chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines given 10/30/ 48 hours S/P vaccines developed myalgias and difficulty walking - admitted to hospital 11/1, observed - no improvement and amb. 11/6 received w/ RN yet making polyneuropathy c/w dx of Guillain-Barre syndrome. Pt received gammaglobulin x 5d and pt dc'd to rehab (11/13) and later discharged home 11/19 w/ neurologist. 1/2/08-records received for DOS 11/1-11/13/07-DC DX: Guillain-Barre syndrome. C/O weakness, not feeling well, tremors for 2 days prior to admission. Progressively getting worse. Unable to walk at time of admission. Lightheadedness and nausea. Tingling in legs. PE: DTRs present but decreased on right. Macules on abdomen. Treated with IVIG.  This is in follow-up to report(s) previously submitted on 12/14/2007. Initial and follow up information has been received from a physician, concerning a 16 year old (previously reported as 15 year old) female student with no known drug allergies or birth anomalies, who on 30-OCT-2007 was vaccinated with a dose (invalid dose # reported) of GARDASIL (lot # 659437/1266U). There was no illness at the time of vaccination. The physician reported that 48 hours after the vaccination, the patient presented with "symptoms similar to GUILLAIN BARRE syndrome," and went into the hospital. Diagnostic testing was done, and a specialist determined that she did not have GUILLAIN BARRE, but rather a severe case of muscle myalgia. Follow up information from the physician, via the company representative, indicated that on the same day of vaccination with GARDASIL, the patient received a concomitant vaccination of a dose of HAVRIX (lot # AHAVB207BA). The patient, contrary to the above information, was actually diagnosed with GUILLAIN BARRE Syndrome. Additional follow from the physician indicated that the patient's symptoms began on 31-OCT-2007, the day after vaccination, and on 01-NOV-2007, she had difficulty walking and had myalgias. She visited the emergency room and was hospitalized for 19 days (dates not provided). She was evaluated by the infectious disease department, neurology, and had a positive "AMG." Treatment included IV gamma globulin and physical therapy. At the time of this report, the outcome of the event was unknown. The physician considered the event to be serious as disabling/incapacitating and for prolonged hospitalization. Additional information has been requested.
DIZZINESS; WRONG NEEDLE WAS USED WHICH THEN HIT THE NERVE; ARM PAIN; HEADACHE; WRONG INJECTION TECHNIQUE; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 40 kilograms, and height was not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date, the patient experienced dizziness, wrong needle was used which then hit the nerve, arm pain, headache, and wrong injection technique. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) negative, and MRI (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, headache, dizziness, wrong injection technique and wrong needle was used which then hit the nerve was not reported. This report was non-serious. This report was associated with product quality complaint: 90000224405.
itched; red; puffy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itched), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (puffy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itched), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (puffy). At the time of the report, VACCINATION SITE PRURITUS (itched), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (puffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Treatments details were not provided.   This case was linked to MOD21-046699 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: NNI; Sender's Comments:  MOD21-046699:Crosslinked
got booster and next day my testicals felt like i got kicked in them. coincidently after initially receiving my  1st and 2nd dose i had a thrombus in my right spermatic cord which led to me having a denervation of the right groin in june. Initially, my doctors chalked up the first incident to coincidence. after talking with my urologist, he had me do 2 weeks of nsaids, with only an increase in pain. now currently on 600mg gabapentin 3x a day with moderate relief. currently continuing to follow with urologist.
mom called clinic p/early lunch & told nurse that hot up this AM 22APR98 & pt was not moving;mom attempted rescue breathing w/no response, pt transported to hosp & is now dead;
Pt suddenly did not feel well at 9:30 am 11/15 went to bathroom, noticed face very red, followed by intense itching - presented to clinic 1 hr after sxs started, developed swollen lips, edema around eyes and throat constriction. Epi 0.05 ml SQ immediately. 3 min later, pt improved.
Diffused confluent erythremia on face, neck, trunk, butt. No target lesion. Vitals well after given Benadryl mysonet on secondary.
Increased swelling, erythema, redness pain at site of injection (of adecel) of R upper arm c/w cellulitis. Patient started on Keflex when seen in clinic 9/9/10.
child was given 3 doses of Rotarix (Extra Dose); This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: child was given 3 doses of Rotarix (Extra Dose)).  The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-SEP-2023 Healthcare professional called today stating 8 months ago a child was given 3 doses of Rotarix, which led to extra dose administered. No further information was known. The reporter consented to follow up.
