chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The batch was administered to 6 patients after 12-Jan-2023, last dose given was 13-Apr-2023; Vial was expired 30 days after being in the fridge; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The batch was administered to 6 patients after 12-Jan-2023, last dose given was 13-Apr-2023), PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The batch was administered to 6 patients after 12-Jan-2023, last dose given was 13-Apr-2023), PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The batch was administered to 6 patients after 12-Jan-2023, last dose given was 13-Apr-2023), PRODUCT STORAGE ERROR (Vial was expired 30 days after being 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 (The batch was administered to 6 patients after 12-Jan-2023, last dose given was 13-Apr-2023) and PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge).    No concomitant medications was reported. It was reported that Moderna Covid-19 vaccine monovalent 6months-5 years was delivered to on 12-Dec-2022 and they have had them in the refrigerator since. They state that it is their understanding that it expires 30 days after being in the fridge, but they were getting notices from the department of health that the expiration date of the said batch were extended, the last one they received said that expiration date was 14-May-2023. The batch was administered to 6 patients after 12-Jan-2023, last dose given was 13-Apr-2023. No treatment drug details was reported. This case contains 2nd patient out of 6 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721723 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721723:1st patient case (Master case)
Early the next morning after the vaccine the scar from a previous turbulosis vaccine I took while a child turned really red, got warm and developed a big hard bump on it but it went away after about about 5 days.  It was really really red and the redness was about 10 inches in size
dizziness; seeing spots; rash on face, arms. upper back; This is a spontaneous report from a contactable consumer.   A 20-years-old (non pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number=PF12EREL9207; Expiration date: UNKNOWN), via an unspecified route of administration in Right arm on 16Feb2021 at 02:30 PM as single dose for COVID-19 immunizations. Medical history includes known allergies to foods-bananas, pineapple. The patient had COVID prior vaccination. The patient previously received the first dose of BNT162b2 on an unknown date for COVID-19 immunisation. The patient did not receive any other vaccines in four weeks. It was unknown if COVID tested post vaccination. Concomitant medication (other medications in two weeks) included ethinylestradiol, levonorgestrel (ALTAVERA) (MANUFACTURER UNKNOWN), sertraline taken for unspecified indication at unspecified dose from an unspecified date and unknown if ongoing.   On 16Feb2021 at 11:45 PM patient experienced dizziness, seeing spots and rash on face, arm and up-per back. Patient received benedryl as a treatment for the adverse events. The outcome of the events dizziness, seeing spots and rash on face, arm and upper back was reported as not recovered.
diagnosed with covid; diagnosed with covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: diagnosed about ten years ago. Concomitant medication(s) included: VARICELLA ZOSTER VACCINE taken for immunisation, in Apr2023 as 2nd dose; AMLODIPINE BESYLATE oral taken for blood pressure abnormal. Vaccination history included: Shingles vaccine (1st dose), for immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15May2023, outcome "unknown" and all described as "diagnosed with covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid). Clinical course: Male patient reporting that he got covid after getting the Pfizer covid 19 vaccine and booster. Advised by his son that is a pulmonologist to get the vaccine since he has high blood pressure. The most recent covid vaccine was the second booster dose that he got on 27Oct2022, which was his fourth Pfizer covid vaccine. He is now prescribed with Paxlovid and is taking atorvastatin. He asked how long he will be protected with booster and if he should take Paxlovid with atorvastatin. Confirms all 4 covid vaccine doses were by Pfizer. The last covid vaccine was a bivalent booster.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
The same day after after receiving the vaccine I noticed while I was doing yard work my leg was swollen, and so I shook it off as if it was nothing. Later on I realized that it didn't get smaller my leg started to get bigger. So I called  the doctor and they advised me to come in immediately to do an ultrasound. They later on told me that the swelling was  due to a blood clot that formed and they prescribed Xarelto 15 mg 2x day and with that prescription I didn't see any improvement so they prescribed me to do 20mg 1x day and I'm just now seeing results now.
This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, and  concurrent conditions was not reported. Concomitant therapies included sterile diluent. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N012135 with expiration date on 14-JUN-2018 by subcutaneous route, for prophylaxis (strength, anatomical location and dose were not provided). No adverse effects were reported. The vaccine was exposed to a temperature range between -9°C to 8°C (-5.9°C), during a time frame of 5 hours and 40 minutes, which was called by a data logger. Previous temperature excursions included -9°C to 8°C (-9°C) for 50 hours. This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-1802USA009695:
At approximately 1:50 PM, the patient reported feeling like she had a seizure "coming on" and "numb lips".  Patient has a documented history of seizures.  Patient soon began having grand mal seizure with observed clonic tonic movements. Initial seizure lasted approximately 10-15 seconds.  This was followed by a few minutes of the patient being alert and recognizing that she had a seizure.  In the meantime, the Services Director called 911.  Approximately 2 minutes later, the patient had a 2nd grand mal seizure that lasted approximately 10-15 seconds.  Approximatelty 3 minutes later, the patient had a 3rd grand mal seizure.  The paramedics arrived at this time. As they transferred her to the gurney, the patient had a 4th grand mal seizure.  The para medics then transferred her to the ambulance.
