chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine expired on 03-Oct-2021 and then stored in refrigerator on 04-Oct-2021; expired dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 03-Oct-2021 and then stored in refrigerator on 04-Oct-2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 03-Oct-2021 and then stored in refrigerator on 04-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 03-Oct-2021 and then stored in refrigerator on 04-Oct-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided. The patient received the booster dose of vaccine. No adverse event was reported. The vial had not undergone any temperature excursion issue. The vial was initially placed in the refrigerator on 04-Oct-2021. Many doses were administered from expired lots due to confusion with the expiration date printed in the carton.
Varicella - Information has been received from a registered nurse concerning a 32 month old female  caucasian patient with no known allergies or medical history who on 17 Aug 1998 was vaccinated subcutaneously via the left anterior thigh with a frist dose of varicella virus vaccine live.  Concurrent vaccinations that same day included a fourth dose of haemophilus B conjugate vacccine lot number m260rj given intramuscularily via the left thigh and a first dose of mealses virus  vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (msd) given subscutaneously via the right anterior thigh.  On 05 May 2000 the patient developed varicella after being exposed to two of her siblings with active varicella who were not vaccinated.  The nurse reported that the patients' varicella was not mild.  The patient was not seen by a health care provider.  The patient's father stated that the patient was covered. It was estimated that there were greater than 100 lesions. Follow up information was received from a registered nurse who indicated that the patient developed multiple lesions and was febrile, otherwise doing fine.  The patient was treated with acetaminophen(tylenol) diphenhydramine hydrochloride (Benadryl, and aveeno baths,  Subsequently the patient recovered.
1 of 4 pts vaxed during the last yr (different lots) who exp large hives @ inj site; hives described as red mound-not abscessed, quarter to 1/2 dollar size; pt also devel sx of Bell's Palsy-numbness & tingling of 1/2 of face; sx subsided;
12/16/21 presents to ED for "SOB and confusion". PMHx of "NASH cirrhosis with portal hypertension, hepatic encephalopathy, esophageal varices s/p TIPS, seizure disorder, gastric bypass, chronic back pain"
systemic rxn from tetanus shot;fever inj site swollen, indurated, nausea several visit to ER, not adm to hosp;
PATIENT'S INJECTION SITE WAS TENDER TO THE TOUCH, SWOLLEN AND HAS BEEN DIAGNOSED AS CELLULITIS.  PATIENT WAS PRESCRIBED ANTIBIOTICS AND BENADRYL
no adverse event; total of 47 patients that received the vaccines after the use-by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date).    Patient was over 18 years of age.  No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 27Jun 2023, 3 doses were administered at administration site 2.  No treatment medication reported.  The case corresponds to 35th out of 47 patients as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow up received, updated vaccination date and I narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case
First time receiving flu vaccine.  Approx. 30 sec after injection when standing stated feeling dizzy.  Had pt sit down , seconds later became unresponsive with eyes rolling back and extremities jerking.  911 called  Very pale, diaphoretic,  unable to palpate radial pulse, assisted to ground with help from staff, pt regaining consciousness able to swallow 50mg benadryl po. B/P a very faint 90/60 supine , incontinent of urine.   Rescue arriving,  pt stable, agreeing to transport.  Alert , stable condition.
I had hives on my neck and head and upper back and this started on 11/08/2013 at 7:00 PM and I still have hives on my neck at this time 11/12/2013 at 4:30 PM and I have been taking Benadryl as treatment of hives and itching.
About 20 minutes after vaccine the edges of my face started to tingle and get a numb feeling. I felt a strong pain go into my right hand and a pain seem to move from my left ankle up to under my knee. It did go away-
After first dose of Moderna COVID-19 vaccine, patient started to experience dizziness and lightheadedness. Patient was given water/juice and observed. Patient was discharged to home in stable condition.
