chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient received only the sterile water diluent; Inappropriate dose of vaccine administered; he administered a dose of Priorix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 39-year-old female patient who received MMR (Priorix) for an unknown indication.   On 22-OCT-2023, the patient received the 1st dose of Priorix. On 22-OCT-2023, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: the patient received only the sterile water diluent), inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered) and inappropriate age at vaccine administration (Verbatim: he administered a dose of Priorix). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration 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: 25-OCT-2023 The vaccine administration facility was the same as primary reporter The pharmacist reported that a patient came in to pharmacy for MMR vaccination and administered with a dose of Priorix, but afterward realized that he did not reconstitute, so the patient only received only the sterile water diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. A 39 year old patient received Priorix, which led to inappropriate age at vaccine administered. The reporter consented to follow up.
Cellulitis, redness, itching, fevered to touch left deltoid area. Approx area sice of hand.
The patient was seen int he ED on 9/15/23 with nasal congestion, sore throat, and weakness for the past three days. She took a COVID test earlier that day which resulted positive. Additionally, she reported frequent falls at home. Ultimately, the patient was admitted 9/15/23 - 9/18/23 with discharge diagnoses including acute respiratory failure with hypoxia due to COVID-19 viral pneumonia, among other diagnoses. Of note, she did require supplemental oxygen, however was able to wean off during admission.  The patient has received the primary COVID vaccine series and one booster.
3 to 4 hrs p/inject pt had elevated t105 exp 2 major & 3 minor seizures; temp remained elevated x 24 hrs;
The child reported to walk-in clinic with mother on 5/6/06 with redness and pain at injection site. Treated with antibiotics 4 times a day for 7 days. Returned to see PCP on 5/8/06. Continue antibiotics. Returned to clinic
This spontaneous report as received from other health professional via company representative refers to a 19 year old female patient. Patient has had no history of allergies to vaccines in the past. On 05-SEP-2013 the patient was vaccinated with GARDASIL (dose number, dose and frequency unknown) lot # J003727 and expiry date 07-NOV-2015), intramuscularly in the left deltoid region. On 06-SEP-2013, in the next morning the patient's arm was very sore and the injection site was red and hot. The patient's mother, who was nurse, instructed the patient to put ice on the injection site. It was reported that patient's reaction lasted 3 to 4 days and nothing else was done for her. The outcome of injection site was red and hot and patients arm was very sore was unknown. No further details were noted. Additional information has been requested.
Expired vaccine administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 6th February 2023, the patient received Havrix. On 6th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 6-Feb-2023 Reporter's comment: The reporter did not had patient information besides gender. The reporter consented to follow-up via email. Additional supportive information: The patient received an expire dose of Havrix, which led to expired vaccine used.
pt recv vax & 9 days post vax pt devel a rash & fever;
Information has been received from a male patient (age not reported) who on an unspecified date was vaccinated with Zostavax. Two days later, the patient developed shingles. The patient did not seek medical attention. No further information is available.
Case number PHEH2015US002909, is an initial spontaneous report received from a Healthcare Professional on 06 Feb 2015. This report refers to a 21 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1412801) intramuscularly at a dose of 0.5 ml on 11 Dec 2014. It was reported that before administration, the FLUVIRIN was stored at 34 degree Fahrenheit for 15 hours. No adverse event was reported following this maladministration.
Pt develop rash on the chest on 22 Dec 06 after small pox vaccination 1 1/2 week ago.
patient became very dizzy and light headed about 5 minutes after receiving vaccine. She also felt hot and clammy.
LOWER BACK PAIN; A BIT OF PAIN IN MY ARM; INJECTION SITE PAIN; LOW GRADE FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced lower back pain. On MAR-2021, the subject experienced a bit of pain in arm. On MAR-2021, the subject experienced injection site pain. On MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site pain, low grade fever, lower back pain, and a bit of pain in my arm. This report was non-serious.
4OcT92 9AM 8 or 9PM approx 3 days to ER @ hosp due to rapid heart rate; (Apical pulse 247); in ICU 3 days;
Reaction to psoriasis, hands started to get bad, hand got scaly, crackly/got little spots on sides belt or waist sides/ Psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Reaction to psoriasis, hands started to get bad, hand got scaly, crackly/got little spots on sides belt or waist sides/ Psoriasis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Reaction to psoriasis, hands started to get bad, hand got scaly, crackly/got little spots on sides belt or waist sides/ Psoriasis). At the time of the report, PSORIASIS (Reaction to psoriasis, hands started to get bad, hand got scaly, crackly/got little spots on sides belt or waist sides/ Psoriasis) had resolved.            Relevant concomitant medications were not reported.  The patient's booster dose triggered a reaction to psoriasis, per his doctor his hands started to get bad, hand got scaly and crackly and he got little spots on his sides belt or waist sides. The symptoms of hand scaly and crackly was unifying under diagnosis psoriasis. The doctor prescribed an unknown cream for this.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  The reporter's causality for the event of triggered a reaction to psoriasis, hands started to get bad, hand got scaly and crackly and got little spots on sides belt or waist sides with SKYRIZI was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
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 70-year-old male patient received BNT162b2 (BNT162B2 NOS), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Zofran, reaction(s): "Known allergies: Zofran". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Had a massive headache and got chills and nausea all together - it was unusual for me, so I called the Doctor and requested an appointment the same day. When I got to the clinic, they advised me to take Tylenol and just have 1 day of bed rest for observation which I did.
