chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Certified Medical Assistant referring to unspecified patients of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unspecified date since September 2016, the patients were vaccinated with improperly stored doses of VAQTA (anatomical route of vaccination was not provided) for prophylaxis. It was reported that on 17-OCT-2016, VAQTA with lot # M027879 with expiration date on 24-JAN-2018, was exposed to a temperature excursion of 47°F to 77°F for 1 hour time range for 1 cycle. Subsequently on 31-MAY-2017 and on 19-JUN-2017, lot # M038572 with expiration date on 11-MAR-2018 was exposed to a temperature excursion of 32°F to 35°F for 1 hour time frame. It was also reported, that the lowest temperature excursion was of 34.3°F and the highest of 46.6°F. Information was provided due to a data logger. Furthermore, no adverse effects were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000715: US-009507513-1706USA009543: US-009507513-1707USA000714.
Administration of diluent only, didn't include the Antigen; Administration of diluent only, didn't include the Antigen; This case was reported by a physician via sales rep and described the occurrence of inappropriate dose of vaccine administered in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number L5A35, expiry date 9th April 2023) for prophylaxis.   On 19th November 2021, the patient received Shingrix (intramuscular). On 19th November 2021, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and incorrect dose administered. On an unknown date, the outcome of the inappropriate dose of vaccine administered and incorrect dose administered were unknown.  Additional details were reported as follows: The patient had received Shingrix where only diluent was administered. Diluent was not used to reconstitute Lyophilized powder prior to administration, which led to inappropriate dose of vaccine administered and inappropriate reconstitution technique. The physician called and shared that they had an administering error in which they gave the patient the adjuvant but did not include the antigen. Patient had not reported any adverse events following administration. The health care professional agreed to follow up by GlaxoSmithKline.
Fibromyalgia symptoms increased pain in lower back, hips, shoulder, neck every night for 4 weeks. Prolonged fatigue, feeling unwell.  Advil, Tylenol, Benadryl OTC have little effect, where they worked well before.  This is worth noting how this vaccine may impact people with this condition, even though it  did not require urgent medical care.
Shot received 2/21/21 and started to feel itchy on my legs about 5 days later and on 3/3/21 i developed a rash on my arm and hands which is itchy and i still have itch on my legs
patient has reported no adverse event from her COVID vaccine. We are notifying you of an inadverdant admisnitration of the Moderna Vaccine to patient who had already received one dose fo the PFizer COVID vacccine.  patient received Pfizer vaccine on 3/16/2021, developed COVID and was treated with monoclonal antibodies on 3/22/2021 . She presented for COVID vaccine and reported that she was instructed by her healthcare porvider that she could receive Moderna eben though she had started series with Pfizer. She had no reaction post vaccine and was instaructed that she had completed her mRNA vaccine series now.
