chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient hip where injection was given had large swollen rounded area that was red. In the middle was a yellowish circle, DR cared for patient. KEFLEX 500 mg PO three times daily for 7 days, Ibuprofen and Hydrocodone/acetaminophen 7.5/325 for pain given every 6 hours, ten tablets given.
CALLED TO NAU C/O SOB ADVISED TO CALL 911. HPV INJ #2 STATES COUGHING Q 30-60SEC 1 HOURS AFTER INJ, C/O VERTIGO, STATES FEELS LIKE THROAT CLOSING
The pt experienced frequent falling, loss of balance for a 2-3 day period. The child has been walking since 10 months, this was a change. He need to hold on to the wall for support. The pt experienced ataxia. Symptoms are resolving.
This spontaneous report was received from a physician refers to a 13 year old male patient. On an unknown date, the patient was vaccinated with 2 doses of GARDASIL (dose and route were not reported) prior to receiving GARDASIL 0.5 ml, intramuscularly on Monday evening 11-MAY-2015 as the third dose in his HPV vaccination series. On 11-MAY-2015 when the patient received the dose of GARDASIL the injection was painful. On 13-MAY-2015 the patient experienced injection site erythema, and injection site warms and injection site swollen to the size of a golf ball. Treatment was not given to the patient. Patient did not sought medical attention. At the time of report, the patient was fine. Action taken was not applicable. The outcome of events was reported as recovered/resolved. The reporter did not provide the causality between the event and the suspect therapy.  This is one of two reports from the same source. Additional information has been requested.
Patient reported a 2 inch area surrounding injection that is pink and slightly swollen. "Like a small raised knot".  She reports it is sore and slightly warm to the touch. She stated she had a slight headache the evening following the injection, but it was relieved with acetaminophen.
Change in patient's condition; Passed away; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (Passed away) and ADVERSE EVENT (Change in patient's condition) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced ADVERSE EVENT (Change in patient's condition) (seriousness criterion hospitalization). The patient died on 06-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ADVERSE EVENT (Change in patient's condition) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.  Very limited information regarding these events has been provided at this time.  Further information has been requested; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested; Reported Cause(s) of Death: Unknown cause of death
Information has been received from a nurse practitioner referring to a 60 years old male patient. The patient had no pre-existing physician-diagnosed allergies, birth defects or medical conditions and no illness at time of vaccination. The patient (or his brother) had no adverse event following a prior vaccination. The patient had no other vaccinations within 4 weeks prior to 07-NOV-2017 was received. Concomitant therapies included omega-3 marine triglycerides (reported as fish oil) and vitamins (unspecified). On 07-NOV-2017 about 15:00, the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose was not provided, lot # M026317, expiration date not provided, system auto-generated as 11-JAN-2018) intramuscularly in the left deltoid for prophylaxis. The vaccination was given at the patient's employer. On 07-NOV-2017 18:00, the patient felt pain in upper arm and shoulder. The reported arm felt very stiff and he was having difficulty moving it. The patient stated "it feels like my rotator cuff surgery" and "I couldn't sleep". The patient was having 8 out of 10 level pain while moving his arm and his arm didn't hurt when it was not moving. The patient's injection site area looked fine. The events were resolved in 48 hours (approximately on 09-NOV-2017) with ice/heat and ADVIL which was an over-the-counter drug (OTC). No prescription drug treatment for the experience was required. The patient sought medical attention via contacting nurse practitioner. The causality was not provided. No product quality complaint (PQC) was involved.
Lethargy, slight cough, sinus drainage, slight fever (98.5, when I normally run 96.8)
tired; mildly sore arm; This is a spontaneous report from a contactable nurse (patient). The 73-years-old female patient received  bnt162b2 (BNT162B2, lot number: EL3302, Expiry Date: 31May2021) via an unspecified route of administration in Left arm on 21Jan2021 10:45 at SINGLE DOSE to gain immunity against Covid-19. Medical history included asthma well controlled Diagnosed 6 years ago. No Prior Vaccinations within 4 weeks. There were no concomitant medications. The patient experienced mildly sore arm on 21Jan2021, tired on an unspecified date. The AEs did not require a visit to emergency room or physician office. The outcome of the event mildly sore arm was recovering.  No follow-up attempts possible. No further information expected.
