chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/08/2021 Patient developed dizziness and burning sensation to both legs after vaccination, on 10/09/2021 developed rash on both knees, on 10/10/2021 rash spread below both knees up to ankles and developed whelps on both legs, on  10/11/2021 the patient was assessed by PCP and received a steroid injection and medication for dizziness, and on 10/12/2021 patient developed bruising on both legs.
This case was reported by a consumer via interactive digital media and described the occurrence of Bell's palsy in a male patient who received SHINGRIX for prophylaxis. The patient's past medical history included herpes simplex. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, several months after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant) and herpes simplex. On an unknown date, the outcome of the Bell's palsy and herpes simplex were unknown. It was unknown if the reporter considered the Bell's palsy and herpes simplex to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter's ex took the shingles vaccine in his part of the herpes simplex virus. Few months after vaccination, the patient came down with Bell's palsy, which was a part of the herpes simplex virus. The patient did not take any shots of that nature anymore.
Patient received a booster dose of Pfizer (Comirmaty) at 11:20 am and immediately developed a red raised rash approximately 4 in in diameter at injection site. Denies any SOB, Chest pain, feeling Nausea, Light hotheadedness. V/S all W.N.L. Rash remained for 15 minutes. No other complaints noted. Patient was able to leave self ambulatory. Was advised to continue to watch for any  life threatening symptoms, if they appear to call 911 and when possible report any abnormal conditions to HCP. Patient stated understanding of instructions.
Baby was 4 1/2 months old when initiating immunization series, No shots prior to this date. No adverse event noted.
The day he got the vaccine he was fine and he got the vaccine earlier in the morning but the next day he woke up and he was very tired and was running a fever of 100.3 and that was at 6 AM. He took a dose of Tylenol and went back to bed. He was very weak and lethargic, and at 1:00 PM his fever was at 103.4  so we called the Doctor and I put him in a bath and let him cool off and his fever broke after the bath. He was still tired and lethargic the rest of the day and two days afterwards but his fever did break. His fever broke at 530 PM and it did not go down with Tylenol or Motrin. His weakness was bad that he couldn't get to the couch to the bath. We only called and talked to nurse and they said if it reached 104 to go to the ER.
pt recvd vax 21SEP92 11AM & mom reports that 11PM that day pt devel severe h/a, nausea, vomiting; by 3AM 22SEP92 h/a gone; t103.5 ax during noc;
diluent other than the one supplied by GSK; diluent other than the one supplied by GSK; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced wrong solution used in drug reconstitution (Verbatim: diluent other than the one supplied by GSK) and inappropriate dose of vaccine administered (Verbatim: diluent other than the one supplied by GSK). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of 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: 06-MAR-2023 The reporter stated that he/she understood lyophilized Rotarix should be reconstituted with the provided diluent but what would be the consequence if it was reconstituted with sterile water or normal saline instead.  The reporter wanted to know would the dose still be effective or it should be repeated. Adverse event was completed as conservative.  The reporter consented to follow up. The reporter stated that he/she understood lyophilized Rotarix should be reconstituted with the provided diluent but what would be the consequence if it was reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Patient reported feeling itchy around the neck after vaccine injection. States this is some reaction she received with sulfa drugs. Patient felt better after 10 minutes.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 28-SEP-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Less than one week after receiving the ZOSTAVAX, the patient suffered from herpes zoster and post herpetic neuralgia. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the herpes zoster and post herpetic neuralgia was considered to be not recovered. Herpes zoster and post herpetic neuralgia was considered to be disabling. Additional information has been requested.
Intensive pain left back-deltoid-pectoral muscles 5 days. 2nd day whole shoulder area turned red like bad sun burn. 3rd day whole area real itchy. First three days mucus discharge would glue eyes shut in mornings. Eyes painful for 3 days.
I woke up on 11/14 morning and was itching all over, later in the day I started having hives to my elbows and a few other itchy spots. I took a zyrtec and it helped. Later in the evening I had to take a benadryl because the itching/hives were bad. On monday I called my PCP and they wanted to do an appt but I worked on Tuesday. Monday night I did not sleep well, I had itching all over, heartburn and some tightness in my esophagus. I went to health office at work on Tuesday morning, they put me on steroids. I did not start any new foods, detergents, lotions, etc.
Pt. went in for routine MRI and was told she had swollen lymph nodes on left armpit - (when questioned about vaccine use) - she said she got a SHINGRIX shot. Dr. said it was probably due to vaccine because SHINGRIX causes swollen lymph nodes.
