chrisvoncsefalvay/vaers-outcomes huggingface dataset:
p/vax pt exp funny felling; like could faint; that evening itchy feeling where shot given; in AM has 4'' red rash area w/itching where shot given; c/o upper arm hurting
painful, throbbing rash w/patchs on knees, and all over Thigh and torso, Pain has gotten worse over The week.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Apr2023 to 11Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
During the evening vaccine event, adminsterd an adult Pfizer vaccine to a PED pateint. She was  confused by the patient comment stating that they are "almost 12". On the label itself it does have that she was a PED.
This spontaneous report as received from a pharmacist refers to a 1 unspecified infant of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 03-JUL-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route of administration were not reported, lot number K010535 and expiration date 27-AUG-2016 or lot number K020216 and expiration date 17-SEP-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
a 12 month old was inadvertently administered the PNEUMOVAX 23 vaccine; No additional AE; This spontaneous report was received from a pharmacist referring to a 12-month-old patient of unknown gender.   Information about the patient's pertinent medical history, concurrent conditions, concomitant medication and drug reactions or allergies was not provided.  On an unknown date, the 12-month-old patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (route and anatomical location of administration were not provided; dose, vaccination scheme frequency, lot number and expiration date were unknown by the reporter) for prophylaxis (product administered to patient of inappropriate age).
I got COVID-19 in the beginning of December. I was sick for a week and half to two weeks. I had diarrhea and a stuffy head for a day and sinus headache. My eyes hurt. I had my teeth hurt and postnasal drip. I was tired and fatigued really bad, it was almost a week and a half, not as bad as the first three days. Two weeks after my COVID-19 I had a sinus infection. I called my doctor, and he said I did not need it. I called my ENT and they put me Amoxicillin, and confirmed my sinuses were inflamed and I had an infection. I have five days of taking my medicine and it's starting to clear.  I still have cheek and teeth pain, but not as bad a five days ago.
States that she immediately felt dizzy and then passed out.  The person sitting next to her said she suddenly fell to her left and hit her head on the concrete.  Has a hematoma to the left side of forehead.  Following fall threw up three times.  Blood pressure initially low but has now returned to norma.  Is now alert and oriented and refusing transport to the hospital.  Per medical direction she can refuse and is having a friend pick her up and take her home.
Vial was initially stored in the refrigerator on 29Sept2022 and administered 05Nov2022; No Adverse Event; Expired Moderna Covid-19 vaccine was given to the Patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to the Patient), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29Sept2022 and administered 05Nov2022) and NO ADVERSE EVENT (No Adverse Event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to the Patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29Sept2022 and administered 05Nov2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to the Patient), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29Sept2022 and administered 05Nov2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to the Patient) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29Sept2022 and administered 05Nov2022).    No concomitant medication details was reported. It was reported that no adverse event reported from the patients. Individual vials was used and vial size was 2.5ml. Vial was initially stored in the refrigerator on 29-Sep-2022. Vaccine was administered 05-Nov-2022 around morning time. The vial did not undergo any temperature excursions. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-669845 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669845:Same reporter
4 days after vaccine, awoke w/sudden onset of bone pain - mid to low back, hips, thighs, knees, wrists; w/ periodic nausea and fatigue ... is slowly improving on NSAIDs. Now w/ LBP = 5/10.
Fever; Headache; Body pains; Body chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 28Oct2021 (Lot number: EW0217) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administration date 28Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6198, Location of injection: Arm Left), administration date: Mar2021, when the patient was 28 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9264, Location of injection: Arm Left), administration date: Feb2021, when the patient was 28 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 28Oct2021 22:00, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 28Oct2021 22:00, outcome "recovering", described as "Headache"; PAIN (non-serious) with onset 28Oct2021 22:00, outcome "recovering", described as "Body pains"; CHILLS (non-serious) with onset 28Oct2021 22:00, outcome "recovering", described as "Body chills". Therapeutic measures were taken as a result of pyrexia, headache, pain, chills. Additional information: No other vaccine in four weeks. AE treatment included Ibuprofen. No covid prior vaccination. No covid tested post vaccination. No known allergies and no other medical history.  No follow-up attempts are possible. No further information is expected.