Very difficult time concentrating at work; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 17Mar2021 at 09:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications were not reported. 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 vaccination. On 23Mar2021 the patient experienced a very difficult time concentrating at work the week after receiving the first dose of the vaccine. The patient did not receive any treatment for the event. The clinical outcome of the event poor concentration was resolving at the time of reporting.  No follow-up attempts are needed. No further information is expected.
ok directly after...about 1800 on the 12th...started to experience chills, body aches, lethargy, low grade fever and injection site pain(to be expected)
Within 15 minutes I noticed my lips feeling different.  When I got to my car and took off my mask is when I found out my lips were swollen.  Returned to the pharmacy and spoke with the pharmacist.  She advised to take a Benadryl and go to the ER if it continued to get worse.  Came home and called Nurse Line for advice.  The nurse advised to go to the ER.  I did some research online and based on what I read, I decided to take a Pepcid AC along with a Benadryl and monitor the situation as I was not having any trouble breathing or swallowing.  (I do not like to go to the ER unless it's absolutely necessary.) As of five and a half hours later, there'b been no progression of the allergic reaction.
Right axillary swelling, pain and warmth, redness at the injection site. Treatment: Tylenol, heat. Outcome: Able to move extremity with difficulty. Able to complete ADLs with out difficulty . No improvement with treatment.  Will continue to monitor.
Headaches; Nausea; soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EL3248) via an unspecified route of administration in the left arm on 09Feb2021 at 07:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. The patient relevant medical history and concomitant medication were not reported. The patient previously took historical vaccine, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3248) in the left arm on 19Jan2021 at 07:00 for COVID-19 immunisation. The patient did not have any allergies to medications, food, or other products. 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 vaccination. The patient experienced headaches, nausea, soreness at injection site on 09Feb2021 at 20:00. The patient did not receive any treatment for the events. The events were reported as non-serious by the reporter. The outcome of the events headaches, nausea, soreness at injection site was recovered on an unknown date in Feb2021.
Right arm swelling, erythema, tenderness, 3" diameter.  Placed on warm compound for cellulitis.
Within one hour or vaccinations, pt's arms began it get pruritic. She noticed the skin on her arms, neck and ears got red and pruritic.
18 y.o. female with a penicillin allergy received Moderna COVID vaccine at a distribution site. After 40 minutes began to develop to develop pruritus, flushing of the face, and started hyperventilating. Nurses laid her on her back and elevated her legs. Her pulse was 200 and 0.5 mg of epinephrine IM was administrated to her thigh. She began to feel better and was transported by EMS.
Arm was sore by 5 pm, Took 1 Advil and took a nap, Woke up very upset at 6:30 saying she felt like she was "hallucinating". She was crying and said that her sight and brain didn't feel "connected" & felt disoriented. This lasted a couple of hours slowly getting better. She ate a little & had fluids and eventually went to bed about 11 pm. She was still a little woozy but then was fine. This was reported to the nurse the next day 08/28/02
pt called monday 9/27/21 stating he was admitted to the hospital over the weekend and diagnosed with myocarditis and stayed for 2 nights.
A couple of days after I got the second dose of Pfizer, my heart beat fast (about 120-130 beats per minute resting). I saw a heart doctor. I also ended up in emergency room. No treatment was received.
