chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He got the vaccine, and when they administered it on his left shoulder it started bleeding.  The younger girl put a band-aide on it, and walked off and called another girl.  The other girl took over the band-aide and it was saturated with blood but stopped bleeding, but area was swollen.  They then had him wait 30 minutes, and everything was fine, and instructed to put ice on it which he did.  The pain seems to have not gone away yet and it's been over 30 minutes.  At night he feels it more as he relaxes, it's the same pain as it was when he got the vaccine and he can also feel a little knot if he rubs it.  He called employee health and they offered to do an US and gave him our information to call.    This pain goes all the way past his elbow on the left side only.  Sometimes he can feel it on his back, but it's mainly on the shoulder area.
dental work after second dose; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH ABSCESS (dental work after second dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TOOTH ABSCESS (dental work after second dose). At the time of the report, TOOTH ABSCESS (dental work after second dose) outcome was unknown.            No concomitant medication was reported. Treatment Medication includes: Antibiotic for dental work.  Action taken with mRNA-1273 in response to the event was not applicable.
Medical Assistant gave a Fluzone High-Dose injection to 5 year old patient / no AE; Medical Assistant gave a Fluzone High-Dose injection to 5 year old patient/ no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 years old male patient who received 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] Prefilled syringe lot UJ274AB (Expiry date 26-May-2020) via intramuscular route in the right thigh on 01-Nov-2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.   At a time of reporting no adverse event was 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.
Case number PHEH2014US006287 is an initial spontaneous report received from a nurse on 28 Mar 2014. This report refers to a 21-years-old male patient. His medical history and concomitant medications were not reported. The nurse reported that the patient came for Tdap vaccine (other manufacturer, batch number: not reported) and he was inadvertently administered the MenCYW-135 liquid component of MENVEO (batch number: not reported) intramuscularly on an unknown date in Mar 2014. The nurse thought that she was administering Tdap vaccine and did not reconstitute the MENVEO vaccine. No adverse reactions were reported following the maladministration.
Persistent migraine. My headache began about 3 hours after and stayed mild until about 30 hours later where it grew to a migraine. It is not day 8 since the vaccine and it has not gone away.  In addition to the migraine I am experiencing light sensitivity, blurred vision, and yesterday I experienced some heart palpitations. I went to urgent care on 2/8 and was prescribed IC Butalb-Acetamin-Caff for the migraine symptom. In addition I have been taking tylenol and advil which are not helping. My injection site pain and brain fog have resolved while the headache has persisted.
Pt had vaccine 3/30/15. Has had increased muscle weakness, severe elevation of CPK level since weight loss (11 lb wt loss since 3/30/15).
Got first shot of the vaccine and tested positive for COVID-19 20 days after; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jan-2021 and was forwarded to Moderna on 18-Jan-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Got first shot of the vaccine and tested positive for COVID-19 20 days after) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011S20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Got first shot of the vaccine and tested positive for COVID-19 20 days after). At the time of the report, SARS-COV-2 TEST POSITIVE (Got first shot of the vaccine and tested positive for COVID-19 20 days after) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2020, SARS-CoV-2 test: Negative. On 16-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included antibiotics.  The patient was isolated and was awaiting for new laboratory results to consult doctor.
This spontaneous report was received from a pharmacist and refers to 4 unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy was not provided. On 07-OCT-2016, the patients were vaccinated with doses of GARDASIL 9 (dose: 0.5 ml, lot # L043214, expiry date: 30-AUG-2017) and VAQTA (lot # L023936, expiry date: 15-MAR-2017). The pharmacist reported that the vaccines underwent temperature excursion at 28 F for 27 hours (dates were unspecified). No data logger was involved. No adverse effects were reported. Follow up information has been received from the reporting pharmacist on 05-DEC-2016. The pharmacist stated that she did not have any further information. Additional information is not expected as no additional information is available. Sender's Comments: MERCK 1610USA005742: Mfr number.
Pt. received IZ below on 5/16/12. later in evening limp (R) leg. No red/swell/fever. 5/17/12 Refuse to bear wt (R) leg with decreased active. flexion (R) hip w/ internal and external rotation. No red swell. Resolved spontaneously 5/17 AM.
Your jabs do not prevent Covid; Your jabs do not prevent Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Your jabs do not prevent Covid".  Clinical course: It was reported that patient had concerns about their new ad with (Name withheld). A sword for unwanted guests. geared toward the unvaccinated. It was insulting, divisive and threatening. They were inciting violence and Patient was reporting them to one of their representatives. Their jabs did not prevent Covid. Stop the (withheld). They had a president placed from his basement who caused enough division. Lay off the unvaccinated.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt was given adult dose (0.5 ml). It should've been (0.25 ml).
4 days after vaccination, pt began to have pain at the injection site, left arm.  7 days after the vaccination, pt developed redness, swelling at the injection site with pruritis.
