chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other AE; An expired dose of GARDASIL9 was administered to a patient; This spontaneous report has been received from a medical assistant, concerning patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, current conditions, previous drug reactions, or allergies.  On 28-FEB-2022, the patient was vaccinated with an expired dose as the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (lot number R030453 has been verified to be a valid lot number, expiration date reported and established as 23-JUL-2021) (exact dose, route and anatomical location of administration were not reported) (expired product administered). No other adverse events (AE) reported (no adverse event), no temperature excursion.
Started developing some "swelling and pain" and "welt-like hives" at the injection site; Started developing some "swelling and pain" and "welt-like hives" at the injection site; Started developing some "swelling and pain" and "welt-like hives" at the injection site/welt-like hives were about "3 inches" in diameter; Hives appeared on her "wrist" as well; Joint and hip pain that was a sciatic feeling pain; Joint and hip pain that was a sciatic feeling pain; Chills; Inappropriate dose of vaccine administered; This is a spontaneous report based on the Information received by Pfizer from Merck & Co., Inc. (manufacturer reference number 01411624) from a contactable consumer reporting for herself. This female patient of unknown age received on 19Nov2019 second dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose for immunization. Medical history and concomitant medications were not reported. About one year before this report (2018), she got vaccinated with the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) with no reportable issues. On the same evening of vaccination, the patient started developing some "swelling and pain" and "welt-like hives" at the injection site and the hives appeared on her "wrist" as well. The patient also added the welt-like hives were about "3 inches" in diameter. The patient also said after getting the 2nd dose experienced "joint and hip pain that was a sciatic feeling pain" and she had the "chills" as well. The patient mentioned she took an unspecified antihistamine to treat her adverse reaction which helped because most of the symptoms "cleared up within 2 days" after getting the vaccination. Final outcome was unknown. No follow-up attempts are possible. No further information is expected.
uncomfortable; armpit completely swollen, sore and tender; armpit completely swollen, sore and tender; This is a spontaneous report received from a contactable consumer. This consumer(patient) reported for herself that the 39-year-old female patient received second dose of bnt162b2 (BNT162B2), via an Intramuscular, administered in Arm Left on 12Apr2021 10:30 (Lot Number: EL3247) at single dose for covid-19 immunization (because she thought that it would be safer she has an 82 year old mother that lives with her). Medical history included allergies: any type of penicillin all the "cillins"; Novocain; sulfa drug any type; aspirin gives an upset stomach, contraception from an unknown date and unknown if ongoing. Family Medical History included dad has agent orange; asthmatic and diabetic. Concomitant medication(s) included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for contraception, start and stop date were not reported and Women's vitamin. The patient previously took first dose of bnt162b2 (BNT162B2) for covid-19 immunization. The patient experienced armpit completely swollen, sore and tender on 13Apr2021 with outcome of recovering , armpit completely swollen, sore and tender on 13Apr2021 with outcome of recovering, uncomfortable on an unspecified date with outcome of unknown. Vaccination Facility Type was Other: Pfizer manufacturing facility. No Vaccine Administered at Military Facility. No AE(s) require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. AE(s) following prior vaccinations was none. Relevant Tests was none. The clinical course was reported as follows: Consumer states that she got her second vaccine Monday morning, 12Apr2021 and when she woke up Tuesday 13Apr2021 her armpit is completely swollen, sore and tender and it still is. Caller states it was very painful when she woke up yesterday morning, could barely touch it to put deodorant on. Caller states today, the pain is gone now, but it is extremely uncomfortable on a scale of 1-10 of uncomfortablity it is about 12.5. Caller states even her clothes touching it is just 'ugh'. Caller stated that the area is still big, but it is not painful.   No follow-up attempts are needed. No further information is expected.
-Swollen left supraclavicular lymph nodes (1 medium and 1 large that are hard like marbles) -Entire left supraclavicular fossa region is swollen around hardened lymph nodes
Pt had Hep-B shot on 4/29/00 and had 2 seizures on 5/2/00. Sent to another hospital and was put on Phenobarbital for a few months. Is now off of it. Doctors said they did not know why she had the seizures after hearing our medical history. Some have said may have been due to the Hep-B shot and others said they would question this. Was in the hospital from 5/2/00 to 5/4/00.
