chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described an adult female subject who did not respond to immunization to hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. On an unspecified date before 03 October 2006, the subject received 3rd dose of Engerix-B. On 03 October 2006, at an unspecified time after vaccination with Engerix-B, a  hepatitis B surface antibody titer was negative. Relevant test results included (laboratory results/hospital investigations). At the time of reporting the outcome of the event was unspecified.
Dizziness, weakness, sweating yet clammy, loss of color in face,  nausea, diarhhea, trouble focusing eyes, trouble standing and walking without assistance
The patient states that symptom onset started at 8 AM.  She awoke at 5 AM and felt fine.  She complains of bilateral weakness in the distal upper extremities and in her bilateral grip. She states that she has never had this weakness, which is worse on the left than on the right.   MRI C-spine showed an Abnormal cord signal from C3/C4 to C6/C7 involves both halves of the spinal cord with a predilection for the central gray matter. No pathologic enhancement. Findings may represent cord infarct although longitudinally extensive demyelinating disease (NMO or ADEM) or transverse myelitis are not excluded.  CSF done - CSF studies reviewed clear less fluid white count 3 RBC 28 glucose 92 with protein 31.4 CSF bio fire negative oligoclonal bands in the CSF are pending serum RPR negative B12 647 folate 6.6 HIV negative  The patient was treated with IV methyl-prednisone then oral prednisone. She had improvement in her weakness
This case was reported by a consumer (the company owner) and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site redness. At the time of reporting the outcome of the event was unspecified. The consumer reported that 5 employees at one company and one employee at another company all reported extreme redness at the injection site after receiving FLULAVAL. This is case 3 of 6 (see case IDs A0952647A, A0952653A, A0952655A-A0952657A for details of the other reports).
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 27-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012479, expiration date: 10-APR-2017) (Incorrect product storage). No adverse effects reported. This is one of several report from the same reporter. Additional information has been requested.
pain between his thumb and pointer finger; pain in elbow/pain in shoulders; left hand is swollen; missed his second dose of vaccine; pain in left hand; This spontaneous case was reported by an other caregiver and describes the occurrence of PAIN IN EXTREMITY (pain in left hand), PAIN IN EXTREMITY (pain between his thumb and pointer finger), ARTHRALGIA (pain in elbow/pain in shoulders), PERIPHERAL SWELLING (left hand is swollen) and PRODUCT DOSE OMISSION ISSUE (missed his second dose of vaccine) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in left hand). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain between his thumb and pointer finger), ARTHRALGIA (pain in elbow/pain in shoulders), PERIPHERAL SWELLING (left hand is swollen) and PRODUCT DOSE OMISSION ISSUE (missed his second dose of vaccine). At the time of the report, PAIN IN EXTREMITY (pain in left hand), PAIN IN EXTREMITY (pain between his thumb and pointer finger), ARTHRALGIA (pain in elbow/pain in shoulders), PERIPHERAL SWELLING (left hand is swollen) and PRODUCT DOSE OMISSION ISSUE (missed his second dose of vaccine) outcome was unknown. 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 product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: non significant follow up case has no new information
Patient received vaccine, was in waiting area, and about 3 minutes later felt light headed and slid out of the chair onto the floor. Ice was placed on her head, she was breathing, and had a pulse. CPR was not necessary. She was laying on the ground for approximately 10 minutes. She opened her eyes at one point, and then her eyes rolled in the back of her head again. Blood pressure was normal at 119/78.  Ambulance came and took her to the hospital.
Numbness to mouth and bilateral legs, dizziness, crushing headache, generalized body pain
Localized reaction at injection site. Warm to touch, reddened, slight swelling. Advised to use cool compresses, OTC analgesics and rest.
