chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of influenza in a child male subject who was vaccinated with INFLUENZA (unspecified, manufacturer unspecified), FLULAVAL. Concurrent medications included Albuterol and SINGULAIR. The subject's medical history was significant for asthma. On an unspecified date in 2010 the subject received a dose of INFLUENZA (manufacturer unspecified). At an unspecified time after vaccination with INFLUENZA (unspecified), the subject experienced influenza. Outcome and attribution of the event to vaccination with INFLUENZA was not known. On 31 August 2011 at 12:00 the 10 year old subject received a dose (dose 1 for 2011) of FLULAVAL at 0.5 ml in the left arm This was the wrong vaccine administration as FLULAVAL is not indicated for use in subjects under the age of 18. No additional details were provided. It was reported that this event occurred in three siblings. See linked sibling cases A0943409A and A0943421A.
Rash at site of injection, hardened bump at site of injection, Whole body rash, Delayed allergic reaction
No adverse effects reported; received improperly stored ROTATEQ between 03-OCT-2019 and 28-OCT-2019; This spontaneous report as received from a Vaccine Coordinator refers to a 9 week old female patient.  The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not reported.   On 22-OCT-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally for prophylaxis (strength, frequency not provided) (lot #S000961 had been verified to be valid lot number; expiration date 19-OCT-2020) (product storage error). The  temperature  excursion was above 9 degrees Celsius (C) (0.6 C, multiple) for a time frame of 5 hours. There were no previous temperature excursion. It was reported that the call was due to data logger. No adverse effects were reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA016835:
Patient reported waking up with chills and severe shaking. Pt took Meloxicam and went back to bed. No fever when he woke up, but unknown if fever during the night. Achy, tired, and sore right arm during the day on 10/14/16. Headache.
After about an hour I was dizzy, mild muscle aches, fatigue and mild soreness at injection site.  Next day, small bruise at injection site.
Pain, Redness, Fever, Headache, Tired, Nausea, Chills, Body Aches, Sore Joints. Rash (started 9/28/11). Fever blisters (started 9/29/11). Headache.
About 12 hours after getting vaccines, the child started crying, seemed very uncomfortable, unable to comfort. She cried for over 24 hours on and off, decreased nursing, decreased out-put. No temp and no redness or swelling at the site of injection . Seen at the office on 03/27/2002.
Administered booster dose of Moderna (blue top). Person should have received Moderna Bivalent (blue top). No adverse event occurred.
Patient got Typhoid vaccine instead of Twinrix vaccine. Patient did not need Typhoid vaccine. Patient did not have allergies and was evaluated by medical provider and had no issues/adverse event. Error in clinic process.
nausea set in that night, sleepless night, pain in joints, nausea and pain in joints is continuing the day after.
BLADDER INFECTION; TOOK MACROBID WHILE TAKING VIVOTIF; This spontaneous case (PVX2019-895) was received from a consumer on 16-Apr-2019. It describes a female consumer who developed bladder infection, after the administration of Vivotif capsule for an unknown indication. She also "took Macrobid while taking Vivotif" for treatment of bladder infection.  Case report: The consumer took three doses of Vivotif. She took the third dose on 15-Apr-2019 and on the same day, she had bladder infection for which she took Macrobid (nitrofurantoin; twice a day for 5 days).  The consumer's concurrent medical condition included hypothyroidism and cholesterol.  Concomitant medication at the time of event included simvastatin (10 mg) for cholesterol, levothyroxine (37.5 mcg/ 0.0375 mg; 1.5 pill) for hypothyroidism.  Action taken with Vivotif and Macrobid with respect to the event bladder infection was unknown while with respect to the event "took Macrobid while taking Vivotif" was not applicable.   The consumer had not recovered from the event bladder infection while with the event "took Macrobid while taking Vivotif" was unknown.  Company's Comment: In this case, a female consumer developed bladder infection, after the administration of Vivotif. Since bladder infection is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "took Macrobid while taking Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, a female consumer developed bladder infection, after the administration of Vivotif. Since bladder infection is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "took Macrobid while taking Vivotif" was considered as not applicable.
Extreme dizziness while lying flat in bed, sat up and lost all balance at 10:00am 2/17/21. Fell into dresser on my way to the bathroom. Dizziness cont throughout the day but was not as bad. Went to bed that night and after reading,  turned to my right to turn off the light and the bed started "turning". Next morning full on dizziness again. I've never had problems with dizziness before.
