chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient stated that he experiences weakness, headache, stinging eyes, achiness, nausea and tiredness beginning the morning after his second Shingrix vaccination.  The patient stated that he took aspirin and Tylenol to manage the symptoms. The symptoms resolved about a day and a half after onest.
my immunologist, stated it caused a "flare" of my arthritis. Pharmacy where I received shot did not tell me to pause my meds before or after shot. Caused extreme pain at site and in my entire L. shoulder area. Pain persists to present day. Doctor gave me prednisone im and p.o. as well as gabapentin and flexaril.
had a blood clot; developed heart issues, and had to have a pacemaker inserted.; lost circulation to his feet/lose his feet from the vaccine; lost circulation to his feet/lose his feet from the vaccine; This is a follow-up spontaneous report from a Pfizer- sponsored program. This consumer reported for a male consumer(patient). This is a third case out of 4 cases.   A male patient of an unspecified age was received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient had a blood clot, lost circulation to his feet/lose his feet from the vaccine, developed heart issues, and had to have a pacemaker inserted. The reporter reported that, caller states that after three of her family members received the Pfizer Covid-19 vaccine that they all developed blood clots. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075369 same reporter/product, different patient / event.
a patient received a dose of VARIVAX after a temperature excursion; No other adverse effects were reported; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.      On an unknown date, the patient was vaccinated with an improperly stored dose varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038177, expiration date 26-NOV-2021 (exact dose and route of administration were not reported) for prophylaxis. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) 0.5 ml (frequency, route of administration, indication, lot# and expiration date were not reported).     Digital Data logger was involved. The vaccine was stored at the temperature that was reported as in the range of 15 degrees of F to 46 degrees of F (-9 degrees of C to 8 degrees of C) (-3 degrees of C) for 44 minutes. There was a previous temperature excursion reported as: in the range of 6 degrees of F to 14 degrees of F (-14 degrees of C to -10 degrees of C) (-10.4 degrees of C) for 29 minutes; in the range of 6 degrees of F to 14 degrees of F (-14 degrees of C to -10 degrees of C) (-13 degrees of C) for 24 minutes and in the range of 15 degrees of F to 46 degrees of F (-9 degrees of C to 8 degrees of C) (-5.6 degrees of C) for 39 minutes. No adverse effect reported.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 16-FEB-2016 the patient was vaccinated with a properly stored, expired dose of M-M-R II (lot # K002036, expiration date 10-FEB-2016, dose and route were unknown). Concomitant therapies were not reported. No adverse events were reported. Additional information has been requested.
The morning after I received the vaccine, I woke with a fever, severe headache and heart palpitations. I previously had COVID before and it felt very similar with my symptoms, but not as bad. I experienced these symptoms for 2 days. I did have a medication, that I was previously taking, replaced with a different medication.
2 hours after receiving the vaccine, I developed left-sided facial numbness/heaviness and some numbness in the left arm. I called my PCP and they told me it was a reaction to the vaccine and to monitor it. They said if it worsens/shortness of breath occurs to call them back. The numbness lasted for about 2 days then it resolved on its own.
Swollen, red, hot, itchy area approximately 3? in diameter at injection site. Began about 8 days after vaccine administered and is slowly resolving.
Signifcant swelling of right thigh up to knees. Low grade fever (? local reaction) Referred to ER. Given Clindamycin. Called to check progression and mother said pt is doing fine.
ten year old patient received MENACTRA before age 11 with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from Nurse via Medical Information (MI) (Reference number- 00840352) and transmitted to Sanofi on 03-Nov-2021.  This case involves a 10-year-old female patient who received a dose (once) of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] before age 11 (lot and expiry date not reported) via unknown route at an unknown administration site on 28-Aug-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency was on same day).  It was reported "HCP requests counseling on revaccination of MENACTRA; ten year old female was given MENACTRA on 28AUG2020 before age 11; the patient's school says the child needs to be revaccinated."  At the time of report, no adverse event 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.  There will be no information available on batch number for this case.
CoVid like symptoms (fatigue, headache, muscle aches, chills) including fever above 102 lasting 48 hours.
Patient experienced a lump which was the size of 1/2 of a softball. It was also red in color, but not itchy. He put ice on it one evening according to his wife.
Itching on the arms and back, lower back pain only on the side the shot was giving. Chest or rib aches underneath the breast on the side the shot was given. Arm is throbbing and very sore.
Post-menopausal (4+ years) bleeding. Nerve problems on left side. Severe abdominal cramping. Pain in legs. Loss of coordination.
This consumer report (initial receipt 18-MAR-2011) concerns a 78 year old male patient with no concomitant medications or drug reactions/allergies. Pertinent medical history included bronchitis. On ??-NOV-2010, the patient received a flu vaccine. In ??-NOV-2010, the patient also received a pneumonia vaccine. The patient had received ZOSTAVAX in ??-NOV-2008. On 11-MAR-2011, the patient went to the emergency room and was hospitalised for a fever of 102.5F and complaints of feeling jittery. The reporter mentioned that he was hospitalised from 11-MAR-2011 to 13-MAR-2011. During his hospitalisation, the patient received an unspecified number of doses of levofloxacin (additional suspect drug) and he experienced swelling in his legs and a 10 pound weight gain. The leg swelling resolved and he lost the 10 pounds that he had gained. Lab studies performed included blood cultures. The patient was still not fully recovered and still had a hoarse voice. Reporter's comments: The reporter considered events serious due to hospitalisation.
Patient is given a Moderna Booster Vaccine, but he is supposed to get a Pfizer Booster due to his age (Moderna is approved for 18 years old and up while he is now 17 years old). He was contacted on 12/26/2021 and stated that he was only tired and has recovered from the tiredness.
Started with a pulled muscle sensation next day; chest pain on right upper chest; Very difficult to breath or move; Very difficult to breath or move; Pain became very severe; felt like what sounded like a snap in neck and was unable to move head; feeling slight pain in chest and behind neck and back of head; feeling slight pain in chest and behind neck and back of head; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration administered in Left arm on 02Apr2021 at 02:45 pm (48-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included Hay Fever, Hashimotos and Graves Disease from an unknown date and unknown if ongoing. The patient had no known allergies. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. The patient had no other medications in two weeks. On 03Apr2021 at 12:00 PM, the patient experienced a pulled muscle sensation, chest pain on right upper chest, very difficult to breath or move, severe pain, a snap in neck, was unable to move head, slight pain in chest and behind neck and back of head. It started with a pulled muscle sensation next day after the vaccine which lasted 2 days. On 3rd day, the patient began having chest pain on right upper chest. Pain became very severe. On 6th day, the patient felt like what sounded like a snap in neck and was unable to move head. Pain was also very severe. Now almost a week after symptoms began the patient was still feeling slight pain in chest and behind neck and back of head. The patient was not sure if it was vaccine driven but cannot think of anything else. The outcome of events were not recovered.  Information about Lot/Batch number has been requested.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I started having a dry cough and a friend of mine had recently gone through the same thing and had gotten diagnosed with COVID19. I went to the doctor and was running a fever, and tested positive. They sent me home and told me to take Tylenol and drink plenty of fluids and if I started having issues breathing to go to the ER, but I didn't need to. By the third day my fever was gone. I also lost my sense of smell but it came back. I've been going to the gym for years and years and years and walking two miles a day, and never smoked. The first time I tried to go walking after COVID19 I got extremely winded really quickly and that is still happening to this day. I've checked my blood pressure and blood oxygen and that's always normal. I have not seen my cardiologist since then but I'm assuming its because of the COVID19 because I am getting really winded so quickly.
Tested positive for COVID after receiving the vaccination. Symptoms began on 10/8/2021. She had diarrhea and weakness.
Used Sterile Diluent instead of Sodium Chloride 0.9% to dilute vaccine.
ARM FELT LIKE I HAD GOTTEN BDAY  PUNCHED; MIGRAINE; DIZZINESS; STOMACH PAIN; FEVER; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced arm felt like i had gotten bday punched, migraine, dizziness, stomach pain, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, stomach pain, fever, and fatigue, and the outcome of dizziness and arm felt like i had gotten bday punched was not reported. This report was non-serious. This parent/child case is linked to 02159521.
Next day post vax, the pt's mom noticed a red lump in area where injection was given. Brought child in on 8/30. Physician noted 3 cm swelling in right thigh.
Child was noted in male arms, after being called into lobby due to child passing out after vaccination, approx 15 mins. Nurse requested child to be placed on floor for assessment, child noted awake and alert, yelling, skin color pale. O2 administered at 3L/m x 10 mins, removed after child calmed down. Male stated, "child fell forward and hit her head." 911 called, child was transported via ambulance to hospital for assessment.
See this form. Abdominal cramps. Abdominal pain. Ache joints. Aches joints and muscle. Aches muscle. Aches whole body. Agitation. Alpha intrusion. Amblyopia. Appetite loss. Blood high cholesterol. Blood pressure spikes and drops. Cold and flu-like symptoms. Concentration difficulty. Concentration loss of. Concentration trouble. Balance dizzy upon standing. Balance falling down. Balance dizzy spells. Balance vertigo and dizziness. Balance dizziness. Balance vertigo. Balance problems. Bladder problems. Blood pressure varies. Coordination problems. Cough. Cramps leg.
The patient stated having pain at injection site . She said there is redness and pain to the touch.