Received Tdap in the afternoon on 7/3/08. Experienced mild Lt deltoid pain, swelling and discomfort. Woke the following morning feeling generally unwell: fatigue, myalgias, arthralgias, tender lump Lt side of neck. Symptoms persisted x 3 days, with mild improvement thereafter.
Pt called on 4/19/00 at 08:15 and had a temperature of 103 last night, has nausea and vomiting and has a bruise at the injection site and red rash where adhesive bandage was. Called pt on 4/20/00 at 08:30 and stated the temperature at that time was 101.2 and is taking Tylenol. Arm is still sore and has bruise at injection site. Will see physician today.
7 days p/vax pt had an erythematous warm rash 2x2cm circular @ the inj site;no induration;no pruritus;no hives or wheal;+ blanches;
Case number PHEH2015US017661 is an initial spontaneous report from a nurse received on 09 Sep 2015. This report refers to a 49-year-old male patient. The patient was vaccinated with 0.5 ml of FLUVIRIN (batch number: 157103) intramuscularly at left deltoid on 08 Sep 2015 (at 10:10). It was reported that patient received an out of temperature range FLUVIRIN which was stored at a temperature range of 33.2F. No adverse event reported following this medication error. Follow up report from the nurse received on 27 Oct 2015. Updated patient's DOB, vaccination time and site.
Fever 103.6F, Axillary lymph nodes swollen, "Feels like a baseball in armpit." Headache. Alternate moist heat and cold compress. Cephalaxin.
This is a spontaneous report from a contactable physician. A 26-year-old female patient received TRUMENBA on 20Feb2015 at 9:30 am at 0.5 ml single dose via intra-articular route. Concomitant medications were none. Medical history included asthma when she was a child, now resolved. On 20Feb2015 the patient developed high fever, headaches, and a small rash on her leg as a reaction to the vaccine. She went to the emergency department after midnight on 21Feb2015 and was admitted to the ICU to rule out meningitis since there was currently an outbreak of meningitis in the community. The patient did not have meningitis. On 21Feb2015 chest X-ray was negative for meningitis, lumbar puncture was negative and showed no WBC, cultures are still pending, multiple laboratory tests showed no signs of infection. High fever recovered on 21Feb2015. Outcome of the events headache and rash was recovering. The rash was described as minimal at the time of reporting.
Huge red bump at injection site, size of a plum, red, hurts, itchy. Lump started small and got bigger overnight.
PATIENT WAS ADMINISTERED HIS FIRST DOSE OF THE MODERNA COVID VACCINE AND APPEARED TO BE FINE AFTERWARD. HE MOVED FROM THE IMMUNIZATION BOOTH TO A SEAT OUT IN FRONT OF THE PHARMACY, AND A FEW MINUTES AFTER HIS VACCINE HE PASSED OUT AND FELL OVER OUT OF THE SEAT. A CODE WHITE WAS CALLED, BUT THE PATIENT REGAINED CONSCIOUSNESS QUICKLY AFTER PASSING OUT, AND WAS MOVED BACK INTO A SEAT WITH ARMS. HE TOOK A FEW SIPS OF WATER AND APPEARED TO HAVE MOSTLY RECOVERED, BUT THE PATIENT LOST CONSCIOUSNESS IN THE SEAT AGAIN A FEW MINUTES LATER. EMS WERE CALLED TO CHECK OUT THE PATIENT, BUT WHEN THEY ARRIVED HE APPEARED TO HAVE MOSTLY RECOVERED AND SHOWED NO MORE SIGNS OF PASSING OUT AGAIN. EMS CLEARED HIM TO GO HOME AND ADVISED HIM TO GO TO THE ER IF HE HAD ANY MORE ISSUES LATER.
Information has been received from a LPN concerning a female who was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. The LPN reported that in Apr 2005, the pt developed a rash. Unspecified medical attention was sought, but no prescription drug treatment was required. At the time of this report, the outcome was unk. Additional information is not expected.
