chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a consumer via a company representative, referring to himself a 60 year old male patient. The patient had no pertinent medical history, concurrent conditions, drug reactions/allergies or concomitant therapies. On 31-OCT-2017, the patient was vaccinated with ZOSTAVAX 19400 Plaque Forming Unit (PFU), 0.65ml (single dose), subcutaneously for prevention of herpes zoster (lot # and expiration date were not reported). Other suspect therapies included influenza virus vaccine (unspecified) (dose, route of administration, lot # and expiration date were not reported). No porduct quality complaint (PQC) was involved. On the same day, the patient experienced swelling and soreness at the injection site of where ZOSTAVAX was given and he was also feverish for approximately 12 hours after receiving the vaccines. No treatment was given for the adverse events. On an unspecified date in 2017, the patient recovered from  feverish. At the reporting time, the patient was recovering from injection site swelling and injection site pain. No further adverse event (AE) information was provided. The causality between the events and the suspect therapies was unknown.
c/o Progressive Redness warmth of injection site (about the size of palm) with mild pain still 10 days post injection. Loose stools x 2 days
Pins and needles at injection site and neck, feeling warm, throat tightness, dizziness Benadryl IM, IV Fluids, Solumedrol, Monitoring Discharged with  tapering prescription of Predisone and Zyrtec
Severe arm pain, body chills, fever, fatigue, nausea and body aches.
Large Erythematous, circular area on right lateral thigh. Approx 8cm in diameters.
Pt received vaccine (Meningococcal) from VPS. Subcutaneous vs. IM. Pt experienced swelling and redness on (R) arm. Site painful 2/10.
Parent states arm became swollen within an hour of the immunization.  The left shoulder is not red, swollen and warm to the touch warm to touch approximately a 3-4 inch round area.
Today, at approx. 10:45, vaccinator  was administering a first Moderna dose to , .  felt extreme back pressure in the syringe, a Magellan 3ml syringe., Lot 729413.  The vaccine squirted out of the back of the syringe, and very little vaccine was administered.  Patient got very lightheaded and nauseated.    Dr.  saw the patient and offered to re-do the vaccine.  The patient refused, but wishes to use her second dose appointment as her first dose.
On 9/10/2017 around 3 a.m. in the morning I experienced 3 heart palpitations and then an extended period of heart racing that I am guessing lasted around 45 minutes.
I AM EXPERIENCING A RINGING IN MY EARS SINCE MY 2ND DOSE OF THE PFIZER VACCINE.
This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 02-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1704USA001661:
Bells Palsy  Blurry sight-3/30/2021 Couldn?t move mouth-3/31/2021 Couldn?t close right eye- 4-1/2021
COVID Moderna vaccine received 12/31/20.  Jan. 7, 2021 R Deltoid started to have redness, itching, warm and hard to touch.
Initial report was received from an office staff member on 04 October 2011. A female patient (age not reported) had received a FLUZONE INTRADERMAL, lot number UT4163AA. On an unspecified, the patient experienced left side muscle and joint pain, swelling two inches in diameter at injection site and swollen gland that necessitated a doctor visit. No further informational was available at the time of the report. The patient outcome was not reported. Follow-up information was received from a healthcare professional on 12 January 2012. A 37-year-old female patient had received an injection of FLUZONE INTRADERMAL on 04 October. On 05 October 2011, the patient experienced the events. No additional information at this time. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
Son son has been sick since the vaccination with vomiting, diarrhea, fever and loss of appetite.  Some of this has been intermittent where he seems to recover for a day and then it starts all over again.  He also has a heavy cough.
