chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Noticed a complete change in the veins in her hands; Blood vessels have shrunk,she can barely see them; Ice cold hands; This spontaneous case was reported by a consumer and describes the occurrence of VEIN DISORDER (Noticed a complete change in the veins in her hands), STENOSIS (Blood vessels have shrunk,she can barely see them) and FEELING COLD (Ice cold hands) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN and AMLODIPINE for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VEIN DISORDER (Noticed a complete change in the veins in her hands), STENOSIS (Blood vessels have shrunk,she can barely see them) and FEELING COLD (Ice cold hands). At the time of the report, VEIN DISORDER (Noticed a complete change in the veins in her hands), STENOSIS (Blood vessels have shrunk,she can barely see them) and FEELING COLD (Ice cold hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-043635 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: no new information; Sender's Comments:  MOD21-043635:Non-significant follow up contact information updated
Delayed inflammation at the injection site began on day 11 after the shot was administered.  The inflammation started as a nickel-sized itchy, red area  that was warm to the touch.  At its peak on day 4, the area was quarter-sized and still red and very itchy.    Hydrocortisone Cream 1% was used twice a day to relieve the itching. The inflamed area began fading on the evening of day 4 and was completely gone on day 10.
This case was reported by a other health professional and described the occurrence of overdose in a 3-year-old male patient who received FLULAVAL QUADRIVALENT (batch number 579G3, expiry date 20th April 2015). On an unknown date, the patient received FLULAVAL QUADRIVALENT .25 ml. On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.
if thrush is also a side-effect from / since I've had both shots; This case was reported by a consumer and described the occurrence of thrush in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced thrush. On an unknown date, the outcome of the thrush was recovered/resolved.   It was unknown if the reporter considered the thrush to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving 1st dose of Shingrix, the patient experienced thrush. The patient said I was wondering if thrush is also a side effect from Shingrix. The reporter did not consent to follow up. This case has been linked with US2020AMR245377, reported by same reporter and same patient.
Chills, headache, dehydration, syncope - 12 hours post-dose
DRUG EXPOSURE VIA BREAST MILK; This spontaneous report received from a consumer concerned a 3 week old patient of unspecified sex. The patient's weight, height, and medical history were not reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced drug exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug exposure via breast milk was not reported. This report was non-serious. This parent/child case is linked to 20210347093.
104 temp x 3 days. Starting on 8/21/04. Then 27th-29th 101 fever. Pt c/o aching all over, these dates.
Arthralgia. This is after the 1st booster shot (3rd shot). A day after the vaccination (less than 48 hrs), there is a pain in the joint of my right knee. The pain has persisted for the last 3 days. When I put weight on my right leg, there is a sharp pain in the knee joint.  The pain dissipates and dulls after taking long walk. My knees and joints have been health, experienced no physical injury or any kind of problem before. (This booster shoot was done where I have been visiting).
read around the site and more swollen; fever of 101 or less; chills; injection site pain; Headache; body aches; nausea; read around the site and more swollen; administration date 15Jan2021; This is a spontaneous report from a contactable nurse (patient herself). A 33-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), intramuscular in the left arm on 15Jan2021 16:00 at single dose for COVID-19 immunisation.  Medical history included ulcerative colitis, depression, and incomplete lupus. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included vedolizumab (ENTYVIO), and fluoxetine hydrochloride (PROZAC). The patient previously took first dose of bnt162b2 (lot number: EK9231, expiry date not reported), intramuscular in the right arm on 29Dec2020 at 12:00 PM at single dose for COVID-19 immunisation. The patient verbalized, "The day after the second vaccine I had a fever of 101 or less, chills, injection site pain, headache, body aches especially in my lower back and neck ,and some nausea. I took Tylenol which helped with the fever, but the headache continued that day. On the second to hear from vaccine I continued to have a fever and chills with some body aches but improving. On the second day I noticed the injection site was not only painful but read around the site and more swollen. Currently it is Tuesday and I no longer have a fever but continue to have injection site pain, redness, swelling. I have an appointment to follow up with my doctor for any further recommendations." Clinical outcome of fever was recovered on an unspecified date; for pyrexia, chills, and body aches was resolving; while for the other events was unknown.
Severe nausea and vomiting 2-3 hr after vaccine administration. Sent to ER for supportive care. Found to be pale, lethargic, rehydrated. Diarrhea next day.
red rash below the injection site; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red rash below the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch:unknown ) for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported  The outcome of the event, red rash below the injection site was unknown.
12/23/2020 Pfizer Covid vaccine 1/12/2021 Pfizer Covid vaccine 8/2/2021 tested positive for Covid with PCR test 8/13/21 potential to return to work
This spontaneous report as received from a patient's friend refers to a 17 year old female patient. The patient's concurrent conditions and medical history were not reported. On 04-AUG-2015 (reported as 1 week ago), the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. On 10-AUG-2015, the patient acquired a swollen lymph node behind the shoulder by the injection site that was causing pain. On an unknown date, the patient had computerized tomography scan and magnetic resonance imaging with no results reported. There was no treatment given to the patient for the events. The outcome of the events was reported as not recovered. The patient sought medical attention. The relatedness between the events and the GARDASIL was not reported. Additional information is not expected, as no contact details were provided.