Numbness right hand immediately after injection for a few seconds, next am inability to move left arm without pain or numbness, had to lift arm, next day motion returned but still sore lateral superior deltoid/subacromial area now worse with abduction and rotation on 9-28-2021 at time of assessment.  Had initial sweating and nausea resolved within 1 day.  Also had typical allergic reaction the next am of swollen eyes, rash around face, upper anterior chest hands and scalp.  This is her typical reaction to her other allergens.  That has resolved by 9-28-2021.  Likely post injection bursitis as it sounds like injection was quite high as well.  This is the only issue remaining.
Left arm swelling, erythema, and warmth. Spreading to entire upper arm within 24hours of vaccine. Treated with oral prednisone. Resolved over 3 days after oral medication.
left arm and chin were so itchy; left arm and chin were so itchy and was all red; left arm and chin were so itchy and was all red and bumps; dizzy spells; headache; pharmacist pricked but then had to take it out and do it again so patient was pricked twice; did not feel like herself and had a weird feeling; very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of INJURY ASSOCIATED WITH DEVICE (pharmacist pricked but then had to take it out and do it again so patient was pricked twice), FEELING ABNORMAL (did not feel like herself and had a weird feeling), DIZZINESS (dizzy spells), PRURITUS (left arm and chin were so itchy) and ERYTHEMA (left arm and chin were so itchy and was all red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PROGESTERONE, LORAZEPAM and FISH OIL for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced INJURY ASSOCIATED WITH DEVICE (pharmacist pricked but then had to take it out and do it again so patient was pricked twice), FEELING ABNORMAL (did not feel like herself and had a weird feeling) and FATIGUE (very fatigued). On 30-Jan-2021, the patient experienced DIZZINESS (dizzy spells) and HEADACHE (headache). On 01-Feb-2021, the patient experienced PRURITUS (left arm and chin were so itchy), ERYTHEMA (left arm and chin were so itchy and was all red) and PAPULE (left arm and chin were so itchy and was all red and bumps). The patient was treated with PARACETAMOL (TYLENOL) on 30-Jan-2021 for Headache, at an unspecified dose and frequency and COCONUT OIL on 01-Feb-2021 for Pruritus, at an unspecified dose and frequency. On 23-Jan-2021, INJURY ASSOCIATED WITH DEVICE (pharmacist pricked but then had to take it out and do it again so patient was pricked twice), FEELING ABNORMAL (did not feel like herself and had a weird feeling) and FATIGUE (very fatigued) had resolved. On 31-Jan-2021, DIZZINESS (dizzy spells) and HEADACHE (headache) had resolved. On 02-Feb-2021, PRURITUS (left arm and chin were so itchy) had resolved. At the time of the report, ERYTHEMA (left arm and chin were so itchy and was all red) and PAPULE (left arm and chin were so itchy and was all red and bumps) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for himself/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles.  The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for shingles were not provided.
Itched at site immediately. Itching,redness,,swelling and heat still after three days. (Area of about a 3 inch circle )
reporter stated that 3 days p/vax rt deltoid became weak & w/in 1wk abscess on rt axilla;MD feels that this was secondary to bacteremia introduced by the flu shot;pt was treated w/ATB & doing fine;
Day #1 after shot started limping, mom noticed swelling at the side.  Day #2, severe swelling 18x10cm of anterolateral thigh right induration of 10x8cm hard and tender, that extended to the patellar region.  Pt active, afebrile.  Temperature: 98.8F.
Extreme drowsiness within 2 hours. Fever and extreme cold chills within 4 hours. Peak fever was 103. The following day around 5 am I started puking from my headache. Headache was an 8/10 on the pain scale. I could not keep any food or water down for more than 15 minutes. I puked all day and afternoon. I was able to eat by 7pm the first day after injection. Fever was still 99-101. I slept most of day one away. The second day my fever was 99 in the morning by the after noon. fever broke and could keep all water and food down. Almost exactly 48hrs later felt great and back to normal with no fever or symptoms.