Patient was administered both PNEUMOVAX 23 and SHINGRIX in the same arm and developed a significant rash around the injection site. Patient was administered the vaccines on 9/26/18 and presented to the pharmacy with an order for keflex after being evaluated by his physician.
pt recv vax 18SEP95 & 25APR96 pt exp 8-12 lesions that the reporter felt was related to therapy w/varicella vax;no further details were provided;
On 11/26/99, the pt experienced a low-grade fever and headache. The temperature was not measured. On 11/30/99, the pt developed a red rash on his head, back, and chest. The rash had not spread to the lower extremities. The pt was seen by his physician who reported to the pt's mother that the rash and fever were due to the vaccine. Additionally, it was noted that the pt also complained of neck stiffness.
Extreme arm pain, syncope, nausea and vomiting, and then diarrhea.
Severe head ache, severe pressure in sinus/ears, severe ringing in the ears, severe body pain/ache, upper abdominal pain/cramping, slight breathing constriction.
Covid vaccine vial good for only 6 hours after initial puncture/ vaccine given 14 hours after. Advised with supervisors and "covid nurse" . Pfizer dose 1 received 10/21/21.
Pt recv vax on 12/24/98; on same day pt exp vomiting, diarrhea, nausea, fever, chills; tx=Lomotil
Patient began to feel light headed and sweaty after 5 minutes of receiving the vaccine. Pharmacist laid patient down where he started to feel better and regained color in face. After a 2-3 minutes patient was sat up again to read blood pressure where it read 90s/80s and in 5 minutes 80s/60s where patient started to feel light headed again; during this time paramedics were called and came within 5-10 minutes where they assessed patient.
Fever, body pain, ear pain, throat pain, nauseated, congestion, dizziness, tiredness, chills a lot of back pain, headaches
Sept97 & Nov97 Pt recvd dose 1&2; Sept97 approx 2 wk p/recvd vax, Pt devel macular erythematous generalized rash, in Nov after recvd 2nd dose;rash "got much worse"; unable to control w/steroids;pt not yet recovered
Intense upper arm pain for 10 days then slowly improving. As of today, March 15, nearly 4 weeks post vaccination, I still have pain when Taking off a sweater or jacket, putting on a seatbelt, etc. Otherwise all normal function has returned
very cold; eyes hurt; don't feel well; chills; head hurts; feel very tired; fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (very cold), EYE PAIN (eyes hurt), MALAISE (don't feel well), CHILLS (chills) and HEADACHE (head hurts) in a  patient of an unknown age and gender 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 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 30-May-2021 at 1:00 AM, the patient experienced FEELING COLD (very cold), EYE PAIN (eyes hurt), MALAISE (don't feel well), CHILLS (chills), HEADACHE (head hurts), FATIGUE (feel very tired) and PYREXIA (fever). At the time of the report, FEELING COLD (very cold), EYE PAIN (eyes hurt), MALAISE (don't feel well), CHILLS (chills), HEADACHE (head hurts), FATIGUE (feel very tired) and PYREXIA (fever) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
Swollen gland in left armpit the size of a tennis ball, in bed with body aches, chills but no actual fever, for 7 days, then was barely able to get out of bed most mornings until around 11:00. I have not been able to get out of bed in the morning to practice yoga, have chronic debilitating headaches, brain fog. I am not overweight and was able to practice Ashtanga Yoga for years before I received the second dose of the Pfizer vaccine. I have never had any positive testing for COVID although I was living with family members after my vaccinations who tested positive. I have never had shortness of breath, loss of taste or smell, no cold symptoms, no nausea or vomiting due to illness.my glands are still swollen in my neck and armpit, I do have better days, and often feel much better at the end of the day, but have very difficult painful mornings. I am not 100% sure this is all related to my vaccination, but I have never felt worse consistently in my life. I have been an active person throughout my life, a runner, a yoga practitioner, working out daily and rarely missing a day. Currently, I do not have the energy to even practice yoga. I just want to feel better and back to how I felt prior to the immunization. Had I known that this is how I would feel a year later, I would never have voluntarily received this vaccination.
