chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; Information has been received from a lawyer and a male patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include 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 preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
This spontaneous report was received from a pharmacist via a company representative regarding an approximately 76 year old female patient. The patient did not have any pertinent medical conditions and previous drug allergies. On 05-DEC-2013, the patient was vaccinated with ZOSTAVAX 19400 PFU (Lot number J)08436, expiry date of 11-OCT-2014) (dose and frequency not provided) subcutaneously in the right arm for prevention of shingles. On an unknown date in December 2013, the patient experienced rash on her lower right arm. On 07-DEC-2013, the patient returned back to pharmacy with the rash. The patient sought medical attention by visiting pharmacy. Treatment to the event was provided using BENADRYL, TYLENOL, and warm compresses as needed. No lab diagnostic test were done. The outcome of rash on her lower right arm was unknown. Additional information has been requested.
Right arm injection site with orange size,red,itchy welt. Right armpit and breast lymph nodes very swollen with throbbing pain.
Patient stated she felt flushed, dizzy and asked to lay down. BP 129/70, Pulse 81, Resp 14, O2 98
recurring ovarian cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVARIAN CANCER RECURRENT (medically significant) with onset Jan2021, outcome "unknown", described as "recurring ovarian cancer". Therapeutic measures were taken as a result of ovarian cancer recurrent.  Clinical course: Patient received Covid Pfizer series Jan/Feb2021. In Antibody study she was enrolled showed no antibodies Jun2021. On her own, she went and got third shot Pfizer Jul2021. She had 6 rounds of chemotherapy Jan-Jun 2021 for recurring ovarian cancer. Dec2021 withheld Covid antibody test results were positive for IgG antibodies. Her question was when she should consider getting a booster, it has been 6 months since the third shot in Jul2021 and received reply as "There was no information about a fourth dose or a booster in immunocompromised patients and refer to HCP". She reported that her antibody test for March, April, and May 2021 showed antibodies. In Jun2021 there were no antibodies. She decided to get another dose. She states that she "got caught after". She tested positive for antibodies since then in Dec2021. She has spoken with her HCP who relayed to let her know when she would want to get another dose. Her question was that for an immune compromised patient has there been any data on essentially a 4th dose being needed or being effective and asked that does it protect against the Omicron variant and received response "To discuss with HCP potential risks verses benefit from another dose with her health history. Relayed that Pfizer cannot suggest or recommend the used of the product outside of the Regulatory Authority approvals. "A third dose was not to be confused with a booster dose. Please see the definitions below on this. A booster dose was an additional dose of a vaccine that was given at least 6 months after completing the primary series because the immune response to the primary series wanes over time. 2, 5 An additional (third dose) of the vaccine was given at least 4 weeks after the second dose to people who were determined to have certain kinds of immunocompromise and did not get an adequate immune response to the primary series. 2, 5. "The early results show that three doses of the Pfizer-BioNTech COVID-19 Vaccine neutralize the Omicron variant. Two doses of vaccine showed decreased antibody response".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Vaccine given 9/22/12. Patient called 9/25/12 at 11:30 am and said then inside of her arm where she received the vaccine was sore and also has redness from shoulder to elbow. Told her to contact her doctor to be seen.
pt recvd vax on 28MAY92 & approx 5 hrs following vax devel a fever of 105; seen by MD; 29MAY92 pt's mom stated temp had returned to nl & then inc again to 105; some vomiting;
Child developed hives on face, chest and back, about 15 minutes, post vax. Child has been crying since IZ's given. Child has no difficulty with breathing. Child was taken to doctor for evaluation and was given Adrenalin at doctor's office. Mother gave Benadryl every 4 hours, during the evening. On 4/18/00, this AM, mother states the child if fine and all of the hives are gone. Was told by doctor that child had an acute reaction to IZ's.
I have a Nexplanon implant. I?ve had it since 11/2018. The entire time I?ve had this implant, I have not had a menstrual cycle. After I received the 2nd shot, I suddenly started bleeding again. I believe there may be correlation between the Covid shot and changes to a woman?s menstrual cycle.
