chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient described as a "shingles-like reaction". Redness, pain to the touch, and eventual blistering on left inner thigh.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-MAY-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # L006545, expiration date 16-NOV-2017). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 168, 32 and R; 936, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Fever of 102 degrees on awakening at 6 AM, temperature increased to 103 degrees at noon. 2 x 300mg aspirin caplets taken at noon. Fever reduced to 100 degrees in evening. May 8 today, fever again of 102 degrees, 2 x 300 mg aspirin caplets taken again.
Arm was swollen and red and hot to touch patient had reaction for about 5 days after vaccination. Patient did go to urgent care and instructed to keep ice on arm
At 09:15 I felt my eyes swelling and they were watering. I was sneezing and my sinuses were draining. At 09:45 I returned to the clinic.
Exactly 2 weeks and 2 days later I had a break through case of COVID-19. I took a home test provided and tested positive. I woke with a sore throat and severe congestion and sinus headache at 8:00 am. By 4:00 pm, I had a fever.
Information has been received from a physician concerning a mother of a pediatric pt who on 4/13/01 was vaccinated with varicella virus vaccine live. The physician reported that the female reported that she performed a home pregnancy test that was negative. A week later, she had a lab test that confirmed pregnancy. The physician reported that because the woman was not the doctor's pt, there was no additional information related to last menstrual period (LMP) or date of delivery. The physician "feels the woman is about 6 weeks pregnant". The physician did not have the name of the obstetrician/gynecologist. In follow-up, the physician reported that she was informed that the pt had an early miscarriage of this pregnancy. Additional information has been requested.
The symptoms that I am experiencing that are worthy of reporting since they are not listed on the Fact Sheet are: earaches, eye pain, sore throat, bloody nose upon blowing and sore nasal cavities (such as when I'd had severe sinus infections). These are still occurring, even though the general symptoms as listed below are subsiding.  Before receiving my vaccine, I was careful to drink a lot of fluid. Eight hours after receiving my second dose, intense body aches began including headache. It was a fitful night of sleep as I remember moving around in an attempt to stretch out the muscles that seemed to be tightening. The next morning as I arose I felt weak and chilled.  Highest temperature recorded was 99.0. Muscle aches, headache, joint pain (especially in my knees) persisted throughout the day. Rest and tylenol helped somewhat.
Immediately after vaccination patient experienced tingling and numbness down her left arm. 30 minutes after vaccine patient felt numbness and tingling on left side of face and tongue.
This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 44-year-old female patient who received FLUARIX QUADRIVALENT for prophylaxis. On 26th September 2018, the patient received FLUARIX QUADRIVALENT. On 26th September 2018, 1 hr after receiving FLUARIX QUADRIVALENT, the patient experienced allergic reaction, nausea, red face, lip redness, facial swelling and lip swelling. On an unknown date, the outcome of the allergic reaction, nausea, red face, lip redness, facial swelling and lip swelling were recovering/resolving. The reporter considered the allergic reaction, nausea, red face, lip redness, facial swelling and lip swelling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient did not have allergic reactions due to flu shots in the past. On Wednesday, the patient received a dose of FLUARIX QUADRIVALENT on left arm. About 1 hour after the vaccination, the patient experienced nausea. About 6 hours after she started noticing that both, her face and lips, got red and puffy. The patient visited to her physician and the physician believed that, it was an allergic reaction due to the flu shot. The contact details of the physician was provided.
Patient has history of anaphylaxis, and carries her own EpiPen.    Patient received dose 2 at 1640, and was instructed to wait in observation area for 30 minutes. At 1650 patient reported that her tongue and back of throat were beginning to itch. No other symptoms. No difficulty breathing. Vital signs stable. Symptoms persisted, so decision was made to send patient to hospital emergency department. Patient did not want emergency transport, and was stable, and husband transported to hospital in POV. Onsite and hospital care team agreed to this plan. RN escorted patient from clinic to car. Patient and husband knew how to use EpiPen and drove directly to nearby ED for observation.
