chrisvoncsefalvay/vaers-outcomes huggingface dataset:
0.1 mL administered in 3 patients each; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INCORRECT DOSE ADMINISTERED (0.1 mL administered in 3 patients each) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .1 ml. On 18-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (0.1 mL administered in 3 patients each). At the time of the report, INCORRECT DOSE ADMINISTERED (0.1 mL administered in 3 patients each) outcome was unknown. Details not Provided.      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.   No concomitant medicines were reported. No treatment information were reported.
This 30 yo received her primary SMPX on 10/19/04 to her left deltoid with normal blistering, scabbing that fell off @ day 40. Denies any robust take or arm paresthesia.  When scab fell off, she noted a firm mole-like blister to site that does not drain, but DOES itch. No erythema to site, just the "blister" See attached pictures.  Blister has never resolved and has remained as is for one year.  Is tender to touch if bumped or hit otherwise no complaints. Received anthrax #1 and influenza same day to right arm. She reported 2 weeks following her AVA, smallpox and influenza vaccine developing flat non-raised pruritic red blotchy spots and hives to her chest and torso area upon awakening one morning. The rash lasted for over 2 hours. She was treated with IM Benadryl. She stated the rash returned 2-3 days later and was again treated with oral Benadryl x 2 before resolution. She has had no reoccurrence but did remember similar rash experience approximately 10 1/2 years ago when using Duravent for a cold. She denied any new foods, detergents, deodorants, clothing, etc. Assessment: Hypertrophic scar formation vs Dermatofibroma vs keloid formation at smallpox vaccination site.
This spontaneous report was received from a registered nurse refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with M-M-R II (dose and frequency were not reported) injection. The nurse reported that PNEUMOVAX23 was exposed to temperature of 11C. On an unknown date in December 2012, there were 13 excursions for a total time of 112 hours. On an unknown date in January 2013, there were 9 excursions for a total time of 72 hours. On an unknown date in February 2013, there were 11 excursions for a total time of 96 hours. On an unknown date in March 2013, there were 7 excursions for a total time of 56 hours. On an unknown date in April 2013, there were 12 excursions for a total time of 120 hours. On an unknown date in May 2013, there were 7 excursions for a total time of 65 hours. On an unknown date in June 2013, there were 6 excursions for a total time of 49 hours. On an unknown date in July 2013, there were 11 excursions for a total time of 104.5 hours. On an unknown date in October 2013, there were 2 excursions for a total time of 17 hours. The nurse stated that the doses were administered to unspecified number of patients on unspecified dates throughout the year. No adverse effects reported. Action taken with M-M-R II (dose and frequency were not reported) injection was unknown. The outcome of the event was unknown. This case is linked to the same reporter linked cases 1401USA000188 and 1401USA000218. Additional information has been requested.
intensely pruritic rash, starting around neck initially and then presenting in perianal area, moving up lower back with sharp linear demarcations, also perinasal bilat .  Also on eyelid with periorbital edema rt>lt.  Typical appearance of contact derm with raised indurated intensely pruritic lesion  except almost exact opposite in distribution (flexoral/internal aspects of skin) and no known exposures.  Now day two and rash is becoming more well demarcated, more red and inflamed and spreading in distribution face, neck and lower back.  There is no logical explanation for this rash.
a dark spot like blood lower down on her arm; real sore; This is a spontaneous report from a contactable consumer (patient, self-reported). A 96-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04Feb2021 18:15 (Batch/Lot Number: ENS318) as SINGLE DOSE for Covid-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Medical history included thyroid disorder, blood pressure abnormal, vitamin supplementation, hip fracture (she broke her hip three years ago), neuropathy peripheral, blood cholesterol abnormal, hypertension from an unknown date and unknown if ongoing. Concomitant medications included benazepril (BENAZEPRIL) taken for blood pressure abnormal, 40mg, one in the morning, Oral; levothyroxine (LEVOTHYROXINE) taken for thyroid disorder, 5mg, once daily, Oral; amlodipine (AMLODIPINE) taken for blood pressure abnormal, 10mg, at night, Oral; simvastatin (SIMVASTATIN) taken for blood cholesterol abnormal, 5mg, one at night, Oral; gabapentin (GABAPENTIN) taken for neuropathy peripheral, 100mg, twice daily, Oral, Since unspecified date of Feb2021; ascorbic acid, betacarotene, copper, tocofersolan, zinc (OCUVITE [ASCORBIC ACID;BETACAROTENE;COPPER;TOCOFERSOLAN;ZINC]) taken for vitamin supplementation, once daily, Oral; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, 81mg, once daily, Oral; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication (taking for years), 125mg, once daily, Oral, all concomitant medications start from an unspecified start date and ongoing. Consumer stated she received the first dose of the Pfizer COVID 19 vaccine 04Feb2021 at 1815PM in the left arm. The place where the shot was, was real sore. The next morning (05Feb2021) she noticed a dark spot like blood further down on her arm. It was fading out some now. Stated Saturday the place with the shot hurt real bad and there was this big old place like a bruise on her arm further down. She failed to tell then she had low dose aspirin and was asking could that have caused this. She did call her doctor who advised maybe blood had pooled there from the shot but she did not understand what he was saying. She was scheduled for the next dose of the vaccine on 19Feb2021. Outcome of the event a dark spot like blood lower down on her arm was recovering and real sore was outcome of recovered on 06Feb2021.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; Poor quality vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ).    No concomitant medicine were reported. No treatment medicine were reported. This case was for 56th of 100 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
I started to have really bad depression. After about 2 and a half weeks, I went to see the doctor. She did not provide any treatment. She told me to go to see my PCP I scheduled an appointment with my primary care doctor. I am still feeling low, and nothing makes sense. I am still having the same feelings.
flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix. On 28th August 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The report was notifed by friend of family via text, stated that he received Shingrix he had flu like symptoms.  No other details were shared by the friend. The reporter stated that she received a text last evening from the friend.
EVENT: I have a roller coaster with fatigue. I do too much and I can just pass out and be down for days. Like right now. Pt reported allergic rx to Moderna which caused a flare up of MS, she was hospitalized. This was with her first vaccine did not provide date but according to allergies it was initially documented in 2021.
This is a spontaneous report from a contactable medical assistant calling on behalf of the physician. A 81-year-old female patient received on 07Mar2017, PREVNAR 13 (R33239, exp.date 31Mar2018, NDC number: 0005-1971-01) for immunization via unspecified route on the left deltoid. Medical history included breast cancer, colorectal cancer and hypertension. On the same date the patient experienced macular rash within 15-20 minutes of receiving injection, she was itchy all over. The patient received as treatment Depo-Medrol.  The outcome of the event was unknown.
Approximately nine and a half hours after receiving the vaccine, I started to feel dizzy. The next day, I experienced vertigo, general dizziness, headache. Over the next few days, I also had loss of appetite due to the dizziness. I reached out to my Primary Care Physician's office and was prescribed meclazine which only helped with the headache, but did nothing to help with the dizziness. The dizziness and vertigo lasted for about seven weeks. During that time, I went to my physician's office for an exam. The nurse practitioner who examined me informed me I had vertigo and witnessed an episode of nystagmus. I went for several sessions of physical therapy and eventually the vertigo resolved. Prior to receiving the vaccine, I never had any issues with dizziness or vertigo.
On day 5 diarrhea and twitching of the right eyebrow (also never before); On day 5 diarrhea and twitching of the right eyebrow (also never before); 72 hours after vaccine; vision distortion on right eye which went away after a few mins (never happened before); This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 12Jan2022 at 10:15 (Lot number: unknown) at the age of 35 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: IRON SUPPLEMENT and VITAMIN C SUPPLEMENT.  The following information was reported: METAMORPHOPSIA (non-serious) with onset 15Jan2022 at 10:15, outcome "recovered" (15Jan2022), described as "72 hours after vaccine; vision distortion on right eye which went away after a few mins (never happened before)"; DIARRHOEA (non-serious), BLEPHAROSPASM (non-serious) all with onset 17Jan2022, outcome "unknown", and all described as "On day 5 diarrhea and twitching of the right eyebrow (also never before)".Therapeutic measures were not taken as a result of metamorphopsia, diarrhoea and blepharospasm.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   The lot number for BNT162b2 was not provided and will be requested during follow up.
No adverse event; Vaccine was expired on 15-Sep-2022 and was administered to the patient on 23-Sep-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 15-Sep-2022 and was administered to the patient on 23-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products were reported.  Concurrent medical conditions included Tuberculosis (Current active infection). Concomitant products included ISONIAZID and RIFAMPIN for an unknown indication.    On 23-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 23-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 15-Sep-2022 and was administered to the patient on 23-Sep-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 15-Sep-2022 and was administered to the patient on 23-Sep-2022) 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 (Vaccine was expired on 15-Sep-2022 and was administered to the patient on 23-Sep-2022).    Patient was not diagnosed or tested positive for COVID-19. Patient had not received other vaccines within 1 month prior to Moderna COVID-19 vaccine. It was reported vial was in open carton in the freezer and vial size was 5.5 mL and vial had not undergone any temperature excursions. It was reported that the vaccine was administered to the patient on 23-Sep-2022 around 5pm. The adverse event had not caused patient to seek medical care (office visit, Urgent care, ER or hospitalized). It was reported that the reporter had not seen the vaccine expiration warning and later noted the expiry date.  It was reported that 2 primary full doses were administered to 2 patients.  Reporter stated that the reporters colleague checked in with the patients to see how they were feeling and they had no complaints. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Live significant follow up received contains patient details and I narrative were updated.
1)Blisters on the face, arms, chest and legs 2)Irritation
Patient experienced nause about 5 minutes after receiving immunization and had a seizure approximately 1 minute later. The seizure lasted for about 2 minutes.
Left arm pain at 11pm on 1/8/21, fever 102.0 body aches head ache began at 5am 1/9/21 , fever and body aches , tachycardia continued throughout 1/9/21, 1/10/21 tired weakness but no fever 1/11/21 all resolved except for slight left arm pain
Experienced the arm pain around the injection site for about 4-5 days. By day 7, a lump formed at the injection site and it was itchy. By day 8, my arm broke out in a itchy rash from my shoulder bone down my arm to just above my elbow. I used over the counter hydrocortisone topical cream to stop the itchiness. The rash went away in 5 days.
