chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen lymph nodes underneath his arm; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 12Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported.  Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 12Dec2021, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 13Dec2021, outcome "unknown", described as "swollen lymph nodes underneath his arm".  Additional information: After 24 hours, patient had swollen lymph nodes underneath his arm. They were as big as half of a tennis ball. Caller wanted to know if it was a common side effect of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It was injected into their fatty tissue instead of the muscle; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (It was injected into their fatty tissue instead of the muscle) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 04-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (It was injected into their fatty tissue instead of the muscle). On 04-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (It was injected into their fatty tissue instead of the muscle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: No new information received.; Sender's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # 029A21A) with no associated AEs reported
After waiting the 15 minutes after vaccine she was leaving and started with shaking in both legs and she stated " I feel dizzy and legs are jelly". Had her lay down on mat, gave water and cookies, declined and placed cool pack on her neck. She was shaking from feet to her arms. No complaint of shortness of breath or chest pains, wasn't cold or sweating. Stated she had eaten before she received vaccine. She refused to have Ambulance come and check her out. 8:15pm vitals Bp  110/62 R 16 P74. Stated she felt better to sit up, sat up on floor mat for 5 minutes, moved to wheelchair and after 5 minutes stood up no shaking. Wheeled her out to truck with her husband. Advised if symptoms come back and don't resolve call 911 to be evaluated.
ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 3/17/2023 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
The pt developed diarrhea which lasted 4 days. She had nausea but no vomiting. No fever. Supportive care only. I suspect viral syndrome but the pt is convinced that this is an adverse reaction.
24 hours after vaccination redness, swelling, warmth at injection site - 36 hours after vaccination vomiting x 3 - mother reports no fever - (ADVIL given warm compress to leg).
Chills; Night sweats; Body aches; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL1284) intramuscular in left arm on 05Jan2021 at 14:00 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On 06Jan2021 at 19:00, the patient experienced chills, night sweats and body aches. No treatment given.The outcome of the events was recovering.
At an unspecified time, the patient received her third injection of Lymerix. Sometime thereafter, probably in early 2000, she experienced feeling listless and run down. The information received on 04/04/2000 provides no further information.
Change in menstrual cycle  Calf pain  Chest pain  Tiredness   All symptoms started after 2nd dose
Sleeplessness; Nausea; Body aches; Headache; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (Sleeplessness), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 23-Feb-2022, the patient experienced INSOMNIA (Sleeplessness), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, INSOMNIA (Sleeplessness), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Headache) had not resolved.            No concomitant medications were reported.  The reporter causality for the events of sleeplessness, body aches, headache and nausea with Humira (adalimumab) was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
pt recv vax & had outbreak of varicella-like rash on 24JAN97 p/exposure to vaccinated child;2nd outbreak of varicella-like rash occurred 1FEB97 p/exposure to vaccinated child;both outbreaks were resolved w/Zovirax;
Have a small bump at the injection site; The area is pink and itches/she felt a knot there that is red and pink, she wants to itch at it, she thinks it might just be because of the person that gave her the dose; Sore arm; Small pink spot and got bigger and bigger with a large knot; it is about 4 in by 4 in; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration, administered in Arm Left on 31Mar2021 (at the age of 55 years old) as dose 2, single for COVID-19 immunization. Medical history included: hypertension She has had this condition for 3 or 4 years and received lisinopril hctz for hypertension at the dose of 20mg/25mg once a day. Concomitant medication(s) included celecoxib (CELEBREX) taken for arthritis. The patient previously BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6208, Expiry date: 30Jun2021) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and experienced pain in extremity. Got her second shot on 31Mar2021 and the first one, she initially said two weeks before and then after being told it was to be given 3 weeks apart, she said yes, it was probably 3 weeks. She has reported this to us before but just wanted to confirm that this was a side effect. She knows some people who got the Moderna shot and had worse side effects. The reporter was calling about the Pfizer COVID 19 shot. She says she got the 2nd shot yesterday (31Mar2021) and, she doesn't consider it a side effect, she had no problems except a sore arm which she had from the first one too. However, this afternoon she felt a knot there at the injection site that is red and pink. She wants to itch at it. She thinks it might just be because of the person that gave her the dose. She says she doesn't really think it is an event, she knows any time you get shots you can get a knot. She just wants to make sure it doesn't mess with getting all the vaccine she is supposed to get. She wants to talk to someone about that. She says she has no headache, no fever, nothing like that. Caller declines to fill out a report, she says she would rather just talk with a nurse or whatever to ask her question. The patient Had a reaction to her Pfizer covid 19 shot. She looked on the CDC website and they had it listed as Covid arm. After the first shot, it was just sore but after the second shot, it started out as a small pink spot and got bigger and bigger with a large knot; it is about 4 in by 4 inches, she had a knot. Over the weekend, it got bigger and was 3-4 inches by 3-4 inches. The patient did not receive any treatment for the events. The outcome of the events was unknown.  Follow up attempts are completed. No further information was expected.
