chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shot was on Left side  (ALL SIDE EFFECTS on LEFT SIDE) - eye was  blurry and numb - Teeth - TOP and  BOTTOM throbbing (Felt like they were being pulled out) - Glands swollen - throat hurt to touch - Ear felt numb  It lasted about 2  to 3 hours  The next day teeth were okay but eye still felt numb and glands were still sore and sore to touch Glands took 2 days to feel better
This spontaneous report was received from a nurse practitioner via a company representative refers to a female patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported. She had no known allergies/drug reactions. On an unknown date the patient was vaccinated with unidentified Merck HPV vaccine intramuscularly. The reporter could not confirm which vaccine was administered GARDASIL or GARDASIL 9. The patient developed "a pea sized nodule" at the injection site following the administration of vaccine on an unspecified date in November 2015. The patient has sought unspecified medical attention and warm compress was used as treatment. The nurse practitioner stated that the "nodule" at the injection site "has shrunk", but "it's still present upon palpation" (recovered with sequelae) on an unspecified date. No lab diagnostic tests were performed. The reporter did not provide the relatedness of the event with the suspect therapy. Additional information has been requested.
Pain under armpit; This case was reported by a nurse and described the occurrence of axillary pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles last October that presented with severe pain under armpit and rash upper left back), axillary pain and rash (rash on upper left back). Previously administered products included Shingrix with an associated reaction of axillary pain (received 1st dose on 25th July 2019, refer case US2019AMR190719), antiviral and prednisone.   On 17th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced axillary pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the axillary pain was unknown.   It was unknown if the reporter considered the axillary pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was anxious to get the Shingrix vaccine to lessen the chance of ever get Shingles.  The patient received Shingrix and experienced the pain under armpit that the patient had when she got shingles.
Hep A was given after checking the system for other shots. None were listed. The father responded no to the question whether child had received shots within the previous 4 weeks.  The next day another system was checked and found that a Hep A was given on 3/14/22 falling outside the 6 month allowance.  The father was contacted and reported that the child's mother may have taken her to the 3/14/22 appointment. The additional shots given on 4/11/22 are within the 4 week time period except Varicella which falls under exception considering 4 week interval valid.
Difficulty breathing; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 60-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration (at the age of 60-years), administered in arm right on 12Mar2021 08:45 as dose 1, single for COVID-19 immunization. Medical history included ongoing asthma and diagnosed over 20 years ago. Concomitant medications included sertraline hydrochloride (SERTRALIN [SERTRALINE HYDROCHLORIDE]) taken for anxiety from 03Mar2021 to 08Mar2021. On 12Mar2021, the patient experienced difficulty breathing. Patient received the first dose of the Covid-19 vaccine on 12Mar2021. She had asthma and thinks she could have had an asthma reaction and is following up. There were 20 steps or more to the waiting room. As she sat down she had diff breathing. She thought it could be asthma. She doesn't do well climbing stairs. The difficulty breathing subsided in a minute or two. She did not take off her N-95 mask though she wanted to in order to catch her breath. She did not have to use her rescue inhaler. She did not have it with her. She tends to worry and over reacts. She was due to get the second dose on 02Apr. She thinks this could have been a reaction, her family received the Pfizer vaccine and no one had any issues. Her sister said she was panicking. The difficulty breathing ended after one to two minutes. She had the second shingles vaccine on 28Jan2021. When providing concomitant medications, she started taking Sertraline HCL on 03Mar2021. It caused her to be more anxious. She was jittery and restless. She did not like how it made her feel. She called her doctor and he said she could stop. Product is filled in pharmacy bottle. NDC, Lot and Expiry are not listed. The doctor said this was common and it goes away in 2-3 weeks. She did not like how it felt and stopped. She wanted to rule out that something else wasn't going on. How does she know if its a side effect and what does she need to do about second dose? The adverse event does not resulted in emergency room and physician office visit. The patient was taking Covid-19 vaccine for Covid protection. Description of Product Complaint: taking Sertraline HCL caused more anxiousness, jitteriness and restlessness. Product strength and count size dispensed: Sertraline HCL 50mg . Additional lot numbers: NDC, Lot and Expiry are not on pharmacy bottle. Is a sample of the product available to be returned, if requested: Yes, caller will retain as a prepaid fedex mailer may be sent in 3-10 business days Packaging sealed and intact was not applicable. The outcome of the event was reported as recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Pt recvd 3 doses of Engerix-B vax 30MAY90, 29JUN90, & 30NOV90 & it was determined that pt did not seroconvert;
Pt recvd Hep B vax on 18FEB92 & 2 days later exp diffuse myalgias, arthralgias, fatigue, nausea & vomiting; @ time of report pt had recovered; No further details were provided;
Started with bump "knot" 4/16/03 about 6in and then 4/17/03-4/18/03 right arm very red hard swollen from elbow to shoulder not running fine but giving Motrin. Advised to call MD with appointment 11:45am 5/18803-giving Motrin 2 x day. T.C. 4/24/03 to mom-doctor treated as "allergic reaction-systemic" Zyrtec po x 3 days and Motrin pretty much "fine now."
