chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, male patient. The patient's medical history and concurrent conditions were not reported. On 19-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Patient got first Moderna vaccine 5/24/2021 and waited to get second one due to malaise. Patient went to Store last night and got the second Moderna vaccine. Patient had possible exposure 1 week ago. Did rapid home Covid test 8/3/2021 and it was negative. Patient took another rapid home Covid test 8/5 and the result was positive. Had positive COVID19 NAA swab in office 8/6. In retrospect, she thinks her symptoms started 8/3/2021. She chalked them up to allergies. Her symptoms include nasal congestion, nasal discharge, and mild cough. She denies SOB, fever, chest pain, and wheezing. She has a h/o asthma and asks about using Albuterol. I concur that she can use it QID to keep her asthma In check. She got her first COVID19 vaccine in 5/2021 but waited until August for the second as the first one caused extreme malaise and she did not want to risk missing work.
7 hours after shot feeling chill , when I found a temp by 4 the Fever 102.9t, chills , headache , body ache , tiredness , nausea . Day Two still have some low grade temp , light headache and tiredness .
Covid 19; Covid 19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (Lot number: 656665) at the age of 64 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: ENG208), on 19Apr2021 as dose 2, single (Lot number: EW0150) and on 24May2022 as dose 4 (booster), single (Lot number: FM7553) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Dec2021 as dose 3 (booster), single (Lot number: 058H21A) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Dec2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid, Treatment start date was 24Feb2023 and stop date was 28Feb2023.  Clinical course: Patient had no Known allergies. Other medication in 2weeks: Yes  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events INTERCHANGE OF VACCINE PRODUCTS, DRUG INEFFECTIVE, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
This spontaneous report as received from a pharmacist refers to a 13 year old male patient. On an unknown date the patient was vaccinated with first and second dose of VARIVAX (Merck), injection, (lot #, expiration, route and indication unspecified). On 07-OCT-2013 the patient experienced shingles on his hand and lower arm. Unspecified diagnostic studies were performed on samples from the rash and it was confirmed as positive for herpes zoster. The patient went to unspecified pediatrician. A cast was placed on the patient's arm to cover the rash and prohibit him from itching it. It was unspecified if any other treatment was given. The patient's rash had improved, however, the patient was not fully recovered. Additional information has been requested.
she had "some reactions" to her first vaccine dose. "Like when I had Covid I was sick for 2-3 days; This is a spontaneous report from a contactable consumer (patient herself). A female patient of unspecified aged received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient had "some reactions" to her first vaccine dose. "Like when I had Covid I was sick for 2-3 days and then after Tuesday night I was fine". Patient wanted to know she would take the second shot after having side effects to the first. Patient reports that she already spoke with safety and was transferred to PMI for her question. No reference number for that encounter. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The outcome of the event was recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Patient developed whelps over most of her body. Reaction was a few hours after shot was given.
This spontaneous report was received from a 75 year old female patient reporting on herself. No concurrent or historical conditions were reported. On 18-NOV-2015, the patient was vaccinated with PNEUMOVAX 23, (lot number and expiration date were not provided), dose, route and anatomical location were unknown. No concomitant medication were reported. On 18-NOV-2015, the patient reported feeling "achiness all over", and nausea, including vomiting on 19-NOV-2015 (also reported as the day after she received PNEUMOVAX 23. The patient did not seek for medical attention. No product quality complaint was involved. At the time of the report, the outcome of the adverse events was unknown. Additional information is not expected because there is not contact information.
10/3/10 at 0200 awoke with "stinging bees", "pins & needles" feeling in right arm & side of torso on Rt. side. Very painful to move c/o muscular pain Rt. arm, upper body to waist area. On 10/4/10 rash appeared red, bumpy, dry, "prickly heat" appearance on Rt arm & torso, itchy, took CLARITIN, saw PCP, took BENADRYL cream with relief then completely resolved.
This spontaneous report as received from a consumer who is 53 year old male patient with prevention of shingles concerning himself. Patient had no pertinent medical history and drug allergies. On 19-JUL-2012 the patient was vaccinated with ZOSTAVAX (strength, dose, dose number, lot number and expiry date unknown). No concomitant medications were reported. In August 2012, the patient experienced rash on his back, feet and arms which comes and goes every other month. Patient sought medical attention and received HIBICLENS as treatment for the event. No laboratory tests were performed. The outcome of rash on his back, feet and arms was unknown. Additional information has been requested.
Hurt chest; Wheezing; 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 CHEST PAIN (Hurt chest) and WHEEZING (Wheezing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication.   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 CHEST PAIN (Hurt chest) and WHEEZING (Wheezing). At the time of the report, CHEST PAIN (Hurt chest) and WHEEZING (Wheezing) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Treatment information were not provided by the reporter.
