chrisvoncsefalvay/vaers-outcomes huggingface dataset:
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 18th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There were 13, 11, and 6 different doses were given. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:Master case
Pt vaccinated with Recombivax HB/DT developed diarrhea within 24hrs, constant HA, nausea, no fever but body aches, temp 99 5 days after continuous HA, nausea.
H/A, body ache & feel warm; suggested to take Tylenol or ibuprofen as recommended. Hydrate well and call poison center if any questions or concerns.
Hives started the next morning on my shoulder of right arm, collar bone, and neck then spread over my right thigh and leg. I still have them, but they are gradually subsiding.
I thought I had a cold/flu. I had a dry cough, fatigue, and body aches. I had a negative at-home COVID-19 on 06/03/2022 and 06/06/2022. But on 06/09/2022, I tested positive. I was treating it like a cold until I contacted my doctor and told her about my positive test; she cancelled my already scheduled normal appointment on 06/10/2022 and told me to quarantine. For treatment, I made juices, rested, quarantines, and ate chicken noodle soup. My doctor prescribed Paxlovid, but my pharmacy never called to tell me my prescription was ready for pickup. So I called my doctor back and informed her, but by that time-- I wasn't interested in taking any medicines. So I just continued my natural juices and rested. Still till this day, I have a light dry cough and fatigue but I am back to normal life again.
Cellulitis on bilateral thighs where injections were given-patient taken to ER-given Keflex po x 7-10 days
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 09-MAY-2018 the patient was vaccinated with M-M-R II, intramuscular for prophylaxis. On 09-MAY-2018, 1 day after onset of therapy the patient experienced incorrect route of drug administration. On an unknown date the patient experienced no adverse event. The outcome of incorrect route of drug administration and no adverse event is unknown. The reporter considered incorrect route of drug administration and no adverse event to be not assessed to M-M-R II.
The next day she had a very bad headache. For 13 days she felt terrible. She had bad back pain and head kept hurting. Went to ER and was DX with a UTI.
Headache, Diarrhea, chills Narrative:  Other Relevant History:
patient states that she felt ongoing and worsening fatigue since receiving the vaccine along with body and joint aches. she has an shingles outbreak at her usual spot of outbreak on 11/14/21.
The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 10-JUN-2014 was vaccinated with (Oka/Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and does schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 28 year old female with no concurrent medical conditions and a history of 2 pregnancies and 1 live birth who on 03Jul2003 was vaccinated with a 0.5 ml dose of varicella virus vaccine. It was reported that the patient did not have any local reactions at the vaccination site, varicella or herpes zoster symptoms post vaccination. On 21Oct2000, laboratory evaluations revealed a negative titer for serum varicella antibodies. The pt's LMP was 06Jul2002 with an EDD of 12Apr2003 (reported as 2002). In July, 2002, the patient was started on prenatal vitamins. On 11Nov2002 a maternal serum alpha fetal protein test was reported as normal. On 15Nov2002, the patient had a routine ultrasound, the results of which are unknown. On 16Apr2003 at 40 4/7 weeks, the pt delivered a live born, normal, 8lb 4 oz male. Apgar score was 8 and 9. The infant had fetal bradycardia during labor/delivery and was delivered with forceps. There were no congenital anolmalies, complications, infections or illnesses during pregnancy. It was noted that there were no unusual diagnostic tests done during the pregnancy. On 25Apr2003 the infant was noted to have a possible tongue tie. He was to return to the clinic the next day for a frenotomy evaluation. On 20May2003 the infant was brought back to the clinic for a consult. It was noted that the infant had rested that morning and had much better tongue movement with go lateral movement and the tongue was protruding past the gums. The infant was seen by a physician. He nursed more effectively. The plan was to monitor the infant's progress and it was noted that the frenotomy would not be performed that day. It was also reported that the infant was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufactuer unknown) and developed a cough, sneezing, rhinnorhea, and wheezing at night. No further information is expected.
Pain at injection site almost immediately. Two days later his wife noticed that his arm was red, also hot to the touch. Went to clinic and saw Dr. He prescribed 7 days of Clindamycin.
