chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an other health professional refers to a 12 month old male patient. The patient had no medical/drug history, concurrent conditions and concomitant medication. On 05-SEP-2017, the patient received a first dose of VARIVAX (lot # N008829, expiry date: 16-MAR-2019) 0.5ml injection for prophylaxis that underwent temperature excursion (incorrect product storage). Date of excursion was reported as 01-SEP-2017 and 02-SEP-2017, with total time in the range 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees Celsius (C) to -10 degrees C) of 1 hour, Total time in the range 15 degrees F to 46 degrees F (-9 degrees C to 8 degrees C) of 3 hours. Data logger was involved and these vaccine vials (20vials) had a previous temperature excursion on 30-AUG-2017, 14.35 degrees C for 30 minutes. No adverse event reported after receiving the vaccine. It was reported that the patient will receive a booster of this vaccine at the age of 4. No relevant lab tests were performed. The reporting healthcare professional also stated that vaccines M-M-R II (lot# M045101 with expiry of 10-NOV-2018 and lot# M045391 with expiry 14-NOV-2018) and PROQUAD (lot# N002325 with expiry 19-JUL-2018 and lot#N010866 with expiry 01-OCT-2018) underwent temperature excursions involving digital data logger but were not administered to patients. This is one of several reports from the same reporter.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX injection (dose, route of administration, lot # and expiration date were not reported) . On an unknown date, the patient's arm became red. On an unknown date, reported as "6 months apart", the patient received the second dose of ZOSTAVAX injection (dose, route of administration, lot# and expiry date were not reported). On an unknown date, after the second dose of vaccination, the patient reported that "her arm got more red".  The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
8 days after vaccination, noted red, raised rash that was itchy on my right upper arm.  It had hurt but no rash or redness the day or 2 after vaccination but now is definitely a rash 3 inches long by 1/2 inch wide.  Itchy.  no other symptoms noted in last 8 days.  no issue with movement.  Nothing else new or different on the R upper arm in those 8 days.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 214K22A and AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 28-Jun-2023, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 25 microgram. On 20-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    No relevant concomitant medications were reported. Patient got Dose 1 on 23 Mar 2023 with Lot number AS1903B with dose 25 mcg. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:
HEADACHE; DIZZY; MIGRAINE; MILD NAUSEA; CHILL; TIRED; SHIVERING; VERY WARM; SWEATING; COLD; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient experienced migraines and more rarely resulted in vomiting under normal circumstances. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced tired. On 12-MAR-2021, the subject experienced shivering. On 12-MAR-2021, the subject experienced very warm. On 12-MAR-2021, the subject experienced sweating. On 12-MAR-2021, the subject experienced cold. On 12-MAR-2021, the subject experienced chill. On 13-MAR-2021, the subject experienced dizzy. On 13-MAR-2021, the subject experienced migraine. On 13-MAR-2021, the subject experienced mild nausea. On 13-MAR-2021 19:00, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, shivering, very warm, sweating, cold, dizzy, migraine, chill, mild nausea, and headache. This report was non-serious.
pt recv vax 14JUN96 & 16JUL96 & lab eval revealed a lack of serconversion;
5 minutes post vax, the pt developed throat tightness, hot flushing, feeling faint, treated with epinephrine twice and also Benadryl and oral prednisone.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 18 years old adolescent patient and unknown gender. On 08-AUG-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J009788, expiration date 17-MAR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Left arm was sore; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Left arm was sore) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Left arm was sore). At the time of the report, VACCINATION SITE PAIN (Left arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-408553 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Dec-2021: Non-significant follow up appended.
no sickness though, just tired the day after; sore arm; feeling run down; lethargy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jul2021 (Lot number: EW0182) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: other medical history: high blood pressure; "Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: LISINOPRIL. Past drug history included: Ampicillin, reaction(s): "known allergy: ampicillin", notes: known allergies: ampicillin. Vaccination history included: Bnt162b2 (Other vaccine 4weeks lot number: EW0173, Other vaccine 4weeks dose number: 1, Other vaccine 4weeks vaccine location: Left arm), administration date: 14Jun2021, when the patient was 46 years old, for COVID-19 Immunization, reaction(s): "Sore arm". The following information was reported: FATIGUE (non-serious) with onset 07Jul2021, outcome "recovered" (2021), described as "no sickness though, just tired the day after"; PAIN IN EXTREMITY (non-serious) with onset 07Jul2021, outcome "recovered" (2021), described as "sore arm"; ASTHENIA (non-serious) with onset 07Jul2021, outcome "recovered" (2021), described as "feeling run down"; LETHARGY (non-serious) with onset 07Jul2021, outcome "recovered" (2021), described as "lethargy". Therapeutic measures were not taken as a result of fatigue, pain in extremity, asthenia, lethargy.  Additional information: Patient had no COVID prior vaccination. Patient was not tested COVID post vaccination. The patient was not provided information regarding the reported adverse event(s) with the use of the product.  No follow-up attempts are possible. No further information is expected.