Pt requested to have flu and shingrix vaccine.  I checked his profile and didn't see previous doses of shingrix.  I processed the claim  and it went through this his insurance .  I proceeded to administer the vaccines.  After that, the nurse from his family doctor office called to informed me that pt already completed his Shingrix series in 2019.
Severe chills.  Couldn't stop shaking.  Went away in approximately 2 hours after getting in warm bed.
Fainted ( hx of similar symptom with venipuncture) and tingling sensation to bilateral fingers Seen and cleared by EMS
This spontaneous report as received from a 63 year old male dentist who was also the patient and was reporting on himself. The patient's current condition was hypertension and kidney stones. It was reported that the patient did not suffer from any drug allergy. On 14-DEC-2014 the patient was vaccinated with ZOSTAVAX (reported as dose: 0.654 ml, in the left forearm, route of administration, lot number and expiration date were not reported). Concomitant therapy included vitamin supplements and unspecified medication for prevention of accumulation of uric acid. On 15-DEC-2014, on Monday, the day after receiving ZOSTAVAX, the patient noticed redness at his injection site when he removed his Band-Aid. At first the patient thought that he was having an allergic reaction to the Band-Aid but during that day of 15-DEC-2014, he noticed that the area of redness expanded until it was about the diameter of a baseball. The patient sought medical attention (consulted the physician at another urgent care clinic). The patient was prescribed KEFLEX and BENADRYL (manufacturers unspecified). The patient stated that the area continued to get larger. On approximately 17-DEC-2014, reported as today, the area of redness has expanded to about twice the size that it was on Monday, 15-DEC-2014, but it seemed to be less red. The patient stated that the area was itchy and warm (started in approximately December 2014) and noticed a low-grade fever of 99.5F (in approximately December 2014). The patient believed that he was recovering, and was not developing a rash. No lab diagnostic was performed for adverse events. The outcome of the adverse events was reported as recovering. The relatedness between ZOSTAVAX and the events was not reported. Additional information has been requested.
Pt recvd 1st vax of Energix-B 15NOV89,2nd vax 13DEC89 & 3rd on 09MAY90. Titer indicated non-responder.P/ booster vax from same lot,pt seroconverted.
flu-like symptoms (tired, body aches) for first evening and third evening after vaccination. Also swelling/tenderness under right arm (lymph nodes?) and right breast that lasted two weeks. Vaccine was administered in left arm. No swelling/tenderness at vaccinated area. I am usually really sore at vaccinated area after flu shots.
Information has been received from a health professional concerning a 3 year old male pt who on 04-MAR-2002 was vaccinated with a dose of varicella virus vaccine live. Subsequently, on approximately 14-APR-2004, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that "there was no single report of adverse reaction following varicella vaccination". The reporter indicated that 49 other patients developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00576, WAES0405USA00577, WAES0405USA00578, WAES0405USA00579, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00586, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00590, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, and WAES0405USA00619). No additional information is expected.
Voice hoarse, body aches, headache, low grade fever. Put pt on a course of LEVAQUIN 500 mg one everyday for seven days.
Pfizer vaccine x 2. Tested positive for COVID 19 on 09/20/2021. Admitted to the Medical Center on 04/20/2022. Expired on 05/06/2022 while still hospitalized.
Patient reports pain in shoulder, pain upon certain movements or articulations of shoulder joint. Patient does NOT report decreased range of motion.
Pt recv vax on 10/16/98; post vax pt exp discomfort, tingling, paresthesia, weak lt leg; pt cont difficulty grasping w/ lt hand
patient received 1st dose on 7/3/2019 and received 2nd dose on 8/8/2019. He also received a dose on 9/2/2022.