My son received the covid primary series shots on 4/25/21 and 5/16/21. After the second shot he had a fever and headache and woke up in the middle of the night complaining of it. I believe that passed within a day. He received the booster shot after his 18th birthday on 12/30/21. He noticed blood in his stool about a week after the shot, however he thought it might be a hemorrhoid since he had been lifting weights. He told me (his Mom) probably about 2 to 3 weeks later since he was embarrassed and I had him apply preparation H. With no improvement I scheduled an appointment with the his doctor on 2/21/22 and his calprotectin was severely elevated so he was referred to a gastroenterologist who did a colonoscopy on 4/7/22 and diagnosed Crohns or Ulcerative Colitis. Dr says it is ulcerative colitis. Dr does not know whether it was the shot but it is very coincidental and pt.had no health issues before this, only went for routine appointments.
Burning neck; Itching on neck; Hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning neck), PRURITUS (Itching on neck) and FEELING HOT (Hot to touch) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced BURNING SENSATION (Burning neck), PRURITUS (Itching on neck) and FEELING HOT (Hot to touch). On 12-Apr-2021, BURNING SENSATION (Burning neck), PRURITUS (Itching on neck) and FEELING HOT (Hot to touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided. The treatment information was not provided.   This case was linked to MOD-2021-141839.
Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Case number PHEH2016US029269, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 46 years old male patient. Past medical history and concomitant medications were not reported. The nurse stated that first temperature excursion of FLUCELVAX Quadrivalent at 52F for 1 hour occurred on 18 Oct 2016. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscularly on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34F and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2F three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
24hr reaction Shakes Chills Fever Migraine Soreness at site of injection  Irregular menstrual bleeding
Patient came to several clinics for COVID vaccines even though the patient had already received second primary doses or completed vaccine series at another clinic and did not require or meet the criteria for any more COVID vaccinations. It is assumed that the patient's parents/ guardians took advantage of the incentive program for patients that receive COVID vaccines. Pt's parents/ legal guardians came in requesting second dose Pfizer Bivalent for toddlers. Patient's parents showed documentation showing patient had already received their first dose. Pt was then given unnecessary Pfizer Maroon Bivalent COVID vaccine and was asked to wait the required 15 minute wait period, after the 15 minute wait period patient's parents stated that the patient was doing fine and did not complain of any effects from vaccine prior to leaving clinic. At this time it is unknown how many COVID vaccines that the patient has received.
70 doses of Pfizer-BioTech Covid Vaccine for patients (orange cap) Lot FK5618 were delivered assigned a beyond use date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility.  The doses were mistakenly administered to 70 patients on 11/26/21
No additional adverse event reported; Caller is a vaccine coordinator calling to report a temperautre excursion for VARIVAX. Caller reports that the VARIVAX was stored in the refrigerator since 15NOV2021. Caller reports that the refrigerator had an excursion with maximum temperautre of 5; This spontaneous report has been received from a vaccine coordinator, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 24-JUN-2022, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX 9) subcutaneous injection, 0,5 milliliters (ml) as prophylaxis (lot number: U015678, which was determined to be valid, with an expiration date on 18-MAY-2023) (scheme, route and anatomical location of administration were not reported) (product storage error). The administered dose was placed on a refrigerator since 15-NOV-2021, where it underwent a temperature excursion with a maximum temperature of 51 degrees Fahrenheit (F) for an unspecified amount of time. It was unknown if any previous temperature excursion took place. No additional adverse event was reported.   This is one of four cases from the same reporter.; Sender's Comments:  US-009507513-2209USA006085:
Patient received vaccination in right arm 10/24/07 at 12 noon.  Next morning upper right arm was swollen and painful to move; swelling was anterior and superior to vaccination site.  No complaints of difficulty breathing, chest pain, nausea, vomiting, fever, joint pain or pain upon touchen swollen extremity.
