chrisvoncsefalvay/vaers-outcomes huggingface dataset:
anaphylaxis; This spontaneous report was received from a pharmacist via Pfizer and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced anaphylactic reaction to vaccine. The outcome of anaphylactic reaction was unknown. The event of anaphylactic reaction was considered to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown).  Upon internal review, the event of anaphylactic reaction was determined to be medically significant.
Swollen Red circular area about 3? across at injection site. . Tender, hot to the touch, feeling of weakness down entire arm.
Adverse events started approximately 6-8 hours after vaccination and completely disappeared by 48 hours after the vaccination. The events were not severe, did not require me to visit a Doctor or take any medication apart from lying in bed for most of the time. The adverse events included: Moderate pain throughout whole body, moderate-to-severe pain at the injection site, feverish feeling (I did not measure the temperature), occasional chill, temporary loss of taste in my tongue for a day or two, lack of appetite, acidic sensation in my upper throat, partially blocked nasal passages, moderate fatigue
07Oct90 pt vax 3rd dose; titer neg.  21Dec90 vax 4th dose;  titer borderline
- On 4/4/2021, received 1st Pfizer dose (lot number ER8734) at around 11:30am - On 4/22/2021, red marks started to appear on right thigh and right side of groin started to ache - On 4/25/2021, received 2nd Pfizer dose (lot number ER8735) at around 11:45am - On 4/27/2021, dermatologist diagnosed shingles and prescribed Valacyclovir which the patient started taking the next day - On 5/12/2021, dermatologist verified that the patient had recovered from shingles - On 6/16/2021, MD (ENT) diagnosed tinnitus; the patient started to notice this condition several months prior (which coincided with the vaccinations); the condition has not resolved
Felt sleepy; lightheaded/dizzy; Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Felt sleepy), DIZZINESS (lightheaded/dizzy), FATIGUE (Tired) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Felt sleepy), DIZZINESS (lightheaded/dizzy), FATIGUE (Tired) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Felt sleepy), DIZZINESS (lightheaded/dizzy), FATIGUE (Tired) and HEADACHE (Headache) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications reported.  This case was linked to US-MODERNATX, INC.-MOD-2021-077630 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077630:2nd Dose Case
arm was itchy; redness on arm inside arm to elbow; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm was itchy) and ERYTHEMA (redness on arm inside arm to elbow) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (arm was itchy) and ERYTHEMA (redness on arm inside arm to elbow). At the time of the report, PRURITUS (arm was itchy) and ERYTHEMA (redness on arm inside arm to elbow) outcome was unknown.      Action taken with mRNA-1273 in response to the events was not applicable     The concomitant product and treatment were not provided.
Polymyalgia rheumatica; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around May 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, and lot # not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).               On an unspecified date, "shortly after" receiving zoster vaccine live (ZOSTAVAX), the patient experienced polymyalgia rheumatica. As a direct and proximate result of the defective Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of Zoster Vaccine Live (ZOSTAVAX), Plaintiff sustained severe and permanent personal injuries. The outcome of the event was considered as not recovered.     The reporter considered polymyalgia rheumatica to be related to Zoster Vaccine Live (ZOSTAVAX).  Polymyalgia rheumatica was considered to be disabling.  Upon internal review polymyalgia rheumatica was considered to be medically significant.
This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1 (Lot Number: Not provided)), for COVID-19 immunization. The following information was reported: INJECTION SITE PRURITUS (non-serious), outcome "unknown", described as "her injection area got itchy". Additional Information: The patient stated that her injection area got itchy on the second or third day after the second dose. She mentioned the itchiness to her daughter and said that she did not want to rub the area because her vaccine administrator told her not to rub the area but her daughter's vaccine administrator said that she should rub the area. The patient wanted a clarification on the correct answer and was not wanting to say that the itching was a side effect and the itchiness was part of the healing process. The patient stated that her concern was that no one should be advising patients to rub the area or not rub the area if Pfizer does not have any information about this. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Ringing in ears. Extreme fatigue. Tingling sensation (like hitting funny bone)  started in fingers and toes until entire body tingled.  Disoriented, feeling spaced out, unable to focus. Symptoms lasted all day. Went 1 week without any symptoms then all of them came back in spells that last 10 minutes to 1 hour or more.  Symptoms still continue.
