chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to 3 patients. The patient were vaccinated with PNEUMOVAX23 (lot number 0491AE, expiration date 15-SEP-2013) (route, site, dose not reported) and had the following injection site reactions: redness of the arm, pain at the injection site extended down to the elbow and tenderness. This occurred over the last 2 weeks approximately in July 2012 with same lot 0491AE, expiration date 15-SEP-2013. Pharmacist would like a lot check for lot 0491AE, expiration date 15-SEP-2013. The patients had sought unspecified medical attention. No treatment information was reported. The outcome was unknown. Lot number 0491AE is an invalid lot number for PNEUMOVAX23. Additional information has been requested.
Covid illness/COVID-19; Covid illness/COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XELJANZ XR oral, start date: 08Oct2019 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered" and all described as "Covid illness/COVID-19". Clinical course: Patient reported that she has had breaks from Xeljanz XR when getting Covid vaccines and due to covid illness in Jul2022. Stated her doctor recommended she take a week off before her vaccine and a week after. Patient can't recall when she last received a vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mild Fever; chills; Body aches; General Malaise; This is a spontaneous report from a contactable other hcp (patient). This Other HCP reported in response to HCP letter sent in a cross reference case which included. A 36-years-old male patient received first dose bnt162b2 (BNT162B2, Formulation for injection, Batch/Lot Number: EL0140) via intramuscular route of administration in Deltoid Left on 21Dec2020 10:15 (at the age of 36-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included escitalopram (ESCITALOPRAM) taken for an unspecified indication from 1998 to an unspecified stop date; famotidine (FAMOTIDINE) taken for an unspecified indication, start and stop date were not reported. On 21Dec2020 14:00, the patient had body aches and general malaise. On 21Dec2020 18:00 the patient experienced mild fever and chills. The patient did not receive treatment for events.  AEs did not require a visit to emergency room or physician office. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jun2020. The outcome of the events mild fever, chills, body aches, general malaise was recovered on 22Dec2020. There was a reasonable possibility that the event is related to suspect product/s.  Follow-up attempts completed. No further information expected.
Fever,Syncope Patient went to ER after falling at home and injuring knee and bruising her face. had cscan done,no brain injury
Fever 1 day after vaccinations, Face Swelling 2 days after, by day 3-4 rash on face
mild discomfort on the left side in her neck and middle of her chest after first vaccine; mild discomfort on the left side in her neck and middle of her chest after first vaccine; she thinks are swollen lymph nodes were on the left side; This is a spontaneous report from a contactable consumer or other non hcp (patient).    A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9267), dose 1 via an unspecified route of administration in the right arm on 03Mar2021 between 11 and 11:30 am, at 70 years old, as single dose for covid-19 immunisation. Medical history included hypertension. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN HYDROCHLOROTHIAZIDE KRKA) taken for hypertension, start and stop date were not reported. The patient previously took influenza vaccine in Oct2020 for immunisation. The patient experienced mild discomfort on the left side in her neck and middle of her chest after first vaccine and she thinks are swollen lymph nodes were on the left side on an unspecified date with outcome of recovering. The patient was seen in emergency room and underwent EKG and chest X-ray on unspecified date, tests were fine in terms of cardiac and they did not admit her. The patient reported that the left side discomfort was not completely gone but it is really mild now.  No follow-up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021475398 Same patient and drug, different event (2nd dose case)
My pregnancy history: gravita 2, para 1. I was 36wks 2days pregnant on 05/27/2021. Estimated date of delivery: 06/22/2021. Delivery date was; Birth weight 6lb 14oz.    Adverse event: Constant excruciating pain deep in right shoulder. Pain and heaviness in upper forearm, inner and outer elbow, and lower forearm. Numbness in thumb, pointer fingers and pinky/ring fingers. Range of motion is severely limited. Unable to reach behind me. Pain when reaching, pushing, pulling, almost any movement. Unable to hold my daughter in my right arm after she was born. Extreme difficulty breastfeeding on right side. Difficulty pumping due to pain. Unable to perform my normal daily functions.  Currently seeing my family doctor, physical therapy, taking oral steroids, ibuprofen, ES Tylenol, using ice/heat, BioFreeze, rest, home exercises provided by PT, ultrasound therapy, chiropractic care, physio tape, massage, and now have an appointment with an orthopedist for continued care.