COVID BREAKTHROUGH  Pfizer Dose 1 2/10/21 (EN6201) Pfizer Dose 2 3/3/21 (EN6199) COVID Positive 8/22/21  8/22/21: Patient is a 75 year old male with past history of coronary disease status post CABG, ischemic cardiomyopathy status post AICD placement, diabetes mellitus, hypertension, and hyperlipidemia who was admitted after having multiple shocks from his AICD.  History is obtained from chart review as well as discussion with the patient and the ED provider.  Patient does have a history of a coronary artery bypass in 1990.  He has a history of multiple stents and appears his last stents were placed approximately 2 years ago at an outside hospital.  Last stents placed at this hospital were an 2016. He does still take aspirin and Plavix daily.  Patient states that he was driving yesterday morning when he rear-ended a vehicle at approximately 12:30 a.m..  He states that the airbags did deploy a and that he had significant pain on his chest from the seatbelt.  He denies losing consciousness prior to the episode.  He did not seek out medical treatment at that time and went home.  He went to sleep and then woke up to after being shocked by his defibrillator.  He thought he was shocked about 3 times however on interrogation he received a total of 10 shocks and a 5 minutes period.  His chest is quite sore and overall just feels weak from the defibrillator episodes.  Not having any current shortness of breath, fevers, chills, nausea, vomiting, abdominal pain.  Transferred to this hospital after being started on amiodarone infusion.  Troponin slightly elevated.  9/3/21: Patient was admitted and Cardiology was consulted given AICD firing for ventricular fibrillation.  Was recommended that he undergo an ischemic workup however he is COVID-19 test returned positive.  He was started on remdesivir as well as Decadron.  He did have some mild hypoxemia.  He was placed on a heparin infusion as well as amiodarone infusion.  He was switched to oral amiodarone and underwent coronary angiogram on 8/27.  He had a drug-eluting stent placed to the saphenous vein graft to the obtuse marginal branch.  Patient was going to be discharged the following day however did develop some hypoxemia.  Hypoxemia worsened and on 08/29 he under went a PA cardiac arrest.  He did have some ventricular fibrillation and ROSC was obtained.  He was transferred to the ICU.  Pulmonary was consulted and he underwent hypothermia protocol.  His neurologic status was quite poor however sedation was not able to be weaned given his significant hypoxemia related to COVID-19.  He was started on broad-spectrum antibiotics.  Family ultimately decided on comfort measures given his poor prognosis from a heart standpoint, respiratory failure, and suspected anoxic brain injury.  He was palliatively extubated and passed away at 1:02 p.m. on 09/03/2021.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2008 the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced extreme injection site redness and extreme injection site soreness. At the time of reporting the outcome of the events was unspecified. The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752835A, A0752836A and A0752837A. Follow-up information received on 31 October 2008 indicated that the subject was an 81 year old female. The events of injection site redness and soreness began 4 days following administration of FLULAVAL and resolved 4 days later on 08 October 2008. In the reporter's opinion, the events were considered related to treatment with FLULAVAL.
On day 7 after my injection, my left arm became itchy.  On day 8 I developed a rash at the vaccination site.  No treatment needed.
she did not developed antibodies to the virus after the vaccine; tested positive for covid19; This is a spontaneous report received from a contactable reporter(s) (Other healthcare professional) from medical information team.  A female transplanted patient with immunosuppression patient received bnt162b2 (BNT162B2), intravenous (Batch/Lot number: unknown) as dose unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "she did not developed antibodies to the virus after the vaccine"; COVID-19 (medically significant), outcome "unknown", described as "tested positive for covid19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive; antibody test: negative. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded.
9 month received Bexsero; Received Bexsero instead of Hep B Vx; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old female patient who received Men B NVS (Bexsero) (batch number 9F3X2, expiry date 31-MAR-2024) for prophylaxis.   On 07-MAR-2023, the patient received Bexsero. On 07-MAR-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: 9 month received Bexsero) and wrong vaccine administered (Verbatim: Received Bexsero instead of Hep B Vx). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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: 09-MAR-2023 The Office Lead reported that the 9 month old female patient was ordered to receive Hepatitis B vaccine and medical assistant inadvertently administered Bexsero vaccine. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received Bexsero who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter reported that, they were intending to administer Hepatitis B and inadvertently administered Bexsero instead of Hepatitis B, which led to wrong vaccine administered.
Pt has ecchymosis that lasted 7 days. Pt also on blood thinner and aspirin.
one day 5 feet swelled with a red, itchy rash and were painful to stand on. This lasted 5 days. Currently, lymph nodes in neck are swollen and painful.
PINK/RAISED/ITCHY, PIMPLE-LIKE AREAS ON SCALP, FACE, ARMS, LEGS, AND TORSO BEGAN ON 11-28-2012 THROUGH 11-30-2012. FOLLOWED UP WITH PRIVATE CLINIC ON 11-29-2012 WITH TEMPERTURE 100.4, WAS ISSUED TOPICAL STEROID CREAM.
