chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-APR-2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a Health Department as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 30-OCT-2015, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, 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. The outcome is unknown. Additional information has been requested.
At night heart rate went up a little bit; Tenderness at the injection site; Nausea; Soreness in the arm at the injection site; Itching at the injection site; Red spot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (At night heart rate went up a little bit), INJECTION SITE PAIN (Tenderness at the injection site), NAUSEA (Nausea), INJECTION SITE PAIN (Soreness in the arm at the injection site) and INJECTION SITE PRURITUS (Itching at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEART RATE INCREASED (At night heart rate went up a little bit), INJECTION SITE PAIN (Tenderness at the injection site), NAUSEA (Nausea), INJECTION SITE PAIN (Soreness in the arm at the injection site), INJECTION SITE PRURITUS (Itching at the injection site) and INJECTION SITE ERYTHEMA (Red spot at the injection site). At the time of the report, HEART RATE INCREASED (At night heart rate went up a little bit), INJECTION SITE PAIN (Tenderness at the injection site), NAUSEA (Nausea), INJECTION SITE PAIN (Soreness in the arm at the injection site), INJECTION SITE PRURITUS (Itching at the injection site) and INJECTION SITE ERYTHEMA (Red spot at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
abd pain, rash all over w/gen itching;presented to ER dept about 12hr p/vax;tx w/DPH;
5 days after administration of Rotavirus immunization Patient became very fussy, in pain and was diagnosed with intussusception at the local Hospital ED.
I received my second Pzifer shot, I had started menstruating for 6 days; This is a spontaneous report from a contactable Other Health Care Professional (patient) reported for herself that a 49-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ew0179), via an unspecified route of administration in left arm on 11May2021 at 09:00 (at the age of 49-years-old) as dose2, single for Covid-19 immunization facilitate at hospital. The patient's medical history included menopause and have not menstruated in 10 years and no known allergies. Concomitant medications were not reported. No other vaccine in four weeks and in two weeks. The patient historical vaccine included first dose of (Pfizer-Biontech Covid-19 Vaccine, solution for injection, lot number: w0161), via an unspecified route of administration in left arm on 20Apr2021 at 09:00 (at the age of 49-years-old) as single dose for Covid-19 immunization. On 31May2021, two weeks after I received my second Pfizer shot, I had started menstruating for 6 days. No covid prior vaccination and no covid tested post vaccination. No treatment received for adverse event. The outcome of the adverse event was recovered on an unknown date.   Follow-Up (14Jul2021 and 28Jul2021): Follow-up attempts are completed. No further information is expected.
Onset of symptoms was quite sudden and happened in short succession of each other. Started roughly 12 hours after receiving the vaccine. Extreme chills and shivering, diarrhea, vomiting lasted about  an hour. Muscle aches, fever of 100 deg. F.  lasted about 3 hours.
Patient states she woke up the day after injection and that is when she noted the reaction. 7:00 a.,. 5-5-15. Redness, warmth and lump at site. 5-6-15 at clinic 9:30 am. 65mm x 55mm redness with induration. Patient is monitoring symptoms.
Tinnitus. Started mid-day 8 days after shot.  First right ear, then left ear as well.  Still present four days later.  Can not tell if it is getting better or worse but it is difficult for me to detect quiet sounds and I need to greatly increase the TV / Computer volume to be able to clearly understand speech.
A rash was observed on the belly and the thigh. Later, the rash disappear but a big branch spot appeared on its place.
in the injection site she has a "large mass hard and stiff"; large mass and it hasn't resolved. The area was really hard and stiff; breastfeeding; breastfeeding; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and baby. This is the maternal report. A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284, expiration date not reported) via an unspecified route of administration on the left arm on 07Jan2021 07:00 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. She received the first dose of the vaccine on Thursday and in the injection site she has a "large mass hard and stiff", she's concerned about this and she would like to know what she can do. In the injection area a large mass and it hasn't resolved. The area was really hard and stiff. Wanted to know if she should be concerned or be seen. Received the first dose on 07Jan2021 and kind of had this issue with the injection arm all week and maybe noticed it Tuesday because she was afraid to sleep on that side. No history of problems with vaccines in past. She is due for the second dose on 28Jan2021. Caller later provides that she is breastfeeding at the moment, but no further details provided. The events did not result to a physician office and emergency room visit. Vaccination Facility Type was hospital. There were no additional vaccines administered on same date of Pfizer suspect. No relevant tests done and no family medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Event was reported as non-serious. Outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021051752 mother/baby
About 45 mins after the injection I started to have an episode of SVT and tried my usual methods to reset. This lasted 25 mins. I have never had an episode that lasted that long. Then 1 week to the day on 2/4/21 at 10 am  I noticed the "covid arm with a knot at the injection site". No itching. Later that night (2/4/21) I noticed more redness and induration at the site so by Friday the 5th I had streaking of redness, induration and pain from the injection site along with lymph nodes.  Saw the doctor and treated for a cellulitis. Ran a fever for 2 days until medication kicked in and then site started to look better by Monday the 8th of February.  I did not receive the 2nd dose.
