chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received on 13 August 2012 via a search of the scientific literature. The following is verbatim per the literature citation: "Introduction: Guillain-Barre syndrome (GBS) is the most feared consequence of influenza vaccination. GBS was reported with the swine influenza vaccine in 1976, affecting approximately 1/100,000 (5-10 times the prevalence rate). Objective: During the fall of 2010, the authors saw four patients who developed GBS as a consequence of swine influenza vaccination. Methods/Results: The patients received vaccination between 10 and 30 days before onset of the first symptom. Two patients had predominantly sensory ataxia, areflexia, extremity and oropharyngeal numbness and paresthesia, and extremity pain. One patient had typical Miller-Fisher variant of GBS and the other developed perianal, groin, and limb numbness; oropharyngeal paresthesias; bowel incontinence; and urinary retention. The latter patient rapidly progressed into quadriparesis, right facial palsy, and areflexia. All patients had elevated cerebrospinal fluid protein. Three patients had sural sparing on nerve conduction studies, and one had absent F waves with abundant A waves; the patient with Miller-Fisher syndrome had normal needle electromyography. All patients were treated with intravenous immunoglobulin (IVIg). Three had excellent recovery within a few months; however, the patient who relapsed had an evidence of axonal loss in the legs, needed a repeat 5-day course of IVIg, and had a slow improvement. Conclusion: GBS may follow the contemporary swine influenza vaccination and may manifest atypically with predominant ataxia, sphincteric disturbance, or Miller-Fisher syndrome. Studies with larger cohorts are necessary to determine the incidence of this consequence of influenza vaccine." Documents held by sender: none.
Stomach hurt/nausea; Dizziness; Stomach hurt/nausea; Fever(99.5); Hot swollen itchy painful lump at injection site that is getting bigger; Blood sugar has been higher since getting the shot; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar has been higher since getting the shot), VACCINATION SITE MASS (Hot swollen itchy painful lump at injection site that is getting bigger), ABDOMINAL PAIN UPPER (Stomach hurt/nausea), DIZZINESS (Dizziness) and NAUSEA (Stomach hurt/nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included GABAPENTIN for an unknown indication.    On 06-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 BLOOD GLUCOSE INCREASED (Blood sugar has been higher since getting the shot). On 09-Mar-2021, the patient experienced VACCINATION SITE MASS (Hot swollen itchy painful lump at injection site that is getting bigger). On 13-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach hurt/nausea), DIZZINESS (Dizziness), NAUSEA (Stomach hurt/nausea) and PYREXIA (Fever(99.5)). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar has been higher since getting the shot), VACCINATION SITE MASS (Hot swollen itchy painful lump at injection site that is getting bigger), ABDOMINAL PAIN UPPER (Stomach hurt/nausea), DIZZINESS (Dizziness), NAUSEA (Stomach hurt/nausea) and PYREXIA (Fever(99.5)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Blood glucose: high (High) blood sugar has been higher since getting the shot. On 13-Mar-2021, Body temperature: 99.5 (Inconclusive) Fever 99.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient post receiving their first dose of vaccine reported that their blood sugar has been higher since getting the shot and on 09-Mar-2021, the patient developed a hot swollen itchy painful lump at the injection site and that was getting bigger. On 13-Mar-2021, the patient experienced dizziness, fever of 99.5, stomach hurt and nausea. Reportedly, all these symptoms were still ongoing at the time of report.  Concomitant medication used by the patient also included Blood pressure medications.  No treatment information was provided.
Patient called stating he was not feeling well feeling fatigued and quite ill on 10/11/22; on 10/13/22 patient's wife called stating the patient had developed blisters
My menstrual cycle started immediately when I was given the shot. It was one week early. The period was extremely extremely heavy. I had severe cramping while bleeding that kept me awake into the night. I do not usually have cramping with my periods.
ADMINISTRATION ERROR We had our drive through influenza clinic at our hall.  We utilize volunteers throughout, including volunteer nurses. We administered the High Dose influenza meant for 65 and older to this 58 year old.
Information has been received on 05-FEB-2019 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) on or about 20-JUN-2016 at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster also known as shingles and other complications. The patient was treated at a medical center for a blistering vesicular outbreak which was diagnosed as severe varicella pneumonia.  As a direct and proximate result of the vaccine ZOSTAVAX and/or despite receiving ZOSTAVAX for long term prevention of shingles,  the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, severe varicella pneumonia was determined to be a medically significant event. Additional information has been requested.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 69-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius (explicitly coded as incorrect product storage). On 12-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location, left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805492 was crossed linked to original cases 201804863 due to same reporter.
Hospitalized weakness, fatigue, cough. treated with remdesivir no O2 needed.
Client and L reported a hive like area on her neck and upper arm and a feeling of unwellness. Vital Signs O2 sat 97% Pulse 75 BP 120/80,repeat vitals x2 pulse76 O2 sat 98% BP 130/80. Redness on throat and arms much less. Client reports small itchy rash on legs.at 1 :30 PM. Client is awake, ,alert oriented,and eating lunch. She feels better.
