chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; improperly stored vaccine was administered; This spontaneous report was received from medical assistant and refers to an unknown age and gender patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-SEP-2022, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, at a dose of 0.5 ml/once, lot #w007371, expiration date: 13-JUL-2023, administered intramuscularly for prophylaxis (strength, anatomical site injection were not provided) (product storage error). The suspect vaccine exposed to a temperature of 34.5 Degree Fahrenheit for a timeframe of 1 Hour 7 Minutes 0 Seconds with a previous temperature excursion of 66.7 Degree Fahrenheit for 13 Hours 52 Minutes 0 Seconds.  No additional adverse event information was provided.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2210USA005917:MSD
sore arm (immediate lasting for over 3 days), fatigue, fever (3 days so far), dizziness, nausea (occurred next day for about 2-3 hours), difficulty breathing Saturday Sunday and Monday so far)
Initial report received from a health care professional on 19 November 2012. A 21-year-old female patient, whose concurrent condition included adrenal insufficiency and concomitant medication Hydrocortisone, "Thyroid 1.50 mg", PREVACID and Desmopressin; had received a dose of FLUZONE ID (dose number 3, Lot number UT4470AA, route of administration was not reported) in right deltoid on 16 November 2012 at 06:45 PM. On 17 November 2012 at 10:30 AM, the patient experienced hives all over body. The patient was taken to urgent care and was treated with Hydroxyzine HCL 25 mg thrice in day and PEPCID BID on unspecified date. No laboratory tests were done. The patient had not recovered. Documents held by sender: none. Follow up information received from a healthcare professional on 26 March 2013: Patient had no illness at time of vaccination and had no adverse event following prior vaccination. The patient also received fludrocortisone as concomitant medication. The patient's outcome was recovered on 24 November 2012.
Patient was admitted to labor and delivery at Hospital and screened positive for COVID-19, asymptomatic at that time.  Delivered twins via C-section, birth weight 6 lb 2 oz and 5 lb 10 oz.  Possible COVID history in 11/2020 and >14 days post completion of vaccination.
arm hurt 6-30 hours after shot, trouble staying asleep 12 hours after shot, headache 18-30 hours after shot, tiredness 24 hours after shot, nausea 24-36 hours after shot took tylenol every six hours to treat symptoms
Pt received flu vaccine on 9-20-13 in left deltoid IM. Presents on 9-23-13 with 17 x 18 cm warm, slightly tender, non indurated area at injection site.
Anaphylactoid purpura - Patient received influenza vaccine on 10/14. He began with abdominal pain 10/20. He progressed to joint swelling and pain on 10/23. On night of 10/24 - purpura observed bottom of feet.
Systemic: Exhaustion / Lethargy-Severe, Systemic: "arm tested positive to be magnetic"-Severe, Systemic: Vomiting-Severe, Additional Details: patients family called to report that the patient had experienced side effects with the 2nd dose. they took the patient to the hospital because he was tired and vomiting. they ran tests and a test showed that his arm was magnetic where the vaccine was given
Pt presented to clinic today one day post PPD plant and varicella vaccine, with multiple large area of edema that appeared to be mosquito bites, possible adverse reaction to shots or bite when pt playing football outside or from ingredients in chinese food.  No resp symptom, no fever or other acute symptoms.  Prescription give benadryl 1 1/2 teap Tid x3 days.
4 cm area of erythema surrouding IM site on left thigh. Mom is not sure which of the 4 vaccines given 2 days ago was administered in left thigh. Warm but not tender to touch.  No fluctuance. No fevers.
Red spots/rash on left arm, hand, and wrist. Petechia rash.
PT FELT THAT THE SITE OF INJECTION WAS SWOLLEN, RED, HOT TO THE TOUCH AND COVERED A 4"x 2" AREA. IT WAS RAISED AND IT WAS HARD. PT ALSO HAD A HEADACHE. THE SXs STARTED TO SUBSIDE AT APPROX 9AM ON MONDAY (6/17/13).
