chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lymph node on the left side of neck/throat. Upon visiting urgent care facility, it was discovered that pulse rate was low and advised to seek further medical treatment at emergency room or cardiologist. Upon meeting with cardiologist, holter monitor was ordered on April 1, 2021 to be worn for 24 hours. The outcome was confirmation of low pulse rate.
This is spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported the same event for two patients. This is the second of two reports. A patient of unspecified age, gender and ethnicity received PREVNAR 13 via an unspecified route of administration, on unknown date, at single dose. Relevant medical history and concomitant medications were not reported. The patient experienced shoulder bursitis on unknown date, after the vaccination. The outcome of the event was unknown. Follow-up (27APR2016): Follow-up attempts are completed. No further information is expected.
Left arm swollen. Hot to touch. Fever 101 x 2 days. Real red.
lt upper arm (deltoid area) red & swollen, traveling to underside of arm-referred pt to MD-given ATB;
Patient stated:  "feels like arm is broken, severe headache, hearing is off - misses every 3rd word in sentence"
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown demographics. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot # M025864 with expiration date of 24-MAY-2018; lot # M033904 with expiration date of 20-JUL-2018; lot # M035142 with expiration date of 30-AUG-2018; doses and routes of administration were not provided). No adverse symptoms were reported. Administered doses of vaccines experienced temperature excursions of: > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 10 hours and 15 minutes; > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 2 hours; > 5 degrees Fahrenheit but < 14 degrees Fahrenheit for 1 hour; > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 1 hour and 30 minutes; > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 3 hours and 30 minutes; > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 6 hours and 15 minutes. Digital Data Logger was involved. This is one of two reports received from the same reporter.  Additional information is not expected because there was no consent to contact physician.; Sender's Comments: US-009507513-1701USA005281:
This spontaneous report has been received from a medical assistant referring to a 42-year-old patient. The patient's pertinent medical history, concomitant therapies, and previous drug reactions or allergies were not reported. On 30-NOV-2021, the 42-year-old patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (RHA) (PROQUAD) at a dose of 0.5 milliliters (ml) as prophylaxis (drug use in unapproved age group) (lot number T030760 has been verified to be valid, the expiration date was not reported but upon internal verification was established as 08-MAR-2022; vaccination scheme, route of administration, and anatomical location of vaccination were not reported). No additional adverse events (AE) were reported.
Patient presenting with complaint of body ache, pain in neck and back. Provider assessed patient states patient felt flushed, sore arm/shoulder. Vitals checked and recorded at 11:30  BP: 140/90 HR: 66  Patient drank water rechecked BP after 10 min BP decreased, patient feels flush has improved no noticeable sheen of sweat.  Vitals  at   11:40 BP: 135/80 HR: 68 Patient sent home advised to go to ER if symptoms worsen.
We had to call 911 due to pt experiencing  extreme fatigue, sweating, palpitations, and dizziness. Pt's head kept falling back as if he couldnt hold it up on his own and we had to continue to tell him to stay awake and until paramedics arrived. I constantly fanned the pt to ensure he remained cool and did not fall asleep. 911 came about 14 minutes later and took over the situation. Im unaware if they took him or if he walked out on his own
Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.  Patient complained of sore arm for "a few days", headache x 1 day, and sore throat.
This case was reported by a consumer and described the occurrence of shingles in a female subject who unspecified age who was vaccinated with Flu vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Flu vaccine (unknown). One week after vaccination with Flu vaccine, the subject experienced shingles. The subject was treated with VALTREX. At the time of reporting the outcome of the event was unspecified. The subject questioned if this would alter her positive response to the flu vaccine and if she needed another flu shot.
Leg & back pain x 10 weeks. Referred to Orthopaedics & Rheumatology.
