chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L020015, expiration date 16-AUG-2017, exact doses and route of administration were not reported). The vaccines were exposed to temperature of 28F during cumulative of 8 hours, which was recorded last week of January 2016. Previous temperature excursion was reported and doses reached then 32F for near 1 hour (date was not provided). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 78-year-old male patient who received SHINGRIX (batch number 3374S, expiry date 22nd November 2020) for prophylaxis. On 31st July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain and pruritus. On an unknown date, the outcome of the pain and pruritus were unchanged. It was unknown if the reporter considered the pain and pruritus to be related to SHINGRIX. Additional details were provided as follows: The day of or the day after the patient's dose of SHINGRIX, he developed a sore located in the area left and lower of the injection site. The sore was very itchy. The patient also said it was not getting any better but remained the same. The reporter's call was transferred to medical information (MI) for further assistance. The contact details of the physician was provided.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Store manager call pharmacy letting us know patient complain about adverse event from vaccine
Low heart rate; Brain fog; Say Teague and muscle spasms; Prolong next stiffness; Pain; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 26-years-old male patient received BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot Number: Ew0186), via an unspecified route of administration, administered in Arm Left on 25May2021 18:15 as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 26 Years). The patient medical history was not reported. Concomitant medications were not reported. Historical vaccine included BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: Ew0176), via an unspecified route of administration, administered in Arm Left on 03May2021 06:00PM as DOSE 1, SINGLE for covid-19 immunization and No reaction on previous exposure to vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 27May2021 14:00, the patient experienced low heart rate, brain fog, say Teague and muscle spasms, prolong next stiffness and pain. The patient was hospitalized for all events for 2 days. The patient hospitalization was prolonged as a result of all events. The patient underwent lab tests which included heart rate: low on 27May2021. Since the vaccination, patient had not been tested for COVID-19. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The events result in Emergency room/department or urgent care. It was unknown if the patient had received treatment for the events. The outcome for all events was not recovered.  Follow-up attempts are completed. No further information is expected.
Skin was horrible; The patient received vaccine dose 1 on 08-AUG-202 and dose 2 on 18-SEP-2021; Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), SKIN DISORDER (Skin was horrible) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received vaccine dose 1 on 08-AUG-202 and dose 2 on 18-SEP-2021) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In 2021, the patient experienced ILLNESS (Sick). On 18-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received vaccine dose 1 on 08-AUG-202 and dose 2 on 18-SEP-2021). On an unknown date, the patient experienced SKIN DISORDER (Skin was horrible). At the time of the report, ILLNESS (Sick), SKIN DISORDER (Skin was horrible) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received vaccine dose 1 on 08-AUG-202 and dose 2 on 18-SEP-2021) outcome was unknown.            No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event of skin was horrible and sick was not provided. The reporter assessed event sick was possibly related to Moderna Covid-19 vaccine.  No treatment details were reported.   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.   Reporter did not allow further contact
sore throat; This case was reported by a consumer via call center representative and described the occurrence of sore throat in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sore throat. On an unknown date, the outcome of the sore throat was not recovered/not resolved.   It was unknown if the reporter considered the sore throat to be related to Shingrix.  Additional information was received as follows: The age at the vaccination was not reported. The patient received Shingrix and experienced sore throat. The patient wanted to know whether sore throat a possible side effect of Shingrix.
Information has been received from a Registered Nurse concerning a 9 year old female patient with allergy to sulfa and penicillin allergy and a history of attention deficit/hyperactivity disorder, who on 07-DEC-2001 was vaccinated with the first 0.5 ml dose of VARIVAX (Merck).  On 14-AUG-2006, the patient was vaccinated with a dose of PROQUAD (MSD) (lot # 652332/1122R).  Concomitant therapy included methylphenidate.  On 19-APR-2010, the patient experienced a vesicular rash.  On 21-APR-2010, the patient was seen in the office with clusters of clear vesicles on erythematous bases.  The patient had three lesions on the right arm, four lesions on right leg, four lesions in the left hip and one lesion on the left hand.  No treatment was required.  The patient was diagnosed with shingles.  The patient was afebrile.  The patient had not been exposed to chickenpox or shingles.  A vesicular lesion sample was collected.  The sample was taken from a vesicular lesion.  Final PCR results indicated that the sample was negative, no VZV was identified.  The nurse had not heard from the patient's mother since the visit so she assumed the patient recovered.  "The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain."  No further information is available.
Information has been received from a 59 year old female with a history of perforated ulcer and no known drug allergies, who on 18-FEB-2009 was vaccinated with 0.65 ml dose ZOSTAVAX (Merck) (lot not reported) subcutaneously. Concomitant therapy included lovastatin, enalapril maleate, aminopyrine, alendronate sodium and omeprazole. On 21-MA@-2009 (reported as within three days of getting vaccinated), the patient developed shingles and " gastric problems". On an unspecified date the patient underwent and endoscopy (results not reported). The patient sought unspecified medical attention. At the time of reporting, 09-APR-2009, the patient was recovering. Additional information has been requested.
