chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Expired Dose of Vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
2/7 1200 dry nagging cough began and continued to get worse --still present 2/8 0700 chest tightness began, no wheezing noticed lung sounds listened to my fellow nurses, no wheezing heard 4pm took albuterol inhaler 630pm took advair inhaler  helped with tightness 2/8 0430am  upon awakening realized voice hoarseness that I have had for the past 4 weeks has gotten worse--still present called clinic  at 4pm 2/8 told to actually go from work but said was still within 48 hours of receiving vaccine so reactions can still occur.  Also told to call my PCP and relay my symptoms, which I did  No fever, chills at all Did have a severe headache, neck ache, and fatigue 2/7
tingling on a spot on lip; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling on a spot on lip) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blister of lip (getting blister on lip if while staying out in the sun without sunscreen.).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PARAESTHESIA ORAL (tingling on a spot on lip). At the time of the report, PARAESTHESIA ORAL (tingling on a spot on lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
pt recv vax 29JAN97 & devel a rash around 430PM on 1FEB97;onset sudden & rash described as whelps on bottom & waist;by 4FEB97 pt also had more of a fine rash which devel on chest, stomach, back & sides of neck
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8734), in left arm, on 21Apr2021 as dose 2, single (Lot number: EW0170), in left arm, on 06Nov2021 as dose 3 (booster), single (Lot number: 320308D), in left arm and on 03Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 59 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL, start date: 24Apr2022, stop date: 01May2022. Past drug history included: Ibuprofen, reaction(s): "known allergies ibuprofen", notes: known allergies sulfa and ibuprofen; Sulfonamide, reaction(s): "known allergies sulfa", notes: known allergies sulfa and ibuprofen. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Apr2022, outcome "recovering" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive, notes: On 07May tested positive via antigen and PCR tests; (24Apr2022) Positive, notes: First positive COVID test: 24Apr; (30Apr2022) Negative, notes: Improved and tested negative 30Apr- 04May; (04May2022) Negative, notes: Improved and tested negative 30Apr- 04May; (07May2022) Positive, notes: On 07May tested positive via antigen and PCR tests. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical information: the patient received other medication in 2weeks product=Tylenol, other medication in 2weeks brand=Johnson & Johnson, other medication in 2weeks start date 24Apr2022, other medication in 2weeks stop date 01May2022.
Shakes; Sweats; Cold Sweats; Skin was blotching red; Up all night; lot of pain; Entire upper body had rash; Chills; Fever; Body aches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), HYPERHIDROSIS (Sweats), COLD SWEAT (Cold Sweats), RASH MACULAR (Skin was blotching red) and SLEEP DISORDER (Up all night) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: NVX COV 2373 on 24-May-2021. Past adverse reactions to the above products included Myalgia with NVX COV 2373.    On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Dec-2021, the patient experienced TREMOR (Shakes), HYPERHIDROSIS (Sweats), COLD SWEAT (Cold Sweats), RASH MACULAR (Skin was blotching red), SLEEP DISORDER (Up all night), PAIN (lot of pain), RASH (Entire upper body had rash), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body aches) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) (oral) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (Shakes), HYPERHIDROSIS (Sweats), COLD SWEAT (Cold Sweats), RASH MACULAR (Skin was blotching red), SLEEP DISORDER (Up all night), PAIN (lot of pain), RASH (Entire upper body had rash), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body aches) and NAUSEA (Nausea) had not resolved.            Concomitant medications were not reported.
Shingles after first Shingrix dose; This case was reported by a nurse via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-Aug-2022 Reporter's comment: The nurse reported that the patient had Shingles after first Shingrix dose. The patient was recovered on 25th August 2022. No additional details provided at that time. The consent to follow-up was granted.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 50-year-old female patient who received SHINGRIX (batch number H7JY4, expiry date 1st July 2021) for prophylaxis. On 8th April 2019, the patient received the 1st dose of SHINGRIX. On 8th April 2019, less than a day after receiving SHINGRIX, the patient experienced pain and heaviness of head. On 9th April 2019, the patient experienced blister and erythema. On 9th April 2019, the outcome of the pain and heaviness of head were recovered/resolved. On an unknown date, the outcome of the blister and erythema were not reported. It was unknown if the reporter considered the pain, heaviness of head, blister and erythema to be related to SHINGRIX. Additional information was reported as follows:  The pharmacist reported that the patient experienced feeling achey, and having a heavy head after receiving 1st dose of SHINGRIX vaccine. The patient told her she was feeling better. 1 day after vaccination, the patient noticed that she had developed a red bubble blister on her right wrist.
administration error, injected 0.5 ml instead of 0.25 ml for the booster shot
Directly after vaccine given, pt felt tired and experienced abdominal pain, vomiting and diarrhea. Next morning 7/9/11 pt woke up with hives all over body with itching skin.  Went to ED on 7/9/11 and received prednisone and Benadryl.  Went home on both medications and took until Sunday.  Went to follow up appointment on 7/12/11 (today).  Hives and itching resolved.  Still having loose stool x 3 today and 3/10 abdominal pain with palpation.
pt stated his shoulder was tender as usual for 2 days then pain from his shoulder to his wrist for the 3rd week now.  hurts to lift his arm.  he stated the shot was given very high near his shoulder. it seemed higher to him than past experiences. pt says his arm feels like he has carpal tunnel. pt stated he has not done any extraordinary movements
Body aches, Headache, Fatigue, Nausea, Restless Took Tylenol
Increased irritability, tremors of arms, some decreased oral intake, lasted one day, then back to normal, no high fever
fever of 103;high pitchy cry 1st 24hr;diarrhea 1st 24hr mild then very cranky x 5 days;
Chest pain, shortness of breath, paresthesia, disturbance of skin sensation and elevated blood pressure reading.