Mother reported 3 inch red pink area over where varicella vaccine was given.  Occured three days after administration and started to fade 6 days after administration.
fatigue, fever, chills, aches, sweats, injection site soreness. Onset 8-10 hours post-vaccine, lasted 48 hours to varying degrees of severity.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 21-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012479, expiration date: 10-APR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Today feeling kinda blah\ shot is awful too; Very sick; fever; nausea; diarrhea; arm swollen; varm ery painful\ arm hurts; This case was reported by a consumer viainteractive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, the patient also experienced fever, swelling arm and pain in arm refer link case US2021AMR190660).   On 30th August 2021, the patient received the 2nd dose of Shingles vaccine. On 31st August 2021, 1 days after receiving Shingles vaccine, the patient experienced sickness, fever, nausea, diarrhea, swelling arm and pain in arm. On 2nd September 2021, the patient experienced feeling abnormal. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness, fever, nausea and diarrhea were recovering/resolving and the outcome of the swelling arm, pain in arm and feeling abnormal were not recovered/not resolved.   It was unknown if the reporter considered the sickness, fever, nausea, diarrhea, swelling arm, pain in arm and feeling abnormal to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shots and was very sick, fever, nausea, diarrhea, arm swollen and very painful. On 1st September 2021, the patient was better. On 2nd September 2021, the patient stated he/she was feeling kinda blah and arm was swollen and hurts. The patient stated his/her physician said the symptoms was better than getting the shingles. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR190660:same patient/reporter
Cold sweat, dizziness, tachycardia, headache, persists after 24 hours but not as much
He is dragging his foot. It seems like he can't walk properly; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (He is dragging his foot. It seems like he can't walk properly) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seizure (is on bunch of seizure medicines) and Disability (adult son who is non-verbal and has special needs.).    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced GAIT DISTURBANCE (He is dragging his foot. It seems like he can't walk properly). At the time of the report, GAIT DISTURBANCE (He is dragging his foot. It seems like he can't walk properly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include a bunch of seizure medicines. No treatment medications were reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
needle sticking pain on her body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD21-160751 (Moderna).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "needle sticking pain on her body". Additional information: The reporter 's friend was the patient. The reporter mentioned that the patient following administration with the Pfizer COVID19 vaccine experienced the same kind of thing as experienced by the reporter, a needle sticking pain on her body. There was no product complaint associated with this case No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored doses of M-M-R II Lot#: M016234, expiration date on 31-MAR-2018 (strength, dose number, route and anatomical location were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. No product quality complaint was involved. The vaccines experienced the following temperature excursions during 20 minutes: 32°F (Fahrenheit), 36°F and 46°F; during 41 minutes: 77°F; during 1 hour and 20 minutes: freezer 5°F and 14°F. The aforementioned ones were identified due to a data logger. There was no previous temperature excursion. It was reported that the vaccines were supported. This is one of several reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided. Sender's Comments: US-009507513-1701USA012289: US-009507513-1701USA012392.
This case was reported in a literature article and described the occurrence of kidney transplant rejection in a child subject who received Flu Seasonal QIV Dresden. The subject's past medical history included kidney transplant. On an unknown date, less than a year after receiving Flu Seasonal QIV Dresden, the subject developed kidney transplant rejection. Serious criteria included GSK medically significant. The outcome of kidney transplant rejection was unknown. It was unknown if the investigator considered the kidney transplant rejection to be related to Flu Seasonal QIV Dresden. Relevant Tests: Lab test performed on unspecified date, within 3 month post-vaccination, de novo donor specific anti-HLA antibodies (DSA). The DSA resolved prior to rejection. Additional information was provided. This case was reported in a literature and described the occurrence of kidney transplant rejection in paediatric patient of unspecified gender who was vaccinated with combined unspecified influenza vaccine (manufacturer unknown). The patient was a part of the single-centre retrospective analysis of paediatric kidney recipients to assessed the graft and patient outcomes stratified by whether the patients received the influenza vaccine from 1 January 2006 to 31 December 2015. The patient underwent kidney transplantation. No information on patient's family history or concurrent condition or concomitant vaccination was provided. On an unspecified date between 1 January 2006 and 31 December 2015, within one year post-transplant, the patient received unspecified influenza vaccine (administration site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, within 3 month post-vaccination, de novo donor specific anti-HLA antibodies (DSA). The DSA resolved. Subsequently, the patient had kidney transplant rejection. It was reported that, due to the timing of the vaccine, baseline was defined as one year post-transplant; those with events with in one year of transplant had an event time of zero. Treatment was unknown. The outcome of the event was not reported. The author stated, "In our cohort of paediatric kidney recipients, the influenza vaccine was safe; larger prospective studies are required to confirm that the vaccine is not associated with increased de novo DSA and rejection risk in paediatric kidney recipients."
PENTACEL vaccine was administered with only the DTaP and IPV portion of vial. Contacted Health Department to verify only HIB portion needed to be administered.  HIB portion administered.
