chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After leaving clinic - 20 minutes of observation, patient was driving home when you experienced slurred speech, flushed face, tingle, dizziness and felt like he would pass out. Lasted for approximately 30 minutes on side of the road. Patient rested in his vehicle until he felt better. Symptoms then resolved and he was able to drive home. All symptoms are fully resolved.
Patient was given MMRV instead of MMR, in error. He received Varicella in right thigh at same visit.  No symptoms at present. Immunization program advised. Parent advised of possible adverse effects.
I got my 1st shot on March 12 at Hospital.   3 days later I got nausea and diarrhrea.   Today (3/22) the diarrhrea is as bad as ever.   I have no expectation that it will go away on its own.  I am very reluctant to get the 2nd shot.  What do I do?  Help!! Pfizer EN6207
fatigued; disoriented; This is a spontaneous report from a contactable physician (patient) via a Pfizer sales representative. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On Dec2020, the patient was fatigued and disoriented for 3 days. He felt fine now. Outcome of the event was recovered on Dec2020.  Information on the lot/batch number has been requested.
This spontaneous report was received from a healthcare worker via a company representative and refers to a female patient of unknown age. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. The patient received GARDASIL intramuscularly (dose, lot # and expiration date not reported) or GARDASIL 9 intramuscularly (dose, lot # and expiration date not reported) (it was unspecified which vaccine) outside of the dosing schedule. In August 2014, the patient received the first dose. The second dose was administered to the patient in April 2015 and the third dose in May 2105. No adverse effects reported. Additional information has been requested.
Expired Bexsero administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 6th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's Comments: The reporter reported that a patient was inadvertently given a dose of Bexsero which expired on 30th September 2022.  No further details provided. The reporter consented to follow-up. Additional Supportive Information: The vaccine was already expired and was administered to the patient, which led to expired vaccine used.
Extremely sore injection site, swollen and hard to touch, difficulty using arm for normal tasks like picking up dinner plate.; Extremely sore injection site, swollen and hard to touch, difficulty using arm for normal tasks like picking up dinner plate.; Disturbed sleep; Difficulty using arm for normal tasks like picking up dinner plate; This is a spontaneous report from a contactable consumer, the patient. An 84-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 23Feb2021 at 10:15 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. Medical history included scapular humeral muscular dystrophy. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid/retinol/tocopherol (OCUVITE) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Feb2021 at 10:15 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021, at 00:00, the patient experienced extremely sore injection site, swollen and hard to touch, difficulty using arm for normal tasks like picking up dinner plate and disturbed sleep. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely sore injection site, swollen and hard to touch, difficulty using arm for normal tasks like picking up dinner plate and disturbed sleep were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Five minutes after receiving her Moderna COVID-19 vaccine patient got weak, sweaty, and felt faint.  I called the paramedics and they came and released her.  I did not have to use an epinephrine pen.  I did advise the patient to check with her PCP before the second dose and that the wait time would be 30 minutes next time if the MD approves the vaccine.
Itchiness; Swelling; Rash; Itchiness; Arm is hot to touch; A spontaneous report  was received from a consumer concerning a 81-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling, rash, itchiness/pruritis, arm is hot to touch/feeling of warmth.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 31 Jan 2021, prior to the onset of the symptoms, the patient received first of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 7 Feb 2021, after vaccination, the patient experienced swelling, rash, itchiness and arm was hot to touch. On 11 Feb 2021, the patient felt itchness.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, swelling, rash, arm was hot to touch, were considered to be resolved on 09 Feb 2021. The outcome of the event, itchiness, was considered to be unknown.
It hurt right away, burning sensation moved up, I could tell it was burning itching. When I got home, it was really uncomfortable I couldn't lift my arm. the next day I took the bandage off the whole area was red and spreading up to shoulder and all the way down my arm. I contacted my PRP he said take Tylenol. Couple days later my stomach was patchy and red and I had a low fever. My arm was still burning, felt like it was on fire. I called my dermatologist, he gave me antibiotics and steroid cream. It took a few weeks before it went away. I went in to see him before my second dose.