eyes swollen, red, watering;edema in face;pain & edema @ inj site;fever, gen achiness/malaise, nausea & h/a;
headache; body aches; fever; hoarse voice; trouble breathing; coughing; pain in chest / sore chest; tightness in chest; increased heart rate and pulse; rash on upper chest; lips started swelling up; hives; diagnosed it as a general allergic reaction to the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache), MYALGIA (body aches), PYREXIA (fever), DYSPNOEA (trouble breathing) and COUGH (coughing) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 047A12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021 at 2:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DYSPNOEA (trouble breathing), CHEST DISCOMFORT (tightness in chest), HEART RATE INCREASED (increased heart rate and pulse), RASH (rash on upper chest), LIP SWELLING (lips started swelling up), URTICARIA (hives) and HYPERSENSITIVITY (diagnosed it as a general allergic reaction to the vaccine). 14-Apr-2021, the patient experienced COUGH (coughing) and CHEST PAIN (pain in chest / sore chest). On 15-Apr-2021, the patient experienced HEADACHE (headache), MYALGIA (body aches), PYREXIA (fever) and DYSPHONIA (hoarse voice). At the time of the report, HEADACHE (headache), MYALGIA (body aches), PYREXIA (fever), DYSPNOEA (trouble breathing), COUGH (coughing), CHEST PAIN (pain in chest / sore chest), CHEST DISCOMFORT (tightness in chest), HEART RATE INCREASED (increased heart rate and pulse), RASH (rash on upper chest), LIP SWELLING (lips started swelling up), URTICARIA (hives), HYPERSENSITIVITY (diagnosed it as a general allergic reaction to the vaccine) and DYSPHONIA (hoarse voice) was resolving.            No concomitant medications were reported.  Treatment of the events included Benadry and her asthma inhaler.  The patient was transported to the ER but discharged that day.   This case was linked to US-MODERNATX, INC.-MOD-2021-071088 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071088:1st dose events
49-year-old female patient was given Fluzone-HD quadrivalent instead of the Fluzone Quad, no AE; 49-year-old patient was given Fluzone-HD quadrivalent, no AE; 49-year-old female patient was given Fluzone-HD quadrivalent instead of the Fluzone Quad, no AE; Initial information received on 15-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case is linked to cases 2020SA253357, 2020SA252226, 2020SA253258 and 2020SA253258.  This case involves a 49 year old female patient who received 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ453AB and expiry date: 30-Jun-2021) via an intramuscular route in the left deltoid for prophylactic vaccination, on 10-Sep-2020 instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered, product administered to patient of inappropriate age and overdose).  Medical history, past medical treatments, vaccination and family history were not provided. No other vaccine was given concomitantly.  It is an actual medication error case due to wrong vaccine administered, inappropriate age at vaccine administration and overdose (latency same day). The caller reported that the error occurred due to grabbing the wrong box, not paying attention, and not looking at the box carefully. It was unknown if the patient was pregnant due to the information not obtained.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a healthcare worker concerning a female patient who on approximately 04-JUN-2008 was vaccinated with the third dose of GARDASIL vaccine (yeast) (Lot number not reported) and broke out in hives on an unspecified date. Healthcare worker also states when the patient goes in a cold pool, she breaks out in hives. Patient sought unspecified medical attention by calling physician's office. Additional information has been requested.
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an unspecified improperly stored dose of VAQTA lot # L028666 and expiration date 04-NOV-2016, (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects were reported. There was no product quality issue involved. This is one of several cases from the same reporter. Additional information has been requested.
Initial and follow-up information has been received from a medical assistant concerning a 14-year-old female patient with type 2 diabetes, anxiety disorder, Disturbance of skin sensation, insomnia hyperlipidemia and no drug allergies, who on 27-Aug-2008 was vaccinated IM with the first dose of 0.5ml GARDASIL (lot number and injection site not reported). Concomitant therapy included PROZAC, CLARATIN, Mirtazapine, Famotidine (reported as "Samotidine" , manufacturer unknown) and gabapentin for type 2 diabetes, anxiety disorder, disturbance of skin sensation, insomnia, and hyperlipidemia. On 27-Aug-2008 after receiving GARDASIL, the patient experienced numbness all over and passed out; she also experienced immediate dizziness, weakness, and disorientation. Since 28-Aug-2008, the patient has experienced daily episodes of temporary numbness of both feet which lasted an unspecified length of time. The episodes have increased to 2-3 times per day and the numbness, during each episode, now extends from the feet to the mid-chest. The patient was referred for neurologic and orthopedic consultation, providers unspecified and 'all testing was normal" The medical assistant also stated that the patient "has missed a lot of school recently because of the symptoms". In October 2008 the patient did receive the second dose of GARDASIL. At the time of reporting, the patient has not recovered. Additional information has been requested.
