chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The Patient had a routine Papanicolau (PAP) smear which was "positive" and she was considered "high risk" and "needed a colposcopy"; This spontaneous report was received from a nurse via a company representative referring to a 25 years old female patient. The patient's concurrent condition was not reported; pertinent medical history, drug reactions/allergies and concomitant medication were unknown by the reporter.    On an unspecified date in 2012, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength and dose not reported; lot number and expiration date were unknown) intramuscularly as prophylaxis. The patient said that she did receive a second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength and dose not reported; lot number and expiration date were unknown) on an unspecified date which the nurse did not have any documentation of the second dose. On an unspecified date in September 2019 (reported as last week), the patient had a routine papanicolaou (PAP) smear which was positive (smear cervix abnormal) and she was considered as high risk and needed a colposcopy. It was unknown if other studies were performed. After the routine PAP, the patient sought medical attention. At the reporting time, the outcome of the event was reported as unknown. The causality between smear cervix abnormal and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)  was not reported.
I was diagnosed with A Fib on 5/13/21. I have never had any history or issue with my heart that I know of before this. It may not even be related
High grade arrhythmia including V tach. Saw Cardiology, and Electrophysiology. Elected observation. Subsequent developed afib requiring Eliquis
Patient felt chest tightness and was given Albuterol per MD order and patient monitored and sent home after 30 minutes with patient re[porting symptoms improved.
This spontaneous report as received from a Registered Nurse (RN) refers to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent medications were not provided. It was reported that the unspecified number of patients were administered doses of GARDASIL, PNEUMOVAX23, ROTATEQ, PEDVAXHIB and VACCIN TD that were exposed to temperatures outside of the prescribing information which could not be supported on unspecified dates since 07-FEB-2014. No adverse events were reported. Additional information has been requested.
Pt recv vax on 7/23/96; on 12/14/98 pt exp chicken pox
2 days after injection, area around site became red, warm, itchy and inflamed. Recommended to apply NEOSPORIN and BENADRYL cream. Next day area has improved.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: Patient has allergy history to Taxol - she felt allergic reaction almost immediately upon administration of dose 2 of Moderna COVID vaccine. RN administered EPIPen immediately and patient felt effects were resolving her reacion. 911 called. EMT arrived and transported patient to hospital. Called patient for update on how she was doing - she was still in hospital for monitoring purposes abouit 3 hours later and would be discharged home soon.
On 8/9/19 The patient emailed Dr. to inform that after 24 hrs. of receiving  the vaccines she started to feel very bad. Had a temperature of 101.6,feeling very achy and tired.
My arm felt heavy - Tender arm; Body aches - Tender arm; A painful lump above the collar bone; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (My arm felt heavy - Tender arm), MASS (A painful lump above the collar bone) and MYALGIA (Body aches - Tender arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 18-May-2021, the patient experienced MASS (A painful lump above the collar bone). On an unknown date, the patient experienced LIMB DISCOMFORT (My arm felt heavy - Tender arm) and MYALGIA (Body aches - Tender arm). The patient was treated with IBUPROFEN (MOTRIN IB) for Pain, at a dose of 1 dosage form as necessary. At the time of the report, LIMB DISCOMFORT (My arm felt heavy - Tender arm), MASS (A painful lump above the collar bone) and MYALGIA (Body aches - Tender arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown.       No concomitant medications provided
Swollen lymph nodes in throat with difficultly swallowing. Heart palpitations and elevated heart rate.
His upper lip started swelling. Mom gave him Ibuprofen in the afternoon - his lip got swollen after that. No problems breathing and no rashes.
