chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from nurse practitioner via field employee referring to her daughter, a 13 year old female patient. Concurrent condition and medical history were not reported. ON an unspecified date in either February or March 2015, the patient was inadvertently administered a dose of GARDASIL (lot #, expired date and dose were unknown) subcutaneously (intramuscular formulation administered by other route) and (Oka/Merck) VARIVAX (lot #, expired date and dose were unknown) intramuscularly (subcutaneous injection formulation administered by other route). On an unspecified date in 2015, the reporter stated that her daughter experienced "a red, hot, super sore area 2 inches in diameter" at the GARDASIL injection site following the administration. The patient didn't seek medical attention but the reporter stated that she gave her daughter BENADRYL and applied ice to the site for treatment. No lab diagnostics studies were performed. The outcome of the event was reported as not recovered. Additional information has been requested.
chills; headache; muscle pain; fever; threw up; felt so fatigue; hives; Slept all day 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), MYALGIA (muscle pain), PYREXIA (fever) and VOMITING (threw up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Headache, Muscle pain, Chills and Fever.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CHILLS (chills), HEADACHE (headache), MYALGIA (muscle pain), PYREXIA (fever), VOMITING (threw up), FATIGUE (felt so fatigue), URTICARIA (hives) and BED REST (Slept all day 24 hours). At the time of the report, CHILLS (chills), HEADACHE (headache), MYALGIA (muscle pain), PYREXIA (fever), VOMITING (threw up), FATIGUE (felt so fatigue), URTICARIA (hives) and BED REST (Slept all day 24 hours) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: No specific follow-up information recorded.
The individual is 14 years old and was given Pfizer Booster dose.  The booster dose was only approved for 16+ as of the date it was administered.
Pt was given SHINGRIX, Developed red/inflamed area on arm slightly below (1 inch) injection sight which grew in size, went to MD and diagnosed as cellulitis. Pt seems to be improving with oral cephalexin treatment.
Chills, Diarrhea,  soreness at Injection site,  red line streaking from injection site
Shaking, chills Narrative: 74 yo M received dose #1 of the Moderna COVID-19 vaccine on 3/5/2021/2021 (Lot# 030A21A; Exp. Date: 08/19/2021) around 16:30. Pt's spouse reports to clinic on 3/31/2021 symptoms including shaking, chills, and fever for three days upon return home the day of vaccination. There is no reported event proximate to that vaccination visit where the acute effects are documented. Reaction classified as mild as no intervention/treatment required or documented.
Severe musculoskeletal pain, severe fatigue, poor memory, poor cognitive function, weight loss, loss of appetite, injection site pain
Had 2-3 days of tinnitus in the right ear. The tinnitus presented as a low-pitched hum, that was most prevalent in the morning upon waking. After the 2nd dose of the Moderna vaccine on May 3rd, 2021, the tinnitus returned within two days. This tinnitus continues to the time of this submission. The symptom presents the same (low hum, right ear), and varies in severity from day to day. It is still most noticeable in the morning, and some days is severe enough to wake me from sleep. I have planned visit to ENT specialist June 1st for this condition.
Guillen Barre; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 2, single (Lot number: EL9267) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OZEMPIC. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL8982, Location of injection: Arm Left), administration date: 22Jan2022, when the patient was 71-year-old, for Covid-19 Immunization. No other vaccine in four weeks. No known allergies. No covid prior vaccination.  The following information was reported: GUILLAIN-BARRE SYNDROME (prolonged hospitalization, disability, life threatening) with onset 25May2021, outcome "not recovered", described as "Guillen Barre". The event "guillen barre" required emergency room visit. In June 2022. Hospital for Guillen Barre Aug2022 hospital again for Guillen Barre Sep2022 diagnosed with CIDP chronic form of Guillen Barre. Ae treatment included: lvlG. The event resulted in: Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jan2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of guillain-barre syndrome.
