chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm and left neck hurt after shots. S/P Menactra and Boostrix on left arm, and HPV on right arm on 11/13, + feeling left neck pain on 11/14/07, worsed on 11/15/07, but arm pain getting better on 11/15/07, + feeling tirdness, fatigue, no vomiting, no HA.
Extreme weakness - 10 days after shot tingling & numb tongue, mouth - Dec. 7 eating became difficult - numbness in body & hands - Dec. 18-24. Received plasmapheresis & IV/IG in Jan.
This case was reported by a nurse and described the occurrence of an injection site reaction in a child who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  The nurse reported that two children had experienced an injection site reaction following the administration of Infanrix from the same lot; however no patient identifiers were provided.  On an unspecified date, the patient received a dose of Infanrix (lot DTPA592B9); dose number not specified.  Approximately two days following the administration of Infanrix, on an unspecified date, the patient experienced an injection site reaction characterized as localized swelling, redness, and induration.  The injection site reaction resolved on an unspecified date.
Vomiting and diarrhea beginning about 8 hours later, lasting 24 hours. Fever and chills beginning about 16 hours after shot.  Body aches.
swelling at the injection site; redness at the injection site; This spontaneous report was received from a nurse concerning a currently 30-year-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions and allergies.  On 24-FEB-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), 1 dose, administrated subcutaneously, lot number R017643, expiration date 20-JUN-2020 for prevention of varicella. The vaccine was reconstituted with diluent MRK (lot number and expiration date were not reported).   On an unknown date in February 2020, the patient experienced swelling and redness at the injection site where she received varicella virus vaccine live (oka/merck) (VARIVAX) (injection site swelling and injection site erythema). Furthermore, the patient called the physician's office; however the patient did not receive treatment for the events and no laboratory diagnostics or studies were performed.  The outcome of injection site swelling and injection site erythema was reported as recovering. The causal relationship between the aforementioned events and therapy with varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.
Fever, chills, aches, nausea, diarrhea, pain, redness, and swelling at site, sore throat
This spontaneous report as received from a physician regarding an unknown age and gender patient with no pertinent medical history reported. In August 2012, the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (dose, route and anatomical location were not reported). The reporter stated that in 09-APR-2013 (reported as "today") the patient received the second dose of GARDASIL (lot number and expiration date not reported) (dose, route and anatomical location were not reported). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
6 inch rash on right arm. Very swollen, and with a thickness to it. Feels warm and very tender.
Arm soreness after received the Pfizer COVID 19 Vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 65 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (1st dose, Lot: ER8733, Expiry/NDC: Unknown), administration date: 02Apr2021, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "arm was sore"; BNT162b2 (2nd dose, Lot: EW0173, Expiry/NDC: Unknown), administration date: 30Apr2021, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "arm was sore"; BNT162b2 (3rd dose, Lot: FJ8757, Expiry/NDC: Unknown), administration date: 24Nov2021, when the patient was 64-year-old, for COVID-19 immunization, reaction(s): "arm was sore"; BNT162b2 (4th dose, Lot: FJ9943, Expiry/NDC: Unknown), administration date: 12Apr2022, when the patient was 64-year-old, for COVID-19 immunization, reaction(s): "arm was sore". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 04Nov2022, outcome "recovered" (Nov2022), described as "Arm soreness after received the Pfizer COVID 19 Vaccines".  Additional information: There were no prior Vaccinations (within 4 weeks) reported. There was no family Medical History Relevant to Adverse Events (AEs) reported. The patient stated that she takes vitamins. The patient verifies that her arm was sore with all of her Pfizer COVID 19 doses. Stated that if you give her any kind of shot, her arm will hurt. Arm soreness after received the Pfizer COVID 19 Vaccines began the night she received the vaccine and lasted about 2-3 days. No prior Vaccinations (within 4 weeks), no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Tenderness at PPSV injection site, slight swelling, no erythema c/o headache, nausea, fatigue.
the clinic was storing the vaccines improperly; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (the clinic was storing the vaccines improperly) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (the clinic was storing the vaccines improperly). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (the clinic was storing the vaccines improperly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The number of patients is unknown in this case.