A report has been received from a Pharmacist concerning a 53 year old, Female subject, who had been receiving Nasal FLUMIST ( Intranasal), 0.2 milliliters, Daily for flu vaccination. The patients concurrent disease(s) included diabetes. Concomitant medication included Indapamide, Perindopril erbumine for hypertension, ENTERCAVIR for hepatitis B and Rosuvastatin for hypercholesteremia. FLUMIST (Intranasal) started on 08-Jan-2014 for flu vaccination. The patient experienced mild blood blisters on the arm which started on 13-Jan-2014. FLUMIST (Intranasal) was discontinued on 08-Jan-2014. The patient recovered from the event of blood blisters on the arm on 20-Jan-2014. The report was considered to be non-serious. Reporter assessed the event was related to suspect drug. Summary of follow-up information received by AstraZeneca/Medimmune 04-Feb-2014 from pharmacist: Patients demography was added. Reporter causality was added. Concomitant medicine and disease were added. Outcome for the event was also updated.
Well at time of vaccination,  2 wks later onset of diarrhea that increased in frequency and became persistent. Associated with lower abd discomfort. No fever, n/v.  Saw PCM 16 Dec. Stool studies nml, Abd CT 06 Jan 22 nml. Colonoscopy 01 Feb 22 with bx. Diagnosed with  collagenous microscopic colitis. No prior GI issues. Will start Budesonide
Severe unbearable fire with prickly needles and numbness started on the lateral side of my left thigh; Severe unbearable fire with prickly needles and numbness started on the lateral side of my left thigh; Severe unbearable fire with prickly needles and numbness started on the lateral side of my left thigh; the sciatic nerve; pain; This is a spontaneous report from a contactable consumer (patient).  A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number EN6200), via an unspecified route of administration, in Left Arm on 21Feb2021 at 15:45 (at 74 years) as single dose for covid-19 immunisation. Medical history included asthma, post gustitorial rhinnus, sleep apnoea, degenerative disk disease in lumbar region and known allergies house dust, house mold ,dogs . Concomitant medication included dutasteride, tamsulosin, budesonide/formoterol fumarate (SYMBICORT), benazepril.  On 28Feb2021 at 22:00, within one week of vaccination, the patient experienced severe unbearable fire with prickly needles and numbness started on the lateral side of his left thigh and pain. This fire, prickly needles and numbness continued without stopping. After a week of this excruciating pain, patient consulted his physician, who thought it was irritation of the sciatic nerve. He prescribed Lyrica 75mg tablets 2x's daily. To date patient have not had any relief. The final outcome of the events was not recovered.No follow-up attempts are possible. No further information is expected.
Eight days after shot, the area became red, slightly swollen, hot, and itchy. Resumed Rinvoq and took 20 mg of prednisone which has helped quite a bit.
Vaccine (10/4 @ 1635) -Sore neck and shoulder within the hour -2300, woke up w/ fever, chills, joint pain, body ache  10/5 -Fever, body aches, joint pain, sweating, chills continued -fever high of 101.0  10/6 -same symptoms continued, fever finally broke around noon -severe joint pain, especially in legs  10/7 -woke up with chest pain, deep breathing like I had come back from a run -numbness in legs and toes and left arm  -swelling to back of knees, vein popping -went to ER, blood work and EKG normal  10/8 -still have slight numbness in legs and arm -shuttle chest pressure -went to bed with painful stomach pain and chest pain, slept on floor  10/9 -still have chest pressure  -difficult to take deep breaths  -chest pressure and difficulty breathing when going to bed, slept on couch  10/10 -woke up with subtle chest pressure, still difficult to take deep breath?s  -1800, hives on left thigh and butt -2200, hives spread to both legs Ann around abdomen   10/11 -hives spread in the middle of the night all over legs, side and abdomen  -chest pressure mostly gone but still subtle  -hives lasted until Tuesday   Allergic Phenotype  10/17 -chest discomfort, shortness of breath came back in evening, difficult to fall asleep  10/18 -chest discomfort, shortness of breath still present  -comes and goes -Negative Covid test in the morning  -went back to ER for recurrent symptoms  -BP 154/98, 162/76 -Pericarditis (swelling and irritation of the thin saclike membrane surrounding the heart)
DID NOT REFRIGERATE AND TOOK VIVOTIF; A spontaneous case report was received from a pharmacist on 28-May-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201905-000431 (PVX2019-1351; 42-year-old female) and PVX201905-000432 (PVX2019-1352, 14-year-old female) were created and cross-linked in the database.  This case describes a 42-year-old adult female consumer who "did not refrigerate and took Vivotif". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer did not refrigerate Vivotif doses for 4 days and completed the course of it.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not refrigerate and took Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not refrigerate and took Vivotif" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000432:
Five minutes after receiving the Covid shot , Patient start sweating and he mentioned that he is  not feeling well.   No other symptoms was reported. After drinking water and sitting at  the waiting area for 30 minutes he was feeling better.
