chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge).    Concomitant product use was not provided by the reporter.  Best used date was reported as 30-Jul-2021. Patient did not report any side effects.  Treatment information was not provided. This case included information for patient 3 out of 31.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master Case ID
It was a slight rash on my upper body, and it was an extreme itching sensation. The flare up didn't pass by. It couldn't be reduced at all. If I was exposed to heat it would cause the rash to flare up.
A spontaneous report was received from a consumer concerning a 19-year-old-male of unknown race and ethnicity patient who felt very sick, headache, nose is stuffy, body chills, severe body ache, trembling, fever of 102F, rust colored spots on hands and fingers after receiving the Moderna's mRNA-1273 vaccine by accident. The patient's medical history was not provided.  Concomitant product use was not provided by the reporter. Additional suspected products included Pfizer vaccine. On 01 Feb 2021, approximately 1 day prior to the onset of the symptoms, the patient received 1 dose of mRNA-1273 (Batch number not provided) intramuscularly in the for prophylaxis of COVID-19 infection. Caller received the mRNA vaccine by accident. The first vaccine dose received by the patient was Pfizer. The patient went to Walgreens and was offered the 2nd dose, he didn't know that he would be receiving the Moderna's mRNA-1273 vaccine. The patient received the Moderna mRNA-1273 vaccine on 01 Feb 2021 at 4pm, the next day, 02 Feb 2021 he felt very sick, headache, nose is stuffy, body chills, severe body ache, trembling, fever of 102F, rust colored spots on hands and fingers. LOT # of the vaccine was not listed in the vaccine card. Agreed to follow up call. Treatment for the event included baby aspirin. The outcome of events he felt very sick, headache, nose is stuffy, body chills, severe body ache, trembling, fever of 102F, rust colored spots on hands and fingers were unknown. The outcome of event wrong vaccine administered was considered recovered.; Reporter's Comments: This report refers to a case of Wrong product administered for mRNA-1273 with lot number not provided and several adverse events. 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.
lot #011A21A, injection given at the clinic, Moderna Covid 19 vaccine, given March 1st, at injection site has deep pink spot for 11day, no pain, 3 inches in diameter, pink in color.  Have site looked at by physician to see if site has become infected.
Patient presented with red rash like spots on upper left arm, more on the side of the PNEUMOVAX administration site. Arm was also reported by patient as sore and unable to move.
I developed vertigo about 24 hours after the injection.  Don't know if this was a side effect or a coincidence since I have had vertigo in the past but not for over a year.
Received booster instead of third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received booster instead of third dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A, 031A21A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer since 2010.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received booster instead of third dose). On 22-Oct-2021, ACCIDENTAL UNDERDOSE (Received booster instead of third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.
double vision- left foot problems- dizziness, loss of balance- all last 2-20 minutes
The day after the second vaccine, I experienced numbness and loss of color in both small toes and distal joint of ring finger on left hand.  I removed my wedding ring and took a hot bath, massaging the affected areas.  Circulation returned as normal.  I have since been experiencing intermittent issues consistent with Renauds syndrome in cold weather.
illness/sickness; lost her voice to an extent as of this morning.; sickness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Brand: Unknown), for Covid-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "illness/sickness"; APHONIA (non-serious), outcome "unknown", described as "lost her voice to an extent as of this morning."; ILLNESS (non-serious), outcome "unknown", described as "sickness".  Additional information: I'm convinced she is vaccinated fully, but don't know what vaccine or when or if already boosted. Cannot confirm 100% but highly likely. She is likely in 40s or 50s. I am not sure what the "sickness" vs "illness" events were. Regardless, I do not know which vaccine this person received or the vaccine the person in AER received, so these both can be closed. The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.  Follow-up (02Mar2022): 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.
This case was considered medically important (OMIC). Information regarding Haemophilus B conjugate vaccine was received from an attorney regarding a 30 month old male pt who experienced neurodevelopmental injuries due to excessive doses of ethyl mercury. The pt received the fourth dose on 2/25/97, at 16 months of age. The pt also received the fourth dose of DTP/ DTaP on 2/25/97. The attorney alleges that the pt experienced neurodevelopemntal injuries caused by his exposure to excessive doses of ethyl mercury added to many of his pediatric vaccines. The multiple symptoms of the pt's injuries occurred and were first manifest by approximately April 1998. No additional info was available at the time of this report.
This spontaneous report was received from a 75-year-old male patient and refers to himself. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant medications was reported. In January 2012, the patient was vaccinated with dose of PNEUMOVAX23 injection (dose, frequency, lot# and expiration date were not reported) for prevention from pneumococcal disease. On an unspecified date (reported as recently), the patient was checked for chronic myeloid leukaemia. The patient sought for medical attention. Upon internal review, the event of chronic myeloid leukaemia was determined as medically significant. The outcome of chronic myeloid leukaemia was not reported. Causality assessment was not provided.
