chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial case report received from a nurse via Novartis Pharma on 30 OCT 2009. A 45-year-old patient was vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. 97848P1A) i.m., on 28 OCT 2009. The patient experienced metallic taste in mouth after receiving S-OIV FLUVIRIN. The patient had not recovered from metallic taste in mouth. MedCom reference no.: NA09-007253. This case was previously entered as MA2009-3785. Follow up information received from the nurse on 05 Mar 2010: This patient with medical history of MOTRIN 400 mg was vaccinated with FLUVIRIN on Oct 2009. It was reported that approximately 30 minutes after the FLUVIRIN administration patient had experienced metallic taste in mouth which was lasted for three to four hours and it did not return. The patient stated that he had taken water prior to vaccination. The outcome of the event was reported as complete recovery on an unspecified date.
Information has been received from a registered nurse concerning a 15 year old female who on approximately 30-JUL-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included "other vaccines" (therapy unspecified). On approximately 30-JUL-2008, the patient fainted and her blood pressure drop after vaccination with GARDASIL and other vaccines gave at the same time. The patient sought medical attention. On an unspecified date the patient recovered. This is one of two reports from the same source. Additional information has been requested. The doctor was going to call an ambulance for one of the girls (unspecified).
Information regarding Prevnar vaccine was received from a healthcare professional regarding a 2 month old female patient who experienced injection site bleeding. At 2 months of age, the patient received a dose on 27 Jun 2006. The patient also received a dose of Comvax and a dose of Polio (manufacturer unknown) on 27 Jun 2006. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 27 Jun 2006. Dose regimen was 1 dose 1 time per day (intramuscular).  Concomitant therapy included Polio Inactivated, Comvax and none. Event Details: It was reported that after Prevnar administration there was blood on the syringe and the patient experienced injection site bleeding (injection site hemorrhage). The reporter noted that the nurse may have nicked a vein during administration (wrong technique in drug usage process). Additional information has been requested.
Severe shaking, nausea, chilling, fever, weakness, shortness of breath, headache.  Most symptoms ended at approx. 7:30 PM, but still some weakness. Totally OK next day.
BACKACHE; HEADACHE; FEVER; CHILLS; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of event reporting and the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced backache. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from backache, headache, fever, and chills. This report was non-serious.
This spontaneous report was received from a female patient of unknown age regarding herself. There was no pertinent medical history. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23, (lot number, expiry date and route was unknown). On an unknown date, the patient was vaccinated with a dose of influenza virus vaccine (manufacturer unknown). Concomitant therapies included allergenic injections (allergenic extract). On an unknown date, a few hours after vaccination the patient experienced injection site redness and a hot, red, raised area and pain in joints above and below the injection site. The patient took over the counter ADVIL and the symptoms dissipated. The patient also experienced mild injection site symptoms after receiving a dose of influenza virus vaccine(manufacturer unknown). There was no lab tests performed. At the time of the report the patient recovered from all the reported events. The patient did not seek medical attention. Additional information has been requested.
It was reportedd that a 77 year old female patient received a Fluzone SV vaccination on 11/29/2000. Within 30 minutes after the injection the patient developed tingling in and around her mouth, no respiratory distress and increased anxiety. The patient was transferred by rescue squad to the ER, treated and released to the family physician.
Swelling of injection site and fever in the same area saucer sized.  The biceps of my arm was twice the normal size. On 03/19/2016 went to doctor on advice of Pharmacist.  Arm was swollen twice the size from shoulder to elbow and red and feeling very hot to touch.  Dr. diagnosis was cellulitis of right upper arm.  Prescribed clindamycin HCI 300 mg capsule one tab 4 x daily for 10 days.
Initial and follow-up information has been received from a physician concerning a 16 year old white, 119 pound, 65 inch, female with pertinent medical history reported as none, with no illness at time of vaccination, except complaints of hunger, who on 03-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 660389/1968U), 0.5 ml. It was reported that immediately when the needle was withdrawn the patient passed out. She was caught by the physician,  her feet were elevated, cool compresses were applied, and smelling salts were used. The event lasted 15-30 seconds. After a "T & R" popsicle she was observed for 20 minutes and had no further sequelae. The patient was reported as recovered on 03-JUL-2008. This is one of two patients from the same source. No additional information is expected.
took one tablet of benadryl over-night. Rashes seems to get smaller and no longer itchy
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-Severe, Additional Details: Patient had seizure after receiving first dose of moderna vaccine while waiting in the seating area.
