chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain at the injection site; Swelling at the injection site; Muscle aches and pains; pains in their upper shoulders and neck; pains in their upper shoulders and neck; The area around where she previously had lymph nodes was also affected; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 9277N, expiry date unknown) for prophylaxis.   The patient's past medical history included lymph node disorder.   On 2nd February 2019, the patient received the 1st dose of Shingrix. In February 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, muscle pain, shoulder pain, neck pain and localized skin reaction. On an unknown date, the outcome of the injection site pain, injection site swelling and localized skin reaction were unknown and the outcome of the muscle pain, shoulder pain and neck pain were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site swelling, muscle pain, shoulder pain, neck pain and localized skin reaction to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine at local pharmacy in left deltoid. Within 12 hours of vaccination, the patient had pain and swelling at the injection site and muscle aches and pains in their upper shoulders and neck. The area around where she previously had lymph nodes was also affected. On the 3rd day, the patient went to a massage therapist who was trained in lymphedema and after several treatments with the therapist the pain had improved. Any further details regarding vaccine, specific information for vaccine facility, or adverse events were unknown.
Body aches; Pyrexia; Cold; Migraine; She felt like a dish rag.; She was so sick; Right arm hurt where I got the shot; Nauseated; Chills; Full body sweats; Light-headed; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Full body sweats), DIZZINESS (Light-headed), NASOPHARYNGITIS (Cold), MIGRAINE (Migraine) and FEELING ABNORMAL (She felt like a dish rag.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20VT, 010A21A and 032L20VT) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced HYPERHIDROSIS (Full body sweats) and DIZZINESS (Light-headed). On 03-Sep-2021, the patient experienced NASOPHARYNGITIS (Cold), MIGRAINE (Migraine), FEELING ABNORMAL (She felt like a dish rag.), ILLNESS (She was so sick), VACCINATION SITE PAIN (Right arm hurt where I got the shot), NAUSEA (Nauseated), CHILLS (Chills) and PYREXIA (Pyrexia). On an unknown date, the patient experienced MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) on 04-Sep-2021 for Adverse event, at an unspecified dose and frequency. On 04-Sep-2021, ILLNESS (She was so sick) had resolved. At the time of the report, HYPERHIDROSIS (Full body sweats), DIZZINESS (Light-headed), NASOPHARYNGITIS (Cold), MIGRAINE (Migraine), FEELING ABNORMAL (She felt like a dish rag.), VACCINATION SITE PAIN (Right arm hurt where I got the shot), NAUSEA (Nauseated), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Pyrexia) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, Body temperature: 103.5 f (High) 103.5- F :  High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.  It was reported that patient took two Tylenol medication at night.   This case was linked to MOD-2021-311278 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Additional information received and updated suspect product start date and event details (start date and event outcome ).
Moderna vaccine vial which was thawed on 10JUL2021 and would expire on 11AUG2021 after thawing. However, a dose was administered from this vial to a patient on 13SEP2021; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine vial which was thawed on 10JUL2021 and would expire on 11AUG2021 after thawing. However, a dose was administered from this vial to a patient on 13SEP2021) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine vial which was thawed on 10JUL2021 and would expire on 11AUG2021 after thawing. However, a dose was administered from this vial to a patient on 13SEP2021). On 13-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine vial which was thawed on 10JUL2021 and would expire on 11AUG2021 after thawing. However, a dose was administered from this vial to a patient on 13SEP2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient has not reported any adverse reactions to this dose yet  No  concomitant and  treatment informations were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow-up include no new information.
Patients mother called office 5/25/12 to state 1 episode of mucousy stool occured on 5/24/12. Also stools went from a yellow to green color. Continues to have mucousy stools.
After PCV13 vaccination 3/3/17. She noted pain in site (she did not really look). On day 3 she noted redness at the site (left upper arm). The redness has since expanded, 20x20 cm now- the redness subsided after one week.
2nd-Moderna shot taken 05/03/2021 at 11:30 am. After 12 hours of injection, (05/04/2021) headache and fever began (12:15am). By 3:00 am, chills and fever of 102.0 F (my normal temp is 98.2 F). Took Tylenol every 4 hours. Due to Full body aches, headache and fever persisted until 8:00 am., unable to sleep all night. Stayed hydrated with water and Gatorade. Finally after 8:30am/ 05.04.2021, was able to sleep few hours. By 2:00pm/ 05/04/2021, chills and fever started second cycle... fever up to 101.5 F, this cycle. Body aches and headache persisted entire time. Fever broke approx. 8:00 -10:00pm. Was able to sleep most of the night. Headache, body aches and fatigue persisted all day 05/05/2021. Only able to eat soup, toast and Gatorade for 2 days. Fever and headache subsided around 10:00 pm/ 05/05/2021. Slept ok 05/05/2021 and 90 percent  body aches subsided by 0506/2021. Moderate fatigue on 05/06/01, but able to regain daily routine.