Information has been received from a registered nurse (R.N.) concerning a 27-year-old female medical student who was vaccinated with a three dose series of Recombivax HB (manufacturer unknown) while in high school.  When her titer levels were checked (on an unspecified date) she was at zero conversion.  The nurse reported that they restarted the series with the patient and when the patient's titer was checked it was at zero and it was checked again after the second dose with the same results.  It was reported that unspecified medical attention was sought.  No outcome was reported.  No product quality complaint was involved.  Additional information has been requested.
On 4/21 Vaccine transported refrigerated and upon arrival to the clinic, vaccine placed in freezer.  On 4/28 vaccine placed in refrigerator and 6 patients received vaccine.  Per manufacturer, patients that received the vaccine is within the excursion allowance  as well as the time period it was stored. Temps ranges from -50 c to -15 c  (freezer) storage between 24 and 2 weeks is a supported excursion.   Per manufacturer, remaining doses are not recommended to be used and will be discarded with wastage reported.
to use other arm to move that arm, it is slightly better/If she engaged her muscle she would not lift it; painful/this is day 12 of pain and describes it as severe/It hurt so much; it was an unusually painful injection; muscle pain and weakness/muscle soreness; muscle pain and weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 27May2022 as dose number unknown, 0.5ml single (Lot number: FJ2601) at the age of 65 years, in left arm for immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Verbatim : Other Conditions: No. There were no concomitant medications. Vaccination history included: pfizer covid-19 vaccine (1st dose, Lot: ER8727, Expiration: Unknown, Dose: 0.3ml in the Right arm), administration date: 27Mar2021, when the patient was 64-year-old, for COVID-19 immunization; pfizer covid-19 vaccine (2nd dose, Lot: EW0161, Expiration: Unknown, Dose: 0.3ml in the Left Arm), administration date: 17Apr2021, when the patient was 64-year-old, for COVID-19 immunization; pfizer covid-19 vaccine (3rd dose, Lot: 32030DB, Expiration: Unknown, Dose: 0.3ml in the Left arm), administration date: 25Oct2021, when the patient was 64-year-old, for COVID-19 immunization; moderna covid-19 vaccine (Date: 31Mar2022, Lot: 066K21A, Expiration: Unknown, Dose: Injection in the left arm), administration date: 31Mar2022, when the patient was 65-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27May2022, outcome "unknown", described as "it was an unusually painful injection"; MUSCULAR WEAKNESS (non-serious) with onset 27May2022, outcome "unknown", described as "muscle pain and weakness"; MYALGIA (non-serious) with onset 27May2022, outcome "recovering", described as "muscle pain and weakness/muscle soreness"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "to use other arm to move that arm, it is slightly better/If she engaged her muscle she would not lift it"; PAIN (non-serious), outcome "unknown", described as "painful/this is day 12 of pain and describes it as severe/It hurt so much".  Additional information: Patient never felt disabled by a vaccine before. Caller stated this was day 12 of pain and describes it as severe. It was painful to even lay on that side. Patient thought it was regular vaccine soreness. If patient engaged her muscle she would not lift it. She would use her other arm to not engage the muscle it was so painful. Caller said that she had a sore arm after her Covid vaccines for a day or so at the injection site. No significant side effects from the Covid vaccines. Patient got both Moderna and Pfizer Vaccines. Patient got the Moderna Dose at Pharmacy. The rest of the Covid-19 vaccines received at another pharmacy.  No follow-up attempts are possible. No further information is expected.
Symptoms: Symptoms: 1. Arthralgia, 2. Diarrhea, 3. Nausea Vomiting, 4. Chills, erythema. Treatment Drugs Used: 1 - INFLUENZA Dose: Units: Freq: Route:.
Left arm swollen, client complained of pain and stinging. States pain goes down all of arm.  Knot felt at injection site.  Denies any difficulty breathing or itching.  Referred to MD.
03/03/2022  I have had back pain starting about a month back . Sought care from  my doctor because it seemed worse after my booster shot. She took my blood work because it was my usual yearly appointment anyway. Also did an x-ray and found a continued degeneration of my disc and curvature.  Nurse called with these results yesterday and suggested to get an MRI.
area of redness/rash/blisters on L arm and shoulder. Diagnosed by primary care MD as shingles.
This non-serious consumer report (initial receipt 15-DEC-2014) concerns a female patient who had a medical history of tinnitus which was diagnosed several years ago. On the 13-DEC-2014, the patient received AFLURIA (batch number not reported) 0.5 ml via the intramuscular route. This was the patient's first flu vaccine. On the 13-DEC-2014, later that evening, she experienced tinnitus and headache. Her left ear felt clogged. She believed the stress from her headaches exacerbated her tinnitus. The headaches only appear in the evening are painful in which she felt sick. She did not seek medical treatment for them and did not take anything over-the-counter for the treatment. The events did not ablate after the suspect product was stopped.  Outcome was not yet reported.
