chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8 hours post immunization, developed arm pain ("6 our of 10"); took ibuprofen; 7 hours later awoke with worse arm pain that was throbbing, a scratchy throat and frontal headache;  3 1/2 hours later, awoke with headache, feeling "cloudy" and having tingling skin ("skin crawling");  arm noted to be red, warm with mild swelling around injection site; took ibuprofen; 2 hours later felt better; then 27 hours post vaccine, still with headache, feeling cloudy, nausea and stomach pain
My colleague Doctor was consulted on this patient by the care team on 10/2/21.  She accepted the patient for ECMO with the condition that the local team cannulate her.     This is a 59 yo F with h/o DM2, HTN and obesity (BMI 33) who was vaccinated for COVID-19 early in 2021 but developed a breakthrough infection.  Symptom onset was 9/10/21, diagnosis with PCR was on 9/13/21, Dex x14 day course started on 9/13/21.  She was then admitted and eventually intubated for worsening hypoxemia on 9/26/21.  CTA on 9/14/21 was negative for PE.  By 10/2/21 she was hypoxemic despite deep sedation, paralysis, prone positioning, and iNO.  She was on empiric Ceftazidime.  Vaccination info unknown, states patient was vaccinated early in 2021, but no other details found.    My colleague Doctor was consulted on this patient by the care team on 10/2/21.  She accepted the patient for ECMO with the condition that the local team cannulate her.     This is a 59 yo F with h/o DM2, HTN and obesity (BMI 33) who was vaccinated for COVID-19 early in 2021 but developed a breakthrough infection.  Symptom onset was 9/10/21, diagnosis with PCR was on 9/13/21, Dex x14 day course started on 9/13/21.  She was then admitted and eventually intubated for worsening hypoxemia on 9/26/21.  CTA on 9/14/21 was negative for PE.  By 10/2/21 she was hypoxemic despite deep sedation, paralysis, prone positioning, and iNO.  She was on empiric Ceftazidime.  The team called by colleague Doctor for consideration of ECMO. Patient had just single organ failure and our ECMO program was on yellow triage status at time time, so we were able to accept her for VV-ECMO.     Per report from the local intensivist, Doctor, the CV surgeon there attempted Fem-IJ cannula for VV-ECMO including cut-down of the Right groin was encountered difficulties advancing the cannula and reportedly kinked guidewires.  The groin wound was closed and pressure applied with a sandbag prior to transport.  Ultimately, the team placed a RIJ Avalon cannula 27Fr via the RIJ with rapid improvement of saturations to the 90%'s.  She was then transported here by our flight team with our staff perfusionist.  En route, she remained on strong doses of NE and phenylephrine.  Upon arrival here she was sedated, vented and on ECMO.  NE was at 0.1 and phenyl at 1 with a resulting ABP of ~80/45.  ECMO blood flows were 4.4 L/min and SaO2 90%.  Vent was set at PC 10/10 with FiO2 60%.  Initial labs upon ICU landing showed: ABG 7.29/48/56/-3, CBC Hgb 8.3, Plt 132, WBC 21.3, Creat 0.87, Lactate 4.7-- >2.9.     Currently, we are adding vasopressin, stress dose steroids, volume resuscitating, adding central access and assessing ECMO cannula position.
Information has been received from a nurse concerning a 5 year old female with no known medical history who on 26-May-2003 was vaccinated with a first dose  and 17-Sep-2007 was vaccinated SQ with a 0.5 ml second dose of varicella virus vaccine live (Oka/Merck) (lot# 658373/1116U). The patient experienced red and inflamed area at the injection site immediately after the vaccination. Medical attention was sought. The patient was recovered. No product quality complaint was involved. This is one of multiple reports of the same source. Additional information has been requested.
Rotateq oral vaccine given 2/13/07 at well child exam.  Blood stool passed this a.m. 2/17/07 x 1 stool.
Pain at vaccination site, followed by dizziness, tingling in arm, and on 8/15/2012 diarrhea and nausea.
I got numb hands and fingers the day after the shot. Through the next 2 weeks I had numbness in my calves. 3 weeks ago I got severe wrist pains and the hand numbness comes and goes.
Left upper arm to upper shoulder/back area to 1/2 way down to elbow-area was red, hot, swollen.  No treatment or medications given.  No temperature.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 28-MAY-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J006955, expiration date: 07-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several report received from the same reporter. Additional information has been requested.
injection site arm that was even more painful; fever that lasted for 8 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (injection site arm that was even more painful) and PYREXIA (fever that lasted for 8 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site arm that was even more painful) and PYREXIA (fever that lasted for 8 hours). At the time of the report, VACCINATION SITE PAIN (injection site arm that was even more painful) outcome was unknown and PYREXIA (fever that lasted for 8 hours) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-347445 (Patient Link).
Loss of smell; Severe Headache; Fever; Pain at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of smell), HEADACHE (Severe Headache), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at the site of injection) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced HEADACHE (Severe Headache), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at the site of injection). On 13-Apr-2021, the patient experienced ANOSMIA (Loss of smell). At the time of the report, ANOSMIA (Loss of smell), HEADACHE (Severe Headache), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        relevant concomitant products usage were not reported by the reporter. Treatment details not included.
