chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from MA and Physician concerning a retired 68 year old white female pt with a history of high blood pressure, degenerative joint disease, complaint of "having stomach trouble", and allergies to PCN and erythromycin who on 10/01/03 at 11:20am was vaccinated IM in the left deltoid muscle with a 0.5mL first dose of pneumococcal 23v polysaccharide vaccine (Lot # 645646/0068N). The pt was also taking other medications. On 10/02/03 pt came in to the physician's office because her left arm was "red and heat swelling", (also reported by MA as the pt developed swelling, redness and pain at the injection site). The pt was told to take Benadryl and use a cold pack (also reported by MA as treated with antibiotics). Lab tests were not performed. A product quality complaint was not involved. The physician reported that the pt recovered on 10/05/03.  The reporter also mentioned two other pt's who had similar experiences post vaccination with pneumococcal 23v polysaccharide vaccine (Lot # 645646/0068N)(WAES # 0310USA01464 & 0310USA01465).  Two of the three pt's felt tired. It was noted that the lot number was the same for all 3 pt's.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  No additional information is expected.
About 40 incidents of  sharp heart pain. Lasting about 1 second per incident.
Client complained that beginning about 12/13/09, that he began having in his right arm, numbness when his arm is at rest. It radiates from the shoulder down the bicep, into the forearm, and ending in the right thumb and pointer finger. He did say he received 2 pokes because the first syringe was not functioning properly. As client is still having numbness.
Rash with many bumps broke out on my upper chest and upper back and on shoulder near (but not on) injection site.  Rash was mildly itchy so I called my doctor and got a prescription for Triamcinoone Acetonide on Wed. 12/14/2022 to put on bumps.  I called my doctor about the rash but did not remember to tell my doctor that I had had a Bivalent Shot a week earlier.  Some of the bumps in the rash are larger than others but smaller than a penny size.  It looks like smaller bumps that are on top of the largest red rash blotches.  I still have the rash today and it doesn't seem to be getting worse, but will continue to monitor it.  I have never experienced this type of rash before but I have always ha very sensitive skin.
Lump at injection site and front of arm.  Ancillary swollen and painful lymph nodes. Swollen and painful subclavian lymp nodes. Swollen and painful left breast.
I had a red rash on the left arm ,but not at the site of the injection.  It itched for two days. Was red for  about 6 days and gradually faded.  It's 3 weeks and still is visible.
Initial report was received from Pharmacist on 13 Jan 2010: This patient received FOCETRIA lot number 102142P1, intramuscular on 13 Jan 2010. The patient experienced muscle aches in her forearm and was "unable to pick anything up" on 13 Jan 2010. The outcome of the events was reported as ongoing.
I got the vax for it and then I got it/Suspected vaccination failure; I got it; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient got the vaccine for shingles and then got them. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirming shingles was unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
no additional AE reported; VARIVAX was administered after a temperature excursion; This initial spontaneous report was received from an unspecified reporter concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were not reporte.      On 19-OCT-2021, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route and frequency not provided) Lot # T032315 and expiration date: 22-SEP-2022, for prophylaxis.     It was reported the vaccine was administered after a temperature excursion at -10 celcius for 7 hours. The vaccine had no previous excursion. No adverse events reported.
gave two Moderna vaccines that were expired by 14 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave two Moderna vaccines that were expired by 14 hours) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 039C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave two Moderna vaccines that were expired by 14 hours). On 27-Jul-2021, EXPIRED PRODUCT ADMINISTERED (gave two Moderna vaccines that were expired by 14 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non significant follow up added.
Nausea, headache, malaise, began about 2 hours after administration. Sx's were gone within 24 hours.
Patient received the 1st dose on 30-May-2021 and received 2nd dose on 01-Mar-2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number AP545, expiry date 25th January 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th May 2021).   On 1st March 2022, the patient received the 2nd dose of Shingrix. On 1st March 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 13-MAY-2022 Reporters comment: The patient received 2nd dose of Shingrix late. The reporter consented to follow up. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Initially with angioedema lips and eyes. Then hives developed. Went to Urgent Care and was given oral methylprednisolone and antihistamines. Seen in our office today for follow up. Stable. No shortness of breath or wheeze. No chest pain. No abdominal symptoms. Never had allergy in the past. No lip fillers.
My cousin took two doses of your Pfizer Vaccine and he now has Myocarditis; these vaccine hurting and it just does not go away; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "My cousin took two doses of your Pfizer Vaccine and he now has Myocarditis; these vaccine hurting and it just does not go away".  Clinical course: My cousin took two doses of your Pfizer Vaccine and he now has Myocarditis and he was been battling with this for some time and I am sure you are aware of it just does not go away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed abnormal discoloration to Lower left leg from hip to toes.  Initially purple in color with no raised areas or swelling.  No petechia.  Able to move limb.  Also was very irritable and hard to console at home. Improved over the course of 1 hour and resolved by the time evaluation occurred.  No respiratory concerns, no facial swelling.  Normal use of extremity.  No other findings.
