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 an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 1:48 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 1:48 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, 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 87.46.  Concomitant medications were not provided.  On 12-Feb-2021, Excursion time was 10 AM and 11 AM, temperature was 35, total doses given for the day was 55, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 12-Feb-2021. 3 vials was sent to clinic. Vaccine BUD dates was 10-Mar-2021.  The vials were only punctured right before administration and all doses were 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 on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient was given the correct 0.25mL of preservative free flu and an extra 0.5mL dose of preservative free flu by mistake at the same office visit.
(Provider statement)Mother called last night around 7 pm complaining of pain, swelling, limping in right thigh.  She stated it looked bad so to take her to ER.  That would be a very expensive visit if they only say put ice on it.  I called her back and she didn't pick up so I went to ER AND COULDN'T FIND HER IN THE WAITING ROOM. i CALLED HER FROM THERE AND SHE PICKED UP AND SAID SHE WAS IN THEIR urgent care.  i WENT DOWN TO THE uRGENT cARE AND they let me look at her where there was a large, slightly tender red area anterior thigh. She was watching movies on mom's cell phone.  Mom told me she had just given Tylenol and was doing better. I told her give Motrin at 10:30 pm and I would check on her this morning. Mother told to draw a circle with black marker so we can see if spreading. Mother text me right when I was about to call her this morning a picture of injection site where redness is spreading.  I told her to come in this morning
Pt presented with abnormal redness and inflammation at injection site. Inflamed site was hot to the touch and pt complained of pain as well. Pt reported red border was continuing to expand and diameter at time of observation was about the size of a softball. Pt was advised to seek medical attention for possible infection. Pt returned after seeing a MD with a prescription for an anti-viral and an anti-biotic and was told she had shingles at the injection site by physician she was seen by.
significant pain; redness in arm; swelling in arm; felt burning; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccination (had the same symptoms as of Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, erythema of extremities, swelling arm and burning sensation. On an unknown date, the outcome of the pain in arm, erythema of extremities, swelling arm and burning sensation were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities, swelling arm and burning sensation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was in her late 60s or early 70s. The medical assistant reported to a field representative that she received Shingrix and felt burning right after the injection. She experienced significant pain, redness and swelling in her arm that she rated as grade 2. The symptoms resolved after 2 to 3 days. The patient has had the same symptoms with the flu vaccine in the past.
All of my bones hurt; Joints felt weak; Go in and out of chills; This spontaneous case was reported by an other health care professional and describes the occurrence of BONE PAIN (All of my bones hurt), ASTHENIA (Joints felt weak) and CHILLS (Go in and out of chills) in a  patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced BONE PAIN (All of my bones hurt), ASTHENIA (Joints felt weak) and CHILLS (Go in and out of chills). At the time of the report, BONE PAIN (All of my bones hurt), ASTHENIA (Joints felt weak) and CHILLS (Go in and out of chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  On third day of vaccination, patient did not had fever but had go in and out of chills. All of bones hurt and joints felt weak.
Some pain in the arm itself a few hours after the shot, but beginning in the afternoon fatigue began to set in. At about 9:30pm I had chills and fever-like symptoms all night. Body aches, headache, blurred vision and my teeth really hurt (a common fever symptom for me) I was tossing and turning all night and woke up at 3:30am,  shot up straight in bed and said, "Freedom!" (Ha, not sure if that was related to a dream? Weird for me! Hee.) I was feeling nauseous at that point and made myself some butter toast and was able to keep it down. Called in sick the next day and the symptoms started to dissapate around 3:30 pm the day after my shot. But, it was a rough time. Had a bit of stomach cramping and slight diahrrea the following day, as well.