Body aches, muscle pain, fever, headache, fatigue (started 8 hours post dose  and lasted ~26 hours). Treated with acetiminophen at first signs and then introduced ibuprofen next day.
dizziness; red knot in her arm; arm turning red; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), MASS (red knot in her arm) and ERYTHEMA (arm turning red) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066d21a) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), MASS (red knot in her arm) and ERYTHEMA (arm turning red). The patient was treated with CINCHOCAINE HYDROCHLORIDE, DIBROMSALAN, DIPHENHYDRAMINE HYDROCHLORIDE, HYDROCORTISONE, TRIBROMSALAN (CORTISONE B.G) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), MASS (red knot in her arm) and ERYTHEMA (arm turning red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided by the reporter.   This case was linked to MOD-2021-359259 (Patient Link).
arm is hurting so bad; could not move her arm, her left arm; it feels like lead; she got the injection in is like equalizing the pain she has; hurts all over; sleeps every 2 hours; This is a spontaneous report from a contactable consumer (patient). An 89-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date), via an unspecified route of administration on the left arm on 13Jan2021 10:35 at a single dose for COVID-19 immunization. Ongoing medical history heart failure, kidney failure, scoliosis and strained hernia (causing pain down her right leg). Other medical history includes patient gave up her car and as a result she went from 5ft 4 inches to 5ft 1 inch and went from 150 pounds to 106 pounds (stated she loves this new weight. She looks fabulous and wonderful in clothes). The patient's concomitant medications were not reported. It was reported that the patient was a retired school teacher, called about the shot, the vaccine, clarified as the COVID Vaccine. She mentioned she has a history of heart failure, kidney failure, scoliosis, and hernias. She was concerned about getting the vaccine and did not think she should get it, but her doctor informed her she should get it so she did. Since getting it she is having a hard time. Stated it feels like lead. She contacted her doctor and was informed to wait it out 24 hours and it would be a lot better. It was reported that the patient got the COVID Vaccine shot yesterday (13Jan2021 10:35). She mentioned her arm is hurting so bad. She contacted her doctor's office and was informed to give it another 24 hours for the pain to go away. It was reported that the patient hurts so bad, she hurts all over. She added she guesses the arm where she got the injection in is like equalizing the pain she has. She stated as soon as she got the injection everything was wonderful. It was afterwards she felt like she could not move her arm, her left arm. She felt like at first she was having a stroke. She did some self testing and was happy she realized she was not having a stroke. It was reported that the patient provided conflicting details of when arm hurting started. She initially stated it started 13Jan2021. She then stated she did not feel it until 8am in the morning of 14Jan2021 (pending clarification) when she could not move her arm and thought she was having a stroke. She commented she sleeps every 2 hours. She would later mention in report she felt the arm pain starting yesterday (as reported). Attempts made to clarify start of arm hurting, but unable to clarify further. She is scheduled to get the second does on 03Feb2021. She commented even with her age she is still very useful. She was told to continue taking acetaminophen. She has the 1000 mg, take two pills every six hours. She was told if she continued to have pain to take Aleve. Treatment was given for the events. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Right upper thigh with area of erythema that is approximately 12 cm x 8 cm. It is slightly warm and appears a little tender. No significant induration.
196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent; No adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medications were reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient received additional booster dose. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Significant follow up received: age group and narrative updated.
Blood sugar went up from A1C 7.5 to 8.6 and NEVER WENT DOWN! It has stayed high.
Woke up with burning, itching rash on upper arms only. Eventually spread to trunk and upper legs.
I could NOT walk, get up out of bed with Severe debilitating pain in hips, legs, arms - I had TramadoL From a surgical procedure - took it 3 days with ExTra Strength TylenoL. Very adverse Reaction; informed PCP - she said "allergic reaction" - I was informed NO Second dose! this reaction was extreme!
Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA and FATIGUE in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 028L20A, and 025J02A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN and OCUPLUS for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced PYREXIA and FATIGUE. On 30-Oct-2021, PYREXIA and FATIGUE had resolved. Not Provided          Concomitant medication includes Vitamin, throne ployresveratrol. No treatment medication reported.  Fever and fatigue started on 30-Oct-2021 at 04:30 am.  This case concerns a  73-year-old, female patient with no relevant medical history, who experienced the expected non-serious events of Pyrexia and Fatigue. The events occurred approximately 1 day after the third dose of mRNA-1273 Vaccine. The rechallenge was positive for Pyrexia as this event also occurred after the second dose. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-313006, MOD-2021-313029 (Patient Link).
Delayed skin irritation, redness around injection site. Approximately 1.25 inches in diameter. Slightly raise, itchy and radiating heat.
Severe joint pain and swelling in all her joints. Unable to walk or bend. On December 24, 2010, Dr. at hospital diagnosed her with psoriatic arthritis. Prescribed Prednisone and Methotrexate and Lucavorin.
