chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recieved the prevnar 20 on 5/6/22. After the vaccine, pt had headches, pain and swollen around inject site and  above elbow area. Pt stated that the swollen area felt hot when touching it.  The pain seems to lessen over time but the swollen still there. Pt has been taking flu med otc. Pharmacist advised pt to take Ibuprofen with food and apply ice for the swelling. Also recomd to see MD if continue getting worse.
Dispensed VIVOTIF prior to travel-within 24 hours of 1st dose pt. became violently ill with vomiting, diarrhea, periods of disorientation and black out-slowly recovered-refused to go to ER.
mild numbness on her throat; This is a spontaneous report from a contactable consumer (patient). This 80-year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3426) at single dose on 08Jan2021 via an unknown route at left arm for Covid-19 immunization, which was recommended for her age. Medical history included ongoing cervical spinal stenosis for 5 or more years (no investigation assessment, no relevant tests), high cholesterol, high blood pressure, heart beat. Concomitant drugs included ongoing amlodipine besilate 5 mg twice daily for high blood pressure, ongoing atorvastatin 10mg daily for high cholesterol, ongoing hydrochlorothiazide 12.5 mg daily for high blood pressure, ongoing losartan 10 mg daily for blood pressure, ongoing metoprolol tartrate 25 mg twice daily for heart beat. Patient had been taking atorvastatin, hydrochlorothiazide, amlodipine besilate for a long time. Patient had been taking losartan for 10-11 years.  Patient had been taking metoprolol tartrate for 4-5 years. No history of all previous immunization with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations within 4 weeks. She experienced having mild numbness on her throat on 08Jan2021 that lasted for an hour and a half. The event clinical course was as follows: After waiting 15 minutes she was ok and was cleared to go. On the way to her car she felt numbness in her throat. It was mild and lasted for an hour and a half and then it cleared on its own. No Emergency Room or Physician Office visit required due to the event. She was scheduled to get the 2nd dose of the COVID-19 vaccine on 29Jan2021. She wanted recommendations on whether she should take the second dose of the vaccine. She was concerned if that would be a problem with getting the second shot. She was asking if this could happen again.  Outcome of the event was resolved on 08Jan2021.
This spontaneous report had been received from a registered nurse via company representative refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with GARDASIL (dose, route and lot number not provided). On unknown dates, the patients fainted after receiving a dose of GARDASIL. These patients recovered on unspecified dates. Additional information has been requested.
Patient had a allergic reaction to Johnson and Johnson. EMS was called. Patient had numbness on left arm, limited mobility, and redness at site of injection. Vaccine given by nurse. She initially couldn't move her arm after the injection. We called 911 afterwards, and stayed with patient. We gave water/Benadryl and stayed with the patient until they arrived. They checked on her vitals. BP 104/60, pulse 72. No SOB, or tightness in chest, no other areas of redness, and patient had more mobility after given Benadryl. EMS said she was fine to leave, and to follow up with PCP. No history of allergic reaction to vaccine.
This spontaneous report as received from a pharmacist and mother's patient refers to a 11 year old female patient. Pertinent medical history and drug reactions/allergies were reported as none. On 12-DEC-2014, the patient was vaccinated with the first dose of GARDASIL in the arm (dose, route, lot number and expiry date were not reported). Other suspect therapies included meningococcal vaccine (manufacturer unknown) (dose, route, lot number and expiry date were not reported) in the other arm and ADACEL (dose, route, lot number and expiry date were not provided) in the same arm of GARDASIL vaccination. None concomitant medication reported. Pharmacist reported that during administration of GARDASIL vaccine, her daughter jumped when needle entered her arm and needle actually came out of her arm when she jumped and little bit of blood from injection site trickled down on the arm. After pharmacist daughter calmed down, nurse administered GARDASIL dose using same syringe and needle from initial administration attempt. GARDASIL was the third and last vaccine her daughter received that day (12-DEC-2014) and shortly after GARDASIL dose, pharmacist's daughter felt dizzy and nauseous but pharmacist was not sure if nausea and dizziness were due to GARDASIL or all three vaccines or because her daughter was nervous about incident happened with GARDASIL. Pharmacist also suspected that her daughter might not have received full dose of GARDASIL because her daughter jumped and some vaccine might had been lost during the incident but nurse did not change needle and syringe to complete GARDASIL administration. None lab diagnostics studies performed. The outcome of felt dizzy and felt nauseous was reported as recovered (in December 2014). Additional information has been requested.
