chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 10 minutes after immunizations administered patient was standing at check out and told mom he didn't feel right.  He sat down on bench and mom reports patient convulsed, b/l arms and head x2 for about 3-5 seconds.  Patient thinks he may have blacked out momentarily, but recalls full event. Patient then reported he felt normal, but appeared pale. He stayed in lying position for at least 5 minutes with cool compress to forehead/neck, patient's coloring returned to normal. He then sat for 10 minutes, drank 2 cups of water continued to report he felt fine. Denies headache, dizziness, lightheadedness or ringing in ear.  HR was 60 bpm, RRR.  Patient walked around waiting area, felt fine and left the office with mom.  Reviewed with mom concerns to monitor for.
-Extreme change in gait. At times could not walk at all ( 2 weeks after vaccine) -headache and swelling on the right side of head ( 1 week after vaccine) confusion (2 weeks after vaccine) abdominal pain (2 weeks after vaccine) Hospitalized for 6 weeks for physical and occupational therapy to attempt to get her walk back to normal and get the pain under control. Was put on gabapentin
Given 7/28/06, Lg local rx right thigh. Injection site swell. 8/2/06 1 1/2 cm slight induration and mild erythema. Not tender. Spoke with mom 8/14/06. Spot was resolved. No redness or signs of swelling.
AE: patient got dizzy, vomited and syncopal walking. No medication was given. food and water improved the symptoms Outcome: patient discharged to POV/Home
I got vaxed two times and boostered once and I still just got COVID/Doctor gave me Paxlovid; I got vaxed two times and boostered once and I still just got COVID/Doctor gave me Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic Bronchitis" (unspecified if ongoing), notes: Other medical history: Asthma, Chronic Bronchitis; "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma, Chronic Bronchitis. The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. The following information was reported: DRUG INEFFECTIVE (medically significant, life threatening), COVID-19 (medically significant, life threatening) all with onset 21Aug2023 at 02:00, outcome "not recovered" and all described as "I got vaxed two times and boostered once and I still just got COVID/Doctor gave me Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19.(Paxlovid on 28Aug2023).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, Covid-19 and the use of suspect product cannot be fully excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 70 years old male patient who experienced numbness in his fingers on the right arm where he received the injection and itching across his back, while he received vaccines DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE and IMOVAX RABIES. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Sep-2018, the patient received a 1.0 ml dose of suspect RABIES (HDC) VACCINE (lot NI8051M and Exp. Date 26-FEB-2019) via unknown route in the right arm and another two doses on 13-Sep-2018 and 17-Sep-2018 respectively. On 06-Sep-2018, the patient received a dose of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On 20-SEP-2018, the patient developed a non-serious numbness in his fingers on the right arm where he received the injection 10 days following the administration of RABIES (HDC) VACCINE, 14 days following the administration of DIPHTHERIA and TETANUS AND NOS PERTUSSIS VACCINE. On 27-SEP-2018, the patient developed a non-serious itching across his back 17 days following the administration of RABIES (HDC) VACCINE, 21 days following the administration of DIPHTHERIA and TETANUS AND NOS PERTUSSIS VACCINE. No information about relevant tests reported. Final diagnosis was numbness in his fingers on the right arm where he received the injection and itching across his back. No information about a corrective treatment reported. The patient outcome is unknown for events. Documents held by sender: none.
pt recvd 1st dose of vax in aprpox MAR92; 1 day p/vax devel a fever blister on mouth; aobut 3 wks following vax pt exp severe dizziness, h/a, lethargy, fever & back neck pain; pt unable to walk, sit, or stand;
20 minutes after shot, face felt hot, swelling in face. Later: chills, fever (99.9 degrees), body aches, fatigue;  pain, swelling and redness that the  injection site; chest congestion. Morning of 2nd day, also had normal nasal congestion, temperature was normal by second day (98. 6 degrees)
Headache after the booster; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache after the booster) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 010M20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache after the booster). At the time of the report, HEADACHE (Headache after the booster) outcome was unknown.            No concomitant medication  were reported. No Treatment information was provided.   This case was linked to MOD-2021-041014 (Patient Link).