Taste and smell became disgusting; on day 1 of symptoms (2/27) everything that I tasted was a range between stale and vomit-flavored. Bread and cheese were altered but 'okay' until day 5 of symptoms. Currently on day 7 of symptom and cannot tolerate smell or taste of anything, including water. Every single food item, anything with scent (like soap), water, even the heat from the stove smells/tastes like vomit. Went to clinic on 3/5/21 and tested negative for COVID-19 (Previously tested positive on Dec 10, 2020 so ensuring had not contracted again) and full blood count came back normal. Expect follow up call on Monday for MRI/CT scan. I have a terrible headache but I imagine it is from lack of food and water since there was no sign of illness at doctor appointment. Doctor indicated he wants to see results of brain scan before saying for sure related to vaccine, but since I have absolutely no other symptoms, he was puzzled.
C/O of nausea and continuing for 5 days after taking oral typhoid. Felt feverish, has some diarrhea and some vomiting. Only can eat soup and crackers.
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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) negative; (21Jun2022) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course of the events: Adverse event: Chemical bitter taste, and diarrhoea during Tx (treatment), which lasted through 19Jun2022. No fever after 17Jun2022. Tested negative 20Jun and 21Jun2022. Developed low grade fever 100 on 22Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
C/o chest discomfort, quickly resolved then had onset of facial swelling, redness, tickle in his throat, no resp distress, Benadryl given, also resolved.
swelling approx size of a quarter duration 5 days; no redness or pain noted on exam;
05FEB95 pt recvd vax & w/in hrs area erythematous, tender, warm to touch 15cm in diameter macular area; devel temp per pt report; APAP & ice for minimal relief; 8FEB95 seen @ clinic w/erythema, tenderness & warm to touch lt arm area;
Dizziness for 3-4 days after shot given. Muscle pain in left deltoid for 8 days, diarrhea for 1 day after shot given.
Pt received Pfizer vaccine as first vaccine.  On 2/16/2021 pt received Moderna for second vaccine.  Pt aware and CDC immunization record given to pt.  Pt counseled to see physician with any side effects or call 911 with emergency.
Anxiety; Intermittent Gastritis, myalgia and brain fog.  These symptoms actually began after my first Moderna Covid Shot in March 2021, and worsened with second and third shots.   The worst of the symptoms have occurred 2-3 weeks after each injection.  I think I had moderate Covid in December 2019, with some pneumonia a few month later.
sharp abdominal pain on left side, bloating. Pain subsided but bloating still present at time employee left work at 4:30pm.
no appetite; slurred speech; red skin on hands, face, neck; balance problems; dizziness; swollen hands; fatigue/severe fatigue/extremely severe fatigue/very tired/some lingering fatigue; severe flu-like symptoms; vertigo; full-body muscle aches; temperature was slightly elevated (98.7) from my "baseline,"  which is around 96.7; This is a spontaneous report from a contactable consumer (patient). A non pregnant 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE;Lot Number: EM9809 and expiration date was not reported), via an unspecified route of administration, administered in Left Arm on 12Feb2021 09:00 (at the age of 25-years-old) at dose 1, single for covid-19 immunization. Medical history included known allergies of Pineapple and other medical history included Fibromyalgia, endometriosis, neurological functioning disorder, ADHD, asthma. Concomitant medications included lisdexamfetamine mesilate (VYVANSE); spironolactone; montelukast; pregabalin. The most recent vaccine was administered at Clinic/ facility. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. It was reported that within 1 hour of injection 12Feb2021 10:00am, patient began experiencing fatigue that got increasingly worsened. By 2:00pm, she had slurred speech; severe fatigue; red skin on hands, face, neck; balance problems and dizziness; swollen hands. That evening through the next morning, she has experienced severe flu-like symptoms, including vertigo, extremely severe fatigue, and full-body muscle aches. Her temperature was slightly elevated (98.7) from my "baseline," which was around 96.7. On Saturday (13Feb2021), she was very tired, no appetite, still experiencing some vertigo and muscle aches. Symptoms improved overnight and by Sunday evening, Patient was mostly back to normal, with some lingering fatigue. The patient underwent lab tests and procedures which included PCR test: Nasal Swab: negative on 17Feb2021, 24Feb2021 and 02Mar2021. No treatment was given for the events. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296198 same patient, different vaccine dose, similar event
Headache, Myalgia, Arthralgia,  fatigue  Narrative: 1/9 onset of body aches, joint aches, fatigue, headache. Felt better on 1/10 later in the day. Resolved as of 1/11. She reports the same symptoms with the first vaccine which was given on 12/17.