Felt faint, nauseated, pale, pulse 68, laid down, elevated feet, rested, still felt weak, laid down in nurse's office.
Injection was given at 8 pm. Six hours later he woke with itching and hives all over his hips and abdomen. He had no respiratory problems. Hives resolved with ZYRTEC and ZANTAC.
lt sided neck & jaw pain;like in molar tooth area, but denies any dental problems;will be seen;
A LOT OF BODY ACHES; PRETTY TIRED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced a lot of body aches, and pretty tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a lot of body aches and pretty tired was not reported. This report was non-serious. This case, from the same reporter is linked to 20211055357.
Developed instability and ultimately inability to walk on 2/9/2018 - referred to hospital.
Child was leaving health unit with mother and when she got out to their vehicle, the grandmother noticed the red streak on child's left arm and told the mother: mother and child immediately came back into the unit and notified clerical staff, who notified the nurse. Redness about 1/2 to 1 inch in width from left deltoid area down to wrist, child's hands puffy, child denied any difficulty breathing, lung fields auscultated, BS clear. I looked at arm again and noted 2 small whelps on lower inner arm above wrist and 3 small hives on right side of face near corner of the mouth; asked mother who PCP was, mom stated clinic (15 miles away) phone call made to local MD office to see if MD/APRN could evaluate child now. Suggested to family that EMS be called to come take child to ER and grandfather stated he could drive there faster, we encouraged them not to drive on their own as other problems could occur. APRN at clinic agreed to evaluate child. Mother called back about an hour later and reported child did begin to have respiratory issues after getting to medical clinic, child received steroid shot and BENADRYL and stated child is doing better and are on their way home. Instructed mother to watch for any other S&S and to take child to ER. TC called at 1530 to see how child was doing mother states doing fine. Mother states APRN prescribed Prednisone but forgot to get it filled, told mom to give child more BENADRYL in 4 hours and to get RX filled.
pt recv vax lt tricep area on 26JUL95 red, swelling, lots of discomfort (almost completely around arm) in inject site; onset 1 day p/vax given;
child was in to get ACWY and Tdap to update her vaccines, nurse accidently gave a DTaP instead of a Tdap.
arms are little bit stiff; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (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: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 15Apr2021, outcome "recovered" (16Apr2021), described as "arms are little bit stiff".  Additional Information: Patient stated that she and her husband recieved the Pfizer COVID-19 shot yesterday and her husband is not feeling well today and she stated his legs are warm and he has a stiff arm. Further she told, "she was calling for her husband. My husband and patient went to have a shot the COVID-19 one and we went to the University and we came back and last night my husband felt fine, patient felt fine, arms are little bit stiff but she get up this morning and took a shower and feeling fine, no stiffness and nothing, my husband get up and he doesn't feel good, his legs are warm, he got a headache, the right arm he had the shot in is sore. He said it is pretty much sore all over."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12 weeks pregnant at time of shot. Due Nov 11 2021. Second pregnancy. First pregnancy had no abonormal instances.   Vaginal bleeding started at about 5pm. Lower abdominal pains + constipation before bleeding.   Went to ER that evening and got RhoGAM. 300 mcg. Intramuscular.
Immediately had an inflamed red patch about 2"x1" in size. Was hot to the touch and eventually broke out into several milia approx. 48 hours after injection. General fatigue and muscle aches for 12 hours after injection.  Injection site swelling and inflammation subsided after 4 days from initial injection.
Stiff joints, fatigued, rash on lower arms, swollen hands (itchy due to swollen ness) - 06/05/2021 7:00am to 8:00pm Rash continue to inner thighs and swollen feet (itchy due to swollen ness) - 06/06/2021 1:00am to present (around 5:45pm)
Fever, chills, swollen glands, swollen legs and hands and eye irritation.
The patient is a resident at a skilled nursing facility.  The facility filled out the paper work with consent from the patient & family that makes medical decisions.  We were under the impression this would be the first shot the patient would receive, but upon entering it into GRITS, found out it is the third shot.  The patient got two doses prior; on 3/3/21 & 3/31/21.  The patient has had no adverse effects from this third dose that we are aware of.
