chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dull headache; arm pain; It traveled from the injection site up to the shoulder and down towards the elbow; delayed response; It was inflammation, swelling, rash, almost in the shape of a square; It was inflammation, swelling, rash, almost in the shape of a square; It was inflammation, swelling, rash, almost in the shape of a square; aching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), VACCINATION SITE REACTION (It traveled from the injection site up to the shoulder and down towards the elbow), PAIN (aching), SKIN REACTION (delayed response) and VACCINATION SITE INFLAMMATION (It was inflammation, swelling, rash, almost in the shape of a square) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Psoriatic arthritis and Immune system disorder.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm pain), VACCINATION SITE REACTION (It traveled from the injection site up to the shoulder and down towards the elbow), SKIN REACTION (delayed response), VACCINATION SITE INFLAMMATION (It was inflammation, swelling, rash, almost in the shape of a square), VACCINATION SITE SWELLING (It was inflammation, swelling, rash, almost in the shape of a square) and VACCINATION SITE RASH (It was inflammation, swelling, rash, almost in the shape of a square). On an unknown date, the patient experienced PAIN (aching) and HEADACHE (dull headache). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain), VACCINATION SITE REACTION (It traveled from the injection site up to the shoulder and down towards the elbow), PAIN (aching), SKIN REACTION (delayed response), VACCINATION SITE INFLAMMATION (It was inflammation, swelling, rash, almost in the shape of a square), VACCINATION SITE SWELLING (It was inflammation, swelling, rash, almost in the shape of a square), VACCINATION SITE RASH (It was inflammation, swelling, rash, almost in the shape of a square) and HEADACHE (dull headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided
Extreme tremors, muscle contraction, tingling fingers in both hands, nausea, dizziness, continued sensitivity in muscles of arm that received vaccine. Treatment: Celebrex, lotrimine
A report has been received from a Health Professional concerning a 51 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on 15-Oct-2014. It was reported that the patient experienced 52 year old received FLUMIST quadrivalent which started on 15-Oct-2014. The outcome of the event of 52 year old received FLUMIST quadrivalent is unknown. The report was considered to be non-serious.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 25-JUN-2012, patient received improperly stored VARIVAX dose 2, from lot # 671861/1907AA expiry date: 05-DEC-2013. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
sore arm within 4hrs; fatigue; joint pain; fever; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot EL3302) at left arm 08:30AM on 20Jan2021 for Covid-19 immunization. The patient had first shot 08:00AM on 30Dec2020 at right arm and experienced sore arm within 12hrs, fatigue, joint pain, skin itch, and enlarged right supraclavicular lymph node. The patient had no known allergies and other medical history was not reported. Concomitant medications included metformin. The patient experienced sore arm within 4hrs, fatigue, joint pain, fever around 12:15PM on 20Jan2021. No treatment received for the events. The patient had no Covid prior vaccination and not Covid tested post vaccination. The event did not resolve at the time of reporting.
Injection site started swelling and turned red I noticed around 8pm on 12/21/21. My husband drew an outline around the welt. At 5am this morning it had almost double in size. It is still swollen as of 1348 12/22/21. It is sore but injection sites this is typical. Each time the injection site has been examined it has been noted to be red and warm to the touch.
15-20 minutes after the vaccination she began having difficulty breathing. She was wheezing and stating that her throat and top of her mouth were scratchy and that she had a lump in her throat. She used her rescue inhaler. EMS was called and gave her 2 treatments of albuterol and transported her to the local hospital.