A 4 inch by 4 inch square of red, raised skin that occurred the day after immunization, sensitive for 1-2 days which has since gone away.  3 days after vaccination, 2 green quarter sized marks on skin appeared on and below chest on the same side of the body as the vaccine.
Had the first SHINGRIX vaccination in June; only adverse effect was a sore arm at injection site. This second shot not only gave me a whopping sore arm, but I woke with the chills and shivering at 3 AM. Still having them (7:15 AM). Started a slight backache last evening but attributed it to overdoing housecleaning. Back much worse and it made sleeping difficult.
Pt reported having a urticaric rash and myalgias from 2nd COVID19 vaccine received 2/26/21. During provider visit on 3/1/2021, patient reports improvement with OTC anti-itch cream and tylenol. Denies SOB, worsening rash, f/c/ns. Reports improvement with OTC anti-itch cream and tylenol. Denies SOB, worsening rash, f/c/ns.
Myalgia, Fever, Malaise Narrative: Missed work following 2nd dose due to above symptoms
Calf pain x 3 days followed by weakness in proximal legs and arms, followed by fatigue, difficulty walking, difficulty with activities of daily living.  Physical therapy initiated.
This spontaneous report was received from a licensed practical nurse concerning a 11 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 12-AUG-2016, the patient was vaccinated with a dose of M-M-R II (unspecified strength, dose and frequency) administered subcutaneously in the left lower thigh (lot number: L024267; expiration date: 07-JAN-2017) at age "11 months and 24 days" (drug administered to patient of inappropriate age) for prophylaxis. The patient had not experienced an adverse effect at the time of reporting. No product quality complaint (PQC) was involved. Additional information has been requested.
got shot still got shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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 was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine years ago and still experienced Shingles but it was not bad. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
At time if Vaccine no illnesses or medication being taken. First shot of Pfizer 04/22/2021 *ER-8735* heavy lightheadedness aprox 2 hours later, than stopped. Second Pfizer shot 05/13/2021 *EW0186* medium lightheadedness several hours, than stopped. Buy June 2021 off & on lightheadedness growing into dizzyness began to set in along with sever Anxiety.  October 2021 sought medical help. Diagnosed high blood pressure out of nowhere and prescribed Lisinopril. Dizzy continued to worssen. Prescribed Meclizine. Ringing in both ears. Sent to an ENT. Found to have excellent hearing. Nothing wrong.  So bad I had to stop daily driving by September 2021.  Now all day everyday dizzy. Can't work, drive or go into a supermarket.
This spontaneous report as received from nurse refers to unspecified number patients of unknown age. On an unknown date the patients were vaccinated with VAQTA (lot# was not reported). Nurse reported the vaccine administered were improperly stored. No adverse events were reported. This is one of the reports from the same reporter. Additional information has been requested.
Initially redness, swelling, pain and itching at the injection site.  Cleared up by end of day the following Monday (1/11/2021) leaving just a bruise.  Starting the morning of 1/13/2021, I woke up feeling nauseous and had a headache by mid day.   All day injection site was itching again.  Woke up morning of 1/14/2021 and injection site is red, swollen, itching and painful again (looks like it did the morning after I received the shot).  Feeling nauseous again this morning and have a persistent headache again today.
her head got under so much pressure / felt like it was going to blow up.; dizzy and very distracted with the head pressure; very distracted with the head pressure; blood vessel in her nose burst in her nostril; spent 5 days in bed; spent 5 days in bed with fever; chills; feeling like she had the flu; side effects including / respiratory; Her lung / hurt.; body hurt.; had a headache; was worried / to have a stroke because her brother had a stroke years ago.; This case was reported by a consumer via call center representative and described the occurrence of head pressure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (family history) and family history of seizure.   On 24th June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 24th June 2020, less than a day after receiving Shingrix, the patient experienced head pressure, dizziness, distractibility, vascular rupture, bedridden, fever, chills, influenza like illness, respiratory symptom, pulmonary pain, general body pain, headache and strength loss of. On an unknown date, the outcome of the head pressure, dizziness, distractibility, vascular rupture, bedridden, fever, chills, influenza like illness, respiratory symptom, pulmonary pain, general body pain, headache and strength loss of were recovered/resolved.   It was unknown if the reporter considered the head pressure, dizziness, distractibility, vascular rupture, bedridden, fever, chills, influenza like illness, respiratory symptom, pulmonary pain, general body pain, headache and strength loss of to be related to Shingrix.  Additional details were received as follows: After vaccination with Shingrix, within 20 minutes the patient headed towards home and her head got under so much pressure that it felt like it was going to blow up. The patient was dizzy and very distracted with the head pressure.  The blood vessel in her nose burst in her nostril.  She spent 5 days in bed with a fever, chills and everything we list as side effects including feeling like she had the flu, respiratory and fever with chills, lung and body hurt.  The patient was worried that she was going to have a stroke because her brother had a stroke years ago.  She had a headache and two weeks later everything resolved and she got her strength back.  She was wondering at the time if her symptoms were COVID related but she was not exposed to anyone and was very careful. The reporter consented to follow up.