7/8/21 0430:  Resident sitting on floor in room.  Staff assisted back up, resident noted to have fever of 103 degrees.  Shaking movements of extremities, weakness in legs,  and confusion noted.   Resident sent to local ER.  Ct of head showed no acute process, CXR showed no acute process, and urinalysis did not indicate a UTI.  Resident returned to facility after about 2 hours in the emergency room.  At time of return was coherent and no longer confused.
After 12 hours: headache, fatigue. By 48 hours post vaccine: nausea, fatigue. 72 hours post vaccine: severe diarrhea, fever, shaking, aches, vomiting and nausea, headache. 4 days post vaccine: headache and diarrhea.
the pain/discomfort even woke him from sleep; pain from the shot in his left arm; the pain from the shot in his left arm has moved up into his shoulder; This spontaneous report was received from a consumer referring to her husband, a 59 years old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On 30-AUG-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route of administration, lot# and expiration date were not reported) in the left arm for prophylaxis.         On 31-AUG-2021, the patient experienced pain from the shot in his left arm, the pain had moved up into his shoulder and the pain/discomfort even woke him from sleep. The outcome of the events was unknown.   The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
ABDOMINAL PAIN,  CRAMPS LIKE KIDNEY PAIN OR LIKE CRAMPING THAT COMES  PREMENSTRUAL; PAIN OVER THE OVARY; BACK PAIN THAT IT IS ON THE RIGHT SIDE IS THE MOST; NAUSEA; This spontaneous report received from a patient concerned a 52 year old female. 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: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced abdominal pain, cramps like kidney pain or like cramping that comes premenstrual. On 25-JUN-2021, the subject experienced pain over the ovary. On 25-JUN-2021, the subject experienced back pain that it is on the right side is the most. On 25-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain that it is on the right side is the most, and the outcome of abdominal pain, cramps like kidney pain or like cramping that comes premenstrual, nausea and pain over the ovary was not reported. This report was non-serious.
Patient hasn't been able to receive the second dose because she was recommended not to until she was fully recovered; Bell's Palsy symptoms; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy symptoms) and OFF LABEL USE (Patient hasn't been able to receive the second dose because she was recommended not to until she was fully recovered) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced BELL'S PALSY (Bell's Palsy symptoms). On an unknown date, the patient experienced OFF LABEL USE (Patient hasn't been able to receive the second dose because she was recommended not to until she was fully recovered). At the time of the report, BELL'S PALSY (Bell's Palsy symptoms) and OFF LABEL USE (Patient hasn't been able to receive the second dose because she was recommended not to until she was fully recovered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.  10-Jun-2021, Patient started to develop bell's Palsy symptoms.  11-Jun-2021, She went to the doctor who confirmed the diagnosis.   It was reported that patient has not been able to receive the second dose because she was recommended not to until she was fully recovered. Patient still has some numbness and a little weakness, not 100 percent recovered  No treatment medication were provided.  Company comment: This case concerns a 50 year-old, female patient with no relevant medical history, who experienced the non serious unexpected AESI of Bell's palsy. Off label use (LLT: Off label dosing frequency) was considered as an additional event. The event occurred approximately 17 days after the first dose of mRNA-1273 vaccine. The rechallenge was unknown since the event occurred after the first dose and no information has been provided regarding second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 50 year-old, female patient with no relevant medical history, who experienced the non serious unexpected an agency of Bell's palsy. Off label use (LLT: Off label dosing frequency) was considered as an additional event. The event occurred approximately 17 days after the first dose of mRNA-1273 vaccine. The rechallenge was unknown since the event occurred after the first dose and no information has been provided regarding second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
arm hard, very red & itchy; treated as a cellulitis w/Keflexx 10 dasy, Atarax PRN;
FLUID FECES, SUDDEN. I WAS TOLD TO REPORT ANY SUCH INCIDENT.