Nausea and Vomiting started 4 hours after vaccine dose and continued for 8 hours. No hospital visit or ER visit. Associated with body aches, low grade fever, chills, fatigue. Vomiting ended that evening. Other symptoms took 48 hours to resolve.
Day 1 through day 24 after the vaccine resting heart rate increased from 67 BPM to 78 BPM.   Sickness experienced during first 24 hours after vaccine.  2/10/22-2/15/22 experienced fatigue, reduced lung capacity, lungs heavy. Starting 2/19/22 at 5:00am Angioedema.  Swelling moved daily: (2/19) right wrist and hand, (2/20) left wrist and hand, (2/21) Upper lip then bottom lip and bottom of both feet, (2/22) around eyes and left ear, (2/23) below both eyes, (2/24) none, (2/25) throat, (2/26) none, (2/27) tongue.
MODERNA COVID VACCINE #3 GIVEN 12/7/21, LOT #076C21A; pt to hospital on 6/29/22 and found to be positive for COVID; respiratory failure; acute hypoxia; intubated; bronchoscopy; steroids; ABX; vasopressors; did not improve with tx; pt passed away in the hospital
SWEATING; SEVERE CHILLS; VERY HIGH FEVER TO 104; BAD HEADACHES; EXTREME FATIGUE; COULD NOT GET HER HEAD OFF OF THE PILLOW; SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a patient concerned a 58-year-old white female of unspecified ethnicity. The patient's weight was 72.57 kilograms, and height was 168 centimeters. Patient had no medical history (illness at the time of vaccination) and no family history relevant to adverse event. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: unknown) dose was not reported, 1 total, administered on 15-MAR-2021 at left upper arm for prophylactic vaccination (dose number in series 1).  On 24-NOV-2021, the patient had Covid (suspected clinical vaccination failure and covid-19 infection). Laboratory data included: COVID-19 virus test (NR: not provided) unknown (event with dose number in series 1). On 18-DEC-2021 around 10:30 am, the patient received additional non-company suspect vaccine included: BNT 162 (Pfizer) (form of admin, route of admin was not reported and batch number: FD0809 expiry: unknown) dose was not reported, administered for prophylactic vaccination on left upper arm (dose number in series 2). No concomitant medications were reported.  On 18-DEC-2021 22:30 PM, (12 hours after vaccination) the patient experienced very high fever 104 F, severe chills, patient could not get her head off of the pillow, bad headache and extreme fatigue. The patient still had a very bad headache on the day of report. She stated her fever probably broke in the middle of the last night (19-DEC-2021) because she was sweating profusely. The patient still had headache and tiredness, but they were better (all events with dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and BNT 162 was not applicable. The patient recovered from very high fever to 104, severe chills,  and could not get her head off of the pillow. The patient was recovering from bad headaches and extreme fatigue. The outcome of  sweating, covid-19 infection,  and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209409.; Sender's Comments: V0: 20211259703-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Dose of 0.2 ml given Instead of correct dose of 0.3 ml. DPH contacted.  needs re-vaccination. Nurse to call  mom, explain, & schedule dose. Pt is in no harm.
100.8 fever and then 96 fever with chills for about 4 hours, extreme fatigue the next day, and more than usual joint pain. Taken on a Monday at 12:10 PM and all better by Wednesday of the same week. Another person in my same group at Noon had the same problems.
Patient experienced near syncopal episode immediately after injection. Patient was placed in the supine position, legs elevated and juice provided. Vitals monitored. Observed in the clinic for an additional 20 minutes and discharged without any further complications.
Syncope within 5 minutes of HPV 9 and MENACTRA. Recovered on own without intervention. Exam at our office and not referred to ED.
