chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine stored in refrigerator; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Expired vaccine stored in refrigerator) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine stored in refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Expired vaccine stored in refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 04-APR-2022, the vial  was initially stored in refrigerator. The vial did not undergo any temperature excursions. The pharmacy was trying to verify the expiration date. Reported that when the pharmacy received the vaccine, a staff member came up with expiration date of June 2022. However, another staff member looked up the expiration date as 01-APR-2022. No concomitant medications were reported. No treatment medications were reported.
stomach issues; headaches; fatigue; This spontaneous report was received from a female patient of unknown age who refers to herself. Her medical history, concurrent conditions and concomitant therapies were not reported.  On approximately 30-SEP-2022 (reported as 2 weeks ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered for prophylaxis (dose, strength, lot number, expiration date, and route of administration were not provided).  On an unknown date in 2022, the patient experienced stomach issues, headaches, and fatigue. The outcome of the events was not provided.   The causal relationship between all the reported events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Throat tightness and tingling , itchy mouth within 15 minutes post-vaccination.  Received diphenhydramine 50 mg PO and hydrocortisone 20mg PO.  VS stable throughout observation period with O2 Sat at 99%.  D/C'd in stable condition.  Will be evaluated by Allergy Clinic for Dose #2 recommendations.
Patient received menactra on 6-28-2007. About 1 month later patient developed mononucleosis.Disease started with 3-4 days of headaches followed by 3 days of 103.5 fever. patient entire midriff tender.-also nausea, tenderness of spleen and ache in back ( kidney ) Blood work at one week after onset of illness showed low platelets 150k/cu mm, liver compromise AST(SGOT) 212 IU/L  ALT(SGPT) 286 IU/L,jaundice bilirubin 2.2 mg/dL, high lymphocytes 9.7 k/cu mm,anemia hemglobon 10.3 gm%. Two days after bloodwork  patient received lymphatic drainage and wholistic and homeopathic supplements. Within about 4-5 days of starting treatment patient able to get off the couch and start eating again. Hepatic function labs after treatment still pending.We didn't know mono could be so serious, or that the menactra vaccine could have compromised her system that much.
Within a few hours of receiving the vaccine, I started feeling nauseated. Since the day I took the vaccine, my appetite has been nonexistent. A day later, I felt very tired and confused. I received the vaccine on Monday and I woke up in a panic on Wednesday morning. My heart was racing, palms were sweaty, I felt like I couldn't breathe and it seemed like I was having a panic attack when I woke up. From that point forward, I fell into a deep depression. At first I didn't connect it with the vaccine, but I kept feeling nauseated and then wondered if it was connected. The depression became unbearable and I felt suicidal by the next week. I finally contacted my doctor's office and had a telemed visit where I explained that I had the J&J vaccine the week before and these symptoms presented themselves afterward. The doctor put me on Zoloft and I HAVE been treated for depression in years past with that; however, I had not taken depression medication for about 8-10 years until this. Likewise, because my doctor put me on an anti-depressant, she also wanted me to see a counselor--which I have done. The medication is helping somewhat but I still don't have an appetite. I don't know if the vaccine had anything to do with the depression, but I wanted to report it just in case others have had similar symptoms.
This spontaneous report as received from a pharmacist refers to a 58 years old male patient. The patient was vaccinated with a dose of ZOSTAVAX (lot # reported as "0257AE", exp date: 15-MAR-2012) on 24-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The patient came into the pharmacy on 02-AUG-2012 to report the adverse event. The patient developed rash and soreness at the injection site, unspecified, and fatigue. No treatment information was reported. The outcome of fatigue, soreness and rash at the injection site was reported as recovering/resolving. Additional information has been requested.
Developed large swelling under and around left breast. . Under left arm it will hurt real deep once in a while.
This spontaneous report as received from a physician refers to a 17 year old female patient. On 18-JUL-2014, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported). The physician reported that on 18-JUL-2014, the patient felt light headed. The patient layed down in the office for a while and that was when they noticed a red/blotchiness mark on her neck when she left the office. Additional information has been requested.
Immedicately after receiving a Hepatitis A vaccine, the patient passed out and was unresponsive for aprox 1 minute.  Patient hit the right side of her head on the tile floor.  Ice bag to lump on head.  911 was called and paramedics checked her out.  BP 118/90 and Pulse 60.
Nausea, vomiting, dry heaving, lump in throat feeling, general lethargy and malaise, stuffed ears feeling
pt recv vax;awoke in early am 18aug;was fed & put back to bed;when mom awoke 1 hr later, pt found unresponsive;
Patient admitted on 8/2 with fever and cough post completion of COVID vaccination series in February 2021.  Diagnosed with COVID-19 and community-acquired pneumonia.