Hospitalization: 4/1/2023 - 4/9/2023 (8 days) Presentation to the ED: fall.  COVID + date: 4/1/2023 Treatment: IV Remdesivir & on IV Decadron x 10 days Discharge to: SNF.   021B21A 4/2/2021  009C21A 4/30/2021 049L21A 5/13/2022
Monday night pt. became ill, threw up and had a fever.  He went to bed, but around 11 pm he woke up disoriented, unable to walk.  Was helped to the bathroom, but was unable to get back to bed on his own.  Fell on his bottom.  I had to call our son to come pick him up and help him back to bed, unable to hold his own weight..  Had trouble sleeping.  Abt 1 pm needed help getting up again, same disorientation, also fell off the toilet and needed help getting back to the bed, unable to hold his own weight.  Finally fell asleep.  Next day seemed fine enough. Tuesday night, became ill again, went to bed.  Got up to go to the bathroom, was wobbly, but able to make it.  Was helped back, wobbly but able to walk. Trouble falling asleep, fever, chills.  Finally fell asleep at 3 am Wed morning.  I had to go to the doctor early, so left him sleeping in bed.  When I came back around 11 am, he was still sleeping, snoring loudly.  Became concerned.  Wouldn't wake up.  Called Paramedics.  CT scan at the hospital revealed a brain bleed.  Transported to hospital. Put on support for almost 2 weeks.  No progress, no response.  Finally support was discontinued and he died April 19th at 7:52 pm.
rash/hive appearance lt upper arm where immun given;area 5x3 (itches), red, sl raised bumps;warm to touch;mom states pt tired;?low grade fever;
PATIENT REPORTED THAT SHE IS STILL HAVING OCCASIONAL SORE ARM. IT GOES ON AND OFF. SHE WAS EXERCISING THE OTHER DAY AND IT WAS SORE. PATIENT ORIGINALLY WENT TO THE DOCTOR TO REPORT THE SYMPTOMS AND DOCTOR TOLD HER TO ICE IT FOR 2 WEEKS. TOLD PATIENT TO FOLLOW UP WITH HER DOCTOR
This spontaneous report was received from a pharmacist, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On an unspecified date, the patient may have been vaccinated, via intramuscular instead of the subcutaneous route, with a dose of Oka/Merck VARIVAX injection (dose and frequency were not reported) lot # reported as N012134 with expiration date of 17-APR-2019, for prophylaxis. No adverse effects were reported. Lot number N012134 has been verified to be a valid lot number for varicella virus vaccine live.
Information has been received from a nurse concerning a patient over the age of 60 years who on 06-NOV-2006, in the am, was vaccinated intramuscularly with Pneumovax 23.  Subsequently on an unspecified date, the patient developed gland swelling under the injected arm.  Unspecified medical attention was sought.  Subsequently, the patient recovered from the swollen glands.  Additional information has been requested.
headache, double, vision, balance problem, chills, uncontrollable shaking, body muscle aches--most resolved within 12 hours
Donor stated that after she recieved a TDAP immunization on 4/10/15 she went home and started to have a little bit of soreness to the left deltoid area where the immunization was given. Donor states that over the next 2 days she started to experience flu like symptoms: body aches, light headedness, dizzy and off and on head aches. Donor came into the center to attempt to donate and reported to the medical staff and stated all of her s/s that she had been experiencing. Donor stated that she has not seeked any medical attention she just wanted to report to the medical staff.
Cellulitus of vaccination site Benadryl day of symptoms starting fever of 102 day after symptoms Keflex 500mg capsule day after symptoms started. positive improvement from Keflex  the day it was taken and day after
Patient planned to wait for 60 minutes post vaccination due to prior allergic reaction to Moderna. At 45 min, she began having throat swelling, difficulty swallowing, and labored breathing.  Epi pen given, albuterol started, and 6 L of 02 placed. EMS arrived within 5 min and transported to the ED.
extreme fatigue day after; fever of 101.2 day after; coughing 20 minutes after injection; sore/dry throat same day; migraine; Arm of inj. very sore and stiff; This is a spontaneous report received from a contactable consumer.   A 44-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, lot number: EN6205), via an unspecified route of administration, administered in left arm on 25Feb2021 17:30 at a single dose for covid-19 immunisation.  Medical history included Vascular Ehlers Danlos, Factor V Leiden deficiency and known allergies (Bee stings, coconut, cherries, red food dye). Concomitant medications taken in 2 weeks included requip, aimovig (injection), dexilant, quinine and xarelto. The patient previously took clindamycin and morphine and had known allergies. No other vaccine administered in four weeks. On 25Feb2021 17:45, the patient experienced arm of inj. very sore and stiff, migraine that started 35 minutes after injection and lasted beyond 48hrs, sore/dry throat on same day and coughing 20 minutes after injection. Day after the patient had extreme fatigue and fever of 101.2 on 26Feb2021. The patient underwent lab tests and procedures which included body temperature: 101.2 on 26Feb2021. The outcome of the events was recovering.
