chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received regarding a case in litigation from a lawyer and female patient of unknown age and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The female patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the female patient was administered the ZOSTAVAX by a healthcare provider at a medical center/hospital (Lot number, dosage and route of administration not provided).  In 2014, the patient was treated by a healthcare provider at a physician's medical group/office for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claims damages as a result of:  injury to themselves, loss of consortium, and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
shortness of breath; This non-serious case was reported by a consumer and described the occurrence of shortness of breath in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included hypertension, cholesterol and gastritis. Concomitant products included clonidine, atorvastatin (Atorvastatine), esomeprazole magnesium (Nexium) and dobutamine hydrochloride (Butamine).   On 09-OCT-2023, the patient received Arexvy. On 09-OCT-2023, less than a day after receiving Arexvy, the patient experienced shortness of breath (Verbatim: shortness of breath).  The outcome of the shortness of breath was not resolved.   It was unknown if the reporter considered the shortness of breath to be related to Arexvy.     It was unknown if the company considered the shortness of breath to be related to Arexvy.   Additional Information: GSK receipt date: 13-OCT-2023 The patient had shortness of breath. The patient had Cardividol and hydroclorathizide as concomitant. The reporter was requested for follow up.
Back Ache; Nausea; Vomiting; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Back Ache), NAUSEA (Nausea) and VOMITING (Vomiting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced BACK PAIN (Back Ache), NAUSEA (Nausea) and VOMITING (Vomiting). In February 2021, BACK PAIN (Back Ache), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Information has been received from a 38 year old female with diabetes and allergy to Septra who on 22-NOV-2006 was vaccinated with Pneumovax 23 (lot # 655289/0958F) (IM).  Concomitant therapy included ACTOPLUS MET.  On 22-NOV-2006, "within two hours" of getting the shot, she experienced "sharp chest pain," she felt like she "was going to pass out", and she was "unable to focus" her vision.  Unspecified medical attention was sought.  Additional information has been requested.
Patient received first dose of COVID-19 vaccine and within 15 minutes felt tongue swelling and lip swelling and felt heart was racing like she has been exercising. Feels lightheaded and dizzy. No trouble breathing. Patient was immediately assessed. Benadryl 50 mg given in clinic. Minimal improvement in lip and tongue swelling. Patient feeling more lightheaded.  Vitals: BP 120/70, Pulse 69-72  O2 saturation 98-99%.  PE: CV: normal rate:  Respiratory: CTAB.  HEENT: swollen upper and lower lip and tongue swelling (angioedema) Skin: mild redness in left hand, no hives noted  Patient has had hx of anaphylaxis in the past to compazine and phenergan.   Recommend ER Evaluation and monitoring.
8/15/02 swollen, firm area, size of child's fist on L upper arm, about three finger widths from top of shoulder.
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On 03-OCT-2016 and on 04-OCT-2016, the patients were vaccinated with improperly stored VAQTA 25/0.5 (units not reported) (route of administration was not reported) (lot # M009377, expiry date: 17-JUN-2017). The temperature excursion was 0.7 degree of Celsius during 6 hours and 24 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Pt called day after injection c/o soreness & small area redness at injection site. Advised to take BENADRYL & use cool compresses. Came to office 10/18/12 c/o fever (99.3), pain at injection site, vomiting & chills, erythema at injection site had increased from 2 cm to 5 cm. (+) induration without fluctuance. Advised ibuprofen 800 mg bid, hydroxyzine 25 mg 1/2 tab 1 tab qd. Clobetasol topical bid.
Fever, chills, headache, runny nose.Treating with Motrin,fluids, and rest.
Covid19 breakthrough.  1st Vaccine received on 05/01/2021.  35y/o with PMHx of bipolar, PTSD, Colitis, and recent gunshot wound to Left hip on 12/24/21 that was treated at a HCF.  Pt presents to ED with fevers and c/o  purulent drainage from wound.  Started on IV abx.
Arm hurt, swelled up, numbness and tingling in corner of left lip and along the jaw line. Tongue had also swelled on left side. Left side of throat swelled up as well.
