chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received his last dose of the Moderna vaccine and he contracted COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (received his last dose of the Moderna vaccine and he contracted COVID-19) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (received his last dose of the Moderna vaccine and he contracted COVID-19). At the time of the report, COVID-19 (received his last dose of the Moderna vaccine and he contracted COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported.  The reporter stated that 'he received his last dose of the Moderna vaccine and that he contracted Covid-19'. No other adverse reactions were reported.  No treatment information was provided by the reporter.  Company Comment: This spontaneous case concerns a male patient, of unknown age, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 after receiving an unspecified dose of the mRNA-1273 vaccine on an unspecified date. The start date of the event was not provided. No further details were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient, of unknown age, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 after receiving an unspecified dose of the mRNA-1273 vaccine on an unspecified date. The start date of the event was not provided. No further details were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Initial unsolicited report received from a health care professional on 25-Apr-2017. This case involves 11-year-old male patient, who was vaccinated with a first dose of MENACTRA intramuscularly (Batch number: U5514AC, expiration date: 12-Mar-2018 and site of administration were not reported) and ADACEL intramuscularly (Batch number: C5212AA, expiration date: 05-Jun-2019, and site of administration were not reported) on 24-Apr-2017. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none and no known allergies were there. Patients Illness at time of vaccination was reported as afebrile possibly feeling a bit poor. Patient's concomitant medication was not reported. It was also reported that patient do not had any other vaccinations within 4 weeks of vaccinations. On 24-Apr-2017, same day following the vaccination, the patient was not feeling well as patient was weak and tired and had burning temperature of 102.4 degree F. It was reported that the patient sort of slumped over in his seat. Next morning temp was again over 102 degree F. Patient required emergency room (ER) / doctor visit. No other laboratory investigation was performed. Patient's corrective treatment was not reported. The patient did not recover from events. List of documents held by sender: none.
Patient was vaccinated on 10-01-2007 and began to feel ill on 10-06-07.Patient missed work on 10-10-2007 and as of today is running a 103 fever. As of 10-10-2007 patient is drinking advil liquid gel, if fever persist patient will be taken to hospital tonight.
Large amount of swelling and redness at site of injection (left arm) lasting several hours after administration.  No treatment.
Both vaccines given in same thigh right next to each other with very little spacing between.  Local injection site erythema aprox 50mm., whole thigh swollen, hard, hot to touch x 2 days. Inconsolable crying, refused feeding, painful-type scream crying when limb moved for more than 4 hours. Axillary temperature 98.4 degrees. Screamed more when cool compress applied, removed immediately. Acetaminophen given every 4 hours for 2 days. Subsequent Prevnar 13 and ActHIB different same manufacturers, different lot numbers administered in separate limbs August 29, 2011. No local reactions. Mild drowsiness.
Tongue and throat swelling; Tongue and throat swelling; not able to breathe; right and left sided face swelling; hives from top of head to lower extremities; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tongue and throat swelling and took diphenhydramine (BENADRYL). Patient was also not able to breathe, had right and left sided face swelling, and hives from top of head to lower extremities. Patient reported that the doctor gave her an epi pen. Patient would like to know if she should get second dose. She is scheduled to receive second dose on 28Jan2021 also if she should get a pneumonia vaccine and was instructed to wait 14 days after the Pfizer Biotech Covid-19 vaccine administration. Outcome of the events was unknown.
Progressive symmetric weakness and areflexia with lumbar puncture and EMG confirming Guillain Barre.
All over body rash on forearms, elbows, progressed to back, thighs, abdomen, waist; Welts; Pustules; Itchy; This is a spontaneous report from a contactable nurse. A 71-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via intramuscular route of administration in the left arm on 08Sep2021 at 16:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included leukemia (the patient receiving chemotherapy for leukemia). It was unknown whether the patient had any known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included oral chemotherapy (unspecified) for leukemia from an unknown date and unknown if ongoing. On 10Sep2021, the patient experienced all over body rash, on forearms, elbows, progressed to back, thighs, abdomen, waist. It was reported that, it started as a fine rash and progressed to welts, pustules and was itchy. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of the events which included treatment with diphenhydramine hydrochloride (BENADRYL). Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events all over body rash, on forearms, elbows, progressed to back, thighs, abdomen, waist and it was started as a fine rash and progressed to welts, pustules and itchy was resolving at the time of this report.
