chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Eexpired vaccine was stored in refrigerator; No adverse event; gave expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Eexpired vaccine was stored in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (unspecified COVID-19 vaccine Dose 1), COVID-19 vaccine (unspecified COVID-19 vaccine Booster dose) and COVID-19 vaccine (unspecified COVID-19 vaccine Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 vaccine, COVID-19 vaccine and COVID-19 vaccine.    On 30-Aug-2022 at 3:16 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Aug-2022 at 3:16 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Eexpired vaccine was stored in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Eexpired vaccine was stored in refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Eexpired vaccine was stored in refrigerator).    No concomitant medications were reported.   The vaccine was delivered and placed into the freezer on 18-Apr-2022. The vial size was reported as 5.5 ml. Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration on 30-Aug-2022 vial was placed into refrigerator on 29-Aug-2022. The vial did not undergo any temperature excursion.   No treatment details were reported.
Chills; Fever; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 30May2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included metformin (MANUFACTURER UNKNOWN), insulin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), glimepiride (MANUFACTURER UNKNOWN) and amlodipine besilate (AMLODIP); all taken for unknown indication from unknown date and unknown if ongoing. The patient previously received lisinopril (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31May2021, the patient experienced chills and fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events chills and fever which included treatment with acetaminophen (MANUFACTURER UNKNOWN). The clinical outcome of the events chills and fever were recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
sore arm - immediately following injection, worst soreness (hurt to raise arm above head) 8-10 hours after injection. Remained sore for about 36 hours, then completely normal   some mild fatigue 12 hours after, resolved within 24
The day after the vaccine - fatigue, muscle aches, mild splotchy red rash that covered the left side of my back, arm, shoulder, lower neck. The rash was not raised. Then a couple of days later I had an itchy feeling in my mouth and feeling like my tongue was swollen. Now, approximately 10-12 days after I got the vaccine I have a raised red rash on my left arm.
approx 6hr p/vax pt became warm w/face & chest erythema & SOB;rxn was treated w/DPH & EPI w/resolution over 30min;
This case was reported by a healthcare professional and described the occurrence of itch over whole body in a 36-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included penicillin allergy and sulfa allergy. Concurrent medications included BYSTOLIC, SYNTHROID, CYMBALTA, DEXILANT. On 18 September 2012 the subject received unspecified dose of FLULAVAL (.5 unknown, unknown, right arm). On 18 September 2012, 1 hour after vaccination with FLULAVAL, the subject experienced itch over whole body, swelling over body and erythema all over body. The subject received FLULAVAL injection on 18 September 2012. Approximately one hour later, the subject began to experience redness, swelling, itching all over their body and pharmaceutical product complaint. The subject presented to the clinic and was given a dose of SOLU-MEDROL and BENADRYL. Symptoms had improved by the next day. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. This is one of three reports made by the healthcare professional, please also see A0995173A and A0995174A. On 09 October 2012, follow-up information was received from the healthcare professional. It was reported that the itch over whole body, swelling over body and erythema all over body resolved on an unspecified date. The reporter considered that the events were not serious. It was also reported that the immunization series with FLULAVAL was discontinued. According to the product complaint investigation results reported by GSK Biologicals quality assurance on 09 October 2012, the product complaint was assessed to be unsubstantiated.
I saw him turning blue and not breathing. I immediately picked him up and rubbed his back and patted his back to get him to breathe and immediately called the nurse. They came in 10 minutes later but they did not check him out and said he was fine.
Patient received the first dose of Pfizer COVID vaccine on 24FEB21 . He then had a change of station overseas. He did not receive his 2nd dose prior to his move. Pfizer vaccine is not available at new command. He was administered Moderna COVID vaccine as 2nd dose per CDC guidance as this was the only mRNA vaccine available. He was educated about the vaccine. No adverse reactions were observed during his observation period and he was released.
Information has been received from a physician concerning an 8 year old female who on September 1997, at 12 months old, was vaccinated with a dose of varicella virus vaccine live.  Subsequently the patient developed chickenpox.  The patient had a fever of 100 degrees, a sore throat, and an unknown quantity of chickenpox.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Starting 2 weeks after the shot, he started getting strange pains from the lower back and down his legs, felt like a severe sciatica but also presented with severe hip pain.  Then he started losing strength in legs, had about 7 days of extreme leg weakness, had trouble getting into and out of the chair, even noticed visual muscle loss in his legs .   Then after 7 days the strength started coming back. Then 2 weeks later described "awful urinary symptoms" getting up every 20 minutes during the night, had to pee dozens of times in the day and night, this has started to abate
Myasthenia gravis; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not provided. In or around 05-JUN-2012, plaintiff was inoculated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for routine health maintenance and for it's intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving the zoster vaccine live (ZOSTAVAX), plaintiff suffered a severe droop to his eye. Plaintiff was diagnosed with autoimmune injury myasthenia gravis. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, plaintiff symptoms had resulted in physical limitations not present prior to using the vaccine. Plaintiff also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), Plaintiff sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, Plaintiff suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.As a direct and proximate result of Defendants' conduct, Plaintiff has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not reported.  The reporter considered myasthenia gravis to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, myasthenia gravis was determined to be medically significant. The reporter considered the event to be disabling.
