chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's Palsy; Fever Blister; lips became sunburnt; first injection of Shingrix in September 2019/second injection of Shingrix in April, 2020; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of swelling face (received 1st dose in September 2019 and experienced swelling of her lymph nodes in her neck, swelling in face and right arm was sore). Concurrent medical conditions included fever blister.   In April 2020, the patient received the 2nd dose of Shingrix (intramuscular). In April 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In July 2020, the patient experienced fever blister and sunburn. In September 2020, the patient experienced bell's palsy (serious criteria GSK medically significant). The patient was treated with ibuprofen. On an unknown date, the outcome of the bell's palsy, fever blister, sunburn and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the bell's palsy, fever blister and sunburn to be related to Shingrix.  Additional details were provided as follows:  The patient received 2nd dose of shingrix and at the end of July, lips became sunburnt, 3  fever blisters and bell's palsy this week. The patient received 2nd dose of shingrix, more than the recommended interval, which led to lenghetening of vaccination schedule. The patient received ibuprofen prophylactically and did not experienced symptoms. The patient received 1st dose of shingrix in September 2019 and experienced swelling of her lymph nodes in her neck, swelling in face and right arm was sore and was treated with ibuprofen and symptoms disappeared next day. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR191361:same patient, 2nd dose
Patient's caregiver brought patient into the pharmacy on Wednesday 11/9/2022 to get a flu shot administered. A dose of Flulaval Quad(Lot 9722R, IM Right Deltoid) was administered to patient per the caregiver's request in the pharmacy. Staff member who administered the shot in the pharmacy was not informed by patient's caregiver that patient already received a dose of Afluria (Lot P100473764, IM Left Deltoid) when our mobile team visited the carehome on 10/26/2022. The caregiver apparently the COVID booster was administered to patient on 10/26/2022 and not the flu shot.  We followed up with caregiver and caregiver reported patient experienced no adverse reaction after receiving the second flu shot.   We encouraged caregiver to inform patient's primary care physician of the incident.
This is a spontaneous report from a contactable consumer reporting for himself. This 52-year-old male patient of other race received on 29Nov2016 a single dose of PREVNAR 13 intramuscular in the left arm for routine vaccination. The patient was diabetic (from 1993). Concomitant medications were not reported. On 29Nov2016 the patient had soreness at the injection site with outcome of not recovered. Additionally it was reported that on an unspecified date in 2016 the patient had soreness in the whole left arm and back, numbness in the arm and no good way to sleep, all with outcome of unknown. Course of the events was as follows: the patient had vaccination on 29Nov2016 and started experiencing soreness at the injection site since that day and was still having soreness 5 weeks later. This event required a visit to physician office. He stated that the soreness was actually the whole left arm and back, explaining that when he sit down in the chair the arm will start going numb and stay numb. Because of that he had no good way to sleep. He had been experiencing numbness and soreness in the arm since an unspecified date in 2016. The arm hurted all the time and he could barely use it. He said a physician tried to take his BP and that the cuff made his arm go numb and feel ice cold, it wouldn't get warm even wrapped in a comforter. He felt like the pain was in the bone, like it was deeper than the muscle. Treatment for pain was provided and included gabapentin 100mg three times at bedtime started on 26Dec2016, but it did not help.
Patient complained about soreness in shoulder joint lasting over a month and still a little bit of discomfort when lifting arm up all the way.Most of the pain and discomfort is resolved but not recovered completely.
Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.            The patient had came into contact with the COVID-19 virus early.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-103013 (E2B Linked Report).; Sender's Comments:  MOD-2021-103013:Mother case (MOD21-085901)
15cm(L)x15cm(w) (L) Deltoid 13cm(L)x13(w) (R) Deltoid - areas with induration, erythema & warmth. Currently being Tx for cellulitis. ROCEPHIN IM.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 09-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiry date were not reported). There was no concomitant medication reported. The pharmacist reported that the ZOSTAVAX leaked from where the needle was connected to the barrel of the syringe while administering to a patient and patient did not receive the full dose of ZOSTAVAX. No adverse effect was reported. The outcome of the event was unknown. Additional information is not expected, because the reporter refused additional contact.
