chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain and soreness in left underarm; Vaccine was administered in the left leg; This is a spontaneous report from a contactable consumer, the patient.  A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left leg on 05Mar2021 at 11:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer diagnosis (right breast), lumpectomy in Mar2020 and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medication included tamoxifen (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 07Mar2021 at 11:45, 48 hours after the vaccination (also reported on 08Mar2021 at 16:00), the patient began to experience pain and soreness in left underarm. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain and soreness in left underarm was recovered on an unknown date in Mar2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Swelling in (L) arm - site of where vaccine was placed; (+) swelling; (+) tenderness; (-) warmth; (-) induration; erythema.
Not enough sterile diluent was added to the pfizer vial prior to administration of the booster. It is likely that not enough  was administered to the patient in order to qualify as a booster.
This spontaneous report as received from a licensed practical nurse refers to an approximately 12-year old female patient with no pertinent medical history and drug reactions/allergies. On 08-AUG-2012, the patient was vaccinated with dose 1 of 0.5 milliliter (ml) GARDASIL (lot number and expiry date were not reported) intramuscularly. No concomitant medications were reported. Approximately on 22-AUG-2012 (reported as 2 weeks after vaccination) the patient developed plantar warts. Warts were not cultured and no lab diagnostic studies were performed. The patient sought medical attention for the events by calling the physician. No treatment was given. The outcome of the event was unknown at the time of this report. Additional information has been requested.
Patient received first of 2 low-dose flu vaccines (all that was left by this time in the season) January 27 in the clinic.  He's had flu shots before and tolerated well.  He came back as follow up on 3/6/23 with plan to get the 2nd dose however he reported that 2 days after he'd received the vaccine he had profound hypoxia which he was unable to correct for using the oxygen concentrator.  His oxygen saturations were in the 70s and 80s for a month.  He has slowly recovered but wanted to report his possible adverse reaction and wasn't sure if he should get the second dose.  We advised him not to.  Of note he has end-stage severe COPD and uses O2 24/7; this was just a profound worsening that was unexpected by patient.
positive Covid-19 test; sore throat; ear ache; swollen lymph node in neck; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), EAR PAIN (ear ache), LYMPHADENOPATHY (swollen lymph node in neck) and COVID-19 (positive Covid-19 test) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 06-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), EAR PAIN (ear ache) and LYMPHADENOPATHY (swollen lymph node in neck).   On 07-Mar-2021, the patient experienced COVID-19 (positive Covid-19 test). At the time of the report, OROPHARYNGEAL PAIN (sore throat), EAR PAIN (ear ache), LYMPHADENOPATHY (swollen lymph node in neck) and COVID-19 (positive Covid-19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, SARS-CoV-2 test positive: positive (Positive) Positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported. No treatment information was provided.
Flu-like sx for 2.5 days (achy, chills, sweats), rash, itching and swelling at and around injection site.  Took Tylenol every 6 hours which helped.  No fever.
Patient fainted after FLUVIRIN (R) was administered, most likely due to low sugars (hypoglycemia) since patient only one egg to eat all day (and shot was administered at 2:30 PM). Observed pt, gave fluids and took BP reading 3 separate times w/n a hour period.
12/22 vaccination 4pm. 4:05 PM, my HR went way up. I broke out on neck, chest, face; fire engine red. Felt like burning from the inside, out. Lightheaded and dizzy. Got puffy. Was NOT anaphylactic.  2 Benadryl. I didn't feel good for a couple weeks. 14-20 days, same experience with redness/burning. I took pictures. That happened every day for 4-5 more days. I went to doctor after doctor; ER after ER. About 6-7 times I have been to the ER; SOB, dizzy all the time, panic attack/anxiety, Stomach is not emptying correctly (NOT diabetic), eye keeps twitching, hurting behind my eyes, all my muscles are shrunken now. Blood panel, stress test; gastroparesis; positive; ringing in my ears; SOB; *COVID; negative.
