chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 26-MAY-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "2", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
Myalgia, Fever, Diarrhea, chills, sweats, loss of appetite Narrative:
Morning after 2nd vaccine I was disoriented and couldn't go out of bed, my husband caught me from falling out of the bed. I was very sick with flu like symptoms, diarrhea, headaches, body aches, no vomiting, wheezing as well.  Improvement of symptoms began after a short while and I called the doctor to talk about what happened. Post neuropathy was also there as well. It took 2 days for it to improve drastically and then it slowly continued to improve gradually.  Currently they are all gone in regards to symptoms.
shingles outbreak; This case was reported by a nurse via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced a shingles outbreak before receiving the second dose. The patient did not received the second dose. The reporter consented to follow up.
Heightened Anxiety; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Heightened Anxiety) and VACCINATION SITE PAIN (Pain at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included LORAZEPAM and HYDROCORTISONE (HUMERA) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 14-Mar-2021, the patient experienced ANXIETY (Heightened Anxiety). On 14-Mar-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, ANXIETY (Heightened Anxiety) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment details were provided.
Patient said he arm bruised immediatly after administration, site became painful later same day. Over next couple of days patient said bruising and redness got worse. Presented to pharmacy on 12/6/2014 and I referred her to urgent care. Diagnosed with cellulitis and prescribes 7 day course of Keflex.
Mild burning sensation in arm (left) and a tingling sensation throughout entire left side of body for about 12 hours. Nodule in shot arm, still evident 2 weeks, post vax.
Acute onset of painful joints. L hand L wrist on 6/7/02. Mild swelling of L knee and L arm. 75% recovered by 7/10/02.
Pt. spiked temp at home - Mom administered TYLENOL - pt. "went limp and was shaking" - proceeded to ER. Diagnosed w/Febrile seizure.
Headache, Fever, Fatigue, chills, injection site pain and swelling Narrative:
A little pink; Vaccination site swelling; Vaccination site warmth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (A little pink), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE WARMTH (Vaccination site warmth) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (A little pink), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE WARMTH (Vaccination site warmth). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (A little pink), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE WARMTH (Vaccination site warmth) had resolved.      No relevant concomitant medications reported.  Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: initial additional
Pain at injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site) in a 98-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 19-Feb-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved.        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 (mild) Pain scale 1 out of 10.  No relevant concomitant medications were reported.
Body ache; chills; nausea; A little bit of a fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), CHILLS (chills), NAUSEA (nausea), PYREXIA (A little bit of a fever) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (Body ache), CHILLS (chills), NAUSEA (nausea), PYREXIA (A little bit of a fever) and VOMITING (vomiting). At the time of the report, PAIN (Body ache), CHILLS (chills), NAUSEA (nausea), PYREXIA (A little bit of a fever) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Pain in L arm evening of vaccination - 9/29/09, redness/swelling/pain at injection site and further into left upper arm mostly on 9/30/09.  Cellulitis upon exam 10/1/09- prescribed KEFLEX 500 TID and 10 days CLARINEX 6mg QD x 10 days, and BENADRYL OTC Q6-8h until resolved. Pt to follow up in office in 4 days.
2 yo child recvd DTP/OPV/HIB 17Jan90 @ 3 pm that afternoon awoke from his nap - vomiting, fever 102.8, crying & arm was red @ inject site - would not let anyone touch it. 19Jan90 child much better - no fever, arm still sore.
This spontaneous report was received from a registered nurse, referring that doses of ZOSTAVAX were improperly stored. Additionally it was also mentioned that the vaccines experienced temperature of -4.1C, in a time frame of 13 hours, 15 minutes, there was not previous temperature excursion, and call was because of a "data logger". There was no product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Did have chills, fever, muscle aches and temp Had  no redness but very painful and swelling in the arm pit, side of left breast (felt like a tennis ball under my arm).  No numbness of pain down the arm.  Lasted for 5 days
suspected vaccination failure; gotten it, got it again; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles.   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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingles vaccine, the patients got shingles again. This case had been linked with case US2022AMR015271, reported by the same reporter.  This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR015271:Same reporter
Menstrual cycle regular, but heavier than normal bleeding and cramping  Severe cramps mid-cycle as well
a little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (a little tired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 027B21A) for COVID-19 vaccination.     Concomitant products included PRAVASTATIN, VENLAFAXINE and LEVOTHYROXINE for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced FATIGUE (a little tired). At the time of the report, FATIGUE (a little tired) outcome was unknown. Not Provided          Patient reports taking pain medicine and ibuprofen.   This case was linked to US-MODERNATX, INC.-MOD-2021-071227 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071227:
Shingles. About 1.5 weeks after shot had burning on lower left side. About 2 weeks after shot blistering rash appeared on front lower left abdomen (side still burns but no rash there). Rash area burns and stings. Random pinching and burning throughout body in evening. 3 weeks after shot, rash still burns but not quite as inflamed/raised. Centers of blisters are now darkly colored. Extremely tired. Neck feels like swollen glands.