Developed circular bumps that itched on lower back 5 hours after administration followed by hives on face that itched following day.  Patient took benadryl which releaved symptoms
Pt requested both vaccines in same arm. Pt stated that day after injection she felt discomfort, tenderness, and sometimes a lump near site. Pt claims her affected arm is limited in usage and mobility. Pt self treated with ibuprofen otc. Pt states that the only time she feels relief is when she sleeps on her right side with her left arm not bearing weight. Pt was referred to PCP. PCP gave order for mobic 7.5mg once daily. Pt claims that PCP is having requesting imaging and sonargraphy of area.
RIGHT UPPER ARM WITH MILD SWELLING, NONTENDER AND SLIGHT ERYTHEMA; LEFT ARM WITH QUARTER SIZE ERYTHEMATOUS AREA- NONTENDER
mom stated approx 3" x 1/2" tender area under rt armpit;grandma noticed today;child says was there yesterday;denies fever or any other sx;advised mom to bring to clinic for check;arm hurting;cyst removed;lymphadenitis;
broke out in Shingles; injection site was hard; arm was sore; had water filled blisters; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 333te, expiry date 15th April 2023) for prophylaxis.   On 23rd November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd November 2021, several hours after receiving Shingrix, the patient experienced injection site induration and pain in arm. On 27th November 2021, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles, injection site induration, pain in arm and blister were recovered/resolved.   It was unknown if the reporter considered the shingles, injection site induration, pain in arm and blister to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient got her first Shingrix vaccine and few hours after the vaccine, her arm was sore and the injection site was hard and this lasted for a few days.   The patient also broke out in Shingles about 2 inches below the site of her injection.   The patient had water filled blisters on that covered about a 3.5 inch radius.   These blisters lasted about a week and she did not had any symptoms since then.   The patient spoke per content and referred to health care professional(HCP) for direction about getting her second vaccine. The patient was very satisfied with her conversation with the representative on the day of reporting. This was a follow up to a shingles outbreak that patient had when she got the first shingles vaccine.  The patient felt that representative was not sympathetic at all, when she called first time to report the shingles outbreak and thus she was very upset.  And the reason she called back was because it was at the suggestion of my physician.  So this representative was much more sympathetic and had a lot of information, the other representative, when she called, which was some time after 23rd November 2021, basically told her to  just call physician and patient asked if they need any information about who she was and they replied no. The reporter did not consent to follow-up.
I had my second shot yesterday afternoon and after 2am the following morning, I had a pretty severe reaction.  Chills, sweat, body aches, vomiting, but what was most concerning was I could feel intense pain in all my joints and lymph nodes. Wondering if the severity was due to my auto-immune disorder. I feel a bit better this morning but I have a wandering internal pain that seems to flare for a few seconds in different body parts: ear, foot, hip.
Elderly Emergency department to inpatient for general weakness w/abrupt onset and recent C19 exposure Tested positive for COVID upon admission on 7/9/22
Symptom onset: 04/12/21  Symptoms include:  o body aches, fatigue, nasal congestion and sore throat Tsted + for COVID-19 on 4/19/2021
After the first shot I experienced racing heart, brain zaps, vertigo, dizziness, nausea, hyperventilation. I assumed it was a panic attack so I got the second shot. I had the same reaction after the second, but worse. Vertigo increased and so did all the other symptoms. After my second vaccine, I started having panic attacks out of no where every day.  One attack continued for three hours and I had to go to the ER two days after my shot to get something to stop it.  My doctor told me that this reaction was from the vaccine, and it caused inflammation in my body which triggered severe anxiety.  She gave me a shot of decagon to diminish the inflammation. From then on, I started having panic attacks twice a day. I was completely debilitated for two weeks and couldn?t do much because of the vertigo.  There were moments throughout the day where I would go out of body a detach from reality. These symptoms faded in intensity but were still around for another month.  A month later, I started having pain in my chest. My doctor later diagnosed this specific pain as pleurisy. Over two months later, I?m still recovering but I still have problems with disconnecting and dizziness .
Felt like I was going to pass out and threw up.  My neck hurts and had a low grade fever. Nauseous and have a headache. There is a rash where the injection was given. The rash is itchy, swollen, and hot.