Information has been received from a health professional concerning an approximately 7 year old female patient who on 16-APR-2001 was vaccinated with the first does of VARIVAX (Oka/Merck) (lot number not provided). On 18-DEC-2007, the patient was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot number 659113/1360U, route, dose unknown). Concomitant therapy included hepatitis A virus vaccine (unspecified) (manufacturer unknown). On an unspecified date, the patient developed a localized rash at the injection site. The physician's office was contacted regarding this experience. This is the first of three reports of rash with the same varicella virus vaccine live (Oka/Merck) (lot number 659113/1360U). The patient recovered from injection site rash on an unspecified date. The caller requested a lot check for this lot number. There was no product quality complaint reported. A lot check has been requested. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2008. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released.
Received Moderna vaccine 2/26 and 3/26/2021.  On 10/26 patient developed urinary retention and was seen in ED, where a catheter was placed and he was discharged.  On 10/31, he was seen at another ED for fever up to 101 and vomiting.  He was discharged.  On 11/2, he returned to ED with progressive weakness and lethargy and another episode of urinary retention.  Patient developed neck pain radiating down to lower back and on 11/4 had MRI that showed myelitis through the entire spine, from cervical region down to the conus medullaris.  Viral panel negative.  LP contaminated with skin flora.  His symptoms continued to worsen despite maximal medical therapy.  Due to impending respiratory failure, patient was transferred to ICU.  He was intubated on 11/5.  On 11/7 patient developed severe autonomic dystonia and developed fevers up to 109.  He developed V tach, coded and expired.
Flu like symptoms nausea acid reflux chills whole body aches tired who is this fever congestion
W/in several hrs of vax, he experienced swollen joints, arthralgia, urticaria, & generalized edema; Condition worsened & on 8MAR89 was treated @ hospital for "an allergic reaction".
Immediately after the vaccine, I had a sore arm and I don't think I had a fever, but felt slight feverish the next day. I took ibuprofen. That was gone by Friday. COVID symptoms later: August 23, 2021 I had positive test for COVID, headache, fever, nauseous and very bad diarrhea. It mostly felt like a sinus infection with diarrhea. I had a cough but it wasn't a bad cough. Mucinex and vitamins for treatment and Zyrtec and Claritin; low dose aspirin; zinc; Vit C; and I isolated and later I used cough syrup when I went back to work. I probably had those through August 30th. I went back to work on September 1st.
Patient denies any ill effects-VAERS submitted only because of special requirements for COVID vaccines. Pt received her 2nd booster 13 days early
Very sore for the first 3 days then the symptoms resolved and starting last Friday, my arm was red raised sore warm and tender to touch. Also had axillary tenderness and soreness down the bicep muscle as well
Medical assistant reported PROQUAD was administered after a temperature excursion to multiple patients. This case is for patient one of four. No further information provided. Cross reference cases: 02219832, 02219848 and 02219874. No additional AE re; No additional AE; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On unknown date, vaccines measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin [rHA]) underwent temperature excursion at 5.56 degrees Fahrenheit for 9 hours and 30 minutes. There was no previous temperature excursion.  On 03-AUG-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) subcutaneous injection, once, lot #W010061, expiration date: 20-SEP-2023 (strength, dose, and route of administration were not provided), administered for prophylaxis (product storage error). There was no additional adverse event reported.  This is one of four reports received from the same reporter.