From telephone correspondence received on 10/14/02, it was reported that a 28 year old (DOB 10/15/74) male patient, received Fluzone (lot # U0918AA) on 10/14/02. Following the administration of the dose, he experienced nausea and vomiting, severe, extreme weakness, achiness and tingling in his lower legs. Reportedly, he went home from work. It is not reported whether the patient recovered from these adverse events.
sniffles on Saturday, next day, w/sl boyd aches;next day Sunday afternoon broke out w/react flushed skin on face, arms, lower extremities, esp groin area w/sl rasied feeling & some hive like skin elevations;also itching
Patient reports persistent radiating pain down left arm to fingers starting 09/13/19 after receiving vaccine on 09/10/2019
She is anaphylactic to some ingredients of the pneumonia shot a few years ago; This is a spontaneous report from a contactable consumer (parent). A female patient (daughter) received Pneumococcal 13-Val Conj Vac (Dipht Crm197 Protein) (Lot/Batch Number and Expiration Date unknown) via unspecified route of administration on an unspecified date at single dose for immunisation.  The patient's medical history and concomitant medications was not reported. Patient was a front liner and was supposed to get the vaccine last week. However, she was anaphylactic to some ingredients of the pneumonia shot a few years before unspecified date, but does not know which specific ingredient. Patient wanted to know the ingredients of the covid vaccine so that they may cross check it with their pharmacist. The outcome of event was unknown.  Pfizer is a marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.  Information on the batch number has been requested.; Sender's Comments: A possible causal association between administration of Pneumococcal 13-Val Conj Vaccine and the onset of anaphylactic reaction might not be fully excluded, considering the known adverse event profile of the suspect product.  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.
This case was reported by a pharmacist and described the occurrence of local reaction at injection site in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL. At an unspecified time after vaccination with FLULAVAL, the subject experienced local reaction at injection site (golf ball sized indurations to distal injection). It was swollen and hard at the injection site. The subject also experienced systemic reactions including 103 degree fever, nausea, vomiting, migraine headaches and hives. The subject was taken to the emergency room. At the time of reporting the outcome of the events was unspecified. Product complaint was also noted. It was reported that 6 subjects experienced adverse events following administration with FLULAVAL. The vaccines were given from two vials with the same lot number. The vaccines were administered by the staff of a nursing home. The director of nursing reported the adverse events to the pharmacist. It was noted that the facility would be shutting down on 16 October 2011. Linked cased include A0947071A, A0947173A, A0947174A, A0947175A and A0947177A. Follow-up information was received on 19 October 2011. It was reported that 0.5 ml of FLULAVAL was administered to the subject on 23 September 2011. The reported events began on 23 September 2011. The events were not considered to be serious and resolved on an unspecified date. No additional information is available. According to product complaint investigation results reported by GSK quality assurance/Biologicals on 31 October 2011, the product complaint was assessed to be unsubstantiated.
Cellulitis patient given Ibuprofen and Cephalexin 500mg.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included chickenpox (had chickenpox at 3 years of age) and shingles (had shingles at 50 years of age). Concurrent medical conditions included reaction to drug preservatives. In September 2021, the patient received the 1st dose of Shingrix. In September 2021, less than a day after receiving Shingrix, the patient experienced pain in arm and general body pain. On an unknown date, the outcome of the pain in arm and general body pain were recovered/ resolved. It was unknown if the reporter considered the pain in arm and general body pain to be related to Shingrix. Additional details were provided are as follows: The patient received a dose of Shingrix in left arm in September 2021 (unknown date) and she felt pain after the injection was administered and then in 3 to 4 hours, she experienced the pain spread throughout her body and had body pain and lasted for 3 to 4 days. The reporter called to inquired how long was Shingrix effective in patients 50 years and older, regarding approval date of Shingrix, placement of Shingrix in arm and ingredients of Shingrix. The reporter reported that she has many allergies including allergy to preservatives and would like to know the ingredients in the vaccine. The reporter was given medical disclaimer and was referred to health care professional. The reporter consented to follow-up. For tolerance of 2nd dose, refer case US2021AMR249057.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR249057: Same reporter.
