chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; a adult patient may have received a pediatric dose; Information has been received from a registered nurse regarding a 26-years-old female patient. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 20-FEB-2020, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis, lot number R025518 with expiration date not reported but upon internal validation established as 15-NOV-2019 (strength, dose, frequency, route of administration and anatomical location were not reported) (inappropriate dose of drug administered).  No adverse events were reported.
Gave patient Prevnar 13 vaccination in left thigh and then immediately gave vaxelis in right thigh and patient went cyanotic and experienced a breath-holding spell and then shortly after took a breath, recovered and then continued crying, then 5-7 minutes later patient became pale.  Continuous oxygen saturations were monitored and stayed above 97%. Patient's color returned to normal within 30 minutes after episode. After discussion with doctor it has been decided that future vaccinations will be given individually at different times for this patient
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment with Paxlovid, from 31Jan2023 to 04Feb2023
Information has been received from a female with no drug allergies and a history of hip replacement in November 2010 who "two or three weeks ago", in approximately January 2011, was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck). Concomitant therapy included SYNTHROID, LIPITOR and alendronate sodium, "2 weeks ago", on approximately 04-JAN-2011 the patient developed a hive near the injection site on her left arm. The patient did not seek medical attention. No treatment was given to the event. There were no lab diagnostics performed. On 18-JAN-2011, the patient recovered from the event. Additional information is not expected.
CELLULITIS IN UPPER TRICEP AREA. VISITED ER. AREA WAS INJECTED 3 TIMES DURING IMMUNIZATION PROCESS. FEVER 101.5 COMFIRMED CELLULITIS WITH TENDERNESS, SWELLING, WARMTH, GENERAL MALAISE, TREATED WITH DOXYCYCLINE.
Anaphylactic shock; choking; Burping; Hands and face red; Hands and face swollen; Hands and face swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid cancer (history of thyroid cancer). Concurrent medical conditions included HIV infection (HIV positive and on a regimen and undetectable for 20 years) and Renal pain (kidneys hurt once in a while and stated as not taking booster dose in October).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant), CHOKING (choking), ERUCTATION (Burping), ERYTHEMA (Hands and face red), SWELLING FACE (Hands and face swollen) and PERIPHERAL SWELLING (Hands and face swollen). On 17-Apr-2021, ANAPHYLACTIC SHOCK (Anaphylactic shock), CHOKING (choking), ERUCTATION (Burping), ERYTHEMA (Hands and face red), SWELLING FACE (Hands and face swollen) and PERIPHERAL SWELLING (Hands and face swollen) had resolved.            No corrective treatment was provided.  It was reported that, after receiving 2nd dose, patient was having similar reaction in 5 minutes when under medical supervision and was revived." to "Patient reported as burping, hands and face red after reaching home about 45mins after receiving the first dose on 12th Mar 2021 and was rushed to Emergency room where caller mentioned as experienced choking and swollen hand and face. Caller received second dose on 17th Apr 2021 and mentioned as having similar reaction in 5 mins when under medical supervision and was revived.  Company Comment: 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.   This case was linked to MOD-2021-209326 (Patient Link).; Sender'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.
Severe deltoid / biceps pain and injection site such that unable to move arm/ shoulder D/T muscle pain; Pt has muscles, but low muscle mass given height 73 inches, weight in 140s.
Pain, swelling arm and shoulder and hand, redness burning upper arm, 4/17/03 decreased pain in hand, shoulder. Redness and swelling continues upper arm. Pt on Benadryl po 25mg bid-tid recheck 4/21/03.
soreness in his arm; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in his arm) and FATIGUE (feeling tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in his arm) and FATIGUE (feeling tired). At the time of the report, PAIN IN EXTREMITY (soreness in his arm) and FATIGUE (feeling tired) outcome was unknown.            Concomitant medication information not provided. Treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-027170 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up information received on 16-JUN-2021, contains no significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-027170:1st dose case
Patient presented for 2nd Moderna vaccine on 6/16/2021; Pfizer administered, instead. RN Vaccinator; RN. Patient advised on 7/28/2021.
Suspected vaccination failure; Experienced Shingles-like reaction; Nerve pain following a dermatome; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and nerve pain. On an unknown date, the outcome of the vaccination failure, shingles and nerve pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and nerve pain to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient experienced almost shingles-like reaction, nerve pain following a dermatome after receiving Shingrix. The reporter was unable to provide full patient and vaccine details. The reporter Did not consent to follow-up.  The reporter asked about any information on this type of reaction after 2nd dose of Shingrix. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation for herpes zoster were not provided.
Right after her shot the patient felt flushed and nauseated and lightheaded. @ hours after her shot she felt sharp pains in her head and dizzy. Also had neck pain on the right side (side where shot given) and the skin on the right deltoid became reddened. Some neck / shoulder area x 2 days.