had the first dose of Pfizer & a week later, I started losing my hair; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200468208 (Pfizer).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "had the first dose of Pfizer & a week later, I started losing my hair".  Additional information included: The reporter stated that people keep telling me that there were conditions that caused hair loss. The patient found it funny that all of the sudden the patient had a condition. The only thing that changed in patient's life was the vaccine. The patient was mandated for the second dose just 4 weeks after the 1st one, which was April 2 and was terrified.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. On unknown dates, unspecified number of patients were inadvertently vaccinated with improperly stored doses (also reported as 10 doses in total of all administered vaccines) of (Merck) VARIVAX (dose and route of administration were not reported; lot #L013068 with expiration date on 14-APR-2017). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Fever 102 degrees 2 hrs after vaccine given with fevers 100 degrees - 101 degrees for 24 hrs after vaccine given.
Dealyed (7-8 days) appearance of rash on left hand followed by rash on both arms and legs.
A report has been received from a health professional concerning a 12 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 05-JAN-2015. The patient was administered of expired product on 05-JAN-2015. FLUMIST Quadrivalent was discontinued on 06-JAN-2015. The outcome of the event of administration of expired product is unknown. The report was considered to be non-serious.
Next day post vax, the pt spiked a temperature and had an episode of lethargy, vomiting, and eyes glazing over. No loss of consciousness. Responded to Motrin. Seen in physician's office on 10/3-believed to  have had a mild febrile seizure.
PATIENT EXPERIENCED A RASH ON LEGS AND SKIN DRYNESS A FEW DAYS AFTER RECEIVING THE VACCINCE. TREATED WITH CREAM AND ORAL ALLERGY MEDICATION, PATIENT ADVISED TO PURCHASE OTC LOTION FOR DRY SKIN.
Narrative: 74yo male patient died on 12/02/2021. No info in patient chart about  pt's death. Last CPRS note 11/3/2021 re: contract adult day care. CURRENT  PROBLEM LIST: disease (SCT 49049000) Osteoporosis (SCT  64859006) Alzheimer's disease (SCT 26929004) Fracture of vertebra (SCT  50448004) Fall (SCT 1912002) Vascular dementia (SCT 429998004) Depression  (SCT 35489007) Anxiety (SCT 48694002) Mild cognitive impairment (SCT  386805003Dysphagia (SCT 40739000) Gastroesophageal reflux disease without  Hyperlipidemia (SC T 55822004) Essential hypertension (SCT 59621000)  Tobacco use (SCT 110483000) Pt had received covid vaccines on 2/15/21 &  3/22/21. This death is likely not related to the vaccinations due to patient's  comorbidities, advanced age, and length of time from vaccine administration.
02/24/2021 = dose #1 within 30 minutes of receiving first dose I had a severe , throbbing headache that lasted 6 days with no relief from Tylenol (only treatment tried), extreme weakness resulting in being in bed x 4 days and needing assistance to get out of bed to use bathroom facilitiy, unable to function with daily ADL's, vision disturbance, extreme fatigue lasting 2 weeks, balance/walking issues that still exist today, weakness to right leg/foot. On 6 different occassions after the headaches landed me back in bed for roughly 36 hours. The headache was in less severity but lasted until approximately 1 month ago (06/2022). 03/25/2021 = dose #2 = same experience as after dose #1.  11/03/2021 = booster #1 or dose #3 = same as above, but bed time was 3 days. 05/20/2022 = fourthe dose or booster #2 = same as booster #1 above.
While shopping after getting my shot, I felt fatigued & experienced severe joint & muscle pain. It got so bad that I had to call out sick the next day. As the week went on, my side effects slowly eased. There also was pain & swelling (the size of a golf ball) at the injection site which faded as the week went on. On Saturday, I absentmindedly scratched the site & it was like scratching open a mosquito bite. I've never had side effects from a shot before.
