chrisvoncsefalvay/vaers-outcomes huggingface dataset:
herpes zoster; Information has been received regarding a case in litigation from an attorney reporting on a patient (pt) of unknown age and gender. There was no information about the pt's concurrent conditions, medical history or concomitant medication.  On or about 11-AUG-2011, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider at the office of a physician for the long-term prevention of shingles and/or zoster-related conditions (dose, route of administration, lot number and expiration date were not reported).  Subsequently to the pt vaccination with zoster vaccine live (ZOSTAVAX), on an unknown date, the pt was treated by the physician for Herpes zoster. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX)vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of Herpes zoster was not provided.
red inflamed gums and feel unhealthy; itchy all over but mostly on her head; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy all over but mostly on her head) and NONINFECTIVE GINGIVITIS (red inflamed gums and feel unhealthy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (itchy all over but mostly on her head). On an unknown date, the patient experienced NONINFECTIVE GINGIVITIS (red inflamed gums and feel unhealthy). At the time of the report, PRURITUS (itchy all over but mostly on her head) and NONINFECTIVE GINGIVITIS (red inflamed gums and feel unhealthy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.  Concomitant products included blood pressure pills and heart pills. Patient rinsed mouth with salt and water for the treatment as per health care professional.
Information has been received from a physician assistant (PA) concerning a 19 year old female patient with no known drug reaction/allergies and no other pertinent medical history, who on 13-JAN-2012 was vaccinated with her second dose of GARDASIL into the left deltoid (route, dose and lot number not reported). The date of the first vaccination was unspecified. Concomitant therapy included ACCUTANE. The PA reported that a couple of hours after the second dose GARDASIL, the patient developed an injection site reaction. The injection site reaction was described as a large red erythematous area at injection site (left deltoid) about 10 cm in diameter. The injection site reaction resolved after an unspecified time period with treatment with ice and unspecified anti-inflammatories. The patient contacted the office for medical attention. No lab diagnostic studies were performed. At the time of the report, the patient had recovered. Injection site reaction and large red erythematous area at injection site were considered to be disabling by the reporter, since the patient had an inability to perform unspecified activities associated with daily living. Additional information has been requested.
PT COMPAINS OF RASH ON HIS FACE: RIGHT CHEEK, ACROSS THE NOSE, ON THE FOREHEAD, LIGHT LEFT CHEEK, AND ON THE CHIN. HE TRIED GOING TO HIS PCP BUT THEY ARE OUT OF OFFICE SO HE WAS REFERRED TO URGENT CARE.
I have a UTI; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) of unspecified age received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0173) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient had a urinary tract infection on an unspecified date. Therapeutic measures were taken as a result of urinary tract infection and included treatment with sulfamethoxazole, trimethoprim (BACTRIM). The outcome of the event was unknown. The patient was scheduled to take the second dose on 01Jun2021 (tomorrow) however she was currently having urinary tract infection. The patient wanted to know if it is okay to have second dose on 01Jun2021.  No follow-up attempts are needed. No further information is expected.
Patient describes feeling very lethargic and heart feeling "funny". Swelling at injection site with some peeling and redness.
This is a spontaneous report from a contactable nurse (the patient). A 25 year-old female patient of unspecified ethnicity received PREVNAR 13 at a single dose and flu vaccine (manufacturer unknown) at an unknown dose both via an unspecified route of administration on arm, on an unspecified date in 2015. Relevant medical history included myelodysplastic syndrome and she was immunosuppressed both ongoing. Somewhere the patient had received transfusion every 6-8 weeks. Concomitant medications were not reported. The day after the vaccination in 2015, the patient did not feel well, she felt terrible and sick. She had extreme exhaustion to the point where she could barely put one foot in front of the other. The patient underwent blood work and the hemoglobin went from 8.7 to 6.9 (unit unspecified) and she was transfused. The outcome of the events was unknown. Causality was not available.
My wife had her first shot on May 11. Has she waited too long to get the second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (My wife had her first shot on May 11. Has she waited too long to get the second shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (My wife had her first shot on May 11. Has she waited too long to get the second shot). On 11-May-2021, PRODUCT DOSE OMISSION ISSUE (My wife had her first shot on May 11. Has she waited too long to get the second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 05/06/2022. I had a headache, sinus issues and sore throat (lost my voice). I contacted my doctor and they prescribed PAXLOVID and I felt much better.
fever; HEADACHE; achy and sore; This is a spontaneous report from a non-contactable consumer. A 29-year-old male consumer reported for himself that he received a dose of BNT162B2 (COMIRNATY, Lot number: unknown, Expiry date: Unknown) on an unknown date as a single dose for COVID-19 immunization. The reporter mentioned that he is currently suffering achy and sore all over, slight fever and headache. The clinical outcome of the events were unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Left arm started hurting in upper arm, stiff, then recently has moved down arm to elbow area.
