chrisvoncsefalvay/vaers-outcomes huggingface dataset:
parent observed alopecia rt parietal region @ 10wk post vax;initial onset period unclear;hair has cont to fall out from lt parietal & crown of head, more rapidly over last 30 days;to dermatologist 23SEP;dx poss allerg rxn;
her son is tested positive 5 days, son is isolating in the basement. Patient has only runny nose, no other worrisome symptoms starting 11/22/21
Diagnosed with Covid on 01/13/22 by my PCP by PCR antigen nasal swab after contacting them with symptoms of sore throat; runny nose; sneezing; low grade fever and productive cough.  Given a steroid inhaler.   Over all, very mild symptoms and felt better within 2-3 days.
This spontaneous report was received from a physician concerning multiple unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of (Merck) VARIVAX (Lot No. L010146 Expiration date: 24-MAR-2017, L017142 Expiration date: 13-MAY-2017 and Lot No. reported as J013732) (dose, route and anatomical location of administration were not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Soreness in deltoid and axilla. Patient reported sleeping on injected arm overnight. Treatment with acetaminophen recommended.
Sore throat and body aches.  Numbness in lower legs, face and arm starting on 11/19/2009.  Better in the morning and worsens as day progresses.  12/07/09 MR received for DOS 11/20/09 DX: numbness bilateral extremities, transverse myelitis, facial numbness. Pt c/o sore throat, dizziness, muscle aches and numbness s/p H1N1 vaccine. Numbness is in LE, face, mouth, tongue, and body.
On May 14th her bronchitis and asthma flared up. Had a tight chest and using her inhaler every four hours. Couldn't sleep because she was coughing so much felt fatigue so much. After the second vaccination which was June 18th she went to see Dr. because the symptoms got worse and she didn't feel any better. Doctor prescribe azithromycin 250mg for five days and stated it help with the cough. Also prescribe dueler twice a day and a cough medicine benzoate 200mg three times a day. Have been using a vaporizer and a steam medication. She also got prescribed Mucinex 1200 ml 2 times a day.
mom states tried to wake pt 14MAR98 but pt did not wake up;pt okay when went to sleep;
Pt noticed itchy red area at injection site,came to pharmacy 48 hours after injection. Pharmacist contacted primary care doctor who advised pt to come into office for exam. Topical steroid cream prescribed with instructions to monitor rash and return to office if rash not improved in three days.
Sinus tachycardia (120-145) that would not decrease.  Doctor's final report says, " We are not sure why this is happening, but it could be related to symptoms after Covid vaccination."
?Pt received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the pt will need to be re-vaccinated.?  Pt received replacement dose on 7/21/21
Patient states she has had severe pain in arm since receiving the vaccine, she says the pain started after vaccination and she is experiencing pain in her hand as well.
01/30/22 presents to ED as transfer for "Perforate viscus". PMHx of "QuantiFERON-TB test reaction without active tuberculosis, Arthritis, Obesity, and Peptic ulcer"
Mother states in AM Thursday 9/29/04, she noticed moderate swelling and erythema of left deltoid area. States child did not complain of pain and no fever. States she gave child Tylenol and cool pack to site. States child had no difficulty with movement of arm. Today 10/01/04 moderate swelling, erythema noticeable. Hot to touch. Child does no complaint of pain, able to move arm with diffculty, advised to continue with Tylenol cool pack. Mother states sx of arm improved, swelling, redness down since 9/29.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 19May2022 at 13:30 as dose 4 (booster), single (Lot number: FK9893) at the age of 82 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prostate Cancer Radiation + Hormone Therapy 2014" (unspecified if ongoing), notes: Prostate Cancer Radiation + Hormone Therapy 2014; "Pollen Allergy" (unspecified if ongoing); "Radiation" (unspecified if ongoing), notes: Radiation + Hormone Therapy 2014; "Hormone Therapy", start date: 2014 (unspecified if ongoing), notes: Hormone Therapy 2014. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (2022) Negative, notes: had aleady tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Treatment included Pfizer covid-19 treatment from 26Aug2022 to 30Aug2022. The patient had no known allergies. Other medical history included Prostate Cancer Radiation + Hormone Therapy 2014; Pollen Allergy.