8/14/22 - 8/18/22 pt admitted to hosp with fever, confusion, and UTI sx; family states he had COVID 3 wks earlier and hasn't seemed to be well since; positive COVID test on admission; CT C/A shows right lower lobe infection; no acute distress related to COVID; DNR/DNI; was dc'd to home; 9/20/22 pt to ED with SOB and O2 saturations at home in low 80s; given breathing treatments with improved O2 levels; dc'd to home with hospice (name of hospice not in medical records); 10/23/22 - 10/28/22 pt in hospital with worsening swelling; lethargic, poor oral intake; malaise; transitioned to comfort measures and passed away in the hospital
BODYACHE; FEVER; .This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced bodyache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bodyache and fever was not reported. This report was non-serious.
A red itchy rash at the injection site that kept getting bigger and itchier until I took a Benadryl about 12 hours after the injection. Had to take a Benadryl for a week once / day for 7 days until the reaction stopped occurring.
Severe vomiting, diarrhea, fever, muscle, bone pain, headache, old injuries inflammatory response, interstitial cystitis severe flare, extreme fatigue. Steroids and nausea meds given by walk in clinic
My mother reported itching and swelling to her right "shoulder" on evening of 3/22, stating it began two nights prior.  On inspection she had a large, warm, erythematous and indurated area just distal to the likely injection site measuring approximately 5x7" wrapping halfway around her arm.
pt recv vax on 7MAR97 & 2 days later 9MAR97 pt devel fever  of 103 & 5 days later exp diarrhea;pt vomited twice on 10MAR97 & had a sl sore throat & dec appetite & was seen in walk in clinic 11MAR97;
Left arm swelling around deltoid muscle, extending circumference of arm to elbow. No erythema present. No fever. Swelling starting at suppertime, the day of injection and continued to grow overnight.
This is a spontaneous report from a contactable consumer. A 58-years-old female patient second dose of received bnt162b2 (Pfizer covid vaccine, formulation: solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 29Mar2021 (at the age of 57-years-old) as DOSE 2, SINGLE and first dose bnt162b2 (Pfizer covid vaccine, formulation: solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 08Mar2021 (at the age of 57-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications not reported. On 12Aug2021, the patient was diagnosed with COVID. The patient had symptoms prior to being diagnosed with COVID. The patient underwent lab tests and procedures which included (PCR test) polymerase chain reaction positive: covid on 12Aug2021. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
slight tiredness; pain in arm; This is a spontaneous report from a contactable consumer (patient). A 74 (unit unspecified) non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Mar2021 at a 2nd dose, single dose for COVID-19 immunization; paracetamol (TYLENOL) taken for headache. The patient medical history included headache ongoing (prior to going for the vaccine). The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at a 1st dose, single dose for COVID-19 immunization. The patient experienced slight tiredness, pain in arm on an unspecified date in 2021. Patient received her second Pfizer Covid vaccine on 04March2021. Patient reports she had a headache prior to going for the vaccine and took two Extra Strength Tylenol. Patient asked if the Tylenol she took will have effects of the vaccine. Patient reported slight tiredness & pain in arm the following day briefly. The action taken in response to the events for paracetamol was unknown. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from an unspecified reporter, via a company representative referring to 2 female patients of unknown age. No information was provided regarding the patients' historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications. On an unknown dates, the patients were vaccinated with GARDASIL 9 by intramuscular route for prophylaxis (dose, lot number and expiration date were not reported). On an unknown dates, after receiving GARDASIL 9, the patients fainted. It was unknown if the patients received any treatment for the event, or if laboratory diagnostic studies were performed. The outcome of syncope was unknown and the causality assessment between GARDASIL 9 and the event was not reported. Upon internal review the event of syncope was considered to be medically significant.
Child was given DTaP, IPV, MMR, and varicella, within 10 minutes after immunizations were given child developed hives and was gagging. She was given Epi 1:100 0.15 CC SC. She was given BENADRYL 1 1/4 tsp. She was take to the ER and observed at approximately 5 PM, needed no other meds according to parent.
Patient began feeling dizzy, nauseous, flushed, shaky, and vomited several times after receiving her second dose of the covid vaccine. Her blood pressure was 127/107 and pule was 120 50 minutes after the vaccination was administered.  The patient was given a cold wash cloth on the back of her neck and on her wrists and water to sip on. EMS was called and they administered Zofran and took the patient to the hospital to be evaluated. The patient was very anxious before receiving her vaccine and said she has anxiety and did not take her anxiety medication today.