This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 65-year-old female patient who received SHINGRIX (batch number H547E, expiry date 22nd February 2021) for prophylaxis. On 10th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 3 days after receiving SHINGRIX, the patient experienced muscle pain and swelling. On an unknown date, the patient experienced erythema and pain. On an unknown date, the outcome of the muscle pain, erythema, swelling and pain were unknown. It was unknown if the reporter considered the muscle pain, erythema, swelling and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine in the right deltoid. The healthcare professional reported that the patient experienced muscle pain and swelling. One week after receiving the SHINGRIX, the patient also experienced a circle area that was red and painful (about the size of a golf ball).
ER @ 10:30, 11/14 - IV, TYLENOL. Chills, fever (101.9), eye red and burning. H/A, dizziness, SOB, sensitivity to touch ("pin-prickly" feeling), mild cough, nasal congestion, weakness. H/A and weakness diminishing, but still present on 11/17/08.
Quadracel is authorized as the 5th Dtap and 4th IPV and it was inadvertently given as the 4th DTaP and 4th IPV
Moderate to severe arm pain extending through whole arm down to knuckles. Felt like I had the flu - very fatigued, raised temperature, chills, body aches, light headed
I tested positive for COVID on 16May; I tested positive for COVID on 16May; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "IBS" (unspecified if ongoing); "TMJ" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Raynaud's syndrome" (unspecified if ongoing); "sciatica" (unspecified if ongoing); "Known allergies: Red dye" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "not recovered" and all described as "I tested positive for COVID on 16May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive, notes: I tested positive for COVID on 16May; (27May2022) Positive, notes: It is now 27May / I have tested positive on a rapid home test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in two weeks of vaccination. Symptoms began on 15May2022, the patient was tested positive for COVID on 16May2022, and began Paxlovid on 17May2022. She took the full course of medication as instructed. It was now 27May2022 and she had tested positive on a rapid home test and feel the same symptoms she did at onset.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 2 days after 2nd covid vaccine I started to get chills, felt like a strong cold, coughed with mucous, skin was very sensitive, had low energy to do anything.
On 10/7/2003 received MMR. On 10/17/2003 noticed pain and redness at injection site and hardness. Some days has pain in arm and other times is not sore. 10/27/03-LUA red, induration 2cmx2cm; warm to touch. No red streaks . 11/04/03 PC to pt.
06/10/2022 (17 days after 2nd booster) - 7-8 am, I felt weakness on right leg and arm, high blood pressure (180/120). - 10-11 am, I was diagnosed with ischemic stroke caused by very small plague located in the left posterior frontal lobe of the brain. - Treatments included PT/OT. Added Plavix, Lipitor, Alleve. Removed Crescor.  Increase Metoprolol to 50 mg - Current issues: Lost of balance, tension headache (frontal and around eyes), fatigue, depression, weakness on right limbs, brain fog.
08/26/17 6 pm reported fever, swelling, redness; 08/27/17 11 am fever resolved, still swollen and red; 08/27/17 9 am ER visit, treatment with prednisone and resolved.
covid vaccine breakthrough case  dose 1 Pfizer 3/11/21 EN6207 dose 2 Pfizer 4/1/21 ER8730
Information has been received from a 75 year old male consumer who is a physician. In about 1993 and Novermber, 1999, the pt was vaccinated with the 1st and booster dose of pneumococcal vaccine 23 polyvalent, respectively. On an unspecified date the pt experienced sub-acute arthritis especially in the elbow, knees and ankles. At an unspecified date the pt also developed a local injection site reaction in the deltoid. The pt sought unspecified medical attention. Additional information has been requested.
Fever (102.7); Rash Left Front forearm; This is a spontaneous report received from a contactable consumer, the patient. A 47-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration on 19Mar2021 at 17:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient was allergic to PEN (penicillin). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration on 26Feb2021 at 15:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20Mar2021 at 15:00, the patient had fever (102.7) and experienced rash on left front forearm. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events fever (102.7) and rash on left front forearm. The clinical outcomes of the events fever (102.7) and rash on left front forearm were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
On 1/13/21 extreme fatigue- sleeping 4 to 5 hours at a time, swollen gland on right side 1/14/21 nausea, headache, dizziness,  fever-100.7, muscle ache, swollen gland still
Generalized muscle aches, arm swell, pain and redness. Resolved with time and medication.  09/06/2007 MR received for DOS 5/25/2007 for c/o pain and swelling in the R upper arm following TDaP vax on 5/23/07.  Pt also c/o generalized body aches. PE reveals patchy erythema, tenderness and guarding.  Warmth noted in the upper arm. Assessment;  probable adverse reaction to TDaP immunization, questionable allergic componant.
