chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine Act-HIB for which cold chain break is reported and excursion vaccine was administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid  non-serious case received via physician.  This case is linked to case 2023SA129826.  This case involves Infant and unknown gender patient who was administered vaccine act-hib for which cold chain break is reported and excursion  happened with no reported adverse event   The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received  suspect hib (prp/t) vaccine Powder and solvent for solution for injectionat dose of 0.5 ml (strength, batch number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization)  On an unknown date, vaccine act-hib for which cold chain break is reported and excursion vaccine was administered (poor quality product administered) (same day latency) with no reported adverse event  Action taken was not applicable.  At time of reporting, the outcome was Unknown.   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:  2023SA124713:
This spontaneous report as received from a Medical Assistant refers to 11 year old patient, gender not reported. On 12-NOV-2014, the patient was vaccinated with GARDASIL, Lot # K004204, expiry 12-JAN-2017, dose unspecified. It was reported that the administered vaccine was subject to temperature excursion during storage. No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
Ssoreness at site, labored breathing, 101.5 temp, cough. Went back to doc today with same. They checked for flu(negative) Said it was reaction to shot. Watch over weekend.
This is a spontaneous report from a contactable consumer (patient). A 22-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 22, via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. Medical history included COVID-19 (prior to vaccination, patient diagnosed with COVID-19). Concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. On an unknown date, patient experienced pityriasis rosea outbreak all over body. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, patient has not tested for COVID-19. Therapeutic measures taken as a result of the  event included treatment with steroid cream (unspecified) and bacteria cream (unspecified). The outcome of pityriasis rosea outbreak all over body: not resolved (at the time of this report).  The lot number for BNT162B2 not provided and will be requested during follow-up.
red face, eyes, extreme stomach pain, nassea, diarrhea, pounding head, heart racing, clammy, hot burning hands
Periods twice a month.  Heavy period, i use to be low period and lots of pain like cramps all the time. Heavy headaches on daily bases.
Blurry vision/sitting 7 feet from tv and couldn't read a word; head aches behind the eyes and pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (Multiple Sclerosis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EN6290) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Multiple sclerosis since an unknown date.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Blurry vision/sitting 7 feet from tv and couldn't read a word), EYE PAIN (head aches behind the eyes and pain), HEADACHE (Headache) and MULTIPLE SCLEROSIS (Multiple Sclerosis) (seriousness criterion medically significant). At the time of the report, VISION BLURRED (Blurry vision/sitting 7 feet from tv and couldn't read a word), EYE PAIN (head aches behind the eyes and pain), HEADACHE (Headache) and MULTIPLE SCLEROSIS (Multiple Sclerosis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included  Tylenol. Concomitant medications were not included.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Did not administer here so unsure of type of flu vaccine. Pt presented to us with dizziness since date administered at doctors office.
administered an Expired Menactra to a patient. Expired December 2018/ No AE; Based on information received on 18-SEP-2019, the report previously considered as non-valid became valid: patient identifier reported.  Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a non-health care professional (office staff).  This case involves 18 years old male patient (195 cm and 112.925 kg) who was vaccinated with 0.5 mL dose of expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U5766AE, expiry date- 02-Dec 2018 via intramuscular route in the right arm on 07-AUG-2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  No adverse event occurred post vaccination.  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 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.  Follow-up information was received on 18-SEP-2019 from Consumer/Non-HCP (practice manager).  Case validity, patient details, lot number, expiry date, dose, route and site of administration updated in field and narrative.  List of documents held by sender: none.
Patient presented 5 days post vaccine c/o sudden onset of vertigo not sure if related.
Rash. Started on left side of chest/stomach area. I took Benadryl and put Cortisone cream on rash at 11:00am. The rash on chest and stomach has gone down but area is still red. Other rashes forming on both arms and center of my chest have appeared.
Shoulder, arm, and neck pain. Subsequent shortness of breath and chest pain. Diagnosis of Parsonage-Turner Syndrome secondary to Shingrix Vaccination.
Sixty one yrs old female presented to foreign travel clinic at local health dept. Client requesting Hepatitis A and Typhoid vaccine. Client was given a 1.0 cc dose of typhoid vi vaccine and a 1.0cc dose of hep A vaccine. Error noted immediately after administering the extra dose of typhoid. Client was given Typhoid vi lot number Lot number G1121-1 in rt deltoid muscle. Failed to recheck dosage amount and recheck name of vaccine being administered. Typhoid iv was provided in multi dose vial. Client # XXXXXX is doing well. Steps to prevent future error slow down and follow rechecking steps with administer any vaccines.
5 minutes after vaccine given patient began experiencing dizziness, throat tingling, nausea, and diaphoretic. BP 127/87, pulse 86, temp 98, resp 20, O2 sat 98%. MD called an in to evaluate pt. Decision made to give patient Benadryl 25mg from kit. Pt reports improvement to symptoms 25 min later. No further care needed.