I was positive for covid on October 28, 2021. On the following Sunday, my sense of smell went away. I started getting a glistening in my eye. It started in one corer and then moved to the central part of my vision. It got worse throughout the day. It was still worse the next day as well. I went to the ER and they said that I did not have a detached retina. They said it was okay. I thought it was an ocular migraine. My eye has a sensitivity to headaches and light. The eye issue has continued and it's always there to some degree. It gets worse when I get tired and have a headache. I have had eye tests did with me retina specialist and they said that everything looks good. They are not sure why this happened. The eye doctor is not for sure if it's from my eye disease or covid that caused this. The issues with my eye has affected me to where I can't do certain activities. I have always had eye issues but since getting covid it has severely worsened. I had had to miss some days from work ass well because of this.
22MAR91 PM 2 days fever 105, Taken to ER; Mom did not notify clinic about rxn; Returned for 2nd immun 17JUN91 referred pt to MD for eval & immun;
A-fib; Acute hypoxemic respiratory failure; Acute on chronic congestive heart failure, unspecified heart failure type; Arrhythmia; Febrile; Multifocal pneumonia; SOB (shortness of breath) on exertion
Sore arm at site of injection (Tylenol was taken to treat the pain, pain lessening 2 days after the vaccine was administered), chills the evening after vaccine was administered (hot shower helped manage chills), headache and fever the day after vaccine was administered (took Tylenol for the headache), nausea the evening of the 2nd day after vaccine was administered (lasted through the 3rd day, no medicine to treat, just tried ginger ale and saltines, nausea did not go away)
Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event) 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.     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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster).    No concomitant product reported by reporter. It was reported that, nurses had no Standing orders other than what they had for the second booster, when first administering Bivalent boosters. So, they assumed the same dose as the second booster, hence they were administering 0.25 ml instead of 0.5 ml to uncompromised adults. It was reported that approximately 100 patients were administered an invalid dose of the Moderna COVID-19 bivalent booster. No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:MOD-2022-646512: Master case
EE stated 15 minutes after getting Flu vaccine at clinic she noted her face was flushed. Twenty minutes after vaccine flushing had developed down neck mid chest and mid forearm.  She also developed puffiness under eyes and felt warm but took her temp and did not have a fever (97.2).  EE did not have any itching or other symptoms.  She stated she has no allergies and has never had an allergic reaction in the past.  She took 25mg of Benadryl when she got home from work  (4hrs after initial reaction to Flu vaccine).  When she woke up today she has improvement of symptoms with some redness of her cheeks and left arm and neck.  She took some Claritin as she had to go to work today and did not want to take Benadryl
COVID-19 treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID-19 treatment"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt was given the Moderna vaccine even though she is <18 y/o. Pt received second dose of Moderna vaccine on 4/28. Pt contacted on 5/17 by our clinic and denied adverse events.
Information has been received from a physician's assistant concerning a 10 year old female, with no pertinent medical history, who three to five years ago, it was approximately 2002, was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently the patient developed a rash on her chest, which the mother reported was chickenpox. The patient recovered from chickenpox on an undisclosed date. Unspecified medical attention was sought. There was no product quality complaint. There was no lab diagnostic studies performed. Additional information has been requested.
blood pressure issues; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE ABNORMAL (blood pressure issues) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE ABNORMAL (blood pressure issues). At the time of the report, BLOOD PRESSURE ABNORMAL (blood pressure issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
nausea/sick to stomach; vomiting; sore arm; might be having a Gall bladder issue; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, Expiry Date: Mar2021), via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization.  There was no medical history. There were no concomitant medications. The patient experienced nausea, vomiting, sore arm on 19Dec2020. She was feeling better today.  She might be having a gall bladder issue, she started feeling sick to stomach yesterday evening (19Dec2020). It had been several hours after she got the vaccine. No treatment received for events. The outcome of events was recovering.
Noticed a pain in her arm approximately 4 hours after administration. Next day she woke with redness, swelling, and warmth at injection site. Taking over the counter Zyrtec and Benadryl.
Patient was vaccinated at pharmacy at 12:37pm.Patient waited in pharmacy for 15 minutes. Patient went to eat. At 2pm, Patient showed up at ER with ventricular bleed.
Narrative:  74yo male patient with the following Past Medical History: Chronic kidney disease stage 3 (SCT 4331 Congestive heart failure (SCT Osteoarthritis of knee (SCT 239873007) Benign prostatic hypertrophy with outflow obstruction (SCT 236646007) Dependent edema (SCT 248499004) Bilateral carpal tunnel syndrome (SCT Major depression in partial remission (SChronic post-traumatic stress Impulse control disorder (SCT 66347000) Diabetes mellitus (SCT 73211009) Morbid obesity (SCT 238136002) Anxiety (SCT 48694002) Coronary arteriosclerosis (SCT 53741008)Gout (SCT 90560007) Hyperlipidemia (SCT 55822004) Benign essential hypertension (SCT) Died on 11/10/2021. Cause of death not clearly defined in chart. Pt did receive covid vaccines on 2/12/21 & 1/13/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.