chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 66 year old female patient with Chronic Obstructive Pulmonary Disease (COPD) -developed at an unspecified time prior to receiving the ZOSTAVAX. The patient did not have drug reaction. On 27-OCt-2014 the patient was vaccinated with ZOSTAVAX lot # K009198, exp. date 27-SEP-2015, 0.65 ml, subcutaneous. Concomitant therapies included fluticasone furoate, BREO ELLIPTA, diclofenac 75mg, Z-PAKK "occasionally" and albuterol. The patient has been experiencing tenderness at the injection site since receiving the ZOSTAVAX (27-OCT-2014). The reporter also reported that the patient developed what "looks like mosquito bite" at the injection site on 13-NOV-2014. No treatment was given for AE. No lab was performed. The patient sought medical attention and came into the pharmacy on 13-NOV-214. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Prolonged fever; body aches and pain; muscle weakness; extreme migraines; nausea; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN6204) via unspecified route of administration in left arm on date 20Mar2021 (at an age of 24-year-old) at 16:00 for COVID-19 immunisation. Medical history included diabetes since an unknown date also allergic to Red40 and aripiprazole (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6202) via unspecified route of administration on left arm on 27Feb2021 as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. The patient experienced body aches and pain, extreme migraines, muscle weakness, nausea, prolonged fever on 21Mar2021 at 08:00. It was unknown if the patient received any treatments for the events. The clinical outcome of the events body aches and pain, extreme migraines, muscle weakness, nausea, prolonged fever was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
itching; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2019, the patient received the 1st dose of Shingrix. In December 2019, between 1 and 2 months after receiving Shingrix, the patient experienced pruritus. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and medication unknown (Anti-Itch Medication). On an unknown date, the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient developed some itching and felt it could be shingles. The patient was not able to see a doctor until 10th January 2019 and was prescribed valacyclovir which did not help.   He then saw a dermatologist on 27th January 2020 and was prescribed an anti-itch medication which helped a lot. He used it for 2 weeks and at the time of reporting, had been off of it for 2 weeks and the itching was almost gone.
16 Jan 09 arms were sore. 17 Jan 09 felt conjested. 18 Jan 09 more conjested 19 Jan 09 felt conjested and run down.  20 Jan had conjestion fever weakness fatigue dyspnea and joint pain, and went to the ER that night.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 10-MAR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 48. The lowest recorded temperatures were of 32 respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Felt like I was having a seizure. I have never been so sick in my life, I almost called the hospital thinking I might stop breathing. Extreme cold for hours that night, I had 4 layers on and all the blankets I had and could not not stop shivering. The headaches were extreme like my head was in a vice and while the chills subsided after maybe 6-8 hrs, I was in bed barely able to think having psychotic thoughts and the worst headaches ever for 48 hours. To this day I feel like I've lost 10 points of IQ. my memory is crap, no energy. more comments on lab tests. I took moderna a year later for booster and had similar symptoms , though not quite as severe or long lasting. I am active working. I wish I had gone to the hospital.
On 7/31/02, pt had temperature of 105.8 (oral) and so was taken to ER. Broke out in the evening after the vaccine with a truncal rash about 72 hours later.
~ 2 wks after vaccine he became weak, next day he collapsed, was taken to ER , was admitted to hospital. Spouse said diagnosis was Guillian-Barre. After a lengthy stay in the hospital, he has been moved to a long term care facility. Information from discharge summary states apnea, pneumonia, urinary tract infection. msv Medical records state dysphagia. msv
Patient reports delayed allergic reaction involving shortness of breath, headaches, hives starting about a week after her shot and having 2 or 3 episodes over the several weeks since receiving the vaccine. The patient reports having used her epipen during at least one episode.
Menstratution straight for 14 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 10Sep2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 17Sep2021, outcome "unknown", described as "Menstratution straight for 14 days".  Additional information: This report was to capture information for reporter's friend. Caller mentioned that she had a friend that also had the same issue. She did not wish to complete a report for her. Reporter did not wish to provide her address, email, or date of birth. This report was not related to a study or programme. Reporter seriousness for Menstruation straight for 14 days was unspecified. Investigation Assessment was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (22Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
when I got the vaccine it was puff for 4 days. On the 5th day I noticed that the injection site was red  and  plump. I also had a burning itch like a mosquito bite. It got to the size of a tennis ball. I tried to refrain from touching the area as well as scratching the area to not spread.