1.2 ml of diluent were added to the vaccine vial instead of 1.8 ml, making it a slight higher dose than authorized
Pain in arm spread to shoulder neck and back.  Over a period of several month traveled down my back into my left hip and travels down by thigh into my left knee
After first vaccine felt flu like symptoms for one week could not function was super fatigued, chills, back pain super achey, After second dose started really bad pelvic pain, pulling sensation compared feeling to endometrosis pain (hx endometrios but had  hysterctomy 3/2019) Feels pulling bloating, pain level 6 out of 10. Also almost passed out blacked out  and was very dizzy at home that night after getting  second vaccine. Pt reports that all her problems started after gettting the vaccines she felt wonderful before getting the vaccines.  Pain has been ongoing for weeks and has not gotten better.
Increasing weakness, fatigue, sleepiness, confusion, lethargy, and chills from time of second dose until hospitalization due to immobilization began June 17, 2021.  Diagnosed with atrial fibrillation, which he had never had before.  Experienced brain fog, confusion, hallucination.  CT scan negative for stroke.  Kidneys unable to produce enough urine for proper urine testing.  Experienced cardiac arrest June 25, 2021 (once or twice, unclear).  Died June 26, 2021 of multiple organ failure and inability to maintain blood pressure.  On the death certificate septic shock is listed as cause of death, no cause of death was known at the time of his death.  Just multiple organ failure, no known cause.
Patient fainted in chair, became pale and was slow initially to respond. Cool wash cloths were applied to face and neck and patient was able to sit up and respond to voice commands and answer questions appropriately. Mother was present and asked for EMS to be notified as he had never had this type of reaction before. Patient continued to respond and became nauseous with some vomiting of clear mucous-appearing substance. Patient asked for his bottle of water and sipped on the water. He then began to close his eyes and appeared to pass out again (police officer and mother) present. Patient became slowly alert when EMS arrived and was able to state his name, height and weight. He was transported at the request of the mother to hospital.
After about 5 days a red circle about 3.5 - 4 inches in diameter appeared around the injection site.  It is warm to the touch and itches.  This is day 10 after the injection and the redness, warmness and itching are still there
I missed my Menstrual period, the last one I had it before vaccine day it was March,13th. I saw OBJYN and she confirmed that I am not pregnant and no health issues in reproductive system (including uterus, ovary ...etc.) that could cause this delay! Please follow and see if someone else has the same issue
5cm x 3.5cm erythematous non pruritic, slightly raised slightly tender and warm to touch, dry rreaction over vaccination site. Appeared within 24 hrs post injection. No systemic signs or symptoms found/noted. Other vaccinations from same vial without incident.
T78.40XA ALLERGIC REACTION, INIT 4/24/2022 ASTHMA, UNSPECIFIED W STATUS ASTHMATICUS
Temperature excursion; Patient received vaccine with temperature excursion; This is a spontaneous report from a contactable Health Care Professional. The Health Care Professional reported similar events for six patients. This is one of six reports.    A 6 months old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot Number: AA7116, Expiry date: 30May2021, NDC number: 0005197101) on 14Oct2019, at 11:37 a.m., intramuscularly, in the left thigh, at 0.5 ml, single dose, for immunization. The patient medical history was not reported. Additional concomitant vaccines administered for immunization, on same date of pneumococcal 13-val conj vac (dipht crm197 protein) (on 14Oct2019) included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL, Lot. UJ013AA, Expiry date: 10Oct2020) intramuscularly, in the left thigh (No of previous doses: 2) and hepatitis B vaccine (Lot. 212B9, Expiry date: 09May2021) intramuscularly, in the right thigh (No of previous doses: 2) and acetaminophen (paracetamol) from an unspecified date, 160 mg/5ml, 2.5 ml dose every 4 hours as needed for fever or discomfort. The patient previously received the following vaccinations: first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot Number: W81743, Expiry date: 30Sep2020) intramuscularly, in the right thigh, on 10Jun2019; second dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot Number: X93780, Expiry date: 30Jan2021) intramuscularly, in the right thigh, on 12Aug2019; first and second dose of diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) on 10Jun2019 and on 12Aug2019 respectively; first dose of hepatitis B vaccine given at the hospital (date of vaccination unspecified) and second dose of hepatitis B vaccine on 10Jun2019; all for immunization. The patient received pneumococcal 13-val conj vac (dipht crm197 protein) after temperature excursion, on 14Oct2019, at 11:37 a.m.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019473602 Different patient ,same event /same drug;US-PFIZER INC-2019473642 Different patient ,same event /same drug;US-PFIZER INC-2019473649 Different patient ,same event /same drug;US-PFIZER INC-2019473822 Different patient ,same event /same drug;US-PFIZER INC-2019473739 Same product/event, different patient;US-PFIZER INC-2019474389 Different patient ,same event /same drug;US-PFIZER INC-2019474349 Different patient ,same event /same drug;US-PFIZER INC-2019474448 same drug/event, different patient;US-PFIZER INC-2019473622 same product/event, different patient;US-PFIZER INC-2019473846 Same drug/event, different patient;US-PFIZER INC-2019473602 same product/event, different patient
Pt states 2-3 hours after receiving vaccine left arm deltoid area became red, swollen and hot to touch. Swelling and redness increased on Friday. Minimal soreness. By Mon. 12/8 redness, swelling and soreness subsided.
