chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; Got his single shot four years ago / had the shingles for over a month now; Lot of pain head; Lot of pain ear; Lot of pain jaw; He's in pain all the time so much for the shot Doctor said it could last up to a year; This case was reported by a consumer via media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, headache, ear pain, jaw pain and pain. On an unknown date, the outcome of the vaccination failure, shingles, headache, ear pain, jaw pain and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, headache, ear pain, jaw pain and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's sibling.  The age at vaccination was not reported. The patient had got his single shot four years ago and he had been having the shingles for over a month then and he was in a lot of pain of head ,ear and jaw. The patient was very much in pain all the time. The patient's doctor stated that it could last up to a year. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and lab test confirmation was unknown at the time of reporting.  Note: This case was conservatively kept valid considering that four years could be exactly four years or approximately 4 years from the time of reporting until further clarification on follow-up.
a 2 month old received both Pentacel and Acthib, no AE; Initial information was received on 18-May-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 2 months old male patient who received first 0.5 ml doses of  both DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (suspension for injection, lot UJ016AAA) and HIB (PRP/T) VACCINE [ACT-HIB] (Powder and solvent for solution for injection, lot UJ077AAB) via intramuscular route in the left thigh as prophylactic vaccination on 14-May-2020.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to extra dose administered (justification: pentacel also has act-hib component in it).   No adverse event reported at the time of reporting.  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.
Severe abdominal pain, cramping, nausea, fatigue (I am not on my period and this pain/cramping felt nothing like period cramps).  This was the worst abdominal pain I've ever experienced in my life. It was worse than food poisoning. It felt like a stabbing pain.  I began feeling fatigued (which I had for both my Moderna COVID vaccines) 6 hours after getting the booster. I am still experiencing fatigue (it's been 48 hours).  The abdominal pain, cramping, and nausea began at 5pm on 1/12/2022 (26 hours after receiving the booster). The pain and cramping lasted for 8 hours. I am still experiencing nausea which has lasted 22 hours so far.  Nothing in my daily activities has changed. I've eaten the same foods I typically eat. This is not related to food poisoning (my fiance has eaten all of the same foods over the past 48  hours as me and he is completely fine.
no adverse event; incorrect product storage (temperature -8.66 C for 42 minutes); This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On 19-AUG-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, strength, route of administration and anatomical location were not provided) lot # T032315, expiry date: reported as 22-AUG-2022, however it was established as 22-SEP-2022, for prophylaxis. The vaccine underwent temperature excursion of -8.66 degree Celsius for 42 minutes. It was reported that there was also previous temperature excursion (-14.87 degree Celsius for 15 minutes). At the time of report, there was no adverse event (AE) reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA005929: US-009507513-2108USA005796:
Fever, large red fever in arm (covid arm), headache, eye infection (blood shot right eye), vision impaired for 1 day (felt like a filter was over my eye, felt like glass in my eye). Day 8 still have covid arm and red has turned brown and looks scarred. Low energy. Symptoms daily for 8 days.
Within 24 hours of receiving vaccine, client experienced severe diarrhea-watery yellow stools x5 and stomach cramping.
Fever over 100 for 3 days, aches, congestion, malaise, hoarsness for 2 weeks.
Patient contacted the Facility on 8/31/31 in the afternoon reporting that she received the 1st Moderna Vaccine on 8/30/21.  She woke up on the 31st and began experiencing arm soreness, chest pain, headache, weakness, temp of 103-104.  Nurse returned call promptly and spoke to patient but patient was educated that due to her complaint of chest pain she needed to either call 911 or go to the nearest E.R. 9/1/2021 Nurse contacted patient @ 0815 and phone went straight to voicemail. Patient returned call to Facility at 1:05 and patient once again informed nurse that she was having "weakness, soreness to both arms and across chest and unable to get up off of recliner". When asked, patient stated she did not go to the E.R. as was recommended because "I was too tired". Nurse re-enforced importance of going to the hospital to have her heart checked due to complaints of chest pain and tightness. Patient agreed to contact Dr. to let him know how she was feeling.
itchy, tingly lips.  Gave 50mg Benadryl IM. Monitored for 45 minutes.  Had driver.  Advised to F/u with PCP about elevated BP.