OXYGEN WENT DOWN TO 92 PERCENT; CHEST TIGHTNESS; SWEATY; COUGH; ARM PAIN; SLEEPY; BRAIN FOG; FELT DRUNK; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, chronic obstructive pulmonary disease, seasonal allergy, non alcohol user, and smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 12-MAR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-MAR-2021, the subject experienced trouble sleeping. On 12-MAR-2021, the subject experienced brain fog. On 12-MAR-2021, the subject experienced felt drunk. On 13-MAR-2021, the subject experienced sleepy. On 15-MAR-2021, the subject experienced arm pain. On 26-MAR-2021, the subject experienced chest tightness. On 26-MAR-2021, the subject experienced sweaty. On 26-MAR-2021, the subject experienced cough. On APR-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. On an unspecified date, the subject experienced oxygen went down to 92 percent. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) 92 %. Treatment medications (dates unspecified) included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oxygen went down to 92 percent, chest tightness on 02-APR-2021, sweaty on 28-MAR-2021, trouble sleeping, and brain fog on 13-MAR-2021, cough on 02-JUN-2021, felt drunk on 12-MAR-2021, and arm pain on 19-MAR-2021, and the outcome of sleepy was not reported. This report was non-serious. This case, from the same reporter is linked to 20210432473, 20210738839 and 20210739000.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious.
Follow-up information provided event outcome and physician's comments. Information regarding Prevnar vaccine was received from a healthcare professional regarding a 12-month-old female patient who experienced irritable, "pinpoint macular rash on her trunk and some on her extremities" and Coxsackie. The patient received the fourth dose on 01-Sep-2006. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 01-Sep-2006. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. The patient received the fourth dose of Prevnar on 01-Sep-2006. On 05-Sep-2006, the patient became irritable (irritability) and developed a "pinpoint macular rash on her trunk and some on her extremities" (rash macular) on 06-Sep-2006, The patient was treated with Benadryl. A few days later the patient developed a few urticarial lesions on her back of the leg, trunk and in her mouth. The patient was diagnosed with Coxsackie (Coxsackie viral infection). The patient recovered. The physician noted that the child was exposed at play groups and that the infection was not related to Prevnar. No additional information was available at the time of this report.
Red welp around the injection site about 3-4" x 1.5" in diameter that was itchy. One week later the welp is now about 2" x 1" in diameter and less itchy.
Since the vaccination the patient has experienced pain in his left shoulder and reduced mobility of his arm.  The patient shared he has been suffering with pain in his upper left arm and reduced mobility since the vaccination.  Describes soreness with movement of left arm towards his back and when he raises it overhead (most severe reaching back). He denies pain when raising straight forward or out to the side.  He reports a mild weakness related to the soreness with movement.    Patient has expressed desiring imaging (MIR of shoulder) to further evaluate and treat; however, patient has not completed any imaging at the time of the report.
Arm Pain - Lasted 2 days, No treatment Headache - Mild to Medium Headache lasted 36 hours. No treatment, no medications taken Fever - Slowly rose to a high of 101.2. Fever last 36 hours. No treatment, No medications taken
mom stated pt had a weird high pitched cry for 10min;this happened a couple hr p/vax;
On 4/11/21 in the morning around 7:30AM I felt chills and I had a terrible headache. I went back to sleep by noon I felt fine then I noticed my arm was red. I started getting zits like rash on my forehead they would feel sore to the touch and would itch they usually lasted 3 or 4 days and then I would get new ones. They cleared up and started on my eyelids and nose and a little bit on my cheeks and near my mouth. This lasted for a couple of months I couldn't get into the doctor till 28th of May. Doctor is a dermatologist and prescribed liquid clindamycin and said it was an allergic reaction.
