chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with Guillain-Barre syndrome (GBS) within three weeks following vaccination with AVA # 4, MCV4P, and Typhoid on 30 Apr 10. Pt reported that approx 1-2 wks prior to his diagnosis on 19 May he began to experience weakness of his legs along with tingling in his feet, hands and then his tongue. Through medical record review it was noted that he was treated for bronchitis in Feb 10. On f/u visit on 09 Apr he reported dyspnea on exertion and back pain and was prescribed VENTOLIN inhaler and a MEDROL Dose pak. Labs noted a low Vit D level at 29ng/ml. He was evaluated on 14 May for progressive leg weakness an evaluation by neurology on 19 May reported progressive weakness over the past 2 days. He was diagnosed as having GBS and was treated with IVIg for a total dose of 2 gm/kg. He was discharged on 24 May with improvement in symptoms. Currently, he reports that he is doing well.
Patient got very sick; Initial information was received on 08-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involved an unknown age patient who got very sick (Illness), after receiving INFLUENZA VACCINE.  The patient's past medical history included Sinusitis.  The patient's past 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 and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got very sick (Illness), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was  illness.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
This case was reported by a nurse via call center representative and described the occurrence of rash in a 2-month-old female patient who received PEDIARIX (batch number A4H53, expiry date 6th November 2017). Co-suspect products included ROTARIX lyophilized formulation (batch number A41CB544A, expiry date 20th February 2017), PEDIARIX (batch A4H53, expiry date 6th November 2017) and ROTARIX lyophilized formulation (batch number A41CB563A, expiry date 27th August 2017). Concomitant products included HIB Vaccine, PCV 13 vaccine, HIB vaccine, and PCV 13 vaccine. On 2nd March 2016, the patient received the 1st dose of PEDIARIX and the 1st dose of ROTARIX lyophilized formulation (oral). On 26th April, 2016, the patient received the 2nd dose of PEDIARIX and the 2nd dose of ROTARIX lyophilized formulation (oral). On 3rd March 2016, 1 days after receiving PEDIARIX, ROTARIX lyophilized formulation and PEDIARIX, not applicable after receiving PEDIARIX and ROTARIX lyophilized formulation and not applicable after receiving PEDIARIX and ROTARIX lyophilized formulation, the patient experienced rash and hives. On 27th April 2016, the patient experienced rash and hives. On an unknown date, the outcome of the rash, hives, rash and hives were unknown. It was unknown if the reporter considered the rash, hives, rash and hives to be related to PEDIARIX, ROTARIX lyophilized formulation, PEDIARIX and ROTARIX lyophilized formulation. Additional details were provided as follows: On 2nd March 2016, the patient received 1st dose of PCV13 and HIB vaccines. About 24 hours later after receiving the ROTARIX lyophilized formulation and PEDIARIX, the patient experienced a rash and hives on both legs. On 26th April 2016, the patient received 2nd dose of PCV13 and HIB vaccines. About 24 hours later after receiving ROTARIX lyophilized formulation and PEDIARIX, again the patient experienced a rash and hives on both legs. The HIB vaccine was non GSK vaccine and the brand was HIB vaccine.
Moderna vaccine, 2nd dose was Pfizer; Moderna vaccine, 2nd dose was Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 04Jan2022 (Lot number: FL3209) as dose 2,  single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "Moderna vaccine, 2nd dose was Pfizer". No follow-up attempts are possible. No further information is expected.
Swollen Thigh (injection site) down to knee and swollen knee.  Significant Leg Pain.
Numbness in fingers; Fever; Chills; Severe headache; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, severe headache and numbness of her fingers.  The patient's medical history was not provided. Concomitant medications reported included blood thinner.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: Unknown).   On an unknown date, the patient experienced fever, chills, severe headache and numbness of her fingers. No treatment information was reported.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome of fever, chills, severe headache and numbness of her fingers were considered as unknown.  The reporter did not provide an assessment for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt recvd 1 dose of Engerix B 27MAR92; 1APR92 exp muscle aches, arthralgia, aches all over, sick feeling, nausea; MD visit was required to treat the events;
Pt. experienced sore redness that night and the next day swelling/cellulitis.