Initial soreness and heavy arm. Now pain from scale 0-10 about 6. Can't raise arm. Right arm.
Patient said he felt flu like symptoms for first day and started to ween off after the second and third day; This is a spontaneous report from a contactable physician reported for self via Pfizer sales representative. This male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot number unknown) on an unspecified date at single dose for COVID-19 immunisation. The patient mentioned that he had severe side effects after taking the second dose COVID 19 vaccine. Patient said he felt flu like symptoms for first day and started to ween off after the second and third day.  Event took place after use of product. The patient was resolving.  No follow-up attempts are possible. No further information is expected.
This spontaneous case, initially received on 25-Oct-2016, was reported by a health professional and concerns a 55-year-old male patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 25-OCT-2016 to 25-OCT-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT55207A. No additional suspect drugs. Adverse event description: On 25-Oct-2016, an AFLURIA dose was partially given to the patient (outcome: unknown, special circumstances: underdose without adverse event).
Approximately 1 month after my 4th dose vaccination I contracted COVID-19 and experienced the following symptoms: Fatigue, Headache, Low grade fever, Malaise, Mild Cough. I took Ibuprofen 2x/day and it did help with my fever, headache and malaise. The next day I had a televisit and was prescribed with Paxlovid for 5 days and total of 6 pills a day (3 in the morning and 3 at night) and so far I am on my 3rd day and so far I am feeling much better than before.
Pneumonia; ill; deep body aches; cough; This case was reported by a consumer and described the occurrence of pneumonia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included pneumonia shot (received second shot a year before the reporting date).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced pneumonia (serious criteria GSK medically significant), unwell, general body pain and cough. On an unknown date, the outcome of the pneumonia, unwell, general body pain and cough were recovering/resolving.   It was unknown if the reporter considered the pneumonia, unwell, general body pain and cough to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient did have the second pneumonia shot last year. The patient reported a side effect to first Shingles shot.  It was reported that the night after shot the patient was ill with deep body aches and a cough. The pharmacist said some get mild flu like symptoms. The next day, the patient had deep coughs and the patient diagnosed with full blown Pneumonia. The patient never had pneumonia not even a cold or flu or last 3 years and there was no reason for me to have pneumonia. The patient asked if GSK had other reports like this. After 2 weeks, the patient finally getting better. The patient was afraid to get the second shot. The case has been linked to the case US2019AMR184953, reported by the same reporter.
Patient presented at vaccination table and identity was confirmed with two unique identifiers (including DOB). Present writer reviewed patient's responses to screening form completed in PrepMod and also screened patient to confirm he was feeling well, had no history of anaphylaxis, does not carry an epi-pen for allergies, and had not received COVID vaccine previously. Educated patient on possible side effects of Moderna product. Pt indicated he wished to be immunized, received Moderna vaccine, and proceeded to observation area where waited for fifteen minutes before departing from clinic without reporting any adverse event. Patient later found to be under the minimum age of 18 years for receiving Moderna.
on 4/30/21 had a fever of 100.2 and felt achy and very tired. on 5/6/21 started having nerve pain on right side of abdomen under arm starting mid front body and wrapping around to mid back. after about 10 days, developed a rash looking like shingles. went to physician office on 05/18/21 and was diagnosed with shingles
lightheadedness; Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health); This is a spontaneous report from a non-contactable other hcp. A 79-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6206) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient experienced lightheadedness and differential diagnosis: vaccine-related anxiety (include misc mental health). During her 30-minute waiting period after the injection, the patient began to experience lightheadedness. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, itching, dizziness, facial swelling, lip swelling and tongue swelling. Patient discharged, stable to go home and follow up with PCP. Differential diagnosis included vaccine related anxiety (include misc mental health) anxiety patient observed in bay area for 15 minutes. Improved and was doing well. Patient assisted out via wheelchair by husband. Patient declined help out. She felt well in standing position in the medical bay prior to discharge. Patient declined water and snacks. Follow up with PCP as needed. Therapeutic measures were taken as a result of lightheadedness and differential diagnosis: vaccine-related anxiety. Follow up response to treatment was excellent. The outcome of the events was Resolved on an unspecified date.  No follow up attempts are possible. No further information is expected.
tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for daughter boyfriend (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date 3 family were vaccinated last week Friday. Daughters boyfriend tested positive for covid. Now Daughter was tested on Wednesday was also tested positive. Wants to know when daughter can get 2nd dose or how this works with having covid. The outcome of the events was unknown.    Information about lot/batch number has been requested.
