chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An expired Covid-19 pfizer vaccine was administered to the patient on 4/18/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient  on 5/10 and patient does not plan to get revaccinated.
Product Storage Error; Injection site reaction; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis.   On 3rd April 2019, the patient received Shingrix. In April 2019, less than a month after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the injection site reaction and incorrect storage of drug were unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional details were provided as follows: Shingrix lyophilized vaccine left at room temperature for 4 days, administered to the patient last week. The reporter did not give consent to follow up.
bad cramps; stomach aches; chills; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE SPASMS (bad cramps), ABDOMINAL PAIN UPPER (stomach aches), CHILLS (chills) and PYREXIA (fever) in a 56-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Retinal white dots syndrome (diagnosis right when COVID-19 virus hit (around November 2019)) since 2019 and Allergy to antibiotic. Concomitant products included FLECAINIDE, AMLODIPINE BESILATE (NORVASC) and VITAMINS NOS for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (bad cramps), ABDOMINAL PAIN UPPER (stomach aches), CHILLS (chills) and PYREXIA (fever). At the time of the report, MUSCLE SPASMS (bad cramps), ABDOMINAL PAIN UPPER (stomach aches), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The first vaccination was the worst. The patient ended up in the emergency room from bad cramps, stomach aches, chills and fever. The patient stated that processes medications (unspecified) really slow.   This case was linked to MOD-2022-551312 (Patient Link).
10 minutes after patient received Moderna booster dose she began not to feel well while sitting in the pharmacy waiting area.  She told another customer.  The customer came to the pharmacy counter and notified pharmacy staff.  Pharmacist ran out to give aid to the patient.  Patient said she was light headed and then she passed out.  She went in and out of consciousness.  Pharmacist called 911.  Paramedics came 10 minutes later.  While we waited for the paramedics patient continued to go in and out of consciousness and she complained that she was cold.  Her breathing remained normal.
Irritable; Live hangover; Sleepy, ate his food and again sleepy; Hungry; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy, ate his food and again sleepy), HUNGER (Hungry), HANGOVER (Live hangover) and IRRITABILITY (Irritable) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On 08-Apr-2021, the patient experienced SOMNOLENCE (Sleepy, ate his food and again sleepy) and HUNGER (Hungry). On 09-Apr-2021, the patient experienced HANGOVER (Live hangover). On an unknown date, the patient experienced IRRITABILITY (Irritable). At the time of the report, SOMNOLENCE (Sleepy, ate his food and again sleepy), HUNGER (Hungry), HANGOVER (Live hangover) and IRRITABILITY (Irritable) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-044103, MOD-2021-044103 (Patient Link).
Woke from sleep with hallucinations.  Was not making sense, but was aware that she was not making sense.  Mom called and I spoke to her.  Within half an hour, she had settled down and was able to fall back to sleep.  She seemed completely normal when she woke up the next morning.
Muscles in her neck have deteriorated; High cholesterol; Headaches; Neck pain; Eye was hurting; Her back and spine have deteriorated as well; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 14Feb2021 (at the age of 73-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The second dose scheduled on 07Mar2021. On an unspecified day in 2021, the patient experienced "muscles in her neck have deteriorated", high cholesterol, headaches, neck pain, eye was hurting, her back and spine have deteriorated as well and eye was hurting. The patient eye was hurting on the second week, had headaches, neck pain, muscles in her neck deteriorated and back and spine have deteriorated as well. Patient hadn't been having problems before the vaccine. Patient also had blood pressure and high cholesterol. Patient was asking whether she get real sick after the second shot, is it safe to take the second one and what are the side effects from the second dose and what if she didn't get it. She was wondering if she could get a different vaccine as second dose. On an unspecified date, the patient underwent lab tests and procedures which included blood cholesterol which was found to be high and blood pressure with unknown results. The outcome of events was unknown.     Follow-up attempts are completed. No further information is expected.
On  11/26/22 evening developed headache and stiff neck; felt like I was getting nasal and sinus congestion.  Sunday 11/27/22 woke up with headache and sinus congestion with body aches and fever 2 degrees above normal.  Received email to test for covid results were positive.
The patient received the pediatric dose instead of the bivalent booster. As of 8:30am on 11/22/22 no adverse events have been reported.
anaphylactic reaction; This is a spontaneous report from a contactable nurse (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unknown date, after receiving vaccination, the patient experienced anaphylactic reaction. The outcome of the event was unknown.  Information on the lot/batch number has been requested; Sender's Comments: As there is limited information in the case provided, the causal association between the event anaphylactic reaction and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Patient received covid booster, started 4th or 5th day after heart palpitations bp 140/120, abnormal heart beats currently consistently going up
Blood pressure,. On 9/11:     8:01 am  81/66 8:56 am  73/61 9:15am  104/78 9:50 am  111/73 10:12 m  87/73 10:20 am  80/66 2:56 pm   87/67 5:20 pm  110/3 9:00 pm 115/83
HIGH fever over 103 that continued throughout the night even with fever reducing medications.  Now, 24 hours after the shot was administered there is still a temperature of 102.7 rectally.