Bilateral facial weakness, weakness of voice with swallowing difficulty.  Extensor weakness of right finger.   Weakness of upper lip when smiling.  C/O oral fatigue, muffled speech, voice fatigue, difficulty using a straw.
Patient was inadvertently administered a Daptacel dose today (18 Jun 2021) that was expired (with no reported adverse event); Initial information was received on 18-Jun-2021 regarding an unsolicited valid non-serious case from other health professional (Inquiry number: 00647472).  It was reported that a two-year-old female patient was inadvertently administered a 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] dose that was expired (batch number: C5624AA, expiry date: 10-Jun-2021] on 18-Jun-2021 via intramuscular route at left leg for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  This was the first dose in the series.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
A report was received from a health care professional on 21 October 2003 concerning a 3-year-old vaccinee who received Fluvirin on 21 October 2003. On 21 October 2003 the vaccinee received 0.5ml Fluvirin. No adverse symptoms were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment.
Vaccine given on 11/30/2021. Vaccine expired 11/27/2021
Fever, diarrhea, sad, whiny, time course was 1 day of diarrhea and 3 days of fever. 2 days of whiny sadness.
Baseball sized cellulitis area to L/tricep-decreased range of motion due to edema. Did not extend past elbow.
Raised, red, bumpy, itchy rash began to develop peri-axially and down upper arms bilaterally 10.5 hours post injection, becoming increasingly angry, raised and itchy over the next two days, and was still present, pronounced, angry and itchy by the date of this report (Monday, 08 February.)
1/19/2021  2nd vaccine Pfizer.   background headache post vaccine, still present 1/22/2021. 1/21/2021 cold, low temp 93F, then  registering "Low" on hand help Temp unit.  Temp unit did register normal temp for other people so not a issue with unit. naseaous, very tired. resolved by 1/22/2021
Broke out in severe rash left side neck, upper shoulder back & front.  Went to doctor - prescribed PREDNISONE.  Rash subsided after 2 days.  Sore throat & swelling of neck.   Nerve endings shoulder & back very touchy few small lesions on chest & back.  Shooting nerve pain in back shoulder.  Dr prescribed LYRICA.  July 20 the 1st day no nerve pain or itching sensation.
Diagnosed with "sub-clinical hypothyroidism" the following day symptoms included malaise without fever, fatigue, and body aches.
After receiving the vaccine, I went into a waiting room for the post-vaccine 15 minute observation. Approximately 2 minutes after sitting down I felt a sensation that can be described as a wave through my body. It only lasted for 10 seconds; however, it was immediately followed by a rapid heartbeat. It almost felt as though I might pass out (I have never passed out before). I alerted a nurse, and she monitored me for the 15 minute duration. After about 2 minutes, I felt 'normal' again.
Lightheaded, facial tingling, weird sensation in left hand. BPs 166/102 (pulse 84), 160/97 (pulse 77), O2 sats 100%.
Approximately 3-5 minutes after vaccination administration the patient lost consciousness. Approximately 5-10 seconds later the patient regained consciousness. Patient complained of feeling warm, blurred vision, and headache. Emergency medical staff arrived at scene approximately 7-10 minutes later in order to evaluate. Upon further evaluation they concluded nothing was wrong with patient and probably was a psychological (anxiety) reaction to getting a vaccination.
Vomiting; Chills; Really sore arm; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Really sore arm), HEADACHE (Slight headache), VOMITING (Vomiting) and CHILLS (Chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Really sore arm), HEADACHE (Slight headache) and CHILLS (Chills). On 16-Apr-2021, the patient experienced VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Really sore arm), HEADACHE (Slight headache), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.            Concomitant products information was not provided by the reporter. Action taken with mRNA-1273 in response to the events is not applicable.