8/25/2009: VZV#2 given SQ to Right Arm. Patient c/o pain and soreness that night. On 8/26/2009 Patient went to school and started to feel pain to right arm, went to the school nurse in the afternoon with a erythematous rash to right arm, tender to touch and warm to touch. Came to clinic at 3:00 pm to f/u on arm with an erythematous 1" x 1 1/2", slightly raised area noted to right arm. No anbxs given at the time. Was told to f/u in two days and to take Anaglesics as needed for pain. 8/28/09 at 9:00 am, patient f/u with a 5" x 5 1/2" erythematous area to right arm, slightly tender, slightly warm to touch, but no drainage. Rx: Amoxil 500 mg: 2 PO BID X 7 days; Zyrtec one tab daily.
right now what is swollen more and more is at the base of his neck, that lump, on his low throat. Caller states its hurting; right now what is swollen more and more is at the base of his neck, that lump, on his low throat. Caller states its hurting; little lump on the base of his neck where his chest starts; arm was swollen/feels like a swollen tendon; unable to raise his arm because of the pain; pain on the injection site on the arm; dizziness; mild diarrhea; This is a spontaneous report received from contactable consumer (patient). A 38-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported), via unspecified route on left arm on 22May2021 at 11:00 as for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 22May2021, two to three hours after receiving the covid vaccine, the patient had some of the side effects marked on product information such as dizziness mild diarrhea. On 23May2021, the patient had pain on the injection site on the arm, arm was swollen/ felt like a swollen tendon and was unable to raise his arm because of the pain. It was stated it just hurts a little in the area where they put the vaccine, but not like yesterday. On 24May2021, when he woke up, the patient had little lump on the base of his neck where his chest started. It was stated right now what was swollen more and more was at the base of his neck, that lump, on his low throat and stated it was hurting, it was not going away, it just started today. It was also stated that the lump was just persisting, it just hurted when he bended down or presses it, it just hurted. Now he reported that he had a lump in his left bone that goes down from his shoulder to his throat and that felt like a swollen tendon, he also mentioned that he can't lift his arm due to discomfort, he had an appointment with his chiropractor today. The outcome of the events arm was swollen, unable to raise his arm because of the pain, little lump on the base of his neck where his chest starts, pain on the injection site, unable to raise his arm because of the pain on the arm, right now what is swollen more and more is at the base of his neck, that lump, on his low throat and it was hurting was not resolved. The outcome of the events mild diarrhea and dizziness was resolved on 22May2021.  Information on the lot/batch number has been requested.
Per chart review, received her Moderna Covid vaccination.  Shortly thereafter complained of bilateral temporal area throbbing.  BP was 181/96.  45 min thereafter, BP remained 195/95.  No history of HTN.  She was directed to the ED.  There, she received Tylenol and BP came down on its own and she was discharged home.
mesenteric lymphadenitis resulting in bowel obstruction and emergent surgery. 7/14/08-records received for DOS 9/3/07-DX: Intussusception. Presented to ED with C/O vomiting began last night.
left vaccine site at 12:30, went to dinner at a local restaurant with family, no appetite, had some french fries, went home and c/o stomach ache.  Pain in lower right side 1/2 inch above her hip bone.  constant dull pain, not piercing.  Hurt when coughing.  no appetite the next day, vomited twice overnight.  went to ER at 2100 on Sunday (the next day) and was admitted.  CBC, UA, ultrasound , diagnosed with appendicitis.  admitted and scheduled for surgery.
Influenza administered at head start school by RN on 11/12/04. On 11/13/04, client observed left deltoid swollen and red (where the injection was administered) and had rashes all over trunk. Was treated by doctor 11/29/04.
Myalgia, Fever, SkinRash, Rash, Fatigue; Rash covered entire upper arm; Rash is identical to the one she got with the first injection Narrative: Required antibiotics. Did not report which one.
High fever; This is a spontaneous report from a contactable consumer. A male patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 02Apr2021 as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 23Apr2021, after the second dose of vaccine, the patient developed a high fever which had lasted for a day. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event high fever was resolved on 24Apr2021.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Erythematous papules and some papulo-vesicular lesions-mostly on face, scalp, few on trunk with some on back-few crusted lesions on scalp.
The pt experienced a localized reaction to the right deltoid and swelling. No itching, but feels warm. No fever was noted.
Patient is experiencing a sharp pain in the arm he received the injection in when lifting or rotating his arm. He states he first noticed the pain the evening he received the vaccine and it has worsened with time. He is not in constant pain and is able to find positions that are comfortable. He will be notifying his physician as well to see what he should do moving forward.
Mild itchy rash appeared behind ears and across lower chest; it persisted for two hours until I took a one antihistamine (diphenhydramine HCl 25 mg) capsule after consulting with my primary care physician's office by phone. The rash has returned each day since, usually in mid-late afternoon, although it seems to be less intense. I have taken one antihistamine each day to alleviate symptoms after they appear. I also had pain at site of injection the following day but that has disappeared.