Fever, chills, body aches so bad my clothes hurt touching my skin, nausea
When giving customer shot, RN noticed "bumpy" areas on shoulder muscle. She believes she gave shot at appropriate landmarks but became difficult to push last small amount of vaccine in so she stopped and removed needle. Customer started having anterior shoulder pain and clavicle pain following administration of vaccine. Customer felt shot "given too high" (unseen by staff). Customer seen in ER with x-rays performed and given meds to help with pain. Seen by company Occupational Health following ER visit. Customer still unable to move arm higher than waist level and will be seen again by OCC Health first part of next week for further follow up.
I30.9 - Acute pericarditis, unspecified J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia
Site of upper left arm, deltoid muscle has a very hard lump under the skin 35mm x 35mm in a circular shape. Site is very tender to touch.
Tenderness and swelling of lymph nodes in same arm of the injection (neck, axillary, groin); swelling of left side of face
It seem injection site was placed wrong and a blood vessel prick and redness has occurred. Blood gathered around site. Swelling. Soreness. Pass 2 days...  Today 3rd day went see my MD.  @ 6:50am then to work.  I am 65+....
Migraine, Brain fog, Blurred vision, Slurred speech, Swollen glance face neck  and eye .  Pain in neck/  spine. fever 108.5 difficult standing/ walking
Patient given intranasal spray (H1N1 flu) MedImmune lot #500803P exp. 02/21/2010.
PFIZER COVID VACCINE, 3RD DOSE GIVEN 9/9/21, LOT #FF2587; 7/15/22 pt admitted to hospital with weakness, sore throat, hallucinations; 5 wks earlier, pt was in the hospital and had a hip replacement; dc'd 5 days ago to a rehab facility; 7/11/22 pt also had a positive COVID test; pt now has hospital acquired pneumonia secondary to COVID; given ABX and steroids; DNR; pt's condition worsened, she became tachycardic and passed away in the hospital
103F fever. Severe muscle pain, chills and sweats, headache. Lasted for approximately 36 hours. Could only manage to get out of bed to go to bathroom and back. After fever broke, still have moderate muscle pain, headache, dizziness and diarrhea.
The morning after receiving the vaccine I woke up with severe chest pain just left of the sternum, shortness of breath, and tachycardia of 140 (40-50 is my normal). I saw my medical provider the next day who explained to me that I might have had a reaction to the vaccine but that it is nothing to worry about and that these symptoms would mean that I have a strong immune system, or I have asthma for the first time in my life. He ordered no tests on me and instead prescribed me albuterol and told me before exercising to take it. I explained to him I am having symptoms continuously and not from exercise but he said it should help when I feel too out of breath. I went home that day and after going up my home stairs I took my heart rate with a pulse oximeter and it was 120 and I felt out of breath so I used the albuterol inhaler, then my heart rate raised over 140 and my heart pain significantly increased and I had to lay down for a while.  I did not ever use the inhaler again because I believe it can kill me with whatever is wrong with me.  I wanted a second opinion so I saw a different medical provider who recently ordered labs and a chest x-ray which both came back normal.   It has been 3 days now that my chest pain is minimal so I was advised by my second medical provider to attempt low intensity exercise to see how my body reacts and that he would treat me accordingly. I am still short of breath from walking and my resting heart rate is now 100.
patient had poison ivy rash and was on prednisone taper at time of 1st moderna dose. patient's rash worsened.
First few days, arm pain.  Since April 1, I've had much more knee pain.  Tremendous and it is affecting my daily routines.
Administered expired Pneumovax 23 vaccine. EXP: 08/31/2021.
