chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received regarding a case in litigation, from a lawyer concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2012 (reported as on or about 2012), the patient was vaccinated with a dose of ZOSTAVAX as permanent prevention and protection against shingles and zoster-related injuries (prophylaxis). (Strength, dose, route of administration, anatomical location, lot # and expiration date were not reported) due to a health care professional recommendation. On an unknown date, the patient experienced shingles (herpes zoster) and other zoster-related injuries despite being inoculated with the ZOSTAVAX vaccine. On an unspecified date in 2015, the patient was treated by its health care provider for shingles. It was also reported that the patient suffered serious physical, emotional and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of latent conditions, lost wages, loss of earning capacity and other losses and damages. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and  the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Really itchy; Feels fluidy like puffy inside arm; Arm has red square shape; Headache; Fever; Body aches; Very tired; Felt out of it; Felt sleepy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE OEDEMA (Feels fluidy like puffy inside arm), FEELING ABNORMAL (Felt out of it), SOMNOLENCE (Felt sleepy), VACCINATION SITE PRURITUS (Really itchy) and VACCINATION SITE ERYTHEMA (Arm has red square shape) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer of bronchus stage IV (Stage 4 cancer).   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced FEELING ABNORMAL (Felt out of it), SOMNOLENCE (Felt sleepy), HEADACHE (Headache), PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Very tired). On 21-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm has red square shape). On 22-Mar-2021, the patient experienced VACCINATION SITE OEDEMA (Feels fluidy like puffy inside arm) and VACCINATION SITE PRURITUS (Really itchy). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 20-Mar-2021, FEELING ABNORMAL (Felt out of it), SOMNOLENCE (Felt sleepy), HEADACHE (Headache), PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Very tired) had resolved. At the time of the report, VACCINATION SITE OEDEMA (Feels fluidy like puffy inside arm), VACCINATION SITE PRURITUS (Really itchy) and VACCINATION SITE ERYTHEMA (Arm has red square shape) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications were reported.    This case was linked to MOD-2021-063795 (Patient Link).
Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. On an unknown date [reported as "shortly after" receiving the ZOSTAVAX, the patient developed a painful rash on the left side of his face, which was accompanied by blurry vision in his left eye, pain, weakness, and fatigue. As a result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the ZOSTAVAX. As a result, 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 proximate result of the ZOSTAVAX, the patient suffered serious physical injuries and incurred substantial medical costs and expenses, including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical expenses and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events were considered to be not recovered. Painful rash on the left side of his face, blurry vision in his left eye, pain, weakness, and fatigue were considered to be disabling. Additional information has been requested.
had 3 shingle shots, then shingles/suspected vaccination failure; 2 bouts of shingles after the shots; had 3 shingle shots; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 17-Dec-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had 3 shots and have had 2 bouts of shingles after the shots. The patient stated not good. The reporter denied to follow-up. Additional supportive information: The patient received 3 shots of Shingrix, which led to extra dose administered. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Chills, shaking for 15 minutes; called pharmacy who recommended Tylenol. The next 2 days was overly exhausted.
p/vax pt rt leg red, hard, warm mom told to apply warm compresses & infant APAP q 4hr still area size of a nickel-hard & red extremely fussy;no fever;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Pt started feeling lightheaded and dizzy 3 mins post injection. He has a phobia of needles and this happens each time he gets a vaccine or blood drawn. Pt reported feeling "whoozy and felt like he was going to pass out". I had the patient put his head between his legs and took his vitals Q5mins until he stablized. He remained seated in the post vaccine area for 30 mins until his vitals were normal and he felt fine to go home! Vitals @ 4:05 pm BP: 79/56 mmHg, HR 156 bpm, O2 98%
Welts Hot to touch Itchy mouth/tongue  Red Severe arm pain Nausea  Fatigue
COVID vaccine breakthrough case. Moderna 018B21A on 4/3/21, Moderna 040B21A on 5/1/21, and booster Moderna 060H21A on 1/10/22
received 4th dose of Kinrix instead of Infanrix; 14 months old received Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 14-month-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   Previously administered products included Infanrix (1st dose received on 20 September 2022), Infanrix (2nd dose received on 23 November 2022) and Infanrix (3rd dose received on 23 January 2023).   On 02-OCT-2023, the patient received Kinrix. On 02-OCT-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: received 4th dose of Kinrix instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: 14 months old received Kinrix).  The outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration 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: 04-OCT-2023 The healthcare professional requested data on the interchangeability of Kinrix and Infanrix. The healthcare professional reported that Infanrix was administered on 20 September 2022 as 1st dose, 23 November 2022 as 2nd dose, 23 January 2023 as 3rd dose and Kinrix was administered on 02 October 2023 as 4th or Booster dose instead of Infanrix which led to inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.  The vaccine administration facility is the same as primary reporter.