Later the same evening of April 7, experienced chills (worst I have had) and body soreness. As the evening went on I didn't have an appetite and over night experienced more severe chills/fever most of the night. Woke up April 8, still very sore, low fever. Hard to do anything, not much appetite. Friday, April 9, I felt better, Saturday, April 10  experienced some soreness and tiredness but after that each day after I felt better and better.
Follow up: Patient stated she was experiencing sharp pain and numbness in left arm after the vaccine. Patient took vaccine on Monday 3/30/21  and on Tuesday morning right when she woke up pain increased. Thursday 4/1/21 patient is now experiencing swollen glands under left arm (armpit). Patient took ibuprofen 800mg on Wed 3/31/21 around 9pm, also stated that she experienced a slight headache during the day that subsided after taking excedrin. Recommended for her to take tylenol to help with the arm pain. Patient is also waiting for an appt to see her PCP.
Metal/metallic taste in mouth & sore of arm pit (just below armpit) without touching the area and also when I touched the area.  Today (5 days after vaccine) it is only slightly sore when I touch the area (kind of like touching a bruise. The metallic taste only lasted 2 days.    Both started Started 2 days after vaccine.
suspected vaccination failure; shingles; pain; uncomfortable; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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), shingles, pain and discomfort. On an unknown date, the outcome of the vaccination failure, shingles, pain and discomfort were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and discomfort to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got the shingle vaccine and still got shingles. He was in a lot of pain and uncomfortable for a long time. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
c/o chest congestion w/o fever given Amoxicillin & Amadine for dx viral synd & poss sinusitis;
After recieving the second dose on Tuesday, 6/22, I experienced burning then  tingling, weakness and soreness in the vaccine arm, as I had with the first dose. This time it was accompanied by a tight, pinching chest pain beginning about a day and a half later. Sunday morning, while making breakfast, I began to experience abdominal pain similar to menstrual cramps with nausea, followed by extreme dizziness. I briefly lost consciousness and fell. My husband helped me to the sofa and stated that my skin was very pale and my lips were a shade of blue/green. After some time I was able to sip water and return to some level of normalcy.  I experienced double vision the day after, and again on July 8. Pain in left arm / under arm, left arm/hand weakness, heart flutters, and Mild to moderate pinching chest pain continues to happen occasionally.
He is feeling fatigued; Pressure on his chest; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program .  A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, patient experienced he is feeling fatigued, pressure on his chest. It was reported that, patient received first  with no problems but with his second  about 7 days after he is feeling fatigued and pressure on his chest. He asked if this could be a side effect to the . Informed him it could but with pressure on his chest he needs to contact his HCP immediately to make sure this is not his heart. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Patient experiencing adverse event is an immunizing pharmacy tech.  While administering a pediatric Pfizer vaccine, the child jerked away and was accidentally stuck with the needle in her left hand.
On 03/04/2019 the patient (12 mo and 8 days old) was inadvertently given both a varicella vaccine and an MMRV vaccine instread of a varicella vaccine and an MMR vaccine. As a result the patient received two doses of varicella on 3/04/2019. There has not been an adverse reaction to date. A member of the nursing staff at the Health Center will call the patient's parents to discuss the increased risk of seizure with the combination vaccination.
Inflammatory reaction (patient said cellulitis). Treatment MEDROL DOS PAK 4 mg.
SORE ARM; This spontaneous report received from a consumer 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 was not reported, administered on 03-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-SEP-2021, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210908685 and 20210908729.
Patient claims that there is a needle still in his arm.  A scab had formed over the site but has not had a medical professional look at it.
On March 20/2021 I went for emergency with tingle and mouth filling  ) Paranesthesia's
Hives 90 minutes after DTaP #4. Wheal/flare reaction.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (Subcutaneous, 0.65 ml, lot # (670613/0657AA), expiration date 04-AUG-2012) on 28-AUG-2012. No adverse effect reported. No other co-suspects were reported. No concomitant medications were reported. At the report time the outcome was unknown. It was unknown if the patient sought medical attention. Additional information is not expected.