ACT-HIB was administered to a 2 year old but it was expired as of June of this year.- with no reported adverse event; Initial information received on 17-Sep-2021 regarding an unsolicited valid non-serious case received from a other health care professional and consumer non health care professional via Global Medical Information number: 00774839. This case involves a 2 years old female patient who was administered an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE VACCINE [ACT-HIB] (wrong product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 17- SEP -2021, the patient received a 0.50 mL dose of suspect HIB (PRP/T) VACCINE batch number: UJ327AA and expiry date: 30-SEP-2021) via intramuscular route in the right thigh for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  IT was reported that "The Medical Information agent confirmed the spelling of demographics with the caller for accuracy".  At time of reporting, the patient was not recovered for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
had a fever with a temperature of 99.8 F earlier & has one of 100.2 F right now; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (had a fever with a temperature of 99.8 F earlier & has one of 100.2 F right now) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, 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 experienced PYREXIA (had a fever with a temperature of 99.8 F earlier & has one of 100.2 F right now). At the time of the report, PYREXIA (had a fever with a temperature of 99.8 F earlier & has one of 100.2 F right now) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) temperature of 99.8 F earlier & has one of 100.2 F right now.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant drugs were reported.  No Treatment information  were reported.
a pharmacist reported that a female received an injection of Tetanus Toxoid Adsorbed, Purogenated and subsequently developed an injection site reaction. No further information was available as of the date of this report.
I am reporting my second dose reaction which is the same as my first dose reaction (i recovered from the first dose reaction which is why I got the second dose).  The second dose reaction happened a lot sooner - second day and covers about 4" x 4"under the injection site on my bicep muscle.  Very itchy.  I used cortisone cream for itchiness and taking claritan once a day.  I received the shot on Mar 1 and it is now Mar 4th and the red color has faded a little but itchiness is still strong and the large area still visible.
Patient is stating that on the day he received his shot, he had localized swelling that progressed to his entire shoulder. He said it felt as if it had fever and the area bruised. Today, four days later, evidence of bruising still remains and patient claims fluid moved from shoulder into forearm.
systemic rash: blotchy red rash-raised urticarial? some older fading to purple & becoming macular;
felt lethargic for a few hours; I had a sore arm for 4 to 5 hours; This is a spontaneous report received from a contactable consumer (patient himself). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/lot number: EN5318) via an unspecified route of administration in the left arm on 04Feb2021 01.30 at single dose for COVID-19 immunization. The patient medical history included Epilepsy, Afib and aortic aneurism. Concomitant medication included Clonazepam, Lamotrigine, dabigatran etexilate mesilate (PRADAXA), Diltiazem and digoxin (DIGOX). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 05Feb2021 at 06:30 Am patient felt lethargic for a few hours the next morning and had a sore arm for 4 to 5 hours. The patient did not receive any treatment. The outcome of event (Lethargic) was recovered on an unspecified date and other event was recovered on 05Feb2021.  No follow-up attempts are possible. No further information is expected.
Developed chest pain after vaccine. Went to PMD given heartburn meds. Came to hospital and found to have hypertension. BPs found to be 134-179/87-102. Chest pain improved with NSAIDS, rest of vitals stable. Afebrile and otherwise without complaint or abnormal physical exam findings.
h/a, stomach ache, high fever w/difficulty standing up or eating; presumed recovered; 1DEC93 no response to f/u request;
Patient received Fluzone High-Dose at Pharmacy. Patient has experienced shortness of breath, excruciating pain, gait instability, blurred vision.
Patient reported feeling dizzy shortly after receiving his vaccination. Tech notified pharmacist and remained with patient. Pharmacist grabbed water and a wet towel to put on patient's neck. Patient's mom got some gatorade for the patient. Patient said his vision was "going". Got patient seated on floor and put the cool towel on his neck and told him to take some deep breaths. He started to feel better within a minute or so and had some gatorade. His color returned and was little sweaty, but reported feeling better. He remained under observation with his mom for another 30 minutes before leaving without issue. Mom stated he has felt dizzy in past, but wasn't noted on VAR.