EYES SWOLLEN, ARM RED AND SWOLLEN AT SITE OF SHOT.  TOLD PATIENT TO TRY BENADRYL, ICE PACK ON SITE OF SHOT AND COOL COMPRESSES ON EYES AND IF GOT WORSE GO TO EMERGENCY   ROOM
Patient was underage for vaccine requirements. No adverse reaction occurred. Patient was seen by a medical provider the day of and the following day. No adverse outcome noted.
after her second dose of the COVID-19 vaccine, she was tired and experienced chills; after her second dose of the COVID-19 vaccine, she was tired and experienced chills; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 25 year-old female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Batch/Lot number: unknown) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 24Mar2021, when the patient was 25 years old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious), CHILLS (non-serious) all with onset 15Apr2021, outcome "unknown" and all described as "after her second dose of the COVID-19 vaccine, she was tired and experienced chills".  No follow-up attempts are possible. No further information is expected.
My arm was so sore I could not hardly move it, starting approx. 6 hours after injection.  Now 5 days after injection still quite sore. Entire upper arm, approx. 7"x4" area erythema and hot to touch (even through clothing).  Redness started a couple hours after injection.   Now 5 days after vaccine red area is approx. 3"x3". At injection site, approx. 1"x1" hard bump that is still present 5 days after vaccine Area of upper arm where injection given, severe itching, which continues now 5 days after vaccine. Approx 9 hours after injection and continuing for approx. 36 hours, body aches and joint pain.  I took Tylenol and Benadryl for 48 hours after vaccine reaction first noted.
This case was reported by a physician and described the occurrence of accidental exposure while preparing drug for administration in a 51-year-old male subject who was to receive Flulaval (GlaxoSmithKline) for prophylaxis.  The reporter is also the subject.  On 23 October 2007 at approximately 11:10 the subject was ready to have an unspecified dose of Flulaval administered.  The Flulaval was accidentally splattered into eye and he experienced accidental exposure to the Flulaval as the vaccine was getting ready to be administered.  He also experienced some burning of his right eye.  The subject washed out his eye with water and applied ophthalmic tear drops.  The subject will possibly seek medical attention with an ophthalmologist.  At the time of reporting the outcome of the events was unspecified.
feeling sick/general malaise; severe arthritis; headache; some confusion; some nausea; This is a spontaneous report from a contactable consumer, the patient. This 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201) via an unspecified route, administered in the left arm on 28Feb2021 at 03:15 (at the age of 71-years-old) as a single dose for COVID-19 immunization. The patient's medical history included migraine, arthritis, Meibomian gland dysfunction, and rosacea. The patient had known allergies which were not further specified. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications the patient received within 2 weeks of vaccination were not specified. In Feb2021, the patient was feeling sick since receiving the second vaccine, and it's been 10 days. The patient experienced general malaise, severe arthritis, headache, some confusion and some nausea. The patient stated common side effects, but they seemed to be lasting a long time. The clinical outcomes of feeling sick/general malaise, severe arthritis, headache, confusion and nausea were not recovered. Since the vaccination, the patient has not been tested for COVID-19.
No adverse effects were reported; Incorrect product storage; This spontaneous report was received from a medical assistant concerning a patient of an unknown age. Information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medication was not reported.   On 20-MAY-2019, the patient was vaccinated with an improperly stored (product storage error) dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) batch # R012001, expiration date 06-NOV-2020, (strength, dose, frequency, route of administration and anatomical location, were not reported) for prophylaxis. No adverse effect were reported.   The vaccine was stored at temperature above of 47° fahrenheit (F) (48.7 F) for the time frame of 1 hour and 38 minutes. No previous temperature excursion was reported.  The call was because of data logger.  This is one of three cases received by the same reporter (1905USA013165-1905USA013166).; Sender's Comments:  US-009507513-1905USA013166: US-009507513-1905USA013165:
Information has been received from a medical assistant concerning a 16 year old female patient with allergy to penicillin. Who on 30-Sep-2008 received a dose of GARDASIL, ( route and injection site not reported). On an unknown date after vaccination, she developed tiredness, headache, and tingling in her ankles. The patient sought medical attention via phone call to office. At the time of reporting she had not recovered from the events. Additional information has been requested.