chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 6 year old male student with no medical history who on 9/1/2000 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccinations on that same day included a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was unknown if there was any illness at the time of vaccination. The physician reported that on 6/26/2005, the patient developed breakthrough varicella characterized by more than 50 lesions on his face, arms and legs. Unspecified medical attention was sought, but no lab/diag test were performed. The patient was noted to be afebrile and had no other complications. Subsequently, the patient recovered from the breakthrough varicella. Additional information is not expected.
Pain in left arm still persists over a month later.. hard to lift anything.. causing twitching and tingling in my  neck and left side of my face.  Horrible Severe all-over-body itching three weeks after still persists and is getting worse as of today's date.  No rash or any sign of reasoning.  Went to an urgent care facility, ran a full CBC, all is healthy as normal-must be from vaccine.  Suffering and losing consistent sleep from the itching rages that come and go.
Started having on and off headache and stomach pain after eating 2 weeks after taking the vaccine. Negative results in Covid19 PCR and antibody test taken 09/12 12nn.
Patient recieved 1st dose COVID vaccine on 2/23/21. Returned for 2nd dose on 3/16/21 and reported "rash that itched about a week later on the same arm" as the vaccine was given. Reports rash remained for about 5-6 days. Denied any pain at site or other s/s allergic reaction. Did not receive 2nd dose as scheduled on 3/16/21 and was advised to present to PCP or allergist to ensure it would be safe to get second dose. Patient presented again to clinic on 3/23/21 for 2nd dose after seeing allergist who patient reports "diagnosed rash as eczema". Patient denies any s/s on 3/25/21.
Thirty minutes after receiving injection pt c/o burning and itching w/8 cm local erythema w/malaise. No fever. W/6 cm center was warm, firm, swollen and tender. Advise pt to take CLARITIN, TYLENOL and use ice pack.
I got my booster shot; it just a little bit of injection site soreness; My lymph nodes must be swollen but its quiet large my armpit is exceedingly swollen and it's painful; My lymph nodes must be swollen but its quiet large my armpit is exceedingly swollen and it's painful; My left armpit was completely swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 12Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021, outcome "unknown", described as "I got my booster shot"; VACCINATION SITE PAIN (non-serious) with onset Nov2021, outcome "recovering", described as "it just a little bit of injection site soreness"; LYMPHADENOPATHY (non-serious), AXILLARY PAIN (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "My lymph nodes must be swollen but its quiet large my armpit is exceedingly swollen and it's painful"; PERIPHERAL SWELLING (non-serious) with onset Nov2021, outcome "not recovered", described as "My left armpit was completely swollen".  Additional Information: Consumer stated, " I was going to assume that my immune system mount to the pretty deep response and my lymph nodes must be swollen but its quite large my armpit is exceedingly swollen and it's painful if you would imagine. I was a little bit concerned because I kind of like understand how long something like this could be expected to last and whether I should be on the lookout for if it was getting if it stays as it was manageable, if it got worse you know how do know when I should see a medical professional about it? In every other respect I feel fine but my armpit was quiet swollen and tender so do you have an opinion or some guidance that you can offer me to make sure that, I did not feel alarmed by it but then, I also did not wait too long to act if there was some signal that I should be looking for to indicate that, I actually might need to seek professional attention? ". Consumer was informed about Pfizer drug safety.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
swollen neck gland; This is a spontaneous report received from a contactable consumer (patient herself). A 66-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982) via an unspecified route of administration, on left arm on 20Jan2021 at 10:30 as 1st dose, single for COVID-19 immunization. Medical history included overweight. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) received within 2 weeks of vaccination. The patient previously took ceftriaxone sodium (ROCEFIN) and experienced known allergies. The patient did not receive other vaccine in four weeks. The patient did not had COVID-19 prior vaccination and did not tested COVID-19 post vaccination. On 29Jan2021 at 10:30, the patient experienced swollen neck gland. She did not receive any treatment for the event. The outcome of the event was recovering.  No follow up attempts are possible. No further information is expected.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a nine-year-old female. Neither past medical history nor concomitant medications were reported for this patient. On 30-Nov-2010, patient received expired vaccine. The product expiry date was 22-Nov-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event is considered resolved. Additional information was received on 07-Mar-2011: no late occurring adverse events were reported following administration of the expired FLUMIST.
