chrisvoncsefalvay/vaers-outcomes huggingface dataset:
40.50 hours later while Patient was in class at school, he moved his arm where he heard and felt a pop. He then doesn't remember much afterward but according to the school nurse Patient kept falling asleep. I woke him up when I went to pick him up and he was confused as to what was going on. I took him home where he became aggressive towards me. He ended up sleeping all day and when he woke up around 4:30 pm feeling hot and had a bloody nose. He went outside to cool off and ended up walking to the clinic where he got his shot and a nurse examined him. He explained all this to her and she also observed a rash to the left side of his neck. He left the clinic and proceeded to walk around. When he got home I observed the red spot/rash on his neck. I told him to take a shower where he seemed to feeling better.
Lethargy, Headache, Sore arm, Body aches for 36 hours
A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on 19Apr2021 as a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On an unspecified date the patient states that on Sunday, her under armpit was painful. When she went to take a shower, it's hurting, and she examined it and it was swelling up a little. On Monday, the swelling got a little bigger. Last night, the swelling got hot. It's bigger this morning and hard and swollen and red and it's cracking and itchy. The patient did not receive any treatment for the event. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt presented with chest pain, diagnosed with myocarditis with troponin peak of 5. Normal ECHO and EKG.
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 16-JUL-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 "10 Single DS 0.5 ml LVIs 10SDV", lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccine was improperly stored exposed to temperature excursion for a sum of 48 hours at a lowest temperature recorded of 34 degrees F (1.11111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator(R)". No adverse effects were reported. There was no product quality complained involved. This is one of several reports received from the same reporter. Additional information has been requested.
Loss of taste; Tightening in the jaw; Tightening is on the side where the forehead is and the front like on the two sides is the pressure on the side of the head; just thinking of a headache; I have been feeling lot of fatigue; crying; This is a spontaneous report from a contactable consumer. This consumer reported for herself that the 63-year-old female patient received first dose of bnt162b2 (Unspecified Shot), via unknown route of administration on 15Jan2021 at single dose for covid-19 immunisation (to make sure because I am a caregiver). Medical history included Sjoegren's syndrome and had like chronic fatigue but "that is not a real thing". Concomitant medications included buspirone hydrochloride (BUSPAR) and other medications that she just take a half every other day, it is a small amount. She take 5 mg every other day. She was really taking much. The consumer had lab work, may be not sure 2 to 3 weeks, she has been feeling lot of fatigue. Actually, she did do lab work, it was just like lot of blood work. The consumer stated, "I am having some loss of taste and tightening in the jaw and that was immediately. Tightening is still there and the taste loss seems to happen like a day later. Tightening is on the side where the forehead is and the front like on the two sides is the pressure on the side of the head. I guess, just thinking of a headache. I guess, I had headache and crying, it is just nerve-racking." The events started from 15Jan2021 with outcome of not recovered. Treatment received included Advil. Information on the batch number/lot number has been requested.
contracting and then drooping muscles on the left side of my upper body and face, blurry vision to the point of causing dizziness and vertigo.  Extreme fatigue, uncontrolable chills. Severe headache. Severe muscle cramping.
fever; headache; neck stiffness; This case was reported by a physician via sales rep and described the occurrence of fever in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENACTRA for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose and MENACTRA at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced fever, headache and stiff neck. On an unknown date, the outcome of the fever, headache and stiff neck were unknown.   It was unknown if the reporter considered the fever, headache and stiff neck to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient experienced fever, headache and stiff neck after vaccination. The patient was not sure if this was attributed to the vaccine.