tired; body aches; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th February 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 28th February 2021, 1 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced tiredness and general body pain. On an unknown date, the outcome of the tiredness and general body pain were recovered/resolved.   It was unknown if the reporter considered the tiredness and general body pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the mother of the patient. The patient received his dose of Bexsero and the next day he felt tired and had body aches but they subsided quickly. The reporter consented to follow up. For tolerance after 2nd dose refer case US2021099742.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021099742:same reporter
Suspected vaccination failure/Vaccinated friend developed shingles; Shingles; Was miserable; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the feeling miserable was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-Oct-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The reporter stated good for you. The reporter have had two friends develop shingles recently one of whom was vaccinated. The vaccinate one was miserable but recovered fairly quickly. The other was in misery for weeks. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a patient who received HAVRIX for prophylaxis. On an unknown date, the patient received HAVRIX at an unknown dose. On an unknown date, unknown after receiving HAVRIX, the patient experienced nausea. On an unknown date, the outcome of the nausea was unknown. It was unknown if the reporter considered the nausea to be related to HAVRIX. Additional details were received as follows: The age at vaccination was not reported. The reporter consented to follow up. No additional information was obtained.
This spontaneous report was received from a Registered Nurse (R.N) concerning multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (rHA) (Lot # M029230; expiration date 08-JUN-2018), (Lot # M034856; expiration date 27-JUL-2018), (Lot # M042846; expiration date 21-OCT-2018), (Lot # M015931; expiration date 30-MAR-2018), (Lot # M029229; expiration date 08-JUN-2018), (Lot # M032157; expiration date 01-JUL-2018) for prophylaxis (dose and route not reported). It was also reported that the vaccine was reconstituted with properly stored diluent (Lot # unknown by reporter). The temperature was 9°C to 25°C for 210 hours and there was no previous temperature excursion. The call was made because of a data logger. adverse effects reported and there was no PQC involved. This is one of several cases from the same source.; Sender's Comments: US-009507513-1708USA003628: US-009507513-1708USA003629: US-009507513-1708USA003630: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA003634: US-009507513-1708USA003635: US-009507513-1708USA003627: US-009507513-1708USA003631:
Initial report received on 11 November 2009 from a health care professional. An 18-year-old female patient, who was 33 and a half weeks pregnant at the time, had received a dose of H1N1 (lot number UP002AA) on 28 October 2009. Later that day, the patient started having itching and rash on her arm. The rash then extended to hive type rash over the whole body. It was not reported whether the patient required medical evaluation or treatment. The patient had no concurrent illnesses, or other medical conditions at the time of vaccination. The patient also had no known allergies. Her expected date of delivery is on 28 December 2009. At the time of this report, it was unknown if the patient had recovered. Follow-up information was received from the health care professional on 14 January 2010. According to the reporter, "a confirmed dermatologist report indicated that this was not a reaction to the H1N1, but rather a dermatologic condition". The reporter noted that the patient's dermatitis was "actually a coincidence". No additional information was reported. Follow up information was received on 16 February 2010 from a health care professional. The date of the patient's last menstrual period was 01 April 2009. Route of vaccine administration was intramuscular. On 11 January 2010 the patient delivered via vaginal delivery at 40 weeks gestation. APGAR scores included eight at one minute and nine to five minutes. The baby boy was without congenital anomalies. The reporter noted an "incidental shingles outbreak" during pregnancy; date of onset and details were not provided. Documents held by sender: None.
This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. This Pharmacist reported similar events for three patients. This is second of three reports. An elderly female patient (65-75 years) received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist report that the patients complained of fever, sever lethargy, redness and soreness that lasts anywhere from 2 days to 7 days on an unspecified date. The outcome of the events was unknown. Information on lot number, batch number and expiration date has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018480203 same drug/effect different patient; US-PFIZER INC-2018480406 same drug, event/different patient.
3JUL96 tx from mom pt has 50mm x 55 of erythema area below inj site on lt deltoid area sl swollen;no apparent pain or discomfort;pt eating;had injury this AM on rt forehead  hit metal PM;mom noticed red area on arm about 1130AM 3JUL96;
No additional adverse effects reported; improperly sotred dose of PROQUAD was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided.     On 29-MAY-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S031702 with an expiration date on 06-APR-2021, for prophylaxis. Vaccine was improperly stored at a temperature of 32.7°F during a time frame of 4 hours. The call was because of a data logger and no previous temperature excursions neither additional adverse effects were reported.
some painful side effects afer getting the first dose of the GARDASIL 9 series; This spontaneous report was received from a consumer, a 27-year-old male patient, reporting on himself. No details regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were provided. On an unknown date, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, strength, route of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced some painful side effects. The outcome of the event was not provided. The causality assessment between the suspect therapy and the event was not provided.
hour after headache, muscle ache, fever, tired, running nose,  feel like i have the Flu and i am still feeling sick a week after taking Vaccine I still feel like i have the flu
terrible back, neck shoulder and head pain, Headache, and disorientation, could not concentrate, malaise, weakness, tired. Went to my family doctor who is monitoring my symptoms.