Information has been received from a LPN concerning a 5 year old male pt with no medical history, no illness at time of vaccination and no adverse events following prior vaccinations, who on 05/06/03 at 3:45PM was vaccinated with a second dose of MMRII (Lot # 644507/1038M) (Lot # also reported as not documented). It was initially reported that subsequently the pt developed a red rash, itching and a fever. Follow up information reported that on 05/07/03 the pt developed a "red rash with itching and bumps at injection site." Unspecified medical attention was sought. The pt was treated with comfort measures included anti itch medication and Tylenol.  There were no relevant diagnostic tests or lab data reported. It was reported that the pt was scheduled to be seen in the office on 05/09/03. Follow up information reported that the nurse stated that as of 05/14/03 the pt had not been seen in the office for follow up. The nurse reported that she assumed that the pt had recovered from the events, as she had not heard back from the parents. The nurse asked if this lot # has had similar adverse reactions reported. Further follow up information noted that the pt had recovered.  The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The nurse also reported that two other children had developed a red rash and itching (WAES @ 0305USA01205 & 0305USA01564).  No further information is available.
After receiving the vaccine there was a sharp pain running through my shoulder the next day it moved to the middle of my back and i were barely able to stand up,the next day it concentrated in my lower back and stomach cramp. and this stayed with me for over a week. I still feel some pain in the area of my right side where i received the injection.
Swelling and dilation of the breasts with inability to drain milk, after six months of uninterrupted breastfeeding.
Patient was immunocompromised and received a 1 shot of the primary series, 1st booster and a 2nd booster dose; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient was immunocompromised and received a 1 shot of the primary series, 1st booster and a 2nd booster dose) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient was immunocompromised and received a 1 shot of the primary series, 1st booster and a 2nd booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient was immunocompromised and received a 1 shot of the primary series, 1st booster and a 2nd booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant drug was reported.  Patient was confused because patient did not understand if due to her condition, patient should get another shot to be fully protected. Patient wanted to know whether patient could receive another shot of the vaccine after patient received 1 primary shot and 2 boosters.  It was unknown if patient experienced any symptoms or if any treatment was given.
Quickly spreading red raised itchy rash(everywhere except for the face). l woke up itching and could feel the rash spreading. I called the MD and was instructed to take Benadryl.  I took the Benadry and soaked in a tub with epsom salts for 45 min. When I was finished the spread had stopped and the itching subsided. Within 24hrs the rash was mostly gone. The physician declined to see me in the office. I HAVE PICTURES
Information has been received from an NP concerning a 7 year old child who was vaccinated with MMRII at the recommended age (approx. 1996). It was reported that "this past week, 2/11/02", the child was dx'd with mumps. Unspecified medical attention was sought. No further info was provided. Additional info has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported). The pharmacist stated that ZOSTAVAX looked clear in the syringe while the reconstituted product was being drawn up in the syringe. The reporter stated that it was administrated to the patient on unknown date, but did not reported if the patient endured any adverse reactions due to the vaccine's color in the syringe. The pharmacist inquired about the safety of this vaccine, which according to the prescribing information was supposed to look "semi-hazy to translucent" or "off-white to pale yellow liquid", Additional information has been requested.
Day 3 after vaccine:  dry cough, fever 100F, mild tightness in chest, shortness of breath, extreme malaise and weakness for 7 days.  Off work.  Saw MD who diagnosed bronchitis and gave Zithromax for 5 days.  She reports she was too weak to get CXR and went home and was weak and tired for a week.  No lab work, no EKG, back at work by 04/04 full recovery.  Denies palpitations or cardiac symptoms.