PE dx 9/1/21 after first dose of Pfizer COVID vaccine 8/23/21
Varicella vaccine administered 10/7/08 Rt arm SQ. Came back to clinic 10/9/08 with redness to area measuring 6.5cm X 7.5cm and 101.2 temp. and adominal pain.
Patient felt pain during injection that she thought was unusual for the vaccination but was unsure since it had been a year since she was last vaccinated. Significant pain started in evening of 10/15, within 6 hours of injection. Noticed significant swelling in the morning on 10/16. Sought care in urgent care clinic on 10/17 at 12pm. Pain in left shoulder is severe and the left should is swollen. Patient is unable to abduct due to pain. There is no numbness or weakness in the left arm, no warmth or redness in the left arm, and no drainage from the injection site. She did bump her left arm while getting out of her car during the past weekend on 10/13 or 10/14 and her anterior left upper arm has a small quarter sized bruise on it from that injury. She denied having any pain prior to 10/15. Xray negative for fracture or fluid collection. Patient's cellulitis is being treated with Keflex, Benadryl for any itching, and ibuprofen for pain.
The mother states small red bumps developed on child's torso and chin, mild itching. No fever present. 09/11 rash fading.
patient was given the pfizer bivalent booster instead of the pfizer monovalent vaccine.
On her way home, the patient said her lips and a small area surrounding the lips went numb.  This continued for a couple hours. The patient called the pharmacy and was instructed to drink water, rinse the area with cool water and send her husband  to get benedryl.  The patient was given a call at 2:20pm to check on her condition. She was completely better.  She did not take benedryl yet.  Will follow up with the patient.  No MD was contacted.  She was instructed to go to the hospital if anything  progressed.
Pt developed swelling and abscess and cellulitis on left deltoid.  Was seen at ER 02/07/04 and was treated with Keflex presently recovering.
No adverse events noted,  Vaccine was administered to early on 08/25/2022, Guardian notified and follow up per next office visit on 09/14/2022 no adverse reaction or concerns stated per Guardian.
Member reports feeling ill the morning after (8/7/2021) the vaccine. Experienced fatigue, SOB, chills. Saw provider on 8/11/2021.
No additional adverse event reported; Expired dose of ROTATEQ  was administered to a patient; This spontaneous report was received from a medical assistant and and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported    On 21-OCT-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally,  lot # 1742415, expiration date 12-OCT-2022, for prophylaxis (dose not reported) (expired product administered).        Medical assistant confirmed the vaccine was stored according to the recommended storage range until administration and was not involved in a prior excursion. No additional adverse event and no product quality complain were reported.
Vaccinated Mon. 7-7-03 at 1:11pm.  Tues 10:00am:  L. arm swollen tight & red from deltoid almost to elbow, hot, tender.  No fever.  Arm swabbed with alcohol, ibuprofen administered.  No complaints from child.  Wed AM:  fever 102-103 degrees; lethargic.  Wed noon:  temp >105; ibuprofen given.  Wed 4:00pm:  temp 106, child taken to ER.  IV fluids & antibiotics administered. Pt returned home late that evening.  Fever broke about 4:00am on Thurs.  Thurs 3:00pm:  No fever, swelling & redness down > 1/2 what it was.  Still tender.  Mother states it looks like a "normal" reaction now.
and her stomach is off; feels weak; doesn't feel great and feels a little crappy; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2021, the patient received the 1st dose of Shingrix. In April 2021, less than a week after receiving Shingrix, the patient experienced upset stomach, feelings of weakness and feeling bad. On an unknown date, the outcome of the upset stomach, feelings of weakness and feeling bad were not recovered/not resolved.   It was unknown if the reporter considered the upset stomach, feelings of weakness and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The reporter reported that she received dose of Shingrix and experienced bad feeling and feeling crappy. The reporter also experienced stomach off. The consumer decline to give any further details. The consumer declined to give any additional details or answer any further questions before ending the call. The reporter did not consented to follow up.
sleepiness; Fatigue that comes and goes; This spontaneous case was reported by a physician and describes the occurrence of SOMNOLENCE (sleepiness) and FATIGUE (Fatigue that comes and goes) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical history was reported.  Concomitant products included LORATADINE for Allergy, ALPRAZOLAM for Sleep problem, PANTOPRAZOLE and ESCITALOPRAM for an unknown indication.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced FATIGUE (Fatigue that comes and goes). On an unknown date, the patient experienced SOMNOLENCE (sleepiness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (sleepiness) and FATIGUE (Fatigue that comes and goes) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported fatigue has come back in full force. It is Friday, Saturday, Sunday, today (understood as 01-Mar-2021) she was feeling a little better.