Symptoms began 2 hours after same day as injection.  Upper left arm from elbow to shoulder and into back was swollen, painful, hot, and itchy with patches of red.  Few hives appeared on back.   Pain and swelling lasted 4 days.  Doctor said to ice arm, take tylenol, and take benedryl. I was lethargic and I felt miserable.
Got the vaccine and still got shingles/Suspected Vaccination Failure; shingles; 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 reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles vaccine and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Was three weeks pregnant (didn't know) started experiencing stomach pain a week after the shot. Still experiencing severe stomach pain, nausea, chills.
Myalgia, Arthralgia, Fever, CHILLS, SORE MOUTH, COLD Narrative:
Diffuse myalgia, arthralgia, malaise for 2 days, not sure if fever. OTC meds only.
INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a patient concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced incorrect product storage. On 29-APR-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210808095.
Pt. received ZOSTAVAX on 01/06/2009. She developed an itchy painful rash on her neck and on itchy sensitive area right scapula and under her right breast on 02/01/2009. T: 96.3. B/P 130/70. P: 74 and regular red papules on back. No lesion seen on trunk. Pt. treated with Acyclovir 300 mg 5 times a day for 7 days. Report made to Vaccine Adverse Event Reporting System via internet site Vaers. org.
Patient received incorrect mRNA COVID-19 vaccine product inadvertently as a second dose in 2- dose primary series. Patient received Pfizer vaccine for original (first) dose.
acute onset shaking rigors, diaphoresis, weakness & lt arm pain-adm to r/o MI which was negative;vaccine rxn suspected;
Extreme Muscle soreness  Area very sore to touch Non-stop headache even with meds (Tylenol, excedrin migraine) "Sinus" type pressure and swollen feeling in ears, cheeks, under eyes
client was provided Moderna COVID-19 vaccination in error; age on date of vaccination (5/14/21) was 17 years 11 mos.  Client also did not provide accurate pre-screening information and was later identified as being given a Pfizer COVID-19 vaccination previously (4/22/21).  No report from staff or client of adverse reactions during or after vaccination.
Excessive swelling at injection site; Redness at injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a female 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 injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were unknown.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-FEB-2023 Reporter's Comment: The patient received Shingrix. The patient experienced excessive swelling and redness at injection site. The patient had photos. The reporter agreed to follow up from GlaxoSmithKline.
This is a spontaneous report from a contactable Other HCP. This Other HCP reported for a patient that: a patient of unspecified age  and gender received PREVNAR 13, subcutaneous on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient was given the shot subcutaneous instead of intramuscular and had a local reaction on an unspecified date with outcome of unknown. The information on the batch number has been requested.
felt like hit by a truck; chills; lost appetite; fatigued; fever; very achy; This spontaneous case was reported by a patient and describes the occurrence of PAIN (very achy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Hypertension.Medication for diabetes three times a day and medication for hypertension twice a week   On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN (very achy) (seriousness criterion medically significant), DECREASED APPETITE (lost appetite), FATIGUE (fatigued) and PYREXIA (fever). On an unknown date, the patient experienced DISCOMFORT (felt like hit by a truck) and CHILLS (chills).      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Crohn's flare up - hospitalized for 2 weeks Found a renal mass in kidney during CT and MRI scans done at hospital
mixed series as primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mixed series as primary series) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mixed series as primary series). On 27-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mixed series as primary series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided. Action taken with mRNA-1273 in response to the event was not applicable.
Syncope after HPV vaccine given. Patient was alert after falling from chair to floor. She was monitored for 1 hour after episode occurred. She was given orange juice and a snack.
Seen in ER, taken by ambulance for febrile seizure 11 days post MMR.
I'm not convinced it was an adverse event related to the shot since it's a "malady" I've experienced prior to covid.  However, the periodic text asks if you are "feeling worse" and the answer was "yes", but there was no place to explain.  I got a call from someone saying I should fill out this form in any case.  The "event" was waking up feeling very bad; weak, fatigued, headache, no energy, stuff nose, leg cramps and spent most afternoons in bed.  This went on for 2 weeks and is gradually fading.  My doctors tested for covid (negative) and ran a series of blood test.  Everything looked normal.  It remains a mystery.