Three days after injection pt developed severe aches/pains from his knees to his feet. Went to MD and tested for gout and test was negative. Back also now is in pain and pt complains of overall body stiffness. He said it's like his body feels poisoned and is being attacked from the inside out. Unsure if fever exists. Pt still having symptoms.
Information has been received from a physician concerning his wife, a 76 year old female patient, with a history of questionable penicillin allergy who on 02-AUG-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included MAVIK, LEVOXYL and vitamins (unspecified).  On 30-OCT-2007 the patient experienced zoster.  The physician indicated that his wife developed zoster after administration of ZOSTAVAX (Oka/Merck).  Initially the area under her left arm was pruritic.  Then she developed slightly raised, red, pruritic lesions on the dermatomes: d7 and d8.  She had a cluster of two lesions and another cluster of 3 lesions on her lateral chest wall.  She also had 1 lesion by her sternum and another lesion 1 to 2 inches to the right of her sternum.  The physician's diagnosis was zoster.  She also was examined by a dermatologist who confirmed the diagnosis of zoster.  The dermatologist prescribed topical cortisone.  Within 3 to 4 days she improved significantly.  The dermatologist's name was not provided.  At the time of reported she was about 75 to 85 % recovered.  She did not have any pain.  The lesions never became blisters or formed scabs.  He stated on a scale of severity of 1 to 10 this was a 1.5.  He was interested in the VZV analysis.  No laboratory diagnostic tests were performed.  Patient's outcome was reported as recovering.  No product quality complaint was involved.  Additional information has been requested. 03/26/2008 Additional information was received from the physician concerning his retired wife with hypothyroidism, high blood pressure, a penicillin allergy and a history of chicken pox as a child who on 21-AUG-2007 (previously reported as 02-AUG-2007) was vaccinated IM in the left deltoid with a dose of ZOSTAVAX (lot # *08846*). Concomitant therapy included MAVIK, LEVOXYL and vitamins (unspecified). In early October 2007 the patient noticed an itching lateral to her left breast (at D6-8). Exam disclosed a cluster of 3 flat, red spots at that spot, another two red spots 2 inches posteriorly and slightly superiorly removed, and one other red spot between her breasts at about the same level. She was seen 2 days later by a dermatologist who concurred in the diagnosis of herpes zoster. On an unspecified date the patient fully recovered. It was noted that the patient's husband had herpes zoster of left V-1 seventeen months prior to the patient. A direct fluorescent antibody was not performed and a specimen was not collected for PCR. No further information was provided.
Pt stated R arm became itchy and red with lump at injection site. Went to urgent care 9-15-16 Dx with skin infection given ABT per P/C.
TOOK A DOSE TOO CLOSE TO TRAVEL; This spontaneous case report (PVX2019-2055) was received from a pharmacist 08-Aug-2019. It described a female consumer who "took a dose too close to travel" (PT: Inappropriate schedule of vaccine administered), while being on Vivotif for travel to endemic area.  Case report: The consumer took a dose of Vivotif on 07-Aug-2019. On 10-Aug-2019, she would be traveling.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took a dose too close to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took a dose too close to travel" was considered as not applicable.
Gentleman  was given Johnson and Johnson vaccine  on 5/13/21 at 4:30 pm. approximately 5 minutes later another customer witnessed him drop all his belongings then faint. He was immediately helped and the fire department and paramedics arrived about 10-15 minutes later. The patient was cleared and was able to go home
Had no reaction to 1st dose other than sore arm and feeling really tired. This time I had those same reactions, but have also developed a rash on my torso and neck sides. Rash does not itch, burn, or hurt.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: El8982), in left arm, as dose 2, single (Lot number: En6203), in right leg and as dose 3 (booster), single (Lot number: 30135BA), in left leg for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient received other medication in 2weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Numbness and tingling both soles of feet, both arms and hands. Shortness of breath, clumsiness of hands. Symptoms started 3 days after receiving flu shot and continued to present day - sx are slowly going away.
I received my second Pfizer booster for COVID-19 on 6/2/2022. On the night of 7/26/2022, I woke up with a sore throat and slight congestion, which continued for two or three days. I took a home test for COVID-19 on the morning of 7/27/2022 and got a positive result. I went to the clinic on 7/28/2022, 7/29/2022, and 7/30/2022 to receive remdesivir monoclonal antibodies. During my illness, my main symptom was fatigue, which lasted for about a week. After the infusions, though, the sore throat and congestion went away quickly. Having said all of that, I would like to add that I suspect that I had a new variant of COVID-19 that not covered by the vaccines that I received. I say this, because the symptoms I had were consistent with descriptions of the new variant symptoms I read about and heard about on the news.
pt recvd vax;t approx 102;napped 2-3 hrs,awoke "acted weird" & "sounded funny";?sz;to er then adm to hosp x 3 days;