chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had Fever all night; My son is sick; Horrible Headache; This is a spontaneous report from a contactable consumer (Patient's parent). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Solution for injection, Lot number: not reported) via an unspecified route of administration on 07May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. On 07May2021, the patient had fever all night. On an unspecified date in May2021, the patient experienced horrible headache and was sick. It was reported that the reporter's son was sick and the reporter had been holding on line for like 30 minutes, so can give the patient tylenol or ibuprofen or what to give him because he had his second vaccine (unspecified vaccine) of pfizer yesterday, he had a horrible headache and he has had fever all night. The outcome of the events was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
before i left the place of the vaccination my body started itching the nurse their sent me home an dafter an hour or so i had rash all over my body. The next morning i still had the rashes and the body hurt a lot and after a month i still have the rash my joint hurts and my heart rate is really fast. My heart and my sugar levels changed drastically after the vaccination. Because of all of this my doctor told me to not get the second vaccination
cold sweats (skin very hot, I assume I had a fever, though was too sick to check it) sleeplessness aches all over body,  pain not quellable with Tylenol headache sensitive glands     all lasting about 12 hours      this was my 2nd dose, first dose had no effects except for site soreness
to get dizzy/light headed; weak; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the parent.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 31Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 01Apr2021, outcome "unknown", described as "to get dizzy/light headed"; ASTHENIA (non-serious) with onset 01Apr2021, outcome "unknown", described as "weak". Additional Information: The patient's age was reported as 30 (units unknown). The reporter stated her stepson received vaccine yesterday and felt dizzy, lightheaded and weak. The reporter would like to know if the reported were side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
had the shot and I got shingles/ suspected vaccination failure; shingles; 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 provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had the shot then got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were not provided.
Patient died 2 weeks after receiving his 4 months immunizations. The medical examiner diagnosed him with encephalitis. He died as a result of a seizure. Prior to this, he showed no signs of distress. Nurse follow up on 05/14/04 states: Complete.
This case was reported by a nurse via call center representative and described the occurrence of tiredness in a 35-year-old female patient who received RABAVERT (batch number SWOI27AA, expiry date 31st August 2020). On 12th March 2018, the patient received the 1st dose of RABAVERT. On 12th March 2018, 2 hrs after receiving RABAVERT, the patient experienced tiredness, appetite lost and malaise. In March 2018, the outcome of the tiredness, appetite lost and malaise were recovered/resolved. The reporter considered the tiredness, appetite lost and malaise to be related to RABAVERT. Additional details were provided as follows: The patient was seen at hospital on 9th March 2018 and received rabies immunoglobulin but the hospital forgot to administer the 1st dose of rabies vaccine on that day. The healthcare professional reported that the patient received 1st dose of RABAVERT late post exposure in the right deltoid. The patient experienced tiredness, fatigue, loss of appetite and malaise that lasted for 2 days. For further tolerance to next dose, refer case US2018GSK054409.
lips and eyes swelled up; lips and eyes swelled up; flu symptoms; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case from consumer/non-health care professional.  This case involved a female patient of unknown age who experienced lips and eyes swelled up (lip swelling and eye swelling) and flu symptoms (influenza), while she received vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On 22-Oct-2009, the patient received INFLUENZA QUADRIVAL A-B VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date in 2009, (latency: unknown) patient who experienced lips and eyes swelled up (lip swelling and eye swelling) and flu symptoms (influenza) following the administration of suspect vaccine.  Relevant laboratory test results included: Allergy test - On an unknown date: [had no allergies].  It was not reported if the patient received a corrective treatment.  Outcome of the events were unknown.  There will be no information available regarding batch number in this case.
Information has been received from a health professional concerning a 29 month old white male who was vaccinated with a first and second dose of Varivax on 16-JUL-1999 and 22-DEC-1999. It was reported that the patient developed chickenpox. The patient recovered. It was not specified if medical attention was sought. Additional information has been requested.
Pt with (+) influenza (a) 1 week later.  (-) pt office visit. The medical record received on 12/29/03 states cough, fever and runny nose.
I had a sore throat and hoarseness. A very mild cough. I did not experience fever or chills. I received the monoclonal antibody infusion. They did an antibody test and I didn't have any antibodies. The sore throat and hoarseness lasted about 3 or 4 days.
Initial: Vaccine was administered on June 2, 2011 during the course of patient's routine annual physical.  Up to this point in time, she was very healthy.   Began with stomach pain, fever and rash across torso and arm, and around mouth within 48 hrs of vaccination.  Symptoms progressed over the course of the following weeks to include fatigue, headaches, sore throat, swollen glands, sores in mouth, swollen hands, abnormal menstrual flow (black colored),  painful joints, intermittent blurred vision in one eye, chest pain, tachycardia, diffuse muscular pain, diminished reflexes, burning and pressure sensations in back of head and neck. Patient has been examined multiple times by her pediatrician, and has been evaluated by physicians in the following specialties: infectious disease, cardiology, rheumatology, and neurology.  All tests conducted to date have come back normal.  Physicians cannot explain this course of events.  Patient continues to live with pain and symptoms each day.
