chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am writing because this is the second time it happens, and my doctor treats like nonchallant.  It happened when I got the first shot of VARIVAX (June 26, 2020), I broke into bump symptoms that look like chicken pox, they were raised fluid bumps a few, no more than 10 spread around my chest, neck and head. They did not itch or burn, only lasted for 5 days and were gone.  I let the time passed and got the 2nd dosage, though it was not within 60 days, the nurse said it was ok. So, I got the 2nd dosage for the VARIVAX - nothing happened in the office, I went home and  continued with normal activities. It was not until almost 2 weeks later that I started to itch, at first I didn't pay much attention but as the days went by it started to itch more. First started in my stomach, then it spread to my side trunks, then to my armpits. It is raised looked like hives - hot the touch. It started to itch, and more started coming out. It is now... on both arms, sides, butt, armpits. See pictures attached, they itch, very itchy.  I called my doctor, but he didn't do much... he just said I had a reaction to the vaccine and that it will go away. Then, he said he would call a dermatologist but so far have not heard anything. I have been taking Benadryl but that doesn't help so I stop taking it, then I put calamine lotion but that only helps for 5 minutes then it itches again.  I have pictures that I took that I would like to share.
1:30 Pt called after driving back to school. Pt reports dizziness, dry mouth, cool clammy    2:30 Pt called back reports she is without above s/s and BP is fine and is no longer having problems.
upset stomach , follow by Blacking out, red rash noted on chest. taken to  ED after epi given . employees symptoms persisted for hours  and included vomiting..
COVID-19 infection in October; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19 infection in October) in an elderly male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 infection in October). At the time of the report, COVID-19 (COVID-19 infection in October) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information Regeneron was provided.. This is a spontaneous case concerning a elderly male patient of unknown age with no reported medical history, who experienced the non-serious  unexpected event of special interest COVID-19. The event occurred on an unknown date after vaccination with mRNA-1273. Patient received Regeneron as treatment.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a elderly male patient of unknown age with no reported medical history, who experienced the non-serious  unexpected event of special interest COVID-19. The event occurred on an unknown date after vaccination with mRNA-1273. Patient received Regeneron as treatment.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
pt recv vax 27FEB98 & c/o  of not feeling well, but remained in class the rest of the day;@ dinnertime mom states temp 102 c/o sore throat & cough;pt wheezing given med;c/o tightness & diff breathing;had trouble controlling asthma sx;
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown demographics. Since 05-MAY-2014 the patients were vaccinated with PNEUMOVAX 23. The reporter stated that on 05-MAY-2014 onwards her refrigerator and freezer units began to have temperature excursions and PNEUMOVAX 23 was improperly exposed to 29F for multiple unspecified excursions (many more than 2 cycles into the freezing range), and also to 49F for 12 hours. No known adverse effects. Lot # and expiration date of PNEUMOVAX 23 was unspecified. All of the data listed here was reconfirmed with the reporter. No further information was available at the time of this report. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
soreness in left arm; back pain; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in left arm), BACK PAIN (back pain), HEADACHE (headache) and FATIGUE (fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in left arm), BACK PAIN (back pain), HEADACHE (headache) and FATIGUE (fatigue). On 11-Feb-2021, PAIN IN EXTREMITY (soreness in left arm), BACK PAIN (back pain), HEADACHE (headache) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product also include cholesterol med, hypertension medicine.  Treatment information was not provided.
The Tuesday after vaccination, I had physical discomfort and pain inside like period cramps. It felt like there was a tampon inserted weirdly, I tried a yeast infection solution with yogurt on a tampon. Later that week I had pelvic bone pain like I had strained to hard using the bathroom. Friday I got a hyper sensitive spot on upper right thigh, diagnosed as paresthesia,  the swelling and discomfort around pelvis was still there. Saturday the swelling and discomfort on the insides started going down, both legs experienced pain, It felt as If I had done a workout and pulled my muscle.  I typically have a high threshold for pain, No change on Sunday. Monday the back of right knee stated aching, sensitivity in left thigh. Both muscles on outside of legs felt like I had done a workout and needed stretched, On the 13th the aching traveled from the back of knees to calves I went to the Hospital. Myalgia and paresthesia and acute vaginitis. Shot of Toradol in left arm, which did nothing. Did ultrasound with normal results, no blood clots. The 14th my legs were comfortable as long as I was moving, started having a sharp stinging in left calf. The soles of my felt felt blistered but no visible blisters. Significant headache. I wore compression socks. I got a weird Charlie horse in left foot toes, top of right foot got really sensitive also. Volotoral is a topical pain cream that I had I used it on specific areas, of pain. Thursday the 15th the left outside of my foot was still sore, my calves had gotten better, the outside of the calf still had hypersensitivity.  The muscles on the back of my knee's and calves were still sore. While driving my Hip and thighs for aching. Ankles are popping a lot. Fri-Sun following I had leg stiffening and muscle soreness mainly in the left side, went for a walk that weekend and while walking they felt ok, until I stopped walking. Mon-tue after I had a headache that felt like my brain was burning near the left temple area.