Information has been received on 01-MAR-2019 regarding a case in litigation from a lawyer and the representative of the estate concerning a deceased male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles. On an unknown date, after receiving the ZOSTAVAX, the patient developed tremors, Bell's palsy, and varicella encephalitis. On 08-APR-2017, the patient succumbed to his injuries and passed away. As a result, the patient suffered sustained severe and fatal personal injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, and loss of enjoyment of life. As a direct result of ZOSTAVAX, the patient incurred medical expenses, and other economic harm. As a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to ZOSTAVAX. As a result patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was considered fatal. It was unknown if autopsy was done. Upon internal review, Bell's palsy, and varicella encephalitis were determined medically significant. Tremors, Bell's palsy and varicella encephalitis were considered disabling. Additional information has been requested.; Reported Cause(s) of Death: Bell's palsy; tremors; varicella encephalitis.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown multiple dates, the patients were vaccinated with improperly stored doses of RECOMIVAX HB (lot # L029631, expiry date: 14-AUG-2017; lot # L000717, expiry date: 15-APR-2017, dose and route were not reported). The doses were stored under temperature of 60 F for 3 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Gross haematuria 24 hours after vaccination/This occurred on both the 3rd dose (1st booster on 07Nov21); feverish; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 07Nov2021 at 10:00 as dose 3 (booster), single (Lot number: EH8027) at the age of 63 years (not pregnant), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfur" (unspecified if ongoing), notes: other medical history: None, known allergies: Sulfur. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed, Manufacturer Unknown), for COVID-19 Immunization The following information was reported: HAEMATURIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Gross haematuria 24 hours after vaccination/This occurred on both the 3rd dose (1st booster on 07Nov21)"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "feverish". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Seriousness criteria did not Result in death nor Life threatening; No prolonged hospitalization; No Disabling/Incapacitating; Did not result in Congenital anomaly/birth defect. Patient did not receive any other vaccine in four weeks. No COVID prior vaccination Patient was not tested for COVID post vaccination. patient received BNT162b2 (BNT162B2), on 18Apr2022, at 10:00 as dose 3 (booster), single (Lot number: FR9893). Adverse event: Gross haematuria 24 hours after vaccination. This occurred on both the 3rd dose (1st booster on 07Nov21) and the 4th dose (2nd booster on 18Apr22) of my COVID 19 shots. After the 3rd shot, my urine cleared up after 8-10 days. I still have brown urine from my 4th dose. I was also feverish and down for 36 hours with both these. AE resulted in: [Doctor or other healthcare professional office/clinic visit]. AE treatment: CT scan of lower abdomen.  No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse concerning a 16 year old female who in July 2008 (reported as "last week), was vaccinated 0.5 mL, IM, with GARDASIL vaccine (yeast) (lot# and dose not reported). Concomitant medication included carbetapentane tannate (+) diphenhydramine tannate (+) phenylephrine tannate (D-TANN CT). In July 2008, the patient experienced syncope after her vaccination. Subsequently, the patient recovered on the same day of the vaccination from syncope. The patient sought unspecified medical attention. It was also reported that the "patient experienced syncope after all immunizations." Additional information has been requested.
tingling under skin on right side of neck. Similar to a low voltage electricity as used in acupuncture.
Sore arm; Pain in my legs when I walk or sit down; Hurts a lot; Knot at the injection site, it was red; It was red; Low grade fever; muscle pain; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events low grade fever/pyrexia, sore arm/pain in extremity, knot at the injection site/vaccination site induration, red/vaccination site erythema, pain in my legs when i walk or sit down/pain, muscle pain/myalgia, hurts a lot/pain.  The patient's medical history was not provided. Concomitant medications reported were gabapentin used for unknown indication.  On 7 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  No adverse events were reported related to the first dose of the vaccine.  On 3 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch:028L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events low grade fever, sore arm, knot at the injection site, red, pain in legs when she walked or sat down, muscle pain, hurt alot.  Treatment details included aspirin with acetaminophen.  Since the patient received both the planned doses of the vaccine, action taken with mRNA-1273 in response to the events was not applicable. The outcome of events low grade fever, sore arm, knot at the injection site, red, pain in my legs when i walk or sit down, muscle pain, hurts alot was unknown on 8 Feb 2021.
This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (lot # J010966 expiration date 20-MAR-2015 and lot # J010140 expiration 26-APR-2015). Strength, dose and route were not provided. ROTATEQ was exposed to a temperature between 46.5F and a highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014: Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. Follow up information has been received from the registered nurse and reported the ROTATEQ stability cut off date was 02-MAY-2014. The registered nurse stated that anyone who was vaccinated with vaccine after these dates needed to be contacted for re-vaccination. The registered nurse refused to share patient identifiers on these patients, per Health Insurance Portability and Accountability Act (HIPAA). Health Insurance Portability and Accountability Act (HIPAA) was reviewed with the nurse and she stated she would need to get that information from her supervisor. The phone call was transferred to her Supervisor. The follow-up information provided the primary reporter's occupation as a medical assistant. She reported that 3 unspecified patients were vaccinated with the improperly stored ROTATEQ. This case refers to a one patient vaccinated with the second dose of ROTATEQ. No demographics, medical history, concurrent conditions or concomitant drugs were reported. There were two other patients vaccinated with dose number 3 (case# 1405USA004216). The patient received the vaccine on 02-MAY-2014. Lot# and expiration date for all patients vaccinated with ROTATEQ was J010966, 20-MAR-2015 (previously it was reported that also lot# J010140 with expiration date 26-APR-2015 was used). This is one of several reports received from the same reporter. Additional information has been requested.
little soreness in my arm; little lethargic; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little soreness in my arm) and LETHARGY (little lethargic) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (little soreness in my arm) and LETHARGY (little lethargic). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Jan-2021, PAIN IN EXTREMITY (little soreness in my arm) and LETHARGY (little lethargic) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021:  This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little soreness in my arm) and LETHARGY (little lethargic) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (little soreness in my arm) and LETHARGY (little lethargic). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Jan-2021, PAIN IN EXTREMITY (little soreness in my arm) and LETHARGY (little lethargic) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: