chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SEVERE BACK PAIN; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced severe back pain. On APR-2021, the subject experienced sore arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe back pain and sore arm at injection site was not reported. This report was non-serious.
This spontaneous report as received from a nurse refers to a 80 year old patient. Medical history and concurrent conditions were not reported. On 31-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Patient previously had a dose of Covid 19 vaccine. The patient does not speak English, the son signed the consent form as well. Another family member heard they received today's dose and then said that the patient already had it, unfortunately after the dose was given.
Back pain radiating down to the L buttocks, down the L leg and ending at the ankle.; Back pain radiating down to the L buttocks, down the L leg and ending at the ankle.  Rating 5/10 pain.; Back pain radiating down to the L buttocks, down the L leg and ending at the ankle.; Back pain radiating down to the L buttocks, down the L leg and ending at the ankle.; Back pain radiating down to the L buttocks, down the L leg and ending at the ankle.; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscular on right arm on 19Dec2020 10:00 AM, single dose for COVID-19 immunization at 29-year-old. Medical history included: COVID-19 diagnosed prior to vaccination. No known allergies. Concomitant medications included: drospirenone, ethinylestradiol betadex clathrate (YAZ); ibuprofen; cetirizine hydrochloride (ZYRTEC); diphenhydramine hydrochloride (BENADRYL); melatonin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Dec2020, 10:00 AM, the patient experienced back pain radiating down to the L buttocks, down the L leg and ending at the ankle, rating 5/10 pain. No treatment received for the adverse events. Lab data included: COVID-19 (positive) diagnosed prior to vaccination; pain 5/10 on 20Dec2020. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. It was reported as non-serious.
12-31-14 HAD LUMP IM THROAT; 1-2-15 EARS FILLED UP AND TUBES KEPT DRAINING; 1-4-15 EYES BURNING AND RED; NO LOCAL REACTION.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU (flu shot).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was stated that But I get the headache & soreness with the flu shot, too. I have to get the regular dose, because of the side effects.  No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2021-367618.
swelling and painful at injection site within first 24hrs in left arm. Red, itchy raised rash after 7 days post injection that increased in area. Burning sensation experienced. Skin still discolored more than 20 days after 1st shot. 2nd dose in right arm: same reaction within 48hrs. redness, burning , itchiness sensation spreading to upper arm.
headache; fever; can't move her arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever) and LIMB DISCOMFORT (can't move her arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included normal medications for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (headache), PYREXIA (fever) and LIMB DISCOMFORT (can't move her arm). At the time of the report, HEADACHE (headache), PYREXIA (fever) and LIMB DISCOMFORT (can't move her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Tylenol
Flushing, redness, faintness, administered EPIPEN and called paramedics.
woke up feeling hungover or flu like, heart rate at resting reached 130 over a 15 min span staying over 125 for a total of 15 min.  My husband was a paramedic so we stayed home and he monitored me and my heart rate. by the 5th I woke up feeling 110% better.
Patient is a 38-year-old female past medical history significant for anxiety, asthma presents today due to concern for stroke-like symptoms.  Patient works at hospital, went down and had flu shot earlier all of a sudden had sudden onset of right-sided painless vision loss.  Last known normal around 14 16.  Also states she feels very dizzy like the room is spinning around her, very nauseous has not vomited.  Denies having any numbness, tingling or weakness anywhere.  No facial droop or slurring.  Blood glucose was 130s, systolic blood pressures in the 150s.  Patient states otherwise she feels fine other than this dizziness and vision loss.  Has never had anything like this before.
Patient arrived for 2nd dose of Pfizer Covid 19 vaccine but did not return with his vaccination card.  Registration staff looked up 1st dose information and wrote Pfizer and the lot number on line 1 which created a new card for him.  Then, inadvertently placed a Moderna sticker on the card to send back to the nurses for administration.  Nurses at vaccine table verified patient and stated they would be administering moderna but no rejections were made from patient and nurse continue with administration.  Patient was in our recovery area when another staff member let me know of the error and I immediately went to check on him for any adverse reactions and explained the situation to him.  Patient was apologetic for the mistake of not bringing his card.  I made patient aware this was not his fault and that staffing should have caught the mishap.  I explained to him that he would need to wait 30min and I would contact my site provider for instruction and call if follow up was needed.  Obtained name, DOB and phone number.  Patient left the area with no complaints and no adverse signs or symptoms.  Once I spoke with site provider, I was instructed to let the patient know he did not need a repeat vaccination at this time.   I then called patient and made aware no further action needed at this time.  Instructed patient to call his primary care physician if any symptoms arose post vaccination or with any questions/concerns may contact our vaccine area.
Less than 24 hours, post vax, pt had a low-grade fever, crying fits and less arm movement. Brought to MD. Parents reassured but cautioned to call MD if symptoms persists. Contacted mom the next day and child is ok; no more fever.
21MAR91 pt vax;  devel itchy rash on hand, swelling, & fatigue on Mar25.  02Apr91 pt had itchy rash when scratched devel hive-like appearance.
Sore left arm 10-28-09. Cough, headache, fever 101, 104, to 105 degrees 11-2-09. Taken to ER 11-3-09 prescribed TAMIFLU q 12 hour. Tested + for INFLUENZA A
Tested positive for Covid 19.  Symptoms include coughing, runny nose, body aches and getting hot and cold.  Delivery date is in March 2022.
SOB; malaise; Chest tightness; blurred vision; poor circulation in hand and feet; headache; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (SOB), MALAISE (malaise), CHEST DISCOMFORT (Chest tightness), VISION BLURRED (blurred vision) and POOR PERIPHERAL CIRCULATION (poor circulation in hand and feet) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (SOB), MALAISE (malaise), CHEST DISCOMFORT (Chest tightness), VISION BLURRED (blurred vision), POOR PERIPHERAL CIRCULATION (poor circulation in hand and feet) and HEADACHE (headache). The patient was treated with IBUPROFEN at a dose of 200 milligram every eight hours. At the time of the report, DYSPNOEA (SOB), MALAISE (malaise), CHEST DISCOMFORT (Chest tightness), VISION BLURRED (blurred vision), POOR PERIPHERAL CIRCULATION (poor circulation in hand and feet) and HEADACHE (headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Patient was  tested positive for COVID-19 around two months prior to vaccine..     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.   Concomitant product use was not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
I contracted COVID-19 on 06/17/2022 with symptoms of congestion, cough, slight fever, weakness, fatigue, sore throat, headache, diarrhea, chills and myalgia, I was prescribed Paxlovid and Benzonatate on 06/18/2022. My symptoms began to resolve 06/21/22 and are still improving at this point. The sinus congestion and diarrhea have not began to resolve as of today, which is day 6 of illness.
PAINLESS NODULE (HARDENING UNDER THE SKIN) AT INJECTION SITE; DID NOT APPEAR UNTIL 30 DAYS AFTER TIME OF INJECTION; PATIENT HAS NO OTHER COMPLAINTS
Narrative:  Patient received Moderna Covid dose #1 vaccine 3/6/21 and then reported hemoptysis/fever/malaise on 3/16- 10 days after dose. Patient presented to urgent care, covid test was negative. They referred him to ER, patient was treated with doxycycline, diagnosis of pneumonia in the left lung. Unlikely the two events are related.
about 1 hr p/getting Hep B vax devel muscle tension, n/v, diarrhea on Wednesday & passed out x 2; had very dark brown urine; feeling fine as of 15JAN93; states arm only sl sore;
My heart went  into A-fib, rapid irregular heart beat and racing pulse (132) started 5 hours after shot.  Called Cardiologist next day about 1:30 pm  after taking morning daily medicine did not relieve the symptoms.  Dr advised to double my Metoprolol med and if that did not help to go to the emergency room.. About 2 hours later my A-fit symptoms stopped and my pulse was back to normal.
Patient has experienced radiating pain down her arm x 15 days in arm received flu shot in she says it hurts to put weight on it. No redness or inflammation. She has been taking acetaminophen and ibuprofen around the clock.
sore arm; tired; Didn't feel good; run a 103 fever; This case has been considered invalid initially upon follow up information case was processed as valid file  This is a spontaneous report from a contactable other health care professional (patient herself) via medical information team.  A 77-year-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3249), via intramuscularly, administered in Left arm on 20Jan2021 02:15 PM (at the age of 77-year-old) as dose 1, single for COVID-19 immunization. Medical history included covid-19 from 09Dec2020 to Jan2021. The patient's concomitant medications were not reported. On 21Jan2021, the patient experienced sore arm, tired, didn't feel good, run a 103 fever. The patient underwent lab tests and procedures which included covid-19 resulted as positive on 09Dec2020, covid-19 pneumonia resulted as positive on 21Dec2020, covid-19 pneumonia resulted as positive on 24Dec2020. It went away in a couple of hours on its own. Clinical outcome of the event was reported as recovered on unspecified date Jan2021 events went away in a couple of hours on its own.  No follow-up attempts are needed. No further information is expected
This spontaneous report was received from a registered nurse referring to a 21 years old female patient. Information about concurrent condition, concomitant medication and medical history was not provided. On 09-NOV-2018, the patient was vaccinated with the first dose of RECOMBIVAX HB on the right deltoid(lot# reported as U5980DA, dose detail and expiration date were not reported) intramuscularly for prophylaxis. On 10-DEC-2018, the patient was vaccinated with the second dose of RECOMBIVAX HB (therapy type: thimerosal free) 10 microgram /1 milliliter (lot #: M037019, expiration date: 04-NOV-2018, 1 milliliter, once) intramuscularly on the left deltoid  for prophylaxis (expired product administered). No adverse event was reported. The data from Manufacture indicated vaccines was still potent, so the physician decided to not repeat vaccination and order patient to return in one month for final vaccination.