In area below injection site patient complained of redness, itching, inflammation.  Patient will try diphenhydramine on 10/07/2010 after pharmacist consultation.
Patient called clinic to report dizziness and a fast heartbeat after receiving MMR vaccine. Advised patient to report to Emergency Room if symptoms worsen.
I started with a fever at 1pm the day of vaccine and was tired. The next morning I woke up with a rash on my neck and had fever, and horrible diarrhea . At around 1, I got Benadryl, took two. The rash kept spreading. The rash spread and continued too until after I had safety taken Benadryl 3 times. It was on my neck, chest, and back of neck and inside elbow  of my right arm.  My rash cleared mostly by the next morning. But my diarrhea did not. And seems to have finally settled down kinda today. I have only had 4 trips today to the restroom with diarrhea. Other than that, I?m fine, you can still barely see my rash. I can tell it?s still slightly pink. But it?s gone enough.
Low grade fever, sore throat, joint pain (knees and hips) nausea, swollen lymph node in arm pit of injection side, bad uterine cramping 2 weeks out from expected menstrual start, fatigue and mild headache
PATIENT RECEIVE A JANNSEN VACCINE FROM AN OPEN BOTTLE FROM THE DAY BEFORE. THE VACCINE BOTTLE WAS OPENED ON 12/09/21 AT 9AM AND PUT BACK IN THE FRIDGE.  THE NURSE USE THIS SAME BOTTLE AND DREW 2 DOSES ON 12/10/21 MORNING AND GAVE IT TO PATIENT.  PHARMACY CALLED PATIENT ON SATURDAY 12/11/21.  PATIENT REPORTED HE AND HIS WIFE WERE DOING FINE.  NO UNUSUAL SIDE EFECTS.  IT WAS SIMILAR TO HIS FIRST DOSE OF JANSSEN VACCINE.
Rash Vesicular; Pruritus; Acarodermatitis; Vomiting Information has been received from a registered nurse (RN) concerning a 6 year old healthy male with no allergies or medical history who on 26-SEP-2005 was vaccinated SC in the left arm with a dose of varicella virus vaccine live (Oka/Merck) (Lot#651176/0424R). Concomitant vaccinations on that same day included the third IM dose in the right arm of hepatitis B virus vaccine rHBsAG (yeast) (MSD) (Lot#650044/0004R). An SC dose in the left arm of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (Lot#647563/0578R), an IM dose in the right arm of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (DAPTACEL) (Lot#C2254AA) and an SC dose in the right arm of poliovirus vaccine inactivated (Vero) (Lot#X0324). The RN reported that on 04-OCT-2005, the patient developed an itchy papulo-vesicular rash on his chest, abdomen and legs. The patient was also noted to have vomited once. The patient was seen in a physician's office and was treated with diphenhydramine HCL (Benadryl). No laboratory/diagnostic tests were performed. On 02-DEC-2005, the patient was again seen in the physician's office with rash that was subsequently diagnoses as scabies. The patient was treated with Permethrin (ELIMITE CREAM). At the time of this report the outcome was unknown. The RN felt that the patient's itchy papulo-vesicular rash and vomiting were not due to vaccination with varicella virus vaccine live (Oka/Merck). Additional information is not expected.
Got all the shots but got them/ suspected vaccination failure; Shingles; Postherpetic neuralgia; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included covid-19 (twice). Previously administered products included Covid vaccine (unknown dose received on an unknown date ).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got all the shots but got them/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and post herpetic neuralgia (Verbatim: Postherpetic neuralgia). The outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received all Shingles vaccines. The patient stated that the vaccines are 90 percentage effective and he or she is in the wrong 10 percentage. The patient tried so hard to not get shingles but experienced shingles anyway and now had post herpetic neuralgia. The patient received all doses of Covid vaccine and experienced corona twice so far. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
slight dizziness; no appetite; Fever; chills; sever head ache; feels real tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (slight dizziness), DECREASED APPETITE (no appetite), PYREXIA (Fever), CHILLS (chills) and HEADACHE (sever head ache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not available) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Diabetes.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DIZZINESS (slight dizziness), DECREASED APPETITE (no appetite), PYREXIA (Fever), CHILLS (chills), HEADACHE (sever head ache) and FATIGUE (feels real tired). At the time of the report, DIZZINESS (slight dizziness), DECREASED APPETITE (no appetite), PYREXIA (Fever), CHILLS (chills), HEADACHE (sever head ache) and FATIGUE (feels real tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt recvd 1st dose of Engerix-B & devel flu-like sx which led to hospitalization w/acute demyelination as the primary dx; sx include an impaired gait, impaired vision, impaired speech, & numbness;
On Sat. 3-13-2021 at 11:53am, Janssen covid shot was administered in left arm.  Approximately 3 hours later, at about 3:10pm, I started seeing bright flashing arcs of light in my upper left vision.  I wondered if these were precursors of a migraine coming, but mine normally are crackles of primary colors in the center of my vision.  I remembered the vitreous detachment in my right eye 5 years ago.  This seemed similar, but not very similar.  Around 6pm I noticed a largish donut in my left eye vision, which I've never seen before.  About 7:30pm I called the consulting nurse, who told me to go to Urgent Care.  Got there about 8pm.  The MD thought it was a vitreous detachment, but wanted to get an OD on the phone. Additional floaters appeared in my left eye vision while I waited.  OD via phone thought it was a vitreous detachment and set up an appointment to see me on Mon. 3-15-2021.  Flashing arcs/donut/floaters continued through the next day.  Last flashing arcs were about noon on Mon. 3-15-2021.  In total the flashing arcs lasted about 45 hours.  5 years ago, in the right eye, flashing lights lasted only 5-10 minutes. On Mon. 3-15-2021 had eye exam. OD said posterior vitreous detachment (PVD).  Wanted second opinion about my retina.  Second OD performed exam, agreed on PVD and that my retina looked okay. On Fri. 4-2-2021 had follow-up exam with same OD.  Retina looked good.  Floaters are diminishing. What terrible timing if this was a coincidence.  It made everything post-covid-shot very confusing.
