chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inappropriate schedule of vaccine; Pain in upper left arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 27th February 2019, 218 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the incomplete course of vaccination was not recovered/not resolved.   The reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received the 2nd dose of Shingrix on left deltoid. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. She wants to know if she had to restart the vaccine series.  Referred caller to CDC guidelines, referred her to her healthcare provider.  Caller also reported that she experienced pain in her upper left arm for a week after receiving the first shingrix shot. No PQC reported. The reporter consented to follow up.
This spontaneous report as received from a physician via a company representative refers to an 18 year old female patient. On an unspecified dates, the patient received 3 doses of GARDASIL (dose, route, lot numbers and expiration dates not reported). In approximately 2013 (reported as about a year ago), the patient had developed postural orthostatic tachycardia syndrome (POTS). At the time of the report the patient was in a wheelchair because she was weak and she could not stand up which was considered as disability by physician. The patient sought medical attention by unspecified contact. At the time of the report the outcome of the events was reported as not recovered. Additional information has been requested.
Rash, ErythemaMultiform & UrticariaPruritis Narrative:  Patient received the COVID-19 vaccine and presented to the emergency room approximately 15 minutes later with a chief complaint of erythema and puritis. Patient denied chest pain, shortness of breath, hives, and voice changes. Patient was treated with one dose of diphenhydramine and famotidine and symptoms improved. Patient was under observation, and after two hours symptoms of erythema and puritis returned. Patient was treated with one dose of methylprednisolone and observed for another 2 hours. Symptoms did not return. Patient was discharged with famotidine, prednisone and diphenhydramine.
Expired vaccine administered to 11 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients). On 16-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.  Reporter stated that the vial was kept under Moderna recommended temperature range the entire time. There was nothing else wrong except that the vaccine was administered beyond the manufacturer's expiration date.   This case was linked to MOD-2021-396165, MOD-2021-396184 (Patient Link).
15 minutes after the vaccine she developed full body pruritus then throat tightness then urticaria.  Evaluated at Urgent care 24 hours after as symptoms persisted.  Saw her PCP who put her on steroids.
Sunday May 2 awoke with my right arm itching and then my left. Got up and saw a rash all over my body and took Benadryl for the  next 3 days. Contacted the dr. Wed., May 4th and am now taking prednisone and the rash and itching is going away.
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 20-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 11:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, 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 20.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 9 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. 18 vials were sent to clinic. Vaccine BUD date was 09-Apr-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 PM: 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 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 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.
From initial information received from manufacturer regarding an adverse event occurring in the USA, it was reported by a physician that a female child received Tetanus Toxoid, Lot # and manufacturer unknown, on 06/30/03.  Sometime after the vaccination, exact date not reported, the pt developed pain, numbness in lower extremities and difficulty walking. The pt's recovery status is currently unknown. From additional information received on 08/05/03, from a CMA, it was reported that the pt is a 12 year old female, who had received her first dose of TD ADS ADULT, Lot # U0831AA, given IM in the right arm at 12:30 PM on 06/30/03.  That evening on 06/30/03 the pt experienced tenderness at the site of injection and generalized muscle pain, especially in the thighs. She also experienced a low grade fever the following day. Reportedly, the pt recovered from these events. No further information is anticipated, this case is considered closed.
Information has been received from a registered nurse (RN) concerning a patient who was vaccinated on an unspecified date with a dose of ZOSTAVAX (Merck) that was stored at a freezer range above the recommended range.  The RN reported that the patient subsequently developed a shingles-like rash.  The patient was seen in a physician's office and the rash was cultured (results not provided).  No other symptoms or treatment was reported.  At the time of this report, the outcome was unknown.  This is one of several reports from the same source.  Additional information has been requested.
6 hours after vaccination I experienced headache, fever, body ache, chills, nausea and fatigue. It took 1-2 days for those symptoms to go away all of them except for the fatigue. About 2 days after vaccination I started feeling lightheaded and dizziness added onto the fatigue that has not gone away since. No matter how much sleep I get/what I do I still seem tired and can't stop the lightheaded/dizziness.
?Covid Arm? redness, swelling, hives, itching on right arm from injection site down about 18cm long and 14cm across. Onset 8 days after first dose. No reaction whatsoever immediately following dose.
Swollen lymph nodes in the armpit area  after got the 1st shot COVID vaccine
PT REPORTED AFTER RECEIVING 3RD DOSE OF GARDASIL STARTED TO EXPERIENCE FEVER,FLU-LIKE SYMPTOMS ABOUT 3 HOURS AFTER INJECTION LASTING ABOUT 12 HOURS. NO OTHER SYMPTOMS AFTER THAT 12 HOUR PERIOD.
