chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning an 87 year old male patient who on 28-AUG-2008 was vaccinated with ZOSTAVAX (Merck) (lot n. 659411/0293X) 0.65ml subcutaneously. Concomitant therapy included VALTREX. On 29-DEC-2010 the patient developed a rash diagnosed as shingles. The patient was treated for shingles with antiviral medication for seven days. Therapy with ZOSTAVAX (Merck) was not reintroduced. The patient didn't recover. The patient sought unspecified medical attention. Follow up information received on 25-JAN-2011 from a Advanced Registered Nurse Practitioner specializing in Cardiology (ARNPC) stated that the patient with history of chickenpox when child was vaccinated with ZOSTAVAX (Merck) in the right upper arm on 28-AUG-2008. On 29-DEC-2010 the patient experienced herpes zoster. The patient developed numerous severe vesicles on his left lower back across to abdomen. The rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. There was no exposure to chickenpox or herpes zoster recently. There was also no specimen collected for PCR and no photo taken. At the time of the report, the patient was still having pain. The pain was 10 in scale 0-10. Additional information is not expected.
Narrative: Patient is Type 1 DM had taken insulin without meal prior to vaccination. Patient was given nutrition and fluids and juice. Reported resolve of symptoms after additional monitoring.
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 03:30 (Batch/Lot number: unknown) at the age of 16 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anorexia" (unspecified if ongoing); "Anemia" (unspecified if ongoing). Concomitant medication(s) included: PROZAC; IRON; VITAMIN D [VITAMIN D NOS]; MULTI VITAMIN [ASCORBIC ACID;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;VITAMIN B1 NOS;VITAMIN B12 NOS;VITAMIN D NOS;VITAMIN E NOS]. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "recovering", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient had no known allergies. 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 did not receive any other vaccines within four weeks prior to the COVID vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia, RIGORS,CHILLS SWEATS, BRAIN FOG, FATIGUE Narrative:
I had a temporary increase of milk supply which lasted for three days. I also noticed this for the second dose. Three days after the second dose I had recovered from the Flu=like symptoms. I woke up with Breast pain and I noticed a red spot on my left Breast. I had fever, muscle pain and chills. I went to the doctor a couple of days later and she diagnosed Mastitis and prescribed some anti-biotics. Dicloxacillin and it was cleared up within 48 hours. I did not have any other problems after that.
On day 7 post vaccine (1/6/2021) patient developed itching at the site of the vaccine then was seen today 1/7/2021 for redness and swelling to the site.  Patient with 2.5inchx3inch area to lateral arm/lower deltoid region of erythema and induration.  Area slightly warm to touch.  Area not tender.  No abscess or drainage noted.  Full range of motion of the extremities noted.  Denies any systemic symptoms.  Denies any chest pain, difficulty swallowing, shortness of breath, vomiting, dizziness.  Patient also endorsed some bilateral lateral pectoral/anterior should soreness - this area slightly tender but patient does endorse exercising and believes it to be related to that.  Advised supportive measures at home (warm/cold pack, tylenol or ibuprofen as needed for pain).  Patient also given course of keflex 500mg TID for possible early cellulitis.  RN will call patient to check on patient in 2 days
Alopecia Areta. This started after the vaccine: we know because we cut my hair short a few days before the vaccine (no sign then) and when I got my haircut again, the bald spot showed up. Diagnosed at clinic.