This case involves a 8 months old female patient who had experienced an event was only given the liquid portion of the vaccine and HCP would like to know if he powder portion of the vaccine can be reconstituted and given as a separate injection with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Dec-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE injection (strength: unknown) at the dose of 0.6 ml once via route intramuscular (batch number: UJ473AAA, expiry date: 09-jul-2022) via unknown administration site for indication prophylactic indication. On 20-DEC-2021 the patient developed a non-serious event "was only given the liquid portion of the vaccine and HCP would like to know if he powder portion of the vaccine can be reconstituted and given as a separate injection with no reported adverse event" (product preparation issue) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) /HIB(PRP/T) VACCINE. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable. At time of reporting, the outcome was Unknown for the event was only gave the liquid portion of the vaccine and HCP would like to know if he powder portion of the vaccine can be reconstituted and given as a separate injection with no reported adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt recv vax on 10/21/98; on same day pt exp aching all over, cough & sore throat; on 10/23/99 pt exp fever (102)
Hives. Rash from head to toe. Itchy Tongue. BENADRYL 50mg PO. Pt sent to ED for further evaluation.
Arm was super sore and felt swollen. Felt numb at times. Slurred words 30 min after shot. Fatigued and exhausted causing me to sleep for hours. Felt like a hangover without the drinking. Another comparison is that it felt like the last day of being sick with the flu, just very groggy and not feeling 100 percent okay.
Felt like the room is spinning after her booster dose of the Moderna Covid-19  of balance/she has had episodes of the room spinning and feeling "off"; Patient says that her balance is off when she is walking.; patient complains of a sore left arm where the injection was; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (Felt like the room is spinning after her booster dose of the Moderna Covid-19  of balance/she has had episodes of the room spinning and feeling "off"), BALANCE DISORDER (Patient says that her balance is off when she is walking.) and VACCINATION SITE PAIN (patient complains of a sore left arm where the injection was) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Sep-2022, the patient experienced BALANCE DISORDER (Patient says that her balance is off when she is walking.) and VACCINATION SITE PAIN (patient complains of a sore left arm where the injection was). On 15-Sep-2022, the patient experienced VERTIGO (Felt like the room is spinning after her booster dose of the Moderna Covid-19  of balance/she has had episodes of the room spinning and feeling "off"). At the time of the report, VERTIGO (Felt like the room is spinning after her booster dose of the Moderna Covid-19  of balance/she has had episodes of the room spinning and feeling "off"), BALANCE DISORDER (Patient says that her balance is off when she is walking.) and VACCINATION SITE PAIN (patient complains of a sore left arm where the injection was) outcome was unknown.            No concomitant medications were reported.  On 25-Apr-2021, the patient received first dose of Moderna COVID-19 vaccine (lot number: 048B21A) in unspecified arm, second dose on 23-May-2021 (lot number: 005C21A and expiry date: 22-Oct-2021) in unspecified arm and first monovalent booster on 29-nov-2021 (lot number: unknown) in left arm.  No treatment medications were reported.   This case was linked to MOD-2022-646300 (Patient Link).
Patient diagnosed with intussusception on 12/24/17. This was reduced with an air contrast enema. It recurred on 12/26/17 and required a second reduction. Family visiting from another state when event occurred and required treatment locally. I do not know which brand of the rotavirus vaccine the patient received.
Dizzy, diaphoretic. Transported via wheelchair to medical screening for evaluation by medic. Left in stable condition at 15:44 p.m.  98/60                       114/75 Pulse 95                   92 97%                             98%  Recorded RN.
Felt hot, dizzy. Eased to floor. Pale, cyanotic, awake & alert. Elem. 12/9/09.
It was the same time I got the Pfizer vaccine I also got the shingles vaccine; It was the same time I got the Pfizer vaccine I also got the shingles vaccine; Had a slight fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), on 02Nov2022 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 02Nov2022, outcome "unknown" and all described as "It was the same time I got the Pfizer vaccine I also got the shingles vaccine"; PYREXIA (non-serious) with onset Nov2022, outcome "not recovered", described as "Had a slight fever".  Additional information: She explained that she had a slight fever after receiving the Pfizer-BioNTech COVID-19 Vaccine, bivalent, on Wednesday (02Nov2022). However, by today (Friday) (05Nov2022), she still felt the slight fever. She wanted to know if this was a normal symptom. Consumer stated that, this might not be important for your that it was the same time she got the bivalent vaccine and also got a shingles vaccine so this might not work for you.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, nausea, and tachycardia - lasting 24 hours after vaccine administration. No treatment. All symptoms resolved after 1 day.