3/15/23 I noticed a couple of lumps on my neck. A week or so later they had not gone away. I went to the doctor on March 23, 2023. I had bloodwork which was all normal. I was prescribed cephalexin which I began taking that day. The lumps did not go away, so I went back to the doctor on April 11, 2023. I have a CT scheduled.
This spontaneous report as received from a 58 years old female registered nurse refers to herself with allergy to thimerosal, latex and penicillin and no pertinent medical history. On 18-JAN-2013 the patient was vaccinated subcutaneously in her right arm with a 0.65 ml dose of ZOSTAVAX (lot# not reported). There was no other concomitant medication. It was reported regarding ZOSTAVAX administered to her on 18-JAN-2013 and swelling at the injection site. Nurse experienced swelling, redness and pain that went down her entire arm to her elbow and also a swollen lymph node under her right arm. Arm compresses administered to treat swollen area of arm. None lab diagnostics studies were performed. The patient did not seek medical attention. The outcome of the events was unknown. The relatedness for the events unknown for ZOSTAVAX. Additional information has been requested.
Right thigh red swollen hot to touch, Keflex 290 T/D, 08/04/2005 increased redness, increased Keflex to 500mg B/D, better 08/05/2005, 08/08/2005 better.
I had a swollen lymph node above my collarbone on the same side of my body the Moderna booster was given.
cold feeling in her chest; bordering on chills; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 14Feb2021 (Batch/Lot Number: EL9263) as single dose for covid-19 immunisation. The first dose was received on 24Jan2021 13:15 (lot number: EL3247) on the left arm. There were no medical history. Concomitant medication included curcuma longa (TURMERIC), ubidecarenone (CO-Q10-CHLORELLA), ergocalciferol (VIT D), monascus purpureus (RED YEAST RICE) and vitamin b complex. Patient had not received any other vaccine 4 weeks prior to COVID vaccine. About 2 days after the shot on 16Feb2021 13:15, patient experienced a cold feeling in her chest that lasted all day, bordering on chills, but not to that point. Eventually, the cold feeling was isolated in the center of her chest, and present, off and on during the day. While playing tennis 3-4 times, the cold feeling returned, and patient became lightheaded and had to lie down. It was like a wave that went away and she could return to play. Patient reported that she still have that feeling just under her breastbone. No treatment was received for the events. Outcome of the events was not recovered. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested post-vaccination (nasal swab) on 25Feb2021: negative.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 60-year-old female patient. Information about the patient's concurrent condition, concomitant medication or medical history was not provided.  On 04-FEB-2014, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, lot # and expiration date were not provided) for prophylaxis. As a result of her receipt of vaccination, on 14-APR-2014 it was caused to suffer shingles, including all its sequelae. It has been caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and medications. At the time of the report, the patient's outcome was unknown, and the reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered the event to be disabling.
I started to develop GI symptoms shortly after the vaccine. They have diagnosed crohns colitis.
Rash around her navel and left side of stomach; Redness on her arm near the injection site; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th July 2019, 1 days after receiving Shingrix, the patient experienced localized erythema. On 30th July 2019, the patient experienced rash. The patient was treated with prednisone. On an unknown date, the outcome of the localized erythema and rash were resolved with sequelae.   It was unknown if the reporter considered the localized erythema and rash to be related to Shingrix.  Additional details were provided as follows: The patient experienced redness on her arm near the injection site. The patient also experienced big rash around her navel and left side of stomach. The patient went to a dermatologist and said it was a reaction to Shingrix. Dermatologist prescribed prednisone tablets and a spray. The patient did not consent to follow up. The patient stated that the primary care physician did not recommend 2nd dose. Dermatologist suggested to patient that 2nd dose reaction might be worse. This case has been linked with case US2019AMR158816, reported by the same reporter.
PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 15-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Parents state, sudden onset of unconsolable crying, fussiness, moaning. Seen by DR approx 3-4 hrs after onset; pt still irritable & slightly lethargic. Nml exam; afebrile. Pt discharged home. Parents report pt at baseline.
Nausea, chills, high fever, throwing up, major headache, body aches.