Beginning 11-12 hours after #2 dose I experienced headache, body aches, chills, slight fever, some stomach discomfort.  It lasted about 18-24 hrs until I felt normal.
Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (dose, lot number and expiration date unknown) for prophylaxis. Data logger issue was involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA005357: US-009507513-1703USA005356.
Sore arm; Chills; This is a spontaneous report received from contactable Consumer (patient).  A 29-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication included: paracetamol (TYLENOL). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; CHILLS (non-serious), outcome "unknown", described as "chills". Therapeutic measures were not taken as a result of pain in extremity, chills. Additional information: the patient was also receiving anxiety medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 before vaccination. Post vaccination COVID-19 test was not done.   No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021533662 Same drug/reporter/patient, different dose (2nd dose) and adverse effect
Patient was added into the schedule this morning due to painful swelling and warm to touch feeling of her L Axilla. Patient did receive her COVID booster on 10/15/2021 and her symptoms became present on 10/16/21 however she is unsure if it is a reaction to the booster or not. Nodule is approximatley the size of a baseball. She does have pain w/ movement.
Momentary loss of consciousness followed by seizure. After two hours of rest, symptoms including dizziness and fever remained.
The next morning of shot, woke up to intense upper abdominal pain, and vomited took Mylanta.  Then an increase itchiness all over.  On the 3rd day, developed hives on back and left arm, sent pictures to PCP and was told I am allergic to the vaccine.  Took antihistamine for the hives.  Dr.  Prescribed, antibiotics prednisone, and famotidine.   The abdominal pain and itchiness was consistent on the first week.
Headache HA, sore throat, body aches, cold/clammy/chills, sore arm Narrative:  Took medications but did not specify what they took for symptoms
Patient got a blood transfusion on 17May2021 due to low iron.; This is a spontaneous report from a contactable pharmacist. A 56-year-old female patient received first dose of BNT162B2 (Pfizer-biontech covid-19 vaccine, Solution for Injection), via an unspecified route on an unknown date as a dose 1 single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient got a blood transfusion on 17MAY2021 due to low iron. Patient wanted to know if there will be a potential contraindication for a blood transfusion patient to get the 2nd dose of the BNT162B2 (Pfizer BioNTech Covid-19 Vaccine). Patient underwent for lab test and procedure which included iron test result was low. The clinical outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected. ; Sender's Comments: Based on current information available, the event low iron mostly represented intercurrent condition in this patient with advanced age, unrelated to Bnt162b2. Relevant medical history and concurrent disease are missing for a medically meaningful assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate
7.5 x 9 cm area of erythema and induration on the left anterior thigh with warmth to touch, no central fluctuance appreciated.
several inches down there was a linear lymphatic irritation on the skin; patient had a local reaction at the injection site; Indication: asthma; patient had trouble sleeping; discomfort in her left arm; This spontaneous report was received from a retired physician who was also the patient's father referring to a 40 years old female patient. The patient's concomitant medication included unspecified asthma medications. The patient had no pertinent medical history and no drug reactions/ allergies.   On 16-MAR-2020 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, lot # and expiration date were not reported) via intramuscular in the left arm for prophylaxis (also reported as asthma) (product use in unapproved indication).         On 16-MAR-2020, the patient had trouble sleeping due to discomfort in her left arm. Whether treatment was given for the events was unknown. On 17-MAR-2020, the patient had a local reaction at the injection site and then several inches down there was a linear lymphatic irritation on the skin. It did not appear to be a cellulitis at this time. The patient was to monitor the site and used ice for discomfort. None lab diagnostics/studies were performed. The patient had sought medical attention.  Outcome of the events was not recovered. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided.
I was brushing my hair and noticed a lot of hair coming out. At first, I thought it was normal. Then I noticed my hair was thinning from brushing so much hair out. I really noticed more shedding towards the end of October 2022.