Pt reported hives to the COVID vaccine.  Unknown time course or which dose pt had hives.
pt recvd vax 21JUN94 pt returned 28JUN94 w/lt arm sore, swollen, red @ area where Td given & below deltoid; referred to MD said defintely react to vax; arm still sore-some redness;
emergency hernia surgery; arm pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm pain at injection site) and HERNIA (emergency hernia surgery) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN and AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced INJECTION SITE PAIN (arm pain at injection site). On 02-Feb-2021, the patient experienced HERNIA (emergency hernia surgery). At the time of the report, INJECTION SITE PAIN (arm pain at injection site) and HERNIA (emergency hernia surgery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
-Tdap immunization given 2/18/08.  -Patient reported redness and swelling developed at the immunization site within 24 hours.  I evaluated the patient on 2/21/08 and measured an area of induration at the injection site 3.5cm x 4.5cm with overlying erythema.
1 day post receiving H1N1 chills, severe vomiting and diarrhea. Medical Rx sought at hospital. Rx with IV for hydration and unknown Rx meds.
HAD SWELLING AND REDNESS ON LEFT ARM, PUT ICE PACK ON ARM AND SWELLING WENT DOWN, STILL LOOKS A LITTLE RED, TOOK SOME PAIN RELEIVER
Cramps all over (mainly in leg and feet at night); Brain fog; Depression; Tremors; Memory loss; 24 to 36 hours after vaccination had a sever reaction; Chronic fatigue (after walks); Muscle pain (comes on at night or hour after walk); This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps all over (mainly in leg and feet at night)), FEELING ABNORMAL (Brain fog), DEPRESSION (Depression), TREMOR (Tremors) and AMNESIA (Memory loss) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOTEPREDNOL ETABONATE (LOTREL [LOTEPREDNOL ETABONATE]), ROSUVASTATIN CALCIUM (CRESTOR) and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 14-Feb-2001, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, 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 experienced MUSCLE SPASMS (Cramps all over (mainly in leg and feet at night)), FEELING ABNORMAL (Brain fog), DEPRESSION (Depression), TREMOR (Tremors), AMNESIA (Memory loss), VACCINATION COMPLICATION (24 to 36 hours after vaccination had a sever reaction), FATIGUE (Chronic fatigue (after walks)) and MYALGIA (Muscle pain (comes on at night or hour after walk)). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Cramps all over (mainly in leg and feet at night)), FEELING ABNORMAL (Brain fog), DEPRESSION (Depression), TREMOR (Tremors), AMNESIA (Memory loss), FATIGUE (Chronic fatigue (after walks)) and MYALGIA (Muscle pain (comes on at night or hour after walk)) had not resolved and VACCINATION COMPLICATION (24 to 36 hours after vaccination had a sever reaction) had resolved.            This case was linked to MOD-2021-289860 (Patient Link).
had 1st dose almost 6 months ago; did not feel good about it; headache; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (had 1st dose almost 6 months ago), VACCINATION COMPLICATION (did not feel good about it) and HEADACHE (headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hypercholesteremia. Concomitant products included ATORVASTATIN for Cholesterol, VALSARTAN for Hypertension.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION COMPLICATION (did not feel good about it) and HEADACHE (headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (had 1st dose almost 6 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (had 1st dose almost 6 months ago) had resolved and VACCINATION COMPLICATION (did not feel good about it) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported. Patient had high anxiety getting the 2nd dose so missed to get the 2nd shot.
vomiting on and off for 3 hrs; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting on and off for 3 hrs) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa drugs).    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VOMITING (vomiting on and off for 3 hrs). At the time of the report, VOMITING (vomiting on and off for 3 hrs) outcome was unknown.            No relevant concomitant medications were provided.  No treatment information was provided.
Narrative: had lumps all over his chest and his axilla after receiving vaccine. he did not receive second dose as he was against it by his provider.
