chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. It was reported that the data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter also stated that no adverse reactions were reported by any patients. The reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion.No adverse event was reported by patient.  Treatment information was not provided.
Painful swelling and rash in left armpit and chest; Painful swelling and rash in left armpit and chest; Painful swelling and rash in left armpit and chest; Painful swelling and rash in left armpit and chest; This is a spontaneous report from a contactable consumer reported for himself. A 40-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration administered in left arm on 07Jun2021 at 13:30 (at age of 40-years-old)  as dose 2, single for COVID-19 Immunisation. Patient medical history  and concomitant medications  were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration, administered in left arm on 17May2021 at 13:30 (at age of 40-years-old) as dose 1, single for COVID-19 Immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within two weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 08Jun2021 at 7:00 ( 1 days after vaccination) Patient experienced painful swelling and rash in left armpit and chest. No treatment received by patient to events. The Outcome of events was not Recovered   Follow-up (14Jul2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to HCP letter sent via telephonic follow-up activity that included:  No information was obtained.  Information on the Batch/Lot number has been requested.
chills; fever; dizziness; splitting headache; lung symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (chills), PYREXIA (fever), DIZZINESS (dizziness), HEADACHE (splitting headache) and DYSPNOEA (lung symptoms) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (fever), DIZZINESS (dizziness), HEADACHE (splitting headache) and DYSPNOEA (lung symptoms). At the time of the report, CHILLS (chills), PYREXIA (fever), DIZZINESS (dizziness), HEADACHE (splitting headache) and DYSPNOEA (lung symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
inc temp, vomiting 1 hrs p/inject; vomiting & fever cont thru next AM; abdo pain, int temp & severe h/a persisted; pt refused foods & fluids; mom denies prob w/prev inject; pt taken to ER told may have virus;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 at 08:00 as dose 6 (booster), single (Lot number: GH9694) at the age of 49 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NP THYROID; DULOXETINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Sep2022) Positive, notes: COVID; (05Oct2022) Negative; (08Oct2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did received other medication in 2weeks. The patient received the COVID 19 Treatment, brand=paxlovid, treatment start date/stop date- 28Sep2022/03Oct2022 and lot number: 1918530A. Patient tested positive for COVID on 28Sep, started Paxlovid 28Sep, tested negative 05Oct, and now just tested positive again on 08Oct. And not only me, but my husband as well. (Same dates as above for him, except he first tested positive on 27Sep. The Seriousness criteria-results did not result in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating, congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Injection 7/29/10 1140 3 immun. given Varicella - (L) arm Hep. A (R) arm and MENACTRA (R) arm. Dad called with swelling , redness, at injection site on (L) arm. Advised BENADRYL OTC and apply ice / ice pack to area.
Second Mondera vaccine was administered approximately 10:00 am by pharmacist.  About 5 minutes later she quickly left the waiting area to get to the bathroom where she vomited and returned to the waiting area with the pharmacist (who had followed her) and sat back down with a bottle of water she was given.  Within 5 more minutes she began complaining of pressure in her chest followed very soon by obvious distress in her breathing (wheezing and gasping).  EMS was called and 0.3 mg of epinephrine was administered from a prefilled auto injector at 10:14 am.  Pharmacist stayed with her to observe breathing status which improved but chest tightness continued.  EMS arrived and transported her to ED.
This spontaneous report was received from a registered nurse refers to a 3 year old female patient. The patient's concurrent conditions and medical history were not provided. On 26-AUG-2015, the patient was inadvertently vaccinated with an unspecified dose of PNEUMOVAX 23, injection, 0.5 ml (route of administration, anatomical location, expiration date and lot number were not reported) instead of PREVNAR. No adverse effect was reported. There were not concomitant medications reported. The patient was at the physician office for medical attention and she did not received any treatment. There was not product quality issue involved. Additional information has been requested.
I had a tight feeling in my chest and I had SOB. These symptoms lasted about 2 days.  I went to the urgent care.  They prescribed me medication and an inhaler. They also tested my for COVID-19 test, negative result.   I am at my primary care to get a chest x-ray today.
Hives started from neck to chest, started next morning after dose, and lasted 4 days. Treated with LORATADINE.