SHORTNESS OF BREATH; EYES BURNING; EXTREME FATIGUE; HEADACHE (PRESSURE IN FOREHEAD) FOR THREE DAYS; TROUBLE LOOKING AT THINGS FOR A LONG TIME/PATIENT COULD NOT OPEN HIS EYES; This spontaneous report received from a patient concerned a 29 year old male. 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: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced trouble looking at things for a long time/subject could not open his eyes. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced eyes burning. On 07-APR-2021, the subject experienced extreme fatigue. On 07-APR-2021, the subject experienced headache (pressure in forehead) for three days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eyes burning on APR-2021, had not recovered from extreme fatigue, shortness of breath, and headache (pressure in forehead) for three days, and the outcome of trouble looking at things for a long time/patient could not open his eyes was not reported. This report was non-serious.
This spontaneous report as received from a consumer (patient's mother) refers to a 22 year old female patient with no drug reactions or allergies and with no medical history. The patient received two vaccinations of GARDASIL injection administered intramuscularly (strength, dose, lot# and expiry date unspecified). The patient went to her gynecologist on 02-OCT-2014 and received a dose of GARDASIL. She then went to her pediatrician on 14-OCT-2014 (reported as "yesterday"), for a physical and the pediatrician administered another dose of GARDASIL. Concomitant therapies included SINGULAIR. The patient suffered from pain in her arm after the injection (since 14-OCT-2014). She was not experiencing any other symptoms. The patient sought medical attention via calling the doctors office back. No treatment was given for the event and no laboratory test were performed. The outcome of pain in her arm was unknown. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
RIGHT SHIN PAIN; ANXIETY; DIFFICULTY CONCENTRATING; HEAD FELLS FUZZY; POTENTIAL SHINGLES; SEVERE LEG PAIN IN RIGHT LEG/RIGHT THIGH PAIN; RIGHT HIP PAIN/RIGHT ANKLE PAIN; LOWER AND MID BACK PAIN; SENSATION IN HEAD AND NECK; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included inflammation, blood pressure, abstains from alcohol, and smoker (1 pack/day or a little less), and other pre-existing medical conditions included the patient had no known allergies and there was no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13/JUN/2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included chlortalidone for blood pressure high, and ibuprofen for inflammation. On 26-MAR-2021, the subject experienced sensation in head and neck. On 27-MAR-2021, the subject experienced right hip pain/right ankle pain. On 27-MAR-2021, the subject experienced lower and mid back pain. On an unspecified date, the subject experienced right shin pain, anxiety, difficulty concentrating, head fells fuzzy, potential shingles, and severe leg pain in right leg/right thigh pain. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) 271 (units unspecified). Treatment medications (dates unspecified) included: cefalexin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe leg pain in right leg/right thigh pain, right shin pain, difficulty concentrating, head fells fuzzy, and lower and mid back pain, and the outcome of sensation in head and neck, right hip pain/right ankle pain, anxiety and potential shingles was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Information has been received from a physician concerning an 11 year child, with a history of natural varicella at 13 months of age, who developed a mild form of chickenpox. The break out occurred subsequent to his sibling breaking out, on approximately 05-APR-2007, in a chickenpox rash of approximately 100 vesicles, papular and very pruritic lesions, after being vaccinated on 22-MAR-2007, with a second dose of varicella virus vaccine live (Oka/Merck) (Waes # 0704USA01455). Unspecified medical attention was sought. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Taking the first dosage of the Moderno vaccine do you lose your appetite; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Taking the first dosage of the Moderno vaccine do you lose your appetite) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Taking the first dosage of the Moderno vaccine do you lose your appetite). At the time of the report, DECREASED APPETITE (Taking the first dosage of the Moderno vaccine do you lose your appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were provided
SLEEP APNEA NEUROPATHY 2/26/2022  --  RECURRENCE OF SAME SYMPTOMS
Red patch of skin at injection site measuring approximately 1.5 inches wide and 3 inches long showed up 8 days after 1st dose on upper left arm. Reddened skin is warm to touch. Reported to GP and instructed to take an anti-inflammatory and put ice on arm.
Mom called and reported redness at injection site, a little warm to the touch, and slight bruising that has since subsided
One day following administration of varicella vaccine a 3.n. diameter of redness + swelling was noticed by pt. on the adminis. area.  Mother of pt. took child to the ER where BENADRYL was administered.  2 days following administration of vaccine pt. presents to office with 2.25 in area of redness and swelling that is warm to the touch. Pt. states "no pain".