Shoulder pain immediately after shot, continuing for months and increasing in severity / beginning to limit activities and movement.
Extreme vertigo; Debilitating; Dizziness; Feels like electrical zaps in my brain; Difficult to think clearly or move; Difficult to think clearly or move; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 03Apr2021 at 10:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and attention deficit-hyperactivity disorder (ADHD). The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 04Apr2021 at 08:00, the patient experienced extreme vertigo, debilitating dizziness-feels like electrical zaps in brain that make it difficult to think clearly or move. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme vertigo, debilitating dizziness-feels like electrical zaps in brain that make it difficult to think clearly or move were not resolved.  No follow-up attempts are possible. No further information is expected.
soreness in arm; exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm) and EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 13-Oct-2020 and the estimated date of delivery was 21-Jul-2021. On 26-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (exposure during pregnancy). On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  On 26-Mar-2021, EXPOSURE DURING PREGNANCY (exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in arm) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MODERNATX, INC.-MOD-2021-086800 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Added pregnancy information LMP 13 Oct 2020, Due Date  21 Jul 2021.; Sender's Comments:  MODERNATX, INC.-MOD-2021-086800:Case for dose 1
1 of 3 pts who experienced swelling & redness fr the inject site to the elbow; tx APAP, DPH, & cold compresses;
Higher fever chills, Muscles aches headache. Received shot at 10:30 Friday 10/3/2008 headache starts shortly after that. Relief at 4:30 am Saturday 10/4/2008 No treatment
Overall body aches, chills, headache, and extreme tiredness for 48 hours.
Got flu vac Tues morn, 11/05/02, By eve 11/05/02 lt upper arm swollen & inj site red, warm + tender 5 cm diameter, Some itching around area. Used ice and Benadryl. Has imporoved but I was encouraged to report event. 2) Past-erythema S/p PPD had 2nd step which was neg, / Thimerosal H/D rash to merthiolate. DX : Hematoma, focal cellulitis
Moderna COVID-19 Vaccine EUA 5 cm X 2 cm irregular macular erythematous rash starting about 3 cm below the injection site 2 days after  vaccine with peak redness and extent on day 3 post vaccine. Slightly pruritic. Also seen after 1st dose, but not as large
Fever, myalgias. Swelling at deltoid injection (over 3 cm lump on arm).
A consumer report has been received. The report concerns an Adult, female consumer, who has been receiving FLUMIST Quadrivalent, 0.2 milliliters, unknown. FLUMIST Quadrivalent started on an unknown date. The patient experienced hand swollen, itchy all over her hands, bumpy red rash after skin contact with FLUMIST Quadrivalent and the liquid landed on the consumers hand. The outcome of the event of hand swollen, itchy all over her hand, bumpy red rash after skin contact with FLUMIST Quadrivalent and the liquid landed on the consumers hand is unknown. The report was considered to be non-serious.
P/receiving HDCV #3 vax began w/sleepiness,itching of neck w/rash & whelps which  spread all over body; swelling & pain in joints, chest pain, swelling of lips & face, dizziness;
About 1-2 minutes after receiving shingles vaccine  patient started with complaints of feeling hot with both hands cramping and numbness/tingling of both hands and feet. Pt diaphoretic but still awake, alert, oriented, muscles in forearms and upper arms relaxed but both hands flexed at MTP joints, radial pulses 2+ bilateral sensation to light touch intact and symmetric in hands . Provider massaged hands to assist patient to open up hands; ice pack applied. Patient monitored for 15 minutes and vital signs were stable. No further cramping; numbness or flexion of hands or feet.