Received Flu vaccine on 3/12/09.  Had R leg pain starting on 3/18 and fever on 3/17.  Seen in the office on 3/19 and noted to be walking slowly on toes, mainly wanting to be carried every where. On exam he had pain in hip with internal and external rotation, but no tenderness.  CBC and ESR normal.  I suspect he has transient synovitis.  I called home today - a couple days after I saw him he was fine to 2 days.  since that time he has intermittently c/o hip pain.  Never as severe as on 3/19.
Patient reported "large red swollen, tender where injected with vaccine (L upper outer arm). Fever 100.4 F. Intercostal pain. This is day 5 - pt continues taking oral pain med, swelling and redness decreased now.
Pt. reports symptoms started 9/8/08 at approx 6 pm (HA), 9/9/08-HA cont., weakness, fever (did not take), but felt like fever, redness at site and swollen area 9/10/08- decreased HA, no weakness, no reddness at site, warm to touch and mildly swollen.
Information has been received from a nurse practitioner concerning a 12 year old male patient who "in the last couple of weeks", was vaccinated with a dose of GARDASIL (route and lot number not reported). On an unknown date, "within 5 minutes of receiving the injection", the patient developed light headedness and almost passed out. The nurse practitioner stated that the patient had a drop in blood pressure and his heart rate lowered. The nurse practitioner stated there was no other adverse event to report. The patient sought medical attention in the medical office. The patient did not receive any treatment for the event. The patient recovered quickly. This is one of several reports received from the same source. Additional information has been requested.
8 days (Saturday , March 13) after 1st Pfizer shot I experienced severe vertigo. I had to go to the emergency room the following day. After EKG and blood work (all normal) I was prescribed Meclizine 25mg and Ondansetron 4mg and told to make an appointment with Dr. I saw him Tuesday the 16th. He stated that he didn't believe it was due to the vaccine but couldn't say definitively.  He prescribed the same medication and set a follow up for Tuesday the 23rd.  I am 71 years old and have never had a problem with Vertigo. I am very hesitant to take the second dose;.
Started out as being light headed and tired. Then the next day noticed arm red and very sore. I watched it and monitored it. Then on the 8th I woke up to the red spot being bigger, warm to touch and very sore. I marked it with a pen to keep track of the red spot spreading. I took an Ibuprofen  at night and put ice on the spot. Today on the 9th the red spot has spread a little, however the redness of the color has gotten lighter. It is still tender to the touch and the spot is still warm to the touch. I am going to continue to monitor it another day or two and if it gets worse I will call my doctors office to make a visit
pt recv vax 1130AM & 5min p/vax pt devel gen urticaria & extreme redness of the face;given DPH & w/resolution of above sx in 10min;DPH repeated IM in 4hr;
Patient was administered vaccine on 2/8/22. Vaccine expired on 2/7/22.  Staff administering vaccine and nurse who did 2nd check both missed the expiration date during preparation.  Manufacturer and CDC consulted for recommendations. Provider to follow CDC guidelines and consider the vaccine not valid. Patient  made aware. Patient agreeable to return in one month to receive again, restart series. Patient denies any adverse effects.
Moderate side effects: body aches, headache, fatigue   Swelling, pain, redness, and itching at injection site that persists even after 6 days.
serum sickness rxn w/arthralgias, myalgias, joint swelling, fatigue, full body rash onset 12hr p/vax;tx motrin/DPH;
Rapid heart rate , hot, stinging, flushed  facial skin Unsteadiness, lightheadedness
Chills started on 11/8. Then on 11/09 whole head felt like is was going fo explode, lymph nodes behind ears and ears felt like going to pop, arm hurt down into elbow and still had chills. By 11/10  felt 95% better.
high blood sugar; This case was reported by a other health professional via sales rep and described the occurrence of blood sugar increased in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced blood sugar increased. On an unknown date, the outcome of the blood sugar increased was recovered/resolved.   It was unknown if the reporter considered the blood sugar increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not known. The patient was type 2 diabetic with controlled diabetes. The patient reported high blood sugar immediately after receiving Shingrix injection. Her blood sugar remained high for several days after Shingrix injection.
Mother called MD on 10.16.2021 and reported that child had been complaining of leg pain on and off since vaccination and is limping today.. She was going to preschool and was still active these past 2 weeks. Upon examination in the clinic, the left hip was guarding so full range of motion could not be obtained. At the emergency room, blood work, xray of pelvis and ultrasound were obtained. C rective protein was 5.7. Moderate simple appearing left hip joint effusion was found on ultrasound. Ibuprofen was given. Child recovered quickly and completely within a few days.
11APR94 very few spotty rash that occurred on both face & chest; (had chicken pox hx of  & resolved); no fever; mom called clinic instructed to contact PMD;
11/14/14 12 pm Redness, swelling and hardness - extending about size of softball. Itchy, arm was hot to touch. Applied lavender essential oil to site through out day and Epson salt bath in evening (800pm) juiced many vegetables and gave probiotics. 11/15/14 Arm swell to 25 cm circumference compared to other ar, at 7 cm. 11/16/14 Redness decreased swelling decreasing at top of arm and increasing at elbow joint. 11/23/14 arm almost back to normal.
