chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID booster dose; Chills; Aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID booster dose"; CHILLS (non-serious), outcome "unknown", described as "Chills"; PAIN (non-serious), outcome "unknown", described as "Aches". It was unknown if therapeutic measures were taken as a result of chills, pain.  Additional information: It was unknown that patient had covid prior vaccination. It was unknown covid tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a female patient reporting in herself. The patient's age was not provided. The patient's pertinent medical history, concurrent conditions, drug reactions and allergies were not reported. The patient received GARDASIL in three doses. On unspecified date, in March 2014, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, anatomical location, lot# and exp. date were not reported). The second dose was administered on an unspecified date, in July 2014, (dose, route of administration, anatomical location, lot# and exp. date were not reported). The patient received the last dose of GARDASIL on an unspecified date in September 2014, (dose, route of administration, anatomical location, lot# and exp. date were not reported). No additional information was provided. Additional information is not expected because no contact information is available.
Swelling in left arm, intermittent sharp pains from left shoulder down to left side, pain when breathing in.
This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date (reported as "Feb27th") at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced have a major allergic reaction to the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) shot given to her on Feb27th. The patient was very upset and wanted additional information so she can reach out to Pfizer. The outcome of the event was unknown. Information on the batch/lot number has been requested.
Large (4? diameter) red, hot, hard rash. Mildly tender to touch.. Very itchy. Hydrocortisone cream applied. Itching less intense after 4 days and rash almost resolved.
PT reported redness, swelling at vaccine site 10 x 10cm the afternoon after the injection. Swelling and redness continued to increase over time. Pt came to health center on 10/17 and treated with Loratadine and ibuprofen. Pt has been icing regularly. Rechecked today, decreased pain, redness, swelling.
Hives immediately after getting HIB/PREVNAR and Hep B - lasted a few days; Also h/o shuttering episodes vs.. seizures - increased after getting vaccines (was once every other day, now multiple times a day).
Information has been received from a physician concerning a young female with an egg allergy who was vaccinated SC with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Subsequently the pt developed a rash all over her body. Unspecified medical attention was sought. Additional information has been requested.
Mom changed diaper on 1/2/00 AM at 9:00 and noticed some testicular swelling. Child had 100.2 fever. Child was taken to ER and admitted. He is on IV antibiotics.
Patient was given dose of influenza vaccine with a 5/8" 25G needle, which would not be appropriate for adult IM dosing. Patient was notified and offered a new vaccine.
Case number PHEH2014US002137 is a combined initial and spontaneous report received from a consumer on 27 Jan 2014. This report refers to a male patient of unknown age. His medical history included a heart attack and had a heart condition. His concomitant medication was not reported. He was vaccinated with FLUCELVAX (batch number: 010021A, expiry date: Jun 2014) on 30 Dec 2013. On the same day shortly after vaccination, he experienced a stroke. Patient's wife reported that he was doing good and feeling ok (complete recovery) on an unspecified date. The seriousness and causality of the event were not reported.
Vaccinated: 17:30; Reaction: 17:47; Pt reported that she felt dizzy. Vitals: 161/100, 98, 18, 100% -- > 144/87, 87, 20, 100%. Pt stable and released from the vaccination site.
Patient received vaccine at 3:15 At 3:20 patient reports she developed palpitations and dizziness  Patient was taken to treatment room, vital signs obtained and WNL. Patient assessed by provider and additional monitoring of 45 minutes was done without further incident.
Headache, extreme lethargy, full body hives, eyes swollen . Symptoms lasted for about 48 hours.
administration of Adacel that has expired on 29Jul2023 with no reported adverse event; Initial information was received on 10-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 82 years old female patient who received diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] that has expired on 29jul2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Aug-2023, the patient received a dose of 0.5 ml of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (Suspension for injection) (strength was unknown) (frequency : once, lot C5921AA, Expiry date : 29-Jul-2023) via intramuscular route in the right deltoid for Immunization and administration of adacel that has expired on 29-jul-2023 with no reported adverse event (expired product administered) (latency : same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administration of adacel that has expired on 29jul2023 with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
lying on the bed she was cold; thought she was not going to be able to wake up from bed,; felt miserable; the hip muscle hurts; back hurts; made her woke up on the middle of the night 2 times; whole body hurts/muscle pain; had Chills; sore left arm,; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (lying on the bed she was cold), GAIT INABILITY (thought she was not going to be able to wake up from bed,), FEELING ABNORMAL (felt miserable), ARTHRALGIA (the hip muscle hurts) and BACK PAIN (back hurts) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore left arm,). On 21-Apr-2021, the patient experienced NASOPHARYNGITIS (lying on the bed she was cold), GAIT INABILITY (thought she was not going to be able to wake up from bed,), FEELING ABNORMAL (felt miserable), ARTHRALGIA (the hip muscle hurts), BACK PAIN (back hurts), INSOMNIA (made her woke up on the middle of the night 2 times), MYALGIA (whole body hurts/muscle pain) and CHILLS (had Chills). At the time of the report, NASOPHARYNGITIS (lying on the bed she was cold), GAIT INABILITY (thought she was not going to be able to wake up from bed,), FEELING ABNORMAL (felt miserable), ARTHRALGIA (the hip muscle hurts), BACK PAIN (back hurts), INSOMNIA (made her woke up on the middle of the night 2 times), PAIN IN EXTREMITY (sore left arm,), MYALGIA (whole body hurts/muscle pain) and CHILLS (had Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includes ¨Tylenol every 4 hours¨. Caller has taken 3 Tylenols ( does not know the dosage of each pill , since 2AM of 21Apr2021). Concomitant medications were not provided.   This case was linked to MOD-2021-083220.