Revaccinated next day; gave patient expired dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave patient expired dose of vaccine) and EXTRA DOSE ADMINISTERED (Revaccinated next day) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 007D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jun-2021 at 4:08 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021 at 3:31 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave patient expired dose of vaccine). On 23-Jul-2021, the patient experienced EXTRA DOSE ADMINISTERED (Revaccinated next day). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (gave patient expired dose of vaccine) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (Revaccinated next day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information  was not provided by the reporter. Treatment information  was not provided. Patient was revaccinated on 23 Jul 2021   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received contains patient race, ethnicity and patient was revaccinated
a lot of pain in  arm; Patient having high fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a lot of pain in  arm) and PYREXIA (Patient having high fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a lot of pain in  arm) and PYREXIA (Patient having high fever). At the time of the report, PAIN IN EXTREMITY (a lot of pain in  arm) and PYREXIA (Patient having high fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 22th of 190 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
Case number PHEH2014US024160 is an initial spontaneous report received from a health care professional on 01 Dec 2014. This report refers to an 11 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A13046) intramuscularly at a dose of 0.5 ml on 20 Oct 2014 . It was reported that the vaccine reached 0 to 1 degree C sporadically for 3 days when it was not reconstituted and was subsequently administered to the patient. The reporter stated that the vaccine did not freeze and it was the first occurrence. No adverse events were reported following the maladministration.
received Shingrix Subcutaneously; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX 23).   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, the patient received Shingrix vaccine subcutaneously, which led to intramuscular formulation administered by other route .  The patient also received Pneumovax 23 vaccine intramuscularly on the same arm. No adverse event was reported .  No patient's identifiers were provided. No lot number and expiration date provided, no vaccination date provided, no information in which arm the vaccines was provided. The reporter consented to follow up.
On day 1 I woke up in the morning with all the typical symptoms of the vaccine. However, I noticed a burn like rash developed on only the arm where I received the vaccine. It would flare up from time to time and lasted about a week. Before reaching out to the clinic and providers, I was taking Benadryl nightly. I then used a steroid cream, which eventually helped resolve the issue. The rash was not like normal. It was not a red hive. It was a white cluster of hives that looked like blisters.
Worst Headache of my life! New onset high blood pressure and increase in uncontrolled migraines
Injection site reaction. Redness, swelling, warm, slight pain. Pt received prescription for KEFLEX 500 qid x 10 days to start if symptoms don't resolve in 48 hrs.
Redness, swelling, and pain. Also, lymphadenopathy, headache, body ache, and dizziness.
Patient received pfizer vaccine on 12/30/20 and 1/20/2021. Presented to hospital on 6/3/22 for pre-labor. COVID positive on 6/3/22 at 38.5 weeks gestation. On 6/6/22 delivered the baby.  Pt does note normal fetal movement. She denies LOF or VB. Pregnancy has not been complicated with hypertension. Pregnancy has not been complicated with diabetes. G5P3013,
pt asked for and received gardasil 9 vaccine which is not recommended for 48 year old
chills; fever; headache; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient wife) reported a male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route single dose for COVID-19 immunisation on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had reaction of chills, fever and headache after his first vaccine. Outcome of the events was unknown. ~ Information on the lot/batch number has been requested.
Mom called today stating child has a "big" rash on RAT, some redness, no fever by mouth, ? feels hot to touch, child is eating drinking OK.  Appears to be fine other than mom's concern of rash on RAT.  Advised take child to her doctor.
Throat swelled a noticeable amount and became slightly sore; no difficulty breathing or swallowing. It began within 10 minutes of the injection and resolved about 90 minutes later. Nothing similar occurred after the second injection.
Injection site reaction with erythema, swelling, pruritus, and warmth for 1 day on left deltoid area.  Pt has reported allergy to Benadryl.  Treated with 20mg Claritin and Ranitidine and Triamcinolone cream.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. The nurse reported that (Oka/Merck) VARIVAX underwent a temperature excursions on 31-JUL-2014, stability was supported. An unspecified number of patients received doses of these vaccines on unspecified dates after 31-JUL-2014 (in August 2014) (dose, frequency, route and lot # unknown). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Post first vax, no untoward effects. Post second vax, and sometime thereafter, he experienced acute pain at the injection site. He also experienced involuntary muscle twitching at the injection site in his upper left arm and shoulder. His neurologist characterized these as myoclonic nature although he had not been witness to or been able to elicit such contractions. The involuntary muscle twitching has lasted for almost one year and has awakened the patient at night. Pt declined any drug intervention.