Flu like symptoms, Rash on trunk, Headache, Welt at injection site, Fever, tired Patient experienced with Both shots
diarrhea; violent shaking chills/could not stop shaking; felt achy; Fever; chills; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), TREMOR (violent shaking chills/could not stop shaking), PAIN (felt achy), PYREXIA (Fever) and CHILLS (chills) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038T5214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DIARRHOEA (diarrhea), TREMOR (violent shaking chills/could not stop shaking), PAIN (felt achy), PYREXIA (Fever), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, DIARRHOEA (diarrhea), TREMOR (violent shaking chills/could not stop shaking), PAIN (felt achy), PYREXIA (Fever), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.    Reporter did not allow further contact
Patient called to report that she took her bandaid off on 11/2/2022 after her vaccine that was received on 10/31/2022. She said that the injection site looked pink and like a blister that had popped. She said there was no fluid and it was not warm to the touch or red, like it might be infected. I recommended that she monitor the site and seek evaluation at an urgent care if the site does not get smaller or stays the same. Also recommended that she apply Neo-sporin to reduce chance of infection. She did mention that she had an allergy to latex. I verified that the bandages are "not made from natural latex" but it is possible that she may be allergic whatever fabric the bandages are made from.
Expired dose of Ipol was administered to a patient/ No AE; Initial information was received on 07-May-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a six years old male patient who, on 06-May-2020 was administered with 0.5 mL dose of expired vaccine IPV (VERO) (lot P1A25 and expiry date 02-May-2020)  via subcutaneous route in the left arm for prophylactic vaccination (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN); HEPATITIS A VACCINE (HEPATITIS A VACCINE) and INFLUENZA VACCINE (INFLUENZA VACCINE) (flu vaccine) for Immunisation.  It was an actual medication error case due to expired vaccine used.  At a time of reporting 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 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.
PATIENT BEGAN HAVING CHEST PAIN DAY AFTER SHOT 10/5/22 AND PRESENTED TO ER.  PATIENT PASSED AWAY AT HOSPITAL
When I tried to get up, the room got black and I just about passed out. My heart was racing, I was clammy and sweaty and it was hard to breathe. This lasted about 2 hours. I recovered slowly. I called my husband and he came home from work. They didn't warn me of any of this kind of reaction and neither did my doctor. He should have.
Three days after the vaccine was administered, the patient began to experience severe upper sternal chest pain. It did not radiate, and he said that taking deep breaths seemed to cause more pain. He did not seek any medical care for this, and by the next day, the pain was significantly improved, with the pain completely resolving by the 3rd day.
pt recvd vax; about 5am, devel fever of 102;cranky;gave non asp at 8am, t 98.1;11am t 103; arm red rash raised around inject site; v; Lt arm affected; to see PMD today;
Approximately 1 hour after receiving vaccine, patient noted she developed swelling of her lips and left eyelid. She also had swelling, erythema, and increased itching of her Left Arm.   Patient reported taking 4 tablets of benadryl with spontaneous resolution of symptoms several hours later. She did not go to any medical office or emergency department for immediate care and did not follow up with any doctor until establishing care in new practice several months later.
rash onset 6/15/99;had about 70 pox per mom;positive for fever;unk temp x 2 days & given APAP for 2 days;child has been on Proventil & Intal since 6/15/97;no complications besides fever & pt recv no meds;about 50-70 pox per mom;
soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
This non-serious event was reported by a health care professional on 13 January 2009. This patient is one of a cluster of 20 patient; the other 19 are captured in case numbers 2008-03509, 2009-00153 to 00160, and 2009-00162 to -00171. A female patient received an injection of FLUZONE SV 2008-2009 (lot number U2762AA; date administration details not reported). On 15 October 2008, the nurse was notified that the patient had complained of aches, chills, sweats, and called off; however the start date of the events were not provided. Outcome was not reported. Follow-up information was received from the health care professional on 13 February 2009. The patient was 30-years-old at the time of the event. On 15 October 2008, the patient received an intramuscular deltoid injection of FLUZONE. Symptoms began approximately 72 hours after vaccination, and she missed one day of work. The patient could not remember if she had taken any treatment medications. Symptoms lasted three days, and subsequently recovered. Documents held by sender: None
Mother called 2 to 3 days after the vaccine indicating that patient had had fever of 103 Fahrenheit in addition to lacy rash with macules throughout upper and lower extremities. Mother also reported a seizure activity at home. Patient was not brought into the clinic nor were they brought into urgent care or emergency room.  PCP was told days after the event.  Patient doing well at home though continues to be fatigued with new lesions on upper and lower extremities per parent. Patient also having these macules around eyes however no conjunctivitis per parent. Patient is approximately almost 1 week out with these ongoing lesions and fatigue. Mother reports also easy bruising. Patient being treated conservatively at home use of Tylenol only for fevers. Mother has refused to take the patient to urgent care or to bring to the clinic for evaluation. We will continue to follow-up with patient in the next week.