Breastfeeding infant of vaccinated mother (self): experienced repeated vomiting on 4/18 @ 10:00am, 11:15am, 1:00pm and 1:30pm Self: Started spotting on 4/19 Self: Started menstruation early on 4/20, a week before next period was expected to occur
Do I get the second shot or do I have to start the series again.?; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2019).   On an unknown date, the patient received 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 details were provided as follows: The patient reported the case for himself. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient wanted to know that do he/she get the second shot or do have to start the series again. The reporter did not want to provide his address or any further information. The reporter did not consent to follow up.
Moderna COVID-19 Vaccine EUA  -  3 Days post administration developed severe headache/ nausea - lasted 7 days , then onset of extreme fatigue and shortness of breathe lasted 7 days.   15 days post administration symptoms subsided
Patient developed an extremely large local reaction extending one joint above and one joint below shot site. The area resolved slowly without treatment.
shingles; large red patch on thigh and back; large puffy patch on thigh and back; large itchy patch on thigh and back; fever on patch; skin warm; inflammed patch; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th June 2019, the patient received the 1st dose of Shingrix. In June 2019, 4 days after receiving Shingrix, the patient experienced shingles, skin red, swelling, pruritus, localized feeling of warmth, skin warm and skin inflammation. The patient was treated with ethanol (Alcohol) and paracetamol (Tylenol). On an unknown date, the outcome of the shingles, skin red, swelling, pruritus, localized feeling of warmth, skin warm and skin inflammation were unknown.   It was unknown if the reporter considered the shingles, skin red, swelling, pruritus, localized feeling of warmth, skin warm and skin inflammation to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in the left upper arm and experinced side effects similar to shingles. After vaccination with Shingrix, the patient experienced large red, puffy itchy pathech on both thigh and back. The patient reported that, the patch was not painful but had fever in it. Two days before the date of reporting, the patient experienced patch on thigh and one day before the date of reporting, the patch was developed on back of the patient. The patient reported that,the patches were not inflammed today, as she rubbed alcohol on it, and took tylenol to reduce hotness of the patch. The reporter reported that, the Shingrix was non live vaccine and could not cause shingles. The reporter called to physician
Hives.  Persistent itching since booster shot till now Taking Zirtec to keep symptoms down
pt recv vax 22OCT96 & 23OCT96 pt devel vomiting & diarrhea w/o fever 48hr p/vax;pharmacist related there were other pt that exp v,d who did not recv vax;
Pt received vaccination at facility 11/15/11 at 9:30AM. Mother reported one seizure in 2009. Clinician was contacted at previous visit and stated no connections to vaccination. Mother reports no adverse rxn after previous vaccination. School nurse calls 11/16/11 to report that student had febrile seizure at 11:15AM. Pt. temp was 98 degrees F - 102 degrees F within 30 min. Ambulance was called and pt. taken to hospital. Nurse states that pt. was found at lunch pale, dusky color. Returned at nurse office. Seizing & whimpering x30 min.
Vaccine expired on 9/30/22 and it was administered to patient on 10/4/22
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 a 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 an 11 years old, female patient with no pertinent medical history reported. On 14-FEB-2013 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). On 16-APR-2013 the patient received 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.
Patient presented with injection site reaction, skin was warm and red, approximate size of 4 fingers in with and length.
Flu shot in (R) deltoid 10/3/07 4 pm which made (R) arm hurt and swell briefly. Then developed (R) supraclavicular swelling which lasted several days. Shoulder still sore 10/13/07. Saw doctor 10/4 and 10/5/07. Treated MDP and Cefzil.
"COVID arm": slight swelling around injection site in left arm. Slightly hardened, itchy, redness, warm to touch
Massive headache, joint pain, chills, fever, nausea, muscle cramps. Symptoms increase at night. 3 days so far.
Patient had flushing/sweating, dizziness; pale and diaphoretic 3 minutes after vaccination. Patient/family reports long-standing hx of vasovagal reactions with "needles", especially lab draws. Gave juice/water. Patient stable, released from vaccination site.
Severe nerve pain. back pain and carpal tunnel issues have never been worse. My hands tingle. I have to take a break from weight training.
Patient reports she received her second dose of the Moderna vaccine on 9/03/21. Approximately 2-3 days ago, a large red rash appeared on her arm and appears  to be spreading .  She reports she will go see a doctor in the morning.