injection site redness, swelling, warmth; headache; body aches; tactile fever and chills
beet red rash to back & chest;rash light 2nd day p/vax;
Patient said that on the night after vaccination she did not sleep, and sunday morning she woke up with fever and fatigue. She took an Aleve in the morning and that did not help. By 5 pm she took a Tylenol and was able to sleep. Monday morning 11/11 she woke to her arm being swollen and tender. The swelling was in the armpit of the left arm and extended over to the left breast. She reported feeling better in regards to the fever and fatigue but was uncomfortable with the swelling. Due to the lymph nodes being swollen she was going to follow up with her primary care physician today.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Knee pain (Right knee pain Knee injection during pregnancy in NOV2020; PrP; no changes) since 2012, Low back pain (No changes) since 2010 and Obesity since 2010. Concomitant products included MACROGOL 3350 (MIRALAX) for Constipation, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Heartburn, PARACETAMOL (TYLENOL) for Knee pain, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Seasonal allergy, ALUMINIUM CHLORIDE (DRYSOL).    On 03-Feb-2021 at 3:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 06-Jul-2020 and the estimated date of delivery was 12-Apr-2021. On 03-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 03-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2020, Ultrasound foetal: normal (normal) Fetal anatomy ultrasound was normal. On 13-Jan-2021, Glucose tolerance test: normal (normal) 3 hour glucose tolerance test. On 15-Sep-2021, Ultrasound foetal: normal (normal) Fetal anatomy ultrasound was normal.     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.   No treatment information provided. Patient had history of subfertility with details as follows: No conception after 10 months of trying. HSG (hysterosalpingogram) was performed in JUN2020. No medications needed for conception.
Right anterior lateral thigh hot, reddened and slight discomfort. Mom using exercise and Tylenol 0.8ml every 4 hours and injection. Referred to PMD if symptoms worsen.
About 18 hours after immunizations baby had stiffening, eyes rolled back, then blinked rapidly, lasted about 45 sec. No rhythmic body movement. Breathing movements noted during stiffening. Very sleepy after episode. Associated with fever up to 103. Generally fussy only. Has continued to be excessively irritable since event.  12/21/07 Reviewed hospital medical records which reveal patient experienced fever, seizure-like jerky movements, irritability,eyes rolling back in head, stiffness followed by period of being difficult to arouse.  Saw PCP who sent to ER. Had rhinorrhea & nasal congestion since vax.  Rash on face & arms.  Admitted 11/16-11/19/2007. Tx w/IV antibiotics.  Ped neuro consult done.   FINAL DX: seizure, likely febrile; viral exanthem. 1/4/08 Reviewed vax record which confirms lot #s as reported.
On Sept 20, 2021, I started experiencing covid symptoms (headache, fatigue, cough, loss of smell/taste, muscle ache, diarreah). I went to urgent care on 9/22 to get a covid test, and was told to rest and stay hydrated. No other treatment.
On 01/31/2001 the patient developed chicken pox with less than 20 lesions. It was also noted, no other symptoms were present. The patient sought medical attention at a physician's office. Subsequently, the patient recovered. No further information is expected. The patient's sibling was vaccinated with varicella virus vaccine live and experienced mild varicella.
Pt given DTP/OPV/HBOC & exp inconsolable crying x 6 hrs;
Patient called said after she got the shingrix her arm was red and really painful. She took some advil and that helped a lot and after two days she felt fine and everything is back to normal. Apologized to the patient for what happened and asked if there is anything we can do to help but she said she is fine now and just want to let us know.
My 6 month old perfectly healty son went to sleep didnt wake up. He passed from SIDS and he recieved his shots 2 weeks prior.
Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016342736) on 21-Jul-2016. This case involves a 16-year-old female patient who was vaccinated with a dose of MENACTRA, a 0.5 ml dose of TRUMENBA (manufacturer: other) and a dose of HPV9 (manufacturer: other) (batch number, expiry date, route and site of administration: not reported for all the vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified day, following the vaccinations, the patient had passed out for a few seconds. The patient's laboratory data and corrective treatment were not reported. On an unspecified date, the patient recovered from the event. Upon internal review, the company decided to consider the event as serious due to important medical event: passed out for a few seconds. List of documents held by sender: none. Sender's Comments: This a poorly documented case as patient passed out for few seconds following MENACTRA, TRUMENBA and HUMAN PAPILLOMA VIRUS VACCINE. Detail medical history, past vaccination history and its tolerance are needed to further assess this case. As multiple vaccine are administered, the role each vaccine cannot be evaluated.