Information has been received from a physician, author of a article, regarding a previously healthy 2-month-old girl (patient 3) who presented with 4 days of vomiting and 2 days of fever, cough, and conjunctivitis without diarrhea (also reported as 3 days of diarrhea with a maximum of 18 episodes in 24 hours, vomiting none and 1 day of fever). On physical exam, she was fussy but consolable with mild conjunctival injection and nasal discharge. Laboratory evaluation revealed an elevated white blood cell count (10 700 1/2 L) with 12% bandemia. Urinalysis and urine culture were negative. The patient was treated with intravenous ceftriaxone and discharged. She received her first dose of ROTATEQ 1 day before illness onset (also reported as 2 days). A fecal specimen was obtained 5 days after illness onset and appeared to contain nonreassortant ROTATEQ component strain BrB-9 (G4P[5]) alone. The VP7 G4 gene of BrB-9 (G4P[5]) was detected (100% identity in 363 bases) along with VP4 P [5] (100% identity in 416 bases), VP6 I2 (100% identity in 342 bases), and VP3 M2 genes (100% identity in 500 bases) consistent with BrB-9 (G4P[5]). By EM. a few unidentified 30-nm particles were observed; all other tests were negative. This patient illustrated a spectrum of potential clinical and virologic outcomes associated with routine use of live, attenuated rotavirus vaccines. The diversity of these occurrences included detection of a nonreassortant ROTATEQ vaccine strain in a recently vaccinated child (patient 3). Patient 3 had upper respiratory symptoms accompanied by vomiting or diarrhea, and her illness was less typical of rotavirus disease alone. This is one of the several reports of the same source. Additional information has been requested.
bursitis left elbow; sore arm; This is a spontaneous report received from contactable reporters (Other HCP (dentist) and Physician). The reporter is the patient.  A 67-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 11Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing), notes: mature onset diabetes. States he doesn't take medication, it is controlled by diet and vitamin supplements. The patient took concomitant medications. Vaccination history included: Moderna (Dose 1), for covid-19 immunization; Moderna (Dose 2), for covid-19 immunization; Moderna (first booster), for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2022, outcome "recovered", described as "sore arm"; BURSITIS (non-serious) with onset 16Mar2022, outcome "recovering", described as "bursitis left elbow". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of bursitis. Additional information: The patient stated in the early part of March he was at his physician and the physician recommended PREVNAR 20, stated he had a sore arm, nothing significant. The patient went and had his hair trimmed a few weeks later (as reported) and his barber said "what is that on your elbow?" The patient went to his physician that did the PREVNAR 20 and was told it was bursitis. The patient stated he has no pain and the physician has him on naproxen (ALEVE) for a few weeks now. The patient stated that it had gotten smaller now. The patient stated he was a righty and he had no trauma. The patient stated that at the time of the report, the patient was just on anti-inflammatories and the physician didn't feel the need to drain it and it had been shrinking. The patient received the PREVNAR 20 on 11Mar2022 and the bursitis was noted on 16Mar2022. The patient sent his physician a picture on 16Mar2022 of his elbow and didn't think it was a reaction. There was no pain or tenderness. The patient clarified it was his left elbow and he got the vaccine in his left arm. The patient provides that he was a righty and he had no history of trauma or sports related or anything. The patient was on blood pressure medication and calcium channel blockers, there had been no change in his medication or batch of medication. No further details provided. The patient went in 11Mar2022 for his routine medical and had lab testing done. The patient stated his hemoglobin A1c was 6.8 and everything else was within normal.  When queried for seriousness criteria, the patient stated he felt no pain, no temperature around it and it had gotten a little bit smaller. The patient stated nothing to go to the emergency room over and being that his physician recommended anti-inflammatories and it appeared to be smaller.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Experienced itching, redness, and swelling of skin estimated at about 80% of body by ER nurse.  Experienced rapid heartbeat, increased blood pressure/heart rate, increased temperature and difficulty breathing.