Large pulmonary embolisms in both lungs resulting from DVT in left leg.  About 2-3 weeks after receiving 2nd Covid-19 vaccine shot, I started to have unusual breathing/fatigue symptoms.  I did not seek any treatment for these symptoms but now believe that these were due to several small blood clots in my lungs.  After another 3 weeks on May 10, 2021, I suffered a pulmonary embolism from a blood clot in my left lung.  I still did not seek treatment.  Two days later on May 12, I suffered a pulmonary embolism from a blood clot in my right lung.  This was sufficiently painful that I went to the Emergency Room on May 13 where an MRI diagnosed blood clots in both left and right lungs.  I was hospitalized until May 15 and now am required to take blood thinner Eloquis.  In the hospital, a DVT was identified in my left leg as a source for the clots, though I had no reason to develop such a DVT.  10 years prior in 2011, I had a DVT resulting from a long plane flight but no symptoms since.
Chills - Began 15 hours after vaccination.  Lasted 5 hours. Headache and Fatigue - Began 15 hours after vaccination.  Lasted 12 hours. Rash - Appeared 31 hours after vaccination and is currently ongoing.  Rash is not painful or itchy.  Rash spread from the left arm where the shot was taken, extends down the side of the body, across the entire lower back, and up to the right arm.  Currently, not undergoing any treatment for the rash.
Pt rec'd Pneumovax on 12/11/07. Pain kept pt awake. Area red, swollen and hot to touch from mid upper arm to elbow. Seen in office 12/12/07, given IV for 2-max. Pt had temp 100. Reports today area resolving and improving.
emperature excursion and states that the vaccine was administered to patient during the excursion.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided.  On 21-DEC-2020, the patient was vaccinated with improperly stored doses os pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T032003, with expiration date of 08-MAY-2022 and lot # T022294 with expiration date of 26-MAR-202 at a dose of 0.5 milliliter for prophylaxis.   The vaccines experimented temperature below 2 degrees celsius(°C) (1.3C) for 0 hours 24 minutes, time frame below 2°C (l.3C) for 0 hours 24 minutes and previous temperature excursión below 2°C (1.6 C) for 24 minutes. Digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T022294; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Nausea; Dizziness; Extreme tiredness; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 26Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. On 26Jan2021 16:00, the patient experienced nausea, dizziness, extreme tiredness. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The vaccine was received frozen from the health department and place in the fridge at proper temperature; Patients received the vaccine pass 30 days in the fridge; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine pass 30 days in the fridge) and PRODUCT STORAGE ERROR (The vaccine was received frozen from the health department and place in the fridge at proper temperature) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 prophylaxis.     Patient was not immunocompromised.     In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine pass 30 days in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was received frozen from the health department and place in the fridge at proper temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine pass 30 days in the fridge) and PRODUCT STORAGE ERROR (The vaccine was received frozen from the health department and place in the fridge at proper temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Some patients allergic to penicillin and sulfa. One was allergic to statin drugs like Lipitor. All patients were taking medication. It was reported that 3 patients received the vaccine on 24-Jun-2022 and 1 patient received the vaccine on 01-Jul-2022. No patients reported having side effects. No treatment information was provided.  This case is of patient 3- elderly male 1.   This case was linked to US-MODERNATX, INC.-MOD-2022-615208 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-615208:patient 1- elderly female 1
Chills, fever, sweats at 8:00 PM.   Itching all over with hives on arms, legs, trunk, scalp.   Eyes itching.   No throat swelling.  No difficulty breathing.  No wheezing.
This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 29, via an unspecified route of administration, left arm, on Apr 14, 2021, at 11:00, single dose for COVID-19 immunisation. Medical history included COVID-19. The patient has allergies to sulfa. Prior to the vaccination, patient diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 15, 2021, at 06:00, patient experienced dizziness, sore arm, swollen lymph node underarm, nausea and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of dizziness, sore arm, swollen lymph node underarm, nausea and headache: not resolved (at the time of this report). No follow-up attempts  needed. Information about lot/batch number cannot be obtained.
Patient reported she was well at time of vaccination and denied any problems with previous immunizations. She stated the following day post vaccination she noted a slight aching in her arm with mild weakness and occasional hand tremor. On the second day post vaccination she noticed fatigue. Denied any fever, chills, headache, local site swelling or redness. Symptoms lasted a day or two and she has fully recovered.  Symptoms: OTHER FATIGUE(R5383), MYALGIA(M791), WEAKNESS(R531).