Information has been received from a pharmacist concerning a 69 year old female patient who in 2008 (reported as last year) was vaccinated with a dose of PNEUMOVAX 23 (dose and lot number not reported) with no problem. On 17-SEP-2009, the patient was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX 23 vaccine (LOT# 663152/0024Y). Concomitant vaccination on the same day included a dose of influenza virus vaccine (unspecified) (manufacturer unknown) in the other arm with no problem. Subsequently, after the patient received the dose of PNEUMOVAX 23 vaccine on 17-SEP-2009, she developed severe pain at the injection site. Unspecified medical was sought, but the patient did not want to see a physician. It was unspecified if lab studies were performed. At the time of the report, the patient still experienced pain but it was milder in intensity. The pharmacist requested a lot check. A lot check has been initiated. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a consumer concerning her approx. 22 week old daughter who on 6/6/00, 8/28/00 and 8/30/01 was vaccinated with the 1st, 2nd and 3rd doses of haemophilus b conjugate vaccine, hepatitis b vaccine recombinant (yeast), respectively. Concomitant therapy included 1 dose of MMRII, 1 dose of diphtheria toxoid/pertussis vaccine/teta and 1 dose of poliovirus vaccine. Following the 2nd dose, the pt developed an abscess and "later on" some breathing problems. She "later" developed an abscess on her leg. Following the 3rd dose, she developed another abscess. It was reported that all of the abscesses were lanced and she was on antibiotics "for a long time". It was also reported that her lungs were normal. The pt sought unspecified medical attention. Upon internal review, abscess and "breathing problems" were determined to be "Other Important Medical Events". Additional information has been requested. A 15-day follow up report received 11/16/2001 adds: Follow-up info was received from a nurse on 10/24/2001. She indicated that it seemed the child's mother had taken her for many tests. It was reported that the child was seen most recently in the physician's office on 10/11/2001, with a right buttock abscess. Follow-up info was received on 10/26/2001 from a physician which indicated that the pt had a history of recurrent bronchiolitis, which was why "breathing problems" and a lung biopsy were mentioned in a previous report. It was reported that these issues occurred prior to vaccination with haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). It was also noted that due to the pt's history of bronchiolitis, the pt pt had an immunologic workup, which was negative. It was reported that after each vaccination with haemophilus b conjugate vaccine(+) hepatitis b vaccine recombinant (yeast), the pt developed an abscess in her thigh at the injection site. The physician reported that the pt's last dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) was administered in the right thigh (also reported as the left buttock) in August 2001. Approximately 20 days post vaccination, the pt developed an abscess in her right thigh, which was lanced and she was treated with unspecified antibiotics. It was noted that the pt was currently doing "well". Upon internal review, abscess was determined to be an other important medical event. Additional info has been requested.
Patient was provided second dose of Pfizer vaccine at 1 PM on 6/16/21. Ten minutes post vaccine, patient reported abnormal heart rate and difficulty breathing. The patient was monitored and 911 was eventually called; with the patient being taken to the hospital. The husband was followed up with later in the day who noted that she was stable and discharged 9 hours after the vaccine. No EpiPen was administered.
Information has been received from a nurse practitioner concerning a female with a history of asthma who was vaccinated intramuscularly on an unspecified date with her first dose of GARDASIL vaccine (yeast) (lot# not reported). Subsequently the patient experienced a headache 10 minutes after the dose. The patient still had the headache 4 hours later. The patient was instructed to take diphenhydramine hydrochloride (BENADRYL) and go to bed. Subsequently, the patient recovered from the headache the next morning. Additional information has been requested.
Got COVID Arm about eight or nine days after first dose.  See previous submission on 2-23-21 with the Temporary VAERS #318903.  First dose was on Feb. 14th and second dose was on March 14th.  It's now been two weeks.  Did not have any symptoms in arm this time.  Swelling was less after a couple days, did not get "hard" like after first dose.  Also, did not get COVID Arm after second dose like I did a week or so later after first dose.  Am blood type A.  Had only minor side effects after second dose - pressure behind eyes and fatigued, for about 30 hours which began about six hours after second dose.  Did not get fever, chills or anything like that.