Bruised Upper Body but not itching; Difficulty Breathing; Rash Upper body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONTUSION (Bruised Upper Body but not itching), DYSPNOEA (Difficulty Breathing) and RASH (Rash Upper body) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII. Concurrent medical conditions included Asthma.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced CONTUSION (Bruised Upper Body but not itching), DYSPNOEA (Difficulty Breathing) and RASH (Rash Upper body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 05-Mar-2021, CONTUSION (Bruised Upper Body but not itching) and RASH (Rash Upper body) had resolved. At the time of the report, DYSPNOEA (Difficulty Breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Non significant follow up received on 07-MAY-2021, no new information
(all of the following is patient reported at the time of her 2nd moderna covid-19 vaccination): Patient reported she experienced esophageal spasm approximately 7 hours after receiving her first Moderna covid-19 vaccination. she was treated at her local hospital with nitroglycerin paste to relieve the spasm. She subsequently had a fever of 102.7 degrees Fahrenheit.
Cough , shortness of breath and dizziness. Personal albuterol inhaler used without relief of symptoms so was taken to the emergency room.
Intussusception requiring hospitalization. Intussusception occurred 6 days after rotavirus, DTaP, HepB, IPV, Hib, OMP, PCV13.
Gas; Diarrhea; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FLATULENCE (Gas), DIARRHOEA (Diarrhea) and FATIGUE (Tiredness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced FLATULENCE (Gas), DIARRHOEA (Diarrhea) and FATIGUE (Tiredness). At the time of the report, FLATULENCE (Gas), DIARRHOEA (Diarrhea) and FATIGUE (Tiredness) outcome was unknown.            Concomitant product included thyroid medications.  It was reported that patient could not keep down thyroid medication, and had to be on a liquid diet.   No treatment information was provided.
Patient stated with symptoms: Flu-like symptoms. Headache. Body Ache. Allergies like symptoms (running nose).
Vomiting Heart rate at 180 Convulsions  High blood pressure  Extreme exhaustion  Neck pain Throat pain  Jaw pain  Headache Diarrhea  Fingers to forearms pins and needles  Toes to calf?s pins and needles  Fingers cramping - specifically thumbs and going stiff  Confusion  Body aches
Patient is a 93 y.o. male patient who originally presented to the hospital on 4/6/2021 due to generalized weakness.  Patient found to have COVID infection as well as UTI.  Patient was started on remdesivir and IV antibiotics.  Patient did not requiring oxygen.  Patient did have decreased appetite which did slightly improve upon discharge.  Patient did not require oxygen throughout hospitalization.  Clinically stable for discharge home.  Will discharge on oral antibiotics to complete course of therapy.  Advised to follow up with PCP as outpatient in 1-2 weeks.
never received second dose; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 20th June 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The retire physician reported that, the patient received Shingrix first dose and she had never receive Shingrix second dose, which led to incomplete course of vaccination. The reporter consented to follow up by email. No information about lot number for Shingrix first dose.
patient presented to emergency department on 12/28/21 with feeling tired, diarrhea, runny nose patient was admitted for further management of acute encephalopathy patient was found to be covid-19 positive on 12/28/21 patient expired on 1/9/22 due to history of kidney transplant, was on immune suppressive medication.  Had problems with fever despite use of antibiotics.  Mental status failed to improve, respiratory for status failed to improve.