This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a 3-month-old male patient who experienced erythema multiforme, diarrhea and irritability. The patient received the first dose in 2007. Relevant medical history was not provided. Indication for PREVNAR was immunisation. Product was administration in 2007. Dose regimen was 1 dose 1 time per day. Additional suspect vaccine included PEDIARIX and Hib vaccine (manufacturer unknown). Concomitant medication were not reported. After vaccination on an unspecified date in 2007, the patient developed a rash and lesions and was subsequently diagnosed with erythema multiforme. He was also experienced diarrhea and irritability. The outcome is unknown. The reporter considered the events probably related to vaccination with PEDIARIX, PREVNAR and Hib.
Large irregular red area on upper arm near vaccine site.  Itchy but no bumps, some pain, some heat.  Not serious but just wanted to report.
Patient called saying injection site is red and sore and hot to touch. Recommended NEOSPORIN, warm compresses and if gets worse to follow up with MD. Will have a pharmacist follow up with her next day.
July 2007, intussusception S/P repair.  9/18/07 Reviewed vax record from provider which confirms RO dose & lot # as reported.  9/17/07 Reviewed hospital medical records which reveal patient experienced vomiting.  Seen in ER 7/15/07 & d/c to home.  Continued w/vomiting, abdominal pain & developed dark stools.  Admitted 7/16-7/19/2007.  Failed hydrostatic reduction & taken to OR for reduction & appy.  Progressed well & d/c to home. FINAL DX: Ileocecal intussusception w/lead point in midtransverse colon; appendectomy.
Saturday 23rd around noon I started to feel sick. Symptoms included fatigue, headache, chills, nausea, and stomach pain.   Symptoms stopped Sunday 24th around 9am.  I was unable to do daily tasks, stayed in bed all day. Did not seek medical attention due to these being listed as possible symptoms to the vaccine and told they would pass in a day or two.
Resting heart rate of 117bpm and fever of 103.8(39.9C)
Severe burning sensation in major tendons of knees and elbows. Symptoms come and go several times a day every day. Symptoms occur during activity as well as during inactivity. Symptoms persist more than 4 months after second dose. No symptoms were present after first dose.
Did not receive the second dose of the Moderna COVID-19 vaccine; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose of the Moderna COVID-19 vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), PARACETAMOL (TYLENOL), IBUPROFEN, GABAPENTIN, ROPINIROLE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SERTRALINE HYDROCHLORIDE (ZOLOFT) and CEFIXIME (FLEXERIL [CEFIXIME]) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose of the Moderna COVID-19 vaccine). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose of the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication information was reported.
Within a week of my second Pfizer vaccine  (I don't remember if it started the day after my shot or several days later - I think I felt mildly cruddy since the day after, and a week later felt a lot worse) I developed severe fatigue, muscle pain, joint pain, migraines, brain fog, nerve pain in my spine, and nausea. It continued until I was eventually diagnosed with Graves disease. Winter 2022.
SEVERE MUSCLE ACHE ON LEFT SIDE UPPER TORSO ALONG RIB CAGE, SEVERE WEAKNESS OF ENTIRE BODY AND FEELING FAINT WHEN WALKING.
This is a spontaneous report by a contactable physician through a sales representative. A male patient (age unknown) received PREVNAR13 on an unknown date. Relevant medical history and concomitant medications were unknown. On unknown date, the patient experienced vomiting and the physician suspected that he might be having flu. The outcome of the event was unknown. Follow-up (14FEB2013): Follow-up attempts completed. No further information expected.
Immediately after the injection the tips of my finger began to go numb my hand started itching my throat started to go numb and itch and I got 25mg of Benedryl symptoms got worse so they had to give me in IV injection of benedryl which made the symptoms a litter better.  I was released and when I got home I went to sleep.  When I woke up my body felt like I had been run over by a big truck.  I took my temp and it was 99.8.  I laid back down and decided to sleep it off and woke up this morning not feeling any worse but not any better.  My hands got red from the rash and is still a little red.