chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:22 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:22 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 32.28.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-APR-2021, vial was moved to clinic on 15-Apr-2021. Vaccine BUD date was 09-MAY-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and the dose was drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566076 (Patient Link).
Chest pain; Chest tightness; Chest cramping; Shortness of breath; Lightheaded/dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Aug2021 12:00 (Lot number: FC3183) as dose 1, single and administered in arm left, administration date 12Sep2021 12:00 (Lot number: FF2587) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lyme Disease" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Naproxen, reaction(s): "Known allergies: Naproxen". The following information was reported: CHEST PAIN (non-serious) with onset 24Aug2021 20:30, outcome "not recovered", described as "Chest pain"; CHEST DISCOMFORT (non-serious) with onset 24Aug2021 20:30, outcome "not recovered", described as "Chest tightness"; MUSCLE SPASMS (non-serious) with onset 24Aug2021 20:30, outcome "not recovered", described as "Chest cramping"; DYSPNOEA (non-serious) with onset 24Aug2021 20:30, outcome "not recovered", described as "Shortness of breath"; DIZZINESS (non-serious) with onset 24Aug2021 20:30, outcome "not recovered", described as "Lightheaded/dizzy". The events "chest pain", "chest tightness", "chest cramping", "shortness of breath" and "lightheaded/dizzy" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of chest pain, chest discomfort, muscle spasms, dyspnoea, dizziness.  Additional information: Vaccine facility type was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Known allergies to Naproxen. Other medical history included Lyme Disease, Hypothyroidism, Fibromyalgia, Anxiety, Depression. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the event.  No follow-up attempts are possible. No further information is expected.
930 AM shot. Symptoms at 11. body aches, fever, chills, miserable
Temperature spike to 104.6; received first dose of bnt162b2 on 20Dec2020 and second dose on 08Jan2021 13:15; This is a spontaneous report from a contactable consumer. A 38-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration, on the left arm on 08Jan2021 13:15 at a single dose for COVID-19 immunization. Medical history included prediabetic kidney disease. Concomitant medications included salmo salar oil (OMEGA-3 [SALMO SALAR OIL]), lisinopril, furosemide, escitalopram, and rosuvastatin calcium (CRESTOR). The patient is reported to have received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Dec2020 15:45, on the left arm, for COVID-19 immunization. The patient had no prior Covid vaccination. The patient was not tested for Covid post vaccination. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient received first dose of bnt162b2 on 20Dec2020 and second dose on 08Jan2021 13:15. On 09Jan2021 at 04:30, the patient experienced temperature spike to 104.6, brought down with TYLENOL to hover around 101.0 to 102.0 for 24 hours, normal after that. The patient called a nurse who instructed to go the emergency room/physician office visit. Outcome of the event Temperature spike to 104.6 was recovered on unspecified date in Jan2021.  Information about lot/batch number has been requested.
On 8/28/2006 Patient complained of rash all over body, advised to see primary care physician.  Physician visit on 8/29/06, diagnosis of patient report of physician visit "toxic dermatitis".  The findings could be consistent with a diagnosis eruption or urticarial eruption.
Itchy mouth/neck.  No hives.  "Chest feel tight" Benedryl 25 mg given. itching decreased 11:14 B/P160/92, Pulse Ox 97%, RR14 and Pulse 71 11:24 140/82, Pulse Ox 98%, RR 12 Pulse 78 11:40 B/P 130/78 , Pulse OX 99%, RR 12 Pulse 77 Per RN observer patient felt fine when she left.  No symptoms.
A patient came in last night who had received his first shot over 1 year ago; This spontaneous report was received from a pharmacist referring to a male patient of unknown age.  The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On an unspecified date in October 2019 (reported as one year ago), the patient was vaccinated with first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis (concentration, dose, anatomical location and route of administration were not reported), the patient is about a year late for his second dose) (inappropriate schedule of product administration).
This spontaneous report as received from a healthcare Worker refers to a female patient of unknown age. On 08-SEP-2014 the patient was vaccinated with an expired dose of 0.65 ml ZOSTAVAX (lot # J003723, expiration date 28-JUN-2014), subcutaneous. No adverse effects noted by patient. The patient had not sought medical attention. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and rash. On an unknown date, the outcome of the influenza-like symptoms and rash were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that patient experienced flu-like symptoms for 3 days and a rash on the arm for 5 days. The pharmacist did not want to provide any further information. She stated that both, herself and the patient submitted a report to VAERS and she only wanted to discuss the questions she called in about.
I've had swollen lymphnodes in my clavicles, my neck, and underneath my chin since I received the second dose of the vaccine. I was giving four rounds of antibiotics from my doctor, but they are still here.