while waiting (by himself) in the waiting area, patient felt dizzy, neauseated, and immediately returned to administration room. He was given gingerale /coke to help nausea. He was sweating heavily, BP dropped to 90/45, pulse 70 (his normal is 110/70). Pt claimed he gets nervous of needles. Pt was  layed flat on the floor (no injuries).  monitored his BP every 5 min. Pt was gradually improving  and left store while was ensuring he was able to walk.  Called pt. 2 hrs later, and he was doing well
Belong to program and had to go back home since he got shingles 1 to 2 days following the covid vaccice Moderna.   He came over to ask us if it was safe for him to get the second shot after 28 days since he got shingle 1 day after the first shot. He also had a rx from ER for 3 medidations prescribed for shingles. We did not fill his rx since he wanted to fill them in a pharmacy close to his family's home.
an 11 year old male was accidentally given a 0.5mL dose of Kinrix; the intention was to give a dtap dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FMS, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th March 2022, the patient received Kinrix .5 ml and Kinrix Pre-Filled Syringe Device. On 28th March 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-Mar-2022 Reporter's Comments: A medical assistant reported that the patient accidentally given Kinrix for wound management and the intention was to give a dtap dose. The healthcare professional was informed by 2nd line agent that DTaP was not recommended by Centers for Disease Control and Prevention in patients 7 years old and up. CDC recommended Tdap. The consent to follow up was given via email. Additional Supportive Information: The 11 year old patient received Kinrix instead of dtap vaccine, which led to age at vaccine administration and wrong vaccine administered.
Had 2 episodes of syncope; Shortness of breath; weakness; Fatigue; 80% O2 saturation on RA; Heart rate up to 180; Rash on his abdomen appeared; This is a spontaneous report received from a non-contactable pharmacist. A 39-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, intramuscularly administered in left arm on 29Apr2021 08:45 (Batch/Lot Number: EW0172) (age at vaccination: 39 years old) as single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. On an unspecified date, prior to vaccination, the patient was diagnosed with COVID-19, unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. He had previously received the first dose of BNT162b2 on 08Apr2021 08:00 (Batch/lot number: EWP0158) (age at vaccination: 39 years old) as single dose for COVID-19 immunisation. Concomitant medication(s) included albuterol (ALBUTEROL) inhaler, naproxen (NAPROXEN) and calcium carbonate (CALCIUM CARBONATE), taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Apr2021, the patient developed shortness of breath, weakness, fatigue hours after administration of the vaccine. He had 2 episodes of syncope, 80% O2 saturation on room air (RA), heart rate up to 180. Rash on his abdomen appeared. The adverse events resulted in emergency room/department or urgent care. The patient was admitted to the hospital on an unspecified date in Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Considering a plausible temporal relationship, a causal association between the reported events and suspect drug bnt162b2 cannot be excluded. 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.
Constant screaming/crying, inconsolable, extremely fussy and seemed to be in great pain.  Lasted 2.5 hours.
REBOUND COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 43 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 01 total administered at left arm on 13-APR-2021 at 12:00 PM for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 41 years old. Concomitant medications included diazepam, and sertraline.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) The patient additionally received non-company suspect vaccine included: (Pfizer) tozinameran (Dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered at right arm on 01-JUN-2022 at 12:00 PM for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2). On unspecified date, patient experienced covid-19 infection and was treated with non-company suspect Paxlovid (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered from 22-NOV-2022 to 26-NOV-2022 for Covid-19 treatment (Dose number in series 2). On 28-NOV-2022, the patient experienced rebound covid-19 infection (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable, and with Paxlovid was drug discontinued. The outcome of the rebound covid-19 infection and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Received #6 Anthrax prior to departing to meet ship assignment. While in flight on 11 June 2011, developed red, itchy rash on body. Given BENADRYL capsule by a nurse on flight to stop over.