Fever of 101.5; Chills; Body aches; Headache; Injection site pain; redness; hot; Swelling; Right arm itching that radiated to back and part of left shoulder; This is a spontaneous report from a contactable nurse, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 31Jul2021 at 09:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took naproxen(MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 10Jul2021 at 10:30 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. On 01Aug2021 at 08:00 the patient experienced fever of 101.5 the next day and chills/body aches. Headache for 24 hours the following day. Injection site pain, redness, hot and swelling. Right arm itching that radiated to back and part of left shoulder for 5 days following injection. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care.No therapeutic measures were taken as a result of the events.  On an unknown date the patient underwent nasal swab SARS CoV-2 virus test and the result was negative. On 01Aug2021 at 08:00, the patient checked body temperature and the result was fever of 101.5(unspecified units).  Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events fever of 101.5, chills, body aches, headache for 24hours, vaccination site pain, redness, hot, swelling and right arm itching that radiated to back and part of left shoulder were resolving at the time of this report.
1 hour after receiving flu shot, began having hives, itching, flushing, small amount of shortness of breath.
Very dizzy; Weak; Nausea; Little apetite; Tired; Shivers; Racing heartbeat; First dose on 10/30/20 / Second dose on 12/5/20; This case was reported by a consumer and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 5th December 2020, the patient received the 2nd dose of Shingrix. On 5th December 2020, less than a day after receiving Shingrix, the patient experienced drug dose administration interval too short, dizziness, weakness, nausea, appetite impaired, tiredness, shivers and heart racing. On an unknown date, the outcome of the drug dose administration interval too short was unknown and the outcome of the dizziness, weakness, nausea, appetite impaired, tiredness, shivers and heart racing were recovering/resolving.   It was unknown if the reporter considered the drug dose administration interval too short, dizziness, weakness, nausea, appetite impaired, tiredness, shivers and heart racing to be related to Shingrix.  Additional details were reported as follows: The patient had 2nd dose of Shingrix too soon, which led to shortening of vaccination schedule. The patient had worse reaction, very dizzy, weak, nausea, little appetite, tired, shivers the night the patient got the shot and racing heartbeat. The patient was better but not great. The information regarding consent to follow up was not reported.
At 1:30 a.m. on Tuesday, February 2, 2021 (88 hours after my vaccination) I  I was awaken with horrific itching on both hands and wrists, I was scratching so hard I thought I would tear my skin.  At times it went up my arms and there were red blotches on my wrists and arms.  After a shower at 3:00 a.m. I went on the couch until 8:00 when I awoke in a complete fog with itching that was subsiding and gone by noon.  I was just 'slow' the rest of the afternoon.
Patient received covid vaccine (Pfizer) on 5/18/21.  About 2 weeks prior to admission to hospital patient began having leg weakness and unsteady gait which has progressively gotten worse.  Patient is beginning IVIG treatment for Guilian Barre syndrome.
The wrong dose for the first Moderna Bivalent COVID vaccine was administered (As7146B) on 10/14/2022 at 0.25mL instead of 0.5m. Gave the other 0.25mL dose with the new Lot number (016F22A) on 10/24/2022
No additional adverse effect reported.; Nurse called to report a patient received improperly stored ROTATEQ on 8/11/2020.; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 11-AUG-2020, the patient received improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (described as "vial 2") orally, for prophylaxis (strength, dose and, vaccination scheme were not reported; lot number 1660981, expiration date 13-APR-2021, which were verified to be valid) (product storage error). The vaccine was stored at a temperature above 47 degrees Fahrenheit (F)/ 9 degrees Celsius (8.9 C) for 33 minutes, as recorded by the data logger. No previous temperature excursion was reported. No additional events were reported.
Had slight swelling, pain, tenderness x 5 days at site of injection. On 4/7/06 employee had fever of 101.6 with achiness, cough starting 28 hours after injection. Fever increased to 102.3 in evening of 4/7/06. Was still feeling sick on 4/10/06 when returned to work a clinic she works in. Dr there prescribed Zithromax which cleared up infection after a 5 day course. Infection lasted approx 1 1/2 to 2 weeks. No residual after effects.
incorrectly diluted the ped pfizer (meroon top) 6mo-4 years Vancian mixed with o.2ml of diluent in place of 2.2Ml. Patient received 0.2mls from vial.