A report has been received from a health professional concerning a 67 year old, Female subject, who had been receiving FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown age. It was reported that a patient had received FLUMIST Quadrivalent and was over 49 years old. The outcome of the event of inadvertent administration of FLUMIST Quadrivalent to patient over 49 years of age is unknown. The report was considered to be non-serous.
Day 1 - Whole body muscle ache the evening vaccination was received. Vaccination site was not painful. Day 2 - 100.4 temperature in the morning, fatigue, headache, mild chills; temp went down to 99.7 during the day, then back to 100 by 8:30pm. Treatment: Tylenol and a 1+ hour nap in the morning and a 1+ hour nap in the afternoon. Day 3 - Woke feeling fine; 98.5 temperature
Within approx 3 1/2 hrs after getting flu vaccine pt felt her throat closing up, throat felt swollen, started coughing and had reddened sclera. Says she had no rxn w/ flu vaccine in 2012, but had cough and reddened sclera after H1N1 vaccine in 2011 and no resp s/s at that time. S/S/ improved w/ 10/11/13 vaccine after taking BENADRYL. Rec. pt f/u w/ allergist.
At 5:30 pm  on 2-24-2021 after receiving my second dose I started having fever,chills,body aches,headaches and bilateral eye pain. I didn't take any Tylenol . My symptoms lasted from Wednesday to Sat. Sunday I felt better.
Pt developed shingles soon after the shot on 8/29/2018. She told the pharmacy on 11/06/2018 that she had developed shingles.
PAINS; FEVER; This spontaneous report received from a parent via a company representative concerned a 29 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced pains, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and pains. This report was non-serious. This report was associated with product quality complaint: 90000207282.
Post vax the patient experienced headaches, fever, dizziness, nausea, diarrhea, raised red spots, blotches and itchiness.
Abdominal cramps that were triggered by drinking, and then when I used the bathroom I had blood. I went to the hospital and I was admitted for a few days. In March it began again. I went to a GI specialist and I am scheduled to run another ultrasound soon to check to see if there is any difference in the colitis diagnosis I had before to now.
Information has been received from a nurse referring to a 16 year old female patient. The patient had no concomitant therapy, pertinent medical history or drug reactions/allergies. On unknown dates in 2002 and 2003 the patient received the doses of the hepatitis B vaccine (recombinant) (manufacturer unknown) vaccination series (strength, dose, frequency, route, lot # and expiration date were unknown) for prophylaxis. In 2018 (reported as "now"), the patient had negative titers for hepatitis B. It was not known if treatment was given for the event. The outcome of the event was not recovered. The causality assessment was not provided by the reporter.
Within 8 hours of my 2nd dose of the Moderna COVID19 vaccine, I?d developed: a fever that stayed within .5 either way of 100F; swelling & pain in all lymph nodes; widespread joint pain, with joints frequently attempting to hyper-extend; pain on the front & both sides of ribs. These symptoms all either mostly or completely resolved themselves within 5-6 days of at-home care (rest, lots of water, & ibuprofen). These symptoms are the same as what I I experienced after the 1st dose of the Moderna COVID19 vaccine, and only lasted about 24-36 hours longer than my symptoms from the 1st dose.  Within 39 hours of the 2nd dose, I also developed numbness in my left pinky & ring fingers, with loss of sensation & tingling. This symptom has remained ever since. While it sometimes varies in degrees of sensation loss, it never fully resolves & reappears at will, with no discernible pattern. As of today, there is now also swelling in those fingers. This symptom is similar to what I experienced after the 1st dose of the Moderna COVID19 vaccine (also in the left arm), but not exactly the same - after the 1st dose, I experienced numbness in the left thumb & index fingers with loss of sensation & tingling, and there was no accompanying swelling - and also has not fully resolved, with only about 95% sensation recovered in those two fingers.