HCP stated no AEs were reported by patients after the vaccines were administered; Patient was administered the Moderna Covid 19 vaccine after use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered the Moderna Covid 19 vaccine after use by date) and NO ADVERSE EVENT (HCP stated no AEs were reported by patients after the vaccines were administered) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 013B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Aug-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered the Moderna Covid 19 vaccine after use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (HCP stated no AEs were reported by patients after the vaccines were administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered the Moderna Covid 19 vaccine after use by date) and NO ADVERSE EVENT (HCP stated no AEs were reported by patients after the vaccines were administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (HCP stated no AEs were reported by patients after the vaccines were administered) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered the Moderna Covid 19 vaccine after use by date).    No concomitant medication was provided.  Beyond use date (BUD) was reported as 28 Aug 2022.  It was unknown whether the vial was initially stored in the refrigerator. It was unknown whether the vial underwent any temperature excursions.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2022: Live follow up received no new information.
Pain in the chest; warm; Arm was sore; Chilly/ it comes and goes 2 or 3 times; This spontaneous case was reported by a non-health professional and describes the occurrence of CHEST PAIN (Pain in the chest), VACCINATION SITE WARMTH (warm), MYALGIA (Arm was sore) and CHILLS (Chilly/ it comes and goes 2 or 3 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Pain in the chest), VACCINATION SITE WARMTH (warm), MYALGIA (Arm was sore) and CHILLS (Chilly/ it comes and goes 2 or 3 times). At the time of the report, CHEST PAIN (Pain in the chest), VACCINATION SITE WARMTH (warm), MYALGIA (Arm was sore) and CHILLS (Chilly/ it comes and goes 2 or 3 times) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: >60 (normal) Normal. On an unknown date, Oxygen saturation: >94 (normal) Blood oxygen level normal, more than 94.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went to emergency but was told to return 24 hours later since the nurse said it was not an emergency.  Concomitant medication was not provided.  Treatment information was not provided by the reporter.
fever from afternoon of shot through next evening; This is a spontaneous report from a contactable consumer (Patient). A 61-years-old male patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EN6200), dose 1 via an unspecified route of administration, administered in Arm Left on 27Feb2021 09:30 as DOSE 1, SINGLE for covid-19 immunisation (Age at vaccination 61 Years). No other vaccine in four weeks. Had covid prior vaccination. The patient not covid tested post vaccination. No known allergies. Medical history included cardiac disorder, covid-19. Concomitant medication(s) included metoprolol tartrate (METOPROLOL TARTRATE); ibuprofen (IBUPROFEN); acetylsalicylic acid (ASPIRIN 81). On 27Feb2021 16:00 patient experienced fever from afternoon of shot through next evening. No treatment was received. The outcome of event fever was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Came home from school stating he had a rash like his brothers. Fine rash to facial area and especially to Left orbit of eye. Gave him Benadryl. Saturday rash contiunes to spread with sporadic areas on arms torso back with the main concentration on face and testicles. Contiued to administer Benadryl on Sat and Sunday. Monday morning took him into urgent care. c/o severe itching to testicles which are red with good amount of rash present. FNP prescribed steriods, antibiotic and antihisamine, medications started immediately.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2020 at 12:00 as dose 1, single (Lot number: 1111-20-EK5730), in left arm and on 12Jan2021 at 12:00 as dose 2, single (Lot number: 1111-20-EL1283) at the age of 34 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 17Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 034F), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing), notes: Vaccine brand other: Moderna, Vaccine dose number: 3. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Positive, notes: Tested positive for COVID again. Therapeutic measures were taken as a result of vaccination failure, Covid-19 included Paxlovid.