HANDS AND FINGER NUMBNESS AND TINGLING BEGAN APPROXIMATELY 2 HOURS AFTER RECEIVING VACCINE
Alleges approx. 5 hours after receiving the flu vaccine in left arm, had sharp pain in back of arm radiating to back of neck. Pain worse for 3 days, lasted 2 weeks. Small red area at vaccination site for 3 weeks. 10/19/2009 pain completely resolved.
Left arm: Round, 3x3 inches of redness and pain. On exam, the area is slightly swollen/indurated and very tender to touch, with limited range of motion at the left arm. Symptoms were developing slowly over the 48 hours following the vaccination. Patient reported low grade fever at home. In office V/S: Temp was 99.3F, pulse 117 bpm, BP 136/83 mmHg. Treatment recommendations were localized cold compresses and PO NSIADs. Should symptoms worsen, patient to seek urgent medical attention. Outcomes are pending as of the time of writing this report.
My husband developed a headache, nausea, extreme malaise, and low grade fever, to the degree that he had to go home from teaching for the day.  He is now throwing up and feeling as if he might pass out (4:30 PM).
Unexplainable systemic rash  severe itching.  May 5th Family dr gave anti itch meds. Helped for a couple of weeks. Symptoms returned went to dermatologist on June 9th . Gave higher dose steroids and ordered all kinds of blood work.
motor control loss that comes and goes throughout his whole body; muscle twitching in leg where it shakes uncontrollably; muscle twitching in his left leg where it shakes uncontrollably; sore throat; mild cough; headaches; Initial information received on 28-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves "an approximately" a 28 year old male patient who experienced motor control loss that comes and goes throughout his whole body, sore throat, mild cough, headaches, muscle twitching in leg where it shakes uncontrollably and muscle twitching in his left leg where it shakes uncontrollably while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history included Dog scratch on 04-Jul-2021. The patient's past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date in Jul-2021, the patient received suspect RABIES (HDC) VACCINE at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for post exposure immunisation. On an unknown dates in 2021 he also received 2 other doses of the same vaccine at an unknown dose with an unknown batch number via unknown route in unknown administration site.  In JUL-2021 the patient developed a non-serious sore throat (oropharyngeal pain), mild cough (cough), headaches (headache) (unknown latency) following the administration of RABIES (HDC) VACCINE. On an unknown date the patient developed a non-serious muscle twitching in his left leg where it shakes uncontrollably (tremor, muscle twitching) and motor control loss that comes and goes throughout his whole body (motor dysfunction) (unknown latency) following the administration of RABIES (HDC) VACCINE. Relevant laboratory test results included: Magnetic resonance imaging - On an unknown date: [everything is clean]   Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for all the events.
Pt returned to Clinic in late afternoon with c/o possible reaction to FLU SHOT given earlier today. Pt reports symptoms as eyes being a little itchy and puffy. The Vaccine Information Statement reports red or itchy eyes as a mild problem. Diphenhydramine.
This case was reported by a consumer via call center representative and described the occurrence of immobile in a patient who received SHINGRIX for prophylaxis. On 26th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a day after receiving SHINGRIX, the patient experienced shivering and feeling cold. On an unknown date, the patient experienced immobile (serious criteria GSK medically significant) and nocturnal awakening. SHINGRIX was discontinued. On an unknown date, the outcome of the immobile was recovered/resolved and the outcome of the shivering, feeling cold and nocturnal awakening were unknown. It was unknown if the reporter considered the immobile, shivering, feeling cold and nocturnal awakening to be related to SHINGRIX. Additional details were received as follows: This case was received via phone. The age at vaccination was not reported or this report. The patient was told by the pharmacist to report. After vaccination with Shingles vaccine, the patient was not able to move for 3 days. In the middle of the night, the patient woke up in the middle of the night with shivering and freezing. The patient reported, these events were horrible. The patient never had a reaction to anything unlike this. The patient was not going to take 2nd shot of Shingles vaccine because of this.
2 days post vax pt reported rt arm soreness that became more painful & sore;weakness started in rt arm & progressed to all extremities;pt stated can't do anything now w/both sides affected, arms & legs;swollen arm, hand;fibromyalgia;
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned multiple patients.  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: 207A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to and 20211017025.
His arthritis was really bad due to having to temporarily stop the medication to get a Covid vaccine; Has a hard time sleeping at night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 68 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRITIS (non-serious), outcome "unknown", described as "His arthritis was really bad due to having to temporarily stop the medication to get a Covid vaccine"; INSOMNIA (non-serious), outcome "unknown", described as "Has a hard time sleeping at night". Therapeutic measures were taken as a result of arthritis.  Additional information: Reporter reported that patient arthritis was really bad due to having to temporarily stop the medication to get a Covid vaccine and he also has a hard time sleeping at night. Patient was prescribed Xeljanz XR 11mg.  No follow-up attempts are possible. No further information is expected.