tachycardia skyrocketed; blood pressure skyrocketed; 194/113; injection site hot to the touch; feet and hands swollen; her head felt hot; feeling flush; charlie horses; Nausea; body aches/muscle aches in legs are so bad; extreme fatigue; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (tachycardia skyrocketed), HYPERTENSION (blood pressure skyrocketed; 194/113), VACCINATION SITE WARMTH (injection site hot to the touch), PERIPHERAL SWELLING (feet and hands swollen) and FEELING HOT (her head felt hot) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure high ((several years ago with illness and pain, had since resolved)). Family history included Blood pressure abnormal.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced TACHYCARDIA (tachycardia skyrocketed), HYPERTENSION (blood pressure skyrocketed; 194/113), VACCINATION SITE WARMTH (injection site hot to the touch), PERIPHERAL SWELLING (feet and hands swollen), FEELING HOT (her head felt hot), FLUSHING (feeling flush), MUSCLE SPASMS (charlie horses), NAUSEA (Nausea), MYALGIA (body aches/muscle aches in legs are so bad) and FATIGUE (extreme fatigue). At the time of the report, TACHYCARDIA (tachycardia skyrocketed), HYPERTENSION (blood pressure skyrocketed; 194/113), VACCINATION SITE WARMTH (injection site hot to the touch), PERIPHERAL SWELLING (feet and hands swollen), FEELING HOT (her head felt hot), FLUSHING (feeling flush), MUSCLE SPASMS (charlie horses), NAUSEA (Nausea), MYALGIA (body aches/muscle aches in legs are so bad) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Blood pressure measurement: 194/113 mmHg, 120/86 mmHg, 156/96 mmHg, 194/110 mmHg and 190/110 mmHg.     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.   Concomitantly patient was taking birth control. The treatment given was lisinopril; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Aprox 4 hrs after vaccine administration, pt developed an swollen arm from shoulder to just below elbow
Fever, body ache, leg discomfort, headache nausea All started about 12 hours after the shot, and have been treated with Tylenol Once Tylenol wears off, the headache and fever come back I had to call in sick, as I wasn?t able to work today
It was reported by a physician that a 5 year old female developed a hand-sized area of erythema with white papules at vaccination site several days after vaccination. Pt was vaccinated with Fluzone (U0941AA), date not reported. This was reported by child's mother, pt was not seen by a physician, recovery status is unknown. From additional correspondence received on 1/23/03, it was reported that the date of vaccination was 11/25/02. The pt did not have any pre-existing diagnosis or illnesses at time of vaccination. No other vaccinations were given within 4 weeks of the original vaccination date. The pt reportedly recovered from the events. This case is closed.
mom stated that pt had a high fever 104, nausea, h/a, swollen glands, nodules behind ears, no rash, no vomiting;states sx started on Friday 16JAN97 got worse on Sunday & saw MD on Tuesday 20JAN98;
Patient received 1st Moderna COVID-19 vaccine on 2/18/21 and in error received the 2nd booster 1 week too soon on 3/11/21, patient should have received her 2nd Moderna vaccine on 3/18/21.
made the patient deathly ill with flu within 2 hours after; This case was reported by a consumer and described the occurrence of near death experience in a 61-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, less than a day after receiving Flu vaccine, the patient experienced near death experience (serious criteria GSK medically significant). On an unknown date, the outcome of the near death experience was unknown.   The reporter considered the near death experience to be related to Flu vaccine.     Linked case(s) involving the same patient: US2022GSK143658   Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comment: The reporter reported that the patient received a dose of Flu vaccine and vaccine made the patient deathly ill within 2 hours after vaccination. This case had been linked with US2022GSK143658 reported by same reporter.; Sender's Comments:  US-GSK-US2022GSK143658:
Woke up at 5 day after shot. Tried to stand and was extremely dizzy with body aches and pounding headache.  Arm extremely swollen with knot and red rash. Around 11am my heart started racing and the middle of my chest was painful. Head continued racing until 10pm. Considered going to hospital but went to bed instead. Took ibuprofen.
Adverse effect: Experienced Atrial fibrillation. (chronic) Treatment: Emergency room visit and was given a cardioversion to bring heart back into normal sinus rhythm. Outcome: Still experiencing episodes of irregular heartbeat and seeking treatment from doctors and hospitals.  Adverse effect: Balance and coordination problems (chronic) Treatment: Neurologist appointment Outcome: Taking medication for basilar migraine  Adverse effect: Restless legs Treatment: None Outcome: None
Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 57-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 57-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.