I rec'd the 1st of the series of SHINGRIX last Fri. and had a pretty miserable 48 hours thereafter. My symptoms can best be described as flu like; total body aches, fever, extreme fatigue (I probably slept 15 hours, on and off) and nausea, as well s severe pain at the injection site. I'm pretty much back to normal today (9.17.18).
General muscle ache Dizziness Chills Very severe headache blew out my nostrils this morning and clotted blood came out
Normal reaction the first 2 days post vaccine, fever (TMAX 102),  fatigue and very bad headache. 6 days post vaccine I then developed a painful itchy rash on my left leg consistent with shingles. Went to the doctor and was officially diagnosed with shingles and started on Valtrex.
My left arm has a big red rash blot around the injection site. It is itchy and hot to the touch.
Patient received shingrix #2 in right arm around 3 pm on 6/7. On 6/8 she noticed small area of redness and warmth below site of injection, bruise to injection site, and itching. She has applied topical hydrocortisone to the area and takes a daily antihistamine. Since initial presentation the area of redness has grown/moved downwards substantially.  She has never had a reaction with any previous vaccines. Pain 5/10  Discussed symptoms at length with patient. Suspicious of cellulitis due to growth of area since initial presentation and presence of streaking. Advised that it is impossible to determine if related to Shingrix vaccine or not, as even a superficial abrasion can introduce bacteria and cause infection. Continue oral antihistamine, otc topical hydrocortisone, NSAIDS, and cool compresses. RTO or seek follow up immediately if area worsens, fever occurs, or other new symptoms arise.   Treated with cephalexin monohydrate 500mg BID x 10 days.
Side effects from the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects from the vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant concomitant medications reported No relevant medical history was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects from the vaccination). At the time of the report, VACCINATION COMPLICATION (Side effects from the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Medications were not provided by the reporter.
Sudden hearing loss; This regulatory authority case was reported by an other health care professional and describes the occurrence of SUDDEN HEARING LOSS (Sudden hearing loss) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL), MULTIVITAMIN & MINERAL and ANTIOXIDANTS NOS for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced SUDDEN HEARING LOSS (Sudden hearing loss) (seriousness criterion medically significant). At the time of the report, SUDDEN HEARING LOSS (Sudden hearing loss) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported the hearing loss happen on left ear.  No treatment information for the event was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
11/17/04 ER Physician told her to take OTC Benadryl for itching and urticaria. 11/18/04 Returned to the ER with increased swelling, redness hives or arms, chest, legs neck. Lips & eyelids began to swell. Denied any difficulty breathing or swallowing. IV Normal Saline, IV Benadryl 50 mg, Iv Pepcid 20 mg, IV Solumedrol 125 mg. Symptoms resolved over the course of an hour. Rx Prednisone 60 mg po daily x 4 days. Pepcid 20 mg  po daily x 14 days, Benadryl 50 mg q6hrs x2-3 days.
Shot given at same time PPD skin test placed. Around 6 hours following vaccination, client felt "feverish". She also experienced chills and sweating. The client expressed a strong sensitivity to band-aids. On (R) deltoid she got a blister where the band-aid was. The client woke up today 11/18 and noticed a bump on (R) wrist and at joint of right of right pointer finger/hand.
Developed hives all over arms, chest, abdomen, back and thighs 3 hours after vaccination. Next day, severe SOB, wheezing. Rx by family Dr for bronchitis (2-pak).
BREAKTHROUGH COVID INFECTION. PATIENT TESTED POSITIVE ON 08/13/2021. PATIENT FULLY VACCINATED ON 04/06/2021.
I started having a scratchy throat, coughing, a runny nose, I could feel congestion in my chest. I had some weakness in my legs, particularly in my calves. Within the first forty-eight hours I had chills. It was really strange, every day something new showed up. I took a home test late in the evening on February 28 that came back positive. I went to an emergency room on March 1 to confirm that my home test was correct. I was given a PCR COVID-19 test that came positive. I was prescribed molnupiravir antiviral, the next day I started having discharge coming from my eyes in the morning for two days. It wasn't like the "sleep" you wake up with sometimes it was very different. I still cough and still have some phlegm, but I feel like I have recovered. Today has been my best morning since March 1.
fever 1 day p/vax -blood curdling cry longer than 2hr started 1 day p/vax given;
Narrative: Hospital, transferred from Medical Center, pt fell C1-C2 fracture. D/c to NH, dx with Covid, Moderna x 3
Rash reaction following immunizations on 7/26/01. On 8/6/01, pt had a rash with a fever, lasting 5 days, and started behind ears and spread over the rest of the body including soles of feet.
Information has been received from a nurse referring to 8 patients of unknown age and gender. On 07-OCT-2015 the patients were vaccinated with improperly stored VARIVAX (Merck) injection (lot # L021216, expiration date 10-JUN-2017; lot # L023592, expiration date 26-JUN-2017) (dose and route were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
adverse effects; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events adverse effects.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.   on unknown date patient experienced the adverse effects.  Treatment details included Not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), adverse effects,  was unknown.
pt presented with excessive sleepiness and SOB; positive COVID test; pneumonia due to COVID; hx of emphysema/COPD, CKD, HTN; pt's condition deteriorated and died in the hospital
Patient is 12 years old and received the 5 to 11 years dose, no negative outcomes occurred.