Burning, tingling, numbness on left arm, shoulder, face.   Most symptoms resolved in 36 hours. Resulted in sinus disease left maxillary sinus and swollen lymph glands in neck
Vaccine given 11-19-14 (FLUZONE HD) patient reported feeling sick and short of breath and sore arm (given tizanidine by MD 11-29-14). Patient reported still sick and short of breath and received cefuroxime from MD 12-1-14. Patient reported dismissed from hospital 12-5-14.
Dizzy, weak, hot in face, runny eyes/nose, seizure like movements. Patient contacted her MD and was advised no treatment necessary. Patient ok now.
Woke up on the 17th of Oct. rt eye under eyebrow swollen. Welts from waist up to head. Seen Medical Dr. was given Solumedrol and Prednisone dose pack. Symptoms resolving.
5/12 85 y/o F presents via ems after being found down.  Initially police called for welfare check after staff had not seen her today. Found her on ground on her R side.
Softball area rash/swell around injection site; BENADRYL and ice treatment; follow up 5/12/15 with almost complete symptom resolution.
Experienced twitching in right ear in or around ear drum at night after my second dose in the afternoon.  The twitching produced a sensation of throbbing sound and was very frequent and constant, occurring almost every other second.  The next day was even worse with constant twitching throbbing sensation and I my sleep was hugely affected.  I would stay up and walk at night.  Got an appointment on May 11 with my Dr. who said basically I have ringing ears, Tinnitus, which might be due to hearing loss from childhood etc.  He checked hearing which was still fine.  I did mention it all started happening right after 2nd dose of COVID vaccine but he didn't think there was any connection with that.  He did say he will keep this in mind and see if any link between vaccine and Tinnitus is found as cases are reported.  He said there is not much that can be done for Tinnitus other than reducing noise levels.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 13-OCT-2012 at 23:26, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Swelling; sensitive to touch; Knot; decreased mobility to arm; Tenderness; This case was reported by a other health professional via sales rep and described the occurrence of swelling in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Bexsero. On an unknown date, less than a month after receiving Bexsero, the patient experienced swelling, touch sensitivity increased, mobility decreased, tenderness and mass. On an unknown date, the outcome of the swelling, touch sensitivity increased, mobility decreased, tenderness and mass were unknown.   The reporter considered the swelling, touch sensitivity increased, mobility decreased, tenderness and mass to be related to Bexsero.  Additional details were provided as follows: This case was reported by the Receptionist. The patient received Bexsero and had swelling, sensitive to touch, decreased mobility to arm for one week. Tenderness 2-3 weeks. Knot formed immediately following injection and still persist at the time of reporting. There was a discrepancy with respect to the primary reporter type, in ARGUS, the reporter type is reported as consumenr however in the source document the Reporter Credentials was reported as receptionist. It seems that the reporter was a receptionist at physician's office where the representative went.
Patient was quiet and anxious prior to shot. Stated he never had a reaction to vaccination before, but has fainted before from blood pressure being taken. Shortly after vaccination he asked to lie down and then he fainted. He quickly regained consciousness and was sweating but talknig and alert. RPH administering the vaccine lowerd him to the floor with no impact. 911 was called and patient was alert and monitored for 30 minutes. He declined further treatment.
ABDOMINAL CRAMPING; BACK PAIN; DIZZY; HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced abdominal cramping. On 07-MAY-2021, the subject experienced back pain. On 07-MAY-2021, the subject experienced dizzy. On 07-MAY-2021, the subject experienced headache. On 07-MAY-2021, the subject experienced fatigue. On 07-MAY-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal cramping, headache, back pain, fatigue, dizzy, and nausea. This report was non-serious.
