chrisvoncsefalvay/vaers-outcomes huggingface dataset:
burning of the tongue; Difficulty in breathing; headaches; Pressure in the chest area; nausea; dizziness; fast heartbeat; tiredness; Had a hard time swallowing at night from the dryness; bitter taste; her mouth went completely dry; patient received 0.45 mL, single dose (225mcg) of PFIZER-BIONTECH COVID-19 VACCINE; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 23Dec2020 15:00 at 0.45 mL, single dose (225mcg) at left arm to prevent COVID. Medical history included a bout of dry mouth about 7 years ago, no other relevant medical history (including any illness at time of vaccination). The patient's concomitant medications were not reported. There's no adverse events following prior vaccinations. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. From the time she got the vaccine her mouth went completely dry on 23Dec2020 and she kept thinking it would go away and she still had it. Event was reported as serious per medically significant. Had a hard time swallowing at night from the dryness. Patient had the bitter taste was also on 23Dec2020, but it went away. It lasted about 5-6 hours. Then after that the dry mouth started right after. It is tolerable but she still had it. Mentioned she had a bout of dry mouth about 7 years ago and it did go away, but she never got a diagnosis for it. Patient thought that something underlying may have triggered it again. Patient also experienced burning of the tongue, tiredness, headaches, pressure in the chest area similar to difficulty in breathing, nausea, dizziness, and a fast heartbeat on unspecified date. Outcome of event dry mouth was not recovered, outcome of event bitter taste was recovered on unspecified date in Dec2020, outcome of other events was unknown. No family medical history relevant to adverse events. No relevant tests. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care.   Relatedness of Pfizer BioNTech Covid-19 vaccine with dry mouth and bitter taste per primary source reporter with method of assessment of global Introspection was related. Reporter seriousness for event bitter taste was not serious.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of dry mouth cannot be excluded, considering the plausible temporal relationship.  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.
Headache, nausea, chills.  Symptoms continued with fever. Rash developed on 12/17/15.  Diagnosed by Urgent Care with Shingles on 12/22/15.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE CHRONIC RESPIRATORY FAILURE 2/17/2022 -- RECURRENCE OF SAME SYMPTOMS
Mom called 2/27/04 8:15 am-states child developed red, hard areas on RAT from above knee to groin-temp 102 deg on 2/26/04 also c/o headache. 3/6/04 talked with mom-reported no more problems.
nurse called to inform that they have given an expired menquadfi to a patient with no reported adverse event; Initial information was received on 20-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional (Nurse).  This case involves a nurse called to inform that they have given an expired meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] to a 17 years old male patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 20-Jul-2023, the patient received an expired dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection (Strength: Standard) at dose of 0.5 ml once (lot number: U6821AA, expiration date: 27-Jun-2023) via intramuscular route in the left deltoid for immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event nurse called to inform that they have given an expired menquadfi to a patient with no reported adverse event.  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 guidelines. 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.
Patient had a near syncopal episode about 5 minutes after receiving the vaccines. Patient was able to lay down to avoid completely passing out. She had no previous reactions to vaccines in the past.
Since the time of my vaccine, I've experienced intense muscle and joint pain throughout my body. I was referred to a rheumatologist who gave me a round of steroids, which had no effect. I have since been diagnosed with IT Band Syndrome in addition to general tightness in muscles throughout my body.
Pt presented to clinic today 05/12/2023 with Family Planning needs. Gardasil 9 dose 3 was given to patient. Last known dose was administered 02/17/2023. Pt should not have received 3rd dose until July 2023
Dizziness, sweating, itchiness, nausea, tongue swelling. Given Epi, Benadryl and a steroid and kept in observation over night. Discharged and ended up back at ER same night because of itching and swelling of the tongue. Extreme Dizziness and itching still present on 11/08/2015.
vaccinated with an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th September 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 14th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The health care professional reported that a patient was vaccinated with an expired dose of Kinrix. The vaccine was expired on 31st August 2021. The reporter consented to follow-up.
Pt was given undiluted vaccine, did not report any AEs at time of injection or 2 hours later
tested positive for COVID after receiving the first dose; tested positive for COVID after receiving the first dose; This is a spontaneous report from a contactable consumer reporting on behalf of the patient via a Pfizer-sponsored program. A female patient (mother) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The reporter mentioned that her mother tested positive for COVID after receiving the first dose. The reporter wanted to know when will the patient take the second dose since she is COVID positive.  The patient is in the nursing home. Outcome of the events was unknown.   Information about batch/lot number has been requested.