Day 2:  Left arm tenderness at injection site, inability to regulate body temperature so felt cold all day and couldn?t get warm,  fatigue and small blisters on left ear and right upper leg that eventually hardened, scabbed and diminished.  Day 13:  large red splotchy area at injection sight that feels hot to the touch and Cystitis (bladder spasms with urgency to urinate constantly with blood in urine as confirmed by a visit to PCP).   Male coworker who received vaccine the same day also reporting cystitis.
Headaches, body aches, weakness, loss of apetite, fever, chills. All symptoms lasted for a day, and were onset the day after vaccination.
This spontaneous report as received from a patient regarding herself who was also a health professional of unknown age via a company representative. Approximately on an unknown date in April 2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date were not reported), 0.65 milliliter (ml), subcutaneously. Around the same time frame approximately on an unknown date in April 2013, the patient was also vaccinated with a dose of PNEUMOVAX 23 (Lot number, expiry date, route and dose were not reported). Approximately on an unknown date in April 2013, the patient reported red circle rash spots at each injection site. These spots were still there but slightly fading and visibly improved. The outcome of red circle rash spots at each injection site was reported as recovering/resolving. Additional information has been requested.
had rashes on her upper extremities and she felt itchy; had rashes on her upper extremities and she felt itchy; This is a spontaneous report from a contactable consumer (patient).   A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number ER8729 and expiry date was not reported), via an unspecified route of administration in arm left, on 08Apr2021 (age at vaccination: 35 years) as a single dose for COVID-19 immunization. Reportedly the patient was supposed to get her second dose on 05May2021. The patient's medical history and concomitant medications were not reported. On 11Apr2021, on the third day after her COVID vaccine the patient had rashes on her upper extremities and she felt itchy. Reportedly the patient thought it was an allergy reaction to food and she had tried to prevent it, so she just ate vegetables and fruits. She then thought how she has never had an allergy reaction to food before and then she read about the Pfizer reactions and after that she thought that was what it was, she was having. It was bad. After 8 to 10 days, it went away, and she confirmed that she has recovered completely from it. Reportedly when the patient went to the pharmacy and told them about the reaction she had on the first dose, they said that they couldn't give her the second dose because of her reactions. Reportedly the patient did not have the second dose yet and the patient queried that what does she need to do or what can Pfizer advise about this. On an unspecified date in Apr2021 the outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
pt to ED via EMS with c/o fever, weakness, confusion, difficulty walking x 3 days; found to be positive for COVID; at that time, did not require O2 supplementation; started on Lovenox for DVT prophylaxis; ABX; O2 requirements increased; started on O2 supplementation, Remdesivir, Dexamethasone; worsening bilateral pulmonary infiltrates; DNR/DNI; family withdrew care and pt passed away in the hospital
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients received doses of improperly stored RECOMBIVAX HB 0.5 ml, lot # L048849 with expiration date: 04-FEB-2018 (route of administration was not reported). Administered doses of RECOMBIVAX HB underwent temperature excursions at 9.5 Celsius degrees, for 1 hour and 10 minutes. Data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, Fever, NauseaVomiting, Malaise  Narrative:
Fever to 102.  Chills.  Full body aches, headache. Unable to sleep.  Resting heart rate was about 20 beats higher than normal. Mild tinnitus got louder.  At 24 hours from  shot fever has reduced to 100.
On an unspecified date, the vaccinee received the 2nd Engerix-B injection. Subsequently, the vaccinee was found to have a positive Hep-B surface antigen result. As of 4/22/02, the outcome of the event was unknown.
This spontaneous report as received from a certified medical assistant refers to a pediatric patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with VAQTA, 0.5ml, intramuscular, third dose (lot number not reported). Concomitant medication was not reported. No adverse effect reported. This is one of several reports from the same source (1407USA011285, 1407USA011906, 1407USA011907, 1407USA011908, 1407USA011909, 1407USA011910, 1407USA011911). Additional information has been requested.