Patient's wife came in stating patient complained of: feeling clamy, having severe pains, diarrhea, nausea, vomiting, no fever, chills, overall discomfort
Shingle shot 15-20 minutes - redness, itchiness on hands - couldn't stop scratching - face rash/redness then arms, neck - looked like a bad sunburn - on way to ER - feet, legs red - eyes were burning - neck in hospital - back and rest of body totally red and itchy. Shot burned when injected.
Fine rash on legs. Benadryl PRN tsp every 6 hours, heat and ice.
patient's back was hurting; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (patient's back was hurting) 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 25-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced BACK PAIN (patient's back was hurting). The patient was treated with PARACETAMOL (TYLENOL) for Back pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (patient's back was hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter.
Within hours of injection R arm sore, by 6 hrs later some what red, mildly, tender. TX - for comfort acetaminophen.
Information has been received from a physician concerning a female (age unknown), who on an unspecified date, was vaccinated with a first dose of GARDASIL. Subsequently, the patient experienced arthralgias. On an unspecified date the patient was vaccinated with a third dose of GARDASIL.  Subsequently, the patient experienced symptoms of GUILLAIN-BARRE syndrome.The patient sought unspecified medical attention. At the timf of the report, the patient had not recovered. No product quality complaint was involved. Follow-up information indicated that the physician did not know the name of the patient. The physician reported that he received infromation on the event through a contact of a friend and he did not have additional infromation on the patient. The physician considered the symptoms of GUILLAIN-BARRE syndrome and arthralgia to be disabling. This is a consolidation of two reports concerning the same patient. Additional information has been requested.
The patient received his 2nd dose of covid vaccine on Monday 2/8/21. The patient did not complain of any ADRs or fever immediately following the injection. However, the next day he had a temperature of 100.4 F. Since the patient was febrile, he received acetaminophen 650mg x1 at 7:46pm. The repeat temperature at 10pm was 98.8 F. He was not in distress. He had no complaints otherwise.
Patient's injection site broke out on Monday 9-10-18. By 9-12-18, the patient's entire upper arm was red and warm to the touch. The patient presented to the pharmacy with a prescription for KEFLEX.
Headache/Chills/Fever (100.7)  1000mg Tylenol every 4 -6 hours for 16 hours.  (02/06/2021  Mild muscle aches, listlessness. Just drank lots of water. (02/07/2021)   100% fine by 02/08/2021
Case number PHEH2012US019580, is an initial spontaneous report received from a nurse on 03 Oct 2012. This report refers to a 56-year-old male patient. His medical history and concomitant medications were not reported. Nurse reported that she inadvertently administered MENVEO to a 56 year old. He looked young and she did not verify his age before vaccination. No adverse reaction was reported.