Client received 2nd COVID vaccine of Pfizer (Lot# EW0186 expiration 07/12/21) at 1358. Client  is being observed in vaccination room with PHN. At 1406, Client reports lightheaded, numbness at the injection site (left arm) and tingling in the left fingertips to PHN. Client reports a history of anxiety, no medications, and has an allergy to tofu/soy. Client was placed onto the zero-gravity chair. At 1412, RN obtains vital signs which are blood pressure 140/82, heart rate 92, oxygen saturation 97%. At 1416, lightheaded is improving, but numbness and tingling is still present. RN assisted in translation. PHN and RN educated Client about common adverse effects on the COVID vaccine and ED precautions. Client was offered and accepted both water and snacks. At 1421, vital signs are blood pressure 152/80, heart rate 82, oxygen saturation 95%. Client  denies headache, shortness of breath, chest pain, lightheaded is improving, numbness and tingling of the arm and fingertips are the same, and reports "feeling heavy" and feels "a little sleepy." PHN offered to call emergency services for further evaluation and Client accepted. At 1426, vital signs are blood pressure 132/82, heart rate 86, oxygen saturation 96%. At 1427, emergency services was called by PHN and arrived at 1435. Emergency services arrived and assessed Client. Client denied transfer to hospital for further assessment and reports tiredness is improving. At 1442, Client goes against medical advice from the emergency services. RN waits with Client as client calls for a ride to pick her up. At 1447, Client reports "feeling better'" while eating Pringles and drinking water. Client states "muscle tightness in the body coming from the back". PHN advises Client to follow up with primary care provider. At 1454, client states feeling "nothing serious" and only tiredness. RN is with Client for observation. At 1540, client is walked to the bathroom with RN. Client denies dizziness, shortness of breath, chest pain, lightheaded, and pain at injection site. At 1546, Client's father arrived. Client stood up with no complaints and with a steady gait. RN and Ancillary accompanied Client to car.
Information has been received from a certified medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female with no drug reactions who on 09-FEB-2011 was vaccinated with the first dose of GARDASIL (lot # 666597/0768Z) (exp date unspecified) and on 27-APR-2011 she was vaccinated with the second dose of GARDASIL (lot # 667866/1437Z) (exp date unspecified). There was no concomitant medication. It was reported that the patient had no other health issues other than pregnancy of 13 weeks at the time of the call. There was a "series of human chorionic gonadotropin (HCG)" done for patient (no result reported). The patient sought medical attention by contacting office. The patient's LMP was approximately on 14-JUL-2011 and estimated delivery date is on 19-APR-2012. The patient was also reported to have had a miscarriage in February 2011. It was unclear at the time of this report if the miscarriage was prior to or after the first dose of GARDASIL. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
Zostavax SC rec'd 5/31/2007. To clinic 6/4/2007 with localized reaction @ left arm with 3 inch diameter area pink et warm with 1 1/4 inch diameter center that is red, hard et raised. C/O itch subsiding with scratching @ perimeter only. C/O  "fullness et pressure" @ occipital area of head et neck. Afebrile @ home. Temp @ clinic 98.0
Two weeks later he woke up midnight and went to the bathroom and he had chills and according to him his whole body was shaking and was very cold and was really tired the next day. So we went to the doctor and she just asked question and just listened to his heart but couldn't figure out what it was.
Macular rash right arm Injection Site after second shot; Swelling right arm Injection Site after second shot; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE RASH (Macular rash right arm Injection Site after second shot) and VACCINATION SITE SWELLING (Swelling right arm Injection Site after second shot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Immune disorder (NOS). Concurrent medical conditions included ANA (Positive) since 1988.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE RASH (Macular rash right arm Injection Site after second shot) and VACCINATION SITE SWELLING (Swelling right arm Injection Site after second shot). The patient was treated with IBUPROFEN at a dose of 100 milligram. On 23-Mar-2021, VACCINATION SITE RASH (Macular rash right arm Injection Site after second shot) had resolved. On 23-Apr-2021, VACCINATION SITE SWELLING (Swelling right arm Injection Site after second shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: normal (normal) Normal and normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The physician prescribed an EpiPen for the 2nd dose.  The patient used cold compress as treatment.   This case was linked to MOD-2022-551364, MOD-2022-551605 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2022: Live Follow up included Laboratory.
administered an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received HAB (Twinrix) (batch number unknown, expiry date 28th November 2020) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th October 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 20th October 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was inadvertently administered an expired dose of Twinrix, which led to expired vaccine used. The reporter consented to follow up.
headache; Loss of smell; COVID-19; Diarrhea; Watery eyes; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), RHINORRHOEA (Runny nose), HEADACHE (headache), DIARRHOEA (Diarrhea) and ANOSMIA (Loss of smell) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 075J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and LACRIMATION INCREASED (Watery eyes). On 14-Jan-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced RHINORRHOEA (Runny nose), HEADACHE (headache) and ANOSMIA (Loss of smell). On 17-Jan-2021, RHINORRHOEA (Runny nose) and DIARRHOEA (Diarrhea) had resolved, HEADACHE (headache) and LACRIMATION INCREASED (Watery eyes) outcome was unknown. At the time of the report, COVID-19 (COVID-19) and ANOSMIA (Loss of smell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Hypotonic-hyporesponsive episode lasting approx 45 min; and brief episode 12hrs later;
doses administered after excursion; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.         For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No concomitant medications were reported.  The pharmacist reported that, temperature excursion occurred several days ago in the freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer, and they just found out about the excursion in an audit.   No adverse event reported for the patient.  No treatment medications were reported.