Patient described having a seizure the next day which lasted 1 and 1/2 hours. She said it was not one of the on the floor arms flailing kind of seizures.
Around 6pm on day of injection I felt waves of incredible muscle and joint pain. It was cyclical. Building up and breaking and building up and breaking. I was barely able to walk I was so stiff. I was crying and my body and mind didn?t know how to process what was happening. The next day my mind felt far away and detached from my normal understanding of reality. Pain persists and confusion. The second day (today) April 10th I was stiff when I tried to walk and overwhelmed with fatigue and headache. I needed to work so I delivered food for a few hours. My mind is still distant and my body is in terrible pain from activity working. I don?t know when I will start to feel normal or like myself again.
Left arm was so sore, couldn't move it or hold anything. At the injection site, hard lump present for 2 weeks. It hurt for about a week but able to use arm after 1st day.
9/3/21 pt to ED with c/o worsening SOB; tested positive for COVID on 8/28/21 at an urgent care; was given inhalers, ABX, steroids, zinc, Vitamins C & D; since dx, pt has had weakness, productive cough, chest congestion, chills with fever, body aches and diarrhea; states O2 was in the 70s at home; admitted; positive COVID test on 9/4/21; O2 supplementation; treated with remdesivir, dexamethasone, baricitinib; progressive hypoxia requiring intubation; pt experienced cardiac arrest; ACLS; daughter then decided to make pt DNR; pt passed away in the hospital
I did not have an adverse reaction to the vaccine. I went on a vacation with my family and got sick on the trip. At first it appeared to be seasonal allergies with runny nose, coughing and sneezing. I tested positive with a home test for COVID-19 on 09/14/2022.
Migraines, fatigue, low white blood and platelet count, no treatment given, eventually all side effects subsided. Seemed to have an allergic reaction to 2nd shot. Was given Benadryl for it. IV saline solution for migraine protocol. time frame from start to finish 12/29/2021-2/21/2021.
Starting 10 hours after vaccination, chills to the bone (never had with previous 2 doses).  The next morning, chills were gone, but her tongue was swollen.  Tongue continues to be swollen 3 days later.  Rash from neck to groin.  Reached out to PCP.  Not able to take anything for symptoms as she is severely susceptible to reaction to meds.  Advised to reach out to 911 if tongue swells further.
Information has been received from a health professional concerning a 6 year old male who on 29Jan1998 was vaccinated with a dose of varicella virus vaccine live. On 12MAR2003 the patient developed break through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other patients were vaccinated with a dose of varicella virus vaccine and developed break through chicken pox. Additional information has been requested.
10AM chills and didn't sleep, headaches. Monday AM diarrhea, awake every 90mins. Tuesday AM called doctor. Did a COVID test.
1/28/21 early morning- upper left arm 2X2 square of red at vaccination site has appeared and tender to the touch, temp at redness of arm is 102
She broke out in a mild ?non contagious? version of varicella. Began on leg in morning, then two on face by 5pm on 9/26, morning 9/27 woke with one on trunk under right breast, one mid neck in scalp, on way to school one popped up behind patient's ear, and in the time it took me to get to her two hours later, she had another behind her ear and three going down her back on the right side that itch. We were not around anyone with chicken pox, no one in our family has it.
TOOK THREE DOSES IN A ROW; This spontaneous case report (PVX2019-1849) was received from a nurse on 17-Jul-2019. It describes a male consumer who "took three doses in a row" (PT: Inappropriate schedule of product administration), while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took three doses in a row. The doses were taken on 14-Jul-2019, 15-Jul-2019, and 16-Jul-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 three doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three doses in a row" was considered as not applicable.