On 12/09/2020 Patient reported to her school Nurse where she works that she has suffered a shoulder injury from a vaccination on 10/27/2020. On 12/10/2020 patient reported she still had shoulder pain and difficulty moving it. Reported an appointment had been made with Dr. for 12/17/2020. On 12/22/20 we f/u about appointment and patient reported "I do not yet have a clear treatment plan, but it is clear that all of the structures of the rotator cuff are involved." Patient reported she is awaiting approval for an MRI.
1 week after the shot, I started itching from head to foot.  No outward rash, just non-stop itching.  A little nausea at times.  I took benadryl which helped a little for a short time.
She can barely sleep; Feeling very tired; Muscles and body aches; Lack of energy/pretty intense; Massive back pain; Tinnitus; Could barely walk; Shacking all over; Felt very ill; 100.2 temperature; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (Could barely walk), TREMOR (Shacking all over), MALAISE (Felt very ill), ASTHENIA (Lack of energy/pretty intense) and BACK PAIN (Massive back pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced GAIT DISTURBANCE (Could barely walk), TREMOR (Shacking all over), MALAISE (Felt very ill) and PYREXIA (100.2 temperature). In March 2021, the patient experienced ASTHENIA (Lack of energy/pretty intense), BACK PAIN (Massive back pain), TINNITUS (Tinnitus) and MYALGIA (Muscles and body aches). On an unknown date, the patient experienced INSOMNIA (She can barely sleep) and FATIGUE (Feeling very tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 01-Mar-2021, GAIT DISTURBANCE (Could barely walk), TREMOR (Shacking all over), MALAISE (Felt very ill) and PYREXIA (100.2 temperature) had resolved. At the time of the report, ASTHENIA (Lack of energy/pretty intense), BACK PAIN (Massive back pain), TINNITUS (Tinnitus), INSOMNIA (She can barely sleep), MYALGIA (Muscles and body aches) and FATIGUE (Feeling very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Body temperature: 100.2 (High) 100.2 temperature.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant medications was not provided by the reporter.  Treatment information included Advil and other OTC medication for the pain.
RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/19/2021 STENOSIS D/T OTH INTRL PROS DEVC IMPL & GRFT INT
increase weakness and fatigue, weakness in extremities, incontinent, jerky arm movements, within first 24 hours, continue to decline sent to hospital returned weaker, within 24 hrs hours BP dropped, low pulse  oximeter reading, diaphoretic, lung sounds diminished, loss consciousness and passed away. 01-12-2021
Pathology confirmed: OXALATE NEPHROPATHY. Unclear trigger for abrupt onset of AKI requiring initiation of dialysis in this lady with hyperoxaluria. Her hyperoxaluria is thought due to roux-en-y bypass. But unclear why she abruptly had Cr go from 1.2 mg/dl in Dec 2020 to 11 on 3/10/21 with oliguria.  I - her attending hospitalist - am unsure what precipitated the crisis. I've attending renal pathology conference which discussed case. Some nephrologist entertained attributing it to Cdiff colitis, but the existing literature for this is very limited and her infection seems to have followed her AKI, rather than preceded it.   Although unlikely, I've considered that patient may have existed with supersaturate hyperoxaluric state  that experienced shock to equilibrium after small PEG injection of pfizer vaccine.
Continuing a week after my vaccine- Painful armpit that felt like someone was scratching sandpaper on my armpit every time I moved, swelling of my left breast along with pain and sensitivity. After icing, I got it to go down but it was twice the size as normal, both of my hands and forearms being swollen every morning I wake up. The pain in my armpit has subsided but my breast is still very painful.  Right after the vaccine for 3-5 days- chills, fever of 99.9-102.4, diarrhea, migraine headaches, lameness, and lethargic
several days after my second shot I developed tinnitus- I have never had it before.  I have not had COVID itself.  I had the second shot over a month ago and I still have intermittent tinnitus- at least 50% of the time.