Patient received 2nd dose of Pfizer COVID-19 vaccine. Was sitting in the waiting area after administration, and about 5 minutes later felt dizzy, lightheaded, and hot. Laid down on the ground. BP and heart rate were normal when checked. Patient able to sit up and drink a little water after 1-2 minutes. Was then able to get up and move to an exam room where she sat for 15 minutes to be monitored. Patient drank water and felt better after 15 minutes. Patient was able to walk out of the clinic with no assistance after that.
On 9/24 at 5:40pm both my arms and legs started to fall asleep, get numb and tingle. I was unable to walk or move my arms properly. I started to have shortness of breathe and blurry vision as well as pain when moving my eyes. I had a severe headache. I went to the ER and was told this was a reaction to the COVID-19 vaccine and recieved two CAT scans and an EKG. I saw a neurologist that same evening on 9/24 who diagnoased weakness and parathesia in my limbs. Today, 9/30 I still have numbness and tingling in my arms and pain when moving my eyes. I saw the neurologist again today and she stated these are symptoms of gullian barre from the Janssen vaccine. She has ordered several MRI scans with dye and a spinal tap.
None known, administered vaccine that expired 9/30/2022 on 10/2/2022
Patient experienced swelling in lymph node under left armpit (same side the shot was given). No redness was reported there or around the site of injection. This developed 2 days after the vaccine.
Left ring finger and pinky finger we?re in constant pain. After 72 hrs the pain subsided so I stopped the auto texts. After 72 more hours the pain returned and hasn?t subsided since. Pain is a very low constant pain. Probably 2/10.
Thursday, 05/20/2021 02:05PM received Janssen 0.5mL to left deltoid IM injection. 04:55PM Noticed a pin needle like rash on my chest, stomach, and neck. 05:00PM Took 50mg of Benadryl. 05:40PM Took another 50mg of Benadryl due to rash being more present on my chest, stomach, and neck. Itching began on the neck behind the ears. 05:50PM Noticed difficulty/restriction to swallowing.  06:20PM Checked into a facility. Waited an hour to be seen by a provider, Dr. He states only an acute reaction without examining my body of the rash; only examined my back & inside my mouth. I informed him that my rash was on my chest, stomach, neck, now my arms, and top of my thighs. He provided Prednisone and dismissed me. (I will be filing for malpractice)  08:00PM- Got home, still have rash with some difficulty swallowing. Friday, 05/21/21 06:00AM- Rash seems to subside and throat is fine, but swollen. 09:00AM While at work, coworker mentions my face is red. Rash came back to my arms and is now on my face. I took 50mg of Benadryl. 03:00PM Left work early since I could not take another dose of Benadryl to drive home.  03:20PM Rash has spread to whole entire body except lower than the knee. Took another 50mg of Benadryl. 09:00PM Took 25 mg of Benadryl went to bed. Saturday, 05/22/21  07:00AM Rash is more noticeable and red. Everywhere on the body, swelling to ears and throat. Took 50mg of Benadryl.
Patient reports vasculitis rash to arms and legs two days after receiving dose. Patient was seen by infectious disease physician who it is vaccine related. Recommendation per physician is that patient should not receive second dose
Nine hour high fever of 102°F, severe chills, severe muscle aches, severe joint pain, nauseous, diarrhea, headache, debilitating fatigue/tiredness
The pt presented hypotonic-hyporesponsive episode (pale, vomited, very lethargic, no loss of consciousness). Per doc 214038, observation only, child recovered in 5 minutes.
my menstrual cycle was affected. I had heavy bleeding in May and June and then nothing in August and September
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On 06-Dec-2021, they placed a LOT 012H2B1A vials in the refrigerator upon receiving.
Frozen lungs; arm hurt and was sore for at least 2 weeks; Large burning welt where ther injection was; My arm hurt and was sore; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Frozen lungs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spasms (onabotulinumtoxinA injection into paraspinous muscles to stop spasms), Spinal cord neoplasm NOS, Bladder infection and Glucose low. Concurrent medical conditions included Blood pressure high, Dysautonomia, Paralysis (could not walk, eat, or go to the bathroom) and Headache.   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 PNEUMONIA (Frozen lungs) (seriousness criterion medically significant), PAIN IN EXTREMITY (arm hurt and was sore for at least 2 weeks), VACCINATION SITE URTICARIA (Large burning welt where ther injection was) and MYALGIA (My arm hurt and was sore). At the time of the report, PNEUMONIA (Frozen lungs), PAIN IN EXTREMITY (arm hurt and was sore for at least 2 weeks), VACCINATION SITE URTICARIA (Large burning welt where ther injection was) and MYALGIA (My arm hurt and was sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 antibody test: high (High) high.         Concomitant product use was not provided.  Patient mentioned she had phone visits with G.I., Pulmonologist, Dermatologist, P.C.P., Neurologist several times during this Botox, Toxicity. She stated that Moderna Vaccine and monthly IVIG infusions had helped a lot to get rid of the Botox after she had suffered extreme symptoms for 6.5 months. The patient told everyone she had "botox/Covid."  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of ht events a causal relationship cannot be excluded.