Hives all over body, but mostly on back and left front torso. On my back - the hives went from my hairline and behind my ears, down my spine to my hip area.  At first, around 3/31/21, I thought they were some kind of bug bites. By 4/11/21 I realized I had a rash or hives. I sent photos to my Doctor. I was Dx with hives from unknown source. Nothing in my environment, diet, soaps, laundry detergent had changed. I also had bumps/sores on my Labia. I was seen by my Gynecologist and tested for infection including herpes.  Everything came back negative. My Doctor agreed that the hives and sores on my labia may be connected. My Doctor recommended that I provide this report as there may be a connection to the vaccine.
I began to have blurred vision; tinnitus; food and odors were no longer strong; food and odors were no longer strong; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Feb2021 (Batch/Lot number: unknown) at the age of 68 years as dose 2,single for covid-19 immunisation. Relevant medical history included: "Stage 3b CKD" (unspecified if ongoing), notes: Other medical history: Stage 3b CKD, Degenerative Disc Disease; "Degenerative Disc Disease" (unspecified if ongoing), notes: Other medical history: Stage 3b CKD, Degenerative Disc Disease; "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: DIAZEPAM; AMLODIPINE; FLUOXETINE. Vaccination history included: Bnt162b2 (lot number L9262, administration date 24Jan2021, administration time 10:00 AM, dose number 1, vaccine location Right arm.), administration date: 24Jan2021, when the patient was 68 years old, for Covid-19 Immunization. The following information was reported: VISION BLURRED (non-serious) with onset 10Mar2021 18:00, outcome "not recovered", described as "I began to have blurred vision"; TINNITUS (non-serious) with onset 10Mar2021 18:00, outcome "not recovered", described as "tinnitus"; TASTE DISORDER (non-serious), PAROSMIA (non-serious) all with onset 10Mar2021 18:00, outcome "not recovered" and all described as "food and odors were no longer strong". Therapeutic measures were not taken as a result of vision blurred, tinnitus, taste disorder, parosmia.  Additional Details: There was no other vaccine in four weeks. Other medications in two weeks: Fluoxetine, Diazepam, Amlodipine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (08Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
HEART PALPITATIONS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced heart palpitations. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart palpitations was not reported. This report was non-serious.
Received Tdap in Right arm on 7/16/2010 then had fever and nausea on 7/17/2010 which resolved on 7/19/2010.  Rash on right arm on 7/20/10.
Patient reported he had difficulty breathing when he laid down the night he got the vaccinations. He could breathe sitting up or standing, but not when lying down.
Heat over my body; allergic reaction; Severe rash; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Heat over my body), HYPERSENSITIVITY (allergic reaction) and RASH (Severe rash) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Heat over my body), HYPERSENSITIVITY (allergic reaction) and RASH (Severe rash). At the time of the report, FEELING HOT (Heat over my body), HYPERSENSITIVITY (allergic reaction) and RASH (Severe rash) outcome was unknown.     No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-642450 (Patient Link).
lips also began to swell pretty bad; worst reaction; woke up the next morning covered in hives; full body rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (woke up the next morning covered in hives), RASH (full body rash) and LIP SWELLING (lips also began to swell pretty bad) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced URTICARIA (woke up the next morning covered in hives) (seriousness criterion medically significant), RASH (full body rash) (seriousness criterion medically significant) and VACCINATION COMPLICATION (worst reaction). On 03-Aug-2021, the patient experienced LIP SWELLING (lips also began to swell pretty bad) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and EPINEPHRINE (EPIPEN) at a dose of 1 dosage form. At the time of the report, URTICARIA (woke up the next morning covered in hives), RASH (full body rash), LIP SWELLING (lips also began to swell pretty bad) and VACCINATION COMPLICATION (worst reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter has asked is there anything she can ask for from her doctor that isn't a steroid that can combat the rash.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: vaccine start date was updated, concomitant medicines were added : Benadryl and Wellbutrin. adverse events were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
twenty four hours after shot, sore on arm, and could not move it. Very fatigue, tired, felt ill with symptoms after shot. Missed several days of work.