Nausea, vomiting, diarrhea, chills, rectal bleeding - all started on the afternoon of March 14, 2021 fairly suddenly around 5:30pm.  Still had some rectal bleeding and nausea on March 15th, contacted my doctor and she said it could be from the vaccine and that maybe the vomiting and diarrhea had burst a internal hemorrhoid and to make an appointment if it continued.  Still had more rectal bleeding on March 18th so contacted my doctor's office and they saw me and did an exam.  They referred me to a colon rectal specialist and I have an appointment with them on March 25th.  My doctor recommended that I report this situation as an adverse event.
Localized injection site reaction. Slight swelling and small red bumps around injection site. Patient applied cold compress and was advised to take an antihistamine. Also advised to follow up with her primary care physician if the rash worsened or any systemic events occurred.
Child developed a rash after )a few hours) receiving the seasonal Flu shot at school. Was given BENADRYL by the school nurse. Went to private Dr after school. Is back in school.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 23rd January 2021) for prophylaxis. On 16th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The patient developed fever and the body temperature was recorded as 103 degree F within 24 hours after receiving a dose of SHINGRIX. The reporter consented to follow up.
Right shoulder sore post 2 weeks vaccine date About 3-4 days post vaccine, an area on lower left leg right above the ankle developed what appeared to be areas of blood vessel bursts under the skin - 5 circular areas developed, the largest was 1/2 inch across.  Spots did not blemish when pressed, meaning, there was no change in color when pressed upon.  2 Physicians inspected area and collaborated and stated they didn't know what it was.  I was given a topical steroid cream and told to return in two weeks if it became worse.  I did not use cream and areas cleared but left a blemish under the skin at 2  weeks post vaccine.
Patient had Covid 19 infection in December. Later had the Pfeizer vaccine. Patient is a well-controlled epileptic. Had 2nd vaccine Feb. 6 and developed status epilepticus.
Upon arriving home: Restlessness, hot/cold sweats, headache, insomnia, nausea.
I have had my antibodies tested 3 times since receiving the vaccine, at week 4, week 8 and 5 months and all have been negative showing NO antibodies to SARS Covid-19.
neighbor could not walk/she was hospitalized; my neighbor experiened the same (as husband) after getting Moderna vaccine/she was hospitalized; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (neighbor could not walk/she was hospitalized) and VACCINATION COMPLICATION (my neighbor experiened the same (as husband) after getting Moderna vaccine/she was hospitalized) in a female patient of an unknown age 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 GAIT DISTURBANCE (neighbor could not walk/she was hospitalized) (seriousness criterion hospitalization) and VACCINATION COMPLICATION (my neighbor experiened the same (as husband) after getting Moderna vaccine/she was hospitalized) (seriousness criterion hospitalization). At the time of the report, GAIT DISTURBANCE (neighbor could not walk/she was hospitalized) and VACCINATION COMPLICATION (my neighbor experiened the same (as husband) after getting Moderna vaccine/she was hospitalized) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  No treatment information was provided.   Case crosslinked with #MOD21-175641.  Limited AE: Reporter did not have information on patient, since it is their neighbor. Reporter said that patient had the same side effects as patient from case #MOD21-175641 (reporter's spouse). Patient is or was hospitalized after receiving Moderna COVID-19 Vaccine. Company comment: This Spontaneous case concerns a female patient of unknown age, with no reported medical history, who experienced the unexpected, serious(hospitalization) events of gait disturbance and vaccination complication. The events occurred after receiving an unknown dose number of mRNA-1273 vaccine on an unknown date. Rechallenge was not applicable, as vaccination date, dose number and events dates are not available. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-175641.; Sender's Comments: This Spontaneous case concerns a female patient of unknown age, with no reported medical history, who experienced the unexpected, serious(hospitalization) events of gait disturbance and vaccination complication. The events occurred after receiving an unknown dose number of mRNA-1273 vaccine on an unknown date. Rechallenge was not applicable, as vaccination date, dose number and events dates are not available. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.
NO ADVERSE EVENTS TO REPORT.  REPORTING THAT DOSE WAS GIVEN TO CHILD UNDER THE APPORVED AGE LIMIT
stomach pain, nausea pain, swelling, redness at injection site fever, chills legs, ankles and feet hurt when walking fatigue
Rash over face and trunk; diffuse papular starting on 12/20/03.  No fever or malaise.
injection site rash; injections site warmth; itching at the injection site; This spontaneous case was reported by an other and describes the occurrence of INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE RASH (injection site rash) and INJECTION SITE WARMTH (injections site warmth) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itching at the injection site). On 26-Jan-2021, the patient experienced INJECTION SITE RASH (injection site rash) and INJECTION SITE WARMTH (injections site warmth). At the time of the report, INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE RASH (injection site rash) and INJECTION SITE WARMTH (injections site warmth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Employee received vaccine at 8:10AM. Slight throat tightness was reported at 8:24AM. Patient given Benadryl suspension 25 mg at 8:26am. Patient then reported throat felt, "a little better". Vital signs BP=189/88; P=90; Oxygen saturation 97% room air; Temp 97.3. At 8:30 patient reports throat feels "worst". Pt. noted to have bumps on tongue - 1 size of chick pea and smaller bumps on back of tongue. Oxygen sats 91%. Epi pen administered at 8:37am and EMS called. 8:45 SAFD on site.BP = 207/81; P=110;oxygen sat = 100% room air. 8:41 Bumps on tongue decreased in size. Oxygen sats 99% room air.  8:52 Paramedics arrive and patient taken to hospital.