Pt recvd 1st dose of Engerix-B 12FEB92 & 1 wk p/1st dose pt exp muscle ache in lt wrist, radiated to whole lt arm & then rt arm;
Information has been received from a health professional concerning a 58 year old Caucasian male patient with penicillin allergy who on 12-NOV-2007 was vaccinated with the first dose of ZOSTAVAX, subcutaneously in left arm, 0.65 ml (lot number "10874").  There was no concomitant medication.  On 15-NOV-2007 the patient experienced nausea, stomach cramps, diarrhea and the onset of a migraine.  The patient's nausea and stomach cramps and diarrhea and onset of migraine persisted.  It was reported that the patient did not seek medical attention.  There was no product quality complaint.  Additional information has been requested.  Follow up information has been received from a physician concerning a 58 year old male patient with a penicillin allergy who on 12-NOV-2007 was vaccinated with the first dose of ZOSTAVAX, SQ, left arm, 0.65 ml (lot number "10874").  On 18-NOV-2007, the patient experienced acute amount of nausea, vomiting, headache, and diarrhea following ZOSTAVAX.  He was treated with phenergan 25 mg IM x 1 dose, an unspecified therapy prn, and bismuth subsalicylate (PEPTO-BISMOL) prn.  It was reported that the patient's symptoms gradually resolved after 2 weeks on approximately 02-DEC-2007.  No further information is available.
Got mine, but still caught the flu; Initial information received on 28-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient with who still caught the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient still caught the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got mine, but still caught the flu).  At time of reporting, the outcome was Unknown for the event got mine, but still caught the flu.
Employee received influenza vaccination in the dept she was assigned.  She stated that "within approx. one hour" she felt a sudden onset of "heart racing" and "blurred & double vision".Her co-workers put her in a wheelchair, took her BP (152/98) and took her to the ER.  She was admitted & treated for allergic reaction to flu vaccination. Treatment: chest xray = normal; EKG = normal sinus rhythm.  Medications given to her were: Decadron 10mg IM; Benadryl 25mg PO x 1; Zantac 150mg PO x1; Ativan 1 mg PO x1. She was discharged @ approx. 4:30PM with prescriptions for Prednisone 20mg (to take 3 /day x 5 days); Xanax 0.25 mg (1 -2 q 8hrs for anxiety); & Bendaryl OTC.
Blisters on erythematous base on upper lip and chin which popped and scabbed over.
Information has been received from a physician concerning a 66 year old female patient who on 19-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 669589/1453Z, expiration not reported). Physician reported that on 05-MAY-2011 after vaccination with ZOSTAVAX (Merck) the patient developed shingles. It was unspecified if the patient sought medical attention. At the time of reporting the patient had not recovered. Follow-up information has been received from a physician via a complete Herpes Zoster Questionnaire concerning the female patient with glaucoma, hyperlipidaemia, hypertension, hypothyroidism, tobacco user, osteopenia with no illness at time of vaccination with unknown history of chickenpox and with no recent exposure to chickenpox or Herpes Zoster, who on 19-JAN-2011 was vaccinated with a first dose of ZOSTAVAX (Merck) (Lot # 669589/1453Z), left deltoid. It was reported that no rash occurred at the site of injection or elsewhere within 42 days of the vaccination. On 05-MAY-2011 the patient developed shingles (severe outbreak) distributed in V1 branch of trigeminal nerve with a maximum temperature of 97.6. The patient systemic symptoms included pain in a grade of 9 (scale 0 to 10), ocular irritation. No direct fluorescent antibody test and PCR test were done. There were no relevant diagnostics test and laboratory data. In July 2011, the patient recovered from shingles (severe outbreak) which was also reported by the physician that the patient still had same residual discomfort in dermatomal distribution and pain, (conflicting information). Shingles (severe outbreak) was considered to be disabling by the physician. Additional information has been requested.
Began dragging left foot/loss of muscle tone - pronated arms and feet - extreme mood changes - sudden pneumonia - refractory seizures - vitamin D depleted - speech changed - core weakness - slower processing - somnolence - hyper metabolic temporal lobes - clumsiness/constant falling - loss of balance.