Start to getting 'twig' on the back of my throat; I thought like I had a full blow taste of flu; All the symptoms of the flu and what you guys got down on that paper for COVID symptoms, but I know I don't have COVID; Headache; Muscle pain; Chills; swelling at injection site; Nauseated; Coughing; Sore throat; I just didn't feel right; I had injection at the pain site; Sore arm; Aching joints/Joint pain; Tired; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection) via an unspecified route of administration, administered in left arm on 11Mar2021 (Batch/Lot Number: EN6207) (at the age of 74-year-old) as dose 1, single for COVID-19 immunization. Medical history included thyroid, macular degeneration and patient had a hearing problem from an unknown date and it is ongoing. Concomitant medication(s) included paracetamol (TYLENOL); levothyroxine sodium (L-THYROXINE [LEVOTHYROXINE SODIUM]); ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2) taken for macular degeneration prescribed by eye doctor, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for thyroid prescribed by his family doctor because of his thyroid is out of way, start and stop date were not reported. The symptoms started on 11March2021. On 11Mar2021, the patient experienced sore arm and achy joints and he was tired, reporter stated he had injection at the pain site, he was tired, he had headache, did have muscle pain but he does not know, chills, joint pain, he had swelling at the injection site, it was times that he was nauseated, he just didn't feel right, he had cough, sore throat. 3 days after injection, on 14Mar2021, he started to getting 'twig' on the back of his throat and by that night which was Sunday (on 14Mar2021) night he thought like he had a full blow taste of flu, that he have it till today but not quite as bad. All the symptoms of the flu but he knew he didn't have COVID. Patient was asked was it possible for him to had a reaction to that shot. Patient was due for his second shot on 02April2021 and enquired if he should get that shot. The outcome of the events tired, headache and cough was not recovered and for the remaining events was unknown.  No follow-up attempts are possible. No further information is expected.
Extreme Fatigue.  Slept 20 out of 24 hrs the first day after shot, accompanied by sore arm.  Second day fatigue not as bad but severe flu light symptoms.  Body ache, headache, nausea, sore arm.  Third day experienced brain fog and slight vertigo.  Pretty good by 4th day after shot
Vaccine stored in the freezer, instead of the temperature range indicated on the package (2-25ºC). Vaccine administered to patient without knowing it was stored improperly.
pt recvd vax 10AM & 5PM pt became pale, limp; c/o both arms being numb, unable ot sit up byself;these sxs lasted x 24hrs; t100.5
Information has been received from a medical assistant concerning a 63 year old male with diabetes and no drug allergies who on 15-NOV-2008 was vaccinated SQ into the left arm with a dose of ZOSTAVAX (Oka/Merck) (663197/1418X).  It was reported that the patient was on a diabetic diet.  On 30-JAN-2009 the patient experienced fever of 104.2 F, fatigue, body aches, swollen cervical lymph nodes and oral ulceration's.  The patient sought medical attention at physician's office.  The patient was examined and prescribed AUGMENTIN.  A rapid strep test was negative and a complete blood count was normal.  The patient was examined again on 04-FEB-2009 and the symptoms were improved.  As of 05-FEB-2009, the patient was recovering.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow-up information was received from the medical assistant.  It was reported that the 63 year old white male patient developed a viral syndrome including severe aphthous ulcers in the mouth not long after the vaccination OF zoster vaccine live (Oka/Merck).  The reporter stated that "there is no connection between the two".  At the time of the report, the patient recovered.  No further information is available.
Doctor circle the wrong vaccines in chart and medical assistant administered them to the wrong patient that was meant for the younger sibling.
Tingling in the lateral right foot, discomfort in the right heel, pins and needles in peroneal muscles of right leg, weakness in calf.
Information has been received from a consumer concerning her 11 year old granddaughter with no pertinent medical history who on an unknown date was vaccinated with a first dose of GARDASIL. On approximately 17-SEP-2009, "about 3 or 4 weeks ago", the patient started experiencing muscle and joint pain in her knees. The patient did not seek medical attention. At the time of the report, the patient's outcome was not recovered. No further information is available.
Injection site warm; Injection site sensitive; Injection site hurting; Injection site pretty red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site warm), INJECTION SITE HYPERSENSITIVITY (Injection site sensitive), INJECTION SITE PAIN (Injection site hurting) and INJECTION SITE ERYTHEMA (Injection site pretty red) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Lyme disease. Concurrent medical conditions included Allergy (Allergic to sulpha drugs.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INJECTION SITE PAIN (Injection site hurting) and INJECTION SITE ERYTHEMA (Injection site pretty red). On 27-Jan-2021, the patient experienced INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE HYPERSENSITIVITY (Injection site sensitive). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Jan-2021, INJECTION SITE ERYTHEMA (Injection site pretty red) had resolved. At the time of the report, INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE HYPERSENSITIVITY (Injection site sensitive) outcome was unknown and INJECTION SITE PAIN (Injection site hurting) had resolved.        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.   Concomitant medications include Cholesterol pill, medications for anxiety and medications for nerves pain.