This spontaneous report as received from a nurse refers to a patient of unknown age. A nurse reported that an unspecified number of unknown patients have been administered doses of GARDASIL lot # K009482, expiration date 06-MAR-2017, lot # K006117, expiration date 14-JAN-2017 and lot # K008621, expiration date 04-MAR-2017, intramuscular that have underwent a temperature excursion. It was reported that GARDASIL was reported at both 47.1 Fahrenheit degrees for 96 hours and -5 Celsius degrees for 48 hours. GARDASIL lot # K009482 was given on 03-DEC-2014, 04-DEC-2014, 05-DEC-2014, 16-DEC-2014, 18-DEC-2014, 19-DEC-2014, 23-DEC-2014, 31-DEC-2014 and on 12-JAN-2015. GARDASIL lot # K006117 was given on 03-OCT-2014, 07-OCT-2014, 17-OCT-2014, 31-OCT-2014, 01-NOV-2014, 03-NOV-2014, 10-NOV-2014, 14-NOV-2014 and on 18-NOV-2014. GARDASIL lot # K008621 was given on 14-OCT-2014, 22-OCT-2014 and on 29-OCT-2014. No adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
Mother came into WIC office with child at approx. 1:00 pm. Child was covered in hives, face, ears and back were red. Mother stated that the child had trouble breathing at home. In the office the child was breathing okay. Referred the child to the physician's office (2 blocks away)  right away. Later in the evening, after the office was closed, the child's mother called the immunization clerk at home. The child's mother stated the child could not walk and that it looked like he was in a lot of pain. Mother also states that the child will not let her touch the injection sites (given in his legs) because of the pain. Immunization clerk instructed the mother to take the child to the emergency room. Called residence at 8:35 am 3/9/04 and there was no answer. Will continue to follow up.
3 pts exp a throbbing pain upon injection of Engerix-B; all pts recvd the inject from the same lot#;
54-year-old female presents for evaluation and treatment of right arm pain. Received the 1st dose of her covid-19 vaccine on 01/07. She initially had some soreness but that resolved over the following days. Her pain returned couple of days ago and has been significantly worse. She has not noticed any systemic signs of illness. No darkening of her urine. She has tried heat and ice. She took 1 dose ibuprofen. Pain is radiating up to her shoulder. It is worse with any kind of movement. Recommend ibuprofen 400 mg 3 times a day and given the muscle soreness will treat with a muscle relaxer.
Suffered stroke. Brain and left side partially paralyzed. Lost mobilty in legs and in doesn't "think too well" anymore.
Pt. c/o pain and itchiness at site of TDAP vaccine; pt - noticed 3 days ago and is getting bigger, noted slight erythema, negative fluctuation positive tenderness to palpation, positive induration 50 mm x 45 mm. RX for BENADRYL & Hydrocortisone topical given.
Dull, persistent headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2019, the patient received the 1st dose of Shingrix. On 24th September 2019, less than a day after receiving Shingrix and an unknown time after starting Aspirin, the patient experienced headache. The patient was treated with acetylsalicylic acid (Aspirin) and paracetamol (Tylenol). On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient has had a dull, persistent headache since getting his 1st dose of Shingrix. The did not respond to aspirin and Tylenol. The reporter consented to follow up.
Patient is a 17 year old female who has completed a 30-minute observation period with the following signs and symptoms of an adverse reaction: loss of consiousness. Pfizer-BioNTech COVID-19 vaccine # 1 in series administered. Parents states that patient become pale and dizzy 1 minute after she received covid vaccination , Patient had a syncopal episode in the  hallway, unknown if patient hit her head against the floor, no bruises, soreness or redness notice  Patient become alert and oriented x 4, pale, diaphoretic, Patient states that she didn't breakfast.Also  Patient mentioned that she  is afraid to needles.  Action(s) taken: Vital sign at 0814: blood pressure ; 75/34, heart rate: 65, respiration ; 16, Spo2: 99 % Repeat Vital sign at 08:28: blood pressure ; 85/44, heart rate: 65, respiration ; 16, Spo2: 99 % Repeat Vital sign at 08:31: blood pressure ; 97/58, heart rate: 66, respiration ; 16, Spo2: 99 % - Patient  denies chest pain ,shortness of breath, nausea vomiting, diarrhea, abdominal pain, difficulty swallow, headache, dizziness, or vision changes - Patient was able to tolerated fluids intake well.   Action(s) taken: Transferred to higher level of care, ER  Patient and parents  advised to discuss second dose considerations with a clinician
Patient with redness and swelling around site of injection on 7/26/16. 7/26/16 patient was noted to have rash on her chest. Patient took BENADRYL for reaction but didn't work.