39yo M with adverse reaction to Pfizer vaccine booster on 14 January causing nausea, extreme body aches, fatigue, dizziness to the point where the pt couldn't move on his own. Was transported via ambulance to ER. Per pt, CXR and labs were unremarkable. Symptoms have resolved except for a slight cough since
Hot bump at injection site; Numb arm; Pain; Red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot bump at injection site), HYPOAESTHESIA (Numb arm), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (Red at injection site) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot bump at injection site), HYPOAESTHESIA (Numb arm), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (Red at injection site). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency and DIPHENHYDRAMINE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot bump at injection site), HYPOAESTHESIA (Numb arm), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (Red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication provided include birth control medication.  The patient reports that she only had pain for the first few days and the other symptoms started after few days.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up appended.
On same day of vaccination, pt reports painful shooting nerve pains of both arms and hands. Subsequently 7 days after vaccination developed severe swelling of both hands and hand joints. Required treatment with course of prednisone.
Developed COVID-19 3/14/2023. Positive rapid antigen test. Fever to 101.4 degress. Myalgias. Purulent cough. Prescribed Paxlovid on 3/14/2023 with improved symptoms in 48 hours. Still with persistant cough but much improved.
No adverse event reported. Pt may have received expired vaccine and this is why Pharmacy has me reporting this as a VAERS.
Starting on night of 8/22/21, father started to experience sever pain and loss of sensation in both legs.  On 8/23/22 father went to ER where he was sent home with pain medicine.  On 8/24/22, father was life flighted to Hospital where he was diagnosed with an acute aortic occlusion.  Father had both legs amputated above the new, a colostomy placed, and I deer went dialysis.  Father spent time in hospital, rehab center, and is currently undergoing physical therapy.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm), PERIPHERAL SWELLING (Swollen, about 4 inches on the left and right arm), VACCINATION SITE INFECTION (Looks infected), VACCINATION SITE PAIN (Hurts) and VACCINATION SITE ERYTHEMA (Red arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm), PERIPHERAL SWELLING (Swollen, about 4 inches on the left and right arm), VACCINATION SITE INFECTION (Looks infected), VACCINATION SITE PAIN (Hurts) and VACCINATION SITE ERYTHEMA (Red arm). At the time of the report, VACCINATION SITE WARMTH (Warm), PERIPHERAL SWELLING (Swollen, about 4 inches on the left and right arm), VACCINATION SITE INFECTION (Looks infected), VACCINATION SITE PAIN (Hurts) and VACCINATION SITE ERYTHEMA (Red arm) outcome was unknown.       No relevant concomitant medications was reported. Treatment information was not provided.    This case was linked to MOD-2021-374319 (Patient Link).
A 1 inch raised skin around the injection sites, not itchy and no fever or body aches. The reaction occurred 1 day after the injection.
Infant received immunizations 2/17/04. Baby fainted this morning, staring and unresponsive with slow breathing. Recovered then slept deeply. Stated this happened before after shots but did not inform us until now. Discharge summary on 04/28/04 states: Patient had 4 seizures 2/19/04. Admitted to hospital 2/19/04. Has neurologic evaluation 3/12/04 and was diagnoed with benign familial infantile seizures disorder. She receives Phenoberab BID.
Patient (DOB 6/11/1980) received dose 1 of the Pfizer COVID vaccine (lot EW0162, expiration 7/2021) at 1050. At 1052, patient laid down on the ground with her feet propped up on her chair in the observation area. PHN and RN approached the patient to assess. Patient reported blurry vision and feeling as though she was going to faint before she laid down. Patient reported a fear of needles and fainting with previous injections. Vital signs: O2 98%, pulse 72, blood pressure 120/90, respirations 14. Patient reported eating breakfast then going on a run before coming to the vaccine POD. Patient denied allergies, medications, or medical conditions. At 1058, patient reported symptoms were improving. Vital signs: O2 97%, pulse 70, blood pressure 120/95, respirations 14. At 1102, the patient sat up, drank some water, stated she felt wobbly and laid back down. Vital signs at 1104: O2 98%, pulse 66, blood pressure 120/90, respirations 14. Patient sat up reporting decreased dizziness. At 1114, vital signs: respirations 16, O2 99%, pulse 72, blood pressure 120/98. At 1116, patient stood up momentarily while monitored closely by PHN  and RN, then laid down again reporting feeling dizzy. Vital signs at 1118, O2 96%, pulse 69, respirations 16, blood pressure 120/90. Patient sat up, then laid down again reporting dizziness. PHN asked patient to contact a family member to drive her home. Patient reported she wanted to leave and wait for her husband in her car instead of the vaccination room. PHN encouraged patient to wait in the observation room so medical staff could monitor until symptoms resolved or called 911 per emergency protocol. At 1130 patient sat up. At 1138, patient stood up, denied dizziness. RN  walked patient out to the parking lot. Patient left at 1140, walking with steady gait.