Had a bout of vertigo; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (Had a bout of vertigo) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 011F21A, 030A21A and 039K20A) for COVID-19 prophylaxis.     The patient never had COVID positive test or diagnosis.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Toradol) and Blood pressure high (controlled by medication.).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VERTIGO (Had a bout of vertigo). At the time of the report, VERTIGO (Had a bout of vertigo) outcome was unknown.      No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2022-654745 (Patient Link).
Evening of inoculation developed significant arm pain at site of injection, fatigue, muscles aches, fever of 100 degrees, lymphadenopathy in groin. Next day had increasing fatigue, persistent fever, chilly. Then improved over 24 hours.
Dizziness; Bone pain; Fever; Headache; barely able to walk; terrible pain in the arm; tired; sleepy; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that:  A 44-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0161), via an unspecified route of administration, administered in Arm Right on 24Apr2021 09:00 (At the age of 44 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included intervertebral dislocated disc and migraine from an unknown date and unknown if ongoing. Patient was allergies to Sulfa and Bactrim when queried for Lot number of bactrim, they found out she was allergic to bactrim at 16 years old, her face was like burned with water blisters in the face, that was almost 30 years ago. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient's concomitant medication no because she is not taking medication, she is taking Tylenol. Patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8737), via an unspecified route of administration, administered in Arm Right on 03Apr2021 (At the age of 44 years) as DOSE 1, SINGLE for covid-19 immunisation. Patient had no issues with vaccine in the past, every year she gets the flu vaccine when it is cold season and has no problems. On the evening of 24Apr2021, patient was feeling terrible pain in the arm, tired, sleepy. On25Apr2021, the patient had experienced fever, bone pain, headache, dizziness, patient basically wasn't able to move, till yesterday, before yesterday she was barely able to walk with even little tasks, she was barely able to walk. Treatment Tylenol. Yesterday she started to take Motrin.On29Apr2021, the outcome of the event fever was recovered. At the time of reporting, the events bone pain, dizziness and barely able to walk were resolving, event headache was not recovered whereas the outcome of the events terrible pain in the arm, tired and sleepy were unknown.  No follow-up attempts are needed. No further information is expected.
Patient presented with dizziness, feeling feverish/chills, shortness of breath and chest tightness
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flublok (First dose given through Intramuscular route in Right Deltoid with Batch no: QFAA2127). Past adverse reactions to the above products included No adverse event with Flublok.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  On 16-Dec-2021 vial was initially stored in the refrigerator. 5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15-Jan-2022. Patient was notified of the error and patient denied adverse effects.  Treatment information was not provided.
Ruptured membrane occurred at 6:30PM on 07OCT2021. Labor began around 9:00PM on 07OCT2021. Premature baby born at 6:38AM on 08OCT2021 at 34 weeks and 4 days.  Original due date was 15NOV 2021. Premature baby admitted to NICU for undetermined length of stay to promote growth. Mother discharged 48 hours following delivery.
FLU LIKE SYMPTOMS, FEVER, ACHES, CHILLS, DIZZINESS, LIGHTHEADEDNESS, AND THEN ON 4/14/2010 AM A RED RASH ANTERIOR AND DISTAL TO THE SITE OF THE ANTHRAX VACCINATION, UPPER ANT ARM
Approximately 15-20 minutes after tetanus shot. Donor stated that she was not feeling well prior to tetanus shot, but did not disclose this to staff or report this to MSA before tetanus shot was administered. Donor experienced lightheadedness/dizziness, nausea/vomiting, and was pale and sweaty. Donor sat on the floor to prevent a fall due to dizziness. Donor stated she was not feeling well prior to vaccine and that she has been having similar reactions to donating recently donor disclosed that after a previous donation she passed out at home. Donor provided 12 oz of oral electrolyte fluids
Patient stated she became flushed after injection. She developed abdominal cramps, diarrhea, and dizziness. Throughout the evening into the next day the patient developed nausea, vomiting, fever, malaise. She stated she is now experiencing itching (generalized and a raised rash). Referred to her family physician. Patient states she had a problem with the flu shot in the past.