Fever; Headaches; Chills; Aches and pains; This is a spontaneous report from a contactable consumer (patient herself).   This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 23Dec2020 at 08:30 AM at single dose for COVID-19 immunisation. Vaccine location was left arm.  The patient was vaccinated at hospital, age at vaccination was 60-year-old. She was not pregnant. No other vaccine was received in four weeks.  Relevant medical history included diabetic, allergies to eggs, chicken and latex. It was reported that prior to vaccination, she was diagnosed with COVID-19. Relevant concomitant medications included insulin aspart (NOVOLOG) for diabetes. On 24Dec2020, at 02:30 AM, the patient developed fever, headaches, chills, aches and pains. The patient was treated for the events. Nasal swab, COVID test (rapid) was performed on 24Dec2020 and was negative. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
suspected vaccination failure; 15 people / experienced shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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. The age group was not reported but was captured as an adult as per vaccine indication. The patient got shingles after getting vaccinated with the shingles vaccine. The patient declined an offer for the current shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided. This case is 1 of the 16 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088476:
Patient received the pneumovax vaccine, but should have received the prevnar 20 vaccine. The patient did not have any negative outcomes from receiving pneumovax. The PCP is aware and will administer prevnar in the future. This report is to indicate that the wrong vaccine was given, not necessarily an adverse effect
Started out as fever two days prior on May 21st then on 5/23/2015 she woke up with a rash on her head back and chest.
Please send all information relating to carcinogenicity or mutagenicity of this drug relating to lot H015863.
Left sided facial swelling. Increased tearing of left eye. Prednisone. Bells Palsy.
REDNESS SORENESS, SWELLING AT THE SITE OF INJECTION. PATIENT STATED VACCINE REACTION IS GOING AWAY, 3RD DAY. 9/2/18 CALLED PT AT 2:30PM.
Patient received the menactra and boostrix vaccine and tolerated the doses fine in the shot room.  While sitting down in the chair in the waiting room to complete the 15 minute post-shot observation period, patient fainted while lowering himself to chair and slid to the floor.  Patient hit his head when he passed out but regained consciousness almost immediately.  Was talking  with pharmacy staff and confirmed no shortness of breath or swelling of the tongue.  We have a quick care facility in the building so staff from the office came over and also spoke with patient.  They agreed that patient did not appear to be having an allergic reaction but since he hit his head, they did recommend being seen in ER or an urgent care facility.  Patient finished his 15 minute observation period here and then left for urgent care with his mother (who was with him the whole time).  Contacted the family later in the day to check up on patient and Dad informed me that patient started vomiting in the car on the way to the urgent care so they proceeded to ER.  ER cleared the patient and sent him home with family.
Fever 102-103,diarrhea, called MD, APAP q4-6 hrs, clear liquids, D/C Erythromycin.
Patient is a 43 year old woman who presented to the vaccine clinic to receive her booster dose. Patient stated she had a previous mild reaction to the second dose of the Pfizer vaccine. Per Dr. was cleared to receive the J&J booster. The J&J Booster vaccine was administered at 1405. Patient began to exhibit symptoms at 1415.   Upon assessment patient was A&Ox4. Respirations were even  with non audible wheezes upon auscultation. Notable erythema on face and chest. Patient expressed having difficulty swallowing with severe increased swelling of the tongue. Unable to assess palate and uvula due to increased swelling of the tongue. Patient expressed feeling tightness of the chest.  EpiPen Auto-Injector 0.3mg was administered at 1416. Patient expressed mild relief. Patient was transported to the ER via wheelchair.    COVID Vaccine Worksheet  Did the patient have an immediate allergic reaction of any severity such as urticaria, angioedema, respiratory distress, or anaphylaxis (<4 hours following administration of the COVID vaccine)?  Yes  Did the patient previously have an immediate allergic reaction of any severity to polysorbate or polyethylene glycol?  No  Has the patient had prior anaphylactic reactions from another vaccine, medication or any other cause?  Yes  Did the patient have an allergic reaction >4 hours after administration? OR have an expected side effect of the COVID vaccine?  Yes