Lack of Response-  Information has been received from a physician concerning a 13 month old male patient with a history of reactive airway disease who on 21 Jul 1998 was vaccinated with a first dose of varicella virus vaccine live (lot 626689/0651H) sc in the right upper arm.  Concomitant vaccinations that same day included a first dose of mealses - mumps-rubella vaccine.  Priorix as part of a clinical study. sc in the left upper arm 1st number 1091.  additional concomitant therapies included acetaminophen tylenol, cefixime suprax, and albuterol.  It was reported that fever, otitis media, reactive airway disease, and an upper respiratory infection were illnesses at the time of vaccination.  With in 42 days of vaccination.  On approximately 02 sep 2000, the patient's laboratory results indicated a lack of seroconversion.  Additional information has been requested.
Large red hot spot sight of injection day after injection and faded for 4 days. Then on the 5th day it got itchy and by the 6th day it was red again and still itchy and it continued and slowly faded for the next 4 days. Reaction lasted a total of 11 to 12 days.
Patient received HPV and Influenza vaccines on 9-24-2013. Some day developed myalgias, back pain and HA/photophobia. Persisted for at least 72 hours.
This case was reported by a pharmacist via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever and injection site erythema. On an unknown date, the outcome of the fever and injection site erythema were recovered/resolved. It was unknown if the reporter considered the fever and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter indicated that he administered the first and second doses of the SHINGRIX vaccine to his sister. With both injections she experienced a fever and localized redness at the injection. The reporter did not consent to follow-up. The field representative was unable to provide additional information. The field representative reported three separate adverse reports from this reporter. This case has been linked with US2018197802 and US2018197797, reported by same reporter. For tolerance after 2nd dose refer case US2018GSK205390.
Patient received Hep B that had expired on 2/8/08.  Vaccine administered on 5-27-08.
Experienced appendicitis and had to remove appendix; This is a spontaneous report from a contactable reporter. A consumer reported for the female patient (reporter's granddaughter).  A female patient of an unspecified age received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced appendicitis and had to remove appendix on an unspecified date. The reporter was curious about what to do with her granddaughter (consumer), 3 weeks is today, after she got her first Covid vaccination (Covid Vaccine) and she experienced appendicitis and she had to have her appendix removed. Today is exactly three weeks. The reporter want to know, when is it safe for her to get her second shot, and she is at home and it's been full 3 weeks." Reporter was informed about Pfizer Medical Information Department. The outcome of the event was unknown.     Information about batch/lot number has been requested.
suspected vaccination failure; shingles/ I got shingles twice after the shot; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got shingles twice after the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
First dose: 48 hours of extreme fatigue, headache, joint & muscle pain, nausea and upset stomach and fever Second dose: First 24 hours extreme fatigue, headache, joint & muscle pain, low grade fever. Second day - debilitating and severe back pain and down the lower left side of my hip and leg. Debilitating to the point of being unable to roll side to side in bed, walk or move with any type of ease. Spasms of pain and discomfort even when still.
This is a spontaneous report from a contactable nurse communicated to a Pfizer Sales Representative. The nurse reported similar events for 6 patients, who experienced the same issues over the past 3 months before this report. This is the 1st of 6 reports. A 65 or older patient of an unspecified ethnicity and gender received PREVNAR 13 (Expiry Date and NDC # Unknown) subcutaneous at 0.5 ml, single in arm (unknown of which one) on an unknown date. The patient medical history was unknown. The patient's concomitant medications were unknown. On an unknown date the patient experienced local site reaction which produced cellulitis. The area became hot, hard, and red; generally a large portion of the arm, not localized to injection site, a more perfused area. The events outcome was unknown. Laboratory tests performed were unknown. Therapeutic measures were taken: prescribed antibiotics for cellulitis.
Left arm went numb to her elbow, numb to palm of hand; Neck and back around shoulder blade was feeling weird; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Left arm went numb to her elbow, numb to palm of hand) and FEELING ABNORMAL (Neck and back around shoulder blade was feeling weird) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced HYPOAESTHESIA (Left arm went numb to her elbow, numb to palm of hand) and FEELING ABNORMAL (Neck and back around shoulder blade was feeling weird). On 11-Mar-2021, HYPOAESTHESIA (Left arm went numb to her elbow, numb to palm of hand) and FEELING ABNORMAL (Neck and back around shoulder blade was feeling weird) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   20 minutes after receiving vaccine patient's left arm went numb to her elbow.  About 10 minutes after her palm of hand was numb. 5 to 10 minutes later her neck and back around shoulder blade started feeling weird. 5 to 10 minutes, left side of her face felt numb. By the time she got home the reaction started to go away except for her face. The patient went to emergency room (ER) and they called it a vaccine reaction. On 12-MAR-2021, patient left side of her face was slightly numb. All the numbness was on her left side.  No treatment information was provided.