Night sweats; Temp elevations; Severe headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), PYREXIA (Temp elevations), HEADACHE (Severe headache) and FATIGUE (Fatigue) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lyme disease. Concurrent medical conditions included Dust allergy and Pollen allergy.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced NIGHT SWEATS (Night sweats), PYREXIA (Temp elevations), HEADACHE (Severe headache) and FATIGUE (Fatigue). At the time of the report, NIGHT SWEATS (Night sweats), PYREXIA (Temp elevations), HEADACHE (Severe headache) and FATIGUE (Fatigue) was resolving.       All the Laboratory tests have been negative.  Concomitant product use was not provided by the reporter.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
nose bleed. multiple 5-10 minute nose bleeds over the course of 2-3 days after vaccination
Pt diagnosed with chickenpox 1 hour office on 3-8-2006. Pt received varicella vaccine through Public Health Dept on 4-11-2001. Started breaking out one week ago-too late to prescribe antiviral.
patient called the day after getting her moderna booster shot and said she had hives and swelling of lips and tongue.she said she took an otc allergy med she thought was benadryl(generic). she was told to go to the er. after checking on the patient the next day the patient said she got bloodwork and vitals taken at the er but left as there was a lot of people there and she took more benadryl. the patient said the hives seemed to be getting better and she was feeling better than before
Administration error: less than 1/2 of 0.5 ml dose given because needle was not screwed on tightly enough. patient left the site and was later called by phone by administering pharmacist to tell her that the dose could be readministered at patient's convenience.
Pt received injection, a few minutes post injection she c/o dizziness, lasting for a few minutes.  No other symptoms noted.  Discharged to home with no c/o.
Swelling in face, eyes and throat. Swelling continued several 12-14 hours with difficulty in breathing. Administered cold compresses to face. Other symptoms continued up to a week: Swelling in arm. General weakness and tiredness.
Patient was administered Moderna (a third Covid vaccine) instead of her second Shingrix vaccination, due to a mix up with vaccine to be administered. Patient waited and did not have any adverse events before leaving the pharmacy. She had already had her two Pfizer vaccines earlier this year, so she got a third covid vaccine  instead of getting her Shingles vaccine, by our error.
Chills, body aches, headache, light headed, hot flashes. Lasted 24 hours
Day 1:  10:30 a.m. injection received. Same evening as receiving the 2nd dose of Moderna, approx 8 p.m. very tired, arm very sore and went to sleep.  Woke up 2 a.m. hot, chills, sweating; upper arm felt doubled in size; could not leave the bed (no strength).   Day 2:  6 a.m. could not lift my head or leave the bed - 1st temp taken approx. 7:30 a.m. temp was 101.  Used cold compresses for high temp, heating pad for chills. 101 temp lasted until 6 p.m. - down to 100.  By 9 p.m. was able to go to sleep; temp was slightly elevated to 98.9 (normal is 96.7).  Husband said my eyes and cheewere swollen during the time between 6 a.m. and 4 p.m. Day 3:  By morning 8:00 a.m., felt better; dizzy; and hadn't eaten for 3 days.
High fever, shaking, can't get warm, aching, fever still persisting at 101 following day.
Rash on legs, followed by swollen left leg, pain in left foot & leg, swollen glands (neck), loose stool
Ache in arms and leg muscles. 10/23/2011 Stomach pain. 10/23/20111 Headache. 10/23/2011 Runny nose. 10/23/2011 Flushed feeling in face. 10/2011 Respiratory symptoms. 10/2011 Pancreatitis 11/2011 - 03/2014 hospitalized 4 times for Pancreatitis. Each hospital stay one week to two. Gallbladder surgery 7/2013 out patient surgery Cardiac Arrest 3/22/2014 Treatment at hospital Hospital Four days Heart pacemaker and defibrillator implanted 3/24/2014
Patient received 2 month immunizations in NICU, on 10/29 thru 10/31. Vaccines were not documented into electronic medical record until 11/03/2017. Discharge summary was sent to Pediatrics. This included vaccines given at the hospital. The vaccines were given again at Pediatrician office, on 11/03.
WITHIN 12 - 24 HRS AFTER VAX, FEVER UP TO 103 AND PERHAPS HIGHER, ALONG WITH PAIN AND SWELLING OF ARM PERSISTING 5 DAYS, INDURATION AND TENDERNESS AT SOI.
Infection to arm, considered local reaction by treating physician. patient treated with Dicloxicillin.
Pt. woke up on 5-9-13 with swelling from injection site to armpit - pt. called MD and took BENADRYL 25mg - prn. Resolved in 5-6 days.