MMR/Varicella (PROQUAD) given on 5/15/15. By 5/17 pt had egg sized area with cluster of fluid filled blisters. Itchy. By 5/19 when reported by mom where already dried up. No other sx.
booster shot; became terribly ill; fever; she felt numb and that she could not move.; she felt numb and that she could not move.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient in her 70's received bnt162b2 (COMIRNATY), administration date 08Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "original Covid Virus" (unspecified if ongoing), notes: in Apr (unspecified year). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Manfacturer: Pfizer), for COVID-19 Immunization; Bnt162b2 (Dose:2, Manfacturer: Pfizer), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster shot"; ILLNESS (non-serious) with onset 08Dec2021, outcome "unknown", described as "became terribly ill"; PYREXIA (non-serious) with onset 08Dec2021, outcome "unknown", described as "fever"; HYPOAESTHESIA (non-serious), MOVEMENT DISORDER (non-serious) all with onset 08Dec2021, outcome "unknown" and all described as "she felt numb and that she could not move.".  Additional information: The patient was in her 70s. The patient got sick from the original Covid Virus in Apr. Then the patient got two Pfizer Covid Vaccines, then 08Dec2021 the patient got seriously ill when she got the booster shot. The patient had a fever and all the original symptoms she experienced with the Covid-19 virus. One serious thing was that she felt numb and that she could not move. She asked her son to bring the walker to help her site up and walk, go to the bathroom which helped her to breath and come out from that numbness. The reporter stated that it was strange that within a few hours she got sick from the booster. The reporter was asked what the test showed after getting sick and having the vaccine. The reporter was unsure of the type of test, so unable to provide an answer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
puking, feverish and laid up in bed; Initial information received on 15-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient). This case involves an adult patient with an unknown demographics who experienced puking, feverish and laid up in bed (pyrexia), while he/she received vaccine Influenza Vaccine.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, patient stated that he/she had been getting them since he/she was 21 and for 26 years not a problem. He/she gotten sick but not dragging it out for days, puking, feverish and laid up in bed (pyrexia) (Unknown latency) following the administration of Influenza Vaccine.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.   There will be no information available on batch number for this case.
Felt progressively weaker; Disturbing dreams; Neck pain; Shoulder pain; Intermittent cramps; Spotting; Terrible headache; Trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EW0164) via an unspecified route of administration, administered in Arm Left on 21Apr2021 08:15 (age at vaccination 38-years-old) as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included melatonin (MANFACTURER UNKNOWN); ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 21:30, after the first vaccine, the patient felt progressively weaker over the course of 2 weeks which ended with terrible headache and trouble breathing on an unknown date in 2021. On an unknown date in Apr2021, the patient had disturbing dreams, neck and shoulder pain for approx. 1 week after first shot. On an unknown date in 2021, the patient also had intermittent cramps not part of menstrual cycle and spotting which the patient doesn't normally had since the patient had been on birth control. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0179) via an unspecified route of administration in the left arm on12May2021 at 09:00 (at the age of 38-years-old) as a single dose for COVID-19 immunization. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 05May2021. The clinical outcome of the events was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
LETHARGY; DIARRHEA; SORE ARM; MINOR HEADACHE; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, chronic anxiety, and depression. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination on left deltoid. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 26-MAR-2021, the subject experienced lethargy. On 26-MAR-2021, the subject experienced diarrhea. On 26-MAR-2021, the subject experienced sore arm. On 26-MAR-2021, the subject experienced minor headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minor headache on MAR-2021, and had not recovered from sore arm, lethargy, and diarrhea. This report was non-serious.
Symptoms:  01/29/2021 @ 11:21 AM: Shortness of breath, chest pain, and weakness.  Two hours later, chest pain began to feel like chest tightness. Continued for the rest of the day.  01/30/2021: Mild irritation when breathing. Getting out of breath when minimal effort in an activity.  A sensation of an increased heartbeat when in reality, it would be 92 BMP. General weakness and dizziness.  01/31/2021: Same symptoms as mentioned. While taking a deep breath, I feel a mild pain around my heart.