had 2-3month sz w/arms & legs shaking followed by eyes rolling back; then about 10 seconds of legs shaking then glassy eyed;no resp distress;sx resolved by 15min;
Arm swollen after 1st dose; Arm hard after 1st dose; Dizziness after 1st dose; Arm sore and tender after 1st dose; Arm sore and tender after 1st dose; Headache after 1st dose; Nausea after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen after 1st dose), INDURATION (Arm hard after 1st dose), DIZZINESS (Dizziness after 1st dose), PAIN IN EXTREMITY (Arm sore and tender after 1st dose) and TENDERNESS (Arm sore and tender after 1st dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030az1a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen after 1st dose), INDURATION (Arm hard after 1st dose), DIZZINESS (Dizziness after 1st dose), PAIN IN EXTREMITY (Arm sore and tender after 1st dose), TENDERNESS (Arm sore and tender after 1st dose), HEADACHE (Headache after 1st dose) and NAUSEA (Nausea after 1st dose). At the time of the report, PERIPHERAL SWELLING (Arm swollen after 1st dose), INDURATION (Arm hard after 1st dose), DIZZINESS (Dizziness after 1st dose), PAIN IN EXTREMITY (Arm sore and tender after 1st dose), TENDERNESS (Arm sore and tender after 1st dose), HEADACHE (Headache after 1st dose) and NAUSEA (Nausea after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.
Strong metal taste in mouth - subsided after a day (no treatment) Nausea - subsided after a day (no treatment) Severe headache - took Target Up&Up extra strength headache relief after 24 hours.  Headache lasted 3 days. (until Thursday) Body aches / joint pain - subsided after 2 days (Monday - Wednesday) Feeling hot and code - subsided after 2 days (Monday - Wednesday)
This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 20-AUG-2018, the patient was vaccinated with a improperly stored PROQUAD recombinant Human Albumin (rHA) (which had a lot # of R006747 and an expiration date of 03-SEP-2019; however, dosage number and route of administration were not reported), for prophylaxis and was reconstituted with properly stored Merck sterile diluent. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion on an unknown date: 6 degrees F to 14 degrees F for 6 minutes. Reportedly, there had been no previous temperature excursions and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1809USA006757; US-009507513-1809USA004794.
About a 1/2 hour after she had her typhoid and Twinrix vaccines at about 3:30PM she lost her voice, sore throat, swollen lips & face, SOB, and at 6:30 PM.
5 minutes after receiving nasal mist student felt dizzy, coldness in her ears and then diaphoretic. Rested x 20 minutes. States something has happened to her when she gave blood & when she had her wisdom teeth removed.
No adverse reaction, Boostrix given in error to 5 y/o who had his last Td containing vaccine in 2003. Pt was given Tylenol after immunization local pain at injection site.
He experienced a fever of 100 degrees F; He experienced body aches; He experienced soreness of the arm at the injection site; He experienced swelling of the arm at the injection site; He experienced headache; He experienced tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (He experienced headache), FATIGUE (He experienced tiredness), PYREXIA (He experienced a fever of 100 degrees F), MYALGIA (He experienced body aches) and VACCINATION SITE PAIN (He experienced soreness of the arm at the injection site) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included No adverse event. Concomitant products included METFORMIN, GLIPIZIDE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), LISINOPRIL, VITAMIN D3 and CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HEADACHE (He experienced headache) and FATIGUE (He experienced tiredness). On 09-Apr-2021, the patient experienced PYREXIA (He experienced a fever of 100 degrees F), MYALGIA (He experienced body aches), VACCINATION SITE PAIN (He experienced soreness of the arm at the injection site) and VACCINATION SITE SWELLING (He experienced swelling of the arm at the injection site). At the time of the report, HEADACHE (He experienced headache), FATIGUE (He experienced tiredness), PYREXIA (He experienced a fever of 100 degrees F), MYALGIA (He experienced body aches), VACCINATION SITE PAIN (He experienced soreness of the arm at the injection site) and VACCINATION SITE SWELLING (He experienced swelling of the arm at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: TCR form attached on 24-may-2021 , Non - significant information , not interested to report details