No signs or symptoms reported. No other AE or PQC reported.; Medical assistant called to report a temperature excursion. PROQUAD (lot/exp. U009260 9/19/2022) was administered to one patient after the excursion occurred.; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 20-AUG-2020, the patient was vaccinated with one (1) time dose Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (dose number, vaccination scheme frequency, route and anatomical site of administration were not provided; lot number U009260 was verified to be a valid lot number with an expiration date reported and established as 19-SEP-2022) for prophylaxis. It was reported that the administered vaccine had experienced a temperature excursion of 4.6 degrees Celsius (C) with a time frame of 3 hour and 57 minutes (product storage error). No data logger was reported. No previous temperature excursion was reported. No signs or symptoms were reported. No additional adverse event (AE) was reported.
Within 5 minutes of injections, pt became nauseous. Mother then observed seizure activity. Pt incontinent urine, lethargic, diaphoretic, mild tongue, pale. Drove pt back to office, vitals NL. Given ice pack, observed. Restart Depakote 375mg bid. Pt had been seizure free for 2 years. Pt left office 4:45 PM.
Chest pain under and to the left of breast plate. Still experiencing symptoms today (5 days after onset of symptoms)
Dec 30: Received Moderna vaccine #1  December 31:  Onset of injection site tenderness, warmth, swelling, redness  Jan 7 delayed reaction reappear at injection site-same as above (site tenderness, warmth, swelling, redness) but now  affected  area is larger and itchy  As of January 10 when composing this submission large area of swelling and redness remain while intermittent itchiness of site area
I am the discharging physician and did not admit her but based off the information at admit: the patient received her Pfizer vaccine and developed nausea during her observation time but it was not significant enough to cause concern for the family. They took her home in good spirits and she appeared to be doing well until the evening when she became unresponsive. She developed high fevers and came to the ER with low normal O2 saturations and evidence of sepsis. Blood work showed a markedly elevated white count and an elevated lactic acid of 8 along with an elevated renal function and cardiac enzymes without EKG changes (multiorgan failure). Her COVID test was negative.  Blood and urine cultures were negative. A CT scan of the abdomen demonstrated no acute findings but likely chronic fecal impaction.  CT Head was negative for bleed or stroke. At this time is is unclear as to what was the cause of her symptoms but we believe it was presumed bacterial sepsis but this diagnosis is in question as all her cultures were unremarkable. The family opted on comfort measures rather than aggressive intervention and she was sent home with hospice.  Since it occurred so closely after receiving the vaccine I think it was worthwhile to bring it to your attention.
First dose / "before COVID" / wanting to resume the vaccination schedule; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 42-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Engerix B vaccine before covid situation and did not received further doses. The patient wanted to resume the rest of vaccination schedule. The reporter consented to follow up.
Vaccine was given at 10:37. Patient to be observed for 30 minutes Patient stated "I'm not feeling well" at 10:54 Patient complained of nausea, light headedness, and feeling warm. Patient transferred to recliner chair then laid back. VS taken at 1055 immediately after complaint: BP 159/86, P 83, O2 97%, Ice pack provided to back of neck/forehead, emesis basin was given to patient. Patient began to have several dry heaves. Patient stated that she did not eat this morning and has a history of diabetes. Patient offered water, orange juice,  and applesauce. Patient states to feel better. Repeat VS at 1059 while laying down BP 136/79, P 73, O2 96%. Patient assisted to sit on edge of chair, and given another orange juice.  Patient stated again she was feeling improved. VS at 1102 while sitting BP 137/93, P 78, O2 98%. Patient sat an additional 10 minutes. VS prior to patient leaving at 1107 were BP 127/85, P 78, O2 98%. Patient felt safe and comfortable to leave. Patient escorted downstairs with staff.