Myalgia, Fever, NauseaVomiting, fatigue and sore arm Narrative:
he tested positive to COVID-19 on 24OCT2023; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (he tested positive to COVID-19 on 24OCT2023) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Patient tested positive to COVID-19 on 24OCT2023.     On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Oct-2023, the patient experienced COVID-19 (he tested positive to COVID-19 on 24OCT2023). At the time of the report, COVID-19 (he tested positive to COVID-19 on 24OCT2023) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2023, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown. It was reported that patient stated he previously received Moderna COVID-19 Vaccines (dates and number of vaccines not specified), and he tested positive to COVID-19 on 24-Oct-2023, he had an appointment to get the new Moderna shot scheduled on 29-Oct-2023 but due to COVID-19 he would cancel it.  Treatment information was not provided.   Reporter did not allow further contact
Patient developed fever, irritability and rash on 12-31-08. Parent took child to ER. ER MD noted fever and maculopapular rash diagnosed viral exanthem or possible chicken pox.
Arm with softball size red area, warm to touch and sore with nod swelling noted.
"Vaccine Arm"  Large red swollen area covering most of upper arm.  Pain and itchiness.  Started 2 days after injection.  Continuing  still.
3MAR97 phone call rt upper arm itching w/redness & swelling about 3 to 4 inches complains that back itches-no rash or redness noted;DPH & calamine lotion given;
On 6/23/21 - I woke up feeling body aches - muscles & joints.  In general feeling off. Low grade temp. 6/24 - 6/30/21 - Continuing mscle aches, dizziness, headache, chills, temp most of time spiking to 103 at one time.  Diarrhea.  Pain mostly in legs. Saw PA on 6/29. Urinalysis - clear.  CRP showed high inflammation. 7/1 - 7/12 - Many episodes of severe burning pain in legs bilaterally from hips to feet.  Episodes lasted from 2 -12 hours.  On 7/3/21 went to ER. Gave me shot of Toradol and told me to see a Rheumatologist if pain continues. Followed up with Dr. on 7/6.  Ordered additional bloodwork and confirmed that I should see Rheumatologist.  Continued to have pain for several more days.  Pain subsided on 7/13/21.  As of today, 8/3/21, I still get very tired easily and have some numbness in my feet. 7/13/21 - Saw Dr. X-Rays taken. 7/22/21 - Saw Dr. Blood work done. 7/26/21 - Saw Dr. EMG ordered t determine if there is muscle/nerve damage in my legs. Scheduled for 9/13/21 Other than inflammation no medical reason has been determined for the severe leg pain.  Dr. believes I may be suffering from post-viral syndrome.
PATIENT WAS HOSPITALIZED AND DISCHARGED AFTER 3 DAYS. 12/25-12/28/21.   The patient is a 25 y.o. female with past medical history of OHT 10/28/20, HTN, HLD, CKD II, migraines, anxiety and depression; she presents with 10 day history of multiple infectious symptoms including cough, congestion, N/V/D, chills, fatigue and fever as noted in ROS with significantly decreased oral intake the last 2 days. She was noted to be tachycardic and febrile on examination. Patient tested positive for COVID-19 on PCR.   She was admitted and given monoclonal antibody therapy (while in observation) and then decadron.   She remained inpatient until she was able to stay off o2 for 24 hours. Symptoms improved and inflammatory markers down-trending. Discharged in stable condition.
Patient developed subjective fever and redness on vaccine site (4 1/4 in x 3 1/2 in) for the first two day. Instructed to apply ice and BENADRYL po.