booster dose of Moderna Covid-19 vaccine (0.25ml) to a patient who was supposed to be given the 3rd dose (full dose); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (booster dose of Moderna Covid-19 vaccine (0.25ml) to a patient who was supposed to be given the 3rd dose (full dose)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 16-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (booster dose of Moderna Covid-19 vaccine (0.25ml) to a patient who was supposed to be given the 3rd dose (full dose)). On 16-Dec-2021, ACCIDENTAL UNDERDOSE (booster dose of Moderna Covid-19 vaccine (0.25ml) to a patient who was supposed to be given the 3rd dose (full dose)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Pain and swelling and redness at the injection site (5 days). Muscle aches and weakness(1 day).
Inside of her mouth was sore like a burn; Soreness at the injection site; This spontaneous case was reported by a physician assistant and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) and ORAL DISCOMFORT (Inside of her mouth was sore like a burn) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism and Allergy to chemicals (Allergic reaction to a dental numbing injection agent). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). On 14-Jan-2021, the patient experienced ORAL DISCOMFORT (Inside of her mouth was sore like a burn). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) and ORAL DISCOMFORT (Inside of her mouth was sore like a burn) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included magic mouth wash which was prescribed by dentist but  has not started using the prescribed medication yet.
On day 8 after receiving vaccine (1/18/2021),  I woke up scratching my left arm at vaccination site.  There was a 4X5 inches red, hot and itchy area.  The redness and itchiness subsided slowly over 5 days.  The night of the 17th of January, the vaccination area was completely normal with only slight bruise left from the injection site.
Patient came to ED for sensation of lip swelling and tingling, throat tightness 12/10/2009 ED records for 12/6-12/7/2009 patient with c/o's lip swelling and tingling, hoarseness and chest tightness, tx'd with benadryl and steroids, DC Dx allergic reaction
MORE THAN HALF VACCINE LEAKED FROM THE LEUR CAP. PT RECEIVED FULL DOSE IN RIGHT ARM AND CONSENTTED.
The day after the vaccine, I had body aches and was extremely tired. The fatigue didnt go away. It persisted for months.  I started having frequent heart palpitations. I went to my doctor on 04/01/22. She ordered various laboratory testing and a cardiac event monitor. Lab results revealed I had mononucleosis sometime in the previous months.  I had EBV mono 20 years ago. It is unclear if this was a reactivation or new infection. Cardiac event monitor revealed SVT, PAC, PVC and ventricular tachycardia.  My previous cardiac event monitor study in 08/2021 was normal. I was sent to a cardiologist and had a stress test done. I have an appointment with electrophysiology for a pacemaker consult in September.
red cheeks, become slightly worse; warm cheeks, become slightly worse; swollen cheeks, become slightly worse; This case was reported by a consumer via call center representative and described the occurrence of red face in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th January 2023, the patient received the 1st dose of Shingrix (intramuscular). On 10th January 2023, 5 days after receiving Shingrix, the patient experienced red face, feeling of warmth facial and cheek swelling. On an unknown date, the outcome of the red face, feeling of warmth facial and cheek swelling were not recovered/not resolved.   It was unknown if the reporter considered the red face, feeling of warmth facial and cheek swelling to be related to Shingrix.  Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's Comment: The reporter was the patient's husband and did not want to give any further demographics.  He stated that his wife got her Shingrix vaccine and then started with red, warm, swollen cheeks.  He states that her symptoms had become slightly worse since they started.  She was still having symptoms at the time of the call.  The reporter did not consent to follow-up. No follow up with HCP.
Swelling in the armpit day 2 post vaccine Day 4: swollen lymph gland left neck.  mild tenderness. 1x1 cm
Pt received vax on 05/14/1999 and subsequently developed a nodule at the Acel-Imune administration site.  The nodule is scheduled to be excised and biopsied if still present in July 1999.
I received my first Moderna shot on 4/9/2021 and had a large rash, itching and pain on my left arm starting on 4/17/2021.  I also had swollen lymph nodes in my armpits.  Today, 04/22/2021 the rash is still visible.