Swelling noticed in left axilla approximately 18 hrs post injection.  Swelling increased to the size of a softball and persisted from 1/8 noon through 1/10 at about 8 pm when I started to notice a decrease.  Ice was applied every 2 hours (while awake) for 2 days and ibuprofen was taken 800mg every 6 hours from 1/8am to present (1/12 pm).
tiredness; Soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 58-year-old female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 58 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergic to Sulfa drug" (unspecified if ongoing), notes: Allergic to Sulfa drug. Concomitant medication(s) included: ATORVASTATIN; LEVOTHYROXINE; CALCIUM WITH VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]; FIBER THERAPY. Past drug history included: Aspirin, reaction(s): "Aspirin: Drug allergy". Vaccination history included: Bnt162b2 (Dose 3, Batch/Lot number: FT8762, Location of injection/shot: Left arm, Route of administration: Intramuscular), administration date: Dec2021, when the patient was 58 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, Batch/Lot number: EP6955, Location of injection/shot: Left arm, Route of administration: Intramuscular), administration date: Apr2021, when the patient was 57 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, Batch/Lot number: EP6955, Location of injection/shot: Left arm, Route of administration: Intramuscular), administration date: Mar2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 11Apr2022 at 19:30, outcome "recovering", described as "Soreness at injection site"; FATIGUE (non-serious) with onset 12Apr2022 at 16:30, outcome "recovering", described as "tiredness". Therapeutic measures were taken as a result of vaccination site pain, fatigue.  Additional information:Adverse event information: Adverse event date: 11Apr2022.Adverse event time: 07:30 PM. The patient Treatment  received with ice applied at injection site and Tylenol.Prior to vaccination, the patient was not diagnosed with Covid-19.Since the vaccination, the patient has not been tested for covid-19.  No follow-up attempts are possible. No further information is expected.
pt received Bivalent Pfizer booster without having original series of covid vaccine by mistake. pt did not experience any ADRs and did not require treatment of any kind.
Fatigue, cold, sore throat and swollen tonsils, confusion, dizziness, gertie, vomiting, sinusitis, moodiness
Patient noticed he had shingles the day after the vaccine was administered. Went to the ER.
MENVEO vaccine given by CMA during a WCC visit, pt developed immediate redness and itching on vaccine site. RN and vaccine coordinator notified. He was given an ice pack within 5 min of reaction  and held it in place. VS checked and stable, Benadryl 25 mg PO given by verbal order 6-7 min after onset of reaction. 3 minutes after the Benadryl  his R upper arm redness and itching had resolved. Vital signs checked 13 minutes after medication administration and still stable. Pt denied diff breathing, swelling, nausea, dizziness, HA. He was cleared to leave the clinic.
Information has been received from a health professional concerning a 20 year old female who on an unspecified date was vaccinated with a dose of HPV Vaccine. Subsequently, the patient experienced three menstrual periods during the next month. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
4:15pm vaccines given.  ~2 min later, infant became abruptly hypotonic & almost unresponsive.  O2 sat 97-98%, color pink, BP 70/palp.  Eyes flickered open with vigorous physical stimulation, then returned to sleeping & limp.  At 440PM, suddenly returned to normal.  Went to ER via ambulance.  6/6/08 Reviewed hospital medical records for 5/19-5/20/2008. FINAL DX:hypotonic-hyporesponsive reaction to vaccinations. Records reveal patient experienced altered mental status & sudden onset increased hypotonia & unresponsive to stimuli lasting appro 4 min s/p vaccinations.  Then returned slowly to baseline.  Twin had no reaction.  Patient had local erythema w/prior vaccinations.  Transported by ambulance from PCP office & admitted for overnight observation.  No further episodes while hospitalized & d/c to home.
Altered mental status. Did start a little prior to vaccine but significantly worsened post-vaccination.
Pt recvd vax 19FEB92 & began shaking, bluish purple color, glazed staring eyes, hard time breathing; lasted 5 or 6 mins; Mom took pt to ER; t103; fluid level lt ear & cold noted by ER MD; APAP & observation;
Patient received vaccines (MMR, Varicella, and ACT Hib) on 9-23-08. Patient reported to emergency room on 10-02-08 with rash, intermittent fever and eyelid swelling.