69-year-old female presents to ED with fever for the past 5 days. MAXIMUM TEMPERATURE 101, alleviated with Tylenol at home. Denies any exacerbating factors. Associated symptoms including hematuria, dysuria. Patient also states she has a cough which is chronic as she is a smoker. Denies any nausea, vomiting, abdominal pain, flank pain, other symptoms at this time.  Is fully vaccinated against covid.  No known sick contacts.   Review of Systems  Constitutional: Positive for fever. Negative for chills.  HENT: Negative for congestion and sore throat.   Eyes: Negative for discharge and visual disturbance.  Respiratory: Positive for cough. Negative for shortness of breath.   Cardiovascular: Negative for chest pain and leg swelling.  Gastrointestinal: Negative for abdominal pain, nausea and vomiting.  Genitourinary: Positive for dysuria and hematuria. Negative for flank pain.  Musculoskeletal: Negative for back pain and gait problem.  Skin: Negative for rash and wound.  Neurological: Negative for light-headedness and headaches
I had no muscles in my fingers in my right hand; I have no muscles in my fingers/ I have trouble with my hand; I cannot feel anything in my fingers; I can't push anything back/ have no strength in my fingers; My whole hand was numb; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 30May2021 13:00 (Batch/Lot number was not reported) as first dose, single dose at the age of 66-years-old for COVID-19 immunization. Medical history enlarged heart, "fibro" (as reported) in chest and arthritis in the patient's right side of hip and it goes to the patient's arm. The patient's mother has arthritis, not in the hand, in the hip like the patient but not in the hand. Concomitant medications included carvedilol, prazosin and benazepril; all taken for an unspecified indication, start and stop date were not reported.  Patient reported that on the questionnaire, he didn't have his glasses and he thought it was all, usually at the doctor's office, asking about allergies and he don't have no allergies, so he put "No", but he forgot to tell them that he has arthritis in right side of his hip and it goes to his arm so he had them give him the shot on his left arm and he knew this, when he tried to put the chain on his dog (the walker), the patient couldn't push the button to get the chain on the hook. The patient has no feelings in his fingers. So he was wondering if that's a side effect from the BNT162B2. The patient had no strength in his fingers. The patient further stated that he has no muscles in his fingers ("clarification unknown" as reported). He had no strength in his fingers. The patient never had trouble with his hand before but after this shot he have trouble with his hand now on the right side only. Saturday night when he tried to walk the dog. He couldn't get the chain on the collar. Patient stated "I had no muscles in my fingers in my right hand. I have no muscles in my fingers I can't push anything back." The patient also stated , "I have a side effect from the shot. I cannot feel anything in my fingers. Like when I push the button downside I cannot feel it.". The patient's whole hand was numb. No treatment received or administered for the events reported.  The outcome of the events was not recovered.    Information on the lot/batch number has been requested.
I know of three people that had the original 2 Pfizer shots and within 90 days contracted the variant; I know of three people that had the original 2 Pfizer shots and within 90 days contracted the variant; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported similar events for 3 patients. This is one of 3 reports. A unspecified age and gender of a patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported), dose 1 and dose 2 via an unspecified route of administration on unspecified date as DOSE 1, SINGLE and DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unspecified date, the patient received original 2 Pfizer shots and within 90 days contracted the variant. The reporter understand that Pfizer was asking the FDA for 6 months booster for the covid 19 to cover the variant, but reporter know of three people that had the original 2 Pfizer shots and within 90 days contracted the variant and six months was too late. The patient had SARS-CoV-2 test within 90 days contracted the variant and results were positive. The outcome of the event was unknown.  Information related to batch/Lot no. was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021885306 Same reporter/ drug/ event, different patients.