Itchy throat, itchy inner ear and slightly enlarged lips (at 3:00am on 1/31) Itchy throat, itchy inner ear and  excessive sneezing (at approximately 5:00pm on 1/31) (I took an extra Zyrtec to subside these symptoms) These are the usual reactions to allergies (not the shellfish allergy though) I was also fatigued for several days but I know that was a listed  as a side affect but I thought I would mention it.
At ~3:10pm, patient received his vaccination for COVID (Janssen brand). Patient was directed to sit in waiting area for 15 minutes for monitoring; during this time, patient started to complain of the following: chest/abdominal pain, "pounding in his head", felt faint, and "scratchy throat" that was not improving. Around 3:35pm, 9-1-1 was called due to worsening chest pain and scratchy throat. EMTs directed me to administer 25mg of diphenhydramine (which as give at 3:46pm) to patient. EMTs arrived shortly thereafter, noting elevated BP (~154/90). Patient left pharmacy area ~4:10pm and was brought to ER via paramedics for further evaluation.
Patient received the pfizer vaccine at 03:18 PM and at 03:22 PM as the patient was walking into the waiting room passed out on the floor. The mother of the patient caught the patient before she hit the floor and therefore the patient did not hit her head. Patient lost consciousness for about 30 seconds before regaining consciousness. Upon regaining consciousness the patient proceeded to vomit about 2 ounces of clear to yellowish emesis. Patient was given water and her vitals were taken. Her vitals are as follows: blood pressure 110/80 Heart rate 82 and oxygen level was 96.  Patient is currently alert. The patient recovered well and is able to answer questions asked of her. The patient waited in the observation room from 03:22 PM-03:50 PM.
Pt recvd 2-1cc injects of Recombivax 29NOV90 & 1JAN91; 29MAY91 recvd Engerix-B; pt "did not develop immunity";
Vomit 10 seconds after the shot, 10 minutes later complained of throat closing (gave diphenhydramine)
About three days after getting her shot, my mother woke up disoriented and unlike herself. She was lethargic and did not want to eat. She drank some tea and soup, and that's a quarter of what she usually eats. This was on Thursday evening, by that Friday she was not getting any better. I did a COVID-19 test on her. She was negative. It was hard for her to walk or move, I had to carry her to the bathroom. She was unable to get dressed. That Saturday she was worse and had to be physically lifted out of bed to go to the bathroom and she was completely weak and had extreme Flu like symptoms. She was coughing and when she tried to eat, she was having a very hard time swallowing and would choke on it. I called 911 to have the medics transfer to the hospital on that Saturday night around 9:30PM. They found at the ER she had lesions on liver, thyroid and right breast, Her X-Ray show her left lung was a third to a half clouded and the right lung a quarter to a third cloudy, and they diagnosed her with pneumonia. She was given medication at the hospital and an antibiotic regime for 5 to 6 days and it was not making any improvement. They changed the antibiotic and that was seemed to be making slight improvement, but then she developed sepsis. Then they made the choice to have a cardiologist change her meds due to her AFIB. The cardiologist changed the meds at 5 PM in the afternoon and didn't get more AFIB medication until 9AM the next morning.
Wheezing, nausea, diarrhea, muscle aches, severe headache. Rx?s albuterol, azithromycin, Mesronian pack and ondansetron.
Flu-like symptoms: body ache, fever nausea.  Later, redness at site with palpable lump.  Hot to the touch.