Shortly after receiving vaccination patient had a witnessed syncopal event while in a seated position. Pt fell forward from the chair sustaining a nasal injury resulting in epistaxis. EMS was called to the scene. Initial VS prior to EMS arrival was: BP138/80, HR 74, RR 16. When EMS arrived patient was moved into a seated position on the floor. Within 1 minute patient stated that they didn't feel well like they were going to pass out again, became nauseous and pale. Patient placed in supine position and repeat VS of BP: 95/53, HR 72 and RR 16. Patient was placed on EMS stretcher and transported to  Hospital Emergency Department for further evaluation/treatment. *Of note, patient stated afterwards that he has passed out with prior lab draws/immunizations.*
received one dose of improperly stored VARIVAX; No additional adverse effects reported; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On 01-MAY-2020, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, lot # R020654, expiration date 18-JUL-2020 (strength, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted in properly stored sterile diluent. The dose of the vaccine was exposed to temperature excursion at 5.7 Fahrenheit (F) degrees (-14.6 Celsius degrees) for 18 minutes. There were previous temperature excursions at -13.3 Celsius degrees for 18 minutes and -13.2 Celsius degrees for 18 minutes. The call was due to digital data logger. No additional adverse effects reported.
Angioedema; ED visit for toes/feet swelled up and got red; improved following treatment with prednisone.
Day of: Soreness in arm, redness/swelling at injection site, headache Next Day: Fatigue, chills, headache, body ache, 100.4 fever, redness/swelling at injection site 2nd Day Post Shot: headache, injection site redness/ swelling less severe
Chills & shaking Arm real sore & hurting a little High Fever (102) at l:30 AM 10/28/2010 Aching all over Used cold wet cloth on face & body for 3 Hrs. Temp. OK at 7:30 AM 10/28/2010
This case was reported by a consumer via call center representative and described the occurrence of chills in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 20th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 24th January 2019, 4 days after receiving SHINGRIX, the patient experienced lung congestion (serious criteria GSK medically significant). On an unknown date, the patient experienced chills, stomach pain, erythema and pain. On an unknown date, the outcome of the chills, stomach pain, erythema and pain were recovered/resolved and the outcome of the lung congestion was not reported. It was unknown if the reporter considered the chills, stomach pain, erythema, pain and lung congestion to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on left arm. Chills and stomach ache were lasted for about 2 hours. Redness and soreness were lasted for 4 days. The patient experienced chest congestion. The patient was referred to healthcare professional. The consent to follow up was provided. No further details were provided.
Swelling, redness, hot, pain symptoms 2/4/03-2/8/03. 2/8 on swelling down pain subsiding. IV treatments of steroids, antibiotics, and Demoral. I was told it was muscle inflammation.
Began getting scaly hard itchy patches on scalp. Within weeks, those same types of patches began forming on my arms and legs. Most recently I am now getting them on my torso.
Patient stood up after vaccine and then fainted and hit his head on the wall on the way to the ground.  He was able to be revived within a minute, we also had EMS come to check him out, all vitals normal and he did not have to go to the hospital.
No adverse event; 17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date).    This case belongs to adult patient 6 of the 17 adult patients reported.  No concomitant and treatment medications were reported.  17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date.   This case was linked to US-MODERNATX, INC.-MOD-2023-698998.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: Live follow up received and contains non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698998:master case
Swollen and rash around area of injection. Gave BENADRYL at home.
The pt experienced a red patch at the injection site. Had also complained of arm pain 6 hours post vax.
MOM CALLED TO STATE THAT PT HAS BEEN CONSTANTLY THROWING UP SINCE 6 PM LAST EVENING.
Client c/o swelling to the site of vaccination.  Client seen and assessed by EMT and vital signs are:  BP 210/90, O2 98, HR 78.  Vital signs were reassessed and client was advised to go to the ER but refused to be transported by EMT.  Pt. stated that she would drive herself but advised to call someone to take her and she called her son to come meet with her and accompany her to the ER.  Client cleared but strongly advised to go to the ER.