Pharmacist on duty noticed patient was sitting in the observation area after her vaccine but did not look well. She seems pale and uncomfortable.  As he approached her , it appeared she was experiencing syncope. He immediately instructed the technician to call 911 while he stayed with the patient. She gained consciousness shortly after. Pharmacist estimates time line to be 3-4min patient experienced syncope. The patient refused care by the paramedics. She was well enough to go home with her husband shortly afterwards. the EMT team that arrived at the scene left as well.
When leaving office, 15 minutes after vaccines were administered. pt felt slightly light headed. Had pt sit down and v/s were taken. VSS HR 74 BP 11/66 RR 18 Sat 100%. Appeared a bit pale but regained full color within seconds. Pt given breakfast bar and apple juice, did not eat all day. 30 minutes after consumption of snacks and being monitored pt states "I feel back to normal". VSS HR 75 BP 115/64 RR 18 Sat 100%. No c/o SOB or any other sign of allergic reaction or acute distress.  Educated mother on s/s to report to MD, verbalized understanding. Pt left clinic with mother ambulatory in stable condition.
Pain Trapezius muscle distribution & lower cervical spine discomfort. No numbness or muscle weakness.
Menstrual period started 5 days early. Accompanying similar symptoms have occurred since including heavier cramping than normal, cramping between periods, spotting, low back pain, and mood changes.
Fever of 102 F at home patient given 1 dose Tylenol 0.4ml- Temp in office was 99 F and monitored in office with pulse and office and 4 hours  swell infection and at home and return to office for re-eval in 4 hours.
Narrative: Nausea and anxiety reported. Relieved by putting head to knee. BP 160/81, P 66, R 20, O2 sat. 97% at 1150; BP 153/74, P 51 , R 20 @ 1155; BP 127/75, P 51, R 18, O298%. Given water to drink; vital improved. Symptoms resolved and was monitored for 30 min.. Verbalized she felt better and was d/c'd to work. Documentation created by MA, RN on form and filed in medical file.
Headache, myalgias, abdominal pain, n/v, fatigue, leg cramps. Unable to perform ADL?s. One day so far.
I developed left arm site pain. I would say by the evening. Not  unbearable/ no meds for it. I woke up with trouble breathing 25th - used my inhaler 7 times that day. Increase in amount of post nasal drip and sinus congestion in my head. Which has previous triggered asthma attacks which has taken me to the hospital. I didn't have to go to Hospital. Was fatigued that day. Saturday, the 26th, I was feeling better. I was fatigued. I didn't have the extensive shortness of breath. 27th, I woke up with painful sinuses - I couldn't touch my face. Because there was a gap between that one day of symptoms - couldn't touch my maxillary - I did go get a COVID swab. They came back negative. I had to use my inhaler every day and continued with post nasal drip to the point I lost my voice for weeks. Which happens with post nasal drip because it irritates my throat. Nothing was taking care of it.I had a lot of thick phlegm. There is a lot of congestion in my sinuses which triggers my asthma. I did saline spray; allergy pills and there was such swelling in my sinuses -  nothing came out my nose - just went down my throat.  History of Atrial Flutter - I have been needed to shocked before but this was different. I had missed one of my meds that controls heart rate and not the rhythm - I went into the Atrial flutter - on January 19th - early morning. I took extra medication to chemically break it which it didn't do. it. After 8 hours, I didn't convert so I started Zyratol 20 mg daily - and I couldn't break and I continued to take an extra dose once a day of the Flecainide - I still didn't break. I stayed in it until the 23rd .  January 21st vaccine at 09:30 am.  I didn't go to the ER because I am use to trying to break it.  Talked to doctor on the Phone - around the 20th or 21st of January.
Refrigerator went in and out of range while there was flu vaccine in it. Doses were administered - no adverse event This spontaneous case initially received on 02-Nov-2016, was reported by a health professional and concerns an 77 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 08-Sep-2016, the patient received AFLURIA for indication not reported. Dose regimen: Not reported. Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.