Swelling of site injection for FLUVIRIN and PNEUMOVAX injection. Site warm to touch and fever over 102 degrees. Patient took TYLENOL, BENADRYL and cold compress to area.
muscle aches; hard shaking chills; chills; loss of appetite; tired/exhausted; nausea; body ache; leg ache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYALGIA (muscle aches), TREMOR (hard shaking chills), CHILLS (chills), DECREASED APPETITE (loss of appetite) and FATIGUE (tired/exhausted) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045821A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced PAIN IN EXTREMITY (leg ache). On 06-May-2021, the patient experienced MYALGIA (muscle aches), TREMOR (hard shaking chills), CHILLS (chills), DECREASED APPETITE (loss of appetite), FATIGUE (tired/exhausted), NAUSEA (nausea) and PAIN (body ache). At the time of the report, MYALGIA (muscle aches), TREMOR (hard shaking chills), CHILLS (chills), DECREASED APPETITE (loss of appetite), FATIGUE (tired/exhausted), NAUSEA (nausea), PAIN IN EXTREMITY (leg ache) and PAIN (body ache) outcome was unknown. Not Provided   Treatment information was provided i.e.,  Tylenol and Flexeril   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This spontaneous report as received from a Nurse practitioner refers to a 13 year old female patient. The patient's pertinent medical history and concurrent condition was not reported. On 30-NOV-2009, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported). The patient received the second dose of GARDASIL on 21-MAR-2010 and receive the third dose of GARDASIL on 22-MAR-2012 at another practice. The nurse practitioner was not able to provide the lot numbers and expiration dates of the doses of GARDASIL that had been administered because they were not transferred with the patient's records from the previous practice. The nurse practitioner reported that on 23-MAR-2016 the patient was administered a dose of GARDASIL 9 (lot number L043213, expiry 28-AUG-2017). The patient did not experience any adverse effects. No additional information was provided. Additional information has been requested.
Information has been received from a Nurse Practitioner (N.P.) concerning three patients who were vaccinated with a dose of Gardasil and developed genital warts within a short period. Additional information is not expected.
This was my booster shot after receiving J&J vaccine (I reported an adverse reaction to this as well).  Approx 2-3 hours after receiving vaccine, my throat began to swell shut and itch.  This was delayed compared to J&J. I immediately took two Benadryl and put my children on notice in case of worsening symptoms. The Benadryl was successful in stopping the swelling again.  The following week, I developed only one itchy red/ purple bump on opposite upper arm as opposed to the several within a day with initial vaccination.  Within days of the bump developing, my bicep area became very sore then began developing a red streak approx 4 inches long and warm to the touch. On November 17th, I went to the local ER . where they confirmed I had Acute Thrombosis of the Right Cephalic Vein. I asked about reporting adverse reactions and they stated they didn?t do that. Since then, I went to my hematologist.  I was advised to take 320mg of aspirin once a day for two weeks. He ordered another ultrasound since the clot had spread from 4 inches long to the distance between my elbow crease to close to my armpit completed 11/24.  I am awaiting his call regarding results.  Since that time, the clot has spread below my elbow crease towards my wrist and closer to my shoulder. It seems no one really knows what to do with this reaction. I am unsure what will happen if this continues to grow.
arm is still sore; can barely move it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is still sore) and MOBILITY DECREASED (can barely move it) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is still sore) and MOBILITY DECREASED (can barely move it). At the time of the report, PAIN IN EXTREMITY (arm is still sore) and MOBILITY DECREASED (can barely move it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was not reported. No treatment medication was not reported   This case was linked to US-MODERNATX, INC.-MOD-2021-042502 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-042502:Same reporter/Husband
The day after the shot I had a headache all day, and a fever of 102 degrees that came and went throughout the day. My shoulder muscle was a bit sore at the injection site. Chills came and went throughout the day as well. Then the following day (Monday) I was completely fine.
I started having cramping on the 11th, and then that got better. On the 14th, I started having bloody stools. I ended up in the hospital starting on 15th - 18th. GI Bleed - It was a lower one. Treatments  - Put me on antibiotics and I had to get two or three units of blood. Had a follow up with doctor - roughly, Feb 5.
Patient got 2 Pfizer shots at Kaiser and wanted Moderna as the booster. Patient said that his doctor wanted him had Moderna as booster. He was counseled with all side effects after the shots. While sitting in the observing waiting area, he felt dizzy and passed out briefly. His body muscle was jerking and wet his pants. He gained his consciousness after the pharmacist removed his mask. He was alert and answered all the questions. Ambulance arrived. The paramedics checked his blood pressure and blood glucose. His blood pressure was fine but his blood glucose was so low 35mg/dL. The paramedics injected him with Glucagon and gave him a sugar drink. His blood glucose was back to normal. His wife arrived and took him home. The pharmacist checked on him 4 hours later at home. He said that he was fine and just finished the conversation with his Kaiser nurse.
Pain, swelling, induration, edema, slight and redness and local vasculitis at the injection site, itch, inflammation .
8 Year-Old Male Received Heplisav-B; Initial Report Received on 25-Apr-2022  A registered pharmacist reported that an 8-year-old male patient (race and ethnicity unknown) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history at the time of vaccination was reported. The patient had no known allergies.  No concomitant medications at the time of vaccination were reported.  On 28-Nov-2021, the patient received a dose of HEPLISAV-B (Lot # 934601, expiration date 16 Mar 2022, NDC # 43528-003-05, route unknown) in the left arm by a pharmacist. No adverse reactions were reported.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Felt bad after shot. Went to eat at food court. Then went to car, shot was in the right arm, painful and hurt to try to raise her arm to the steering wheel. Started having neck pain within a few hours. This was Friday 3/4/2011. Called and saw me, Monday, 3/7/2011. Pain by Saturday very painful in neck and shoulders. Moved down spine but still worst in neck by Monday. By Tues hurting in left knee (replaced). No fever, didn't act meningeal, discussed with Health Dept on Monday, rheumatologist on Monday (patient refused steroids), Dr. (ID for the health dept) on Tuesday. He suspects rheumatological disorder flared by the flu shot, so did rheumatology. Friday 3/11/11 she had a temporal artery biopsy, which today came back negative. Seeing rheumatology for consult on 3/13/11.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP. A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 4 (booster), single (Lot number: CTH9703) at the age of 73 years, in left arm for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (3rd dose:, Date: 22Oct2021, number, lot number, expiration date: Pfizer FC3590.), administration date: 22Oct2021, when the patient was 72-year-old, for Covid-19 immunization; BNT162b2 (2nd dose:, Date: 23Feb2021, number, lot number, expiration date: EL9267), administration date: 23Feb2021, when the patient was 72-year-old, for Covid-19 immunization; BNT162b2 (1st dose:, Date: 26Jan2021, number, lot number, expiration date: Says Pfizer EL9265.), administration date: 26Jan2021, when the patient was 72-year-old, for Covid-19 immunization. The following information was reported: ADRENOMEGALY (non-serious), BREAST SWELLING (non-serious), outcome "not recovered" and all described as "adrenal glands under arm, breast, and arm became swollen"; BREAST PAIN (non-serious), outcome "not recovered", described as "soreness/in a lot of pain"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "adrenal glands under arm, breast, and arm became swollen"; SENSITIVE SKIN (non-serious), outcome "unknown", described as "noticed sensitivity"; BREAST MASS (non-serious), outcome "unknown", described as "breast lump". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of adenomegaly, breast pain, breast swelling, peripheral swelling, breast mass.  Confirmed all 4 doses were Pfizer. For dose 4 number, lot number, expiration date caller thinks, handwritten on vaccination card. Might have had a blood test but not much to do with this. Had no other shots that day. Had genetic testing done, but no results yet. No additional information provided. Any suggestions for what caller should do for this problem? This was a terrible way to feel after a month after getting shot, makes caller think caller could have breast cancer and then found lump.