Information has been received from a registered nurse concerning a female who on an unspecified date was vaccinated with a dose of Gardasil.  Subsequently the patient's arm still feels heavy and has a tingly feeling one month after getting the Gardasil.  Unspecified medical attention was sought.  At the time of the report the patient had not recovered.  Additional information has been requested.
Discharge Provider: MD Primary Care Physician at Discharge: FNP Admission Date: 3/16/2023  PRESENTING PROBLEM: Acute on chronic respiratory failure with hypoxia and hypercapnia (HCC) [J96.21, J96.22]   HOSPITAL COURSE: Patient is a 88 y.o. female, patient of FNP who presented with increasing SHOB and cough the past few weeks with more sleepiness the past few days. She is chronically ill with diastolic heart failure, diabetes mellitus controlled, idiopathic pulmonary fibrosis/on 2L continuous, chronic lower leg lymphedema with recurrent wounds, chronic kidney disease stage IV-V (follows with Nephrology). She was diagnosed with UTI on Mar 10 and started on ciprofloxacin, cultures confirmed it is susceptible.   In the ED, she was severely dyspneic. She was placed on BiPap. CXR showing pulmonary vascular congestion and bilateral pleural effusions. Labs revealing pH 7.20, pCO2 70, with worsening renal function, creatinine 3.15 (usuaally 2.30 - 2.70) and BUN 115, along with lactate 4.1, potassium 5.4. BNP quite elevated at 46,000. She was given breathing treatments, Lasix, Solumedrol and Bipap. Unfortunately, she did test (+) for Covid. She requires admission for a/c heart failure, a/c renal failure.    Daughter at bedside, very involved in care, visits her mom at facility daily and is often caring for her wounds. She explains that her mom recently had code discussion and wished to be DNR. She also would not want dialysis. Palliative care/hospice care also broached with PCP, however daughter didn't feel her mom was ready for that stage of care, as she doesn't have any chronic pain.    The patient was treated with oxygen which needed to be progressed to BiPAP for her respiratory failure, and she also developed hypotension requiring norepinephrine.  She had progressive confusion and decreasing urine output and worsening renal failure, and after discussion in regards to very poor prognosis decision was made to transition her to comfort care measures.  She was treated with norepinephrine while her daughter was trying to arrived to see her from another state, but was otherwise treated with comfort care measures beginning on 03/19/2020.  On 03/20/2020 her norepinephrine was discontinued and her oxygen was also removed.  She was treated with IV Ativan and morphine for distress, and passed away with family at bedside at 11:10 a.m..
The person received the 3rd dose within a 8 months time frame when the schedule for this vaccine (SHINGRIX) is only 2 doses lifetime. Spoke with the patient, he had no adverse effect due the vaccine.
Received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021 at 3:49 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 17-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information were reported.    Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Non significant follow up received includes reporters address updated and email address confirmed.
11-16-06 developed fever 103, irritability, fussiness seen in ER, admitted to Pediatrics for studies and IV antibiotics. 02/06/07-records received and reviewed for DOS 11/16-11/18/06 DC DX: fever  PMH:ureteral strictures requiring surgery immediately following birth. Amoxicillin daily prophylaxis. Seen in ER with temperature of 103 degrees and after admission 102.9 (r)
09Feb96 Pt recv 1 dose vax. 31Jan98 Pt devel "moderate case zoster left thoracic cage front to back".
Patient reported developing a red rash/bruise on right arm near injection site as well as throat, face, and neck swelling and partial throat closing. She could only consume liquids and was afraid to sleep after symptoms started. She stated it started the night after and day after receiving the vaccines. She saw the doctor on 5/24 and started a medrol dose pack using pack directions, which she is still taking. Symptoms have resolved somewhat but not fully and only started resolving on 2nd day of medrol therapy.
3/26/21 ER to Inpt Admission: Patient was admitted to the hospital for comfort measures after patient suffered MI and did not want any life-prolonging therapies. Patient was started on comfort medications and symptoms were monitored closely. The patient passed peacefully before she could be fully assessed
Severe pain in abdomen (resembling appendicitis) during menstruation; This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,), administered in arm left, administration date 21Dec2020 09:30 (Lot number: EJ 1685) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Uterine leiomyoma" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication included: NORTREL [LEVONORGESTREL]. The following information was reported: ABDOMINAL PAIN (medically significant) with onset 27Dec2020 00:30, outcome "recovered", described as "Severe pain in abdomen (resembling appendicitis) during menstruation". The event "severe pain in abdomen (resembling appendicitis) during menstruation" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (unspecified date) unknown results; sars-cov-2 test: (28Dec2020) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of abdominal pain which included intravenous pain medication. The patient received her second dose on 11Jan2021 at 09:30 (lot number: EJ 3246) for Covid 19 immunization.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Abdominal pain cannot be excluded.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.