Immediate pain during vaccination, young man said he had hit the bone.  Arm is sore and aches, especially on waking.  Soreness extends to neck and down arm.
PRODUCT STORED AT ROOM TEMPERATURE FOR 3 HOURS; EXPIRED DOSE WAS ADMINISTRATED TO THE PATIENT; This spontaneous report received from a pharmacist concerned an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAY-2021, the subject experienced expired dose was administrated to the subject. On an unspecified date, the subject experienced product stored at room temperature for 3 hours. The action taken with covid-19 vaccine was not applicable. The outcome of the expired dose was administrated to the patient and product stored at room temperature for 3 hours was not reported. This report was non-serious.
Dose #3 was administered to early.     Pt was supposed to be scheduled for a lab collection not vaccine administration.
Pt. became confused and forgetful approximately 2 days after vaccine. Her daughter took her to hospital where she was admitted for 2 days. She could not remember her daughter's name, for example. Drs were unsure what caused it. She does have liver dysfunction. Her liver doctor asked her if she was exposed to any virus and pt. told him about ZOSTAVAX. He told her that her illness was likely due to exposure to the live vaccine virus.
Hospitalization for COVID-19. Symptoms (increased shortness of air) started on 9/8/2021 and tested positive for COVID-19 on 9/10/2021 upon admission to the hospital.
Physical Tics and vocal Tics Involuntary movements/twitching. Ongoing and has not stopped.
Started 11/14 with numbness and Tingling in toes and fingers. Progressed to waist and then on Saturday, Nov 12, developed a Bell's Palsy and ataxia.
Extreme exhaustion from 6pm night of throughout next day Nausea  Fever of 102.9 Chills
Patient had already recieved the PNEUMOVAX immunization at her primary care dr office, but did not remember so she ended up getting it again with the pharmacy. She has not reported any side effects, but the PCP is upset the vaccine was repeated.
Information was received on 16-MAR-2017 from a pharmacist regarding a male patient (age not provided). Medical history, concurrent conditions and concomitant medications were not reported. On 15-MAR-2017 the patient was inadvertently administered an expired dose of ZOSTAVAX (lot number L046893, expiration date 23-FEB-2017). The pharmacist reported that the sterile water diluent (unspecified lot number and expiration date) used to reconstitute the ZOSTAVAX was not expired. No adverse effects were reported. No additional information was provided. Additional information has been requested.
Pt presents with 50 plus chicken pox lesions all over face and body on 03/08/2002
Pt states that it first started with her jaw locking up while brushing teeth/tongue. She states that she had to release her tongue to relieve the sx. Pt states that she developed what she describes as a "charlie-horse like pain in jaw." Sx calmed down and pt went to bed, upon that morning pt noted that her right side of her face felt numb and is if she had anesthesia from dental work on the right side of her face. Pt denies any facial drooping at this time. Pt does state that she has some slurring of speech occasionally, no drooling. She states that when she presses her tongue she can not feel her teeth with it. Pt denies any blurred vision, dizziness/lightheadedness. Pt was advised to not take anymore of this medication. Pt verbalizes understanding. Pt was given a f/u appt with Dr. on 10/29/2012 at 1600. We discussed reasons that pt should seek immediate medical attention. Pt verbalizes understanding.