This spontaneous report was received from a registered nurse 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 07-AUG-2018, the patient may have received an improperly stored dose of GARDASIL 9 injection, intramuscularly, lot # N035032, expiration date 24-SEP-2020 (exact dose and anatomical localization were not reported). No adverse effect was reported. Data logger was not involved. Administrated doses of GARDASIL 9 were exposed to the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 52 hours. Previous temperature excursion was not reported.
100? Fever, total body aches, nausea, inflammation, some shortness of breath, chest tightening, fatigue, headache.
big rash on her abdomen; arm getting stiff; it feels like went to sleep; Tingling in my injection arm but it was like more in my hands; Tingling in my injection arm but it was like more in my hands; it feels like went to sleep; This is a spontaneous report from a contactable consumer or other non hcp. A 39-years-old female patient received bnt162b2 (BNT162B2 Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm on 03Feb2021 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation.  Medical history included contraception from an unknown date and unknown if ongoing. Historical Vaccine BNT162B2 from 15Jan2021 to 15Jan2021 (On my first dose I did not ever call back again. I called initially when I got the numbness and called my physician right way. This was back in 15Jan, I got the first dose but 24 hours after that first dose I did get a headache that lasted for 30 hours. I took Tylenol and Ibuprofen every three hours and nothing touched it but that was the first dose). Concomitant medication included ethinylestradiol, levonorgestrel (LEVONORGESTREL AND ETHINYL ESTRADIOL) taken for contraception, start and stop date were not reported. The patient experienced tingling in my injection arm but it was like more in my hands; it feels like went to sleep on 03Feb2021, big rash on her abdomen on 04Feb2021, arm getting stiff on 03Feb2021  it feels like went to sleep on 03Feb2021 and tingling in my injection arm but it was like more in my hands on 03Feb2021.  That was tingling in my injection arm but it was like more in my hands last time but this time more in palm of hand, up in elbow and it feels like went to sleep kind of but there is haven't any numbness. There is tingling like it fall to sleep and wake up. In last couple of hours it feels like it is getting better. Last time it lasted about 20 hours and this time it is getting better already. I don't feel in my in my palm as much. My arm feels still would more close to the elbow. It is still little bit tingly but everywhere else it feels like it is going away." She said that she noticed the rash on her abdomen this morning at 0500 04Jan2021 when she left for work. She said that she took a shower last night and it was not there last night. She stated that she has not taken anything yet for her rash. Therapeutic measures were taken as a result of tingling in my injection arm but it was like more in my hands; it feels like went to sleep and  tingling in my injection arm but it was like more in my hands. The outcome of the events Tingling in my injection arm but it was like more in my hands; it feels like went to sleep was resolved, big rash on her abdomen was not resolved, Tingling in my injection arm but it was like more in my hands was resolving and other events was unknown.   Follow-up attempts are completed. No further information is expected.
diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Shortly after receiving the first dose, the patient was diagnosed with COVID-19 on unspecified date in 2021. The patient was given plasma on 17Feb2021. The provider recommended getting vaccinated with Johnson and Johnson vaccine. HCP asked if there is any information or recommendations for the patient. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 06-APR-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 0.55 degrees C for 488 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
After receiving TDAP vaccine pt experienced swelling, shortness of breath, muscle rigidity, temp increase 102 A.
pt recv vax 14JAN99 & late onset group B strep sepsis & meningitis diagnosed on 17JAN99;elevated temp on 16JAN rx w/APAP-back to normal on 17JAN normal in AM awoke from nap 3PM ashen, fever up;taken to ER meningitis;Annual follow-up dated 09/26/00 stated that the pt has recovered from the meningitis. He now has a speech delay which was most likely 2nd to prematurity. He also has mild hearing loss.
2hr p/vax recvd temp began; mom gave APAP q4hrs; 28 hrs p/vax t104 orally pt had sz taken to ER sz lasted 30 min; had respiratory arrest intubated on ventilator till next AM; in coma 16 hrs no residual problems;
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves female patient (age unknown) who received 0.5 ml dose of vaccine FLUZONE HIGH DOSE, lot number, expiry date not reported via unknown route in unknown administration site. The patients past medical history and family history were not provided. Concomitant medications included VACCINE SHINGRIX on unknown date, lot number not reported via unknown route in unknown administration site. It was an actual medication error due to vaccine underdose and syringe issue. It was reported that received only part of her FLUZONE HD dose after noticing a drop fall down her arm. It leaked because the needle wasnt completely attached to the syringe. But caller said it was screwed on tightly with the luer lock. The leaking occurred during injection but did not seep from the injection site. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender - none.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date, patients were vaccinated with improperly stored LIQUID PEDVAXHIB (dose, frequency, route of administration and indication were not provided). No concomitants were reported. No adverse events were reported. The outcome of events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.