Swollen Enlarged Tongue, round boil on the side  & rippled along it edge, Bell's Palsy, numbness on right side of face
Shingles; Rash; Back Pain; Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2019, the patient received Shingrix. In September 2019, less than 2 weeks after receiving Shingrix, the patient experienced back pain and influenza-like symptoms. On 20th September 2019, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles, back pain, influenza-like symptoms and rash were unknown.   It was unknown if the reporter considered the shingles, back pain, influenza-like symptoms and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be between 87 or 88 years. The patient experienced some flu like symptoms followed by back pain all within two weeks of the shot. The patient also developed rash. The patient was diagnosed with Shingles and she was on a medication protocol currently.
Moderna on 2/25 and 4/1. Positive on 8/31 admitted on 8/30 to current
Report received from colleague at CDC, who spoke with provider. Immediately after vaccination with Menactra, site was "red and itchy". Seen day after vaccination with 11 x 12 cm swelling ("from shoulder to elbow") and redness on injected arm. No reported fever. Additional symptoms and signs included "burning", warmth at site, and headache. Symptomatic treatment with diphenydramine given. No call back or other follow up from patient as of 2 days after follow up visit; provider assumes condition has resolved. Had received most recent dose of Td 6/8/04, also in left deltoid. (lot # SP U1185AA) Provided expressed concern that this event, as well as some mild erythema and tenderness after Td last year that was not medically attended, may be related to latex content of vaccine packaging.
Pediatric Hep A Vaccine given to patient mistakenly.   Pt's father contacted by MD and informed.  Father stated patient doing ok.  No issues
Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (Headache) 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.    In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). At the time of the report, CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were provided. Treatment information was not provided. The reporter wanted to know if the patient could take Ibuprofen.
1st 4 days extreme arm pain (woke me up from sleep).  On 1/1 I noticed one enlarged lymph node on my neck.  Over the next couple days my lymph nodes are multiplying and growing in size
Allergic reaction or throat tightness; Allergic reaction or throat tightness; Swollen tongue; Increased phlegm; Loss of voice; This case was reported by a consumer and described the occurrence of allergic reaction in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th January 2020, the patient received the 2nd dose of Shingrix. On 5th January 2020, 2 hrs after receiving Shingrix, the patient experienced allergic reaction, throat tightness, swollen tongue, phlegm and loss of voice. The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the allergic reaction, throat tightness, swollen tongue, phlegm and loss of voice were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, throat tightness, swollen tongue, phlegm and loss of voice to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix vaccine at the pharmacy and about 2 hours later she had an allergic reaction or throat tightness, swollen tongue, increased phlegm and loss of voice. The patient did not go to emergency room, but was seen by her doctor on 6th January 2020 Monday or 7th January 2020 Tuesdays and was started on steroid and some other medication. It took a total of about 2.5 to 3 weeks for all the adverse events to resolve. The reporter consented to follow up.
My left arm has limited mobility from the shoulder and the injection site "stung" during the entire injection
AFTER WAKING UP FOLLOWING MORNING- LISTLESS, NO EYE CONTACT, NO EMOTION, NO BABBLING, NO LAUGHING, WOULD NOT RESPOND TO NAME, DEVELOPMENTAL REGRESSION & STARING SPELLS. CONTINUES TO HAVE STARING SPELLS (ABSENCE SEIZURES).
Information has been received from a physician, via a company representative, concerning a 12 year old female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not provided), and subsequently developed lymph node swelling under her arms.  She recovered from the event (duration not specified).  On an unspecified date, she was vaccinated with the second dose of Gardasil (lot # not provided), and again developed the lymph node swelling under her arms.  The patient recovered after an unspecified duration of time.  Additional information has been requested. 04/07/2008 Initial and follow up information has been received from a physician, concerning a 14 year old (previously reported as 12 year old) female student with no pertinent medical history, who on an unspecified date was vaccinated with the first dose of GARDASIL (lot # not provided), and subsequently developed lymph node swelling under her arms. There was no illness at the time of vaccinations. She recovered from the event (duration not specified). On 05-DEC-2007, she was vaccinated IM with the second dose of GARDASIL (lot # 659055/1522U), and again developed lymphadenopathy of the axilla. The student recovered after an unspecified duration of time. Additional information is not expected.
first dose of Shingrix in 2018, the second dose was administered on July 13th 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number MS4G9, expiry date 01-SEP-2023) for prophylaxis.   Previously administered products included Shingrix (In 2018, received first dose).   On 13-JUL-2023, the patient received the 2nd dose of Shingrix. On 13-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose of Shingrix in 2018, the second dose was administered on July 13th 2023).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 29-AUG-2023 The reporter called to ask for information about a patient who received the first dose of Shingrix in 2018, and second dose was administered in 2023. The reporter asked if the vaccination was completed or if the patient need to re-start the series. The reporter consented to follow up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.