Patient given expired vaccine. They did not experience any side effects or adverse reaction. Patient was immediately notified and discussed with provider to revaccinate in 1 month.
SEVERE MUSCLE PAIN AND SWELLING OF THE ARM WHERE THE VACCINE WAS ADMINISTERED. THIS LASTED FOR 48 HOURS
Took to ER at 5am because he was dry heaving, and vomiting.  They did an EKG and a CT scan of the abdomen and lab work. He was placed on hydratation, 6 bags of fluids as well as Zofran for the vomiting also he also had tachycardia.  He also experienced chills to the point he was shakiness when he go the tachycardia. He also has fever of 108.F and he was given Tylenol for relief of pain. He was then transferred to Hospital at 4pm and stayed there till 11pm. He also received an EKG exam at the Hospital.  They also did a Covid test which was negative.   As far os today my son has recovered.
Information has been received from a physician concerning a male child with no known drug reactions/allergies and no pertinent medical history who several years ago was vaccinated SC with Varviax (Lot # 643092/0551M). On approximately 25 Sep 2006, this week, the patient experienced chicken pox after being exposed to another child with chicken pox. The patient's symptoms included about 20-30 crusting and vesicular lesions with a runny nose. No other symptoms were noted. As of 02 Oct 2006, the patient was recovering from chicken pox. Additional information has been requested.
No adverse  effects until I received the booster on 12-04-21.  Please see description provided earlier in this form.
Pt developed right tibial osteomyelitis 2 days following vaccine.  Treated with antibiotics
The pt experienced red, warm, painful right arm for 1 week. The pt was given Prevnar instead of Pneumovax.
Episode of stiffening & shaking 2 hrs post inject w/fever of 102F; Normal growth & developement;
Redness - from shoulder to wrist - 4 days Swelling - shoulder to elbow - 3 days black and blue - shoulder to elbow - 3 days fever - 3 days
Stared with small rash 3/5/07, then spread from head to toe by 3/8/07. Mom tried benadryl and tylenol when symptoms first occured, no relief. Mom refused any further treatment, going to used calamine lotion for itch relief.
Neuropathy; Vision loss; Trigeminal neuropathy; This initial spontaneous report was received from a lawyer on 03-AUG-2020, regarding a case in litigation and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or around 31-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (the dosage regimen information was not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered burning pain on the left side of his face. The patient was diagnosed with neuropathy, trigeminal neuropathy and vision loss. As a direct and proximate result of vaccination, the patient's symptoms resulted in physical limitations not present prior to the use of the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. The patient sustained severe and permanent personal injuries. Further, the patient 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. The patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.
FREQUENT BOWEL MOVEMENTS; CRYING; HORRIBLE PAIN ALL OVER BODY; This spontaneous report received from a patient concerned a 5 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. Age at time of vaccination 41 years old. No concomitant medications were reported. On an unspecified date, the patient experienced frequent bowel movements, crying, and horrible pain all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from crying, and horrible pain all over body, and had not recovered from frequent bowel movements. This report was non-serious.
pt had 4 black out spells of unresponsiveness lasting 1 1/2 mins. between 5APR & 8APR no tonic clonic or other seizure activity; pt had an acute allergic reaction to VANTIN on PM of 2APR;
lymph node in her throat looks swollen; This is a spontaneous report received from a Pfizer-Sponsored Program, . A contactable consumer reported a female patient of an unspecified age received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), 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's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 on unspecified date (lot number not provided) for COVID-19 immunization. The caller's daughter got first vaccine her arm was swollen and went away. The consumer reported it's been a week since the patient had the second one and a lymph node in her throat looks swollen. The clinical outcome of lymph node in her throat looks swollen was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
12 hours post vaccine administration pt developed "hot" swollen area around injection up and down arm (L) shoulder to elbow.
During 15 minute waiting period after receiving vaccine, the mother of the patient called staff over and reported the patient had experienced seizure like activity. When staffed arrived to assess the patient was startled, however was lucid and coherent. Staff then directed the patient to the hospital emergency department for further evaluation.
This case was reported by a healthcare professional and described the occurrence of injection site pain in an adult subject of unspecified gender who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis. The subject's medical history. Concurrent conditions, and concurrent medications were not reported. No other vaccinations were administered on the date of Flulaval administration. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm). At an unspecified time after vaccination with Flulaval, the subject experienced injection site pain and product complaint. The subject returned to the clinic for further evaluation. The healthcare considered the events were disabling. The clinic used a 1 inch needle, 30 gauge needle to administer the vaccinations. The office is very concerned about using additional doses of this vaccine and believe there is a quality issue associated with it. The healthcare professional reported that the injection site pain lasted greater than two weeks and the outcome of the events was unspecified.
SORE ARM, AT FIRST ATTRIBUTED TO muscle ache, but later realized it was very specific to injection site, and very intense pain.  I was unable to sleep more than a few short spurts the entire night as the pain was so intense.  I read online that Benadryl was to be used for the pain, as well as ice.  Originally I had used heat, before finding the information online.  Nothing seems to help at this point.
arm is little numb; I am still having little tingles in my left arm and in my hand; my arm  at injection site it is swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jul2021 (Lot number: FA7485) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "arm is little numb"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "I am still having little tingles in my left arm and in my hand"; VACCINATION SITE SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "my arm  at injection site it is swollen". Therapeutic measures were taken as a result of hypoaesthesia, paraesthesia, vaccination site swelling.  Additional information: The Tylenol was used as treatment drug. No Investigation Assessment.  No follow-up attempts are possible. No further information is expected.