Approximately 20 hours after the injection I began to suffer from flu-like symptoms; headache, fever, chills, aches, and extreme weakness. I was also very tired and spent the afternoon through the night in bed. I had heavy covers but needed a sweatshirt with a hood up to stay warm.  I am not sure when I went to sleep, but when I awoke the next morning most of the symptoms were gone.   Except for being somewhat tired, I felt fine.  I was completely recovered by about noon, so I would estimate that my symptoms were less than 24 hours in duration; no recurrences to date.
Death:  5/2/2021 Causes of death listed on death certificate: Covid 19
multiple patients were vaccinated with improperly stored VARIVAX; No adverse effect; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 10-DEC-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R017642 and expiry date 20-JUN-2020) for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
My gums  have white spots, got worse after booster dose; My gums  have white spots, got worse after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL SWELLING (My gums  have white spots, got worse after booster dose) and APHTHOUS ULCER (My gums  have white spots, got worse after booster dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 002A21A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Had history of cancer and was seen by oncologist who ruled out leukemia.). Concomitant products included LOSARTAN, LEVOTHYROXINE and ANASTROZOLE (ANASTRAZOLE DENK) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced GINGIVAL SWELLING (My gums  have white spots, got worse after booster dose) and APHTHOUS ULCER (My gums  have white spots, got worse after booster dose). At the time of the report, GINGIVAL SWELLING (My gums  have white spots, got worse after booster dose) and APHTHOUS ULCER (My gums  have white spots, got worse after booster dose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had experienced inflammation in the gums, white spots, deep red inflammation/swelling. The side effect started after the second dose and got worse after the third dose.Patient had seen 3-4 doctors and a biopsy on gums to rule out lupus, oral surgeon could not diagnose. The symptoms are still ongoing, patient will see a rheumatologist on 26OCT2021.  Treatment medications include Antibiotics of unspecified name   This case was linked to MOD-2021-365942 (Patient Link).
Mother reported on 08/08/2005 when she came to the clinic on 08/03/2005 in PM baby had fever and crying, loss of appetite and throat pain.  Stated fever 102.5 Mom gave Tylenol, no fever on 08/04/2005 or 08/05/2005.  On 08/06/2005 baby again ran fever, on 08/08/2005 nurse examined observed very slight red throat and temperature 97.4, lump on left leg, no redness at site of vaccine.  Baby cries when not held, requested baby see a physician for possible illness.
Case number PHEH2014US025040, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 74-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 23 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Redness and swelling of injection site about 2 inches in diameter. Warm to the touch and painful. (2 out of 10 pain scale)
This case was reported by a nurse via sales rep and described the occurrence of photophobia in a 18-year-old female patient who received BEXSERO (batch number 16A901, expiry date 28th February 2019) for prophylaxis. Previously administered products included BEXSERO with an associated reaction of pain in extremity (1st dose received on 14th June 2018, for tolerance see case US2018GSK134400). On 18th July 2018 09:30, the patient received the 2nd dose of BEXSERO (intramuscular). On 18th July 2018, immediately after receiving BEXSERO, the patient experienced photophobia, vomiting, neck discomfort, balance disorder, looked pale, sickness, headache and fever. The patient was treated with MOTRIN. On an unknown date, the outcome of the photophobia, vomiting, neck discomfort, balance disorder, looked pale, sickness, headache and fever were recovering/resolving. It was unknown if the reporter considered the photophobia, vomiting, neck discomfort, balance disorder, looked pale, sickness, headache and fever to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in the left arm. On 18th July 2018, in the morning around 9:30-10, the patient received a dose of BEXSERO and immediately after receiving vaccine experienced headache, light sensitivity, vomiting, fever, and her balance was off. The patient stopped back to HCP's (healthcare profession) office around lunch and looked pale and sick. The doctor did a neurological assessment and the patient looked better from a neurological perspective, with the exception of the headache and light sensitivity. The patient's balance was better, as per the physician when the physician bent the patient's neck, the patient did complain but it was not really stiff. On the same day around 4pm, during a phone conversation, it was revealed that the patient took 800mg of MOTRIN and was doing better and that her symptoms were improving. This case has been linked with case US2018GSK134400 (1st dose) reported by the same reporter for the same patient. Lab Comments: The patient looked better from a neurological perspective, with the exception of the headache and light sensitivity.
Patient was given Meningococcal B vaccine verses the ordered MCV4. Patient informed of administration and notes no adverse effects. Patient notes understanding and will observe for any symptoms if they should arise. Patient instructed to call clinic or EMS if any adverse effects occur.
breast pain, swelling of the breast, and swelling of the lymph nodes underneath my right arm, breast soreness,  sensitivity,  could not wear clothes, had trouble sleeping on my side, but  the right side was the worse. Was told to apply warm compresses and  Evening primrose oil  and vitamin E oil a couple of times a day and especially at night.