Information has been received from a published literature, titled as stated below, referring to a 10 months old patient of unknown gender. On an unknown date the patient was vaccinated with rotavirus vaccine, oral, (manufacturer unknown) (strength, dose and lot # not reported). The patient had been fully immunized. On an unknown date in 2013, during the patients' February 2013 school break, on the road of family vacation to a beach, the patient's old sister who had previously complained that she did not feel well, proceeded to vomit. The patient's old sister did not receive rotavirus vaccine. Over the next several days, the patient's old sister was mildly ill with abdominal pain, occasional vomiting, and diarrhea. Although she showed glimmers of improvement, 3 days later she awoke with bilious vomiting and periumbilical abdominal pain. On arrival at the closest pediatric hospital, the physician noted significant dehydration, administered ondansetron, attempted oral hydration, and thought that intravenous rehydration and basic laboratory tests were needed. The physician stated that she probably had gastroenteritis. The patient's old sister's laboratory results were notable for bicarbonate level of 10 mmol/L and an anion gap of 33. On hospital admission, bacterial stool culture and rotavirus antigen tests were ordered. After receiving hydration overnight, the patient's old sister recovered, and they left the hospital to resume their family vacation. On an unknown date in 2013, the patient experienced gastroenteritis rotavirus despite vaccination (vaccination failure). Within 5 minutes of returning from the hospital, the patient's two old brothers vomited while attempting to reach the bath room. That night, the patient's two old brothers had vomiting and diarrhea, and missed the toilet. 6 of 6 family members of the patient had been ill within 2 weeks. The patient experienced looser-than-usual bowel movements in a single day (which would not meet criteria for gastroenteritis in many study). On an unknown date, the patient recovered from gastroenteritis rotavirus with no lasting effects. The outcome of vaccination failure was unknown. The reporter considered vaccination failure and gastroenteritis rotavirus to be related to Rotavirus vaccine, Oral (manufacturer unknown). This is one of the three reports regarding the same article. The patient's siblings adverse events were captured in 1506USA003700 and 1506USA002868. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Given 1st set of vaccines 9-16-11, including ROTATEQ. Seen at hosp. ER for intussusception 9-21-11.
Information has been received from a registered nurse (RN) concerning a 16 year old female with no medical history or no drug allergies who on 25-JUL-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL vaccine (yeast) (lot # 660391/0063X). There was no concomitant medication. On 25-JUL-2008 the patient experienced an allergic reaction. The patient had pain and swelling at injection site. The patient then developed hives and fever. The patient saw the physician to seek medical attention. On an unspecified date, several days later, the patient recovered. No product quality complaint was involved. Additional information has been requested.
she was pregnant; she was feeling so bad and terrible; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient) reported for herself. A female patient of an unspecified age (patient was pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller stated that she took the first dose of the vaccine and when she got home, like the second or third day, she was feeling so bad and terrible and went to the ER and found out she was pregnant. She did not know how far along she was but she will be seeing her OBGYN on the 28th. She wanted to know if she should continue with her second dose. The outcome of the event she was feeling so bad and terrible was unknown.  Information about lot/batch number has been requested.
Covid AE was reported 05-Dec-2022 to 18-Dec-2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid AE was reported 05-Dec-2022 to 18-Dec-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    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 and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2022, the patient experienced COVID-19 (Covid AE was reported 05-Dec-2022 to 18-Dec-2022). On 18-Dec-2022, COVID-19 (Covid AE was reported 05-Dec-2022 to 18-Dec-2022) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported.  Vaccination dates were provided as 27-Feb-2021, 20-Mar-2021 and 28-Dec-2021. Reporter did not know which vaccines corresponded to which dates. The patient received one vaccination from Moderna and two vaccinations from Pfizer. It was reported that patient had COVID-19 with previous Pfizer COVID vaccinations. Confirmation via a test was not provided.  Reporter became aware that the patient had Pfizer COVID vaccinations on 07-Apr-2023.  The reporter became aware of the COVID AE on 20-Dec-2022.  No treatment medication information was reported.