WHEN I PULLED OUT THE NEEDLE SOME OF THE WHITE LIQUID CAME OUT OF THE INJECTION SITE -ABOUT 2 DROPS
Pt came in on Sept 14 with rash on body. Dr gave child a BENADRYL, child also came in on Sept 5, for cough, and congestion. Dr gave child there RX for amoxicillin 125/5 one TOP PO TID X 10 Day.
Quick, involuntary muscle jerks of both legs; Gas and bloating; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient (consumer) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EM9809), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 09:00 (at the age of 76-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The medical history included rheumatoid arthritis and peripheral neuropathy from 09Feb2021 to an unknown date, and allergies to sulfa, levofloxazone from an unknown date and unknown if ongoing. The concomitant medications included gabapentin, doxazosin mesilate (CARDURA), finasteride, ibuprofen, paracetamol (TYLEN) taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks, no prior vaccinations and not tested for covid test post vaccination. The patient experienced quick, involuntary muscle jerks of both legs as he tried to sleep the night of his vaccination also, severe gas and bloating the afternoon after vaccination on 09Feb2021 21:00. The patient received no treatment in response to events. The clinical outcome of events was not recovered.  Follow-up (11May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient passed out and fell walking out of the store, then regained consciousness upon falling to the floor. Patient was given water, EMR was called to evaluate patients vital signs.
patient was 18 months of age at time of vaccination; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 31-MAY-2023, the patient received Kinrix. On 31-MAY-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient was 18 months of age at time of vaccination). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-JUL-2023 The recommended dose schedule stated that Kinrix might be used for the fifth dose in the DTaP immunization series and the fourth dose in the IPV immunization series in children aged 4 through 6 years (prior to the seventh birthday)whose previous DTaP vaccine doses had been with Infanrix and/or Pediarix for the first 3 doses and Infanrix for the fourth dose.  The reporter called as a precautionary measure, seeking information on possible adverse events that might arise.  No adverse events had been reported by child's guardian as of present time. The reporter transferred to medical information. The reporter consented to follow up. The reporter reported that an 18 months of age patient received a dose of the Kinrix vaccine, which led to inappropriate age at vaccine administration.
Immediately after vaccine was administered, patient began shaking and stated she had difficulty breathing. Patient's ankles were swollen.  Patient was alert and oriented x 3 but had difficulty answering questions and appeared anxious. EMS was called and epinephrine injection 0.3mg was administered in patient's right thigh by RN while EMS was on the phone. EMS arrived and took V/S: BP 151/108, HR 120, O2 sat 100% on RA.  Pt transported to nearest acute care hospital by EMS at 1:39 p.m.
pt recvd vax;grandma described 10 mins of jerking hands & legs;gray color;eyes partially closed;tired p/ episode,but recovered quickly;possibly febrile at the time;no one else witnessed;
severe headache, severe muscle pain, redness (2-3cm in diameter), swelling, soreness
Pt. states within 24 hours of receiving vaccine pt. had swelling in arm from elbow to underarm. Pt. took Ibuprofen and BENADRYL and swelling is slowly resolving.
Redness and swelling from about 1 inch above injection site down to her elbow of her right arm. Arm feels stiff, mobility diminished and very painful. Reddened area is warm to touch. Iced area and took TYLENOL. Reported adverse event on 8/9/11 at 11:51am.
MA called provider to report pt not reacting well to vaccine "having seizure" upon entering of room; pt lying on exam table A and O x 3 pulse ox 98% RA, moved all extremities w/o restriction, normal speech. Mother present during episode and states that eye rolled back (pt fell backward with no limb jerking or incontinence. Vitals reviewed no distress at 10:30 am pt. reevaluated no changes as above. ED precautions given per PCP.
Tiredness; headache; joints pain; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 72-years-old female patient (patient was not pregnant at the time of vaccination) received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 26Feb2021 at 12:30 pm (age at vaccination was 72 years) as UNKNOWN, SINGLE DOSE for COVID-19 immunization. The patient did not have any chronic health conditions. The patient did not have any known allergies. Concomitant medications included pravastatin. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Feb2021 at 10:00 am, the patient experienced tiredness, headache and joints pain. No treatment was received for the adverse events. The outcome of the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
After 1st dose and 2nd dose of Pfizer Covid vaccine, I had mild side effects: very sore arm, slight headache, dizzy, nausea, some ringing in my ear. Most symptoms would come and go over a couple of weeks. However, two months after the 2nd dose, I developed sores on the side of my tongue. They were painful but went away after 1-2 weeks. Then, at about 3 months after the 2nd dose, I had extremely itchy bumps (skin rash) develop on my skin. During the time I developed these bumps, I had the sensation of being pricked by needles or something sharp all over my skin. I had about 2 dozen bumps develop on various parts of my body (arms, thighs, stomach, butt, ankles). Some of the bumps formed blisters. They remained very itchy for several days, and they've taken 2-4 weeks to heal.