No additional AEs were reported; patient supposed to receive only PROQUAD and also received VARIVAX on the same day due to human error; This spontaneous report was received from a registered nurse and referred to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Concomitant medication included sterile diluent.  On 02-MAY-2022, the patient supposed to receive only measles, mumps, rubella and varicella (oka-merck) virus vaccine (live recombinant human albumin (rHA)) (PROQUAD) (0.5ml/once, lot # was reported as u029323, upon internal validation established as U029323, expiration date: 19-MAR-2023) for prophylaxis (strength, and route of administration were not provided) but also received varicella virus vaccine live (oka/merck) (VARIVAX) (0.5ml/once, lot # was reported as t021825, upon internal validation established as T021825, expiration date: 25-JUN-2022) for prophylaxis (strength, and route of administration were not provided) due to human error (accidental overdose).  No additional adverse events were reported, no further information provided (no adverse event).
Adult given a pediatric dose of HAVRIX instead of the adult dose. Age of patient at time of event: 60 years.
Pt had black lettered tattoo on arm. He was given vax # 2, one week later he presented to MD with a blister on left arm that had blistered and was hot to touch. Pt was given Benadryl.
RLE cellulitis devel 25JAN97;pt was adm to hosp through the ER;cellulitis resolved w/ATB therapy;
Within a few minutes of sitting in waiting zone, I had what I thought was severe heartburn.  Simultaneously I felt my heart racing and feeling flush.   I raised my hand to alert attendant.  Took pulse and it was very high.  They called EMT.  Upon connecting me to heart monitor is was erratic,   Very high blood pressure.  When they touched chest it hurt more.  They said I was bright red.   They transported me via residue to Hospital.  Residual mild rash under skin  for several days. Had severe headache for 14 hours.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, dose number, route of administration, lot# and expiration date were not provided) and a dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). On 12-JAN-2018, the patient was re-vaccinated with a dose of GARDASIL 9 (dose, dose number, route of administration, lot # and expiration date were not provided) and a dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001551: US-009507513-1806USA001552: US-009507513-1806USA001553: US-009507513-1806USA001554: US-009507513-1806USA001555: US-009507513-1806USA001556: US-009507513-1806USA001557: US-009507513-1806USA001558: US-009507513-1806USA001559: US-009507513-1806USA001560: US-009507513-1806USA001561: US-009507513-1806USA001547: US-009507513-1806USA001548: US-009507513-1806USA001549: US-009507513-1710USA003103.
I started a menstrual bleed that lasted 3 months a couple days later.  I actually ended up having a hysterectomy because we could not figure out how to make it stop. There was no other cause that we could find.
Moderna COVID-19 Vaccine EUA Pt. presented with dizziness, weakness, double vision, slurred speech, nausea, vomiting, diarrhea, and unable to stand/walk. Vaccine given at 1030, patient first c/o symptoms at 1135.  Symptoms progressively became worse and was sent to ER at 1650.
This spontaneous report was received from a female nurse, of an unknown age, reporting on herself. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of hepatitis B vaccine (manufacturer unknown) (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse reported that she received an hepatitis B vaccine (manufacturer unknown) vaccine on unspecified dates years ago. The nurse reported that on an unspecified date she had titers drawn for  hepatitis B and results were negative. The nurse reported that because of this she received another series of unspecified hepatitis B vaccine (manufacturer unknown). At the time of the report the outcome was unknown. Additional information has been requested.
I have noticed that the arm that I received the H1N1 vaccine in has begun to ache and be numb.  Numbness from shoulder down to finger tips.  This has gone on for several days....
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient was vaccinated with dose 1, 1 ml RECOMBIVAX (intramuscular, lot number was not reported) on 20-JUN-2012 and was vaccinated with dose 2, 1 ml RECOMBIVAX HB (intramuscular, lot number was not reported) on 13-AUG-2012. No adverse effect was reported. Additional information is not expected (reporter does not went to be contacted).
Pain in muscle trying to lift the arm.  Tenderness at site of shot.  2 " circle.  seems like nerve pain  back of upper  arm.  Numbness in pinky finger.  On 11/14pain so severe it woke me up and then I couldn't sleep. continuously from 10/16 to 11/19/2021.  12-10 Reports pain a little better.