Complex partial seizure 3- 5 minutes in length. Deviated eyes, blank stare, limpness, weird breathing pattern, postictal sleep for one hour. *Captured on video. 60 Day follow up: seizure disorder; speech delay (is not talking); elevated liver enzymes. Per follow up report-onging seizure disorder, elevated liver enzymes, developmental delays speech and sensory. Mother is now convinced the immunizations caused sons problems. He was vaccinated 22 shots in 6 months. Her son and daughter who are older and healthy had 1/2 the amount of shots their first six months of live. In the 2.5 years that my daughter was born and then younger son immunization schedule was changed. Many more immunizations were being given to infants in their early months of life. I don't understand the rush. Why not spread the immunizations out over the first 5 years of life? Why not go to single immunizations? Pediarix is terrible how it combines many vaccines at once. There is no need for this. I'm sure parents would rather have healthy children and more pricks than less pricks and unhealthy children. Also, why not test the titers of children before administering Booster shots. The titers of my children are sky high. They do not need Booster shots for the diseases they have already been vaccinated for. Our life and the life of our son is now forever changed because of an aggressive immunization schedule. Additionally, the medical bills we have incurred over the last 2 years are extremely high. They have no help in paying these bills. Mother knows they are not alone in sharing these opionons. She thinks the epidemic of Austistic children in this country needs immediate attention especialy with the big incidence occurring in boys.
16 yr old female feeling faint & then had seizure within a few min. /p Td/MMR immunization.  MD is uncertain if seizure was due to hyperventilation episode. No treatment initiated. Pt asymptomatic. Vaccine given routine
chills, fever, muscle aches (especially in back), pain around injection site, fatigue, pain/strain along armpit (arm of injection site)
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; SORE ARM; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included: confirmed covid-19 infection, and other pre-existing medical conditions included: On 05-JAN-2021 (one year ago), the patient had PCR (polymerase chain reaction) test and was confirmed with Covid-19 prior to receiving the Janssen Covid-19 vaccine. The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 1) (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 26-JUL-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 26-JUL-2021, after vaccination the patient experienced sore arm for a day and no other side effects. On 02-JAN-2022, the patient experienced congestion, runny nose, and intermittent cough (subsumed under suspected Covid-19 infection). She noted that she thought her symptoms were consistent with a cold. On 05-JAN-2022, the patient took Abbott Binax now home rapid test and was tested positive, hence Suspected clinical vaccination failure (dose number in series 1). The patient reported, she followed up with the county for confirmation of the rapid test result with another 4872-hour test (PCR (polymerase chain reaction) Covid-19 test) performed on 05-JAN-2022, the result was pending. The patient reported, she went to the new year weekend with her husband, and they were exposed to many other people in number of social settings. The patient reported, she received confirmation on same day that one of those settings she might have come into contact with 3 people who now have confirmed positive covid-19. The patient said she let her employer and work know she had an exposure to someone who tested positive. The patient noted she tested herself before attending these social gatherings to be safe and ensure she was not the source of any infection for others. The patient also reported, she performed a rapid home test for covid-19 today, along with her husband. The patient reported her husband tested negative, but that she tested positive on the rapid test.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 27-JUL-2021, had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220107289. This report was associated with product quality complaint: 90000210423.; Sender's Comments: V0: 20220107982-JANSSEN 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.
waves of dizziness; loss of appetite; Nausea; is very tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (waves of dizziness), DECREASED APPETITE (loss of appetite), NAUSEA (Nausea) and FATIGUE (is very tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (waves of dizziness), DECREASED APPETITE (loss of appetite), NAUSEA (Nausea) and FATIGUE (is very tired). On 05-Mar-2021, DIZZINESS (waves of dizziness), DECREASED APPETITE (loss of appetite), NAUSEA (Nausea) and FATIGUE (is very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Updated outcome of events from Unknown to Recovered/Resolved
pt recvd vax 1030AM premedicated w/APAP started crying inconsolably @ 3PM; seen in office @ 5PM; screaming; no inc crying w/pressure applied to thighs; mom had been giving APAP every 4 hrs; mom now reports pt's father had react to pertussis
Trouble Breathing / Throat Closure for about 4 hours the night of the vaccination delivered.
Patient began exhibiting signs of allergic reaction, reddening of skin and burning sensation. Patient denies any shortness of breath and does not exhibit signs of anaphylaxis. Patient administered 25mg of Benadryl for symptoms. Patient is instructed to wait longer in observation. Patient does not go on to develop any anaphylaxis signs or symptoms. Patient released and instructed to call ED if symptoms worsens.
ICU admission: rule out Guillan-Barre Syndrome vs. Myasthenia vs. myopathy.
POSITIVE COVID TEST 4/5/21. PATIENT ASYMPTOMATIC AND PRESENTS TO ED FOR A FALL. NON-COVID RELATED ICU ADMISSION
Hard painful lump in left armpit; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 04Mar2021 at 09:00 (at the age of 37-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 24Mar2021 at 14:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. It was unknown if patient had any allergies to medications, food, or other products. Concomitant medications included unspecified hair, skin and nails vitamins (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown start date. 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 COVID vaccine. On 06Mar2021 at 03:00, the patient experienced hard painful lump in left armpit. The patient stated that she developed a hard painful lump in left armpit a few days after getting the first shot which was about the size of an egg. After getting acupuncture, lump went down and after the second shot it came back, but was not as painful and went away on its own. Therapeutic measure was taken as a result of adverse event and included treatment with acupuncture. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event hard painful lump in left armpit was resolved on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.