Extreme abnormal mentsrual cycle; intense cramps and bleeding; intense cramps and bleeding; Severe chest pain when lying down; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0162, Expiration Date: not reported) via an unspecified route of administration in Left Arm on 16Apr2021 18:30 as dose 1, single for COVID-19 immunization (at the age of 31-year-old, non-pregnant). Medical history included attention deficit hyperactivity disorder (ADHD) from an unknown date and unknown if ongoing. Patient had no known allergies. Patient had no covid prior vaccination and was not covid tested post vaccination. Concomitant medication(s) (in two weeks) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for attention deficit hyperactivity disorder, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. The patient experienced extreme abnormal mentsrual cycle, intense cramps and bleeding, severe chest pain when lying down on 19Apr2021. Patient was sent for two days. Ae resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The outcome of the events was not recovered.  No follow up attempts are possible; no further information expected
Sore throat; nasal congestion; chills; headache; nausea; feels like the flu; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program Pfizer First Connect. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore throat, nasal congestion, chills, headache, nausea, and feels like the flu in Jan2021. The clinical outcome of sore throat, nasal congestion, chills, headache, nausea, and feels like the flu was not recovered.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
expired dose administered to patients; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter who was a Physician stated that 3 vials of the Moderna COVID-19 vaccine were used to administer the COVID-19 vaccine to patients and after the vials had been used, they realized that some patients had received the Moderna vaccine more than 12 hours after the vials had been punctured.   The number of patients affected was unknown at the time of reporting and said that this incidence was still being investigated and only limited information was available at this time. The dosage for the patients ranged from 1st, 2nd, or booster dose and the date of administration ranged from 4-Dec-2021-10-Dec-2021. Reportedly, there were no known side effects that have been reported by the patients from the expired dose.  No Concomitant product use was reported. No treatment information was provided.
I gave an IM  TDAP injection on 8-19-19 in patient's left arm for work purposes. He did not have any symptoms immediately after the vaccine. He left my clinic and went back to work.  I received an email from patient at 0733 om 8-20-19 stating he  began to have symptoms last night (8-19-19) including significant pain, neuropathy and other neurologic symptoms in the left lower extremity. He was directed to go to PCM/ER  on 8-20-19 to be evaluated. He went to ER and was evaluated and discharged. He stated he was diagnosed with peripheral neuropathy. I spoke with him again on 8-22-19 and he stated his symptoms were getting worse as the peripheral neuropathy had spread to his mid-thigh on his left leg. He stated he had a Neurology appointment the next day (8-23-19). I spoke with him again on 8-27-19. He states he was admitted to the hospital the same day as his Neurology appointment and was still in the hospital. He stated the neuropathy is worse still extending through his left leg, right leg, right arm, and lower back. He stated he thinks he will be in the hospital for about a month.
INCORRECT PRODUCT STORAGE; VACCINE GIVEN AFTER A TEMPERATURE EXCURSION COLLECTIVELY FOR 472 HOURS; This spontaneous report received from a health care professional concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: 24-SEP-2022) dose was not reported, administered on 07-MAR-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 39 years old. No concomitant medications were reported.  On 07-MAR-2022, the patient experienced vaccine given after a temperature excursion collectively for 472 hours. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given after a temperature excursion collectively for 472 hours and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220945899, 20220945957, 20220945831, 20220948245 and 20220948255.
Syncopal episode following vaccination with GARDASIL - full vasovagal reaction, unconscious for 30 seconds. BP initially 62/30.
3 months diarrhea, loose stools, gas, bloating. Nonstop without any improvement. Even with taking Immodium daily.