I began to have heart palpitations approximately 2 hours after the first shot. Palpitations would come and go for approximately 8 or 9 days and then stopped. I had my 2nd dose on 9-10-2021 at approximately 4:45pm. Approximately 2 days after I began to have heart palpitations again with shortness of breath and dizziness.
some no-local itches day after Shingrix first shot; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced pruritus. The patient was treated with benadryl (nos) (Benadryl Oral). On an unknown date, the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacist believed that this patient had no history of allergy. Pharmacist called a patient was unhappy with the information that her doctor gave regarding some no-local itches day after Shingrix shot. The patient took oral Benadryl and then she was perfect.  The reporter did not consent to follow-up.
My husband and I sat down at the same time to get the shot. I got the shot stood up waited for my husband to get his. We then went to the chairs to wait. Right as we sat down I started  having to clear my throat. They gave me water and I couldn?t swallow it. I started struggling  to breath. They had me lay down and I was still having a hard time breathing. They took my oxygen and it was extremely low. I started having convulsions. They used an Epi pen on my right leg and then called 911.  I started convulsing and couldn?t breath or control my body. I lost consciousness right after the ambulance got there. Last thing I remember was somebody picking me up and putting me on the stretcher and then I woke up in the emergency room with them hooking me up to an EEG.
Shot was received 4/15.  4/16 fever was 102.  4/17 fever was 101.  4/18 fever was 99.6.  4/19 temp. was 98.0.  However on 4/18 left arm started to get red and swollen at the injection site. It was hot and itchy.  By 4/19 the redness had traveled from side of left arm to front of arm and down to almost the cook of my elbow.  Called doctor who had me come in so he could see the redness, and he gave me a script of cephalexin, BID for 10 days and to report back to him if not better in 48 hours.
2 days post vax pt developed a fever, feels warm and is vomiting. Taken to ER and was told it is the vaccine. The next day pt better, no fever or vomiting, support offered.
a rapid heartbeat; This is a spontaneous report from a contactable consumer (patient). This 62-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 30Mar2021 at single dose for COVID-19 immunisation. Medical history included pneumonia for 5 days which was really bad, not sure whether this was caused by the covid vaccine and blood pressure abnormal. Concomitant medications included lisinopril in the middle of March for blood pressure. The patient received the 1st dose of the covid vaccine on 30Mar2021. Her neighbor was sneezing and all of a sudden through the night he started coughing and hacking. She was exposed to him last night. He had not received his result of the viral test yet. She had not taken a viral test. The patient asked if she was still susceptible to the covid virus if having the 1st shot. She also reported that she had a little reaction from the vaccine but had subsided which included a rapid heartbeat. Outcome of the event was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY  6/30/2022 --  RECURRENCE OF SAME SYMPTOMS
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 65-year-old female patient. Information about the patient's concurrent condition, concomitant medication or medical history was not provided.  In September 2016, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, lot # and expiration date were not provided) at the pharmacy, for prophylaxis. As a result of her receipt of vaccination, in September 2016 was caused to suffer shingles, including all its sequelae. It has been caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. At the time of the report, the patient's outcome was unknown, and the reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered the event of shingles to be disabling.
PM p/DPT had t104-105; pt had recent ear infect & took Ceclor, advised to see MD to evaluate ears; 15JAN92 MD stated poss pertussis reaction but most likely viral ears infected & placed on ATB;
High BP of 190/105, hives ,headache ,fever, chills, increased brain fog, increased joint pain, frequent periods. feeling like throwing up constantly
Very stiff neck. Mouth hurt, my teeth hurt, I couldn't open up my mouth wide. My whole left side of my body was numb and tingling, it felt like I was getting a stroke. Went to the doctor on 11/23/2021 he gave me a steroid shot in my neck.
nausea; chills; Headache; This is a spontaneous report from a non-contactable Other healthcare professional. A 38-year-old female (not pregnant) patient received BNT162B2 on 22Dec2020 10:00 AM intramuscular Right arm at singe dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No Known allergies. Facility type vaccine was Hospital. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Patient had headache, nausea and chills on 24Dec2020. No treatment received. The outcome of the events was recovered. The seriousness was reported as no.   No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Need walking aids and wheelchair for the rest of life; Need walking aids and wheelchair for the rest of life; This serious case was reported by a consumer via interactive digital media and described the occurrence of wheelchair user in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced wheelchair user (Verbatim: Need walking aids and wheelchair for the rest of life) (serious criteria disability) and walking aid user (Verbatim: Need walking aids and wheelchair for the rest of life) (serious criteria disability). The outcome of the wheelchair user and walking aid user were not reported.   It was unknown if the reporter considered the wheelchair user and walking aid user to be related to Shingles vaccine.     It was unknown if the company considered the wheelchair user and walking aid user to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-Mar-2023 The reporter reported the case via interactive digital media. GBS or CIDP is a debilitating life sentence if you had an allergic reaction to this shot.  The patient went from being a health active person to needing walking aids and wheelchair for the rest of his/her life.  The patient said if he/she could go back and redo getting the shot he/she would rather suffer with shingles than go through what he/she went through and would always had the reminder of getting the shot. The follow-up would not possible as no contact details were available.