had a cough; BNT162B2 dose 1 07Aug2021 Flu 07Aug2021; BNT162B2 dose 1 07Aug2021 Flu 07Aug2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old patient received BNT162b2 (BNT162B2), on 07Aug2021 at 15:10 as dose 1, single (Lot number: FA7484), in right arm for covid-19 immunisation; influenza vaccine (FLU), on 07Aug2021 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history included: "hypothyroidism", start date: 11Jul1997 (ongoing), notes: I take levothyroxine 88mcg; "Hashimotos Hypothyroidism" (unspecified if ongoing). The patient's family history included: "High blood pressure", start date: 11Sep2012 (ongoing), notes: I take bisoproplol 6.25mg, low dose aspirin, losartan 50mg; "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LEVOCETIRIZINE taken for blood cholesterol increased, start date: Jun2022 (ongoing); BISOPROLOL;HYDROCHLOROTHIAZIDE taken for hypertension, start date: 2013 (ongoing); LOSARTAN taken for hypertension, start date: 2018 (ongoing); LEVOTHYROXINE taken for autoimmune thyroiditis, hypothyroidism, start date: 2002 (ongoing); ALPRAZOLAM (ongoing). The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 07Aug2021, outcome "unknown" and all described as "BNT162B2 dose 1 07Aug2021 Flu 07Aug2021"; COUGH (non-serious), outcome "recovered" (14Jul2022), described as "had a cough". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of cough.  Additional information: Upon follow up information received on 02Sep2022, it was reported that patient received BNT162b2 on 28Aug2021, in afternoon as dose 2, single (lot number: FC3182) in arm for covid-19 immunization and also received dose 3 on 19Apr2022, in morning as dose 3 (booster), single in arm for covid-19 immunization. Booster dose due to a weekend immune system. Vaccine facility type: Doctors office/ Urgent care. Vaccine administered at military facility: No. Patient received "Shingles" vaccine on 19Apr2022 in arm, as prior vaccine (within 4 weeks). Patient had cough with onset date: 08Apr - 08Jul2022. Pertinent details: for cough Allergy meds helped.  Amendment: This follow up report is being submitted to amend previous information: added the event 'off label use'.  Follow-Up (17Aug2022): Follow-up attempts are completed. No further information is expected.  Follow-up (02Sep2022): New information received from a same contactable consumer in response to Non-Hcp follow-up letter sent in cross reference case. Updated information included that RMH was added, lab data added, concomitant drugs were added and new event (had a cough) added and clinical information added.
Patient noticed a visible lymph node under her collarbone 12 days after first dose on the ipsilateral side (Left). Patient states it appeared oval and during palpation was noted to be rubbery, non-tender, and mobile. After 3 weeks, patient went to primary care physician because it had not decreased in size. PCP noted it was approximately 1cm and mobile. Physician suggested patient wait another 4 weeks to see if it decreases, and then to get an ultrasound. Pt. was able to schedule an ultrasound for 11 weeks after first noticing the lymph node (8 weeks after PCP visit). It remains visibly swollen today, 12+ weeks after first dose.
Skin warm to touch from left shoulder up the neck (trapezius). Awoke next morning with painful and stiff shoulder and neck (trapezius) muscles. Condition continued through 8/31/11.
First pregnancy. Didn't know I was pregnant when I received the first shot so marked no on the form. Informed the pharmacist of knowing I was pregnant and to change my form from the first shot but he said he didn't have to.  I had a miscarriage within 44 hours of receiving the shot. Bleeding.
sore arm at puncture site, like swollen bruise (but no swelling or bruising very mild headache for a couple of days very tired for a week
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 25-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and allergies were reported. Treatment medications were not reported.
For 2 days I experienced extreme fatigue, body aches, joint pain, chills, and headache.
Cold like symptoms; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold like symptoms) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 56-year-old male patient 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 30-Aug-2021, the patient experienced NASOPHARYNGITIS (Cold like symptoms) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, NASOPHARYNGITIS (Cold like symptoms) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and medication information provided.  No treatment information provided.
raised soreness at injection site; Nausea; 100F temperature; Upset Stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2022, the patient received the 2nd dose of Shingrix. On 26th August 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, nausea, fever and upset stomach. On an unknown date, the outcome of the injection site pain, nausea, fever and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, nausea, fever and upset stomach to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-AUG-2022 Reporter's Comment:  The reporter was husband. The reporter stated that the patient was experiencing raised soreness at injection site, nausea, 100F temperature, upset stomach. The reporter want to know how long these adverse events would last. The reporter gave consent to follow up. Additional Supportive Information:  For Husband case refer case US2022AMR125353.; Sender's Comments:  US-GSK-US2022AMR125353:Same Reporter
Felt fine all evening after the injection (6pm). Woke up feeling fine around 8am. Started feeling cold around 10am. Took temperature several times and body temperature had fallen to 94. Got back into bed with heating pad on back and feet. Temperature quickly jumped to 100. Body temperature continued to fluctuate into the evening. As evening rolled in started experiencing excruciating pain in the neck at the base of the skull and migraine like symptoms.
symptom onset within 24 hours. Fever occurred for 12-18 hours. Patient took tylenol for fever. within 3 days (or 36hrs) Patient had a bulge that was large, red, warm, baseball size bump on arm that lasted 7-10 days and started after the fever. She did not take anything for this. she simultaneously also had a rash on arms and legs that were itchy. This lasted 3-4 weeks. Patient took topical benadryl OTC. Pt did not go to doctor, resolved from self care.