Patients vision from left eye was very blurry; The left eye was swollen; The left eye was red; The left eye was pain; Developed an inflamed left eye Cornea.; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Patients vision from left eye was very blurry), EYE SWELLING (The left eye was swollen), OCULAR HYPERAEMIA (The left eye was red), EYE PAIN (The left eye was pain) and KERATITIS (Developed an inflamed left eye Cornea.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included Corneal disorder (history of Cornea problems starting 40 years ago due to a history of a virus in her eyes) and Corneal transplant (two times). Concomitant products included ACYCLOVIR [ACICLOVIR] and LOTEPREDNOL ETABONATE (LOTEMAX) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced VISION BLURRED (Patients vision from left eye was very blurry), EYE SWELLING (The left eye was swollen), OCULAR HYPERAEMIA (The left eye was red), EYE PAIN (The left eye was pain) and KERATITIS (Developed an inflamed left eye Cornea.). In June 2021, KERATITIS (Developed an inflamed left eye Cornea.) was resolving. At the time of the report, VISION BLURRED (Patients vision from left eye was very blurry), EYE SWELLING (The left eye was swollen), OCULAR HYPERAEMIA (The left eye was red) and EYE PAIN (The left eye was pain) outcome was unknown.            The patient's medication kept her cornea stable. The patient received acyclovir 5 times a day.  The patient's cornea was improved 5 weeks later.  The patient had to get newcontact lenses after the inflammation stopped.  No treatment medication were provided.  The patient's doctor told her that several patients have came to the doctors office with similar complaints after receiving Covid - 19 vaccines.   The doctor did not specify about manufacturers.  The patient comments to the agent that this ordeal was getting expensive cost of eye drops.   This case was linked to MOD-2021-391819, MOD-2021-391835 (Patient Link).
Headache, severe fatigue,  body aches, nausea, feverish feeling but no fever., brain fog.. Slept for 3 days initially, then very weak with headache continuing for 5 more days.  Felt well for 3 days then all symptoms re-appeared . It is now  8 days I have been feeling extremely fatigued, headache, nausea, faint, aches, feverish without a fever.,, brain fog. Not getting better or worse.
Hospitalization - acute hypoxemic respiratory failure due to SARS-CoV-2 disease
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female. Initial information processed with additional information received from a regulatory authority on 28-DEC-2021. 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: 041A21A and expiry: UNKNOWN), dose was not reported, dose series in number was 1, administered 1 in total on 06-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. The patient also received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN) dose was not reported, dose number in series was 2, 1 in total, administered to left arm on 10-DEC-2021 for prophylactic vaccination. On 19-DEC-2021, the patient experienced cough, chills and low grade fever. on the same day the patient went to get tested by Polymerase chain reaction (PCR) and found positive which was confirmed clinical vaccination failure and confirmed covid-19 infection (dose number in series was 1). Laboratory data included: Polymerase chain reaction (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000208077. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20211247358-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Moderna COVID-19 Vaccine EUA Side-effect symptoms: vomiting (once), fatigue Recovery was complete by 4/5/2021, the next day.
fever, arm soreness, headache, fatigue day after.  2 days after started unusually heavy period 8 days early.
Fever (100.5-101) sustained  for 3 full days while on Tylenol q8. Redness and swelling at site. Nausea and vomiting. Malaise. Sneezing. Fatigue. Throbbing headache. Occasional shooting pains and soreness in joints. All symptoms sustained through today (over 72 hours post vaccine. This was  Pfizer booster, had moderna for first and second dose?
Father reported pt exp rash; On 20MAR pt was called to office & examined; t98.6 fine macular papular rash on anterior trunk & posterior trunk; no c/o of malaise;
Developed symptoms of COVD on 3-10-2021 and subsequently tested positive by PCR on 3-11-2021
Covid vaccine for 11 years and older was diluted with 1.3ml of dilution  was given to patient under 11 years old. 0.2ml = 10mcg was given to the patient (the correct dose was given to the patient) No sign effects reported 30 min after receiving the vaccine.
GI distress: severe diarrhea, severe bowel cramping, short term nausea and vomiting, chills, fever.  So far the symptoms have lasted for an entire week.