had covid a couple of weeks after the first vaccine for covid; had covid a couple of weeks after the first vaccine for covid; This is a solicited report based on the information received from contactable consumer, the patient by Pfizer from. (Manufacturer Control No: 21K163402660400).  A 66-years-old female patient received first dose of BNT162B2, (tozinameran) (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via intramuscular route on an unspecified date in 2021 as dose 1, single for COVID-19 vaccination, and received upadacitinib (RINVOQ, Batch/Lot number was not reported), oral from an unspecified date to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. Medical history and concomitant medications were not reported. On an unspecified date in 2021, after couple of weeks of the first vaccine, patient experienced COVID. It was also reported patient later received second dose of BNT162B2 (Batch/Lot number was not reported), via intramuscular route on 10Jul2021 as dose 2, single for COVID-19 vaccination. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The action taken in response to the events for upadacitinib (RINVOQ) was unknown. The outcome of the events was unknown. The reporter's causality for the suspect product BNT162B2 to event of COVID with onset 2021 was possible, and the reporter's causality for the RINVOQ to event of COVID with onset 2021 was not provided.  opinion is that there is no reasonable possibility that the event of COVID is related to RINVOQ(UPADACITINIB).  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (Drug ineffective, Covid-19) and the administration of the vaccine cannot be excluded.
9 days after the vaccine, my arm at the injection site became red and swollen. Pain began the next day with increased redness. 3 days later and redness is still present but swelling and pain have subsided.
pt recvd vax 13JUN94; w/in 12 hrs p/vax exp generalized facial twitching & a fever of 104; pt conscious-no pallor; no difficulty breathing; no paralysis present; tx w/APAP; pt recovered w/no residual problems;
patient received MENQUADFI after it experienced a temperature excursion, with no reported adverse event; patient received MENQUADFI after it experienced a temperature excursion, with no reported adverse event; Initial information received from on 16-Nov-2022 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 16 years old female patient who received Meningococcal A-C-Y-W135 (T CONJ) vaccine [MENQUADFI] after it experienced a temperature excursion, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hpv Vaccine ; and Influenza Vaccine.  On 21-Oct-2022, the patient received a dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine solution for injection at dose 0.5 ml(lot U7447AC and expiry date: 20-SEP-2024) (with unknown strength, frequency) via intramuscular route in Left Deltoid for immunization, after it experienced a temperature excursion, with no reported adverse event (product storage error),(Poor quality vaccine administered)  (Latency: same day) following the administration of Meningococcal A-C-Y-W135 (T CONJ) vaccine.  Action taken was not applicable.  The outcome was Unknown.  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.
Developed "tiny red bumps" on arms, legs - None on back or stomach - itching - Unknown fever - to ER 7-25-09 - Rx Amox. 500mg tid x 21d.
This spontaneous report was received from a physician refers to a 20 year (reported as patient currently in her 20s) old female patient. Current conditions and medical history was not reported. On an unknown date (reported as many years ago) the patient (at an unspecified age) was vaccinated with VARIVAX (Merck) injection, dose 1, 0.5 milliliter (ml), subcutaneous. Concomitant medications were not reported. The patient did not receive dose 2 of VARIVAX (Merck). On an unknown date (many years ago) patient developed gastroenteritis (hospitalization) and when the patient was 4 or 5 years old patient had chickenpox (hospitalization). At the time when the patient had developed chickenpox she was in the hospital because she was being treated for gastroenteritis. It was while she was hospitalized for gastroenteritis that she developed chickenpox. It was not known if her hospitalization was prolonged due to her development of chickenpox in the hospital. Unspecified if the gastroenteritis was related to the VARIVAX (Merck) (the gastroenteritis had developed sometime after the patient received Dose 1 of VARIVAX (Merck)). Treatments provided were unspecified. On an unspecified date, outcome of the events were reported as recovered. Patient sought medical attention. No product quality complaint (PQC) has been reported. Causality assessment was not provided. This case is related to case number 1411USA000474 (same reporter). Additional information has been requested.
This case was reported by a health professional and described the occurrence of an injection site reaction in a 15 month old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. On 6/6/03, the patient received the fourth dose of Infanrix (lot DTPA598A2). On 6/7/03, 24 hours post immunization, the patient experienced an injection site reaction characterized by swelling and redness. The patient was seen by the physician, who prescribed an unspecified antibiotic. The events resolved within 48 hours of initiating antibiotic therapy. The reporter considered the injection site reaction to be related to Infanrix administration.
Pt with COPD, hypertension, and oxygen dependent at night only, presented to ED with increasing shortness of breath , and change in his sputum production.  He was tachypneic and placed on high flow.  COVID test returned positive.
Within 48 hrs of receiving vaccine child had abdominal pain. On 11-4-13 child had white pus in his throat and had problems breathing. Child has also been coughing and sneezing a lot.
Shot given 11:58am. Within 2 minutes symptoms began with feeling symptoms: nauseous, hot forehead. I asked CVS for the nurse to help. By 12:01 patient was feeling extreme pain in her stomach, was sweating profusely, felt tingling sensation from head down to her stomach (including her arms and hands). Patient began screaming in pain.  Her hands became rigid and paralyzed. She was completely unable to move both hands. Patient was able to feel if someone was touching her hands.  Her face began tingling and feeling numb. Patient was lying down and almost passed our. I asked CVS to call 911 and if they should administer an epi pen.  The epi pen was not administered.  I (mother) went w/ child in the ambulance to  Hospital. EMT monitored her vitals, which were normal. Patient was still unable to move her hands until after she was admitted to Hospital. Patient did not receive any IV r medication at Hospital. The sensation in her hands slowly came back with the numbness subsiding  after about 1.5 hours in the ER. Patient was discharged at about 2:00pm on 5/16/2021.
The day after the injection she had a baseball size area on her arm where injections was given that was swollen, red, warm to touch, and firm, it spanded the whole width of her arm. She reported it was itching her and she did have two stretch marks across the area. She did not have any other problems, felt fine, no breathing problems. Instructed them to apply warm pack to area and gently massage area and continue to monitor. Her father was called on 4/8/21 and he reports area is still hard and swollen, no changes, she was not feeling any worse. They did think would take her to medical facility to see physician 4/8/21.
The parents provided a misleading date of birth stating that the child was born 4/6/2009 - which is one year older that she actually is. Thus the 12+ pfizer vaccine was given to an 11 year old. There were no adverse reactions reported.
bunch of adverse event; This case was reported by a pharmacist via other manufacturer and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix 50 mcg/mg. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced bunch of adverse event to Shingrix.
soreness in arm; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. The patient had soreness in arm after receiving Shingrix. The patient was asking what  was best to treat soreness in arm from Shingrix dose.
n/a , a 10ml single dose vial of saline was used for 2 vials of covid vaccine
This is a spontaneous report from a contactable pharmacist. A female patient of unspecified age and race received PREVNAR 13 at single dose for immunization on unknown date. Medical history and concomitant medication were unknown. On unknown date the patient experienced soreness and limited arm movement. The outcome was not reported.
No local site reaction until 9 days following vaccine. Awoke with swelling, erythema, itching at site of injection.
At 12:15 am the child woke and profusely vomited. He was lethargic and hard to wake up. No fever noted. At 1:00 am vomiting stopped and child was fine. No further vomiting. No redness or swelling to Left arm. Doesn't remember vomiting.
Exaggerated side effects (sore arm, flu like symptoms, tiredness)- the first day Severe head pain (sharp) not normal headache - still present Equilibrium is off to the point of almost falling, unsteady feeling-still present Tightness in chest, productive cough-still present Diarrhea
7JUL95 ears hurting; 9&10JUL c/o stomach hurting, t103; taken to primary MD who placed on Keflex; 12JUl ankles began to swell & knees sore/legs hurt; adm to hosp; abd cramping w/screaming;
Per event is to be reported if patient gets COVID if fully vaccinated. This patient was vaccinated on 1/23/21 & 2/13/21.
Recurring throbbing pain in left breast - intermittent with no apparent explanation and no previous throbbing pain years prior around April 30th.  Left breast only.  Contacted Gynecologist May 3rd on whether there should be some concerns.   Gynecologist responded on May 3rd and recommended a mammogram scheduling and placed the authorization for Radiology.  Was contacted by Radiology on May 4th to schedule the mammogram. Was asked by the scheduler when I had my last Covid-19 Vaccine and was informed by the scheduler that the Covid-19 Vaccine often causes swelling of the lymph nodes and may give a positive-false results, therefore  I was required to schedule mammogram  4 - 6 weeks after my last Covid-19 Vaccine.   The mammogram has been scheduled for May 11th.