Laryngitis, mild shortnes of breath,  generalized hives treated with Bebdryl 50mg PO q12 hours x 2; Reddness  and swellng at injection site 3 days.
experienced lyme/co-infections; immune system collapsed; experienced lyme/co-infections; Initial information received on 30-Jan-2021 regarding an unsolicited valid serious case received from an other health professional.  This case involves adult patient who experienced lyme/co-infections (Lyme disease and coinfection), and immune system collapsed (immune system disorder), while patient received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [TDAP ]and while treated with PANCREATIN [CREON].  It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient started taking therapy of CREON (PANCREATIN) at dose and route unknown (with an unknown batch number) for unknown indication.  On an unknown date in October 2019, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious experienced lyme/co-infections (lyme disease) unknown latency following the first dose intake and following the last dose intake of PANCREATIN and unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed a non-serious immune system collapsed (immune system disorder) unknown latency following the first dose intake and following the last dose intake of PANCREATIN and unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.   On an unknown date in-Jan-2020, the patient developed a non-serious immune system collapsed (immune system disorder) and experienced lyme/co-infections (coinfection) unknown latency following the first dose intake and following the last dose intake of PANCREATIN and unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.   There were no lab data/results available.  Action taken of PANCREATIN (CREON) was unknown with respect to all the events.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for events.; Sender's Comments: This case involves adult patient who presented with Lyme disease, coinfection and immune system disorder after vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [TDAP] from unknown manufacturer and while being treated with PANCREATIN. The time to onset is unknown. There is, however, no information regarding patient's condition at time of vaccination, past history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of an individual suspect cannot be assessed.
PATIENT RECEIVED VACCINE AT AGE 54 NOT AGE 60 HAD NO ADVERSE EVENTS FROM INJECTION/VACCINATION
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L000453, expiration date 06-JAN-2007, dose and route unspecified). No adverse effect reported. Additional information has been requested.
Received immunization around 11:30 am. Starting feeling bad not long after. Thought it was seasonal allergies so took off work and went home to bed. States she woke up at 5 or 6 in the evening and felt fine. States That evening the injection site became hard like a knot and red, raised, swollen left deltoid/upper arm.
Pt had got SHINGRIX on 3/6/19, after about 10 days, he had few rash on his body, but after a month he was covered all over his body with rash and he called and I told him to go to Dr and she gave him Prednisone for 5 day course.
I started not feeling good on 11/16/22. My throat was sore and an unproductive cough. I went in to see my PA-C, my throat was bright red, my white blood count was elevated, I tested positive for the flu, I had a fever of 100.1F I had a headache, watery eyes. She told me to go home and treat myself for the flu. The cough became productive as the congestion moved down. By Sunday, 11/20/22, my fever broke but I felt different. I decided to use a home COVID-19 test and it came back immediate showing positive. I was unable to PAXLOVID due to an interaction with my drugs. I still have a cough, my energy is down, my oxygen level is around 97, I am feeling better.
I had recurring severe hives for 2 weeks and fatigue. My entire body would itch all over nonstop for 2 weeks.
Numbness weakness in both legs. Lost the ability to walk.  Numbness in fingers Abdominal pain  Loss of feeling in lower abdominal area  Stomach problems. Numbness and pain
Itchy puffy eyes, facial skin hot red itchy, granular, progressing to rash on face eyebrows, cheeks, neck, and chest over a period of time from 10/13/2011 until 10/24/2011 when rash began to fade and itching somewhat subside.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2009 (unspecified if ongoing), notes: treatment. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 31Jul2023 to 04Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
03/26/2021 PM Slightly fatigue and lethargic, arm hurt and tingly and was thrusty  after the vaccination after the vaccination, next day a head ache, and have aches and pains. 04/16/2021 chest ex De diamer test, primary care doctor  Ultra sound of the gallbladder Stomach and nausish  gallbladder and chest exray and blood work on  04/20/21 Rash developed  Currently, still have the rash today 04/26/2021 ER Chest pain, Chest CT,  De diamer, EKG
This spontaneous report as received from a certified medical assistant (CMA) refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# not reported) that was exposed to temperatures outside of the proper storage range. There was no adverse effect. This is one of the four reports from the same reporter. (Linked to 1411USA002890, 1411USA002891 and 1411USA002892). Additional information has been requested.