Large raised spot at spot of injection. Has become very itchy, and should pain developing in both shoulders.
6/28/10- Pt received MMR, VARIVAX, and PREVNAR. 7/7/10- Onset of rash on face, progressed to neck and torso next day. Also, mom reports "whelps" on right leg. 7/8/10 - Pt. developed wide, "wobbly" gait. 7/9/10- Developed central weakness, eg.- falling backwards while sitting. 7/11/10 Improved, running around and playful, but mom feels his gait is still slightly wide. 7/15/10-Gait and personality back to normal per mom.
Received phone call from school nurse, who said patient's new physician reported patient has contracted mild case of chicken pox.
Pt accidentally given Dapatecel instead of Tdap. The MA was confused since the patient was 7 which vaccine to give. The Pt or family did not report any adverse reactions. MA conferred with provider and immunization coordinator and PT will receive a TDAP at 11 years old.
9 cm x 6 cm area with warmth, tenderness, erythema and itchy on injection site. Started about 11 hours after injection, but rapidly increased in size.
Worsening confusion, inability to perform normal daily tasks Soreness at injection site 3/17/2021 symptoms resolved
Temp 99 degrees F. Complained of sharp pain down right arm to below elbow. Complained of swollen glands in right neck and right breast tenderness. Treatment 24 hours quarters and PRN Darvocet.
Patient began feeling achey and developed a high fever with severe headache, the fever reached 103.7 and would not come down. Her Dr.'s office advised if her fever reached 104 to take her to ER. I gave her ibuprofen and acetaminophen, rotating between the 2, every 4 hours. This kept her fever from rising, but did not reduce it. She missed a whole week of school and was, I felt close to death, which was very distressful for me. All she did was sleep and sleep. She was extremely thirsty and was able to keep down the small amount of food she ate, she had no appetite.
Left thigh had knot on it, it was red and hot to the touch. Mom thought he had a fever. Small bruised area over injection site. Treatment: Tylenol and Benadryl PRN and cool compresses.
Patient received several vaccinations on 8/25/05 and on 9/1/05. Had completed pre-vaccination forms and did not have any concerns of pregnancy at that time. Pregnancy was diagnosed in January 2006 with date of last normal menstrual period 9/29/05.
COVID 19 Treatment; COVID 19 Treatment; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 1, single (Batch/Lot number: unknown), in right arm and in Oct2022 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "emphysema" (unspecified if ongoing); "copd" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. There were no concomitant medications. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (medically significant) with onset Oct2022, outcome "not recovered", described as "Inappropriate schedule of vaccine administered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Currently on 15 days post positive Covid test; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. On 15 days post positive Covid test and, the patient was still very symptomatic.: lost taste and smell on day 14 and also Congestion, mild sore throat, lymph nodes tender near upper breast and underarms, fatigue, light headedness.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe arm pain, total body pain, headache, fatigue,. mild chills  Have recovered somewhat but not totally
the patient was administered with a dose of frozen MENECTRA, no AE; Initial information received on 19-May-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked to cases 2020SA133784, 2020SA133785, 2020SA133787 and 2020SA133786 (same reporter).  This case involves a 18 years old patient who received a dose of frozen MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  It was an actual medication error due to product storage error temperature too low (Product storage error) as the patient was administered with a dose of frozen MENECTRA.  At the time of reporting, the patient did not experienced any adverse event.  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.  There will be no information available on batch number for this case.
Moderna COVID- 19 Vaccine EUA: patient presents to the emergency department (ED) with shortness of breath, dizziness, abdominal pain, nausea, cough, malaise, and headaches. Symptoms started four days prior to arriving in the ED when shoveling snow. Three days prior to arriving in the ED patient received vaccination and reports fever and persistent shortness of breath ever since. Seen by primary care provider one day before presenting to the ED and prescribed prednisone but did not take it. Initial vital signs showed tachycardia, fever, tachypnea, and decreased oxygen saturations on room air. Physical exam noted faint wheezing. Patient placed on oxygen, received albuterol, ipratropium, and steroids with improvement. Patient discharged to home with steroids, inhalers, and oxygen.
Had inc temp in evening p/MMR/HIB temp to 104 by 2A 19DEC91 convuls 2-3min ; treated w/APAP; normal exam in ER & office 19DEC: