chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Physician is asking for safety information about QUADRACEL is mistakenly administered to a 9 year old with no reported AE; Initial information received on 16-Feb-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 9 years old patient with unknown gender in whom physician is asking for safety information about quadracel is mistakenly administered to a 9 year old with no reported AE (adverse event) while receiving vaccine Diphtheria-15/Tetanus/5 Hybrid AC Pertusis/IPV (MRC5) Vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Feb-2022, the patient received 0.5mL dose of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertusis/IPV (MRC5) Vaccine suspension for injection (route, batch number and expiry dates: unknown) in an unknown administration site for immunization.  On 15-Feb-2022, physician is asking for safety information about quadracel is mistakenly administered to a 9 year old with no reported AE (product administered to patient of inappropriate age) (latency: same day) following the administration of Diphtheria-15/Tetanus/5 Hybrid AC Pertusis/IPV (MRC5) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event product administered to patient of inappropriate age.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.; Sender's Comments:  00981348:
15x19cm urticarial lesion at injection site (right thigh) Central Clearing of lesion noted.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 at 10:45 as dose 1, single (Lot number: En6198), in left arm, on 22Mar2021 at 10:45 as dose 2, single (Lot number: Ep7534), in left arm, on 27Sep2021 at 11:00 as dose 3 (booster), single (Lot number: Ff8839), in left arm and on 27May2022 at 11:00 as dose 4 (booster), single (Lot number: Fj4989) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "pancreatic pseudocysts" (unspecified if ongoing), notes: Other medical history: Previous pancreatic pseudocysts from acute pancreatitis from blocked duct; "acute pancreatitis" (unspecified if ongoing), notes: Other medical history: Previous pancreatic pseudocysts from acute pancreatitis from blocked duct. The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 14Jul2023 to 19Jul2023 as treatment for the events.
Bells Palsy on right side of face.  Droopy eyes and mouth on one side Started antiviral and corticosteroid x 1 week on 3/18/2021
Nose is stuffy; Trembling; Metallic taste in mouth; Hands and fingers turned a rust orange color; severe body ache; Headache; body chills; fever of 102F; Fatigue; Received first shot of Pfizer vaccine and scond shot of Moderna's; A regulatory authority report was received from a healthcare provider concerning a 19-year-old, male patient who received first shot of Pfizer vaccine and second shot of Moderna's/wrong product administered, headache, nose is stuffy/nasal congestion, chills, trembling/tremor, fever of 102F/pyrexia, hands and fingers turned a rust orange color/skin discoloration, metallic taste in mouth/dysgeusia, fatigue and severe body ache/myalgia.  The patient's medical history included allergies to codeine and anxiety. Products known to have been used by the patient, within two weeks prior to the event, included Fluoxetine 40mg, Lamotrigine 100mg, Amlodipine 10mg and Lunesta 3mg.    On 01 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received a dose of the mRNA-1273 (Batch number: not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 01 Feb 2021, the patient went to pharmacy and was offered his second dose of the vaccine, at the time of administration, the patient stated he was unaware that the vaccine given to him was from Moderna. His first vaccine was from Pfizer.  On 02 Feb 2021, the patient stated he felt very sick, he had a headache, nose was stuffy, body chills, severe body aches, a fever of 102 degree Fahrenheit, and noted rust colored spots on his hands. The patient stated these symptoms lasted two days after the vaccine was administered. The patient also stated he had a metallic taste in his mouth that worsened when he drank water or other beverages. At the time of this report, the metallic taste in mouth had not resolved. The patient visited Urgent Care and was instructed to take a baby acetylsalicylic acid once a day.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event, metallic taste in mouth/dysgeusia, was considered not resolved.   The outcome of event, received first shot of Pfizer vaccine and second shot of Moderna's/wrong product administered, were considered resolved on 01 Feb 2021.  The outcome of events, headache, nose is stuffy/nasal congestion, chills, trembling/tremor, fever of 102F/pyrexia, hands and fingers turned a rust orange color/skin discoloration, fatigue and severe body ache/myalgia, were considered recovered on 04 Feb 2021.; Reporter'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.
Patient got the expired Covid vaccine (vaccine expired on 02/12/22). No ADEs is reported. Called Pfizer medical rep and she said there is new data that Covid vaccine ( purple cap) is stable in the fridge for 45 days. Advised patient to call doctor if the new data is acceptable. if not, revaccination is required.
Pt recvd Hep B vax 1MAY91 & 6 hrs following devel sore arm & arthralgia in lt shoulder; treated w/ASA & recovered in 6 to 7 wks; 3 months following 3rd vax devel arthritis-type signs & sx;
shiver; body pains; This case was reported by a physician via call center representative and described the occurrence of shivers in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced shivers and general body pain. On an unknown date, the outcome of the shivers and general body pain were unknown.   It was unknown if the reporter considered the shivers and general body pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient had body pains and shiver within 24 hours of vaccination. No other information was provided before the physician ended the chat and wanted to know if it was fine to receive the 2nd dose of Shingrix in a patient with these side effects. The reporter did not consent to follow-up.
Soreness and tiredness within one day.  One week later experienced swelling, rash, itching, burning, and redness at injection site.
This spontaneous report was received from a register nurse, refers to an unspecified number of patients, of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date the patients received improperly stored, VAQTA (strength, dosage, route, lot# and expiration date were not reported). No adverse were reported. This is one of several reports received from the same reporter. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid treatment start date: 04Oct2023, stop date: 09Oct2023) were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300329600 same patient, different drug and different event.;
Approximately 1 hour after receiving vaccines, mom noted that she started walking funny and "appeared drunk." Her hand-eye coordination was off for about 2 days. Trouble walking and falling down lasted about 5 days. No fussiness. No fevers. No vomiting. Good PO.
Information has been received from a nurse practitioner concerning a 16 year old female who was vaccinated with her first dose of GARDASIL and has a syncopal episode right before getting into her car. The patient recovered from her syncope. The nurse practitioner could not confirm that these events were definitely related to vaccination with GARDASIL. The practice began observing the patient for 15 minutes after the patient received vaccination as a result of the event. This is one of three reports received from the same source. Additional information has been requested.
rebound covid on 7th day after last day of paxlovid; rebound covid on 7th day after last day of paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 26Apr2021 as dose 2, single (Lot number: EW0176), in left arm and on 10Dec2021 as dose 3 (booster), single (Lot number: FJ8762), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SUMATRIPTAN; FAMOTIDINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "rebound covid on 7th day after last day of paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient taken antiviral (Paxlovid; lot no.FY9928) for treatment of COVID-19 on 26May2022 and stopped on 31May2022.
Fifteen days post vax the pt developed a very large lesion at the injection site, followed by a couple of small lesion on the face and scalp.
Patient reports burning feeling and redness in eye that did not go away for 7 days.  We reached out to patient after advising her to call her physician, and the symptoms seem to have resolved without dr's intervention. patient did not call physician.
Mother reports "dark, red place 9 days later where shot was given." Also describes site as "hard."
4 INCH SWELLING TO LEFT ARM. RED AND WARM. INSTRUCTED PARENT TO APPLY COOL COMPRESSES TO ARM.
This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a female patient who received ENGERIX B (batch number AHBVC190AA, expiry date 25th January 2015). On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. It was unknown if the reporter considered the incorrect storage of drug to be related to ENGERIX B. Additional information received: Vaccines were stored below recommended temperature ranges. ENGERIX and BOOSTRIX were stored at 25 degree C and administered to patient. Facility unsure of how many other patients were involved.
colds; runny nose; a little muscle pain at the injection site; mild muscle pain; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer-sponsored program a 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0185 and Expiration date not reported) via an unspecified route of administration, administered in left arm on 26May2021 at 09:16 (at the age of 73-year-old) at a (0.3 dose, units not provided) single dose for COVID-19 immunization at Pharmacy/drug store. Patient was healthy when he took the first vaccination. The patient had no medical history and concomitant medication were not reported. The patient did not receive additional vaccines administered on same date of the vaccination and within four weeks prior to vaccination. The patient previously received vitamins including Vitamin C. On an unspecified date in May2021, after the vaccination, patient had colds and runny nose for a week, and still have a little cold, had just a little muscle pain at the injection site and mild muscle pain that went away the following day. Reporter stated that he got this virus or cold because of the weather. It's very hot right now and believe that was the reason why he had the colds. The patient received treatment with NyQuil, Dayquil, and Tylenol for the cold. Events were not resulted in emergency room or physician Office. The patient was scheduled for the second dose for the Pfizer COVID-19 vaccine tomorrow, 16Jun2021. So, he was afraid of the second dose since he was just getting over and still recuperating from the cold and won't know what the effect will be. The outcome of the events colds and runny nose was recovering, and the rest of the events was recovered on an unspecified date in May2021.
Headache, muscle aches, fever (101.1), shivering and fatigue lasting about 24 hours.
Pt was ready to go and mom was signing some papers and pt fell forward. I caught her lowered her to ground and she had a small 10 sec seizure. Mom said she has hx of them. Pt woke and asked what happened. Pt was checked by doctor and left. Follow up with pt 3/22/10. Pt doing fine.