Patient developed tachypnea 5-10 minutes after vaccinations. Evaluated by EMS. SpO2 100%, HR 90-100, BP 200/? RR 20s. Lungs were clear on exam. No wheezing, no edema around the mouth/lips/tongue/uvula. No rash. Pt transported via EMS to  Hospital
Sharp stabbing pain like someone stabbing her in the back; Back muscles hurt; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Sharp stabbing pain like someone stabbing her in the back) and MYALGIA (Back muscles hurt) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Sharp stabbing pain like someone stabbing her in the back) and MYALGIA (Back muscles hurt). At the time of the report, BACK PAIN (Sharp stabbing pain like someone stabbing her in the back) and MYALGIA (Back muscles hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported
Equilibrium problems since vaccine; Bad back; Alot of headaches; Arm red; Arm sore; Arm swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BALANCE DISORDER (Equilibrium problems since vaccine), BACK PAIN (Bad back), HEADACHE (Alot of headaches), VACCINATION SITE ERYTHEMA (Arm red) and VACCINATION SITE PAIN (Arm sore) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 VALACYCLOVIR [VALACICLOVIR] for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced BALANCE DISORDER (Equilibrium problems since vaccine), BACK PAIN (Bad back), HEADACHE (Alot of headaches), VACCINATION SITE ERYTHEMA (Arm red), VACCINATION SITE PAIN (Arm sore) and VACCINATION SITE SWELLING (Arm swollen). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Vaccination site pain and Vaccination site swelling, at an unspecified dose and frequency. At the time of the report, BALANCE DISORDER (Equilibrium problems since vaccine), BACK PAIN (Bad back), HEADACHE (Alot of headaches), VACCINATION SITE ERYTHEMA (Arm red), VACCINATION SITE PAIN (Arm sore) and VACCINATION SITE SWELLING (Arm swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had injections in her spine. Other concomitant medications included steroids for spine. Treatment also included ice for sore and swollen arm.; 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.
Patient experienced swollen lymph nodes on left collar bone and under left arm pit. Nodes could be seen and felt. The node under the arm pit was also painful to the touch. Patient experiences also experienced soreness on the left side of her neck and left side at the base of the neck; however, no swollen lymph nodes could be felt in those last two locations.
I developed hives all over my body. I was taking a steroid dose pack for my symptoms.
Client made a phone call to clinic on 8-31-09.  States she received HBV #2 & TDAP vaccine on Friday 8-28-09.  Last night, 8-30-09, developed a rash (itchy) starting on chest moving towards stomach - back then arms & legs.  Took P.O. BENEDRYL slept well and woke up & red was gone.  Denies fever, n/v.  Never experienced this before with vaccines.  No other changes noted with personal products or med. changes.
On 03/14/2021 I started having chills and flu-like symptoms at night four days after my vaccination. Normal side effects but I was concerned since it was days after and my heart was racing and my pulse was up to 164. I was feeling like I had the flu, the next day I had a telehealth visit on the 15th and my doctor was concerned if I had Covid. I had a test and it was negative. My symptoms continued for 4 days until the18th. My doctor told me to just take ibuprofen or Tylenol as needed and doctor told me it wasn't unusual to have symptoms days later but I was concerned about my heart racing. I have had three miscarriages was in October 2021, second was in December 2021, and then most recent was beginning of February 2022. I had no problems getting pregnant before and she was born in 2019 full-time.
herpes genitalia.; herpes simplex on her lips; This case was reported by a consumer and described the occurrence of herpes simplex labialis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2020, the patient received the 1st dose of Shingrix. On 17th October 2020, 5 days after receiving Shingrix, the patient experienced herpes simplex labialis. On an unknown date, the patient experienced genital herpes. On an unknown date, the outcome of the herpes simplex labialis and genital herpes were unknown.   It was unknown if the reporter considered the herpes simplex labialis and genital herpes to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix and about 5 days later she started to have herpes simplex on her lips and a few days later herpes genitalia.  The patient did not want to provide her date of birth or address. The reporter did not consent to follow-up.
Information has been received from an unknown type reporter referring to a 24 year old female patient. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route were unknown) (inappropriate schedule of drug administration). The patient's concomitant medication was not reported. No adverse reactions occurred. Additional information has been requested.
32/89 pt failed to maintain adequate titers 27mo post vax w/Rabies vax
little bump at the injection site; swollen lump; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE MASS (non-serious) with onset Dec2021, outcome "unknown", described as "little bump at the injection site"; VACCINATION SITE SWELLING (non-serious) with onset Dec2021, outcome "unknown", described as "swollen lump".  Additional information: Patient asked had anyone else reported a little bump at the injection site. How long will it last. Caller further describes that as a swollen lump. Patient received her 1st Pfizer BTC vaccine (12 and older, purple cap formula) dose last week. It was reported that Across both age groups, 18 through 55 years of age and 56 years of age and older, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days), for redness 2.6 days (range 1 to 34 days), and for swelling 2.3 days (range 1 to 34 days) for participants in the Pfizer-BioNTech COVID-19 Vaccine group. The mean duration of pain at the injection site after Dose 1 was 2.4 days (range 1 to 10 days), for redness 2.4 days (range 1 to 16 days), and for swelling 1.9 days (range 1 to 5 days) for adolescents in the Pfizer-BioNTech COVID-19 Vaccine group.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flu shot received on 9/15/2014 and patient returned to the pharmacy on 6/03/15 to let us know that he thought he had a reaction to the flu shot he received 9 months before.  He said that the night the shot was given to him that his arm was sore and a little swollen, but he was still able to bike 40 miles that evening.  He said the next day he experienced "flu-like" symptoms including dizziness.  He has been going to eye movement training the past few months (not related to the dizziness) and recently (within the last month) has discovered he has a detached retina in his right eye.