Local site reaction: warm, red, swollen  Left upper arm times 3 days;   No fever                Six days post treatment, 10/20/08, in A.M., patient noted pain and tingling in right hand, traveled to right wrist and arm over course of day; the same evening, same symptoms began in left hand, right foot and right thigh. A.M. of 10/21/08, this "deep nerve pain" is felt same locations as well as a "cinnamon like burning" around mouth.  No redness or swelling of face. Also noted at this time, marked heaviness noted in both legs. No swelling, discoloration noted in hands, arms, ankles, or legs. 12/15/2009  MR received from PCP. Pt initially seen for local reaction to flu shot-redness & swelling which resolved in 4 days. Now reporting pain, numbness and tingling in the R hand/arm. Decreased sensation in extremities Impression:  Paresthesia-arms and legs.   Neurology consult 11/3/08 with DTRs hypoactive in arms and legs with normal strength.  Spinal H/A 2' to LP.  Assessment: EMG c/w median and ulnar neuritis.  No evidence of GBS. Probable lumbosacral radicular irritation.
Post vax on 4/20/00 pt friend noticed she had 4 or 5 hive like bumps on her right cheek, neck & side. Pt also complained of being tired.  The bumps were not itchy and pt's mom gave her Benadryl as af 4/26/00 the bumps have disappeared.
SWOLLEN THIGHS (SITES OF ADMINISTRATION) LASTED < 24 HOURS; TREATED WITH WARM COMPRESSES.  EXAM THE FOLLOWING DAY WAS NORMAL.
Left knee pain and stiffness 1/7 which is resolving, right knee pain and severe stiffness as of yesterday. Hard to bend leg.
Rash; pt given prelone syrup and Benadryl. Rash occurred on face, back, abdomen, legs, was diagnosed in ER with allergic reaction. Mom states she thinks drug due to something in child's room since he broke out with similar drug one day later in same environment.
nausea; chills; ~5 hrs: nausea. ~12-20hrs: chills, muscle pain, feverish, tiredness. All gone after I took an Aleve pill more than 24 hrs after the shot 1-2 days: injection site swelling. Gone after icing the site.; feverish; tiredness; injection site swelling; injection site pain; I regularly get similar flu vaccine reactions; This is a spontaneous report from a contactable consumer. A 55-years-old non-pregnant female patient received first dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 16Feb2021 08:45 PM as 1ST DOSE SINGLE DOSE for covid-19 immunisation. Medical history included Malign melanoma (cured, no chemo or radio needed), multiple bcc along the years. Patient had allergies with Intolerances to gluten, sugar and dairy. Mild allergies to pollen, dust and latex. Cannot take ibuprofen.  Patient was exposed to Covid, had some of the symptoms but all tests were negative. Concomitant medication included Vitamin C and D, Ca, Zinc, Omega 3, 5HTP, levothyroxine taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks. On 16Feb2021 15:00 PM patient experienced 5 hrs after vaccination nausea. 12-20hrs after vaccination chills, muscle pain, feverish, tiredness. All gone after taken an Aleve pill more than 24 hrs. after the shot 1-2 days injection site swelling. Gone after icing the site. after 5-6 days injection site pain. patient had to rest it on top of a pillow. Icing the injection site did wonders. Patient regularly get similar flu vaccine reactions. The site pain was much longer though. Since the vaccination, patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: Negative. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
allergy to the vaccine; itchy eyes started from eyebrows; eye redness; swollen really bad; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 14Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE on 24Mar2021. On 21Apr2021, the patient experienced allergy to the vaccine, itchy eyes started from eyebrows, eye redness, swollen really bad. The events assessed as non-serious. Case narrative: Caller stated that she would like to talk to someone to ask them about a reaction to the vaccine she had. She states that she had some reaction. Two or three people told her it might be a reaction to the vaccine, and she wanted to know if it is or not. She got her second shot 14Apr2021, after a week she developed itchy eyes started from eyebrows, her eyes, both eyes and around her eyebrows started itching getting red and keeps getting swollen really bad. Sought consultation to ophthalmologist 28April2021 or 29April2021 and she was advised that it might be an allergic reaction to something, became worst as days went by. She was seen by her primary care doctor and prescribed cream for itchiness. She will visit her dermatologist tomorrow, since her eyes are itching and bothering her. She is going to see a doctor to calm down the swollen and itching, she couldn't really see. She does not feel good. She heard from her friend that she also had itchiness after being vaccinated for COVID 19, did not specifically mentioned that it was Pfizer. She wants to know if itchiness of her eyes is an allergic reaction from the COVID 19 vaccine that she had. The event outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
INCORRECT STORAGE OF DRUG; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a 34 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: 26-JUN-2021) dose was not reported, administered on 25-MAY-2021 13:21 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced out of specification product use. On an unspecified date, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine was not applicable. The outcome of the out of specification product use and incorrect storage of drug was not reported. This report was non-serious.
Soreness and some swelling at and below injection location, similar to a FLU vaccine. No sever or flu like symptoms. I took some Tylenol for the soreness at the injection site. Next soreness was reduced but there was still some swelling. I was able to do yard work with the left arm. There did not appear to be and reduction in usability of the arm.
Extreme gasping for breath, extreme weakness, sudden onset. NO pain, vomit or nausea Called Doctors emergency number. Saw GP the next day.
11/5/06 Tingling in hands, leg weakness, arm grip weakness, back pain, leg pain, chest discomfort with shortness of breath, facial numbness.  Hx of Chronic Obstructive Pulmonary disease Hx thyroid takes synthroid Vital Capacity decreased and intubated and later required tracheostomy.Pt is currently in rehab. facility Pt also was noted to have a cerebrospinal fluid Lyme antibody positive and placed on Rocephin 2 gm IV q 24hr x 3wks. 12/21/06-records received and reviewed for DOS 11/7/06-12/2/06 DC DX: Guillan Barre syndrome respiratory failure requiring intubation secondary to Guilland Barre syndrome status post tracheostomy leukopenia secondary to Neurontin positive cerebrospinal fluid for Lyme serology Panic disorder chronic back pain history of old tobacco usage history of chronic obstructive pulmonary disease.  MRI of head: multiple sulci with increased flare and T2 signal throughout the pervitricular white matter which was nonspecific.  MRS: showed no significant stenosis, aneurysmal dilation or vascular malformation. LP: protein: 106.5, IgG was 15.8 Trach placed after extubation. TX: IV immunoglubulin G. Noted increasing strength of her lower extremities.  CSF: lume antibody reactive  CSF cultures: negative, all other cultures negative ANA >5 WBC 2.9.
Patient had vaccine administered in her left upper arm at 1100am and by that evening she had significant swelling to her right upper thigh/groin area. On 06/25 the area of swelling measured 9 inches long by 5 inches wide. No erythema, warmth, tenderness, or fever.
A red, warm-to-the-touch, itchy patch developed in the area of the injection site on my left upper arm.  It was about 3" x 3" initially.  The rash migrated down and forward toward the bicep about the 5th day and was about 6" in length. I had been applying Benadryl gel to the rash. The third day of the rash, the fifth day after the shot,  I called the doctor's office. He recommended I take Benadryl oral tablets as recommended on the package.  After two days of  taking oral Benadryl the rash was significantly reduced and I quit taking the Benadryl.  Since then, I have seen COVID arm online which looks very much like mine did.
Patient came in to receive  2nd dose of Moderna vaccine. Patient revealed to vaccinator a reaction to 1st dose of Moderna.  Vaccinator reported to lead nurse. Patient reported itchiness and swelling of left and right hands 3 days after 1st dose of Moderna.  Pt reported symptoms lasting for 2 weeks. Patient reported taking Bendadryl every other day and taking prescribed hydroxyzine HCL 25 mg tablet  to alleviate symptoms.  Patient reported similar reaction to prior shingles vaccine. For the shingles vaccine, patient reported the onset of similar symptoms approximately 2 days after shingles vaccine.  Situation elevated. Medical team consulted. Patient did not receive 2nd dose of Moderna on 03/06/21.
The pt called and  complained with her first dose - she had an swelling in her arm where she felt her arms were swollen along with her fingers to the point she couldn't bend it at all.  She did ice packs everyday.  She also reported that she had a hard time breathing and she couldn't use her inhaler (albuterol) because she was having a hard time taking good breaths in which was leading to asthma attacks. With her second dose she had similiar symptoms but she prepped herself before hand by taking pulmicort inhaler first so she was able to use albuterol and she wasn't struggling as bad as first dose.  She had taken zyrtec, zofran, valium, medical marijuana and imodium before coming and she kept complaining she felt like she was going to die. She had fever with both shots for which she was using motrin every 6 hours and it took 6 days roughly for the fever to go down but usually it stayed at 102. It took 2 weeks for her fever to break. She also had dizziness, for which she had to go to the doctor and get meclizine rx. She also had fluid in her ears both times which is what was causing the spinning effect. She couldn't eat or drink for a long period of time - matter of days.  She had throbbing pain. She also used tramadol along with other medications mentioned above with her second shot.  She also complained of her breast swollen and right arm and periods were more clot looking.
Initial report received on 11 October 2011 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 8-month-old male subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject's vaccine history included 3 doses of PENTACEL; lot number C3613AA received on 03 February 2011, lot number C3723AA received on 07 April 2011, and lot number C3752AA received on 07 June 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 25 August 2011, 79 days after the last dose. On 02 September 2011, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 08 September 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 08 September 2011 for five days. The subject was not hospitalized. At the time of final contact on 21 September 2011, the subject's cough had resolved. The duration of the cough was reported at that time as 22 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.