Muscle aches started the afternoon of 9/27/14 then woke up in the middle of the night with a fever and muscle aches that had progressed from minor to severe, increased arm pain, and nickel-sized redness and swelling at the injection site.  I iced my shoulder area and took Tylenol every 4 hours but the fever would not break. The fever continued into Monday, 9/29/14, and the redness had more than doubled in size.  I went to urgent care, they diagnosed me with cellulitis, and put me on Keflex 500mg, 4 times a day for 10 days.  The swelling still persists with a large lump in the deltoid area.
Patient at clinic for ADHD evaluation. During the exam patient given KINRIX (DTAP and IPV). That night the patient had no problems with fever. He went off to daycare the next morning and went swimming. Following he had lunch and then was to take a nap. Ten minutes later he sat up and said he didn't feel well and was going to vomit. He was able to walk to the bathroom. He proceeded to vomit, had sagging of his face and became unresponsive although continued to stand. The school nurse was called and 911 response was activated. His eyes rolled up, and when the paramedics put him on a gurney he started with left sided seizure activity. His head turned to the left. He had 5 further episodes of seizure activity and inbetween he sat up and stated he was tired. He was transported to hospital. A CT scan of his head was done which was negative. There was a large local reaction in his left arm measuring 3cm by 3 cm due to the KINRIX. He also has mild hemophilia. Due to the concern of a cerebral bleed his hematologist was contacted and the patient was transported to another hospital. He was given Factor VIII replacement and put on TRILEPTAL for seizures. On 7/17/2010 he had an MRI and an MRA both of which were negative. The patient was discharged to be followed by neurology. No etiology except for the KINRIX could be found for the seizure.
Pt had an episode of syncope shortly after the visit. Pt was aroused and offered juice and crackers. He stated that he felt weak shortly after the episode but once he had juice and crackers he was back up and feeling more like himself.
had the coronavirus; fluid in the bottom of my lungs; having fluid in the bottom of her lungs that could not be replaced or removed and breathing problems; This is a spontaneous report from a Pfizer sponsored program . A contactable 57-year-old female consumer (patient) reported for herself that she received pneumococcal 13-val conj vac (dipht crm197 protein) (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. Patient got her pneumonia shot while she had the coronavirus because even with the shot she wound up having fluid in the bottom of her lungs that could not be replaced or removed and breathing problems, and she felt that if she hadn't got that shot then she would be in a totally different situation. Outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein)in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein)has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Member  starting experiencing pressure in the back of his throat, light headed with dizziness,  diaphoretic and pale with coolness to touch. Member has extremely high blood pressures with positive orthostatic blood pressure. Fire Response unit arrived on scene with Fire engine 183 enroute. Member was transported to West Campus for further treatment by Service.
Patient and siblings all received varicella vaccine at different times, recently 11/18, all developed chicken pox. The follow up received on 12/23/03 states varicella not given in our office. Was given 9/26/97 in another office, don't have lot #.
got the flu every year; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via social media.  This case involves an unknown age patient who experienced got the flu every year (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious got the flu every year (influenza) unknown latency following INFLUENZA VACCINE.  Details of laboratory data not reported.  Final diagnosis was got the flu every year.    It was not reported if the patient received a corrective treatment.  The outcome was resolved on an unknown date for events.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 26-NOV-2018, the patient was vaccinated with improperly stored M-M-R II (lot # N024698, expiration date 08-SEP-2019) and VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). The sterile diluent used to reconstitute M-M-R II was properly stored. No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Pain in chest from sternum to a bit above the nipple on my left side. Feels like a "pulled muscle" pain that happens when rolling over in bed, sitting up, sneezing or doing anything where chest is pushed out or squeezed in.
gave me the worst flu of my life; Initial information received regarding an unsolicited valid non-serious case from a consumer (patient) via Social Media and transmitted to Sanofi on 30-Oct-2020.  This case is linked to cases 2020SA307387, 2020SA307451, 2020SA307452, 2020SA307939, 2020SA307941, 2020SA308033, 2020SA308034, 2020SA306301 and 2020SA302198.  This case involves unknown age patient who experienced worst flu of life, while patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received one dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown) via unknown route in unknown administration site for prophylactic vaccination and gave the worst flu of patients life (influenza).  Final diagnosis was gave influenza.   No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for influenza.  Lot number was not reported for this case.
Diarrhea since 2-16-12 ongoing still. Rotavirus 2-20-12 still with diarrhea.
My son was injured by MMR shot; This spontaneous report was received from patient's mother concerning to a male patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a shot of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis (strength, formulation, dose, dose number, route of administration, anatomical location of vaccination, lot number, and expiration date were not reported).  It was reported that on an unknown date, the patient was injured (injury) by measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) shot. The outcome of the event injury was not reported.  The causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the occurrence event was considered as related.