Information regarding FluMist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a 45-year-old female who did not receive FluMist vaccine but experience subsequent accidental exposure and development of and adverse event on 28-Dec-2003. Medical History: None reported. Product Details: Indication, dose and dates of FluMist (2003-2004 Formula) therapy were not provided. The reported did not receive Flu Mist. Concomitant Therapy: Reporter was not taking concomitant therapy. Event Details: A 45-year old female reported that she developed a sore throat (pharyngolaryngeal pain) and nasal congestion (nasal congestion) on 28-Dec-2003, after six hour visit with a person who had received FluMist on an unspecified dated (accidental exposure). The reporter indicated that the FluMist recipient, "did not seem to be sick." and stated, "your product made me sick." Manufacturer's comment: The reporter declined to provide information necessary for follow-up. No additional information was available at the time of this report.
swelling in arm; Diarrhoea; hot to the touch / hot; big red spot on arm; Itchy; Nausea; whole body aches / arm sore to the touch; chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in arm), DIARRHOEA (Diarrhoea), FEELING HOT (hot to the touch / hot), ERYTHEMA (big red spot on arm) and PRURITUS (Itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Asthma and Heart disorder.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling in arm), DIARRHOEA (Diarrhoea), FEELING HOT (hot to the touch / hot), ERYTHEMA (big red spot on arm), PRURITUS (Itchy), NAUSEA (Nausea), MYALGIA (whole body aches / arm sore to the touch) and CHILLS (chills). At the time of the report, PERIPHERAL SWELLING (swelling in arm), DIARRHOEA (Diarrhoea), FEELING HOT (hot to the touch / hot), ERYTHEMA (big red spot on arm), PRURITUS (Itchy), NAUSEA (Nausea), MYALGIA (whole body aches / arm sore to the touch) and CHILLS (chills) outcome was unknown.            No concomitant medications reported by investigator.  No treatment medications provided by the reporter.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA278726, 2018SA278737 and 2018SA278731 (same reporter). This case involves a 12 years old male patient who was vaccinated with a dose of IPV (VERO) (lot P1A171M and expiration date 20-APR-2024) via unknown route in the left deltoid on 25-Sep-2018 which was stored incorrectly. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. It was reported that vaccine was exposed to temp. Elevated for 3 days to 46.6 F & 48 F. No information reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
was very nervous about taking the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of ANXIETY (was very nervous about taking the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.  Concomitant products included ESTRADIOL (ESTROGEN), METOPROLOL SUCCINATE (TOPROL XL), ACETYLSALICYLIC ACID (BABY ASPIRIN), CELECOXIB (CELEBREX) and MONTELUKAST for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received 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 ANXIETY (was very nervous about taking the vaccine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ANXIETY (was very nervous about taking the vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient got dose 1 and 2, still don not know if vaccine worked for him. Patient stated that he would not recommend to any patient to took the vaccine or not.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-230245 (Patient Link).
Information has been received from a literature article, which was based on data from the VASP concerning a five year with a history of asthma who received one dose of Varivax (Oka/Merck) and developed a rash.  The time intervals between the vaccination and rash onset for the child who had experienced varicella related hospitalizations (VRH) and who had received 1 dose of varicella vaccine >42 days before rash onset was 271, 280, 291, and 1445 days.  The child was admitted to an intensive care unit (ICU) for 1 day for meningitis and was discharged with a diagnosis of altered mental status/post varicella syndrome.  Six weeks after hospital discharge, the child's mental status had returned to normal.  In the opinion of the author, the data demonstrated the sizeable and continuing reduction in severe varicella-related morbidity with the use of the varicella vaccine since 1995.  It was also noted that the data highlighted the fact that the majority of hospitalizations that occurred during this time period were preventable through implementation of existing vaccination-policy recommendations.  The author noted that varicella incidence and varicella-related hospitalizations (VRHs) and deaths have decreased substantially since the implementation of the varicella vaccination program.  A copy of this published article is attached as further documentation of the patient's experience.
pt started having sz-like movements;BP 160/100,tachycardia;taken to ER by EMT;on exam had diffuse wheezing & devel a rash;pt is diabetic & it was first thought pt was hypoglycemic,but blood sugar WNL;tx Solumedrol & DPH
Adverse event(s):  Hives/red swollen skin(arms, legs, abdomen, back), fever, swelling of lips, fast heartbeat, high blood pressure, dizziness, weakness, headache  Treatment: Prescribed Medrol (Pak) 4mg tablets, OTC antihistamine Zyrtec daily x 2 weeks, Benadryl at night  Outcome: N/A. side effects have been reduced, occasional flare of hives.
Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and no treatment medications were reported.  About 2 weeks later, 06-Dec-2021, tested positive for COVID. Patient was asking about when could get the 2nd dose now or does have to start over.  Company comment: This spontaneous case concerns a 56-year-old male patient with no medical history reported, who experienced the unexpected non serious event AESI of COVID-19, approximately 12 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 56-year-old male patient with no medical history reported, who experienced the unexpected non serious event AESI of COVID-19, approximately 12 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Next day woke up with severe dizziness. Entire room spinning violently, like body was on full tilt had to hold on to wall, furniture to walk. The rest of the day felt mildly dizzy but felt better by end of day. Every morning experiencing similar symptoms start really dizzy and gets better. Feel fatigue and heavy feeling like if weighed 100 more pounds. Pt is not allergic to thimerosal but prefers not to receive it. Doctor refused to give him thimerosal free vaccine saying it is reserved for children and pregnant women.
Patient stated about five minutes after vaccine that her throat was itchy and tight. Gave patient 50 mg of diphenhydramine. About 5 minutes later, patient stated she was feeling better and left pharmacy.
This case was reported by a pharmacist via call center representative and described the occurrence of syncope in a 53-year-old male patient who received (Reduced antigen) BOOSTRIX (batch number AH4LF, expiry date 8th July 2018). Concurrent medical conditions included fasting. On 3rd August 2016, the patient received BOOSTRIX. In August 2016 several hours after receiving BOOSTRIX, the patient experienced syncope, dehydration and low blood pressure. On an unknown date, the outcome of the syncope, dehydration and low blood pressure were unknown. It was unknown if the reporter considered the syncope, dehydration and low blood pressure to be related to BOOSTIX. Additional details were provided as follows: The pharmacist stated that the patient received a dose of BOOSTRIX and was fine when she administered the vaccine and observed him after. Then the patient went home and did 3 hours of yard work in the hot heat. He said he fainted when he was doing yard work also had been fasting and was dehydrated. He dto go to the emergency room because of the fainting, where they stated he had low blood pressure. No further information was provided.
Case number PHEH2014US02496*, is an initial spontaneous report from a nurse received on 09 DEC 2014. This report refers to a 31 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 20 NOV 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.
Shock, metabolic alkalosis, high fever & diarrhea are reported p/recvd flu vax 21NOV91; pt has had cryptococcal meningitis & is HIV positive; Seen in ER t106.7F in shock &  diarrhea admitted to hosp & found to be oliguric;
Pt presented with rash and soreness at the site of injection.  Pt decided to go to PCP.  PCP decided that the pt received an abscess and infection from the immunization.  PCP prescribed an antibiotic for the pt.
Starting within 24 hours of the shots body aches and flu like symptoms aches, and sick in bed for 7 days. No vomiting or diarrhea; recovered on his own.
12/06/21 presents to ED for "SOB x 3 weeks". PMHx of "asthma, HTN, dyslipidemia., DM, breast cancer"
Information has been received from a registered nurse concerning a female patient who was vaccinated with a dose of PNEUMOVAX (lot number not provided).  Subsequently the patient experienced severe local injection site reaction and the swelling was measurable.  The patient sought medical attention via telephone call.  Additional information has been requested.
Severe arrhythmia lasting several hours.  Increase in heart rate to over 150 beats per minute.
The patient MAY have received a dose of Janssen vaccine that was administered after the Beyond Use Date.  The provider may have given the dose outside of the 6 hour window after the vial was opened.  No symptoms or signs.  Pt will be contacted and offered to be re-vaccinated to offer full protection, per our MedicalGroup.