Information has been received from a health professional concerning a female who in approximately December 2007, was vaccinated with her first dose of Gardasil.  Within 20 minutes of receiving the dose, the patient experienced abdominal cramping and vomited.  Subsequently, the patient recovered from abdominal cramping and vomiting on the same day.  She sought unspecified medical attention.  Additional information has been requested.
pt recvd vax 3PM on 23OCT95 @ around 9PM was not feeling well, heart rate inc sl itching of arms, chest area;around MN had inc itching & rash on arms, hands, inc HR & apprehension;no noted SOB; also quite warm & then had chills;
MENACTRA given left upper arm 3/18. Increased redness and swelling around site 3/20. 7"x7" warm, firm with vesicular lesions in center, with crusting.
Mouth pain; tooth pain; Dysphagia; blisters on top of mouth; painful blister; itch over majority of body; Nodule at injection site; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site nodule in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2022, the patient received the 1st dose of Shingrix. On 10th March 2022, 1 days after receiving Shingrix, the patient experienced fever. On 14th March 2022, the patient experienced injection site nodule. On 15th March 2022, the patient experienced localized itching. On 17th March 2022, the patient experienced blistering of mouth and pain. On 18th March 2022, the patient experienced oral pain, toothache and dysphagia. On an unknown date, the outcome of the injection site nodule and localized itching were recovering/resolving and the outcome of the fever was recovered/resolved and the outcome of the blistering of mouth, pain, oral pain, toothache and dysphagia were not recovered/not resolved.   It was unknown if the reporter considered the injection site nodule, fever, localized itching, blistering of mouth, pain, oral pain, toothache and dysphagia to be related to Shingrix.  Additional details reported were as follows: This case was reported by the patient. The patient received Shingrix in the right arm. After receiving Shingrix, the patient experienced fever. The fever lasted approximately two days.  Five days after receiving Shingrix, the patient experienced nodule on the right arm at the injection site. The nodule was still present but was gradually getting smaller. Six days after receiving Shingrix, the patient experienced an itch over the majority of their body including on the arms, legs, back, and head. The itch was ongoing but gradually improving.  Eight days after receiving Shingrix, the patient experienced blisters on the top of the mouth and blisters were painful.  Nine days after receiving Shingrix, the patient experienced mouth and tooth pain they believe was associated with the blisters.  Nine days after receiving Shingrix, the patient experienced difficulty in swallowing. The consent to follow up was given Vaccine was administered by pharmacist.
I started to develop congestion in the back of my throat and a postnasal drip. By Saturday, the cough started it was not a productive cough. It was a hard cough. I went to the urgent care. The doctor gave me a Z-PAK and antibiotic, azithromycin 250 mg tablet, for 5 days. And albuterol HSA PROAIR inhaler. The congestion went away but I could not shake the cough. On 11/09/2022, I went to my doctor, and she amoxicillin ClAZ875, 125 mg tablet and also a cough medicine promethazine CM 6.25. I have been taking those 2 medicines since 11/9/22 and I am still taking it now. It has helped greatly, but I still have it a little bit.
8 hours post-vaccination:  Severe chills (teeth chattering) followed by a wave of muscle spasms from left shoulder and scapular region, into neck traveling across to the right shoulder and scapular region, down arms, down back to hips, legs and feet.  This was followed my deep aching into every joint.  In the areas of my body that had previous injuries, the pain was worse.    12 hours post-vaccination:  Chills stopped, aching and spasms continued.  It felt like my insides were on fire.  Loss of balance when attempting to walk, weakness.  15 hours post vaccination:  Aching, ,spasms, weakness and balance issues resolved.  Temperature elevated to 99.6 and severe headache began.    19 hours post-vaccination:  Headache resolved but nausea and diarrhea commenced.    24 hours post-vaccination:  All symptoms resolved except elevated temperature.  36 hours post-vaccination:  Temperature continues to be elevated at 99.1.  No other symptoms.
Vaccine 2/2 @09:20am Pain at injection, unusual   2/2@ about hour after Arm sore all day, felt bruised at site, slight headache  2/3- am -Felt like body wasn?t straight, angling to the right side -stiff neck, feel wiggling down mid spine  -headaches  -neck pain -arm pain Noon-rest of the night  -nausea  -arm pain -stiff neck -light headed  2/8-mid day- all day -Neck stiffness -Pain to rotate left to right, up and down ?mostly looking down -Pain in mid upper back, feels almost on spine a little to the left  -headaches    2/9- am -Injection site red and puffed up  and increased in size -Headaches -site is a little itchy PM- all night -nausea -light head -feeling like I need to vomit  -site is warm to touch -burning sensation, Still itchy. -redness spreading larger
9/20 onset of numbness, low back pain; 9/21 admission to hospital and start IVIG x 5 days; 9/27 start plasma exchange x 5 days; 9/26 BiPAP 9/27 mechanical ventilation x 16 days 10/13 PEG and trach for discharge to LTAC. Acute inflammatory demyelinating polyneuropathy/GBS. Office of vaccine administrator was contacted about reaction. Info about vaccine date of admin, type, lot, exp was provided. They gave no indication of plan to submit a VAERS report but they may.