A report has been received from a Health Professional concerning a patient, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 15-Oct-2014. The patient experienced rash on the trunk. The patient recovered from the event of rash on the trunk on an unspecified date. The report was considered to be non-serious.
Headaches, body aches, low grade fever, sore throat the day following vaccine administration. Vaccine dose was most likely correct but an excess volume of diluent was also administer. Parent gave age appropriate dose of Motrin the evening of vaccination.
Fever (100.3), headache, joint pains, muscle aches, fatigue/tiredness, nausea
She was in bed for a better part of the week; she drank tea and heard it swish in her stomach; Pain on my left side of my body; projectile vomiting 6 or 7 times until I emptied out the stomach; a horrible reaction to it; feeling horrible; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain on my left side of my body), VOMITING PROJECTILE (projectile vomiting 6 or 7 times until I emptied out the stomach), VACCINATION SITE REACTION (a horrible reaction to it), FEELING ABNORMAL (feeling horrible) and ASTHENIA (She was in bed for a better part of the week) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN (Pain on my left side of my body), VOMITING PROJECTILE (projectile vomiting 6 or 7 times until I emptied out the stomach), VACCINATION SITE REACTION (a horrible reaction to it) and FEELING ABNORMAL (feeling horrible). On an unknown date, the patient experienced ASTHENIA (She was in bed for a better part of the week) and NAUSEA (she drank tea and heard it swish in her stomach). At the time of the report, PAIN (Pain on my left side of my body), VOMITING PROJECTILE (projectile vomiting 6 or 7 times until I emptied out the stomach), VACCINATION SITE REACTION (a horrible reaction to it), FEELING ABNORMAL (feeling horrible), ASTHENIA (She was in bed for a better part of the week) and NAUSEA (she drank tea and heard it swish in her stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has used heating pad for body pain. No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up information was received. Reporter's email was added. It contains non significant information.
Yawning type behavior, possibly a tic with onset within 24 hrs of receiving IPV & Influenza vaccine.
The patient was asked before vaccine administration if any reaction had occurred in the past and patient replied no "I just don't like getting shots." Patient was administered vaccine 2:58 pm and at 3:00 pm patient reported feeling faint, looked flushed and was laid down onto the bed with head of bed at 45 degree angle. No syncope. Vital signs checked at 3:00 PM: BP 88/50, pulse 71, 02 98% and respirations 20. Given cold cloth to forehead. Blood sugar checked at 3:02 pm 81. Patient given water and apple juice. Patient was alert and oriented x3. Vital signs taken at 3:05 pm: BP 90/58 02 98%, pulse 73, resps 16. Patient verbalized she felt better after drinking apple juice. Patient vital signs at 3:19 pm: BP 104/64, pulse 74, temp 98.0 and resp 18. Patient was able to walk out to waiting area with her mother and was advised to call the office if she experienced any further symptoms.
"Covid Arm"  appeared 9 days after initial injection.  Measured 6 inches across and 2 inches down.  First 2 days was burning and sore.  After that time, no pain just red rash that faded completely 1 week later.
Pt with fevers, max 103 degrees F. Pt with LP done showing 115 WBC & 55 RBC. Appears to have viral meningitis type picture. Fevers began in evening after vaccines given.
This spontaneous report was received from a License Vocational Nurse referring to an unspecified amount of unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. From 05-NOV-2017 to 27-NOV-2017, the patients were vaccinated with improperly stored VARIVAX lot # M046924, expiration date on 28-NOV-2018, for prophylaxis (strength, dose and route were not reported); which were diluted, concomitantly, with a properly stored sterile diluent (MERCK). The reporter did not know the details about temperature and/or time frame at which vaccines were improperly stored. There were previous temperature excursions but the reporter, also, did not know the details. The call was because of a data logger and no adverse effects were reported.