Patient had no mensuration (has Nexplanon). After getting J&J began to have new and increased menstrual bleeding 1 month after that has persisted monthly to date.
pt has been feeling unwell for the last 9 months reporting changes in taste, smell, difficulty breathing
Anaphylactic reaction; Pink hives of full body; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0U9C21A, 013F21A and D39A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced URTICARIA (Pink hives of full body). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criteria medically significant and life threatening). The patient was treated with LORATADINE (CLARITINE) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for Anaphylactic reaction, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency and METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) and URTICARIA (Pink hives of full body) outcome was unknown.            No concomitant medications were reported.  Company Comment: This is a spontaneous case concerning a 31-year-old, male patient with no medical history, who experienced the expected serious event of Anaphylactic reaction and non-serious event Utricaria. The event Anaphylactic reaction occurred on an unknown day and event utricaria occurred 17 days after the second dose of mRNA-1273 vaccine. Patient was treated with Claritine, Benadryl, solumedrol, prednisone and Medrol. The event utricaria was resolved in three weeks. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-422932 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 31-year-old, male patient with no medical history, who experienced the expected serious event of Anaphylactic reaction and non-serious event Utricaria. The event Anaphylactic reaction occurred on an unknown day and event utricaria occurred 17 days after the second dose of mRNA-1273 vaccine. Patient was treated with Claritine, Benadryl, solumedrol, prednisone and Medrol. The event utricaria was resolved in three weeks. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a physician concerning a 57 yr old female who on 27Jan05 at approx 10:45AM was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 650084/0605P). On 27Jan05, shortly after being vaccinated, the pt developed a fever, rash and local arm pain at the injection site. The pt went to the ER and was treated with diphenhydramine HC1 (Benadryl). The pt was considered to be recovering. No product quality complaint involved. Additional information has been requested.
Pharmacist on duty at clinic reported back to the store after the clinic that patient experienced some shaking and shortness of breath after the vaccine administration. Due to the size of the clinic EMS was already on site and monitored patient but chose not to administer any treatments.
Pt. developed onset of paresthesias (tingling) in B/L hands, neck stiffness, occas. hand numbness, hip pain, & feeling flushed on eve of 11/17/08. Flu shot given 11/4/08. NV on 11/18/08 -> referred to PCP. Eval. at ER 11/28/08 -> D/C with script for anxiolytic. Increasing ext pain -> ER 11/29/08 -> inpt. x8 days for daily plasmaphoresis.  7/1/09 Hospital records received DOS 11/30/09 to 12/07/08. Assessment: Guillain-Barre syndrome. Patient presented with tingling of hands and fingers, followed by flu-like symptoms with myalgias and arthralgias in several muscles and joints. Could barely ambulate and unable to work. Decreased muscle strength upper and lower extremities. Gait is wide-based, slow, and unsteady. Daily plasmaphoresis.
Received DTaP and IPV L thigh 2/24/03. Mom noted swelling entire L thigh to knee next am. C/O discomfort, limping. Seen in office 2/26/03. L thigh swollen entire anterior thigh, including knee, inner aspect thigh red. Afebrile Rx Keflex 250mg TID x 7 days. Swelling improved 2/27, resolved by 3/3. Similar incident in 6 yr old child 2 days later who received IPV only (same lot #) in thigh.
Patient was given an adult dose of Hepatitis A vaccine. No notable adverse effects observed by parents after vaccination
Patient received 2 doses of flu vaccine, the second 5 days after the first. Both were same lot # at 0.25 ml each. (See below.) No adverse reaction noted at the time of this report.
pt recvd 3 doses of Hep B vax; series was completed DEC87; MAR92 tested no immunity; had not been tested prior to this point;
chills, sweats, severe headache, nausea, diarrhea, swelling in arm and redness.  Mostly better after 24 hours.  Redness and swelling still apparent 5 days later.
1.Severe abdominal cramping that started about 2 hrs after injection.  2. 1 day after injection heavy menstrual bleeding and severe cramping that lasted for twelve consecutive days. Prior to injection, periods would last for 3 days with  mild cramping on the first day and light flow. Had a regular  period a week before injection.