Admitted with-injury, DM2 with hyperglycemia, hypochloremia, fall, head transaminitis, non alcoholic fatty liver disease, microcytosis without anemia, overweight, COVID-19 (+)-all present on admission No indication for any immunomodulator antiviral at this time as patient is asymptomatic.  Isolation precautions per protocol
Sick; This is a spontaneous report from a contactable consumer (reporting for herself). A 68-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 11Jan2021 (Batch/Lot Number: 1283) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was sick. She was at the ENT and they thought she had a respiratory infection, but she did not have one, and she did not get second shot. The outcome of the event was unknown.
?Vaccine arm?  left arm has become swollen, hard, tender and hot at injection site, with symptoms appearing 7 days following injection.
PAIN IN ARM, MOSTLY WHEN SHE TRIES TO LIFT ARM OR PUSH WITH IT.
left arm numbness; tingly; muscle aches; This is a spontaneous report from a non-contactable other healthcare professional. An 18-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6207) via an unspecified route of administration on 18Mar2021 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 18Mar2021, during 15-minute waiting period after the vaccination, the patient experienced left arm numbness and tingly. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient also complained of muscle aches. The patient was treated with water and she had an excellent response to the treatment. The patient was stable to go home and follow up with primary care physician. The clinical outcome of the events arm numbness, tingly and muscle ache were unknown at the time of report.   No follow-up attempts are possible. No further information is expected.
FLUZONE HD vaccine from last year, which expired on 30JUN2021 given to patient with no AE; Initial information received on 27-Oct-2021 regarding an unsolicited valid  non-serious case received from a other health professional via number: 00829590.  This case involves a 87 years old female patient who was administered an expired dose of  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (expired product administered).   The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On 26-Oct-2021, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ515AA and expiry date: 30-JUN-2021) via intramuscular route in  in the left deltoid for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
(R) arm dominate. (R) arm bright red - hot to touch. Very nausea. 101 temp at 2 PM 9/25/12 - by 8 PM 102 temp - nauseated. By 9/26 - fever reducing. 9/26 - took BENADRYL. Both vaccine in (R) arm.
Patient is a 39 y.o. male who was admitted on 1/17/2023 and diagnosed with acute pericarditis.  He had onset of symptoms on Monday 1/16/2022 with chest pain.  He initially took ibuprofen but the chest pain worsened and woke him up around midnight yesterday morning.  He therefore presented to ER yesterday.  He required several doses of NSAIDs yesterday for analgesia including IV hydromorphone, indomethacin, IV Toradol and IV morphine.     He has been started on HD NSAID and colchicine.   He reports having COVID twice once in November 2021 and likely again in May 2022. Had Moderna injections on 3/2/2021, 3/29/2021 with Moderna booster on 1/4/2022 and Pfizer bivalent on 10/25/2022.   Denies any recent fevers, chills, URI symptoms or autoimmune disorders.  He has 2 school age children.  Reports significant improvement in chest pain compared to yesterday now reportedly only 2/10.  Denies any orthopnea, PND, palpitations.  Has had no arrhythmias.  There is no biochemical evidence of myocarditis.
Information has been received from a physician's assistant concerning a female patient "in her 20's" with unspecified medical history and no drug reactions or allergies reported, who in early November 2009 and in early December 2009 was vaccinated with the first and second dose of GARDASIL (route and lot # unknown) respectively. Concomitant medication was unspecified. On an unspecified date, the patient experienced itchy bumps on her opposite arm (not the arm where the injection was given) and her back, after the first and second doses of GARDASIL. The physician's assistant also reported that the doses were separated by only one month. Lab diagnostic studies performed were unspecified. The patient sought unspecified medical attention. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Information has been received from a dentist concerning his daughter a 16 year old female who on an unspecified date in approximately February 2007, was vaccinated with the first dose of Gardasil (Yeast) (lot# not provided). Subsequently, "within one week of vaccination" the patient developed extreme anxiety, sleeplessness and was in a "bad psychological state". The patient was seen by a counselor for unspecified treatment. The patient was said to be recovering on an unspecified therapy. Additional information has been requested.
Dose 2 felt like I had the flu for a couple days. Threw up, skin hurt/sensitive to touch Foods continue to hurt my stomach to this day, upset stomach nausea and pain. my skin still hurts. I now have red marks all over my feet, legs and arms that look like broken blood vessels. my skin is sensitive to the touch. My feet have swelled several times for no reason. I have never had that problem before
Arm is feeling better. Had pain for 3 days. Now feeling better. Now feeling better. Tender to touch. Can lift her arm--Starting to feel better. Took Motrin for the first 2 nights.
Body aches, head ache, chills, low grade fever, slight nausea. Initially took advil (400 mg) and then moved to Tylenol (500 mg) every 6 hours. The symptoms lessened after 30 hours, and completely resolved after 38 hours.
Initial information received on 08-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 24 months old female patient who received only diluent from ACT-HIB batch number U6073AA (expiry date 14-Nov-2019) via unknown route in left thigh. And ACTHIB Powder lot number UI914AA (expiry date 28-Nov-2019). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A, VARICELLA VACCINE, MMR, PREVENAR 13 and DAPTACEL. It was a case of actual medication error due to inappropriate reconstitution technique. (It was reported that consumer only got the diluent from the ACTHIB box.) It was not reported that if any adverse reaction was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
This spontaneous report as received from a physician refers to an unspecified patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories. On unknown dates, the patient was vaccinated with improperly stored 0.5 ml dose of VARIVAX lot # M025871, expiration date 24-MAY-2018 (route of administration was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 36.3 degrees Fahrenheit for 2 hours and 51 minutes. Product quality complaint was not involved. Additional information has been requested.
Temp 101, "not herself" within 24 hours of Flumist. Then had fever off and on every day until 10/23/14.
Information has been received from a licensed practical nurse concerning an 87 year old male patient with chronic obstructive pulmonary disease (COPD), asthma, melanoma and leukaemia who on approximately 20-JUN-2012 was vaccinated IM with a 0.5 ml of a single dose of PNEUMOVAX 23 (lot # 672673/0492AE; Exp date: 22-AUG-2013). On approximately 20-JUN-2012, within the last week, the patient experienced cough after vaccination. The patient went to emergency room (ER), given an unspecified antibiotic and discharged. Subsequently, on an unspecified date, the patient recovered from cough after vaccination. This is one of several reports received from the same source. Additional information has been requested.
Heartburn; Pain in my chest; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient).  A 40-year-old male received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0153 and expiry date was not reported), via an unspecified route of administration into left arm on 04May2021 (At the age of 40-year-old) as Dose 2, single for COVID-19 immunization. Medical history included High Blood pressure. Concomitant Medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EW0171 and expiry date: not reported) via an unspecified route of administration into left arm on 13Apr2021 as dose 1, single (At the age of 39-year-old) for COVID-19 immunization. On 08May2021 (last night from reporting) after taking second dose of vaccine, the patient complained of two problems: One was swollen lymph nodes and other was like pain in his chest. The patient thought it was heartburn and took unspecified treatment for it. The lymph node was what gone now feel anymore, now it's not like that. The patient did not undergo any laboratory tests. Outcome of Swollen lymph nodes was recovering, and outcome for Heartburn and chest pain was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021531972 same reporter and drug, different patient and event
After I received the Pfizer vaccine, I developed severe painful, blistery rashes all over both hands, palms , wrist & forearm? This lead me to urgent care and I had to be prescribed antibiotic cream.
Itching and rash on upper left arm-started 1 week later and is slowly resolving