injection site is a little itchy; Upset stomach; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th December 2022, the patient received Shingrix (intramuscular). On 30th December 2022, 1 days after receiving Shingrix, the patient experienced injection site itching, upset stomach and headache. On an unknown date, the outcome of the injection site itching, upset stomach and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, upset stomach and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-Jan-2023  Reporter's Comments: The patient would contacted to healthcare professional.  The reporter did not consent to follow up. Note: As per clarification the route of administration was considered as intramuscular.
heart palpitations; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162be (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Mar2021 at 12:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse. Patient had allergies to medications, food or other products but it was not specified in the source report. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Allegra, Flonase, Melatonin, Yaz and Benedryl all for unknown indications from unknown dates and unknown if ongoing. Vaccine was administered in a Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 16Mar2021, at 13.30 hrs the patient experienced heart palpitations. The patient did not receive any treatment for the event heart palpitations. The clinical outcome heart palpitations was resolved on an unknown date.   Information about lot number cannot be obtained. No further information is expected.
Day 2- started out fine, at 9am got bad headache, then started feeling very tired and dizzy, layed down woke up around 1pm started feeling nauseated ran a fever, stomach was hurting (whole abdomen) had diarrhea had no appetite could not even eat more than 1 bite of a dry bagel.  Was so tired couldn't do anything but sleep.   Day 3- same symptoms as above but no fever, stomach a little better.  Finally at 8pm ate a banana and husband made me eggs.  Took until almost 10pm to eat eggs.   Day 4- felt much better but still tired and a little weak but was able to walk around house a little and had yogurt for lunch and was able to eat a regular dinner.
Chills, Malaise, injection site pain discomfort right under arm. Narrative:
She got the vaccine, had no issues other than regular symptoms.  The following day had a temp of 100, tired, and was achy and fine by that Monday.  On 3/9/21 she developed goose bumps all over her body, even her face, and then had freezing chills that lasted every day around 5:00 PM and lasted for hours for weeks and weeks.  To this date she is still getting a weird sensation like a shiver and goosebumps multiple times a day, every day.   She has had a woozy feeling, not real stable feeling at times.  She has seen her PCP, and also has had multiple telehealth appointments including an infectious disease provider who said he reported it to the CDC.  Because of the fainting the night before the vaccine, she had to have an echocardiogram that was normal, an MRI of the brain/neck to make sure she did not have an injury when she fell and is scheduled for an EEG tomorrow.  If everything continues to be normal then the reactions are related to the vaccine.
Cold sores on lips and stinging raised welt on left side of shoulder/ neck area. Prescribed Valacyclovir HCL 1 Gram 3 times a day for 7 days Via online care from Dr. through HCF Website. Feeling better now and cold sores cleared up.
I got Jonson and Jonson vaccine on 4/8/2021 . I was fine after that and suddenly on 4/13 /2021 I had cramping in my both leg and foot whole day. At night I woke up from deep sleep and started crying that my leg  was hurting badly and felt like something was stuck in my knee couldn?t  move for couple min.  5 min later I got up to take pain medicine and try to walk  and  I was able to walk after that so went to use bathroom ( to urinate) while I got up.   After that since I had pain in my leg earlier  I went to grab  pain medicine than again I started crying and saying I don?t feel good than I passed out completely and was unconscious.   My husband picked me up and brought me to bed and said I had black out and fell on my face  on floor .
Patient came in on 6/24/2022 for his 2nd booster vaccine which should have been a partial dose of 0.25 mg, instead patient received the full dose 0.5 mg. Quickly after discovery, I called patient around 4:30 p.m. to make aware of the incident. Made aware symptoms may intensify or may not have symptoms at all. Made him aware if any severe go straight to ER. Patient stated at the time, he had only a sore arm. Called patient back on monday to see how they were doing and patient stated he felt great and had no other side effect other than the sore arm.
Experiencing tingling; Partial numbness all over my body; Dizziness; Having difficulties focusing up close with my eyes; This is a spontaneous report from a contactable consumer or other non hcp.  A 35-year-old female non-Pregnant patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 01Jun2021 13:00 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included covid-19. There were no concomitant medications. The patient was not pregnant at the time of vaccination. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm left (Batch/Lot Number was unknown) as single dose for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported on 03Jul2021 02:30, about a month after receiving her second dose, she was experienced tingling and partial numbness all over my body. It started in just my arms and legs, had three MRIs and a spinal tap, all our normal. She had dizziness. Also sometimes having difficulties focusing up close with my eyes. Main symptoms are the partial numbness and dizziness. The outcome of the events was not recovered. No treatment was received before, and patient was not hospitalized. The patient underwent lab tests and procedures which included lumbar puncture: normal in 2021, magnetic resonance imaging: normal on 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Patient was in the passenger seat with a male driver. Patient stated "no" when asked if any medical issues. Stated "no" when asked if had any adverse reactions in the past to vaccinations. Vaccine administered, pt within seconds lost consciousness. Few seconds later pt had a seizure. 911 called. Help called for pt to be moved to cot. Pt started coming to and feeling better. Male driver later stated something to the effect of "this happens to her every time". BP 110/60. HR 78. SPO2 96%