H Zoster outbreak L Gluteus 24 hours after administration. This is in follow-up to report (s) previously submitted on 10/2/2006; 10/5/2006. Information has been received from a physician concerning a male patient who on 08-SEP-2006 was vaccinated with a dose of varicella-zoster virus vaccine live (Oka/Merck). On 09-SEP-2006, the patient was hospitalized with a rash. The patient was diagnosed with a zoster infection. No outcome was reported. No product quality complaint was involved. Additional information has been received from a physician on 09-0CT-2006. He reported that the patient was an 84-year-old male with Early Senile Dementia, steroid dependent chronic obstuctive pulmonary disease (COPD), coronary artery disease (CAD), hypertension (HTN), hyperlipidemia and osteoporosis/osteoarthritis, who on 08-SEP-2006 was vaccinated in the left upper extremity with a dose of varicella-zoster virus vaccine live (Oka/Merck) (lot# 652925/0621F). Concomitant therapy included: predisone 5mg daily, potassium supplements, digoxin, antibiotics prn, simvastatin (MSD), tiotropium bromide (SPIRIVA), clopidogrel bisulfate (PLAVIX), furosemide (LASIX), formoterol fumarate (FORADIL), aspirin (CARTIA), donepesil hydrochloride (ARICEPT) and ramipril (ALTACE). On 09-SEP-2006 the patient was seen in the emergency room and diagnosed with Herpes Zoster; however, the patient was not admitted (as previously reported). The physician reported that the patient was in a lot of pain and was treated with hydrocodone which made dementia worse. The patient was treated with valacyclovir hydrochloride (VALTREX). 1gm, TID for 7 days, for herpes zoster. The physician saw the patient a few days alter and hisrash looked like a "typical zoster rash". The rash was only on his left buttock. The physician felt that the patient's experiences were serious. He was concerned about the patient and believed that his medical condition was "extremely brittle" due to his COPD. The physician reported that the patient recovered on an unspecified date. The physician considered the herpes zoster to be an other important medical event. Additional information is expected.
Recombivax HB administered into right deltoid on 12/08/2003.  Patient stated had pain in arm from 12/08/2003 through 01/05/2004.  Pain was described as being mild; patient took ibuprofen (dosage unknown). Denied fever, headache, redness at injection site.
The d day after the vaccine I started having tremors in my head and then within the next couple weeks I was talking like I had MS and was unable to work severe anxiety after my second shot my daughter finally figured out that I was not able to take my thyroid pill so I came off of that and 6 days later I was much better but then everything I started to relapse again after 3 or 4 months again having the same speech problems and vagus nerve I think my vagus nerve is being pinched off that is why I originally had the discectomy, my body is rejecting the disc so I think the vaccine was just immune response but I'm going into 2 years of this and I am not able to work now I've lost 30 40 lb and I'm homeless and it's getting scarier and scarier and still not able to take any thyroid medicine until I'm almost in a coma and then it gives me too much energy and anxiety and the voice starts going again and the shaking in my head happens.
Pt stated that she had extreme difficulty breathing and chest pain the next day after her shot.  She stated that she stayed in bed all day.  Today is 10-12-21 and is complaining of continuous chest pain.  Suggesting that she sees her PCP>
This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with first dose of ROTATEQ route of administration reported as oral, dosage schedule was not reported). The physician stated that the patient received three other concomitant unspecified vaccines (unspecified names, doses/frequencies and manufacturers) on the same unspecified date. The physician also stated that she was unsure if the patient will receive any subsequent doses of oral, ROTATEQ. On an unknown date the patient experienced projectile vomiting and was extremely ill. Patient sought medical attention (office visit on an unspecified date). The outcome of projectile vomiting and was extremely ill was reported as recovered/resolved on unknown date. Relatedness between events and vaccination with oral, ROTATEQ was not reported. Additional information has been requested.
Nausea at the first 30mint after the vaccine, chills and body aches next day in the morning, but the afternoon can?t walk or move my arm. The evening I have lower fever 99.8 I took ibuprofen.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent condition and concomitant medication was not reported. On 18-MAR-2019 the patient was inadvertently vaccinated with an expired VARIVAX lot # N008828, expiration date 16-MAR-2019, for prophylaxis (strength, dose and route of administration were not provided). No adverse event reported.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. It was reported that the patient was inoculated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) vaccine on or about 01-JUL-2014 at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster and nerve damage. On or about 12-APR-2017, the patient was treated by a physician for a vesicular outbreak that had caused unbearable and persistent residual pain. The patient was diagnosed with post herpetic neuropathy, which the physician noted is a chronic and painful nervous system impediment that would be a lifelong condition.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result. the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Patient reports arm soreness in the left arm and reports not being able to raise her arm. She reports being in great discomfort. Report to adverse/med reporting line for pharmacy.
Adverse events: Hypotension, Lactic acidosis, Leukocytosis, Elevated LFTs Symptoms:  Weakness, nausea  Treatment: Vancomycin, Zosyn, Pressors
A legal complaint was received from an attorney alleging that a male child received a four dose series of HBOC (haemophilus B conjugate vaccine) and DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed) vaccines between 5/8/91 and 8/6/92. It is alleged that "as a result of the mercury in the thimerosal-containing vaccinations," the child "suffers, and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning."