chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Still birth on 13Aug2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 (Lot number: EW0180) at the age of 27 years as dose 2, single and administration date 13May2021 (Lot number: FW0172) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. No covid prior vaccination. No Known allergies. Date of last menstrual period: 25Mar2021. The patient was 10 weeks pregnant at the time of exposure to bnt162b2. The patient was 20 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 30Dec2021. The patient took concomitant medications Prenatal pills. No other vaccine in four weeks. The following information was reported: STILLBIRTH (medically significant) with onset 13Aug2021, outcome "unknown", described as "Still birth on 13Aug2021". The pregnancy resulted in still birth (30Dec2021). The fetal outcome is intrauterine death. No covid tested post vaccination. Therapeutic measures were not taken as a result of stillbirth.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
I suffered a minor nosebleed this morning. I am prone to these but nonetheless fearful as to how big a deal I should make this. Otherwise been okay.
a man recvd 1st dose of vax; his son devel chicken pox on 31oct95;
Painful, round, raised, 2-inch in diameter swelling of arm near injection site within 12 hours, slowly dissipating over time. Very severe headache and body aches setting in within 12 hours and lasting between 12-20 hours Slight shakiness and nausea setting in within 12 hours, lasting around 36 hours.
Pt received Moderna Monovalent Series Dose #1 on 2/8/23. Pt reports dizzy. Upon RN assessment, pt had episode of sycope, weakness, N/V, vitals WDL, A&0x2. Family member stated that pt's LOC was not at baseline. Pt experiencing photophobia, H/A, neck pain, and clammy skin. 911 called at 1732.
Burning tongue "like biting into a habenero pepper". Tongue burning has improved after Benadryl, but still burning today, but mild. Pt denies, swelling of lips, tongue, trouble breathing or trouble swallowing. Pt speaking in clear sentences.
Rash on the upper lumbar that appeared about 2 weeks after administration of Pfizer vaccination. Described it as pruritic. No discharge or bleeding. Did not respond to OTC moisturizers and antibiotic cream and husband's prescription steroid cream (unsure of potency).
delirium; Vaginal ulcers 48 hours after vaccine with high fever and body aches; Vaginal ulcers 48 hours after vaccine with high fever and body aches; Vaginal ulcers 48 hours after vaccine with high fever and body aches; This is a spontaneous report from a non-contactable consumer. This 33-year-old female consumer (patient) reported for herself that she received a 33 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Aug2021 at 14:30 at left arm for COVID-19 immunisation (age at vaccination: 33 years old). Medical history and concomitant drugs were not provided. The patient had Vaginal ulcers 48 hours after vaccine with high fever and body aches, delirium on 26Aug2021 14:00. Events resulted in Doctor or other healthcare professional office/clinic visit. Steroids were received as treatment. Outcome of the events was resolved in 2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2014US019650, is an initial spontaneous report from a pharmacist received on 29 SEP 2014. This report refers to a 62-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 14515P) intramuscularly at a dose of 0.5 ml on 28 SEP 2014. It was reported that she received vaccine after it reached 49 F for up to a maximum duration of 1 hour. No adverse events were reported following the maladministration.
Injection site pain.. extremely tired fell asleep at 1130am  awoke at 3:55 pm
Diplopia 03/09/2021 Acute onset diplopia  Vertical and torsional    34 yo M here with double vision. Pt states a week ago he started to notice double vision. No childhood strabismus    3/2/2021. COVID Moderna vaccine at noon.  The same night felt that his vision was blurry and split.     2 weeks ago severe migraine   3/3/2021.  His depth was off.  Similar that tuesday his vision was blurry and split.     3/4/2021.  Woke up with definite vertical diplopia   Stable since that day    With chin down he can see single    PMHX Gout, Afib, no other symptoms such as repiratory, join pain or anything else, no traveling outside state   15 years ago got elbowed playing basketball.  He thinks was his left eye for sure no ocular symptoms   On examination   Severe limitation to downgaze rotation right eye worse in the field of action of the right inferior rectus muscle There is also moderate limitation to full abduction right eye    On motility he has right hypertropia, esotropia and incyclotropia   No pain  No conjunctival injection    Differential diagnosis  Acute ophthalmoplegia  Rule out orbital apex or cavernous sinus No ptosis no pain.  Isolated donwgaze  Myositis IR LR vs SR and MR with restriction and weakness Unlikely TED unsual presentation no family history  Brain inflammation affecting 3rd nerve, 6th nerves  Always MG is within the differential diagnosis
Ringing noise in my ears after my booster shot 1st other shot was j&j on 3/4m21
Child received 2 Varicella vaccines. Presented today with >50 Varicella like lesions
Myalgia, Diarrhea, violent body shaking, fever, chills, Narrative: N/A
Client began to experience numbness in left forearm and wrist at 1049am, 14 minutes after 2nd dose of Moderna vaccine. Symptoms resolved after 3 minutes. Blood pressure listed below, within normal limits. Patient was given education about when to call doctor or seek emergency care. Client agreed to the plan and was able to leave of own volition.
Patient reports received Pfizer vaccine lot#EH9899 to left deltoid on Monday 12/21/2020 at facility. He returned to work in radiology w/o issues. The next day he began to experience site tenderness, night sweats w/no confirmed fevers, and diffuse headaches with mental fogginess (not able to concentrate). He denied any fevers being able to work, no SOB, or any other systemic symptoms. He had some mild nausea, but this resolved with food and headaches-fogginess resolved with Tylenol or NSAID use. It is now day 6 and his symptoms persist with last night being the worst, however HA/sweats are better today. His discomfort is now a 0-1/10 on meds (NSAIDS) otherwise 3-6/10 range w/o meds (last night). He denied any recent exposures
On the 17th, he has a difibulator and we got word that he went into A-Fib. And he came into the room and said that he could barely breathe before I could tell him. He ended up going to the hospital that day.  See below for other hospital visits.
pt states that a few days after getting the monkey pox vaccine he developed a very itchy rash.  The rash started on the abdomen.  He took Benadryl and went bed. Upon waking the rash had covered his entire back and chest.  It was bright red and itchy bumps. He had incredible itchy and he could see the rash moving up his neck into his ears so called Teledoc.  He was told he needed to call the ambulance to go to the hospital for treatment.  He refused saying he had to get to work so would call an ambulance or go to the ER if he started having trouble breathing.  His breathing was never impaired. He was prescribed prednisone and steroids. His symptoms improved over next few days but he still has a red bump around the injection site.
Patient reported nausea, some cramping and diarrhea (no blood) after receiving the vaccine. Symptoms lasted throughout the day for several days.
Awoke at 414am with itching scalp, palms, eyelids, skin folds (neck, elbows, knees, hips), welts, swelling in eyes, hands, face, neck.
This spontaneous report was received from a medical assistant, concerning a child (>12 months) patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2018, the patient was vaccinated with improperly stored VARIVAX injection, lot # N022986 and expiration date 23-AUG-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes on 02-JAN-2018. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one among the several reports reported by the medical assistant. Sender's Comments: US-009507513-1801USA002808: US-009507513-1806USA010177: US-009507513-1806USA010178: US-009507513-1806USA010179: US-009507513-1806USA010180: US-009507513-1806USA010176: US-009507513-1806USA010181: US-009507513-1806USA010174: US-009507513-1806USA010171: US-009507513-1806USA010175.
After receiving the vaccine, the patient stood up and expressed feeling "dizzy". Patient was seated with legs up on a chair and head laid back. Assessed patient for anxiety, hunger, fear of needles, and checked vital signs. Vitals were within normal limits and no other symptoms. Patient was offered and accepted apple juice. Patient responded feeling better. Patient was asked to wait longer for observation. After 15 minutes, patient felt better and exited the clinic.
1449: Pt reporting complaints of lightheadedness, nausea, weakness, tingling in toes, BP 82/42, HR49, O2 96%, Blood glucose 93 1454: Provided pt crackers and sprite to pt d/t him not eating at all today 1455: BP 78/40, HR 56, O293% EMS called  1501: BP Rarm 88/42, BP Larm 90/50, HR 59, O2 95%, pt declines nausea/SOB/dyspnea 1507: EMS left with pt via stretcher
COUGH; CONGESTION; FEVER; TINGLING AT INJECTION SITE; SORE ARM; SLIGHT HEADACHE; BRAIN FOG; HEAVY HEAD; This spontaneous report received from a patient. The patient's height, and weight were not reported.  The patient's concurrent conditions included coronary heart disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced tingling at injection site. On 01-APR-2021, the subject experienced brain fog. On 01-APR-2021, the subject experienced heavy head. On 01-APR-2021, the subject experienced sore arm. On 01-APR-2021, the subject experienced slight headache. Laboratory data included: Body temperature (NR: not provided) 101 F. On 01-APR-2021 19:00, the subject experienced fever. On 04-APR-2021, the subject experienced cough. On 04-APR-2021, the subject experienced congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling at injection site, brain fog, heavy head, and slight headache on 01-APR-2021, cough, and congestion on 05-APR-2021, and fever on 02-APR-2021, and the outcome of sore arm was not reported. This report was non-serious.
This spontaneous report was received from a healthcare worker and refers to a 19 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 30-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L011846 and expiration date 16-JUN-2017) (dose and route of administration were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
TOOK ALL UNREFRIGERATED DOSES OF VIVOTIF; This spontaneous case (PVX2019-1485) was received from a pharmacist on 10-Jun-2019. It describes an adult male consumer who "took all unrefrigerated doses of Vivotif." The consumer was receiving oral Vivotif (one capsule every other day) (lot number: 3003272) for typhoid prophylaxis.  Case report: The consumer did not place the Vivotif in proper storage condition and took all the doses. The first dose was taken on 01-Jun-2019 and the last dose on 07-Jun-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took all unrefrigerated doses of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took all unrefrigerated doses of Vivotif" was considered as not applicable.
GUILLAIN BARRE SYNDROME.; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. 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 administration not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Two weeks after taking vaccine, on an unspecified date the patient started having problems and ended up with Guillain Barre syndrome. Patient almost did not survive. Number of days hospitalized and discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of guillain barre syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220359620-Covid-19 vaccine ad26.cov2.s- Guillain Barre Syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.
No pain with injection, after a few hours couldn't bring arm up with elbow over shoulder. Still having pain with crossing arm over shoulder like to take shirt off. Pt feels injection was given too high.
Every 3-4 months he complains of episodes of worsening joint pain with swelling beginning in 2006. The episodes come on suddenly with diarrhea occasionally with blood followed by pain in his right knee which then swells the next day. The pain and swelling lasts a few days in the right knee then subsides, but begins in the left wrist/hand. A few days later the hand pain subsides and is followed by the same symptoms in his left foot. The pain is finally accompanied by fatigue and finally all symptoms resolve after about 6 weeks. The pain is so severe that his wife must help him with dressing if a hand/wrist is involved. He is incapacitated. Codeine does not help pain, so he goes to the ED and receives steroid and pain injections with relief and beginning of improvement. His right knee has been especially troublesome in the last few years. He is unable to bend it completely because of pain; 2-3/10 to 7/10. Sometimes the joint is warm, no redness. There is usually some swelling. His military work as a flight loader and his civilian work as a rancher have been negatively impacted. He began having joint stiffness "like an old man", in 1991 following the AVA immunizations. WHO causality assessment resulted in "Possible" only because of temporal relationship. The symptoms are likely due to other conditions.
On days 4-7 post injection, I experienced facial nerve pain that felt like herpes or shingles including ear pain, cheek hypersensitivity, swollen gland in neck, and sores along the bottom left gum line in my mouth.  This all occurred on the right side of my face.  I did not treat the pain or eruptions in any way except for regular dental care.  The symptoms healed/subsided after 5 days .  I have a small amount of residual sensation in my jaw near my ear but it is much better.
I tested positive for COVID in mid September. I had a high fever and a lot of coughing and a hard time breathing. I went to ER and they admitted me to hospital for five days. I received Steroid injection: anti-viral - Remdisiver - had that every day. They put me on blood thinners, too. My breathing is better now but I am still having a cough - but it's much reduced.  They sent me home with prescription for these:  I took Benzonatate - for a cough and Prednisone.  Side issues now - I cannot feel the top of my left foot or shin - I noticed that when I left the hospital - happened during the hospital stay. I am waiting to see  a specialist for this. I now have frequent urination - almost like a prostrate issue that started with the event. Follow up with NP.  I probably had the flu vaccine six months prior to the first COVID vaccine.
11/05/2001 the patient was flushed. On 11/06/2001 the patient developed malaise, redness, warmth and a raised area of the right upper arm at the injection site. 11/07/2001 the patient feels better, has an area of redness 2 1/2"x 1 1/2", slightly raised with warmth at the injection site. The patient was already on Voltaren and applied ice to site. 11/08/2001 the redness and pain had decreased.
7/22 Woke up during the night from a really bad sharp pain in chest. She barely touched it and the sharp pain would return same with shoulders. 7/22 Tired and sore from therapy. I want to give a little history on this patient. She was a cheerleader, majorette, and was in a weight lifting class. She was very active and athletic. I didn't have enough room on the VAERS for this so I am attaching this sheet for a timeline. 10/14/08 1st GARDASIL. 12/29/08 2nd GARDASIL. 01/09 School reported she was generally weak and fatigued to the point of needing to leave school. 02/09 She started with having leg weakness and would like wrap her ankles for performances and practices (no injuries) just weakness. 03/09 The actual leg and joint pain started. She was refusing to do stunts in cheerleading because it hurt so bad. She is the "flyer" because of her small size and she said it hurt too bad to climb up and to be caught. 04/09 Not a lot of activity during the month with cheering or anything, but she had to be picked up from school several times because the exertion just from walking from class to class made her so tired she had to go to bed. 05/09 The week of the 11th she had to be picked up from school because of lethargy just from decorating for the prom. The week of the 18th she started with a limp more prominent in the R leg. Substantially increased pain in the joints and "shooting, needle-stick pains in the shin area". The following week she started losing muscle control and could not walk or stand without help and started using crutches. She complained of "burning, stabbing, achy" pains in many different areas. Her hips, arms, and leg muscles had significantly increased pain. Because of the severity of the pain and loss of muscle control in her legs, she was taken to ER on May 31. She was sent to hospital at that time. 06/09 She went to an Orthopedic Dr and they said it was neurological. She started seeing a Neurologist, she was doing MRI's and further testing and they couldn't find anything so they are sending her to a Neurologist (08/14/09). She also started losing clumps of hair, not sure of the actual date but it started in June and is worsening some throughout the month of July with actual thin spots where her scalp is visible. 07/09 Since 3rd shot 7/14/09 - 7/23 Low grade fever and nausea, said stomach felt like there was a fork in side scratching on it. 7/24 Tired not wanting to eat much stomach hurting. Sore after therapy 2:30 ended - take pain pill around 4:30. By 5:30 pain was so bad she cried and asked to be brought home (watching movie at friend's house) & severe pain in fingers, thumb, wrist, lower arm and behind arm at elbow (home by 6:30) usually not home till 9 or 10 when at friend's house watching movies. 07/14/09 3rd GARDASIL. Also, when she was in weight lifting classes she was documented to be bench pressing 90lbs. She can now barely lift a 1 lb weight at Physical Therapy.
they were under the impression the expiration dates were extended and that this lot had an expiration date of 18Sep2023 but when they checked with the vial expiration checker it came up as 18Jun2023; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they were under the impression the expiration dates were extended and that this lot had an expiration date of 18Sep2023 but when they checked with the vial expiration checker it came up as 18Jun2023) and NO ADVERSE EVENT (no adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (they were under the impression the expiration dates were extended and that this lot had an expiration date of 18Sep2023 but when they checked with the vial expiration checker it came up as 18Jun2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they were under the impression the expiration dates were extended and that this lot had an expiration date of 18Sep2023 but when they checked with the vial expiration checker it came up as 18Jun2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (they were under the impression the expiration dates were extended and that this lot had an expiration date of 18Sep2023 but when they checked with the vial expiration checker it came up as 18Jun2023).    Concomitant medication details not reported by the reporter. Suspect product dosage text was reported as unknown. Treatment details was not reported by the reporter.
Information has been received from a physician concerning a 9 month old patient who was vaccinated with VAQTA by mistake due to an office error.  At the reporting time, the child was 12 months of age and no adverse reaction had been reported.  Additional information has been requested.