chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a RN concerning a 66 year old female pt who on 15Dec03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently in approx Dec03, the pt developed right arm swelling and tenderness.  Medical attention was sought. The pt was treated with ice and rest. A product quality complaint was not involved. The reporter also mentioned a male pt who experienced an adverse event post vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
We had a family gathering for the Christmas holidays. A couple of days later, I had a moderate-grade fever, body chills, light sensitivity, cough, light body fatigue, sore throat, nasal congestion, and diarrhea. I still had my senses of taste and smell, no body aches, it just felt like a spiked flu. This was steady symptoms for 3-5 days. My father and I were battling the same symptoms. We took at-home COVID-19 tests on 12/29/2022 which both came back positive so fast. I was able to get my father and I both prescriptions for PAXLOVID. Currently, we're both doing better and coming out of it with more energy.
All joints sore and site sore. Left lower are, wrist, and hand continues to get worse to where the pain makes it unusable. It?s now 4:30 on the 31st and I?m taking  numerous Advil 6 so far today just to slightly dull the severe pain. No visible exterior signs or swelling but I can?t even take the cap off a toothpaste tube Not sure what I should be doing at this point. Very uncomfortable
Inner ear pain; ringing in ears; migraine; Jaw pain; ear pressure; dizziness; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 21Apr2021 (at the age of 35-years-old) as a single dose and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 12May2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included magnesium oxide (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), vitamin d (MANUFACTURER UNKNOWN) and riboflavin (VITAMIN B2). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021 the patient experienced inner ear pain, ringing in ears, migraine, jaw pain, ear pressure, dizziness and nausea. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with balance therapy (unspecified). The clinical outcome of the event inner ear pain, ringing in ears, migraine, jaw pain, ear pressure, dizziness and nausea was not resolved at the time of report.
Two days following vaccination I started having tingling in my feet.  Often it felt like pins and needles, and eventually more like a burning sensation.  My understanding is generally we would refer to this as neuropathy.  It comes and goes in my hands as well.  I've had some significant leg pain in my hip off and on, and a couple of headaches, but the consistent for more than  two weeks has been the neuropathy issue and it is not going away.
asthma worsened; could not exercise as much anyone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "asthma worsened"; EXERCISE TOLERANCE DECREASED (non-serious), outcome "unknown", described as "could not exercise as much anyone". Additional information: Patient's asthma worsened after their Pfizer Covid vaccine, could not exercise as much anyone.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Felt really warm & feverish a hour or so after the shot (12/27). Had changed into pjs right away so I didn't notice the hives until the next morning when I got up to get ready for work (12/28).
Burning dysesthesias in all extremities with flushing of arms and mottling of legs and changes in extremity temperature with increased skin temperature in arms and decreased in legs.
Approximately two days after receiving Moderna Covid-19 immunization, developed redness, slight swelling and itchiness below injection site.  Within 24 hours, site increased in size and redness and remained itchy.  I had no fever.
Redness on the left arm where immunization was given the day prior. Temp of 100 degrees.  Follow up received states vaccine name, manufaturer, lot number: VARIVAX, Merck, lot 1771Y.
Started with flu-like symptoms. Then at night started having vivid dreams, where he could/felt himself talking - like out-of-body conversations. This lasted three nights. He could not sleep, eat, or do anything except lay in bed.
fever; headache; body aches; did not sleep well that night; felt generally unwell; This is a spontaneous report from a contactable consumer (Patient).   A 25-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the second dose and next day he woke up and had a fever, headache and body aches all day. He did not sleep well that night. The next day he had headaches and felt generally unwell, although milder than the previous day. The outcome of all events was unknown.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Itching and rash on both lower arms 2 hours after receiving MedImmune Nasal H1N1 vaccine, lot 500756P.
I tested positive for COVID on 03/22/2023. I got sick, and I had congestion, runny nose, cough, fever, chills, mild sore throat, severe headache, photophobia and sore eyes. I had PAXLOVID and that helped, and I've just been trying to recover. The highest my fever went up to was 102. I also did experience some muscle aches as well.
It was reported in a published article, that a 16 month old pt with a history of asthma NOS and eczema was vaccinated on an unknown date with a dose of MMR II. Within one hour post-vaccination, the pt developed anaphylaxis with erythema, wheezing, tachydardia and rash. The pt was treated with albuterol and diphenhydramine elixir. The pt's outcome was not reported. Upon internal review, it was determined that anaphylaxis, erythema, wheezing, tachycardia and rash were other important medical events (OMIC). Additional info is not expected. It was reported that other patients also developed adverse experiences following vaccinations (WAES0310USA01792, WAES0310USA01903, WAES0310USA01904, WAES0310USA01905 and WAES0310USA01906).
