chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pass out; was drenched in sweat; she slept throughout the day and the next day she was okay.; chills; shaking; Headache; dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 80 year-old female patient received bnt162b2 (COVID-19 MANUFACTURER UNKNOWN), administered in arm left, administration date 22Feb2021 (Lot number: EN6202) at the age of 80 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOXYL taken for hypothyroidism (ongoing). No additional vaccines administered on same date of the Pfizer suspect. Vaccination history included: Bnt162b2 (First Dose , Date:  01Feb2021 , Lot- EL1283, Administered in left arm , AE(s) following prior vaccinations: None), administration date: 01Feb2021, when the patient was 80 years old, for COVID-19 immunisation, reaction(s): "None". The night she got the vaccine (22Feb2021), she had chills and shakes for over an hour that she could not stop. In the morning she got up, went to the bathroom and passed out. Her husband came in there and she was sweating, drenched in sweat. Her husband was finally able to get her up out the bathroom and put her to bed and she slept. The sweats went away by mid afternoon. However, she slept all day. By the next day she was okay. She commented she is in excellent health. Everything is perfect. She recently went to the doctor to have an annual physical. Her doctor gave her a little test first, this was in Dec2021. The blood test was to test to see how much antibodies she had in her system and she had antibodies. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 23Feb2021, outcome "recovered" (24Feb2021), described as "pass out"; CHILLS (non-serious) with onset 22Feb2021, outcome "recovered" (23Feb2021), described as "chills"; TREMOR (non-serious) with onset 22Feb2021, outcome "recovered" (23Feb2021), described as "shaking"; HYPERHIDROSIS (non-serious) with onset 23Feb2021, outcome "recovering", described as "was drenched in sweat"; HEADACHE (non-serious) with onset Feb2021, outcome "recovering", described as "Headache"; DIZZINESS (non-serious) with onset Feb2021, outcome "recovering", described as "dizzy"; SOMNOLENCE (non-serious) with onset 23Feb2021, outcome "recovered" (24Feb2021), described as "she slept throughout the day and the next day she was okay.". No Emergency Room. No Physician Office; Only went to doctor due to annual physical. The patient underwent the following laboratory tests and procedures: antibody test: (Dec2021) had antibodies.
Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. On 09-JUN-2016 the patient was vaccinated with an expired dose of VARIVAX (lot # K007974 with expiration date of 03-JUN-2016, subcutaneous; dosage and frequency unspecified). No known adverse event. The outcome of expired product administered and no adverse effects was reported. Additional information has been reported.
I was the fittest and healthiest I probably ever have been. Ran 3+ miles the day before. And as of today can barely walk without chest pain let alone run comfortably. Can not complete regular exercise routine
DIZZINESS; BLURRY VISION; FEVER; FATIGUE; TINGLY ALL OVER HER BODY; CHILLS; NAUSEA; This spontaneous report received from a consumer concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included heartburn, and allergic to codeine, and other pre-existing medical conditions included the patient was on unspecified acid-reflux medication and was not pregnant at the time of report. The patient experienced drug allergy when treated with pantoprazole, and oseltamivir phosphate for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAY-2021, the subject experienced tingly all over her body. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced nausea. On 20-MAY-2021, the subject experienced fever. On 20-MAY-2021, the subject experienced fatigue. On 21-MAY-2021, the subject experienced dizziness. On 21-MAY-2021, the subject experienced blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingly all over her body, chills, and nausea on 20-MAY-2021, and fever, and fatigue on 21-MAY-2021, and had not recovered from dizziness, and blurry vision. This report was non-serious.
On internal audit, we discovered that a patient received a vaccination that was not expired but was held at refrigeration temperature for 36  days.  Appropriate steps were taken to notify the Regulatory Authority and are coordinating efforts to notify patients to repeat vaccination.
Lost taste; Lost smell; Back aches/Achy; 99.8 fever; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost taste), ANOSMIA (Lost smell), PAIN (Back aches/Achy), PYREXIA (99.8 fever) and ARTHRALGIA (Joint pain) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history is provided and concomitant are provided.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced AGEUSIA (Lost taste), ANOSMIA (Lost smell), PAIN (Back aches/Achy), PYREXIA (99.8 fever) and ARTHRALGIA (Joint pain). On 09-Feb-2021, AGEUSIA (Lost taste), ANOSMIA (Lost smell), PAIN (Back aches/Achy), PYREXIA (99.8 fever) and ARTHRALGIA (Joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 99.8 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs included diabetes medicines and blood pressure medicine. No treatment medication information was provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEXAPRO. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective and included treatment with paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
0945: dizzy, lightheaded, shaky, tingling in fingers HR 109, BP 122/84, RR 12, O2 sats 99%, T 98.0 without resp. difficulty without rash. Lungs CTA (B). Symptoms did not resolve. 1008: called for ambulance to transport to ED for eval. ED assessment: migraine.