Strong metal taste in the mouth; Nauseated; very chilled; Hurting arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Strong metal taste in the mouth), NAUSEA (Nauseated), CHILLS (very chilled) and VACCINATION SITE PAIN (Hurting arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced DYSGEUSIA (Strong metal taste in the mouth), NAUSEA (Nauseated), CHILLS (very chilled) and VACCINATION SITE PAIN (Hurting arm). At the time of the report, DYSGEUSIA (Strong metal taste in the mouth), NAUSEA (Nauseated), CHILLS (very chilled) and VACCINATION SITE PAIN (Hurting arm) outcome was unknown.        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.   Concomitant medications were not provided. No treatment medications were provided.
Received immunization 8/24/2004 right thigh 3 days later rx'ed erythema and induration at site. No fever. ~ 8mm erythema/induration right lat thigh.
1st dose was given on September 2022 / She wants to know if the second dose would be valid and how long after the 1st dose the second dose can be given; there is no adverse event; This spontaneous report was received from a pharmacist regarding an adult patient of unspecified gender. Information regarding medical history, concurrent conditions and concomitant medications was not reported.   On an unspecified day in September 2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (no more vaccination details provided).   It was reported that patient was coming in soon on 06-JUL-2023 to get the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX). The reported wanted to know if the second dose would be valid and how long after the first dose the second dose could be given as the first one was given in September 2022 (inappropriate schedule of product administration). The reported stated that there was no adverse event. No additional information given or reported.
"My mensural cycle moved forward two weeks. My period started 5 days after my second shot which was mid cycle. It is continuing regularly and the moved forward timing"; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 03Apr2021 at 14:15(at-the-age-46-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 13Mar2021 at 14:15(at-the-age-46-years-old) as a single dose for COVID-19 immunisation. On 08Apr2021 at 14:30, the patient reported that her mensural cycle moved forward two weeks as the period started 5 days after her second shot which was mid cycle continuing regularly and moved forward timing. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event her mensural cycle moved forward two weeks period started 5 days after her second shot which was mid cycle continuing regularly and moved forward timing was resolved with sequelae at the time of this report.  No follow-up attempts are possible; no further information is expected.
Received the shot no side effect  however in August was diagnosed with DCIS breast cancer stage 0 Upon biopsy pathology found 2 invasive not detected by MRI stage 1 A.  My heredity gene test states I tested negative for all 36 cancers.  I believe if I did not get this shot I would not have gotten cancer.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Feb2021 as dose 1, single (Lot number: 031L20A), in left arm, on 17Mar2021 as dose 2, single (Lot number: ? 010 A21A), in left arm and on 23Oct2021 as dose 3 (booster), single (Lot number: 038C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergic rhinitis" (unspecified if ongoing); "Seasonal" (unspecified if ongoing); "Intolerances" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Aug2022) Positive; (Aug2022) Negative, notes: previously negative; (18Aug2022) Positive, notes: again positive today; (08Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that, Patient received Paxlovid for COVID-19 Treatment, start date 09Aug2022 and treatment stop date "06Aug2022".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and drug ineffective, Covid 19 cannot be completely excluded.
Pt experienced rash on right forearm and palpitations approx. 10 min post vaccination. Vital signs obtained at intervals 11:14 BP 146/78 HR 119 Sp02 100%, 11:19 BP 193/84 HR 108 Sp02 100%. Called at 1122 and arrived at 1124. Deep breathing and calming measures carried out. Vitals reassessed at 1125 BP 118/81 HR 120 Sp02 100%. Pt transported to ED at 1126. Recovery from reaction unknown at this time.
Patient had first dose of Pfizer vaccine for COVID 19. He had the COVID-19 infection 2 months prior. He was found to have fevers, chills, myalgias 12 hours following vaccine and then 24hrs after vaccine administration, developed chest pain and found to have a troponin elevation to 31 and EKG consistent with pericarditis. Found to have mildly reduced EF with mild global hypokinesis, suggesting viral myocarditis.
chills  the 2nd day 3rd day he had diarrhea low grade fever, chills. 4th day the same thing. 5th day he went to the ER- and had to have fluids for dehydration and last night he had diarrhea, and  weakness  and fever went to 102, today he is feels better but feels weak.