The patient had her Janssen vaccine on 4/7/21. On 4/15/21 she began having a very severe headache (10/10). This was followed by dysarthria and facial droop. The symptoms persisted until the following day at which point she went to urgent care and then here to our ER. We did a head CT which showed she has and acute/subacute stroke in the right posterior MCA territory. I am the Hospitalist physician that admitted her yesterday. I have and MRI of the brain as well as an MRA and MRV ordered though not performed yet. Her symptoms are improving.
Evening of 5/26/18 pt noted blistering rash under right breast. It is not painful or itching.
rash; itching; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included prednisone (PREDNISONE), mycophenolate mofetil hydrochloride (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) and belimumab (BENLYSTA). On an unspecified date, the patient stated, "I have a question regarding the Pfizer covid vaccine as it relates to someone allergic to contrast dye, if it would be a problem. I was pre-medicated when I received it. After that I had a breakthrough of rash and itching that lasted a few days. No respiratory throat closing or any thing like that. There are several medications that I am taking and want to knowif they need to be stopped: prednisone, cellcept and benlysta infusion. Along with Long term opioids." The outcome of the events was unknown.  No follow-up attempts are possible. Information on lot/Batch could not be obtained.
Numbness in left lower arm and hand - lasted 7 days after injection.  Severe muscle pain in lower left leg on day 6 after injection, severe muscle pain in right leg day 7-8 after injection. Tingling and numbness in legs. Sharp pains in right arm and continued leg pain day 8. Overall body pain and sharp pains continued 7 days post vaccination.
Headache; Exhausted; Sore arm; stuffy; This is a spontaneous report received from a non-contactable consumer. An adult (non-pregnant) female patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 20Mar2021, at dose 2, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: unknown), via an unspecified route of administration on 27Feb2021 at dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had been tested for COVID-19. On an unspecified date, the patient experienced headache, stuffy, exhausted and pain in arm/ sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received treatment for the reported events. The clinical outcome of events headache, stuffy, exhausted and pain in arm/sore arm was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment (01Jul2021): This follow-up report is being submitted to amend previously reported information: Country of patient added.
lt inner thigh w/1.5cm circular erythema underlying 2cm firmness;* reaction to HIB vax*
On March 10, 2021 I woke up at 0500 and experienced extreme dizziness.  I walked to the bathroom and was fatigued, dizzy, and lost my balance.  Went back to the bed and when I closed my eyes, felt like the world was spinning.  Rested for a bout 4 hours and woke up feeling very fatigued, but no dizziness.  Went to the Emergency Room at Hospital and was seen around 3pm by a doctor.  CT scan was conducted and doctor believed that I had spontaneous vertigo.  I have never had these symptoms before and have not had them since.  On April 6, 2021 woke up with extreme pain in the lower back.  After pain became worse and front abdomen became painful went to Emergency room.  After two doses of fentanyl and one dose of Morphine was discharged with a diagnosis of a muscle strain.  The following day there was very minor pain in the lower back, and by the next day (April 8th) no pain.
Eye swelling in her right eye; Some pain in her arm; Eye was goopy; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye swelling in her right eye), PAIN IN EXTREMITY (Some pain in her arm) and EYE DISCHARGE (Eye was goopy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06M20A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (Eye swelling in her right eye), PAIN IN EXTREMITY (Some pain in her arm) and EYE DISCHARGE (Eye was goopy). At the time of the report, EYE SWELLING (Eye swelling in her right eye), PAIN IN EXTREMITY (Some pain in her arm) and EYE DISCHARGE (Eye was goopy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided.  Treatment details included Compress, eye drops, ice and Tylenol.
expired dose was administered to a patient with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid  non-serious case received from Other Health Care Professional.  This case involves a 44 years old female patient and expired dose was administered to a patient with no reported adverse event while receiving vaccine influenza quadrivalent recombinant vaccine [Flublok].  The patient's past medical history, medical treatment(s) and family history were not provided.   On 26-Sep-2022, the patient received a dose of suspect influenza quadrivalent recombinant vaccine at a dose of 0.5 ml (strength, formulation: not provided; lot number: QFAA2125 and expiry date : 30-Jun-2022) via intramuscular route in the left deltoid for Immunization.  On 26-Sep-2022 the patient had expired dose was administered to a patient with no reported adverse event (expired product administered) same day following the administration of influenza quadrivalent recombinant vaccine,  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Developed covid-19 symptoms on April 11th. Confirmed covid infection April 19th.  Have chest pain, coughing, sore throat, congestion, aches and pains, fatigue.
Hives started on face and head initially on 9/15/00 and then on 9/16/00, hives went to trunk and legs. No fever, crankiness or increase in sleepiness. Contacted doctor on 9/16/00 and was treated with Benadryl. Resolved in 4 hours. No rash.