Infection site is red, hot, painful, itchy, about 50mm in size, treatment, Ice to redden area right arm.
instead of mixing the Pfizer Covid vaccine with sodium chloride it got mixed with 1.8ml of the Moderna vaccine and 2 shots were given before they realized what had happened; instead of mixing the Pfizer Covid vaccine with sodium chloride it got mixed with 1.8ml of the Moderna vaccine and 2 shots were given before they realized what had happened; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (instead of mixing the Pfizer Covid vaccine with sodium chloride it got mixed with 1.8ml of the Moderna vaccine and 2 shots were given before they realized what had happened), PRODUCT PREPARATION ERROR (instead of mixing the Pfizer Covid vaccine with sodium chloride it got mixed with 1.8ml of the Moderna vaccine and 2 shots were given before they realized what had happened) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (instead of mixing the Pfizer Covid vaccine with sodium chloride it got mixed with 1.8ml of the Moderna vaccine and 2 shots were given before they realized what had happened), PRODUCT PREPARATION ERROR (instead of mixing the Pfizer Covid vaccine with sodium chloride it got mixed with 1.8ml of the Moderna vaccine and 2 shots were given before they realized what had happened) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (instead of mixing the Pfizer Covid vaccine with sodium chloride it got mixed with 1.8ml of the Moderna vaccine and 2 shots were given before they realized what had happened), PRODUCT PREPARATION ERROR (instead of mixing the Pfizer Covid vaccine with sodium chloride it got mixed with 1.8ml of the Moderna vaccine and 2 shots were given before they realized what had happened) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (instead of mixing the Pfizer Covid vaccine with sodium chloride it got mixed with 1.8ml of the Moderna vaccine and 2 shots were given before they realized what had happened) and PRODUCT PREPARATION ERROR (instead of mixing the Pfizer Covid vaccine with sodium chloride it got mixed with 1.8ml of the Moderna vaccine and 2 shots were given before they realized what had happened).    No concomitant medication was reported.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
1414- 18min after injection Patient stated he was feeling funny. He reported feeling hot and discomfort to Left side of his neck. Upon evaluation he was mildly tachycardic HR 110. Symptoms began to worsen with redness spreading through his hands and upper torso and pt became diaphoretic. by 1420 Pt BP increased to 171/104. Pt was given IM Benadryl and Decadron per Dr. orders. by 1440 redness had completely resolved and Diaphoresis was gone, HR down to 144/82. by 1500 all Pt's symptoms resolved.  Pt was able to be discharged from clinic without s/sx of distress.
Blister on elbow; Rash Leg (R) above ankle; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blister on elbow) and RASH (Rash Leg (R) above ankle) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 129L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date. Previously administered products included for an unreported indication: SHINGRIX. Concurrent medical conditions included Sulfonamide allergy (Sulfa allergy).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced BLISTER (Blister on elbow) and RASH (Rash Leg (R) above ankle). The patient was treated with ZINC OXIDE at an unspecified dose and frequency. At the time of the report, BLISTER (Blister on elbow) and RASH (Rash Leg (R) above ankle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included High blood pressure medication.     Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Re[porter address and email updated This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blister on elbow) and RASH (Rash Leg (R) above ankle) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 129L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date. Previously administered products included for an unreported indication: SHINGRIX. Concurrent medical conditions included Sulfonamide allergy (Sulfa allergy).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced BLISTER (Blister on elbow) and RASH (Rash Leg (R) above ankle). The patient was treated with ZINC OXIDE at an unspecified dose and frequency. At the time of the report, BLISTER (Blister on elbow) and RASH (Rash Leg (R) above ankle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included High blood pressure medication.     Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Re[porter address and email updated
9 patients received expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were given. No treatment information were given.   This case was linked to MOD-2021-395880 (Patient Link).
Soreness of the arm; Rigid near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the arm) and VACCINATION SITE INDURATION (Rigid near the injection site) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE and ROSUVASTATIN for an unknown indication.    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 (Soreness of the arm) and VACCINATION SITE INDURATION (Rigid near the injection site). The patient was treated with IBUPROFEN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness of the arm) and VACCINATION SITE INDURATION (Rigid near the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Injection stung when he received it.  He has had many vaccinations in his life and none have every stung like this.  Achy.  General heavy weight flu like symptoms.  Extreme nerve pain at site of post herpetic area.  Symptoms lasted about 3 days.