Left arm swollen at site "the size of a softball", tense, hot, red, tender. Called PCP Friday evening (3/28) who assessed for anaphylaxis. No respiratory or GI symptoms. 3 small nonpruritic blanching pinpoint erythematous lesions on ipsilateral trunk. Advised likely large local reaction, instructed parents to ice area, give Benadryl and ibuprofen until resolved and follow up if no improvement in 3 days or worsening at any point. Patient came in for reassessment Monday 3/31 and arm was still slightly swollen, hot, and tender but vastly improved as per patient and family.
recent COVID vaccination on 06/12, who presents for arm pain.  He had received his vaccination on 06/12 in the left arm, and states that the next day he noticed a lump in his axillary region, and significant pain.  acetaminophen (TYLENOL) tablet 975 mg (975 mg Oral Given 6/16/21 2052) ibuprofen (MOTRIN) tablet 800 mg (800 mg Oral Given 6/16/21 2053)
Found golf ball size lump in middle of sons throat.  Called PCP.  Told if he was ok and breathing to keep an eye on it.  Throat was so swollen by 5:30AM next morning we rushed to the ER.
Information has been received from a registered nurse concerning a female patient with no allergies, who on 06-MAR-2008 was vaccinated subcutaneously with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot # 655291/0985F). On 06-MAR-2008, the patient developed redness and warmth at the injection site and body chills. The patient sought unspecified medical attention. No diagnostic laboratory studies were performed. At the time of this report, the patient was recovering. No product complaint was involved. This is one of three reports from the same source. Additional information has been requested.
Arm was red; Arm swelling; Arm felt warm; A spontaneous report was received from a consumer concerning a 84-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm swelling, arm felt warm, and arm was red.  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 her 1st dose of mRNA-1273 (lot/batch: 029L20A) in the right arm for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced the events- Arm swelling, Arm felt warm, and Arm was red.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, swelling and Arm felt warm was considered  resolved. .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
accidentally gave an expired dose of Menatra to a 69 years old patient/No AE; accidentally gave an expired dose of Menatra to a 69 years old patient/No AE; Initial information received on 25-Nov-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 69 year old female patient who received expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment, vaccination and family history were not provided.   On 25-Nov-2019, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6002CA, expiry date- 24-SEP-2019 via unknown route in the unknown administration site.  It was a case of actual medication error due to inappropriate age at vaccine administration and expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Started with a little bit of light headedness on 6/14 and following day 6/15, woke up with serious vertigo. Minor vertigo still continues occasionally yet today 07/12/2021
Face was significantly red; Face had swelled more/ Face was significantly swollen; Hives were blotchy; Hives on face/Hive were red; Dry scalp; Eczema was inflamed; The general appearance of my skin was significantly dry for about a month.; The general appearance of my skin was significantly irritated for about a month.; This is a spontaneous report from a non-contactable consumer (Patient). A 44-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 12Mar2021 at 16:30 (at the age of 44-year-old) as a single dose for COVID-19 immunization. The patient medical history included asthma, eczema and allergy to some nuts, nickel, shellfish and environmental allergies. The patient previously took wool fat (LANOLIN) and experienced drug allergy. Concomitant medications included BCP (MANUFACTURER UNKNOWN), multi vitamins (MANUFACTURER UNKNOWN); both for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 19Feb2021 at 16:30 (at the age of 44-year-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021 (Friday) at 18:00, after leaving the clinic, the patient experienced hives on face. On 13Mar2021 (Saturday), the patient experienced that the hives were blotchy and red. The patient took diphenhydramine (BENADRYL), but it did not help. On 14Mar2021 (Sunday), the patient's face had swelled more and Benadryl still did not help. On 15Mar2021 (Monday), her face was significantly swollen and red mostly on the left side. On 16Mar2021 (Tuesday), the face was still significantly swollen. The virtual physician (MD) prescribed a high dose of prednisone. The patient's primary care physician said not to take the prednisone. The patient's allergist changed the prednisone to a low daily dose. It took about a week and a low dose of steroids to reduce the swelling. On an unknown date in Mar2021, the patient experienced eczema inflamed and the general appearance of skin was significantly dry and irritated for about a month and developed a very dry scalp which took about 6 weeks to treat. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken because of the events and included treatment with diphenhydramine (BENADRYL) and prednisone (MANUFACTURER UNKNOWN) 20 mg twice daily. The clinical outcome of the event eczema inflamed, dry scalp, skin was significantly dry and irritated was recovered on an unknown date in Apr2021; while that of hives on face, hives were blotchy and red, face had swelled and face was red were recovered on an unknown date in 2021.    No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. Deltoid was reported as anatomical Location The vial was initially stored in the refrigerator on 27May2022. The vial did not undergo any temperature excursions. Treatment medication was not provided by the reporter. This case was linked to MODERNATX, INC.-MOD-2022-600655 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-600655:Master Case