Presented to urgent care on 5/1/21 with dry cough which started about 4 days prior. Symptoms worsened and presented to emergency department on 5/5/21. Was found to be COVID-19 positive and was admitted for further management. Patient had been exposed to COVID-19 positive person prior to presentation. Patient is currently admitted at time of writing.
I had headache and chest pain. I went doctor about this. They did an EKG and x-ray. They also referred me to a cardiologist.
She had 104 temperature; she almost loss consciousness at work; This spontaneous report has been received from the patient via Pfizer, regarding herself a female patient of unknown age. Information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions or allergies were unknown.  On an unspecified date, the patient was vaccinated with Measles, Mumps, and Rubella (MMR) (manufacturer unknown) as prophylaxis (exact dose, route of administration and anatomical location of vaccination, lot number and expiration date were not reported).  On an unspecified date, the patient stated that she almost lost consciousness at work (presyncope) and had a 104 grades (units not provided) temperature (body temperature abnormal).   The outcome of the events, and the causality assessment between the events and the suspect therapy was not provided.  This is one of two reports referring to the same patient.; Sender's Comments:  US-009507513-2201USA001553:
Patient woke up with area feeling very warm to the touch.  Area is red and puffy over entire right deltoid region.  Also complains of itching in same area.
Next day lower abdomen area broke out in rash. Red, warm/ hot to touch, very itchy. At times would flare up; using hydrocortisone to help alleviate. Area of rash is shrinking.
Rash developed on anterior (L) thigh. Presented to a walk in clinic. Note states "blotchy red rash with erythema centered at vaccination site about 6 cm." Diagnosed with cellulitis, prescribed clindamycin 7 mg 3 times daily x 5 days. Improved with antibiotic.
Above left elbow arm was warm to touch and swollen. Arm circumference was 24 cm and swelling length was 17 cm.
vertigo; altered smell and taste; altered smell and taste; sharp pains in left side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes; "Known allergies: seafood" (unspecified if ongoing), notes: Known allergies: seafood. Concomitant medication(s) included: SERTRALINE; DRAMAMINE. The following information was reported: VERTIGO (non-serious) with onset 31Dec2021, outcome "not recovered", described as "vertigo"; PAROSMIA (non-serious), TASTE DISORDER (non-serious) all with onset 31Dec2021, outcome "not recovered" and all described as "altered smell and taste"; PAIN (non-serious) with onset 31Dec2021, outcome "not recovered", described as "sharp pains in left side". The events "vertigo", "altered smell and taste", "altered smell and taste" and "sharp pains in left side" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vertigo, parosmia, taste disorder, pain.  Additional information: There was no other vaccine in for weeks. There was no covid tested post vaccination. Treatment included Dramamine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Mar-2021 at 1:56 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 1:56 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The vial was initially stored in the fridge on 09-Mar-2021, moved to the clinic on 20-Mar-2021 and proposed beyond use date was 08-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 30 degree Fahrenheit that has been reached by the vial. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided. This case was linked to MOD-2022-566976 (Patient Link).
Temp increase 103, screaming - inconsolable crying for 6 hours following shot. Possible Pertussis reaction.
Mild topical reaction top back of area down to elbow is red and warm, Advised to take BENADRYL as directed.
Diarrhea; Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach pain). At the time of the report, DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 as dose 2, single (Lot number: EN5318), in right arm, on 19Sep2021 as dose 3 (booster), single (Lot number: 30145BA), in right arm and on 13Jul2022 as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: negative for COVID; Positive, notes: COVID test positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 11Feb2023 to 16Feb2023).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 22-Apr-2009, the patient was inoculated with ZOSTAVAX at a Medical Center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at a Nurse Practitioner for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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. Additional information has been requested.
pt recv vax 21JAN98 & 24JAN98 GBS devel;pt was transported to hosp;
an allergic reaction; rashes; fever; swelling; This is a spontaneous report from a non-contactable consumer via Medical Information team. A male patient (reporter's brother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Reporter stated that her brother had symptoms of an allergic reaction after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. She said he had rashes, fever, and swelling on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.