Hospitalized 7/24/22-7/27/22 rectal bleed, dyspnea, fatigue, cough, dizziness, anemia,
LACK OF APPETITE; HEADACHE; SYSTEMIC PAIN AT THE INJECTION  SITE; TINGLING IN LEFT ARM DOWN TO  FINGER TIPS; ACHING BONES/ACHE; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 127 pounds, and height was 164 centimeters. The patient's concurrent conditions included hypertension, non-alcoholic, and non-smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A2221A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced tingling in left arm down to finger tips. On 06-APR-2021, the subject experienced aching bones/ache. On 06-APR-2021, the subject experienced systemic pain at the injection site. On 07-APR-2021, the subject experienced lack of appetite. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching bones/ache on 07-APR-2021, and lack of appetite, and headache on 08-APR-2021, and had not recovered from tingling in left arm down to finger tips, and systemic pain at the injection site. This report was non-serious. This case is associated with PQC number: 90000175947, 90000175948. The suspected product quality complaint has been confirmed to be voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0 Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
headache, body aches, chills, sweats, swollen lymph node in left neck
37 Years  old Male  with history of foot disorder and autism presenting emergency department complaining of upper respiratory infection symptoms x 1 days.  Patient states yesterday he got his covoid booster received the Moderna vaccine although all of his previous vaccines and the Pfizer he is unsure if this is related to current symptoms.  Symptoms viewed as moderate. Better with nothing, worse with nothing.  No history of other contacts with same symptoms.  Positive cough without phlegm. No travel overseas.
No adverse event; Patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced UNDERDOSE (Patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster) 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 UNDERDOSE (Patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster).    No concomitant medications were reported. 20 patients received 0.25mL instead of 0.5mL of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022. No treatment information was provided.  This case contains information for the 6th of twenty adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662860 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662871:Patient  US-MODERNATX, INC.-MOD-2022-662860:Patient
3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint pain, chills, shot area is swollen, nausea, lymph nodes swollen and sensitive to touch.  Face is tender. SOB with movement and dizziness. Patient is a cancer survivor and she said that it feels like she had a chemo treatment.
Entire body covered in red, raised, itchy hives.  I was mildly itchy immediately following injection, but did not break out  until the  next day,   Approx 30 hours after shot.   It was miserable.   Attempted to do home remedies for 48 hours but could not handle it.  Went to urgent care early Sunday morning and received a steroid shot in my butt and a methyl prednisone package to take for 6 days.   Hives subsided after 4 days of medication
Narrative:  Pt. called in to PRC, reports he had second shingrix vax on 8/27 and  he has some redness, "blotchiness", and still tenderness at the injection site.  Denies any difficulty breathing, denies any blister/fluid filled rash. Denies any  fevers/chills. Denies any warmth really at site. No future workup on the patient  suggests that the reaction abated.
within 2 hours, injection site was red, swollen and warm to touch, and hot. In 5 hours I was so fatigued I could barely walk. I went to bed. In the morning, my arm was still sore, but otherwise I felt better.
headache, fever(48 hours), stomach pain with constant burping, body aches, fatigue (still continues a week+  from onset)
Patient was walking to observation room when she began to feel dizziness, vision changes and tinnitis resulting in syncope 1-2 minutes.   Patient was on floor in sitting position supported by staff member. Diaphoretic. Pale. Unresponsive <1 minute. No head or face injury noted. No bleeding, swelling or ecchymosis noted. Full ROM to neck, LE and UE. Denies pain, CP, SOB, HA, palpitation or vision changes. BP 94/53 HR 99  O2 99%  Patient was assisted to chair. A&O x 4. Reports that she was fasting x 1 month, reports eating small amount of granola bar and small amount of water.   Patient was observed for 30 minutes. d/c home in stable condition w/ dad. ED warning s/s discussed. Patient and father repeated instructions w/ good understanding.