Got shingles right after they got the shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's Comment: This case was reported via interactive digital media. The reporter know patient that received Shingles vaccine and right after experienced Shingles. Additional supportive information: This case had been linked with US2022AMR132557 and US2022AMR132560 reported by same. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR132560:Same reporter US-GSK-US2022AMR132557:Same reporter
No additional AE reported; Nurse reporting a patient was administered VARIVAX after a temperature excursion. No additional information provided. Additional AE cases: 02138009, 02138049, 02138054, 02138052, 02138050, 02138056, 02138057 field. No additional AE reported. No PQC r; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 11-JAN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number U019904, expiration date 24-JUN-2023 (route of administration not reported)  for prophylaxis (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of 12.4 degrees Farhrenheit (°F) for 20 Minutes. Also, the vaccine had undergone a previous temperature excursion from 6°F to 14°F (11.6°F) for 25 Minutes.
swollen painful vaginal area- difficulty walking; swollen painful vaginal area- difficulty walking; difficulty walking; This is a spontaneous report from a contactable consumer (patient). A 84-year-old non-pregnant female patient received the BNT162B2 (COMIRNATY, Solution for injection, Lot number: EL9262) via unspecified route on left arm on 24Feb2021 at 10:15 (at the age of 84 years) as single dose for COVID-19 immunization.The patient had no medical history and no known allergies. The concomitant medication included Venlafaxine taken in two weeks of vaccination. There were no other vaccines administered in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Feb2021 patient experienced swollen painful vaginal area- difficulty walking. The patient did not receive treatment for the events. The clinical outcome of the event not recovered.   No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Erythematous  papules with suggestions of vesicular lesions. Few on chest arms, pelvis, 1 on leg.
pt recvd vax on 27JAN93 & mom states on 31JAN93 & 1FEB93 sx included cyanosis, extremity jerking & apnea; episodes were short lived both times p/by emesis; MD notified by phone; MD told mom probably sz; no tx done;
Patient fainted.  Given water and lemonade and requested patient to remain in place for 30 minutes.  Episode passed, patient reported feeling fine.
shortness of breath, to ER ,  patchy consolidations. + for COVID after vaccination, records do not say which one she got
Patient may have received Pfizer vaccine as second dose instead of Moderna. Patient completed observation period without incident.
Presented w c/o weakness. Pt also found to be COVID-19+; tx w/ abx, steroids; pt did not require O2.
Significant swelling with firm area of induration measuring 6cmX4cm, no erythema, no discharge. Mild TTP, no radicular component, no gross motor weakness.
Body aches, fever, injection site pain and redness, bilateral upper arm erythema, sore throat lasting 8 hrs
After pt. received 2nd varicella vaccine at 8:30 A.M. she noticed at 1 p.m. that her legs were itching. She raised her pant legs and had approximately 15 fluid filled vesicles on legs. During the night, she had a temp of 101.3 degrees, headache and fatigued today 9-24-15. Pt may go to the doctor today - 9-24-15 if symptoms persist. 9-24-15, Pt reported back to the Health Dept and stated she went to the doctor. Her BP was 142/96 and she still has the fluid filled vesicles. She was advised to stay out of school x 2 days and was prescribed steroids to take.
Rt. deltoid swollen, redness, warm to touch. Itching, some pain - state patient. Tx. KEFLEX 250MG/5mL 1 tsp po every 6 x 10 days. ATARAX 10/5mL.
Vial was first punctured on 04-Nov-2022 and was administered on 06-Nov-2022; No adverse event; given vaccine from vial punctured for more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given vaccine from vial punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 04-Nov-2022 and was administered on 06-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 45-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 immunisation.     No Medical History information was reported.    On 06-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine from vial punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 04-Nov-2022 and was administered on 06-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given vaccine from vial punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 04-Nov-2022 and was administered on 06-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (given vaccine from vial punctured for more than 12 hours) and PRODUCT STORAGE ERROR (Vial was first punctured on 04-Nov-2022 and was administered on 06-Nov-2022).    Concomitant product use was not provided by the reporter.  Nurse practitioner reported that they inadvertently administered the bivalent booster dose from a vial which has been punctured for more than 12 hours. It was reported that patient received vaccine from vial with size of 2.5 ml.  There was no information provided when vial was initially stored in the refrigerator. Vial was first punctured on 04-Nov-2022 and was administered on 06-Nov-2022. Vial was stored post puncture in the fridge.  Treatment information was not provided.
MOM SAID PT PASSED OUT  PT WAS SEATED AND RESPONSIVE WHEN I SAW HIM
arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
2/22/22- 1915 Recipient  attended vaccine clinic on 2/22/22 to receive her second dose of MODERNA COVID vaccine.  At the end of the clinic, when recipient was no longer on premises, it was determined that the recipient received a dose of 0.25 ml instead of the 0.5 ml required for a second dose, as confirmed by the administering RN. APN, Director of Health Services notified of occurrence. Employee advised to contact recipient to return for additional 0.25 ml dose of vaccine as soon as possible. The recipient was contacted upon discovery of the incident.  A certified Another language interpreter provided interpretation.  Recipient was made aware that she received a half-dose and needed to receive an additional half-dose as soon as possible to complete her second dose of MODERNA COVID vaccine. Recipient made aware that she is not fully vaccinated until she receives the additional dose of MODERNA COVID vaccine. Recipient verbalized understanding and agreed to return on 2/24/22 at 0800 for additional dose of MODERNA COVID vaccine.  Recipient did not return to receive the required additional dose of vaccine as agreed to. Multiple phone calls were made to recipient with messages left in another language. No calls have been returned. No further contact has been made with recipient. APN, aware.
High Fever (remained at about 104 F) that did not break with high doses of Advil or Tylenol for about 7 days.