Patient calling office c/o right arm pain, swelling nausea, dizziness, blurry vision.  Patient sent to Urgent Care. At Urgent care patient was transferred to ER d/t localized reaction to immunization vs TIA.  At patient was worked up and sent home with adverse reaction to immunization.
redness of face, skin peeled-progressed to other parts of the body; dry scaling, peeling sking 3 different MD's have used pred, erythromycin, Lidex, triamcinolone; dx of effoliative erythederma;
1st given on 12/22/20 2nd given on 1/18/21  1/22/21: Symptoms of headache, muscle/body aches, chills, nausea uncontrolled by PO medication, dry cough and arm swelling at injection site plus axilla swelling in injected site.  No redness. +Fatigue.  On date of second shot I did have the typical reaction of chills and headache for about 12 hours but controlled and then resolved with Motrin.
hives; This is a spontaneous report from a contactable Physician via a Pfizer sales representative.  A 41-years-old male patient received unspecified dose of BNT162B2(PFIZER COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient developed hives after receiving the vaccine. Patient still  have hives after 3 months but not as bad. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
DIARRHEA; VOMITING; This spontaneous case (PVX2019-1255) was received from a nurse on 20-May-2019. It describes a female consumer who had diarrhea and vomiting, after the administration of Vivotif for typhoid prophylaxis.  Case report: The consumer took the first and second dose of Vivotif on 16-May-2019 and 18-May-2019, respectively. On 19-May-2019, she had vomiting and diarrhea, which was continued till that night. She vomits out intact pill. She was fine after taking the third dose. It was also reported that she did not take any unhygienic food and water.   The consumer had no medical history or allergy.   The consumer had no concomitant medication.  Action taken with Vivotif was dosage maintained.  The consumer had recovered from the events on 20-May-2019.  Company's Comment: In this case, it was reported that the consumer had had diarrhea and vomiting, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhea and vomiting are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had had diarrhea and vomiting, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhea and vomiting are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
has also been checking her temperature and it has been between 96-98 and earlier she was feeling warm but she was in class and couldn't check; a slight cough/had a cough and it wasn't long just a couple of times, a little more than normal; nausea/feels the nausea in her throat; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0158, NDC number: not reported, Expiration Date: Jul2021) via an unspecified route of administration, administered in upper right arm on 08Apr2021 09:45 (age at vaccination 21-year-old) as dose 1, single for covid-19 immunisation. The patient's medical history included COVID-19 from an unspecified date in Dec2020 to an unknown date. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) (200mg and took 2 for a total of 400mg) for unknown indication from an unknown date. Patient stated she took ibuprofen one time around the beginning of the 2 weeks before the vaccine. There were no additional vaccines administered on same date of the pfizer suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, patient stated she got the Pfizer vaccine last thursday and she feels fine, none of it was very drastic. Caller stated that her side effects started on 09Apr2021. Stated she was feeling some side effects where the 1st day she had a cough and it wasn't long just a couple of times, a little more than normal. Stated she was nauseous but was not throwing up and that has been off and it will come at random times throughout the day and on since then. Patient stated she was concerned if this was normal or if she should see a doctor. Patient stated she had also been checking her temperature and it had been between 96-98 and earlier she was feeling warm, but she was in class and couldn't check. Patient stated this was her 1st shot and she was skeptical and knows it can last a couple days but not this long. stated she only had slight nausea and she can feel it in her throat, that it's not like she was going to throw up, but she was cautious about what she eats. Stated the cough was for the first 2 days. Caller wanted to know if she was fine or was there something else, she should do. Caller was concerned because her side effects have lasted seven days. The events did not result in emergency room or physician office. The outcome of event was resolved for cough on 10Apr2021 and unknown for other events.  No follow-up attempts are needed. No further information is expected.
Patient was experiencing tingling in her right arm and hand and her lips were numb. She was given 50mg of Benadryl at 4:10pm.
1 of 5 pts recvd flu vax & devel inject site react w/in 24 hrs; reactions consisted of itching, erythema, induration, hot to touch & tenderness (the size of a silver dollar);
The patient had Pneumovax 23 administered; he developed a temperature of 103.2 for 2 1/2 days, and cellulitis in his arm. Treated with Augmentin.
Symptom onset late Saturday night, March 13.  Symptoms included high fever, joint aches, muscle aches, slight nausea, fatigue.  Spent the next 36 hours in bed, unable to function normally, and with no relief from symptoms.
The pt presented cold symptoms on 04/30/2002, cough on 05/02/2002, coughing and vomiting on 05/05/2002.