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer concerning an approximately 77 year old female patient. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 14-OCT-2011, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. In 2017, the patient was treated by a physician for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
Information has been received from a physician concerning a 24 month old male patient with minor eustachian tube problems and no know drug allergies who on 04/24/2002 was vaccinated subcutaneously in the left arm with a 0.5ml first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine.  Post vaccination the patient experienced parotid swelling and fever.  The patient sought medical attention but it was reportedly unknown what treatment was recommended.  Subsequently, the patient recovered from parotid swelling and fever.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/27/2005. Information has been received from a physician concerning a 24 month old male patient with minor eustachian tube problems and no known allergies, who on 24-APR-2002 was vaccinated SC into the left arm wih a 0.5 ml first dose of MMR II (lot # 641723/0426M). There was no illness at the time of vaccination. On 01-MAY-2002 seven to eight days after vaccination, the patient experienced swollen glands behind his ears, and a fever. Unspecified medical attentionwas sought. No diagnostic laboratory tests were performed. It was noted that the patient was minitored by a surgeon and a pediatrician. No treatment or surgery was needed. The swollen glands lasted for several months. In July 2002, the patient recovered. no further information is expected.
On Sept 1, pt was having trouble breathing. I took him to the ER. They said he had pneumonia. They prescribed an antibiotic, Pred Salpho and an albuterol inhaler.
Received call concerning redness and swelling at site of injection that was given on 8/7/02. Mom reported child was active and playing, taking fluids and food. There was no fever. Mom given instructions to apply cold compresses and give Tylenol as needed.
pt recvd flu vax & devel myalgia, dark urine (bilirubinuria), h/a, abdo pains, fever, fatigue 7 hepatosplenomegaly; sx peaked about 10 days p/vax;
Rash started on 4OCT neck & axilla w/fever in eve of 102; full blown rash on 6OCT; Now has pustules forming; Not confluent rash x/on buttocks; Seen by MD today who didn't dx rash, probably not infectious;
Breakthrough COVID case: 12/30/2021: My sister and brother tested positive for COVID. I tested my mother and she tested negative, but she started to have cold symptoms. I decided to do another rapid test and she tested positive. The next day 01/01/2022 I did take her to the emergency room because she started to sound like she was getting a bit sicker since she has asthma. I wanted to make sure she wasn't getting pneumonia. The ER tested her and found her positive for COVID. They gave her an inhaler, an oximeter and a thermometer and had her monitor for 10 days. She didn't get any worse during the course of her COVID case.
A consumer report has been received. The report concerns a 38 year old, Female consumer, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced sore throat and serious runny nose. The outcome of the event of sore throat and serious runny nose is unknown. The report was considered to be non-serious by company physician. Corrected report 24-Aug-2012: Initial unit corrected.
Kinrix was given to a patient who was 3 years old which is outside of the licensed ages.
Being miserable; Experiencing eye pain/eye pain as feeling like someone had hit her in the eye; The itchiness was like a poison ivy reaction/tickling it with a feather; itchiness was like a poison ivy reaction and tickling it with a feather; Shingles all over the left side of her face and scalp; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included feeling unwell (patient felt unwell on a Thursday in September 2021, before received vaccine).   In September 2021, the patient received the 1st dose of Shingrix. In September 2021, 1 day after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced feeling miserable, eye pain, pruritus and tingling. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles, feeling miserable, eye pain, pruritus and tingling were unknown.   It was unknown if the reporter considered the shingles, feeling miserable, eye pain, pruritus and tingling to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient reported feeling unwell on a Thursday in September 2021. The Saturday after that, the patient received the first dose of Shingrix.  The next day, the patient broke out with shingles all over the left side of her face and scalp. The patient also felt being miserable and was experiencing eye pain described as feeling like someone had hit her in the eye with a baseball bat and the itchiness was like a poison ivy reaction and tickling it with a feather. As a measure the patient received three rounds of antivirals. The reporter also mentioned that her physician thought that the symptoms experienced that Thursday before the first dose of Shingrix were prodromal symptoms of zoster. The reporter consented to follow-up. GSK note- Time to onset for eye pain and itchiness was captured as less than 9 months because it was not clear, exactly when these events started.
Chills; Headache; Body aches; A spontaneous report was received from a consumer for a 60-year-old female patient who experienced chills, headache, and body aches.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 30 Dec 2020, the patient received his first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient experienced chills, headache and body ache.  She took Tylenol and the headache improved.  Action taken with mRNA-1273 in response to the event, chills, headache, and body aches, was not provided.  The outcome for the event, chills and body ache, was not recovered/resolved.  The outcome for the event, headache, was recovering/resolving.; Reporter's Comments: This case concerns a 60-year-old female with nonserious events of expected chills, headache, myalgia.  Event onset the same day as the first dose of mRNA-1273. Treatment with Tylenol. Headache resolved, but chills and myalgia ongoing. 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.
I developed wheezing, shortness of breath, and tachycardia. I went into the doctor on the Monday after it started and getting tested. I've had a monitor for a week that I sent back today. They said I have developed asthma which I have no history of and rapid heart rate.