This spontaneous report as received from a male patient of unknown age regarding himself. On an unknown date in 2007, the patient was vaccinated with 0.65 ml ZOSTAVAX, (lot number, expiry date was not reported and the route was subcutaneous). Concomitant medications were not reported. On an unknown date in 2007, the patient experienced serious chicken pox after receiving ZOSTAVAX. The outcome of serious chicken pox was reported as recovered in end of 2008. Additional information is not expected.
Patient called on 7/31/17 and reported a problem with her right shoulder, arm and hand after getting a TDap vaccine injection on 7/25/17. She said she had pain in her right shoulder she used ice, heat and was taking TYLENOL. She said she started having trouble picking up items like her cell phone. She said she is having difficulty turning at the wrist or moving her wrist from side to side. She said the pain radiates up to the shoulder. She again said this all began after the injection. Patient was seen again on 8/16/17 and presented with no complaints. Patient was a G2P2 with an EDD of 10/20/17.
Patient developed Varicella Zoster infection after being fully immunized against it. Clinic only has documentation of one dose of vaccination given, however mother states that two doses had been previously given. Patient developed rash on 8/3/21 on arms and torso and on 8/4 it spread to face and legs. On 8/10/2021 vesicles were reported to provider.
Case number PHEH2016US023433, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 46 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in left arm on 11 Feb 2016. On 11 Feb 2106, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error (incorrect product storage). The case was assessed as non serious by the nurse.
Approximately at 03:45 PM in April 2021, I received the shot and within the 30 minutes of waiting my vision became blurry in the right eye. My right eye swelled up a little and it went away the next day. I continue to have blurry vision in the right eye and have a headache for the next four days. I spoke with my doctor and was told if it persisted for more than four days to contact him again. The blurry vision and headaches subsided after day five.
was given the diluant only; was given the diluant only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a child patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 27th August 2021, the patient received Boostrix. On 27th August 2021, unknown after receiving Boostrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows: The age at vaccination was not reported. The reporter stated that only the diluent was given for a Boostrix vaccine to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. The health care professional office gave permission to contact them. This case was linked with US2021192892, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192892:same reporter
1/25/21 Day 21 after Moderna Covid 19 first dose--Started getting tingling/numbness/burning sensation on right side of face. Tongue and mouth not moving how I want. Bit tongue. Feel like I have a slight lisp  1/26/21 Occupational Health at hospital said it's not related to vaccine so they will not treat me or be involved unless my dr identifies problem as related to the vaccine. 1/26/21 1000--Had virtual Dr appt. Possibly the beginnings of Bells Palsy. Prescribed Prednisone and Valacyclovir. Suggested high doses of Vitamin C, Vitamin D, and Zinc.  1/26/21 2200--Drooling from Right side of mouth, Right eye watering. Still right sided tingling/burning sensation.  1/28/21 --Slight improvement in drooling and eye watering. Less burning sensation.
LOCALIZED RASH ON THE RIGHT DELTOID, ESTIMATED 6.0 CM IN DIAMETER. WARM, NOT TENDER TO TOUCH, HAD A FEVER OVER THE WEEKEND. RASH STARTED 4-17-05 PER FATHER. WATCH FOR SIGNS OF CELLULITIS PER DOCTOR.
Redness and bump in a 2 inch diameter at the injection site 8 days after injection
p/vax pt exp fever, chills, lt gluteal pain, redness & inflammation;MD reports 2 days post onset pt to MD who felt pt exp a localized rxn to pneumococcal vax;rx dicloxacillin x 10 days, ice on area 10-15min twice day & inc Relafen;
10-1-13 Pt. rec'd Quadrivalent FLUZONE Vaccine. Immediately c/o itching. 5 min. later - sm. blisters (hives) formed next to injection site. BENADRYL 50 adm. into other deltoid. Itching subsided. Pt. returned home and medicated self with BENADRYL again. No further itching. 10-2-13, general malaise and body aches - relieved with ADVIL.
37 yo male patient presented with complaint of lump on back of right upper arm after anthrax vaccine (dose #6). Pt states that he never had a reaction like this with any other dose of anthrax vaccine.
Rash, upper torso, neck and chest, around rib cage at bra line.