Stroke; She was normal before and know she cannot run her phone and he has to take care of her.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Stroke"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "She was normal before and know she cannot run her phone and he has to take care of her.".  Clinical course: It was reported as he was calling on behalf of his wife that got the vaccine. Asking if there was a compensation from Pfizer since his wife had a stroke after getting the Covid vaccine and she has not been ok since then. Has anxiety so bad and this happened two years ago since she got the shot. Not right, cannot read or spell good and wish that he could be sent something to help. He would like the doctor to be contacted. He did not have any contact details handy. He gets so confused. He was not the only person to be affected, there should be a line for the people to be hurt by this. Calling for two years trying to get help for his wife. There should be a phone number to be able to call. Other people have been hurt by it. People did not want to talk about compensation. He just got a doctor to say his wife's stroke was from the covid shot. He was going out of his mind. He has been giving her shots for two years now and there should be some help for him taking care of her. It should not be so hard to get help, he was not all there. They made his wife take it. He wants someone to call him. Ever have anxiety so bad that cannot sleep or eat, that's what going on with him since he was taking care of his wife.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
tooth infection, described as some bacteria got inside the tooth; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (tooth infection, described as some bacteria got inside the tooth) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced TOOTH INFECTION (tooth infection, described as some bacteria got inside the tooth). The patient was treated with CLINDAMYCIN for Tooth infection, at an unspecified dose and frequency. At the time of the report, TOOTH INFECTION (tooth infection, described as some bacteria got inside the tooth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
PICKED UP THE WRONG BOX OF VACCINES AND ADMINISTERED, DIDN'T REALIZE IT UNTIL, I WENT TO DOCUMENT THE VACCINATION IN THE CHART
Received Moderna vaccines on 1/15/21; 2/13/21 Tested positive for COVID by PCR on 7/30/21 Admitted to Hospital on 7/23/21 for altered mental status, hypoxemic/hypercapnic respiratory failure.  Testing on admission for COVID-19 was negative. Tested on 7/30 as a family member that was exposed to the patient was just recently diagnosed with COVID-19.  CT scan shows bilateral ground glass opacities, treated w/ Dexamethasone, remdesivir.  Diagnosed w/ moderate to severe COVID-19 pneumonia.
Pt awoke at 10:30 the day after receiving vaccines and cried nonstop until 13:30. He was totally inconsolable.
9MAY96 lt arm area swollen (size of tennis ball) area warm to touch;edema started 7AUG96 PM;
No adverse event; adult individual was only given 0.25ml dose of the new updated booster for Covid rather than the full 0.5ml dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (adult individual was only given 0.25ml dose of the new updated booster for Covid rather than the full 0.5ml dose) and NO ADVERSE EVENT (No adverse event) in a 55-year-old patient of an unknown gender 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 22-Sep-2022, 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 22-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (adult individual was only given 0.25ml dose of the new updated booster for Covid rather than the full 0.5ml dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (adult individual was only given 0.25ml dose of the new updated booster for Covid rather than the full 0.5ml dose) 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 ACCIDENTAL UNDERDOSE (adult individual was only given 0.25ml dose of the new updated booster for Covid rather than the full 0.5ml dose).    No Concomitant medication was reported.  No treatment information was provided.
This spontaneous report as received from an approximately 54 year old female patient with asthma, allergy to penicillin and codeine. The patient's medical history included appendix removed, back surgery, foot surgery, knee surgery, elbow surgery, rib removed, hysterectomy and bladder mesh implant. The patient reported she developed shingles and then received one dose of ZOSTAVAX "about" 2 years ago. Concomitant therapies included CLARITIN, ALLEGRA, PROAIR, ADVAIR, LEXAPRO, CRESTOR, NEURONTIN, FLEXERIL, PREMARIN, BONIVA, CHANTIX, ADVIL PM and BENADRYL. The patient reported that after receiving this dose of ZOSTAVAX she developed shingles again, and then received a second dose of ZOSTAVAX 1-2 months after receiving her first dose of ZOSTAVAX. The patient reported after receiving the second dose of ZOSTAVAX she developed shingles "last week" on about 05-AUG-2013. Patient sought medical attention by having a doctor's visit and capsaicin (unspecified manufacturer) was given for the treatment of shingles symptoms. There was no lab performed.  The outcome of shingles (after second dose of ZOSTAVAX was reported as not recovered/not resolved. Patient experienced an adverse event on the treatment of CLARITIN on an unspecified date (1308USA009902). Additional information has been requested.