Painful burning skin, feels like a sunburn, all over body, worse in scalp, face, neck, and torso. Anything touching skin hurts
Pt recvd a very sore, achey arm for several day p/sore throat, congested chest & nasal passages for several days;
Swelling got worse; left breast started hurting/pain in the breast/it was getting bigger; left breast started hurting/pain in the breast/it was getting bigger; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling got worse), BREAST ENLARGEMENT (left breast started hurting/pain in the breast/it was getting bigger) and BREAST PAIN (left breast started hurting/pain in the breast/it was getting bigger) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 046B21A) for COVID-19 vaccination.     The patient's past medical history included Fibrocystic breast. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for Flu.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SWELLING (Swelling got worse), BREAST ENLARGEMENT (left breast started hurting/pain in the breast/it was getting bigger) and BREAST PAIN (left breast started hurting/pain in the breast/it was getting bigger). At the time of the report, SWELLING (Swelling got worse) had not resolved and BREAST ENLARGEMENT (left breast started hurting/pain in the breast/it was getting bigger) and BREAST PAIN (left breast started hurting/pain in the breast/it was getting bigger) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: gained weight (High) gained weight and lost weight (Low) lost weight.         Treatment information was not reported.  The patient would be undergoing a mammogram test soon (in about a month). Usually the patient felt the pain when the patient gained weight, and felt better when the patient lost weight.  The patient had skipped mammogram test in 2021 last because of the pain. The patient had not been exposed to COVID at all, and was being overly cautious.   This case was linked to MOD-2022-513823, MOD-2022-513833 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2022: Follow-up received contains no new information
A spontaneous report was received from a physician, concerning a patient of unknown age and gender, who received two COVID-19 vaccine accidentally on the same day. The patient's medical history was not provided.  No concomitant medications were reported. On an unknown date, prior to the onset of the events, the patient was accidentally administered two doses (Lot number: unknown) on the same day for prophylaxis of COVID-19 infection. Physician reported that, after administering both doses of the vaccines, the patient was followed closely for safety outcome and "did fine".  No treatment information was provided. Action taken with second dose in response to the event was not reported. The event administered two vaccinations on the same day was considered as resolved.; Reporter's Comments: This report refers to a case of extra dose administered.  There were no reported adverse events associated with this case.
Information has been received from a nurse practitioner concerning a 6 month old female who was vaccinated with first dose of ROTATEQ.  The patient did not have adverse reaction with the first dose.  The patient was vaccinated with the second 2ml dose of ROTATEQ.  The patient experienced diarrhea and developed green stool after receiving the second dose.  At the time of this report, the patient was recovering.  The patient sought medical attention from a nurse practitioner.  Follow-up information has been received from nurse practitioner concerning the 17 week old white female with no illness at time of vaccination and no pre-existing allergies, birth defects or medical conditions who on 09-DEC-2008, at 14:10, was vaccinated with the first dose of ROTATEQ (lot # 661685/0967X) and on 03-FEB-2009, at 14:41, the patient was vaccinated with the second dose of ROTATEQ (lot #: 660926/0308X).  Other concomitant therapy received at the same date included the first dose of PENTACEL into the left thigh and the first dose of PREVNAR into the right thigh on 09-DEC-2009 and the second dose of PENTACEL into the left thigh and the first dose of PREVNAR into the right thigh on 03-FEB-2009.  It was reported that the patient was vaccinated with the first dose of hepatitis B vaccine, recomb (MSD) on 02-OCT-2008 and the second dose of hepatitis B vaccine, recomb (MSD) into her left thigh at 14:23, on 04-NOV-2008.  On 03-FEB-2009 the patient experienced large watery diarrhea and green stool for two months.  No relevant lab test was performed.  Subsequently, in May 2009, the patient recovered.  On 19-MAY-2009, at 15:13, the patient was vaccinated with the third dose of ROTATEQ (lot #: 663142/1462X).  No further information is available.
No pain with injection.  Left shoulder pain began around 4 pm the same day, unable to raise left upper extremity against gravity without severe shoulder pain.  Took 1000 mg of Tylenol immediately after injection and 600 mg of Advil at 9 pm as well as used Ice to decrease swelling and pain.  The pain increased and I was unable to sleep at all secondary to pain.  The shoulder pain has continued and loss of active shoulder range is apparent.  I am stretching and taking NSAIDS as able for the pain.  I have been unable to sleep well since receiving the vaccine secondary to the pain.   Today is day 7 and I am slowly getting back some active range however I continue to increased shoulder and peri scapular pain that limits my ability at home and at work.
Rapid heartbeat started almost immediately.  Subsided in approximately 15-20 minutes.
Pt states 3 days after vaccination. Maculopapular rash developed on right arm, this rash then spread to right rib, then left arm. Also describes dry skin on earlobes. Denies any changes in detergents, lotions, or soaps. States he has been applying calamine and Neosporin to affected areas and that the skin eruption seems to be improving. Pt reports to provider for documentation purposes. Pt did not wish to come to the clinic for follow up, notified provider in passing her in the grocery store.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report refers to a 4-months old patient of unspecified gender, with no known drug allergies and no illness at time of vaccination.. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 11-JAN-2014 at 9:00 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient was revaccinated on 01-APR-2014 (the reporter reported the outcome as recovered on 01-APR-2014). No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
color pale, t102.7, c/o stomach pain, nausea, lying down w/wash cloth on forehead x 2 hrs; sore arm;
Both shot areas were hot and red --- Pneumo (right side) more severe.  I was nauseated and weak for several days.  Internal Medicine instructed me to ice the areas and take pain reliever.  I contacted the pharmacy per dr's instruction & was told to take benedryl, ice the areas and apply cortisone creme.  lt's been since the 9th of the month & I'm still feeling tired, but the swelling/redness is almost gone but my arms 'ache' slightly when I carry any weight with them.
No symptoms being reported; patient received first dose GARDASIL 9 in April 11, 2019 but missed second dose. Patient to receive second dose in office today, 3/2/2020; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 11-APR-2019 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route, lot number and expiration date were not reported) for prophylaxis. The patient missed the second dose schedule and received second dose in the reporter's office on 02-MAR-2020 (inappropriate schedule of product administration). First dose was administered at another facility. No symptoms were being reported.
Esophageal spasms lasting three hours; Hives over full body 7 days after injection; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 2613) via an unspecified route of administration on 24Mar2021 at 15:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, 7 days after injection, at 04:00, the patient experienced hives over full body which lasted for 48 hours and esophageal spasm which lasted for 3 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events hives and esophageal spasm which included treatment with Benadryl. The clinical outcome of the event esophageal spasm was recovered on 30Mar2021 at 07:00 while hives recovered on 01Apr2021.  No follow-up attempts are possible. No further information is expected.
swelling @ site of administration sz w/fever @ 48hr p/vax;dx w/ROM in ER;@ time of ER visit T103R:
I received vaccine on Friday, April 23 at 1:10 PM. Over the next 3 days had a sore arm. The only other symptom was a heart flutter that lasted 20 to 30 seconds on 3 or 4 occasions.  On Tuesday, April 27, I again had a heart flutter, I felt like I was going to faint, my blood pressure dropped to 92/52 while sitting, my temples were sore, and I had a slight elevation in temperature of 1 degree.  I saw the doctor the next day, he ran: 1. blood work (it came back normal), 2. an EKG (which was normal), and 3. ordered a Heart Monitor (I began wearing it the morning May 7 and will wear it until May 21.) For three days my BP was off and on in the 90s/50s range most of the time and I did not feel the best. The doctor suggested that this may be related to my body adjusting to the first dose of the Pfizer vaccine, though he is not for sure that it is.  I had Covid at the end of January (1st symptoms  the 19th) and received the Regeneron monoclonal antibody infusion on January 22. . It seemed as though I recovered well within a few days- only a few Heart flutters during the first few days after the infusion.  I waited the prescribed 90 days prior to receiving the vaccine.
Information has been received from a registered nurse concerning a 20 week old infant who was vaccinated on 04-DEC-2005 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.