Pt recvd Td vax 24JUN92; 18 hrs later a hive occurred @ inject site & was measured to be 3" by 5" & firm in center, itchy; 29JUN92 swelling going down;
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-JUN-2015, the patient was vaccinated with the third dose of improperly stored oral ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
She presented to the emergency department, by ambulance, from the a Care Center, for shortness of breath and hypoxia.   According to the nursing staff she os positive for Covid-19 (unsure of when she tested positive).   When the paramedics arrived, she was hypoxic and tachypneic, she was placed on supplemental oxygen at six liters per minute by nasal cannula, her oxygen saturation was then in the "80's" and she then was placed on twenty-five liters per minute by a non-rebreather and her oxygen saturation improved to 90%.  Disposition: She will be transferred today to nursing home on Hospice.
She began to run a fever, the fever was very high she had a seizure due to the fever, had to be taken to the ER.
Approximately 2 hours post vaccine I noticed my scalp feeling hot, tight, and tingly in the bilateral occipital area. Some neck pain and traveling from neck to scalp. Today is 3/17/21 and the symptoms are still present but somewhat improved over the last week. The sensations are now mostly on the R side. I took Advil 400mg TID for 2 days and also applied a heating pad to the neck and back of head. I saw my PCP today as this is causing me a lot of anxiety, she prescribed Prednisone 40mg daily X 3 days.
Nausea; Headache; Fever; This is a spontaneous report from contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8727) in the left arm on 29Mar2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included high blood pressure and idiopathic intracranial hypertension (IIH). The patient had a known allergy to sulfur medication. The patient's concomitant medications included amlodipine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and fexofenadine hydrochloride (Allegra) all from unknown dates for an unknown indications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA, lot Number: EN 6204) in the left arm on 08Mar2021 at 08:15 (at the age of 43-years-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021, the patient experienced nausea, headache and fever. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of headache, fever and nausea. The clinical outcome of the events of nausea, headache and fever was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Patient reported developing a large, egg-shaped whelp at the injection site with 3 to 4 hours post vaccination. She also reported experiencing some throat tightening/constriction but never had trouble breathing. She reported taking a Benadryl 25mg. Symptoms resolved after approximately 10 hours. No further complications reported.
Temp 102.5 lethargy for 24 hours. sepsis evaluation, clinical follow up.
Initial report received on 25 June 2013 and follow-up information received on 26 June 2013 from a healthcare professional. A 30-year-old female patient had received intramuscular first dose of ADACEL vaccine lot number: U4612AA in right deltoid on 25 June 2013. The patient was not sick at the time of vaccination. The patient had Penicillin and Sulfa drugs allergy. The patient had no serious reaction after receiving a vaccination in past. The patient had no history of cancer, leukemia, AIDS or any other immune system problem and did not receive any Cortisone, Prednisone, other steroids or anticancer drugs or had any X-ray treatment. The patient had not received a transfusion of blood or blood products or any immune (gamma) globulin in past 1 year. The patient did not receive any vaccination in the past 4 weeks. The patient's treatment for infertility, health during pregnancy and risk factors was reported as N/A. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 13 November 2012 and the estimated date of delivery was 20 August 2013. As of 25 June 2013, the patient did not experience any adverse event. List of documents held by the sender: none.
Can not lift or move arm.; Bad headache; shakes; nausea; clammy feeling; achy joints; Feel awful.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205); via an unspecified route of administration in the right arm (reported as right deltoid) on 23Mar2021 at 08:45 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma and elevated BP. The patient had known allergy to aspirin, monocyclin and a sulfate drug. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown); via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. On 23Mar2021 at 16:00, the patient could not move or lift her arm, experienced bad headache, shakes, nausea, clammy feeling and achy joints. The patient also felt awful. The patient did not receive any treatment for the adverse events. The clinical outcome of bad headache, shakes, nausea, clammy feeling and achy joints, felt awful and could not move or lift arm was not resolved. No follow-up attempts are needed. No further information expected.
The clinic did not see email to stop giving the original (monovalent) COVID until after the Moderna -monovalent was given on 9/2/22. The other 4 were administration errors, patients were given a dose of COVID monovalent instead of Bivalent by MA mistake. DOS 9/7/22, 9/9/22, 9/23/22, 9/30/22
pt recvd flu vax 27OCT93 c/o nausea, vomiting, low grade fever 98.9 starting 28OCT-1NOV93 assoc w/cough & body aches; to contact MD
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 04-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot# K010437 , expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.