The received the first dose on 3/29/2022 (lot u008315  8/15/2023) and second dose on 3/17/2023 (lot w013165   12/14/2024).; injection site reaction consisted of redness and swollen; injection site reaction consisted of redness and swollen; injection site reaction tender to the touch; This spontaneous report was received from a medical assistant and referred to a 42-year-old non-pregnant female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included colecalciferol (VITAMINE D), birth control pills, inhalers and iron supplement.  On 29-MAR-2022, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 milliliter, lot #U008315, expiration date: 15-AUG-2023, strength, anatomical location and route of administration were not provided) administered for prophylaxis.  On 17-MAR-2023, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 milliliter, lot #w013165, expiration date: 14-DEC-2024, strength, anatomical location and route of administration were not provided) administered for prophylaxis (Inappropriate schedule of product administration).  On an unknown date in 2023 (after receiving the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)), the patient experienced injection site reaction consisted of redness and swollen (Vaccination site swelling; Vaccination site erythema), it was also tender to the touch (Vaccination site pain). At the time of reporting, the outcome of events vaccination site swelling, vaccination site erythema and vaccination site pain was recovering. The causal relationship between all events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Last Dtap 16Apr2022, Kinrix 30Aug2022; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   Previously administered products included DTaP (received last DTaP vaccine on 16th April 2022) and IPV (received last IPV vaccine on 3rd February 2020).   On 30-AUG-2022, the patient received Kinrix. On 30-AUG-2022, an unknown time after receiving Kinrix, the patient experienced drug dose administration interval too short (Verbatim: Last Dtap 16Apr2022, Kinrix 30Aug2022). The outcome of the drug dose administration interval too short was 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: 11-APR-2023 A nurse reported a patient received a dose of Kinrix, but that dose was given 25 days before than when it was supposed to be administered.  The reporter reported that Kinrix was the patient's 5th dose of DTaP and 4th dose of IPV.  Phone number for follow up redacted. The reporter consented to follow up. The patient received a dose of Kinrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Initial misuse case was received from a healthcare professional on 16 OCT 2013. Cases were received on 21 March 2014. A 3-year-old patient whose demographic details, medical history and concomitant medication were not reported received a FLUZONE vaccine on 08 Oct 2013 (route, site, dose and batch number not reported). It was reported that on 08 Oct 2013 patient received an extra dose (two flus) of vaccine. No adverse event was reported. List of documents held by sender: None.
He received a flu shot during his appointment on 9/19/14.  He was sent by his primary MD to see us (after having x-rays and a MRI) because of continued pain in the shoulder since his injection. The patient was seen by Dr. and was given a cortisone injection for shoulder bursitis.
Multiple patients (25) were vaccinated with lot number FK9894, but the number was erroneously entered in the system and on vaccine card as FK9729.
I got the shot on Monday, 10/18 at about 3:30 in the afternoon.  On Tuesday at 11:30 a.m. the body aches started.  At noon, the fever started.   I continued with both body aches and fever until Wednesday, October 20 at around noon.  My highest temp was 100.  I took tylenol.    I had the same reaction with Vaccine # 2.  I had no reaction with Vaccine # 1. I did not report any of this to my physician.
case of shingles approximately 6 weeks post first dose of Shingrix; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 6 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a shingles approximately 6 weeks post first dose of Shingrix. The reporter agree to follow up from GSK.
530PM 1JAN95 recvd vax & vomiting started MN 2JAN95 & cont all noc; devel diarrhea 2JAN95 & vomiting cont; 3JAN95 devel rash 3JAN95; to ER, tx w/IV fluids, compazine, dx rxn to MMR
Patient previously exposed to burning corn fields with prior symptoms of sinus, bronchitis and allergies. Afternoon following injection patient began itching in hands and arms. Followed by difficulty breathing. Son took to Emergency Room.
Cellulitis at injection site. Arm red, swollen, warm. Treating with ZITHROMAX.
Extreme left shoulder and arm pain. Shoulder and arm weakness. Xrays and MRI of neck to rule out nerve compression. Referred to Ortho June 24, 2013. Ordered MRI of left shoulder. MRI on June 26, 2013 indicating edema and atrophy of supra scapular and infra scapular muscles resulting in compression of supra scapular nerve. NCS/EMG scheduled for July 8, 2013.
Left arm swollen; warm to touch & red in color - Cellulitis- prescribed antibiotics Cephalexin Tabs 500 mg 1 tab orally BID for 10 days.
Missed his second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed his second vaccine) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed his second vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed his second vaccine) had resolved.            No concomitant medication information was provided. No treatment medication were provided.   Reporter did not allow further contact
Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 031620A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.   This case was linked to MOD-2021-030908 (Patient Link).
Pts arm felt very heavy and sore, also broke out in cold sweat, nauseated, felt like passing out.  Did not eat for two days because of GI symptoms.  Small raised area at site of injection.