Day 8, I received the "COVID Arm" - a red blotch on my arm and it continued to spread down my arm. I talked to our employee health nurse. Benadryl didn't help. It kept spreading four four days. She had me go to  ER - they gave me antibiotics in case there was an infection. It's gone now.
large marked area of erythema , warm to touch and tender almost circumferences entire arm. significant localized reaction
Information has been received from a physician concerning an 18 year old female patient with a history of "pre existing baltrim" who on 17-AUG-2009 was vaccinated with her first dose of GARDASIL (Lot #659054/0314Y). The physician reported that on 19-SEP-2009, the patient experienced a rash on her ankles that progressed up to her legs and arms, her neck become red and she developed swollen glands and low grade fever. It was reported that the patient saw a different physician for what the patient experienced, and the patient had performed a throat culture, strep test and mono test which all results came back negative. The physician reported that on 21-SEP-2009 the patient had recovered. Additional information has been requested.
Local redness, warmth and irritation around site of injection. Diagnosis: Adverse reaction. Treatment: MOTRIN Bid with meals, may use TYLENOL, warm compress; CLARITIN, BENADRYL for discomfort. Patient education reviewed and received by patient. Follow up in 3-5 days.
Patient under 65 received Fluad QIV; Rash of both arms and hands with blisters on L hand side (injected arm); Rash of both arms and hands with blisters on L hand side (injected arm); This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04837) and concerned a 51-year-old, female patient.   The patient's medical history included psoriasis. The patient's concomitant medications were not reported.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for an influenza prophylaxis. The batch number reported was 286592.   On an unspecified date in 2020, an unknown time after receiving Fluad Quadrivalent, the patient experienced rash of both arms and hands with blisters on left (L) hand side of injected arm. The patient visited dermatologist, who stated it could have been from the flu shot. The patient did not receive any corrective treatment.  The outcome of the events was not reported.  The reporter assessed all events as related to Fluad Quadrivalent.   The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter).  Company comment: A 51-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed rash and blister. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Reporter's Comments: The reporter stated that the events could have been from the flu shot.; Sender's Comments: A 51-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed rash and blister. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided. On 26-APR-2017, the patient was inadvertently vaccinated with an expired dose of GARDASIL lot # L040459 expiration date on 06-APR-2017 for prophylaxis. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000644.
DIZZY; BODY ACHE; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 06:07 to left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced dizzy. On 08-MAR-2021, the subject experienced body ache. On 08-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, body ache, and dizzy. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Patient received first dose on 5/15/2021 of the Pfizer Covid vaccine in the right arm. Patient experienced mild pain on the arm as well as lymph nodes on neck for few days after dose 1. The patient received dose 2 on 6/5/2021 in the right arm. Patient experienced pain on the left side under her arm as well as the same lymph node pain. On Monday 6/21/21 patient experienced heart palpitations around 2pm. On Tuesday 6/22/2021 patient experienced palpitations again around 2pm and  spoke to oncologist and was advised to have VAERS report submitted.
feeling bad all over; Headache; Nauseated; really tired; aching all over; little weak/it is getting better; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 25Sep2021 (Lot number: FC3184) at the age of 64 years as dose 3 (booster), single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1; Lot number: EN6198; Expiry: Jun2021; Anatomical location: Arm), administration date: 28Feb2021, when the patient was 64 years old, for Covid-19 immunization; Bnt162b2 (DOSE 2; Lot number: ER2613; Expiry: Jul2021; Anatomical location: Arm), administration date: 21Mar2021, when the patient was 64 years old, for Covid-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 26Sep2021, outcome "unknown", described as "feeling bad all over"; HEADACHE (non-serious) with onset 26Sep2021, outcome "recovered" (27Sep2021), described as "Headache"; NAUSEA (non-serious) with onset 26Sep2021, outcome "recovering", described as "Nauseated"; FATIGUE (non-serious) with onset 26Sep2021, outcome "unknown", described as "really tired"; PAIN (non-serious) with onset 26Sep2021, outcome "recovering", described as "aching all over"; ASTHENIA (non-serious) with onset 26Sep2021, outcome "recovering", described as "little weak/it is getting better". Additional information: By Saturday afternoon, patient got her booster shot at a pharmacy. Nothing had changed and she was feeling good when she went to get booster. By Sunday, patient was feeling bad all over and then got a headache and then nauseated and then really tired and she stayed in bed. Now, the patient is a little weak and a little less nauseated and was getting better. Patient didn't have anything with the first two so she was so surprised when she started to feel bad. Patient clarified the shots as Pfizer COVID-19 shots. It was reported that patient goes to a clinic at work. Patient still works out in the public. Patient hasn't been to her primary care provider in years. Patient didn't feel like messing with it until now. She thought she should call and say that it gets better in a couple of days. It was also reported that patient was not aching like she was. Her stomach is getting better. Patient ate some toast and patient's stomach is calming down. She is just weak now mainly. Headache went away by Monday evening. She was just aching and nauseated bad still. Patient didn't want to get COVID19. She heard that Pfizer was supposed to be better than others. That is why she was surprised that she had a reaction. Patient hadn't had a reaction with the first two. Patient had no prior vaccinations within 4 weeks. None of the AE(s) required a visit to the emergency room o physician office. There were no AE(s) following prior vaccinations. The patient has no family medical history relevant to AE(s).  No follow-up attempts are possible. No further information is expected.