I received a flu shot from walk-in facility. They gave me Fluzone. I have never before had a reaction to flu vaccines, but the flu vaccines that I had were all out of state. This was my first one in state. Within half an hour both of my ears began to ring and I began losing my hearing. I estimate hearing loss at about 15%. I developed a feeling of fullness in my ears, they were also painful, and they felt itchy/prickly somewhere way inside my ear. My ears began to hurt. I called my doctor and she said to call the ear doctor she recommended. I went in to see the ear doctor immediately. He said that I had an allergic reaction to the shot, that he had seen this before. If my ears are not better today, I am to see him again and get a prescription. My ears still hurt and feel full.
Low temperature 95.8, extreme generalized skin pain to touch, large red area at injection site 4?x4?, raised and hot to touch
Erythematous, swollen 8.0cm x 6.0cm, non tender area anterior aspect left thigh.
nerve damage; pain on their arm, like a burning pain, from the elbow to the shoulder blade; A spontaneous report was received from a consumer concerning herself 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain on their arm and nerve damage.   The patient's medical history included Migraine. Products known to have been used by patient, within two weeks prior to the event were not provided.  On 04-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) via unknown route on arm for prophylaxis of COVID-19 infection.   On 04-FEB-2021, after receiving mRNA-1273, patient experienced pain in her arm, like a burning pain from the elbow to the shoulder blade. Patient wonder if this is related to vaccine or nerve damage.  Treatment details were not provided/unknown.  Seriousness criteria included nerve damage which is a medically significant event.  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the event experienced pain on their arm and nerve damage were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events and a causal relationship cannot be excluded. Further information has been requested.
On 7/19/04, experienced severe abdominal pain, nausea, vomitting.In ER-numerous tests and X-rays.Inconclusive results.7/20 - back to ER - scoped and removed 5 liters of liquid from stomach according to her mother. Had been constipated and then had diarrhea. Distention of stomach is pushing against pancreas. Has been home with IV therapy and is returning to hospital today for more tests.Had Tetanus shot several days AFTER Yellow Fever immunization.
pt stated that evening after getting the covid vax he started getting a pain like a cramp that started in the left buttock and hip that went all of the way down the outside of his leg.  Pt went to ER on 3/5/2021 in early am since was having problems breathing and very nauseated.  His back and legs were still hurting.  He was given something for pain and nausea.  Blood Pressure was elevated.  They did blood work and chest X-ray with normal results.  He was observed for about an hour and then discharged since nothing was found and told him he had a reaction to the vaccine.  Pt still has constant pain in left leg and has not been able to work.  Pt has an appt w/ PCP on 3/12 for FU.
Hives on torso and arms which began approx. 8 hours, post vax. Did not appear to cause discomfort. No treatment. By morning, gone, except for a couple patches of redness.
Shaking chills; vomiting; fever; extreme achiness; This is a spontaneous report received from a contactable consumer reporting for herself. A 69year old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 26Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient did not have underlying conditions and rarely get ill. The patient's concomitant medications were not reported. On Mar2021 (10 hours after vaccination), the patient experienced shaking chills for about 3 hours, vomiting, fever, extreme achiness etc. which lasted about 22 hours. The outcome of the events was unknown.               No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
patient started to have headaches and lost hearing  in both ears. Headaches was 6/10 with pressure located in the forehead, Blood pressure 136/98 ,16, 56,patient continue to become dizzy, at this time laid patient on the floor with lower extremities elevated in chair . Blood pressure at this time was 100/56 , 56,16 lying,sitting @916 100/71,73,18, standing b/p 123/100 ,81,18 denies sob, chest pain and headache at this time , hearing return at this time, continue to monitor patient @ 930  patient drinking water without any difficulties, )941 b/p 127/76 ,64, 16 denies any discomfort discharged home @0949
pt recv vax 15OCT96 & 2wk p/vax pt devel pericarditis;tx w/Indomethacin & became much better;