Yesterday he started to feel bad; Not feeling well; This is a spontaneous report from a contactable consumer(patient's sister).A 55-years-old adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number was not reported ) via an unspecified route of administration on 14Jun2021(at the age of 55-years-old) as 2nd Dose, Single for COVID-19 immunization.The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number was not reported ) via an unspecified route of administration on an unspecified date as 1st Dose, Single for COVID-19 immunization. After 2nd dose of vaccination, on 14Jun2021,the patient reported of not feeling well. On 17Jun2021,yesterday he started to feel bad. She would like to know what kind of side effects are to be expected from the vaccine. Seriousness by the reporter was No. The outcome for the events was Unknown.  Information on lot/batch number has been requested.
Seriousness Criteria other medically significant (OMIC). Initial report received on 5/23/2006 from a physician. A five year old female patient, with no past medical history, had received a left gluteal (administration not recommended in this site), fifth dose injection of Daptacel, lot number C2396AA, a right gluteal, fourth dose injection of IPOL, lot number not reported, and a right gluteal, second dose injection of Measles Mumps and Rubella vaccine, lot number 0579R, on 5/17/2006. Routes of administration were not reported. The patient woke up in the middle of the night after receiving the vaccinations and complained that her butt hurt. She had a large four x six inch swollen area at the injection site that was red in the middle and white around the edges. She had a fever of 99.9 to 101.9 degrees F. The patient was taken to the pediatrician who prescribed Tylenol alternating with Motrin every four hours and application of cold compresses. The next day, the site had worsened. The site was not five and a a half by six inches, and the redness had spread to the lower back and down the left leg. The patient was taken to the ER and treated with intravenous fluids, Keflex and Benadryl. Per the reporter, a blood count was fine but positive for bacteria. Blood cultures were positive for gram positive bacilli. The next day, the patient was feeling better. The fever has resolved, and the swelling had gone down. At the time of this report, the patient had mad a full recovery.
Initial information received on 28-Mar-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 65 years old female patient who was vaccinated with an expired dose of FLUZONE HIGH DOSE (lot UI993AA, expiry date: 18-Mar-2019, via intramuscular route in the left deltoid) on 28-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to expired vaccine used. It was unknown whether the patient had any adverse event or not. 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 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.
pt complaining of pain, numbness, tingling in left arm x 10 days. two small nodules near vaccine injection site. Dizziness and just not feeling well.
covid-19; sore throat; cough; loss of taste and smell; A spontaneous report was received from a nurse concerning a female patient who received Moderna Covid 19 vaccine and experienced sore throat, cough, loss of taste and smell and tested positive for Covid 19. The patient's medical history shows allergic to medications and also is on OTC medication. No relevant concomitant medication were reported. On 26 Dec 2021, patient received first of two two unplanned doses of mRNA-1273 ,Batch number:37K20A for prophylaxis of covid 19 infection.  Patient was tested positive for COVID on 25Jan 2021. She had a sore throat, cough, and loss of taste and smell. She was prescribed azithromycin medication 250mg 5 tablets total for 2tablets the first day and 1 tablet a day afterwards which was ordered on 01FEB2021 Lab parameters were not provided. No other reactions observed. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was unknown.
pain; redness; This case was reported by a consumer and described the occurrence of pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th March 2020, the patient received the 1st dose of Shingrix. On 16th March 2020, less than a day after receiving Shingrix, the patient experienced pain and injection site erythema. On an unknown date, the outcome of the pain and injection site erythema were unknown.   It was unknown if the reporter considered the pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received vaccine at local pharmacy. The patient received 1st dose of Shingrix 4 hours ago on he day of reporting. The patient stated that, after vaccination had pain and injection site erythema. The patient was told that she might get a fever from the shot. The patient advised to took tylenol or advil for fever for 2 to 3 days.
Rash presented 4 days post vaccination. Appeared first on face(cheek and temple) also on inner arms, abdomen and hip. Rash appears like bite marks, but no one else in household experienced similar rash  and no known exposure to insects in time frame.; Rash is itchy but responds to topical steroid creams; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 30Mar2021 at 09:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included HPV vaccine vlp rl1 4v (yeast) (GARDASIL) on 02Mar2021. The patient previously took Naproxen and experienced drug allergy on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the vaccine, GARDASIL within four weeks prior to the vaccination. On 03Apr2021 at 07:00 the patient experienced rash which presented 4 days post-vaccination. The rash appeared first on face (cheek and temple) also on inner arms, abdomen and hip. The rash appears like bite marks, but no one else in the patient's household experienced similar rash and there was no known exposure to insects in the time frame. The patient reported that the rash was itchy but responded to topical steroid creams. Therapeutic measures were taken as a result of the event which included treatment with topical steroid cream and antihistamines. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. The clinical outcome of the events rash and itchy rash was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Burning and heat on foot; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BURNING SENSATION (Burning and heat on foot) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Burning and heat on foot). At the time of the report, BURNING SENSATION (Burning and heat on foot) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Patient had vasovagal response. passed out in waiting area. Pt immediately laid on his back by pharmacist and another patient, legs were propped up and patient started to come to. He was aware of all surroundings and had no trouble breathing. no rash was noted and no other injection site reactions were apparent.