Initial and follow-up information has been received from a medical assistant concerning a 15 month old female, whose reported birth weight was 7 pounds (lbs) and 5 ounces (oz) with no preexisting allergies, birth defects, medical conditions and no illness at the time of vaccination, who on 10-AUG-2006 was inadvertently vaccinated with a dose of Pneumovax 23 9lot #650456/0974P), instead of a Prevnar. It was reported that the patient had received the following vaccinations (date not reported) DTaP (manufacturer Adventis) Hib (HIB) (manufacturer Adventis) and poliovirus vaccine (manufacturer Adventis). At the time of report, no symptoms had been reported. The medical assistant also reported that the Risk Management Department of her organization, which includes 30 clinics, was working on a company-wide program to develop a standardized protocol for vaccine administration. Some of the issues it was addressing included identifying the correct patient and rechecking the vaccine with another person. She noted that it was to protect both the patient and the health care professional who was administering the vaccine. Her office also sent a letter to the parents of the children who had received the Pneumovax 23 (lot #650456/09974P), instead of a dose of Prevnar. No product quality complaint was involved. Additional information has been requested.
Pt seen in ER w/ear infect & LVL pneumonia; mom reported sz that lasted 2-3 sec; pts t104.6 R; pt given meds;
Patient received VARIVAX on 2/15/05 and 9/18/07.  Both immunizations were administered in the left thigh.  Patient returns to clinic on 3/2/06 with a diagnosis of shingles.  The case was described in the medical record as "chicken pox like lesions or rt. mid side in nerve line pattern like shingles."
induration, blanching erythema, warmth skin and 3cm areas; administered cold compresses. - Local reaction
swelling of lymph node; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm soreness) and LYMPHADENOPATHY (swelling of lymph node) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031220A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness). On 28-Feb-2021, the patient experienced LYMPHADENOPATHY (swelling of lymph node). At the time of the report, VACCINATION SITE PAIN (Arm soreness) and LYMPHADENOPATHY (swelling of lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not reported. Treatment information were not provided.
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of Zostavax. Subsequently the patient experienced raised bump the size of a quarter after vaccination. Patient were advised to take non-steroidal inti-inflammatory drugs (NSAIDs) and apply ice to the site. The symptoms have occurred about a day or so after administration of the vaccine and dissipated a day later. VAERS reports have been already filed on the two cases. No product quality complaint. This is one of several reports received from the same source. Additional information has been requested.
Mild chicken-pox like rash, not itchy. A little bit tired. No fever. Otherwise well.
pt recv vax 7JUN95 & 8JUN95 exp malaise & tiredness; 9JUN95 pt devel vesicular lesions on rt hip; By 11JUN95 had over 300 lesions on body & pharyngeal area;
This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. Information regarding concomitant medications, concurrent condition and medical history was not reported. On an unspecified dates in April 2015, reported as since 03-APR-2015 unspecified patients were vaccinated with ZOSTAVAX (dose, frequency, lot number, expiration date were not reported). The ZOSTAVAX was exposed to temperatures outside of the recommended range. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Was fine for about 8 hours, outside of a little soreness in arm. Then I started feeling cold chills, and had to lie down in bed for the rest of the day.  Slight fever also occured and intense body aches. However, these slowly subsided after taking tylenol at about 6PM. I slept through the night and outside of feeling a little lethargic the next day, I was back to normal.
No immediate effects other than soreness at the injection site on Wed 4/28.  Upon waking on Thurs 4/29, I had a fever of approximately 99.5F.  Took acetaminophen afterwards for the next 24/48 hours as the fever steadily rose throughout the day peaking at approx 102F around 5 pm.  Also developed chills, fatigue, all over muscle soreness, a headache, and nausea.  Overnight 4/29 into 4/30 was pure misery but by 4/30 a.m. the fever starting to break.  Took pain relievers and antacids(for the nausea) through Sat 5/1.
I had broken out in a little rash; Numb arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. During the call caller stated, after I taken the shot the first dose of the Pfizer shot my arm was a little numb and sore but also I had broken out in a little rash as well and it's all over my body. Before I've taken the shot I didn't have any rash and everything and I heard your arm gone be a little sore or numb. but then I got out the shower and I'm like what's going on I looked over my body and I was like woah what the heck is happening. Caller later stated, this been about the last 2 and a half days and it's really irritating this rash what they have available either something for me to put on it. It keep getting worse or what you know after I did this shot I'm like woah. The outcome of events was unknown.  No follow up attempts are needed. No further information is expected.
I recently got the vaccine while on my period and I feel that it exacerbated my symptoms; This is a spontaneous report from a contactable consumer reported for self.  This female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation. The patient recently got the vaccine while on period and felt that it exacerbated symptoms. The patient spoke with many of friends and consulted online resources and they all agree. Women who get vaccinated while menstruating have much worse reactions than those who are not. The patient believe you should research this further because it can be really harmful. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Pt was seen in ER 22OCT91 @ 1115 inc fever 103-104; Jerky movement observed while in ER; MD did not witness these movements; Pt was admitted to hosp overnight; no other problems; MD felt pt should have DT next visit;