen at physician's office. The outcome of the events was not reported. The nurse considered the events to possibly be related to vaccination with Infanrix.
Pt described redness and itching at admin site that day and following day. Area approx 4" circ. Pt states she treated with BENADRYL x 1 dose with relief. No other treatment needed.
chills; fatigue; rash on lower back.; eczema; 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 CHILLS (chills), FATIGUE (fatigue), RASH (rash on lower back.) and ECZEMA (eczema) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), FATIGUE (fatigue), RASH (rash on lower back.) and ECZEMA (eczema). At the time of the report, CHILLS (chills), FATIGUE (fatigue), RASH (rash on lower back.) and ECZEMA (eczema) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.