R vax May85 1wk/p mult joint pain;jun85 pain/swelling finger/joints/knees/ankles 2wk;knee pain&swelling;26mar86 effusion rt knee;10Sep86 lt knee pain&swelling;ANA&RF-neg;4nov86 arthroscopy lt knee-neg no virus grown;5dec89 arthralgia X2days
received her first dose on 10/3/2019; Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number X9GM4, expiry date unknown) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Influenza vaccine Quadrivalent unspecified season. On an unknown date, the patient received the 2nd dose of Shingrix. In June 2021, less than 2 years after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.   Additional details were reported as follows: The case was reported by the patient. The reporter stated she received her 1st dose of Shingrix and not received 2nd dose till the time of reporting which led to incomplete course of vaccination.  The patient had shingles after 1st dose of Shingrix and Flu vaccine. The reporter inquired about how close one could receive the Shingrix vaccine after having shingles.   The reporter consented to follow up.  Note: Shingles reported as current condition but occurred after received Shingles and Flu vaccine, so captured as an event.
This information was obtained via a search of the scientific literature on 29 December 2009. This report involves a total of 26 unidentified pregnant female patients. The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommends routine influenza vaccination for all women who are or will be pregnant during the influenza season. During seasonal influenza epidemics, during previous pandemics, and with the current influenza A (H1N1) pandemic, pregnancy places otherwise healthy women at increased risk for serious complications from influenza, including death. Inactivated influenza vaccine can be safely and effectively administered during any trimester of pregnancy. No study to date has demonstrated an increased risk of either maternal complications or adverse fetal outcomes associated with inactivated influenza vaccination. Moreover, no scientific evidence exists that thimerosal-containing vaccines are a cause of adverse events among children born to women who received influenza vaccine during pregnancy. The article reviewed the evidentiary basis for the recommendation of vaccination of all women who will be pregnant during the influenza season and safety data of influenza vaccination during pregnancy. The Vaccine Adverse Event Reporting System contains a database for reports regarding influenza vaccination during pregnancy. It is a postmarketing surveillance system with strengths and weaknesses inherent to passive surveillance systems. Of 26 reports related to influenza vaccine in pregnant women from 2000 through 2003, 6 concerned misadministration of the influenza vaccine without negative consequences, 9 described self-limited injection site reactions, 8 were related to systemic symptoms that regressed with time, and 3 reported miscarriages. During this time period, an estimated 2 million pregnant women received influenza vaccination. These data suggest a low rate of adverse events associated with administration of the inactivated influenza vaccine during pregnancy. Information pertaining to dates of vaccine administration, adverse event onsets, past medical and obstetrical histories, and recovery status was not reported. The reporter for this case is the same as for case number 2010-00010. Documents held by sender: None.
temporary numbness in left arm and face about 30 minutes after receiving vaccine. Lasted about 5 minutes and went away.
Patient reports passing out from shots other than vaccines.  vaccine was administered, and we continued a conversation for 5 minutes before the patient became verbally unresponsive.  Then, Patient's eyes rolled back,  and body convulsed.  Legs, arms, and trunk went stiff, hands/fingers and feet/toes curled under, lasting about 30 secs.  Patient opened her eyes, but was still unresponsive for another 30 secs. I laid her in the floor after she was able to talk again.   Patient was asking where she was and was asking for her mother (who was not present).  She could not recall the 5 minute conversation from the vaccine that led to the episode, the episode, or the conversation immediately after.   she reported a throbbing headache, but that she was feeling much better.  She moved back to the chair slowly.  She did not want to have an ambulance, so I recommended her friend drive her somewhere to get evaluated.  She had someone to drive her home and could walk without aid.
hearing ticking sound in ears after 3 days of 1st dose of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (hearing ticking sound in ears after 3 days of 1st dose of vaccination) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure and Diabetes. Concomitant products included METFORMIN, ATORVASTATIN and AMLODIPINE for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced TINNITUS (hearing ticking sound in ears after 3 days of 1st dose of vaccination). At the time of the report, TINNITUS (hearing ticking sound in ears after 3 days of 1st dose of vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.