Patient felt jittery and experienced insomnia the night after immunization.  She also felt more emotional than usual and had site pain for 5 days.
Inflammation left axilla; headache; twitching left side of face. large tender axillary lymph node assessed and Dx Cranial mono neuritis and reactive lymphadenopathy secondary pertussis vaccination. No treatment. 1/14/10 follow-up - no numbness, lymph node imp
86 year old pleasant gentleman with a history of coronary artery disease (noted on MPS in 2003, unclear if prior intervention), hx of SSS with PPM, type 2 DM, ischemic CM with EF of 41%, chronic kidney disease with a baseline Cr 1.5 - 1.9, hx of popliteal artery embolism felt to cardioembolic in origin (in setting of cardiomyopathy) on lifelong coumadin, and chronic thrombocytopenia with baseline plts of 100s. He has been admitted for acute respiratory failure due to COVID pneumonia. There may also be a component of pulmonary edema given elevated BNP.    Plan: 1. Acute Resp Failure/COVID-19 Disease -  - Symptom onset on 07/15. COVID positive on 07/17. Last fever on 07/15   o Pt has been started on Remdesivir on 07/20. He is to have a 5 day course.  o Continue decadron 6 mg daily - started on 07/20, will continue for 10 days o Trend LFT's and chemistry daily as he is on remdesivir. Hold Remdesivir if ALT >10xULN or CrCl<30 o Continue awake proning: 2 hrs prone, 1 hr left, 1 hr right and back to prone. Limit the hrs supine. Explained in detail to patient who understands and is agreeable.  o May use MDIs as needed for bronchospasm o Check d-dimer, ferritin, ESR, and CRP every other day. If rising will need to consider CTA/LE doppler  o Monitor I/O and make sure patient is net negative. Continue bumex home dose for now per patient request. Will increase tomorrow UOP not adequate.  o Continue Coumadin for prophylaxis active bleeding o Nasal Cannula 3 liters. Goal SpO2 >92%. Consider ICU evaluation if requiring >40LPM and 60% FiO2 for SpO2 >/= 90% o Pepcid for GI prophylaxis o Continue isolation in hospital per Regional/Local ID guidance.
pt recv vax 27OCT97 & devel t103.4 & was adm to hosp;pt also found to be hypotensive in ER;blunting of lt costophrenic angle consistent w/lt pleural effusion;UA many bacteria;
Heart attack; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 04Feb2021 (Lot number: EN9581) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PLAVIX; BABY ASPIRIN; ROSUVASTATIN. Past drug history included: Versed, reaction(s): "Known allergies: Versed". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, lot number: EK9231, administrator route: Intramuscular on 13Jan2021, on left arm), administration date: 13Jan2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 13Jul2021, outcome "unknown", described as "Heart attack". The patient underwent the following laboratory tests and procedures: sars-cov-2 test negative: (15Jan2022) negative, notes: Covid test type post vaccination: Nasal Swab and Covid test name post vaccination was unknown; (17Jan2022) negative, notes: Covid test type post vaccination: Nasal Swab and Covid test name post vaccination was unknown. Patient received vaccine at Workplace clinic. Patient did not receive other vaccine in four weeks. Patient had covid prior vaccination.  No follow-up attempts needed. No further information expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported events Myocardial Infarction and the suspect drug BNT162B2 cannot be excluded.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Arm sore at injection site left deltoid. Pain extended to left neck. "Lumps" on left side neck noticed 10/28/09.
Pt started having shortness of breath, DOE, having difficulty breathing and speaking full sentences.  She used her rescue inhaler for asthma, but it didn't help to much, as day 3, she still has SOB .  Same day, she has had : + bone pain + SOB  No facial swelling didn't feel like her throat was closing or difficulty swallowing. + fatigue Feels like she is going to die x1 day ago Pt sent to ER ASAP
approx 3hr later pt devel hive on forehead, legs itchy, back itchy, lips itchy & head/scalp itchy;tx non initially;6hr later took DPH, DPH, itchy completely stopped;
It was reported that a 30 year old male received a Rabies Imovax IM vaccination on 6/15/00. Reportedly that same day the patient developed nausea, fatigue, general body aches. His face became red, resembling sunburn but not determined as a rash. The patient is to be evaluated by physician. Further information requested. From correspondence received on 8/8/00, it was reported, We requested the patient be seen by the doctor before we continue with the rabies series. The doctor was satisfied with us continuing, the rest were given with no adverse reaction. Reportedly the patient recovered from this experience. Additional patient, vaccine and responsible physician information were also provided. From correspondence received on 11/15/00, it was reported, Reviewd, no additional information. No further information is expected. This case is closed.
Can?t raise arm or sleep in that side, chills, fever, horrible headache, achy, queasy
The following night I woke up with chills mainly and not feeling good, I think I got up and took an aspirin cause I was expecting those symptoms, I think I got back on bed for 20 minutes, Then I got up and next thing you know I'm in the ground and fainted. My husband put a washcloth on me and he decided to take me to the ER which I wasn't seen because I was there almost all night so I decided to leave, The next morning I felt fatigue and I couldn't get up all day, the only thing was the fainting part that indicated that I had a reaction.
Case number PHEH2014US021747, is an initial spontaneous report received from health care professional on 27 OCT 2014. This report refers to a male patient of unknown age. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412801) intramuscular on an unknown date. On an unknown date post vaccination he experienced similar reaction but not as strong. He experienced arthralgia, it burned when injection went in, arm was little sore and by the next day it was bad. Reaction continues feels like a rotator cuff injury. Final outcome of the events was unknown. Seriousness and causality assessment was not reported.
Tues, Dec 1, 2020 after 8 pm. Arm sore; chills and shivering; eyes and head felt hot, but cool to touch; diarrhea. Wed, Dec 2, 2020 wake up around 7 pm. Feeling bad, like having the flu; ears ringing; aches and chills/can't get warm; joints achy (hands and knees); light headed (feels like sinus stuffed up, but not). Drink tea, scrambled eggs and toast. Keep it down. Thought I was going to throw up with the tea by itself as first thing in mouth, but didn't.  I have been working from home since April, wife and I wear masks everywhere, and rarely go out. Wife tested for COVID with negative results on Tues, Dec 1, 2020. I am healthy. I noticed on CDC site that younger people get these symbols more than older people, may because they have a stronger immune system fighting the foreign material. Just curious.
4/10/21: pt came to ER c/o progressively worsening pain with lower extremities.  HX of MS.
mom heard pt gasp for air during noc found pt jerking, white frothy bubbles coming from mouth, vomited green mucus x 3, wouldn't respond to mom approx 15min;took via ambulance to hosp ER eval & d/c home;
Difficulty breathing, crushing chest pain, heart racing , heart felt like it was flip flopping in chest, elevated BP, extreme fatigue, insomnia due to not being able to breathe properly even with head elevated, raynauds syndrome now of bilateral toes.  I was diagnosed with myocarditis post vaccine, bronchitis/asthma, raynauds syndome.   I was placed on multiple bronchial medications and other supplements for myocarditis.