no adverse effects reported; The nurse midwife reports that on 01-JUL-2015, a female patient recieved her first dose of GARDASIL(lot and expiration unknown by reporter).The patient came back on 16-SEP-2016 for her second dose and GARDASILl 9 was administered.; The nurse midwife reports that on 01-JUL-2015, a female patient recieved her first dose of GARDASIL(lot and expiration unknown by reporter).The patient came back on 16-SEP-2016 for her second dose and GARDASILl 9 was administered.; The nurse midwife reports that on 01-JUL-2015, a female patient recieved her first dose of GARDASIL(lot and expiration unknown by reporter).The patient came back on 16-SEP-2016 for her second dose and GARDASILl 9 was administered.; This spontaneous report was received from a midwife referring to a patient of unknown gender and currently 17 years of age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-JUL-2015, the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb vaccine (GARDASIL) (strength, dose, lot\batch#, expiry date not reported) for prophylaxis. On 16-SEP-2016, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose not reported), lot# L036301, expiry date: 20-DEC-2017 for prophylaxis (inappropriate schedule of vaccine administration, wrong product administered, interchange of vaccine products). There were no adverse effects reported (No adverse event). There was no product quality complaint.
Information has been received from a physician concerning a 14 year old female with no medical history and no drug allergies, who on 13-SEP-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included clonazepam for "sleep." Subsequently, post vaccination the patient experienced obsessive compulsive behavior. It was reported that the patient was checking doors and under the bed. The patient began to recover until  the second dose. On 20-NOV-2007 the patient was vaccinated with a second dose of GARDASIL. Subsequently, after the second dose of the patient had a more severe reaction. The patient experienced paranoid behavior. It was also reported that the patient had began her menses after the second dose of GARDASIL. The patient was referred to a psychiatrist and was placed on PROZAC. It was reported that the patient's symptoms had improved. However, the psychiatrist did not believe that the patient had been taking the PROZAC long enough for the improvement to be from the treatment. The patient's mother believed that the patient had improved because time had passed since she had received the second dose GARDASIL. The patient spoke with physician. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Approx 39 hours after being vaccinated, noted left eye periorbital swelling which proceeded to swelling shut over the next 72 hours and bruise like discoloration to eyelid/periorbital area.
Patient states that on 07/27/2017 she noticed small water looking blisters forming on her left leg (ankle up to knee and around knee). Patient then popped some of the blisters before realizing what it could be (she thought it was some kind of reaction to her working outside). Patient did not contact the pharmacy or doctor or go to have the blisters looked at. She then cleaned the area with alcohol and put some zinc ointment on the wounds. That had no effect so patient put on BENADRYL, bacitracin ointment and calamine lotion because the wounds were weeping and itchy. Blisters cleared up around 21 days and patient has recovered.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 19-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medications was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
w/in 1wk p/vax pt cramped up, vomited alot, extremely agitated, restless, uncomfortable;devel reflux sx;had blood in stool, couldn't tolerate regular formula;had very dark stools;body rejected everything;hasn't been the same since;60 day follow-up dated 09/29/00 states that weight gain has been poor. At four months of age, the infant developed loose, bloody stools, decreased appetite and nasal congestion. She was seen by the physician who has attempted to rule out food allergies and GERD reflux disease.
TDAP given 8/9/16 for new hire. Employee notified me the following day of significant pain down into the (L) axilla area. Very tender to movement and palpation.
fine red splotches all over body x/face-itches; had mono 6JUN-released 23JUN by MD; told to take DPh or call MD
Pt broke out in a patchy, rash all over body. 5 ml of BENADRYL was given and he was fine after that.
Second Moderna shot, lot 024M20A given on 2/10/021. Chronic Hives appeared after 2nd Covid vaccine shot given. Doctor has prescribed antihistimines, no improvement. Hives appeared 1 month after 2nd vaccine shot. Doctor does not think it is related to  vaccine. Still experiencing hives as of this date. The vaccine is the only thing that was different in my daily routine.
Forty minutes after injection nausea. At night I got chills and headache.  Headache, chills, fatigue the next morning. The highest my fever got was 100.3F, body aches.  On the third day I got rapid pulse and dizziness. The dizziness was worse on 11/01/2021. Pulse was higher than it will normally be after a run.
My shoulder joint started hurting. The pain has gotten progressively worse to the point of severe.  I am having a hard time lifting my arm. The pain is a burning deep pain that starts in the top shoulder joint of my left arm a d the pain radiates down the shoulder and arm.