This spontaneous report has been received from a Licensed Practical Nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with 3 doses of GARDASIL after the age of 28 years. No adverse symptoms were reported. No product quality complaint was involved. Additional information has been requested.
violent shaking; high fever; swollen lymph node; headache; nausea, like the gamut; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (violent shaking), PYREXIA (high fever), LYMPHADENOPATHY (swollen lymph node), HEADACHE (headache) and NAUSEA (nausea, like the gamut) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (violent shaking), PYREXIA (high fever), LYMPHADENOPATHY (swollen lymph node), HEADACHE (headache) and NAUSEA (nausea, like the gamut). At the time of the report, TREMOR (violent shaking), PYREXIA (high fever), LYMPHADENOPATHY (swollen lymph node), HEADACHE (headache) and NAUSEA (nausea, like the gamut) had resolved.            Co-suspect included unspecified steroid.  Concomitant product use was not provided by the reporter.  It was reported that Every time she gets the vaccines the first two, then all the boosters, and the one that just became available, she gets every side effect on steroids. They are really bad. She did not know if they were allergic reactions or not. All the side effects she gets, like violent shaking, high fever, swollen lymph node, headache, nausea, like the gamut.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-741651 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741651:Bivalent dose
Had flu vaccine administered by Nursing Supervisor in Main Hospital earlier on 10/10/19  - stated she had had flu vaccines in past years with no reactions.  Night shift nursing supervisor noted employee began having "redness and swelling at injection site then progressed to lips swelling  and hives with itching.  Employee became short of breath and noted "throat tight." Supervisor took her to ED where she was treated
Information has been received from a certified medical assistant concerning an 8 month old (also report as 4 month old) male who on 21-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (therapy route and lot # not reported). No AE occurred. Additional information has been requested. Follow up information received from the certified medical assistant indicated that it was "product confusion". PNEUMOVAX 23 and PREVNAR were pretty similar and they both looked alike. She further stated that they had now highlighted the packages to "please read before dispensing" so that this did not occur again in the future. Additional information is not expected.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
feeling sick; broke out in severe hives; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling sick) and URTICARIA (broke out in severe hives) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) injection for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MALAISE (feeling sick) and URTICARIA (broke out in severe hives). At the time of the report, MALAISE (feeling sick) and URTICARIA (broke out in severe hives) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient took the covid booster Moderna and Dupixent injection on the same day and broke out in severe hives. Patient went to the hospital because of bad hives and feeling sick.  No treatment information was provided.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL, subdermal. Dose number, dose and lot number were not reported. On an unknown date the patient experienced unspecified allergic reaction to GARDASIL. The outcome of unspecified allergic reaction was unknown. Reporter causality assessment was not reported. Additional information has been requested.
Flu-like symptoms, All-over body aches, Stomach slightly upset, Tired, Short-term tightness in chest.
On December 10, 2022, my heart rate went up to 200 as I was just sitting. I couldn't get it to come down. My husband took me to an emergency room around 12PM. They gave me Cardizem in an IV. My heart rate converted back to about 60. This was the first time I ever didn't feel good after a vaccine. Unfortunately, there are 2 variables there. I've never gotten the flu vaccine at the same time as the COVID-19 vaccine. This was the first time I had gotten Moderna. I experienced some fatigue after getting the vaccine as well.
the results were low titre levels; the results were low titre levels; the results were low titre levels; This spontaneous report was received from a pharmacist, who was also a 59 year old female patient, reporting on herself. The patient had no pertinent medical history, concomitant medications, drug reactions or allergies. Information regarding the patient's pertinent concurrent conditions was not provided  On an unknown date, reported as years ago, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, anatomical location, route, lot # and expiration date were not provided) for prophylaxis. In approximately 2009, reported as "possibly 10 years ago", she had an unspecified blood titre test performed for mumps, measles and rubella and the results were low titre levels (measles antibody negative)(rubella antibody negative)(mumps antibody test negative). Therefore, on an unspecified date, the patient was administered a second measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) series. It was reported that the patient sought medical attention and treatment was given for the events.  The outcome of measles antibody negative, rubella antibody negative and mumps antibody test negative was reported as resolved. The causality between the events and therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Patient received the seasonal Influenza injection (CSL BIOTHERAPIES 075491HA Exp 6/20/2010) as outpatient 09/29/09, 0.5cc influenza vaccine was administered IM to the left deltoid. Immediately after, patient experienced shortness of breath and redness and itching at injection site. Patient was then sent to urgent care and was examined. Patient did not want medication, but nurse recommended diphenhydramine OTC, and ice to swollen area if symptoms worsened.
TOOK FOURTH DOSE A DAY EARLY; This spontaneous case (PVX2019-1420) was received from a consumer on 03-Jun-2019. It describes a male consumer who "took fourth dose a day early", while being on oral Vivotif (one capsule every other day) for typhoid fever prophylaxis.  Case report: The consumer took three doses of Vivotif on every other day. His fourth dose was due on 04-Jun-2019 but he took it on 03-Jun-2019.   Action taken with Vivotif was not applicable.  The clinical outcome of the event "took fourth dose a day early" was unknown.   Company's Comment: The causality of the event "took fourth dose a day early" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took fourth dose a day early" was considered as not applicable.