Narrative: COVID infection following COVID vaccine series 04/03 Janssen, dose #1 09/07 pt cc: chills, cough, diarrhea, nausea, rhinorrhea, vomiting, exposure: unknown 09/10 COVID swab, result: detected 09/10 SARS-COV-2 Variant Sequencing result: pending
Very deep muscle ache on left shoulder area, base of neck, and upper back. This is my 3rd day takin 2 Capsules of extra-strength Tylenol. Pain goes away but not completely. Also getting intermittent headaches, but not as frequently as muscle pain
13yr old patient was administered Moderna COVID Vaccines instead of Pfizer COVID Vaccine. CDC is currently not recommending Moderna for patients under 18 years of age. Spoke to patient mother on 07/21/2021 and stated patient is currently not having any adverse reactions or any major symptoms if any at all.
I had a headache, sore throat, fatigue, I lost my voice for about 5 days, and lack of appetite. I tested positive for COVID on 01/17/2022.
Her firs was on 12/24 and she reports 7 hours later she had blurry vision and passed out.  She continued to have nausea and couldn?t eat missed several days of work and lost 5 kg due to nausea.  She received the second on 1/24 and she reports that 3 ½ hours later her heart rate was high, blurry vision and soa.   She reports she does not remember much other than resting and her husband picking her up.  She stated that she couldn?t remember much after that and was difficult to wake up by her family. Was off work a few days and is now back but feeling weak.
improper injection regarding the nerve damage;  it's about injection procedure done at a drug store that I went to; improper injection regarding the nerve damage;  it's about injection procedure done at a drug store that I went to; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FM9992) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVE INJURY (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown" and all described as "improper injection regarding the nerve damage; it's about injection procedure done at a drug store that I went to".  Additional Information: It was reported that improper injection of Pfizer COVID 19 vaccine not mentioned what is the caller of the cap and the effects of the improper injection regarding the nerve damage. It was not really in reference to the actual vaccine substance itself, it had to do with the actual injection procedure and the patient was to visit doctor regarding the injection issue, so reported about any side effects or any other issue with the substance of the actual vaccine. The patient was not reporting any substance reaction to its recent vaccine. The injection procedure was done at the drug store patient went to.  No follow-up attempts are possible. No further information is expected.
Death Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was admitted to hospital from 11/18/20-1/26/21 for Dx: generalized weakness. Previously admitted 10/21/20-11/17/20 for a pulmonary embolism. Patient did not last long after being discharged from short term rehab and passed away at home on 2/2/2021
immediately after the vaccine my arm and hand were itchy and hot. later that night i had normal cold symptoms which i expected. everyday after that i have experienced severe headaches. i wake up everyday with a pounding headache. my arm is still sore. Most  concerning is the fact that i have started menstrating again. i have and IUD and havent bleed in 6 months. now iam. my glands are swollen under my jaw as well. These symptoms are still current 7 days after the vaccine.
Patient given a higher dose than ordered. Pt given 4.5 mcq vs. 3 mcq dose that was ordered. Pt parent was notified and told what symptoms to watch for.
Arm was pretty sore; Headaches off and on. Constant dull pain with some intermittent sharp pains around temples/side of head.; felt a bit tired and lightheaded about 2hours after vaccination.; felt a bit tired and lightheaded about 2hours after vaccination.; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732), via an unspecified route of administration in the arm left on 27Mar2021 at 10:15 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS), seasonal allergy and pet allergy. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), quercetin (MANUFACTURER UNKNOWN), PRENATAL, vitex agnus-castus extract (BIOFEM PMS) and 5-Hydroxytryptophan (MANUFACTURER UNKNOWN); all for unknown indications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 27Mar2021 at 12:00, the patient felt a bit tired and lightheaded about 2 hours after vaccination, and her arm was pretty sore on the day of vaccination and the day after she had difficult to reach above shoulder. The patient also experienced headaches off and-on and constant dull pain with some intermittent sharp pains around temples/side of head. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tiredness, light-headed, pain in arm and headache was resolved on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
injection site swollen; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 80-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovered/resolved.   It was unknown if the reporter considered the injection site swelling to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced injection kind of bubbled Up, it was not anything that went anywhere and it stayed localized. This case has been linked with case US2019077746, reported by the same reporter for adverse event following Shingrix.
Pt received Johnson vaccine at 5:36 pm and around 6:17 complained about pins and needles in her hands traveling to the back and her fingertips were cold and little to no sensation
Pt was administered PCV23 instead of PCV13. Provider was notified. Parent was notified. No reaction noted.