Case number PHEH2015US011796 is an initial spontaneous report from a nurse received on 18 Jun 2015. This report refers to a 32-year-old male patient. Medical history included vaccination with TD booster in 2005. Concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number unknown) in his left deltoid on 23 March 2015 which was outside of normal temperature range at 19.1 C for 68 hours. No further information was reported.
Two hours after the injection, I started to not feel "right."  My head felt heavy, I was getting a little dizzy and all I wanted to do was to lie down.  By the third hour, my body completely shut down.  I was so tired I had no energy to move, to talk, and even breathing was difficult (not because I couldn't breathe, just that the effort was difficult).  I was dizzy, nauseous, and lost my appetite.  My temperature was elevated, 98.5, but no fever.  I slept for 5 hours as if in a coma.  Woke up to drink water, felt total-body aches, and slept the rest of the night again getting at least 12 more hours of sleep.  At some point during the night, I had chills so bad my body was shaking uncontrollably.  I had 2 layers of clothes and 3 layers of blankets and could not warm up.  Day #2 (today), I have a tremendous headache, dizzy, nauseous, my heart rate is abnormally fast and I am out of breath.  My resting heart rate is typically upper 50's and is currently averaging in the 70's, jumping into the 90's often.   Sitting up, my heart rate is between 80-100 (which is typically my rate when I exercise).  When I stand up or walk to the other room, my heart rate is around 115-120 (typical of when I am running/sprinting or participating in taxing exercise).  Along with this, I am out of breath as if I am exercising, although I am barely moving around. All I am doing is laying down, only getting up to go to the bathroom and my body feels like I ran a marathon.  Breathing is difficult even at rest.
Child was inadvertantly administered Zostavax vaccine instead of Varivax by nurse administering vaccinations.  No known untoward effects.
Patient was administered an expired vaccine with no reported A/E; Initial information was received on 11-Oct-2021 regarding an unsolicited valid non-serious case received from a physician via consumer (Regulatory authority Inquiry Number: 00807266).  This case involves a 74- years old male patient who was administered an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event (expired product administered).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On 08-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ469AA and expiry date: 2021 via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "There are no side effects but since it's a different formulation, do we advise to give the 21-22 version. How long should we wait. The nurse who administered the vaccine wrote the expiration down and put expired next to it, and then proceeded to administer the vaccine. The physician stated that her facility would be documenting the event as an incident report. The patient is fine."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
sore arm nothing else; Initial information received on 13-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involved a patient of unknown demographics who got a sore arm nothing else (Pain in extremity), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, after receiving vaccine the patient got a sore arm nothing else (Pain in extremity).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown.  There will be no information available on the batch number for this case.
Patient received his second dose of Pfizer and about 15 minutes after started to complain of sore arm and also tingling in the side of his face. The tingling was on the same side as the arm that received the vaccine (left arm). I administered 50 mg of liquid Benadryl to address the face reaction and watched the patient for 20 minutes. At this time the patient said he felt better and was going to leave. I advised him that if he started to have trouble breathing or his throat started to close up to call 911 and go to the ER. I also advised that a sore arm is a normal side effect from the vaccine.
CDC reports: 5 yo child developed fever (not measured) & local rxn at inject site following DTP/OPV immun. Lasted 4 days.
2 weeks after 1st shot, unusual amount of hair loss.  Since 2nd shot, hair loss has continued at an alarming rate.  I always have noticeable hair loss in the fall but never in spring and summer.  I have not yet sought medical assistance.
Case developed symptoms 06/08/2021. Hospitalized and tested positive for Covid-19 on 06/13/2021 at   Hospital. Has had symptoms including respiratory issues, a-fib, fever, chills, cough, shortness of breath, loss of smell, wheezing, headache. As of 6/16/2021 (date of entry) case requires oxygen. Remains hospitalized.
Patient states had one day of chills at about 9 days after immunization then had another day around day 25 or November 15th. The second one was followed by not feeling well for a few day also. No treatment was needed.