Initial unsolicited report received from a non-health care professional on 29 Sep 2016. This case was linked with case 2016SA181116 (same vaccine). This case involves a patient (gender and age not reported) who was vaccinated with a dose of Fluzone QIV (Batch number, expiration date, dose, dose in series and site of administration were not reported) intramuscularly on 16 Sep 2016. Patient's medical history as Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not provided. Illness at the time of vaccination was also not provided. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date, unspecified timeframe following the vaccination, the patient developed redness, swelling and tenderness at the injection site. It was reported that the symptoms progressed over three days to encompass her whole upper arm. Laboratory investigations and corrective treatment were not reported. The patient recovered from all the events on an unknown date (reported as symptoms resolved). List of documents held by sender: none.
Patient is a 66-year-old female with a history of diabetes hyperlipidemia hypertension low back pain who presents from vaccine clinic complaining of numbness and tingling in her left lower extremities. Patient also states she has been having nausea and mild headache. she notes that she took her blood pressure medicines this morning as per her usual. She denies any chest pain palpitations domino pain or diarrhea. Patient states she thinks she may have history of sciatica note that this pain feels different from her normal numbness and tingling in the lower extremity.
A few days post second dose of Moderna COVID vaccine, symptoms included frequent episodes of heart palpitations, chest pain, dizziness, and fainting.
The pediatric Pfizer vaccine should have been taken out of the fridge and not used on 1/27/2022 but it was given to patient on 1/28/22. Shot was expired by about 18 hours. We contacted pfizer but they have no further data on stability. No adverse effects reported by patients parents.
After the initial fever, chills and vomiting for two day after shot, I now have weird tingling under my skin across my entire back. Almost like their is something crawling around under my skin. Sometimes that feeling extends to shoulders and hips. I feel weak most of the day.  My blood pressure is more elevated than normal.  It has been 14 days since the shot.
No additional AE information; MMRII that had been reconstituted with expired diluent had been inadvertently administered to a patient.; MMRII that had been reconstituted with expired diluent had been inadvertently administered to a patient; This spontaneous report was received from a consumer referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  A dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route, lot number and expiration date were not provided) which had been reconstituted with expired sterile diluent (STERILE DILUENT) (lot# S025290, expiration date 20-MAR-2022) was inadvertently administered to the patient on 30-MAR-2022 for prophylaxis (expired product administered, product preparation issue). The vaccine was not expired and did not experience any temperature excursions. The diluent did not experience any temperature excursions. There was no additional adverse event or product quality complaint.
Form would change his DOB. Patient's DOB. Vaccine was adminstered post expiration. A letter was sent to the patient's address on 2/17/2023 stating manufacturer's vaccine activity at the time of administration.   Manufacturer Statement: Moderna reviewed the stability of the vaccine you received and determined that it maintained the activity necessary to protect against COVID-19 at time of administration. Moderna cannot guarantee the protection you have received is equivalent to what was seen in studies and data is not available to support administering an additional dose of vaccine to you. However, if you wish to undergo revaccination, we will provide you access as outlined below.  Patient called on 2/22/23 at 11:29 am and left a message stating" I received a letter in the mail about an error in recording the expiration date. I just want to know if I need to receive another vaccine."; I, called the patient back at 12:18 pm on his cell phone as requested and left a voicemail for a return call. The patient called back at 12:49 pm; he was informed of the manufacturer's response; he verbalized understanding and gratitude; he also declines revaccination at this time.
Information was received on 20-APR-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine on or about 24-FEB-2012 at a medical facility, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-MAR-2013, the patient was treated at a physician's office for a painful rash that was diagnosed as shingles. Although shingles is a viral condition that is incurable, the patient was prescribed valacyclovir (VALTREX) (manufacturer unknown) to manage his outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
No initial adverse reactions to shot until 5am the next morning, temp 103.2, right arm at injection site red, hot, swollen around and indurated. Despite Motrin and Tylenol cycling, fever did not drop below 101 and continued to spike to 103 until Monday 4/18/22. Arm continued to be swollen, pain felt like a tourniquet around my arm despite continued OTC medications and trying warm and hot packs. Also at this time, despite not being or expecting to menstrate, extremely heavy flow with clots lasted from 4/17 until stopping entirely 4/19. Right armpit swollen and painful lymph node also started the morning of 4/16 and is still as of this report date palpable and painful
Patient stated that about 10 hours after receiving the prevnar 20 and Pfizer bivalent he became very lethargic, chilled and sweaty, nausea and vomiting and experienced full body pain.   This lasted severely for about  12 hours throughout the night and he stated he could not sleep and just paced.  It took 4 days for him to be able to fully recover.