Migraine headache within 30 min of injection.  Fever, chills, body aches within an hour of injection. Nausea and vomiting about 14 hours after injection. Symptoms lasted for approximately 36 hours.
felt slightly fatigued; they had sore injection site arms; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INJECTION SITE PAIN (they had sore injection site arms) and FATIGUE (felt slightly fatigued) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 001B21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE and INFLUENZA VACCINE. Past adverse reactions to the above products included Fatigue with INFLUENZA VACCINE; and Vaccination site pain with INFLUENZA VACCINE.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, fourth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and fifth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (they had sore injection site arms) and FATIGUE (felt slightly fatigued). At the time of the report, INJECTION SITE PAIN (they had sore injection site arms) and FATIGUE (felt slightly fatigued) had resolved.        mRNA-1273 (Spikevax) (Intramuscular) and mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that, the patient received 5 Moderna vaccinations and had no side effects to the Moderna vaccine except they had sore injection site arms and felt slightly fatigued. "Just like with a Flu shot". Arm was sore for a day.   No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-710518, US-MODERNATX, INC.-MOD-2023-710735, US-MODERNATX, INC.-MOD-2023-710736, US-MODERNATX, INC.-MOD-2023-710737, US-MODERNATX, INC.-MOD-2023-710738 ( Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2023: Follow-up information included patient age group updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710518:Master case US-MODERNATX, INC.-MOD-2023-710738:5 out of 5 siblings US-MODERNATX, INC.-MOD-2023-710736:3 out of 5 siblings US-MODERNATX, INC.-MOD-2023-710735:2 out of 5 siblings US-MODERNATX, INC.-MOD-2023-710737:4 out of 5 siblings
pt devel a low grade fever 2 days p/receiving Typhoid vax; pt also devel a red welt 3inches @ the inject site which lasted 3 days;
pt found by mom shaking vigorously arms crossed & hands up to chin; pt was taken to hosp by ambulance; mom stated all kinds of tests were ran & everything was nl; mom also stated MD said did not think it was related to immun given;
This spontaneous report was received from a pharmacist regarding a 65 years old female patient. On 09-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot #, route, dose and expiry not reported). No concomitant medications were reported. On Sunday evening 11-NOV-2012, the patient experienced pain and redness at the injection site. No treatment was given for the adverse event. At the time of this report, she stated that she did not develop a rash, and that the pain and redness was improving. She has not notified her primary healthcare provider. The patient sought medical attention(consulted the pharmacist). Additional information is not expected.
pt recv vax 28OCT97 2PM & appearance of rash 29OCT97 generalized on extremities & trunk;seen by MD;rx of DPH;31OCT97 f/u recheck of rash-med change to atarax;
pt recvd vax; several hrs later, pt exp nausea, dizziness & weakness;
About 4 hours after patient received vaccine, she started feeling dizzy and short of breath. Mom states that she looked pale and the areas around her lips were cyanotic. She also developed a rash on her chest and face. Mom gave her benedryl twice. She also developed a subjective fever on the same day. Mom gave some Tylenol and it resolved. Has not come back.
Patient received expired vaccine on 14-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 14-Apr-2022) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 14-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 14-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Paxlovid for COVID 19 Treatment; Paxlovid for COVID 19 Treatment; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 80 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9263), in left arm, on 18Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 14Oct2021 as dose 3 (booster), single (Lot number: FF3590), in left arm for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid for COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, COVID-19. Paxlovid was given from 27Feb2023 to 03Mar2023 for COVID-19 treatment. Clinical course: The patient has no known allergies.
Pt was given influenza and Moderna booster vaccines at local pharmacy, 3 days later came into our clinic with lymph node enlargement and surrounding edema to L axilla.