For unknown reason (not documented in chart) patient received the first Moderna COVID-19 Vaccine dose on 07/01/21, the  second dose of Moderna COVID-19 Vaccine on 07/29/21 and the third/booster dose on 12/09/2022 which is earlier than the required 5 months and outside of the 4-day grace period. There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
The patient received the second dose of SHINGRIX on August 18, 2023 (AE - Inappropriate schedule of vaccine).; pins and needle sensation in the right leg.; the patient has been experiencing itching in the right leg; Muscle soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of pins and needles in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included clot blood (left foot) and intervertebral disc protrusion. Previously administered products included Zyrtec. Concurrent medical conditions included shellfish allergy. Additional patient notes included Undefined procedure to improve blood flow. Concomitant products included COVID-19 VACCINE (COVID 19 BOOSTER), VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX), hydrocodone and neosporin (nos) (Neosporin).   On 18-AUG-2023, the patient received the 2nd dose of Shingrix (right arm). In AUG-2023, an unknown time after receiving Shingrix, the patient experienced pins and needles (Verbatim: pins and needle sensation in the right leg.), itchy legs (Verbatim: the patient has been experiencing itching in the right leg) and muscle soreness (Verbatim: Muscle soreness). On 18-AUG-2023, the patient experienced drug dose administration interval too short (Verbatim: The patient received the second dose of SHINGRIX on August 18, 2023 (AE - Inappropriate schedule of vaccine).).  The patient was treated with gabapentin. The outcome of the pins and needles, itchy legs and muscle soreness were not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the pins and needles, itchy legs and muscle soreness to be related to Shingrix.     It was unknown if the company considered the pins and needles, itchy legs and muscle soreness to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2023 The reporter was the patient.  The patient has been using Neosporin, Hydrocortisone, Gold Bond Powder, washing with Ivory Soap (3-4 times daily). The patient received the first dose of Shingrix on June 23, 2023.  The patient also received another shot at the same time, which the patient believes to be a COVID booster.  The patient received the second dose of Shingrix on 18th August 2023, which led to shortening of vaccinations schedule. The patient states the Shingrix vaccine was administered in the right shoulder on both dates.  It is unclear which site the COVID vaccine was administered.   Since receiving the second dose of Shingrix, the patient had been experiencing itching, muscle soreness, and a pins and needle sensation in the right leg.  The patient was prescribed gabapentin for the symptoms.   The patient gave consent to follow up with HCP (pharmacy).
Administered Moderna vaccine to patient and wife. Patient sat for approximately 8 minutes after receiving vaccine and the wife alerted pharmacy that her husband was having an issue. I ran out to check on the patient. The patient sliding out of chair with head hanging back. I asked the patient questions to assess and did a pulse check. He was hot to touch and unresponsive; however his eyes were open and his limbs were stiff. It looked as though he may have had a seizure, but he denied having seizures in the past. My technician dialed 911 and I ran to get an epi pen in case he was having an anaphylactic reaction. When I came back out he was becoming more alert. We got both of them bottled water and assessed the patient to make a sure he was feeling ok before leaving. He admitted he suffers from anxiety at times and faints. He said after getting the vaccine he began to read the vaccine informational, became anxious, and blacked out. The ambulance was cancelled after the patient became alert.
1st vaccine: Patient reports hives 4-6 hrs later, took Benadryl, itching stopped within 24 hrs, spots remained (upper calf to her knee)  2nd vaccine: talked with her doctor who agreed it was a good idea to preload with Benadryl, she stated that she took several doses for 24 hours after vaccine and thought she was still in the clear. Wed 2/17 hives started at work, itching arms and legs, noticed hives/spots left elbow, several both hips, a few more on legs near previous spots from 1st dose, both fingers swollen and red with some bumps, felt "unwell" and achy "grumpy" for 24-48 hours- took Benadryl,  could not take Benadryl 2/19/21 because she had to work, itching is better 2/19 and she feels okay, spots remain.
Initial information received on 06-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves elderly female patient who experienced flu-like symptom, feeling weak and gi issues, while she received vaccine FLUZONE HIGH DOSE and while treated with BOSUTINIB [BOSULIF]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included LEVOFLOXACIN (LEVOFLOXACIN); and BENZONATATE (BENZONATATE). On an unknown date, the patient started taking  in the OSULIF (BOSUTINIB) 100 mg (with an unknown batch number) for Product used for unknown indication. On 24-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported. The patient developed a non-serious flu-like symptom (influenza like illness) following the first dose intake and following the last dose intake of BOSUTINIB. The patient developed a non-serious feeling weak (asthenia) following the first dose intake and following the last dose intake of BOSUTINIB. The patient developed a non-serious gi issues (gastrointestinal tract irritation) following the first dose intake and following the last dose intake of BOSUTINIB.The patient developed a non-serious flu-like symptom (influenza like illness) 3 months 14 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient developed a non-serious feeling weak (asthenia) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient developed a non-serious gi issues (gastrointestinal tract irritation) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Final diagnosis was flu-like symptom, gi issues and feeling weak. BOSUTINIB (BOSULIF) was <<action taken blank>>. The patient was treated with AZITHROMYCIN (ZITHROMAX Z-PAK). The patient outcome is reported as Unknown for flu-like symptom, as Unknown for feeling weak and as Unknown for gi issues.