Started getting red itchy bumps all over my body.  First noticed when I got home from work around 5pm.  Took Benadryl every 6 hours.  Bumps continued to get worse as the week went on.  They are on my arms, legs, tops of feet, chest, and stomach.
The week of the injection I had headache, fatigue, and a constriction high in my chest if I breathed in deeply. The restriction in my chest continued past the first week but did not interfere with aerobic exercise even when it developed into an intermittent small cough. Seven weeks later, I felt very fatigued, sick. At urgent care, based on a chest x-ray, I was diagnosed with pneumonia and prescribed an antibiotic. A week later, I returned to urgent care because I felt my lungs were not healed, and I was told that it had not been pneumonia after all. This was after a second x-ray which still showed fuzziness and cloudiness in my lungs. All lab tests were normal except for c-reactive protein, which was 43. I use an inhaler 2x a day (abuterol), which helps to open my bronchioles. I am still fatigued and must ration my activities each day to allow for hours of rest.
This spontaneous report as received from a practice manager refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-FEB-2017, the patient was vaccinated with an expired dose of VAQTA (formulation, dose, frequency, route of administration and anatomical location of administration were not reported) lot # L031196, expiration date 05-FEB-2017, for prophylaxis. No adverse effects were reported. Product quality complain was not involved. Additional information has been requested.
Crying for 36 hours, high pitched whining, fever 102 degrees, mild diarrhea. Slept only 3 hours night of 5-16-07. No bottle on 5-17-07. Visited doctor on 5-17-07.
Several Hours after receiving Prevnar, developed redness, Swelling at site. No other symptoms. was seen in office the next day. PE c/w above. Was recovered by 08/04/2005
Swelling and Redness; (R) arm - 3.5 in x 2 3/4 in; (L) arm - 30 mm x 26 mm.
I received sharp chest pain in my upper chest on the left side and later the right side.  I also started to have some dizzy spells when I would go to stand up suddenly. A couple of weeks later I received some numbness and soreness in both my legs. All of these pains would come and go regularly and started to subside over time.  I did not think this was related to the shot at the time. I went to see my doctor after 2 weeks and she thought it was muscle related so I have been going to physio but they felt that these reactions were not related to normal muscle problems (especially the sharp chest pains). I am reporting now because I read about possible heart inflammation issues recently and thought maybe this may be related but I am not sure.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age who on an unknown dates, were vaccinated with an unspecified number of doses of ROTATEQ (doses, routes and lot numbers not reported) that were exposed to 20C for 15 hours on 17-FEB-2014 and an additional excursion of 14C for 19.5 hours beginning on 01-MAR-2014 which was supported. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Pt recvd 3 vaccines within 6 months & did not seroconvert p/ 3 doses. Booster vax given.
only reactions seem to be itching w/ a little painful swelling of lymph nodes;little red spots that looked like pimples on face, lumps under armpits, jaw, under ears , hives where pt. scratched
I developed a cough on or about beginning of May 1, 2021. After accidentally double dosing myself with my ACE inhibitor I went into the ER on 5/11 with light headedness/high heart rate and cough. After multiple tests were done it was  discovered that I had a large satellite embolism. in my lung and another one in my left leg.
VACCINE ALMOST KILLED; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine almost killed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine almost killed was not reported. This report was non-serious.
Started having episodes of light headedness, dizziness, palpitations.  Went to ER on 1/23 and 1/30 noted to be in bigeminy both times.  Episodes resolved within 1 to 2 hours.  However occurred multiple times a day in the following weeks.
After 2nd dose chills started in middle of night. Experienced severe nausea, diarrhea, vomiting with extreme pain in lower back and hips. Intense headache that lasted for over 1 week close to 2 weeks causing me to have to call off work. Large painful lump in left axilla that lasting 2 weeks. Axilla remains to be tender to touch. Also, had sweats after the chills subsided.   Thought that my blood pressure was elevated, but now I am relating the elevation  to the 1st injection. I have never had hypertension and after 1st dose blood pressure went as high as 160/104.