Diarrhea; feeling sick evening 27Mar2021; feeling tired and sluggish; feeling tired and sluggish; sense of taste is off; headaches; chills; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: ER2613 and expiration date: not reported), via an unspecified route of administration, in Right Arm, on 25Mar2021 at 14:20 (at the age of 44-year-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included slight anemic, low potassium, thyroid and Blood pressure high. Concomitant medications included amlodipine taken for hypertension, levothyroxine taken for thyroid disorder, iron taken for blood iron decreased, potassium taken for blood potassium decreased. The patient previously got sick from the flu vaccine. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine.  On 27Mar2021, the patient started to feel like she was tired and sluggish. The patient had headache, loss of taste/ sense of taste being off and feeling sick. The patient also had chills and lost appetite. On 30Mar2021 patient had diarrhea. The outcome of the event Taste loss was not recovered, Headache was recovered in 28Mar2021 and all other events was recovering at time of report.  No follow-up attempts are possible. No further information is excepted.
Radicular pain right leg then zoster rash on 05/31/2012 right flank.
8/16/10 pt. received vaccines & 24 hrs. later develop redness & warmth on (R) deltoid. Seen 8/18 dx with cellulitis treated with abx. 8/20/10 - much improved.
Dizzyness at time of injection. Injection site pain, tiredness, Headache,  feeling unwell.  using ibprophen. Headache relieved after 1 day post injection.
Adverse reaction; Ruining quality of life; Feel like I have the flu for 7 weeks; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feel like I have the flu for 7 weeks), VACCINATION COMPLICATION (Adverse reaction) and IMPAIRED QUALITY OF LIFE (Ruining quality of life) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 004C21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced INFLUENZA LIKE ILLNESS (Feel like I have the flu for 7 weeks). On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reaction) and IMPAIRED QUALITY OF LIFE (Ruining quality of life). At the time of the report, INFLUENZA LIKE ILLNESS (Feel like I have the flu for 7 weeks), VACCINATION COMPLICATION (Adverse reaction) and IMPAIRED QUALITY OF LIFE (Ruining quality of life) had not resolved. Not provided.         It was reported that the patient was caused weeks and weeks of adverse reaction and felt like had the flu for 7 weeks. The patient had been to several doctors to find out what was wrong as it just went on and on and was ruining the quality of life.  No concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jan-2022: Follow up document contains no new information.
2nd dose given too soon given first dose at other site , 2021- 2/27/2021 states was moderna ? , patient denies adverse effects or symptoms
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 64-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. The patient's past medical history included shingles. On 12th June 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced fever, herpes virus infection, fatigue, injection site pain and myalgia. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the herpes virus infection was not recovered/not resolved and the outcome of the fatigue, injection site pain and myalgia were recovering/resolving. It was unknown if the reporter considered the fever, herpes virus infection, fatigue, injection site pain and myalgia to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left deltoid. The patient experienced fever, injection site pain, fatigue and myalgia. The patient stated that, they had what looked like an outbreak on their tailbone. A follow up request was made for the event outbreak on tailbone and it was not diagnosed at the time of the report. The pharmacist did not see the outbreak.
Child received yearly flu vaccine in left deltoid while sitting on exam table. A few minutes later, she walked over to sit in a chair. While sitting in the chair, the pt stated, " Mom, I'm not feeling good" and was observed by this RN to turn pale and head dropped to chest. Pt's mother and this RN scooped up child and carried her over to the exam table. While lying on table, child opened her eyes and was alert. A doctor was called and vital signs taken. VSS, A+Ox3, extremities warm to touch, good radial pulses bilaterally. Child rested for 15 minutes prior to having her sit up after 5 minutes, she stood up and walked normally around the room. Provider and parent agreed child was able to leave and was escorted out to car with RN, MOC and sister.
9/18/07 Pneumovax given (R) arm Td given (L) arm - (R) arm with 10 cm x 10 cm red, warm, tender, edematous resolved after 2 wks. Treated with Triamcinolone BID, Zyrtec 10 mg and Benadryl.
A non-serious spontaneous report of hypertrophy of gums, ulcers in throat manifested with sore throat and ulcerations in mouth has been received from a pharmacist concerning a 49-year-old female, subsequent to FLUMIST. The patient's past medical history included start of a cold, runny nose and cold sores on lips. The patient had received FLUMIST in 2010 with no problem or side effects. Concomitant medications included levothyroxine sodium, esomeprazole and zopiclone. The patient received FLUMIST for flu prevention in Nov-2011. After receiving FLUMIST, the patient experienced severe ulcerations in mouth (too painful to eat), hypertrophy of gums and sore throat. The dentist thought that it was a bacterial infection of the throat, a diagnosis that was discounted by the physician who prescribed antiviral (valacyclovir hydrochloride). Reporter states that improvements may be due to time as well. Two-three weeks have gone by and ulcerations still have not fully recovered. The patient did not have lesions on the lips, she had ulcers in mouth and throat. The outcome of events hypertrophy on gums, ulcerations in mouth and ulcers in throat was recovering.