Sore left arm at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm at the injection site.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J02A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PAIN (Sore left arm at the injection site.). At the time of the report, VACCINATION SITE PAIN (Sore left arm at the injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided by the reporter.  The consumer stated that she took treatment, but did not specified at the time of reporting.   This case was linked to MOD-2021-313029 (Patient Link).
Flu vaccine--I don't know which one. Received 9/27.  Starting 9/28 the area was very warm to the touch, almost felt round like the vaccine didn't start absorbing or something. 9/29- the skin over the area that felt round is now red and tight. it hurts if any pressure is applied. the upper arm area is a little achy too.  I have not treated it with anything. Just letting it run. The achy-ness isn't uncomfortable enough that I'll take anything and it only hurts when its actively pushed on so I've just been careful about leaning up against things with that arm. I don't expect it to get much worse just reporting to keep y'all in the loop.
Information has been received from a physician concerning a pt who was vaccinated with varicella virus vaccine live. Subsequently the pt experienced a breakthrough after vaccination. it was unspecified if medical attention was sought. The pt's present status was unk. No further information was given at the time of this report and there was no produt quality complaint.
Primary Series of Moderna Vaccine received after  patient received a different Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary Series of Moderna Vaccine received after  patient received a different Moderna Covid-19 vaccine) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Astra Zeneca Vaccine on 24-Mar-2021. Past adverse reactions to the above products included No adverse event with Astra Zeneca Vaccine.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary Series of Moderna Vaccine received after  patient received a different Moderna Covid-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary Series of Moderna Vaccine received after  patient received a different Moderna Covid-19 vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2022-507124 (Patient Link).
Asymptomatic - positive PCR test result; Asymptomatic - positive PCR test result; This is a spontaneous report from a contactable consumer. This consumer reported for herself that a 50-year-old female patient received first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) at the age of 50-years, via an unspecified route of administration in left arm on 24Feb2021 for COVID-19 immunisation, at workplace clinic. Medical history included breast cancer. No known allergies. No COVID prior vaccination. Patient was not pregnant at time of vaccination. Concomitant medications were not reported. The patient experienced asymptomatic - positive PCR test result on 15Mar2021. No treatment to AE. The patient underwent lab tests and procedures, which included PCR (Nasal Swab) tested positive on 15Mar2021. Outcome of the event was unknown.
Tachycardia Lightheadedness and perioral paresthesia after vaccination; in addition to tachycardia, feeling of "tiredness" not felt prior to vaccination, didn't feel "quite right" Narrative:  Employee seen in ED; most symptoms resolved without intervention. Give a script for diphenhydramine for home use. Does not appear to have been given any medications while in the ED.
Approx 12 hours after receiving injection, around 4am on 12/29/20, I woke up with a low grade fever, chills/sweats, excoriating joint pain and muscle pain, trouble sleeping. This lasted until approx. 4am  on 12/30/20.
Initial case was received from a health care professional on 14 October 2013. A 87 years old patient (gender unknown) had no medical history reported, received a dose of FLUZONE HD (batch number U4783AA). Patient had not reported concomitant medication. It was reported that on 13 October 2013 patient had horrible aches and pains, feels like she is vibrating. Patient took two ES TYLENOL and then took ALEVE (route, site and dose not reported) as a corrective treatment. At the time of report the outcome of event was unknown.
Sore shoulder/back, followed by numbness, paresthesia, and mild pain in left arm, from shoulder to fingertips. Symptoms are intermittent and seem to relate to position & posture but not in any consistent way. Soreness in shoulder sometimes returns, but main symptom now is the intermittent paresthesia. Consulted with primary care MD by video, he prescribed  cyclonenzaprine orally at bedtime to relax muscles, referred physical therapist but haven?t seen them yet.