There is a golf ball size lump at the injection site 5 days after vaccine. Not painful but has not gone away
Right arm & shoulder aches and get very sore and stiff Sense of taste & tough is way  off
On the 19th, arm hurt and underarm hurt - both left; chest hurt; cough and sore throat. Headache upon standing. Very tired. Skin felt bad. I couldn't do any sort of lifting and walking around was problematic. My eyes were sore. Breathing was frustrating. Smelled toast but there was no toast. A cough with chest pain. Ears hurt like there was fluid in them. My left hand started hurting with a pulsing sudden pain. Scratchy throat, jaw, teeth, neck and arm hurt - started in evening. That's when the pain behind my eyes (both) got persistent with movement.  The day after that, pulsing burning and intensely hurting boob pain on the left side. I yelled out when it occurred. Pain in head, ear, eye, shoulder, under arm and right knee; had an overall sunburnt feel in my skin.  Next day, a Thursday - Unwell feeling; sunburn feeling again and inside mouth peeling; headache continued; back of eye pain continued, difficult to sleep and everything felt bruised. Day after that, I had headache that was improving. GI issues: I couldn't eat - didn't sound good; Red, itchy bumps on face, jaw and neck - red and purplish. Almost a week later, woke with my finger hurting so bad - almost misaligned feeling and somewhat tingling. Monday night - especially the joint into my hand and it continued through Friday night when whole hand hurt. Saturday night - right hand still hurt. My pain had become restricted from the pain. The clicky middle finger hurt and other parts of my hand hurt, too. On 10/31 that continued and the bones in my legs hurt, and my right knee hurt; left boob outer pulsing pain came back. November 1st. Hand still hurt; teeth and bones hurt and lower back hurt and everything was still - unnecessarily. Hands got work into Tuesday. It was really difficult to write. It was hard to hold a pen - especially couldn't use the middle finger, stiffness in my arm as well. Teeth started aching. I was up awhile and needed to put heat packs on knees, ankles and I tried to ice my finger, but doctor told me not to. Woke up - similar feeling in joint as finger. I would have a hard problem moving. Overall, my bones still hurt. And overall stiffness. The hand and the middle finger hurt - it felt rubber bandy. And then my right eye started hurting again. I went to the doctor - NP - and she said that she didn't really think it was trigger finger (not an injury) and that it could be an auto-immune thing. She suggested I tell Rheumatology. It's better today but not better all the time. I have been having problems with both fingers - both into the hands as well. The clickiness in the finger but the pain in the joints is in the hands. Higher than normal heartrates - it may have been an issue that started after the flu vaccine (end of September 16, 04:00 PM)  that I had in the month prior to his vaccine.
C/O mouth dryness, dizziness, nausea after IM injection. Vitals obtained at this time/ V/S as follows BP143/88 HR67. SPO2 96% R/A. Patient currently under additional observation. Patient provided with water and cracker. Second set of vital at 9:35AM BP124/82 HR65 99% RA. Patient states she feel comfortable to leave. Patient advised to rest if feeling tired. Drink plenty of water. Take OTC pain med Tylenol or IBU per direction on bottles, if she has pain. Move the arm injection (Moderna) was provided in. Patient thanks writer for advise and for caring for her. Patient able to ambulate without assistance. Patient recovered from adverse event
Rash in circular type pattern on torso, front left below breast and a few other spots going to left of front torso. Rash was itchy and woke me up.
I got the shot and waited the 30 minutes since I tend to have adverse reactions, but nothing noticeable happened. I went to get a donut, drop something off with my partner's sister, then home to take a nap. All I had that day was a donut and water. When I woke up about 4-5 hours later my throat felt tight and like a more mild anaphylactic reaction than my really severe hospital one to triptans. I calmly went downstairs and took benadryl and waited around my partner a to see if it would improve which it did.  It ended up going away and I though nothing of it the rest of the day. I just had a sore arm for the next two days.  I also ate the rest of the donuts the following days and didn't have any reactions.
7/3-3 days post vaccine started having dry cough, tight chest, shortness of breath; heart flutters 7/11 urgent care visit- negative covid pcr test (2 days later) clear chest x-ray- give Steroid Dose Pack and cough medication 7/13 telemed with GP prescribed stronger steroid dose (10mg twice a day) 7/28 dry cough so hard throwing up, severe breathing issues visit to pulmonologist; she indicated that she believed it was a vaccine reaction as I suspected.  Started 40mg of prednisone daily and codeine to suppress the cough.  Breathing treatments. Referral to cardiologist. 8/3 Cardiologist appointment ordered echo cardio gram; acknowledged I  was on meloxicam for neck and prednisone from pulmonologist so no additional medication. 8/9 echocardio performed 8/16- Chest CT Emergency Room visit for chest pain 8/26 Cardiologist visit feeling no better prescribed colchicine .6 mg daily and ordered cardiac mri 10/14 Cardiac MRI performed; mild pericarditis with clinic symptom compare 10/28- Cardiologist appointment; requested I report issue to VAERS.  I feel better but not normal short of breath easily winded.  Chest is tight and cannot sleep on myside because of discomfort with heart.
below the site of injection on my left arm I have experienced swelling, redness, pain, warm and tender to touch. Started 2/10 the evening I received the vaccine very light systems, next day 2/11 it was worse and uncomfortable to sleep on the left arm that night. Day three 2/12 the spot had reduced in size and the pain, other than soreness when touched, had lessened.   On 2/17 the spot enlarged, redness increased and the pain and heat returned.  As of today 2/21 I am still having they symptoms.
arm felt feverish; flu symptoms; sore arm on the injection arm; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced arm felt feverish, flu symptoms, sore arm on the injection arm on an unspecified date. It was reported that after the first shot had flu symptoms for a week, and a sore arm on the injection arm. From the second dose had pain at the injection site. Arm felt feverish after both vaccines. The clinical outcome of the event was recovered for influenza on unspecified date in 2021; unknown for vaccination site pain and pyrexia.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information was expected.