This spontaneous report as received from a physician (the patient's mother) 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 M-M-R II subcutaneous injection (dose, lot # and expiration date were not reported), with an oragne color instead of yellow. The patient was vaccinated by an anonymous healthcare worker at an unspecified consumer value store pharmacy. No adverse effect was reported. A product quality complaint (PQC) had been filled. Additional information is not expected because there was no consent to contact physician.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date; No adverse event; Patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date).    No concomitant medications were reported.  The patient received half dose of Moderna vaccine.  The vial had not undergone any temperature excursions.  The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected.  No treatment medications were reported.
Woke up with lower back pain and that occurred almost every day for two weeks. At first I took Ibuprofen. When I couldn't take it anymore, I called my doctor and I asked for an x-ray.  I had physical therapy. Was referred to Spinal specialist  - did some alignment- have had a bone x-ray and an actual scoliosis x-ray - will find out results on July 15th. I have never felt the lower back pain before - the every day pain on the lower back. On the tailbone area. Right now, I'm doing exercises and Dr. will do some more alignment on my back.
Urticaria, itcy over whole body for 3 days, treated with diphenhydramine and herbal medicine.
severe pain with no ability to contract muscles in mu arm/shoulder.  Arm was basically paralyzed
FELT THAT THE VACCINE WAS "ALMOST DEADLY" BECAUSE SHE HAD EXTREME WEAKNESS AND FATIGUE AFTER PCV13, SHE COULD NOT MOVE OUT OF BED AFTER THE VACCINE, HAD AN EPISODE OF MILD URINARY INCONTINENCE IN THE BED.
On 5/15/21 pt was in a drive through vax site.  He says immediately after he got the vax he was trying to drive away from the vax site but he has to pull over since he was passing out.  He came to so put his car in park and then passed out again.  He said he was nauseated, dizzy, and lightheaded. He kept going in and out. He blew the horn and got someone's attention.  EMTs loaded him into an ambulance then he started vomiting.  They took him to the  Medical Center.  They did multiple tests.  He was admitted for further testing which had normal results. Pt was discharged after about 28 hours.  Pt says he could stand up about 4 hrs after inj but the symptoms lasted about 18 hours total.
RECEIVED 2.5 ML OF VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) dose was not reported, administered on 20-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-NOV-2021, the patient experienced received 2.5 ml of vaccine. On 20-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5 ml of vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219871, 20211220129, 20211220916, 20211220152, 20211219681, 20211219953, 20211220145, 20211220155, 20211165041, 20211200723, 20211200752, 20211200769, 20211201046, 20211201228, 20211201963, 20211202199, 20211202193, 20211202161, 20211201963, 20211201450, 20211201443, 20211201392, 20211201351, 20211201304, 20211201286, 20211201179, 20211220697 and 20211220928.
Slight shortness of breath lasting 15-20 minutes  occurring 2 hrs. after injection  Joint stiffness/soreness early next morning in limbs,  with need to stretch, resulting in muscle soreness, lasted 2 hrs . Subsided after sleeping 1-2 hrs.  (Possibly attributable to MEcfs symptoms, similar symptoms in past)  Injection site stiffness/soreness during movement, early next morning, lasting 1-2 hrs  (same time frame as above).  Experienced no side effects with initial injection other than very slight tenderness to touch night of injection
General muscle pain, neck & hand joint pain, ST, occ. fever, severe headache & occ. dry cough.
initial presentation of LGF, myalgia, headache then with localized swelling, erythema and heat
Excruciating pain in left shoulder and arm and numbness in hand. Restricted range of motion. 6 weeks of physical therapy. Pain is greatly diminished but motion is still restricted.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Moderna vaccine on 1/26/21, 3/01/2021 and 12/22/2021. Presented to ED 10/04/22 after several days of increasing lethargy, and weakness and eventually became encephalopathic. In route, she was identified as having both bradycardia and hypoglycemia. In ED, dx'd w/multi-system organ failure 2/2 septic shock due to Covid-19. Went into PEA arrest, ROSC after 2 rounds. Overnight she was completely aneuric. Transitioned to comfort care and expired on 10/04/22. Tx'd w/cefepime, vancomycin, zosyn and decadron.
I took TDAP (Tetanus vaccine) from doctor and severe rash, itching, ulcers happened on my tongue. It has been persisted since I have taken this vaccine. And, I told the doctor's nurse and they said the expiry of this vaccine is in 2019 and cannot cause side effects.
Receive 0.3ml instead of 0.5ml first dose; A spontaneous report  was received from a friend of the patient concerning an elderly female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and receive 0.3 ml instead of 0.5 ml first dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided). On an unknown date, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.  The friend of the patient reported that the patient was frantic and worried about first dose of Moderna vaccine she got. She stated that this elderly lady received 0.3 ml of the first dose and 0.5 ml second dose. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273, therefore action taken with the drug in response to the events was not applicable.  The event received 0.3 ml instead of 0.5 ml first dose, was considered resolved.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting accidental underdose without any associated adverse events.