Vaccine in at 2:27 pm. Taken to Observation for 30 minutes. Left Observation at 2:57 pm. Was being assisted outside clinic entrance into a car (while in her walker) and was noted to have seizure like activity.  Taken back into Observation area. NP and EMS onsite assessed patient.  15:20 VS: 97/71; p.88; Sat 97; R 10 and shallow.  Airway opened.  15:20. EMS called per Police Officer onsite.  Pupils pinpoint and non reactive.  Bilateral downward gaze noted. Did not respond to verbal commands.  Moaned to sternal rub. IV started in R arm TKO.  O2 administered at 2 L.  15:29; BP 190/92'; p 94, fingerstick BS 89;  R. 12.  on cardiac monitor showing NSR.  15:42. BP 192/109; HR 90. Transferred to Fire Dept care @ 3:49 pm.
Guillain-Barre syndrome; Initial information received on 30-Sep-2021 regarding an unsolicited valid serious case from a consumer/non-health care professional via social media.  This case involves a patient (unknown demographics) who had guillain-barre syndrome after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  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 (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious guillain-barre syndrome (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events.  On an unknown date Laboratory test: [Guillain-barre syndrome. Tests proved it]  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  Information on batch number was requested for this case.; Sender's Comments: This case concerns a patient (unknown demographics) who had guillain-barre syndrome after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination and other relevant laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
On 9/15 I started having nausea and very abnormal acid reflux causing me to choke.  On 9/16 I had severe nausea, diarrhea, stomach cramping, headache.  During that night, I had all of those symptoms, in addition to difficulty breathing and coughing.  On 9/17, I started the day out feeling completely fine, however that evening, I have the severe cramping, diarrhea, nausea and headache that returned.  On 9/18, I received a negative rapid covid test after doing a virtual appointment with a Dr.
I did not feel good when I went to bed. My temp was 100.4. I took Tylenol. Then I started getting joint pain and flu like symptoms. I then developed GI issues with upset stomach and diarrhea. The fever and flu like symptoms lasted for 4 days and I called my doctor. This happened with my 3rd dose but not as strong but I had GI issues this time. The GI issues lasted for weeks. I got COVID-19 on 7/16/2022 with a positive COVID-19 test. My doctor prescribed Paxlovid. I took 3 doses of Paxlovid with a horrible taste and the medication has caused diarrhea. My COVID-19 symptoms are similar to a sinus infection with a cough and runny nose.
Within a week of immunization, parents felt he had increase in frustration level & over sensitivity to extend stimuli. Cried more easily. Changes from routine seemed to bother him.
Drowsiness, headache, whole body and muscle cramping 12 hours after vaccine. Blotchy rash noted 29 hours after vaccine under both arms, on both sides of axillary area, and on bilateral thighs.
Narrative:  95yo male patient died on 12/12/2021 of unknown cause. Pt in assisted living (outside facility) for dementia. Pt with hx of: Bilateral hearing loss (SCT 95820000) Hyperlipidemia (SCT 55822004) & Benign hypertension (SCT 10725009). Pt had received covid vaccines outside facility on 1/29/21 & 2/19/21. Likely pt's death is not related to covid vaccines given pt's advanced age, comorbidies, and long length of time between death & date of vaccine administrations.
Reported to us by FNP:  pt presented to walk in clinic with complaints of left chest pain, left arm pain, left jaw pain and back pain.  Went unresponsive. Clinic started CPR, AED advised no shock. Admitted to ER.  Had heart cath - pericarditis diagnosed.  EKG had changes consistent with pericarditis.  sed rate 74.  CRP 13.3  Admitted to hospital for 4 days.
Information has been received from a registered nurse concerning an adult female patient with drug allergies to penicillin, AMBIEN and ULTRAM and no medical history reported, who on 28-JAN-2008 was vaccinated intramuscularly with the first 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot # 655501/1035F). There was no concomitant medication. On 04-FEB-2008 (reported as one week after vaccination) the patient developed an injection site reaction including redness the size of a quarter and a cold. The patient sought unspecified medical attention and called the office. No diagnostic laboratory studies were performed. The patient did not report the symptoms until after she had recovered. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.