I felt tingling like kind of about 10 minutes after having the vaccine as I was standing there, I felt a little tingly.; little zingy feeling in my left pinky and ring finger; Pain injection site; This is a spontaneous report from a contactable physician (patient).  A 50-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at left arm on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included was none.  The patient's concomitant medications were not reported.  The patient reported: " pain injection site" and "I felt tingling like kind of about 10 minutes after having the vaccine as I was standing there, I felt a little tingly. I had the vaccine in my left arm in my right hand I had a little tingly feeling and I was like well maybe because I am holding my pocket book on that side I shifted over, at work I am getting like just a little zingy feeling in my left pinky and ring finger". The patient outcome of the events was unknown.
symptoms like having the flu but without a fever; extreme Tiredness; Headache; muscle aches throughout entire body; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date).   On 29th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 30th July 2020, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, tiredness, headache and muscle pain. On an unknown date, the outcome of the influenza-like symptoms, tiredness, headache and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, tiredness, headache and muscle pain to be related to Shingrix.  Additional case details were reported as follows: The patient experienced next day after vaccination headache followed by muscle aches throughout entire body and then extreme tiredness towards the end of the day.  The patient described symptoms like having the flu but without a fever. The reporter consent to follow up.
Fainting after 1st shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting after 1st shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Fainting after 1st shot) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting after 1st shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided. Treatment medication was not reported.  Very limited information regarding this event has been provided at this time. Details including the date of vaccination and onset of syncope, medical history, concomitant medications, tests/diagnostics, and treatment are required for further assessment.; Sender's Comments: Very limited information regarding this event has been provided at this time. Details including the date of vaccination and onset of syncope, medical history, concomitant medications, tests/diagnostics, and treatment are required for further assessment.
I first encountered nausea. Approximately 30 minutes later my skin began to feel hot, a rash appeared on my entire body and then itchy hives. I immediately took (2) benadryl tablets and drank a glass of milk. This seemed to help decrease the hives and itchyness in about an hour. My body felt hot from the inside out but I did not have a fever. My temperature at the time was 96.8 but my skin felt hot to touch. I continue to have digestive issues since the side effects began. I haven't had hives any longer but continue to feel hot and itchy from the inside out. I have to take benadryl tablets every 8-10 hours. The hotter I feel, the more I seem to itch.
I received the tetanus shot in the right upper arm, immediately following, I had a muscular pain that restricted all movement and lifting ability.  It slowly became manageable, but even currently, three weeks later, it still limits my range of movement, becomes sore after a days' movement, and limits my ability to pick up normal items like a gallon of milk.  I have used ibuprofen, heat, showers, ice, and temporary limiting my use, nothing has helped more than temporarily.
Within 5 minutes post-administration the patient reported dizziness, sweating, vision disturbances (blotchy vision), shaking hands.  Over the next few minutes it appeared to worsen.  EMS was called and by the time they arrived 10 minutes later he was feeling better.  He was released from the their care and claims he is fully recovered.  It is suspected that it could be a panic attack, but he is not sure.
Patient presented on May 15, 2021 with sudden right lateral inferior chest pain that awoke him. He noted a feeling of heaviness and mild dyspnea for two days prior. Worse when flat. Hypoxic. Right upper quadrant guarding and tenderness. Treated with anticoagulation as an outpatient.
Aprox 6-8 minutes after getting the vaccine, pt stated felt slightly dizzy.  Heart rate: 48, Pulse Oximeter: 98%.  heart rate went up to 61  Paramedics took her to the ER.  Pt was alert and oriented.
Beginning at 9 pm: alternating fever, chills; continuous  pain in arms and legs, did not sleep well- looked at the clock almost every hour. In the morning, suddenly felt nauseated and hot. Went to bathroom and lay on the cool tile floor. Nausea went away.STill aching all over. Took 2 Tylenol with a glass of milk , and within 15 mins, felt better. Was OK the rest of the day.
cardiac injuries requiring triple bypass surgery; post herpetic neuralgia; balance injuries; neurological injuries; lesions on face; atherosclerosis; chondrocostal junction syndrome/tietze syndrome; painful and crippling shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age .The pt's medical history, concurrent conditions and concomitant medications were not provided. On 09-NOV-2016, the pt was vaccinated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) at a pharmacy for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In March 2017 (reported as "approximately four (4) months after receiving zoster vaccine live(ZOSTAVAX)"), pt suffered debilitating injuries including painful and crippling shingles, post herpetic neuralgia, balance and other neurological injuries, lesions on her face, atherosclerosis and other cardiac injuries requiring triple bypass surgery, and eventually chondrocostal junction syndrome/Tietze syndrome, all as a result of zoster vaccine live(ZOSTAVAX). As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX) and caused by the zoster vaccine live(ZOSTAVAX). Pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and disfiguring personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, 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 zoster vaccine live(ZOSTAVAX), pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   The events painful and crippling shingles, post herpetic neuralgia, balance and other neurological injuries, lesions on her face, atherosclerosis and other cardiac injuries requiring triple bypass surgery, and eventually chondrocostal junction syndrome/Tietze syndrome were considered as disability. Upon internal review, cardiac injuries requiring triple bypass surgery was determined to be medically significant.
Staring spells, loss of 12 word language, loss of eye contact, no longer looks when named is called, excessive spinning, loss of finger pointing, white coated tongue, yellow colored diarrhea on/off for three weeks straight.
pt recvd vax & devel high fever 105;  high pitched crying hypotonic;
No menstrual bleeding. My period should?ve started five days after the first vaccine in it did not. No menstrual period for two months and then September 19 Began spotting brown blood for about a week and now bleeding heavily for the last three days