12/31/2020: Around 2pm, feeling dizzy and rapid heartbeat. 3:30pm, rapid heartbeat. 6pm rapid heartbeat 01/01/2021: 6am, rapid heartbeat. 8pm, rapid heartbeat 01/02/2021: 8am, rapid heartbeat. 2pm, rapid heartbeat 01/03/2021: 1:30pm, rapid heartbeat lasted until around 3pm. 01/04/2021: 7am, rapid heartbeat. around 8pm, rapid heartbeat. 01/05/2021: 10am rapid heartbeat The first two days I experienced the rapid heartbeat, I almost had an anxiety attack but I learned to breath through my nose and I would be okay after that. Today is January 7 and i haven't experienced anything in the last two days.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On 18th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient reported that she received a dose of the SHINGRIX a day before the date of reporting, and she experienced flu like symptoms. The patient did not want to provide demographics nor answer any further questions.
only received the DTap-IPV diluent portion of PENTACEL and that it was not reconstituted with lyophilized Hib component prior to injection/ no AE; Initial information was received on 21-Sep-2021 regarding an unsolicited valid non-serious case from other healthcare professional and consumer/non-healthcare professional via call center via Medical Information (Reference number- 00778581).  This case involves a 3-month-old male patient who received only received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] which DTaP-IPV diluent was not reconstituted with lyophilized HIB component (product preparation issue).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  On 20-Sep-2021, the patient received a first dose of 0.5 mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: U69445AA and expiry date: 22-Jul-2022) via an intramuscular route in the right quadricep for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique (latency: same day).  It was reported "Nurse states that a patient on 20SEP2021 only received the DTaP-IPV diluent portion of PENTACEL and that it was not reconstituted with lyophilized HIB component prior to injection. Nurse asked for information on how to proceed and whether or not the patient would need to receive the entire PENTACEL injection over again."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Received flu shot 10/30/2020 (Fluzone High Dose) and 24 hours later my arm swelled, turned red, was hot, and hives broke out. The affected area was 2"s below the injection site and went just below the elbow. The redness and itching was the circumference of the upper arm. Reaction and symptoms lasted 5 days before dissipating.
Limp/pale within a couple of minutes after injection. Then lost consciousness and experienced general seizure for 30-40 minutes. Epinephrine adjusted.  Nurse follow up on 09/09/04 states: "No new information."  Nurse follow up on 09/14/04 states: "Anaphylaxis."
1FEB93 11AM recvd 3rd Hep B vax; 230PM feeling nauseated cont until 630PM became violent, vomiting 5 hrs n/v; 730PM diarrhea started & cont;
Out of the blue, with no changes to anything else, I started breaking out in hives. These hives would hit me daily, and were the worst case of hives I?ve ever had. One day they would be all over my upper body, armpits, neck, head, face, ears. The next they would be on my torso, legs, groin. These hives required daily Benadryl and then Zyrtec. I?m now a month in to the hives and I no longer have them every day. I now break out about once every 2-3 days.
from correspondence received on 11/12/01m it was reported that a 61 year old female patient received a Fluzone SV '01-'02 vaccination administered on 10/18/01 in Savannah, Ga while traveling to Florida. the patient developed a rash at the injection site the same day. The next day developed "hives" - one at a time over her body-the size of a grapefruit. She was seen in ER and treated with cortisone injection and oral medications -still unresolved.
Pt given vaccines on 8/29/07. Returned on 8/31/07 with complaint of "bump on leg". Pt with a 6cm by 6cm area to right upper thigh that was red and swollen. No other symptoms. Dx with probable "side effect" of Proquad vaccine vs. mild cellulitis. Treated with Keflex.
swelling; itching; swollen lines; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), PRURITUS (itching) and PERIPHERAL SWELLING (swollen lines) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced SWELLING (swelling), PRURITUS (itching) and PERIPHERAL SWELLING (swollen lines). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, SWELLING (swelling), PRURITUS (itching) and PERIPHERAL SWELLING (swollen lines) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Asthma Inhaler. Following the administration of vaccine, the patient had been experiencing, on her left hand, some itching, swelling and a couple of random lines that are extra swollen on top of the area. It looked like a bug bite. This was between the thumb and pointer finger. The patient believed this area was slowly growing and was still present at the time of reporting. This reaction occurred on the same arm of the injection.