Took the shot and still got shingles/ Suspected vaccination failure; Shingles / Horrible; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingles vaccine and still got shingles which was horrible for months. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
This spontaneous report as received from a licensed nurse practitioner refers to an unspecified number of patients of unknown age and gender. The nurse reported that unspecified number of improperly stored (Oka/Merck) VARIVAX 0.5 milliliter (ml) doses have been administered subcutaneously to unspecified number of patients on unspecified dates. The vaccine have been stored at -10 C (celsius) (above recommended temperature range in product information) since July 2013. No adverse effects reported. Follow up information has been received from a healthcare worker concerning a patient of unspecified age and gender. On 26-AUG-2013, the patient was vaccinated with a dose of (Oka/Merck) (VARIVAX) (lot # H018786, exp date: 15-OCT-2014) that had been stored at -10 C (celsius) (above recommended temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one source of several reports received from the same source. Additional information has been requested.
Got all 3 vaccines at once.  Sore arms.  During night, got up several times to go to bathroom.  Felt heart pounding, almost fainted (made it to bed), then vomited.  Next day weak with a slight headache.  Next day ok, just slightly weak.  No fine.
received only the liquid component; received only the liquid component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30-APR-2023) for prophylaxis.   On 09-MAR-2023, the patient received Menveo. On 09-MAR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: received only the liquid component) and inappropriate dose of vaccine administered (Verbatim: received only the liquid component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 9-Mar-2023 The reporter consented to follow-up via email. The patient received only the liquid component of Menveo (without the lyophilized component), which led to inappropriate preparation of medication and inappropriate dose of vaccine administration.
Lethargic, disoriented, fever 103.7, muscle weakness, joint pain-  needed help to walk,  weakness, joint pain and fever lasted 2days.  Still feeling a little disoriented, balance off a little after 6 days and sore arm,
Mother noticed around 13:30, a rash around the injection site on the right thigh. She described it as a rash that was red, flat and splotchy and about the size of the mother's palm. Also reported that child was having diarrhea X 4 between 13:30 and 15:00. The mother took the child to the doctor and was instructed to put warm compresses on the thigh. As of 13:00 on 8/28/01, the child is doing well; no rash or diarrhea.
(At site of injection) 3.5cm nodules, red in band on posterior right upper arm. 2 nodules almost flat, one nodule raised 0.5cm.
Headache, Myalgia, Arthralgia, Fever, Reaction- Temperature (taken 6am)- 101.6, body aches, headache (mild/moderate headache) I had some reactions to the first vaccine too- headache (moderate/severe headache), body aches Narrative:
"COVID arm" slight swelling, soreness, itchiness, warm to the touch, red.
Tingling tongue; odd taste on her tongue; neck swelling; This is a spontaneous report from a contactable pharmacist.  An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 13:00 at single dose for COVID-19 immunisation. Facility-type-vaccine was Hospital. It was unknown if pregnant at time of vaccination.  The patient medical history and the concomitant medications were not reported. Patient experienced an adverse reaction to the COVID-19 vaccine on 29Dec2020 01:00 PM. Symptoms experienced: Tingling tongue, odd taste on her tongue and neck swelling. Patient stated she had her own 50 mg of Benadryl with her and had taken it at 13:05. She stated she has other reactions to medications in the past and it felt the same way. EMS arrived at 13:22 and care transferred. Patient was alert and oriented. AE-resulted-in Doctor or other healthcare professional office/clinic visit. The outcome was unknown.    Information about lot/batch number has been requested.
Patient fainted when exiting exam room after getting HPV to go wait in waiting room for 15 minute monitoring-.
Mild swelling of tongue and throat. Very mild difficulty breathing. Waited and monitored. Symptoms started to lessen approximately 2 hours after received vaccine.
pt recv vax 1AUG97 & 14AUG97 pt presented to MD office w/ 3.5 x 4.5cm induration & sl large area of erythema w/a significant warmth in this area;17AUG97 pt recovered;
Fever, nausea, vomiting, diarrhea, headache, x 4 days, L deltoid red x 4 days, R deltoid red, swollen, tissue hard at site x 10 days, Treatment of symptoms until resolved.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age with no medical history provided. The nurse reported that an improperly stored PROQUAD (Merck) was administered (0.5 ml, subcutaneously, lot#, expiration date not reported) on an unknown date. The nurse stated that all the vaccines reached a temperature of 39.2F for 6 hours. She also stated that there was a "possibility" that PROQUAD (Merck) reached up to 59.4F but she was unsure at the time of report. She reported that she would find out if PROQUAD (Merck) did reach to 59.4F and give the national service center a callback. There was no adverse effect reported. No further information was provided. This report is linked with MARRS# 1405USA001152 and with MARRS# 1405USA002847 via same reporter. Additional information has been requested.