66-year-old male presents to urgent care complaining of acute onset pain in the right deltoid muscle at the site of the intramuscular injection of the PNEUMOVAX 2 days ago. He noticed the pain yesterday gradually and getting worse throughout the day. He describes deep soreness aching, pain radiating down the arm, unable to sleep, chills last night. He had mild flulike symptoms yesterday now resolved. No known fever. No facial swelling, generalized rash, shortness of breath, choking. No upper extremity swelling. Right arm pain subsided today compared to yesterday. He has chronic low back pain and takes gabapentin and NORCO as needed. He has been prescribed NAPROSYN in the past but has not taken this medication for the right arm pain. Assessment and plan. Allergic reaction to PNEUMOVAX localize pain at the injection site and erythema. Symptoms subsiding. May take NAPROSYN 500 mg 1 tablet twice a day for the next few days. May take BENADRYL 50 mg 1 tablet 3 times a day for the next few days as needed. Discussed potential adverse drug reactions. May try ice first or heating pad as needed. Symptoms: and pain, erythema. Treatment: Naproxen 500 mg BID, diphenhydramine 50 mg TID.
Information had been received from a field representative who was informed by a pharmacist that a female patient who had received ZOSTAVAX (lot# H009779) on 18-SEP-2012 experienced "cellulitis". The representative also said that the patient had "a red spot the size of a small lemon with a lighter shade of red covering the injection site to her elbow". It was verified with the representative that she learned of the AE on 23-SEP-2012 (onset date not provided). No other AE information was given. Additional information has been requested.
BP 178/110, HR 112, ACC check 95, O2 100%. Client states that she feels anxious.
From telephone contact received at a manufacturer's on 08/28/01, it was stated that a 4 year old received his 5th dose of Tripedia on 08/21/01. patient was seen on 08/23/01 at physician's office, his left thigh from thigh to knee was warm to the touch  with erythema and a rash with a lacey horder. Placed on Keflex,by 08/26/2001, all syptoms were resolved. It was reported on 10/25/01- Resolved, no addition information. This case is closed.
Day 2 after injection just injection site pain and tired. Severe hips/knees/ankles/wrists/back pain on day 5 and 6 after injection and calves pain and tightness.
shock-like synd, pt turned pale, limp & was drowsy/sleepy 2-5 minutes p/shot was given;
headache, sore throat, light headed, nauseous, fatigue, cold and sweaty-no fever
Case number PHEH2014US024686, is an initial spontaneous report received from a nurse on 08 Dec 2014. This report refers to a 61 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: unknown) on 08 Dec 2014. No adverse reaction was reported. No further information was provided.
ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 1/3/2023,  3/4/2023,  2/2/2023,  2/19/2023,  2/11/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Pt states 2 hrs post vaccine her throat started to itch and had uncontrollable hacking cough. States no difficulty breathing.
rash, fever, swelling leg, Diabetes Mellitus discovered 5/3/99
PT RECEIVED 2ND DOSE IN SERIES ON THURSDAY AFTERNOON. ON SATURDAY MORNING, SHE WOKE UP WITH MUSCLE ACHES, CHILLS, HEADACHE, HURTING ALL OVER. HER ARM WAS SWOLLEN AND RED.
Very mild soreness at injection site; Eye ache; Felt unwell; Tiredness; Headache; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Eye ache), MALAISE (Felt unwell), FATIGUE (Tiredness), HEADACHE (Headache) and MYALGIA (Muscle pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE PAIN (Eye ache), MALAISE (Felt unwell), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and VACCINATION SITE PAIN (Very mild soreness at injection site). At the time of the report, EYE PAIN (Eye ache), MALAISE (Felt unwell), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) had resolved and VACCINATION SITE PAIN (Very mild soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment for the events included 2 anti-inflammatories ibuprofen.
p/1st & 2nd dose of Engerix-B pt exp pain in shoulder; p/3rd dose of Engerix-B pt exp pain between back & migrating arthritis; pt still has occasional discomfort;
This spontaneous report was received from a nurse referring to an unspecified number of patients of unspecified demographics. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On unknown dates, improperly stored doses of VARIVAX lot # M041513 with expiration date 11-OCT-2018, lot # M047660 with expiration date 02-DEC-2018 and lot # M040139 with expiration date 29-SEP-2018 (dose, route of administration and anatomical location were not reported) were administered to the patients. No adverse effects were reported. It was reported that the vaccines were exposed to temperature between 6 and 14 degrees Fahrenheit for 174 hours. No previous temperature excursion was reported. Digital data logger was involved. No product quality complaint was reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-0009507513-1706USA004366: US-0009507513-1706USA010087:
Pt developed reddened area on thighs and hips, huge hives on right arm, stomach and back. He also had a fever.