This spontaneous report was received from a physician via company representative, refers to a adolescent, female patient of unknown age. The patient's medical history and concurrent conditions were not reported. The physician reported that on an unknown date the patient received the first two doses of GARDASIL (dosage, route, lot# and expiration date were not reported) and was not specified if the doses were given together or not. Then on 18-DEC-2015 the patient received the third dose of the vaccine but was given GARDASIL 9 subcutaneous, (dosage, lot# and expiration date were not reported). There was not concomitant therapy. On an unspecified date in December 2015, the patient experienced injection site erythema, nausea, pyrexia, injection site pain and injection site swelling. The outcome of the injection site erythema, nausea, pyrexia, injection site pain and injection site swelling was reported as not recovered at the time of this report. Additional information has been requested.
slight tingling on the tongue; This is a spontaneous report from a contactable Consumer or other non-health professional (patient).  A 28-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot number: EN6206) via an unspecified route of administration in deltoid left on 09Mar2021 14:00 (at the age at vaccination of 28-year-old) as dose 1, single for CVOID-19 immunization. Patient's relevant medical history included ongoing Asthma which was recently diagnosed, and concomitant medications included ongoing Montelukast sodium (MONTELUKAST SODIUM) taken for asthma from an unspecified start date and ongoing Tiotropium bromide (TIOTROPIUM BROMIDE) taken for asthma symptoms from an unspecified start date. Patient had historical vaccine of booster shot of for the flu in Nov2020. He was mostly taking supplements and allergy medications. Family Medical History Reported as Maternal Grandfather had heart problems. History of all previous immunizations with the Pfizer vaccine considered as suspect were reported as None and no additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations taken within 4 weeks and no AE were reported following prior vaccinations. On 09Mar2021, patient experienced a slight tingling on the tongue that he had right after his Covid vaccination that subsided after 5 minutes or so. He has been exposed directly, more than likely and got a test kit on 24Mar2021 (reported as today) and he do not know whether or not he was positive for another few days for the virus and he said he got his first dose of the vaccine just over two weeks ago. Also, he went to the doctor recently and found out he was Asthmatic and he was referred to a pulmonologist in April. And his histamine levels were pretty high, that was out of blood work he had a month or so ago, it has been a consistent issue for the last year to him and his doctor have been trying their best to get this level down. Adverse event did not require visit to emergency room and physician office. Patient said he got his first dose of the vaccine just over two weeks ago. Also stated if his test comes back positive does he have to start the vaccination process over again and what are his options. The patient underwent lab tests and procedures which included on an unspecified date in 2021, histamine level was pretty high and on 24Mar2021, COVID test and results was unknown. Outcome of the event was recovered on 09Mar2021.  No follow-up attempts are possible. No further information is expected.
My arm was very sore; I have a lump in my arm; I am itchy/it is very itchy; The upper arm is swollen; Covid arm; I couldn't lift it (the arm); It hurts to touch it; hives; redness; hypersensitivity reaction; Pain injection site; red spot where it was injected; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm was very sore), SKIN MASS (I have a lump in my arm), PRURITUS (I am itchy/it is very itchy), PERIPHERAL SWELLING (The upper arm is swollen) and VACCINATION SITE REACTION (Covid arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu Vaccine (FLU vaccine). Past adverse reactions to the above products included Flu like symptoms with Flu Vaccine. Concurrent medical conditions included Blood pressure high and Cholesterol. Concomitant products included ACETYLSALICYLIC ACID (ASPRIN) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced URTICARIA (hives), ERYTHEMA (redness), HYPERSENSITIVITY (hypersensitivity reaction), INJECTION SITE PAIN (Pain injection site) and VACCINATION SITE ERYTHEMA (red spot where it was injected). On an unknown date, the patient experienced PAIN IN EXTREMITY (My arm was very sore), SKIN MASS (I have a lump in my arm), PRURITUS (I am itchy/it is very itchy), PERIPHERAL SWELLING (The upper arm is swollen), VACCINATION SITE REACTION (Covid arm), HYPOKINESIA (I couldn't lift it (the arm)) and PAIN (It hurts to touch it). In August 2021, INJECTION SITE PAIN (Pain injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (My arm was very sore), PRURITUS (I am itchy/it is very itchy), PERIPHERAL SWELLING (The upper arm is swollen), PAIN (It hurts to touch it), URTICARIA (hives) and ERYTHEMA (redness) had resolved, SKIN MASS (I have a lump in my arm), VACCINATION SITE REACTION (Covid arm), HYPOKINESIA (I couldn't lift it (the arm)) and HYPERSENSITIVITY (hypersensitivity reaction) outcome was unknown and VACCINATION SITE ERYTHEMA (red spot where it was injected) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs are cholesterol medication and high blood pressure medication .  Treatment information was not provided by the reporter. The adverse event for Flu vaccine includes Flu like symptoms. The event pain at injection site , swelling and itching recovered after 2 and half weeks from the date of start of event 27-Jul-2021.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up information includes-Added patient height and weight, Prior vaccine added, Added e concomitant drug, Added event and Updated events outcome from unknown to recovered for Pain in injection site, swelling and itching event.
Soreness at injection site for 24 hours; This is a spontaneous report from a non-contactable physician (patient).  A 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in Right arm on 23Dec2020 at 15:30 at single dose for COVID-19 immunisation.  Medical history was none. No known allergies to medications, food, or other products. The patient's concomitant medications were not reported.  The patient experienced soreness at injection site for 24 hours (non-serious) on 24Dec2020. No treatment given and patient recovered from the event on an unknown date in Dec2020. No follow up attempts are possible; information about lot/batch number cannot be obtained.