This spontaneous report as received from a nurse refers to a 14 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 08-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N019923, expiry date: 28-APR-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: US-009507513-1709USA007012: US-009507513-1709USA007011: US-009507513-1709USA007014.
Administered orange cap Pfizer of 0.2ml to a 14 year old.  Monitored for 15 minutes afterwards. No side effects noted or reported.
DVT left leg requiring surgical procedure 04/13/2021. Went to ED on 4/12/2021 with severe leg pain, warmth of area.
Patient's mother reported child got a big red rash on left arm after flu shot. No pain or itchiness.
Major soreness at site of injection, chills, fever, back pain, soreness and muscle aches all over
Starting 2 weeks after receiving the vaccine, I woke up with an itching sensation and slight burning in my left eye. 2 days later, it continued to get red and puffy. So, I went to the optometrist and they gave me an antibiotic eye drop. 2 days later, it got worse and my face started swelling and my eye was very painful. I went back to the optometrist and they sent me to an eye specialist. Doctor's associate saw me and started me on another antibiotic eye drop. She had me see the other doctor a few days to a week later. Then I started seeing him every 2 weeks until recently. He ended up putting me on oral prednisone and prednisolone eye drops. He diagnosed it as scleritis.
Loss of appetite; weight loss; weariness; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Er5218), via an unspecified route of administration, administered in left arm on 25Jan2021 (at the age of 78-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history includes asthma, hip replacement, arthritis and high cholesterol from an unknown dare and unknown if ongoing. The patient previously took clindamycin and experienced known drug allergies. Concomitant medications included ibuprofen 400 mg (MOTRIN [IBUPROFEN]), simvastatin 20 mg (SIMVASTATIN) and vitamin D NOS (VITAMIN D NOS) all were from an unspecified date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Jan2021, the patient experienced loss of appetite, weight loss and weariness. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for adverse events and the treating medication was ferrous sulfate 325 mg twice daily. The clinical outcome of the events loss of appetite, weight loss and weariness were not recovered.  No follow-up attempts are needed. No further information is expected.
Inadvertently administer the vaccine 11 days after expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administer the vaccine 11 days after expiration date) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 071F21A, 013A21A and 012M20A) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products.  Previously administered products included for Drug use for unknown indication: TDAP (0.5ml and right deltoid.) on 22-Nov-2021. Past adverse reactions to the above products included No adverse event with TDAP.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administer the vaccine 11 days after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administer the vaccine 11 days after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Date the vial  initially stored in the refrigerator was 27-May-2022 and the vial had not undergone any temperature excursions.  No treatment information was provided.
This is a spontaneous report from a contactable consumer reporting for himself. This 75-year-old male patient received in Nov2017 (about a week and a half before this report) a single dose of PREVNAR 13 in the left arm as recommended by doctor. Medical history and concomitant medications were none. On 11Nov2017 the patient experienced leg pain and knee joint pain. Outcome was recovering. Course of the event was described as follows: Patient started having pain after waking on Saturday, 11Nov2017. He described it as being gradual, similar to pain from exertion like shin splints or nerve pain. Both legs were affected.
I received fatigue; severe cough; severe sore throat; congestion; runny nose; fever for 6 weeks and loss of voice for 3 days. I took PAXLOVID. As of now I still have fatigue and cough.
This spontaneous report was received from a healthcare student concerning an approximately 42 year old female patient. It was reported that the patient never had chickenpox but experienced outbreaks of shingles "every few months" since an unspecified date. The patient had no drugs reactions or allergies. "About 5 years ago, maybe longer" in approximately 2010, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not provided) at an age younger than 50 years old, with the intent of stopping the shingles outbreaks. However patient continued to develop outbreaks of shingles "every few months" since an unspecified date after receiving ZOSTAVAX. The patient was given acyclovir (manufacturer unknown) as treatment for the shingles outbreaks. It was reported that patient had "just gotten over" her most recent outbreak (unspecified date). The patient sought medical attention by visiting her physician. Additional information is not expected because there is no consent for follow up.
soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in her arm). At the time of the report, PAIN IN EXTREMITY (soreness in her arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant product use was not provided by the reporter.   Treatment information was not provided.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Jan2021 as dose 1, single (Lot number: fc3184), on 07Feb2021 as dose 2, single (Lot number: e19269) and on 16Sep2021 as dose 3 (booster), single (Lot number: e18982) for covid-19 immunisation. The patient's relevant medical history included: "pollen allergies" (unspecified if ongoing); "frequent sinus infections unless diligent with care" (unspecified if ongoing), notes: Other medical history: frequent sinus infections unless diligent with care. Concomitant medication(s) included: LEXAPRO; ESCITALOPRAM; ASPIRIN 81; COQ10 [UBIDECARENONE]; HYDROCHLOROTHIAZIDE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jun2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jun2022) Positive, notes: Began Paxlovid day first tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Report about covid treatment reported as Yes. If vaccine received and Other medication in 2weeks reported as Yes. Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 08Jun2022, Treatment stop date: 13Jun2022, Indication: Treatment of COVID-19. Known allergies reported as No. Adverse event reported as Began Paxlovid day first tested positive. Fever resolved within a few days and feeling better each day. Today is day 10 and fever and tiredness has returned. Cough has been consistent however has gotten better over time.  No follow-up attempts are possible. No further information is expected.
Expired vaccine used; Incorrect product storage; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Incorrect product storage) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Incorrect product storage). On 15-Oct-2021 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Oct-2021, PRODUCT STORAGE ERROR (Incorrect product storage) had resolved. On 15-Oct-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  Moderna vials were in refrigerator when was discovered the refrigerator door was slightly agar. The data  logger showed that temperature was out of range at 10 degree Celsius for 1 hour and 20 minutes. The door was immediately closed and temperature retuned to normal. Patient did not experience any side effects.
she tested positive; she tested positive; 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. Other Case identifier(s): US-PFIZER INC-202200229279.  A 78-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: PHENYLEPHRINE taken for nasal congestion; CEPHALEXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative; positive.  Additional information: Additional information: The patient first stated already having two COVID 19 Vaccines and booster dose almost 4 months ago (no brand stated). She had annoying dry eyes, a mild headache and that her throat still hurt with the same intensity as previous to treatment. She said she usually works with special education kids as a volunteer, which causes her to regularly get bacterial infections and she stated not being completely sure at first if she was having this infection or COVID-19, but that her Doctor was on vacation and she was left in charge with a Nurse Practitioner who didn't believe she had a bacterial infection and refused to perform a throat culture on the caller. The patient stated a discomfort with the treatment received with by the Nurse Practitioner, so much, that she stated that she preferred going to an emergency room or waiting for her doctor to return, instead of asking him for assistance. She then stated that she lives in causes her to have allergies that just keep getting worse and worse, but that she takes phenylephrine tablets for nasal decongestion, which she stopped after starting her treatment with Paxlovid. She stated that the symptoms that she described could be cause by not taking her medicine, but that she wasn't sure and that that's why she was calling. She also said that, since at first, when she tested negative for COVID-19 and thought it was a bacterial infection, she went to her medicine cabinet and started taking Cephalexin. The patient was tested positive and her doctor, who was unavailable until 22Feb2022, started her on Paxlovid. she stopped the antibiotic. Then she stated that the first 2 days after started the antibiotic and previous to the treatment with Paxlovid, she felt her chest and throat much better, like if they were being freed.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Redness, tenderness and slight swelling at injection site. Patient reports arm was still swollen a week after injection
This case was reported by a consumer and described the occurrence of back pain in a patient who received SHINGRIX for an unknown indication. On 16th November 2018, the patient received SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced back pain, headache, chills and injection site reaction. On an unknown date, the outcome of the back pain, headache, chills and injection site reaction were unknown. It was unknown if the reporter considered the back pain, headache, chills and injection site reaction to be related to SHINGRIX. Additional details were reported as follows: The patient experienced injection site reaction 2 by 3 cm. The reporter in this case agree to be contacted by GlaxoSmithKline to follow up.
pt recv vax;devel severe HA;tx w/ meds;exp soreness at inject site & flu like sx;HA & flu like sx persisted for 1 wk;
Patient stated that on 08/05/2020 in the morning they experienced nausea/ fever which lasted until 08/07/2020.  starting 08/07/2020 patient stated that their left arm got "hot to the touch" , started itching, and was red.  Patient reported that the itching spread to her whole body starting 08/11/2020 and has persisted and not diminished.  Patient stopped by the pharmacy 08/20/2020 at 6 pm and reported the side-effects to the pharmacist on duty.  Patient was counseled to seek immediate medical attention which the patient stated that they did not want to go see a doctor they would just buy Benadryl.  Patient bought Benadryl and left the store after repeatedly being told to seek immediate medical attention.
Extreme fatigue, some dizziness, lasted for multiple days.  Not bad enough to skip work but was not very productive during, avoided extra activities and slept instead.  Also delayed my period by 7 days.