Noted nickel size induration nodule, redness, edema, painful to touch, painful ROM, body aches, chills/flushed and H/A
bump below injection site; swelling below injection site; injection arm soreness; injection arm redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection arm soreness), INJECTION SITE ERYTHEMA (injection arm redness), INJECTION SITE SWELLING (swelling below injection site) and INJECTION SITE NODULE (bump below injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced INJECTION SITE PAIN (injection arm soreness) and INJECTION SITE ERYTHEMA (injection arm redness). On 02-Apr-2021, the patient experienced INJECTION SITE SWELLING (swelling below injection site) and INJECTION SITE NODULE (bump below injection site). On 27-Mar-2021, INJECTION SITE PAIN (injection arm soreness) and INJECTION SITE ERYTHEMA (injection arm redness) had resolved. At the time of the report, INJECTION SITE SWELLING (swelling below injection site) and INJECTION SITE NODULE (bump below injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Symptoms included: redness, swollen, and hot to touch above and below vaccination site, headache, coughing, and minimal wheezing. BENADRYL was given upon coughing and wheezing which subsided symptoms. The coughing and wheezing occurred on 12/5/17. The redness, swollen, and hot arm symptoms have occurred almost evert time Anthrax has been administered. This was the first time I have had issues with the feeling that my throat was closing.
3 to 4hr episode jerky movements during sleep &  wake period;pt seen in ER;
Allergic reaction; This is a spontaneous report from a contactable consumer reporting for the daughter.   A 15-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 03Sep2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced allergic reaction  (medically significant) on Sep2021 with outcome of unknown.  Therapeutic measures were taken as a result of the reported event including Benadryl.  Information about Lot number has been requested.
Bell's Palsy House-Brackmann class V 2 days after 1st dose
Beginning 4 hours after Fluzone and Hepititis A vaccines began to vomit and continued for the next 4 hours. Approximately 12 hours later started to vomit again and continued for another 3 hours. No fever, no rash. Home symptomatic treatment given at first and then Phenergan 12.5mg q 4-6 hours prn. No further complaints of vomiting.
Hypersensitivity reaction; red and swollen face; red and swollen eyes; dry face; could not see properly; swollen face; red and swollen eyes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), ERYTHEMA (red and swollen face), EYE SWELLING (red and swollen eyes), DRY SKIN (dry face) and VISUAL IMPAIRMENT (could not see properly) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O23621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gastrointestinal disorder (GI problems: on restricted diet) and Egg allergy (Throat swelled up,Could not swallow.) since 01-Dec-1956. Concomitant products included ALBUTEROL [SALBUTAMOL] from 02-Nov-1960 to an unknown date for Breathing difficult.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction), ERYTHEMA (red and swollen face), EYE SWELLING (red and swollen eyes), DRY SKIN (dry face), VISUAL IMPAIRMENT (could not see properly), SWELLING FACE (swollen face) and OCULAR HYPERAEMIA (red and swollen eyes). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 06-Jun-2021, HYPERSENSITIVITY (Hypersensitivity reaction), ERYTHEMA (red and swollen face), EYE SWELLING (red and swollen eyes), DRY SKIN (dry face), VISUAL IMPAIRMENT (could not see properly), SWELLING FACE (swollen face) and OCULAR HYPERAEMIA (red and swollen eyes) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 130/80 mmHg (abnormal) 130/80.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received contains information about patient allergies and concomitant medications and updated outcome of events, additional event was updated
Debilitating fatigue and muscular pain could not move my arm at all along with numbness and tingling going throughout my right shoulder blade I also had severe swelling of my lymph node under my right armpit which was an agonizing pain that was unrelenting.
Blurry Vision; This serious case was reported by a consumer via call center representative and described the occurrence of blurred vision in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rheumatoid arthritis (history of rheumatoid arthritis with sardosis).   On 29-AUG-2023, the patient received the 2nd dose of Shingrix (left arm). On 07-SEP-2023, 9 days after receiving Shingrix, the patient experienced blurred vision (Verbatim: Blurry Vision) (serious criteria hospitalization).  The outcome of the blurred vision was not resolved.   It was unknown if the reporter considered the blurred vision to be related to Shingrix.     It was unknown if the company considered the blurred vision to be related to Shingrix.   Additional Information: GSK receipt date: 4-Oct-2023 The caller states she had a dose of Shingrix and had blurry vision and was admitted to hospital overnight to run tests.  Referred to health care professional, medical information, phone number were provided. The reporter consented to follow up.
sore left injection site arm; tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (tired). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-455192, MOD-2022-455193 (Patient Link).