This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients. This is 2nd of two reports. A female patient of unknown age and race received TRUMENBA for immunization at single dose on unknown date via an unspecified route.  Medical history and concomitant medication were unknown. On unknown date the patient experienced syncope. The outcome of the event was unknown. Sender's Comments: 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 Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available. Linked Report(s): US-PFIZER INC-2016497578 same reporter/drug, different patient/event.
patient report that after the shot she couldn't swallow, her neck was swollen , and she was short of breathe, chest felt heavy, swelling on left knee
Pain when lifting arm almost at shoulder level (left arm). I thought the symptom might just go away on its own. Pain is near site where shot was given.
serious eye infection; lost 50 percent of the vision; This case was reported by a consumer via interactive digital media and described the occurrence of eye infection in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pinkeye (history of pink eye).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced eye infection (serious criteria other: serious as per reporter) and partial sight. The patient was treated with medication unknown (Pill (Medication Unknown)) and ophthalmologicals (nos) (Eye Drops (Ingredients Unknown)). On an unknown date, the outcome of the eye infection and partial sight were not recovered/not resolved.   The reporter considered the eye infection and partial sight to be possibly related to Shingles vaccine.  Additional Information: GSK Receipt Date: 29-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got shingles vaccine, no one warned her that if you had a history of pink eye this shot could trigger a serious eye infection. The patient had lost 50 percent of the vision in her eye and after a year he/she was still taking pills and applying eye drops four times a day. The reporter thought that the event might had been related to product/device. Additional Supportive Information: The follow up would not possible as no contact details were available.
Patient had immediate redness at site of injection.  Within 5 Minutes redness spread to chest area.  Patient was given 50mg of Benadryl.  Patient did not experience any trouble breathing.  Benadryl helped the red rash with 15 minutes of administration.
Information has been received from a health professional concerning a 67 year old male with no known allergies or medical history who on 30-NOV-2007, was vaccinated with a 0.65 ml subcutaneous dose of Zostavax (Oka/Merck) (lot# /658867/1413U). There was no concomitant medication. On 14-DEC-2007, the patient was seen by a physician. It was reported that the patient developed a mild case of shingles beginning on 11-DEC-2007, and presented with five lesions with pain and discomfort on his right rib cage. The patient was prescribed VALTREX, one gram every 8 hours for 7 days. On 20-DEC-2007, the patient via phone reported to the nurse that he had been taking 2 ibuprofens (strength unspecified) with meals for pain. As of this report, the patient was reported to have been recovering. A product quality complaint was not reported. Additional information has been requested.
axillary lymphadenopathy x 2 weeks right side (same side as first injection).; nausea; vomiting; transitory trigeminal neuralgia - right sided; This is a spontaneous report from a contactable physician (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular at the right arm on 30Dec2020 14:30 at single dose for COVID-19 immunization. The patient has no medical history. The patient has no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included influenza vaccine (FLU) on 10Dec2020 at the left arm. The patient experienced axillary lymphadenopathy for 2 weeks right side (same side as first injection), nausea, vomiting, and transitory trigeminal neuralgia - right sided; all on 01Jan2021. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included nasal swab (COVID PCR): negative on 19Jan2021. The patient recovered from the event axillary lymphadenopathy on 15Jan2021 and recovered on an unspecified date for the rest of the events.
had rash start on 1/6/22 at 930 pm, rash has been going since.  have gone to dermatologist and primary doctor.   diagnosed as urticaria.  had blood work drawn for autoimmune disease, hepatitis abc, iron, uric acid, sed rate westergren, c reactive protein.  all tests showed no issues.  have appointment with allergist april 4, 2022.   have taken allegra and xyzal for 6 weeks and rash was still activie.  prescribed clarinex, rash is still active.   rash will appear in random spots on body, itch for 30 mins and then go away.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 20-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Injection site was hot, red, and painful the next morning. After 24 hours the pain spread up the neck and halfway down the upper arm. There was extreme pain. The pain lessened to manageable levels over the next 72 hours. Two  weeks after the vaccine, the injection site is still hot to the touch and aches.
Severe shivering, fever (102), severe headache, upset stomach, severe chills started around 9:00 pm, chills and fever lasted until approximately 12:30 am, headache and upset stomach along with on/off chills lasted throughout next 24 hours.