Wrong series was given to patient. Patient should have received Pfizer bivalent and not Pfizer monovalent.
Information has been received from a Registered Nurse concerning a 35 year old female patient with no allergies and no pertinent medical history who on 28-FEB-2010 was inadvertently vaccinated with a 0.1 ml dose of PNEUMOVAX 23 (Lot#667913/1021Z, Exp date 27-FEB-2012), Intradermally, when supposed to received the MANTOUX II test (PPD). There was no concomitant medication. The nurse reported that on 28-FEB-2010 the patient experienced local injection-site reaction, after the patient was inadvertently administered PNEUMOVAX 23. There was no treatment given for the events. There were no laboratories diagnostics performed. At the time of the report the patient had recovered from the symptom. The patient sought unspecified medical attention. Additional information has been requested.
Information has been received from a chiropractor concerning a pt who was vaccinated with varicella vaccine. It was reported that the pt experienced dizziness. Unspecified medical attention was sought. Additional info has been requested.
06/02/2021- Immediately (under 5 minutes) - Mottled skin on both legs, upper and lower (last 45 minutes), Extremely dizzy and lightheaded. Face went dumb 4 hours after vaccine, both legs turned bright pink like sunburn 10 hours after vaccine. 06/03/2021 - Broke out in hives on inside of arms. Lasted 3 days and no longer there 06/08/2021 - Metrorrhagia (my period was not due for 10 more days, I am always exactly regular for my whole life) 06/08/2021 - Hypoglycemia (Multiple episodes since vaccination, Bloodwork showed one episode of 56 mg/dL) No history of diabetes. Hypoglycemic episodes still happening as of 06/13/2021 when blood sugar was 72.
fast heartbeat; headache; pain; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heartbeat), HEADACHE (headache) and VACCINATION SITE PAIN (pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (fast heartbeat), HEADACHE (headache) and VACCINATION SITE PAIN (pain). At the time of the report, HEART RATE INCREASED (fast heartbeat), HEADACHE (headache) and VACCINATION SITE PAIN (pain) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.    Reporter did not allow further contact
After receiving the injection I experienced slight soreness at the injection site, which was expected.  later that evening I experienced swelling in the left axilla lymph nodes. The swelling in that area was extreme on 01/20/2021 throughout the night and has continued until day of reporting on 01/27/2021. The pain and swelling involved the entire underarm and pain could be felt deep in the tissue. On pain scale of 1-10 with 10 as extreme, I would rate pain as a 9 on days 1-5. Pain has gradually diminished in severity on subsequent days and is a 2 today. Measures to reduce the pain included elevation of arm and shoulder during the night, discontinuation of deodorant during period of discomfort and application of warm and cold compresses to decrease pain and swelling.  Initially contemplated seeking emergency room evaluation and treatment for evaluation , but decided against because there is no way to remove the vaccine and treatment would probably include measures already implemented.
Patient with lightheadedness and dizziness after vaccine administration.  Patient was lying on exam table, HR=80, B/P=102/68, pale, given, drink and lollipop.  Patient did not eat or drink prior to visit.  Patient waited 15 minutes then discharged to home without incidence.
This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine ;manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant ;manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated ;manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose Fluarix (.5 ml, unknown) intranasally (intramuscular administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental over dose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as "Flumist" and administered intranasally. There were no other adverse events other than "bad taste."
Pt developed dizziness and tingling shortly after vaccination. She notes that she felt very anxious prior to vaccination. No skin, respiratory or ENT symptoms. BP 130/70, HR 66, SPo2 99%. Pt improved over the course of several minutes without intervention. She elected to drive home with a family member.
This case described the occurrence of arthralgia in an adult female pt who received Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis.  This report was received from the pt, who is a nurse.  The pt's medical history included two episodes of Lyme disease.  On unspecified dates, the pt received an unspecified number of doses of Lymerix.  At an unknown time post-immunization, the pt began to experience arthralgia.  The pt was seen by a physician, who prescribed unspecified IV antibiotics.  The outcome of the event is unknown.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, frequency, lot# and expiration date were unknown). On an unknown date (about six months to a years ago) the patient developed a red blister at the injection site. The outcome of developed a red blister at the injection site was reported as recovered. Additional information has been requested.
Parents feel patient had a change in personality after her first set of immunizations. She seemed to develop hyperacoutis and became very fussy, spending a lot of time crying.  Hyperacoutis improved about 2 weeks ago.
Covid Breakthrough case. Vaccinated with Pfizer x 3. c/o nasal congestion, cough. Not a candidate for Paxlovid due to greater than 5 days with symptoms. Seen by clinic.