Hives all over torso and face/head. Started 48 hours after administration of first dose and still present two weeks later.
her arms are a little sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arms are a little sore". Additional information: Patient said that she just had the first dose today and her arms are a little sore. She would like to know if it is okay to take alcohol after the first dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a health professional concerning a 65 year old white female nurse with no known drug allergies and with a history of recent back surgery who on 11/02/2004 in the afternoon was vaccinated intramuscularly in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot #647029/0514P).  At the time of vaccination, she complained of dyspnea and fatigue.  On 11/03/2004 in the morning, the patient stated that her arm was very sore, and she was unable to raise her arm above her head.  Her arm was red, swollen, and it hurt.  The patient stated that this lasted for 3 days.  The outcome was reported as recovered.
Macolopapular rash noted on abdomen spreding to back after vaccination.  At 11:20 nurse noted one maculopapular lesion on rt knee.  Mom said that was new.  At 11:21 Nurse noted 3 maculopapular lesions on right knee.  No SOB or color changes.  Baby alert and acting normally.
A 64 year old male reportedly developed a vaccine-associated paralytic poliomyelitis when he was 49 years of age after his granddaughter was immunized with Orimune in late 1979. He reported that now at the age of 64 he has experienced Post Polio Syndrome (pain and weakness) which has diminished his only means of daily life (upper body function). As of 6/13/00, no further information is available. Follow up information received 4/8/02 from the physician indicated that the patient was permanently paralyzed.
30 hours after vaccine a warm, red, hard marking, approximately 3 inched in diameter , appeared at the injection site. Treatment was Ibuprophen and Ice. The next morning the mark spread, appeared lighter, warm and hard to the touch. As the day progressed my arm felt heavy, by the afternoon my arm and hand (not the red spot) felt cold. That evening my shoulder to my fingertips were numb with a "falling asleep" sensation. I still had control of movement but was unable to feel any touch. I wrapped a heating pad around my arm for two hours, unable to feel the heat, and took Ibuprofen and Benadryl. Around 11:00 that night I was able to feel my pinky finger. Continued to apply heat every 20 minutes for 20 minutes throughout the night and continued with ibuprofen and Benadryl. The next morning I was able to feel my ring finger, the red spot had disappeared, and the hardness was decreasing. That evening, continuing with heat, Ibuprofen, and Benadryl, I was able to feel 4 fingers. Continued into Sunday with same treatment and by Sunday morning I was able to feel my entire hand and wrist. As the day progressed I regained feeling up to my elbow and the shoulder by the night. Monday I discontinued treatment. Had full feeling of my arm, with pain in my elbow and shoulder. Tuesday morning all was back to normal.
PT REPORTS ITCHY RASH ON BODY AND ON THE PALMS. PT WAS TOLD TO TAKE BENADRYL AND IF SYMPTOMS CONTINUE PT SHOULD CONTACT PROVIDER.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 69 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EN5318), in right arm, on 23Feb2021 as dose 2, single (Lot number: EN6200), in right arm, on 05Oct2021 as dose 3 (booster), single (Lot number: FD8448), in right arm and on 20May2022 as dose 4 (booster), single (Lot number: FM7553), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Arterial sclerosis" (unspecified if ongoing); "Have two arterial stents" (not ongoing); "Hydrocodone allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovering"; COVID-19 (medically significant), outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Test was very faint, barely visible; Positive, notes: Test was boldly positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: On day 10 after initial onset of Covid, patinet had essentially no symptoms, but still tested positive. However, the positive (home antigen) test was very faint, barely visible. Then after symptoms resumed (day 13), the test was boldly positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175662 Same patient/reporter, different drug/AE (Paxlovid);
This spontaneous report was received from a medical assistant who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reactions or allergies was provided. On unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot# N001533 with expiration date 16-OCT-2019, lot# M042853 with expiration dates of 07-JUL-2019 and 17-JUL-2019 and lot# reported as M042843 with expiration date: 17-JUL-2019 (dose and route of administration were not reported) as prophylaxis. The sterile diluent (manufacturer unknown) used was stored properly. The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 3 hours and 18 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006289: US-009507513-1707USA009050: US-009507513-1707USA009051: US-009507513-1707USA009053: US-009507513-1707USA009054: US-009507513-1707USA009055: US-009507513-1707USA009056: US-009507513-1707USA009057.