Is diahrreah common side effect?; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Is diahrreah common side effect?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Is diahrreah common side effect?). At the time of the report, DIARRHOEA (Is diahrreah common side effect?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.   Reporter did not allow further contact
Alopecia areata; Sudden hair loss in patches on scalp and beard; This is a spontaneous report from a contactable consumer or other non hcp. A 26-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6199) via an unspecified route of administration in Arm Left on 09Mar2021 (age at vaccination 26years old) as single dose for covid-19 immunisation. Medical history included testis cancer, drug hypersensitivity, all from an unknown date and unknown if on-going. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included famotidine (FAMOTIDINE); lysine (LYSINE); calcium carbonate (TUMS [CALCIUM CAR-BONATE]), all taken for an unspecified indication, start and stop date were not reported. Since the vaccination, the patient had been tested for COVID-19. On 12Mar2021 the patient experienced alopecia areata, sudden hair loss in patches on scalp and beard. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Apr2021. The patient received treatment with steroid cream for the adverse events. The clinical outcome of the event was not recovered. Therapeutic measures were taken as a result of alopecia areata, sudden hair loss in patches on scalp and beard.  No follow-up attempts are needed. No further information is expected.
Rash below injection site, tender to palpation and slightly itchy.  2 inches wide, 4 inches long in a semi circle pattern.  Rash started day after injection and is still present 5 days later.  Also,  during the 24 hours following injection, I experienced fever, chills, nausea, aches and fatigue.  These symptoms have subsided.
Acute on chronic hypoxic respirtory failrue, COVID 19, Afib RVR, ESRD, AV fistular malfunction, Dm2, Hypotension.    Hospital Course:  The patient was admitted with the above. She was treated with remdesevir and IV steroids for 5 days. She her oxygen requirement came back down to her baselien of 3 liters. Her course was complicated by Afib RVR. She was seen by cardiology. She was kept on Amiodarone, digoxin and cardizem were added.She had a hight dig level even after HD. She was taken off digoxin an her cardizem dose was increased. She was asked to follow up outpatient.  She was felt to be a poor candidate for OAC. She had some AV fistula dysfunction and had to have a fistulogram with a stent placed. She was quite debilitated on discharge and she was offered nursing home but declined and wished to go home with home health.
Patient here for 12 month well child exam.  Originally physician ordered Pentacel, Prevnar and Varivax but after chart review it was determined that child missed the 6 month well child exam and was in need of 3rd dose of Vaxelis.  The consent form (paper) had been prepared based on the original orders of Pentacel, Prevnar and Varivax.  When the medical assistant asked the MD to sign the order, the MD said (per the MA) we are giving VAXELIS, instead of Varivax.  Per the MA, the MD watched the MA cross out VARIVAX and add VAXELIS as well as having the PENTACEL checked off.  The MD then signed the order.  MA administered the vaccines and upon documentation in the medical record, noted a different set of orders in the chart that DID NOT include the Pentacel but did include the Varivax.  The MA did notify the physician and myself right away. The parent was notified of the event and was advised to monitor for increase in fever, irritability, or local reaction.  I apologized for the experience and that I would be looking into how this occurred in spite of our careful attention to safety.  I gave her my name to call for any additional questions.  Parent did bring child to the  ED for evaluation about 2 hrs after the incident.  ED diagnosis of 'parental concern'. after the dual vaccinations received. Vital signs at that visit WNL with no fever. All other physical exam WNL except for '3 Vaccine sites notes with mild surrounding erythema but no tenderness'.   The department on call physician was notified in case there were any further concern overnight which there were not.  No subsequent calls were made to the office since then and no further ED evaluations noted.
First, I noticed a rash on my left breast. It was itchy. Then when I looked at it, it was very red but not raised. I went to the doctor about it because it would not go away. She thought it was an infection and gave me antibiotics for it. She had me to come back. Then she thought it was not an infection because it did not go away. Then finally it went away.
itchy eyes; This is a spontaneous report from a non-contactable physician (patient). This physician reported similar events for two patients. This is the first of two reports.  A female patient of an unspecified age (reported as age: 79, unit unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 26Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer vaccine on 26Jan2021. Patient had itchy eyes that day and day after, then subsided. The next shot is scheduled for 26Feb2021, patient was struggling in making a decision on the second shot. Patient asked for any information on this side effect. The outcome of the event itchy eyes was recovered on an unknown date in 2021.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.; Sender's Comments: Linked Report(s) :  same reporter/drug/AE, different patient.
Swollen tongue and throat, fever, aches, cough, headache, stuffy nose, itchy eyes.
02/22 Headache; 02/23-25 malaise; 02/27 cold, cough; 03/04 physician diagnosed bronochitis, pneumonitis and "rubbing" of right lung only, no x-ray, improvement with Biaxin but never completely resolved; 04/14 "rubbing" persists - cough - appt. with nurse practioner - chest x-ray - began another course of Biaxin with no improvement and "rubbing" of right lung continues.