Injection site soreness Noticeable fatigue starting approx 7 hours after administration Fever peaking at 101.8 overnight accompanied by moderate to severe chills Significant nausea starting approx 13 hours after administration Dizziness and tunnel vision while standing during this time Vomiting about 1 hour later Nausea mostly cleared up after vomiting Insomnia, unable to sleep at all the night after administration Fever persisted into the next day, mostly resolved by 26 hours after administration
Fever of 102, chills, diarrhea, lethargy, malaise. The diarrhea was only one episode about three days after the shot. The fever last two days between 101 and 102 and dropped to between 99 and 100 after the second day, then returned to normal. Fatigue and malaise lasted about 4-5 days.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 19-JAN-2016 the patient was administered with a dose of improperly stored M-M-R II (albumin status rHA, lot# L019989 and expiration date 01-JUN-2017, dose, dose# and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected since there was no consent for follow up contact.
Malaise and Unable to perform ADL, Hot flashes, Muscular pain, headache, Insomnia  from 12/31-1/2/2021, peripheral tingling or numbness on 1/2/2021. Took 800 mg Ibuprofen BID to help with symptoms,
Severe rash/ blistering right armpit, rash spreading down right arm down to elbow
Symptoms included, nausea, headache, lethargy, soreness at sight that radiated somewhat up and down arm, shivering - (fever-like) and general malaise.
Patient was scratching her arms. She did not have hives or swelling. When she stopped scratching the redness went away. I sent her to walk in clinic to get medically cleared. No swelling on neck or face no redness on any part of body except arms.
Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
74 year old vaccinated female was admitted for CHF exacerbation. She was also treated for Covid-19 infection. She is on 2L NC today which is her baseline and will be transferred today.
Approximately 12 hrs after vaccine experience chills, joint and muscle pain, low grade fever, headache
Pt recvd 1st dose of vax exp malaise & nausea which lasted approx 2 wks; On 20NOV90 pt was vaccinated w/2nd dose of vax & exp malaise, nausea & also rt upper quad abd pain; Reporter felt that pt's malaise & nausea were related to vax;
Started having sharp substernal chest pain that was positional in nature - worse when laying down and with deep breathing. Persisted for 2-3 weeks and was improved with NSAIDs
Pneumonia vaccine shot left arm. Upper arm swelled, was red, tender to touch, could not raise arm because of pain, for 2 days. That evening my fever was 103.5 but we are not sure that was related, I was admitted to ER for stomach pains and feel inq ill; arm ok now.
left sided upper and lower body weakness, HA, left eye blurred vision; onset 7/17/2021 until today Testing ordered today 8/30/2021
Rash noted by pt 2 weeks after Hepatitis B #1.  No itchiness, no fever. Saw MD in another state. Started on Doxycycline 1 week later out of the country.  Biopsy-negative for antibodies.  No systemic reactions. Biopsy by dermatologist negative in Oct.  10/25/04 Kenalog injection given. Rash diminishing.
5 days following MMR patient developed intense formication, to the point of not being able to wear clothes, sleep disturbance, and anxiety.
pt recv vax 10OCT95 & 11OCT95 pt noticed that the inj site had a red, raised, tender, & itchy area;s/s have resolved;
Patient reports knee swelling up immediately after 1 or both administrations. Patient states in December she was unable to walk, has been seeing doctor since to treat rheumatoid arthritis. According to patient, doctor states that RA was caused by the vaccine.
This spontaneous report as received from a other health professional refers to unspecified patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (strength, dose, frequency and route of administration were not reported) lot #L008053 with an expiry date of 30-NOV-2016 and lot # K004795 with an expiry date of 30-JUL-2016. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the two reports from the same reporter. Additional information has been requested.
7.5" x 6.5" local reaction of erythema, mild edema, and pruritis.
Client has reddened area at injection site approximately 3/4" in diameter. From this area radiating around back of arm is a reddened streak approximately .5" wide and 6" long. Injection site is site of pneumonia vaccine.