Swell, developed hard lump at injection site; Redness, hot, like allergic reaction; Redness, hot, like allergic reaction; Redness, hot, like allergic reaction; Uncomfortable when clothes would touch injection site; Slight bruise; This is a spontaneous report from a contactable Physician via Pfizer sales representative.   A 62-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot # X93809) via an unspecified route of administration at single dose on 02May2019 for immunisation.   Medical history included diabetes, hypertension, high cholesterol. The patient's concomitant medications were not reported.  The patient experienced swell, developed hard lump at injection site on an unspecified date with outcome of unknown, redness, hot, like allergic reaction on an unspecified date with outcome of unknown,  uncomfortable when clothes would touch injection site on an unspecified date with outcome of unknown, slight bruise on an unspecified date with outcome of recovering.    On 02May2019 at night started to swell, she developed hard lump at injection site, redness, hot, like allergic reaction. The lump was about the size of silver dollar for about 3 days, then it started to decrease in size. Tender to the touch. Uncomfortable when clothes would touch injection site. On 14May2019, still slight bruise, almost gone, with smaller than a dime-size lump. The outcome of still slight bruise was recovering, of all events was unknown.
vaccine was expired, no temperature excursion occurred and moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of admission".  Patient reported no adverse reactions.
Information has been received from a consumer regarding a "4 to 6 year old" child who may have been vaccinated with a dose of varicella virus vaccine live. The reporter indicated that a child at the day care center where his children go had developed chickenpox over the past two to three weeks. The reporter believed that the child may have been previously vaccinated. It was unknown if medical attention was sought. A product quality complaint was not involved.  The consumer also reported up to nine other children at the day care center that had similar reactions after being vaccinated with a dose of varicella virus vaccine live (WAES # 0306USA01223, WAES # 0306USA01369, WAES # 0306USA01383, WAES # 0306USA01535 AND WAES # 0306USA01834).  He also indicated that the cases were mild, however he didn't know that two of the cases were not mild. Additional information has been requested.
pt's leg became very red & swollen; swelling was noted down leg to & including the foot; inc temp of 103 & very fussy;
Patient came into the office for one year old immunizations. Patient was given a PROQUAD immunization instead of a MMR immunization due to the fact that the package of the MMR and PROQUAD looks similar.
Symptoms started at 10:30 PM on 01/04/2021, complains of headache, body aches, temp 100.4, congestion, fatigue. Took Tylenol for fever.
Congested tight feeling in upper throat after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Congested tight feeling in upper throat after 1st dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044a21a) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, LISINOPRIL, CARVEDILOL, PANTOPRAZOLE, ATORVASTATIN and MONTELUKAST for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced THROAT TIGHTNESS (Congested tight feeling in upper throat after 1st dose). At the time of the report, THROAT TIGHTNESS (Congested tight feeling in upper throat after 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment Information was reported.
This spontaneous report as received from a immunization worker. The reporter stated that a facility vaccinated clients with improperly stored VARIVAX (Merck) (Lot# 1878AA Exp 20-NOV-2013, Lot# 0359AE Exp 15-FEB-2014) within the last 3 months (route unspecified). Unknown how many clients were vaccinated with the improperly stored VARIVAX (Merck). No adverse events reported at this time. It was unspecified if patients sought medical attention. The outcome of patients was unspecified. Additional information has been requested.
Later same night 1/8//21 my arm was red swollen with hard lump at injection site.  Not sure if injection might have been given subcutaneous instead of intramuscular.  The redness and swelling has increased each day.  Have been marking borders abs each morning the redness has expanded and is bigger. It does not hurt or itch.  The lump is not as hard but can still feel hard area surrounding injection site.   clinic called in antibiotics  to treat cellulitis.
Patient received 0.5mL of the Moderna Bivalent covid vaccine instead of 0.5mL of the Moderna covid vaccine (primary series)
devel t105, lethargy & dec appetite;had been on Amoxicillin for prv wk so d/t concern aobut miningitis, LP done (neg) & pt's temp resolved
I had usual symptoms, fever, headache, nausea. Then I felt like i was going to be sick (vomit) arouns 3 a.m.  When i tried to stand, i had no feeling in my legs and I went down. Ended up breaking my right wrist. My husband was up too. He said I turned pale befoe I went down.
This spontaneous report was received from a healthcare worker concerning multiple unspecified patients (demographics unknown). On unspecified dates, the patients were administered with doses of improperly stored VARIVAX (Merck) (Lot # K003420; expiration date: 06-MAR-2016) (dose and route not provided). No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.