Waking up at 4:30 AM I went to urinate. Feeling weak I started to slouch and have trouble standing while urinating. Upon returning to my room I fainted. I suddenly lost consciousness and fell on my clothes/bed. I drank about 1.5 liters of water and felt better after about 15 minutes.
Patient received the vaccine with no history of allergic reaction or fainting .   Approximately 7 minutes after receiving the vaccine and moving to a chair the patient stood up to tell pharmacist he wasn't feeling well.  He began to faint and fell to the floor in a seated position.   Patient looked very white and he said his heart was racing and his body felt cold all over and he felt nauseous .  After observing him for about another 20 minutes he began to feel better and was able to then leave the pharmacy on his own.  He had his vitals checked by EMT and all was fine.
Syncope after receiving vaccines. Approximately 5 min. after receiving vaccines, while waiting in exam room, patient was observed sitting on exam table and looking pale and feeling nauseated. RN used ammonia inhalant on patient. Patient responded by verbalizing that she felt better. Patient remained in room lying down with father for additional 15 minutes.
I had severe chest pain it was short in duration, I was checked out by a local clinic . The tests ran were an EKG and a stress test.
15AUG95 chicken pox lesion on scalp, map of neck then trunkal spread to legs; itchy & fever; around neck area red-secondary cellulitis; 21AUG95 started keflex x 10d; came back to ofc 6SEP95 w/area still itch & red dry
SORE FEELING; FEVER; EXHAUSTED FEELING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sore feeling, fever, and exhausted feeling. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, exhausted feeling and sore feeling was not reported. This report was non-serious.
She was admitted as above.  She was severely encephalopathic throughout her hospital stay.  She often refused food and therapies.  She was maintained on hemodialysis.  Because of her developing malnutrition from lack of oral intake, she developed a severe sacral decubitus ulcer with necrotic and infected tissue and bacteremia.  Efforts to prevent this were unsuccessful as the patient steadfastly refused to allow a feeding tube and refused to take more nutrition.  She was seen by Dr. and taken to the operating room for debridement.  Unfortunately, she remained poorly responsive.  I discussed extensively with her sons over the last few hospital days.  They agreed that she would not want heroic measures to keep her alive.  She deteriorated further with an episode of ventricular tachycardia, and the family decided to pursue comfort measures only.  She passed away peacefully.
On 3/11/03, she stayed home form work due to flu-like symptoms, nausea, vomiting, GI-complaints. She said others in her househould also had flu-like symptoms.  Initially, they thought she had a "regular take", but then some cellulitis was observed around it; it was red and swollen for a couple of days. She again missed some work (a day or two) due to flu-like symptoms around 3/18/2003.  4/11/03 received phone call from physician stating patient had received the smallpox vaccine and was one week pregnant, but did not know she was pregnant, per physician report. Last menstrual period was 3/4/03. Pt. estimates she is 3.5-4 weeks pregnant.
Narrative:  She has a PMH significant for migraines and developed a migraine a/w nausea/vomiting about 5-6 hours after the initial injection. The issues  persisted for about another 2x days prior to resolving. While she is on maintenance rx for migraines, she did not take any abortive rx as she was unsure if this was ok in the setting of vaccination. She went to see her private PCP last week and was provided with the advice to take her maintenance rx prior to vaccination. Discussed common side effects of COVID vaccination and discussed when to week care. Noted that this vaccination has triggered migraines for others.  Reviewed taking currently prescribed abortive rx and potentially already prescribed anti-nausea rx and when to take depending on how she does after this vaccination.
headache; muscle pain; joint pain; chills; nausea; fever(100.8); headache; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced the first episode of HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever(100.8)) and the second episode of HEADACHE (headache). The patient was treated with IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (MOTRIN COLD & FLU) for Adverse event, at a dose of UNK dosage form. On 20-Feb-2021, MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever(100.8)) and the last episode of HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.
This literature marketed report was received from the authors of a published article, and refers to a 23-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patient was vaccinated with a full series of ROTATEQ, orally (dose, lot # and expiration date were not reported). On an unknown date during 2014-2015 season, the patient experienced apparent vaccine failure and was infected with rotavirus. The outcome of the event was not reported. The authors considered the event to be related to ROTATEQ. This is one of two reports derived from the same literature article (cross-referenced in US-009507513-1801USA005735).
This spontaneous report was received from a nurse referring to a 6 month old patient (gender unspecified). No pertinent medical history and concurrent conditions reported. On 26-JUN-2014 the patient was vaccinated with PEDVAXHIB does 3, intramuscular (dose not reported). The patient received the first dose of PEDVAXHIB in February 2014 (reported as at 2 months of age) and second dose in April 2014 (reported as 4 months of age). No other concomitant therapies reported. No adverse effect reported. The outcome of the events was unknown. No PQC reported.
Redness and swelling around injection site. Mother reports pt began having redness and swelling within one hour of injection. When pt came in for appointment today, mother reported reaction. There was still redness and swelling noted to the injection site.