3 doses of the Moderna Covid-19 vaccine and one dose of Pfizer.; his wife and himself had Covid mid Aug2022 after getting 3 doses of the Moderna Covid-19 vaccine and one dose of Pfizer; his wife and himself had Covid mid Aug2022 after getting 3 doses of the Moderna Covid-19 vaccine and one dose of Pfizer; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): MOD22-022731 (MODERNA), 147942 (MODERNA).  A female patient received BNT162b2 (BNT162B2), on 17May2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Feb2021 as dose 1, single (Lot number: 011M20A), on 05Mar2021 as dose 2, single (Lot number: 002A21A) and on 08Nov2021 as dose 3(booster), single (Lot number: 065F21A) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "his wife and himself had Covid mid Aug2022 after getting 3 doses of the Moderna Covid-19 vaccine and one dose of Pfizer"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "3 doses of the Moderna Covid-19 vaccine and one dose of Pfizer.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) positive.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
While I had some stronger initial symptoms following the first 36 hours of the 3rd dose of vaccine, I had very noticeable shortness of breath for days afterward, to which I connected the timing of the symptom with the vaccine. I asked my doctor if it was possible to have had this as a side-effect, and she said yes. I asked her what supplement I could take to help with the symptoms, and she recommended BCQ. Taking BCQ three times a day alleviates the symptoms. If I forget a dose, the shortness of breath returns. I have had a chest xray within the last year, a cardio workup (including EKG and Echo) -- post Pfizer 3, plus regular labs, nothing else shows up as causing this shortness of breath.
Initially, no issues at all. Blood drawn on 1/15/21 and discovered elevated liver enzymes on 1/22/21. Blood was drawn again during the 1st week of March and everything was back to normal.  I hadn't changed anything in my daily life besides getting the vaccine.
One half-hour after injection, I experienced a sudden tight feeling around my chest (rib cage).  Pain was about a 4.  I was able to breathe normally at rest. I did not have any other symptoms. Once it came on, the pain may have worsened gradually and then stabilized.  After 1.5 hours it subsided and I did not experience any other symptoms since then.
Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm Pain) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm Pain). On 25-Jan-2021, VACCINATION SITE PAIN (Arm Pain) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
When I went to bed on Thursday night, my left armpit was hurting. The next morning, I noticed I  couldn?t sleep on that side because my armpit was so painful (in addition to the normal injection site pain). I also noticed painful joints everywhere, but especially my left wrist.
Diagnosed with Varicella on 10/10/2003- multiple red papules primarily on trunk especially on left shoulder, few with central vessicles.
Client received Janssen COVID vaccine lot #: 211D21A on 04/16/22/22 and Pfizer COVID Booster lot #: FP7138 on 08/07/22 at local Public Health Center. Client denied any chronic conditions, medications, or any known allergies. Lead PHN submitted a medical consult via text message to the doctor because client came on 10.02.22 local Testing Vaccine Site Team requesting to receive Pfizer COVID Bivalent booster five days earlier than the recommended timeframe of two months apart from the last Pfizer COVID booster per CDC guideline. Medical consult sent to the doctor at 0951. The doctor approved Pfizer COVID Bivalent booster at 0953. Client received a Pfizer COVID Bivalent booster Lot# GJ3277 exp. 12.05.22 IM by a nurse at 1010 today. Client stayed the recommended time frame in the observation area and client was educated on when to seek emergency care. Client tolerated the vaccine well and left the facility at 1025.
Severe headache, body aches, chills, and fever. Fever reached 107.1 but was reduced with Tylenol and cold compresses.  Chills and shaking started approximately 10 or 11 hours after vaccine.   Temperature is now fluctuating between normal to 100.  Severe headache and body aches persist.
pt recvd vax 30AUG93 & lab eval on 16DEC93 revealed a neg measles titer; No further details were provided;
t 3am she woke up and noticed some facial tingling on the ride side that felt  like "pins and needles" - she reports like "when you get a numbing shot at the  dentist". She also had some right arm and right leg tingling. She reports the leg  tingling as "normal" as she has a hx of sciatica.  She she woke up for the day then this morning the tingling in her arm/leg had  resolved. She had coffee and cinnamon roll then started to clean the hou   also had inner eye lid with itchiness.  She began to have mild chest tightness so she took her inhaler - Albuterol and she took Claritin.
All of a sudden  3 to 5 days after I received the second dose I began to get hives. They were striations like marks  Raised like hives , swelled like hives, itched like hives. They appear out of the blue and go away as fast as they appear. The appear on the back of my upper arms, around my waist , on my wrists and forearms, and on my back. The itch is intense and need to take Benadryl.  Sometimes i am not bothered for 2 days or so but other days its several times a day.
SORE THROAT; HEADACHE; FEVER; PAIN AT THE INJECTION SITE; VACCINES WERE GIVEN OUTSIDE OF THE 6 HOUR TIME FRAME; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-JUL-2021, the subject experienced vaccines were given outside of the 6 hour time frame. On an unspecified date, the subject experienced sore throat, headache, fever, and pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, sore throat, fever, pain at the injection site and vaccines were given outside of the 6 hour time frame was not reported. This report was non-serious. This case, from the same reporter is linked to 20210802909 and 20210803269.
Pt recvd 3 doses of Engerix-B & failed to produce protective antibody titers 9 months p/last inject;
Red spots appeared soon after the second shots with circles around them, covering both legs.   Personal physician suggested that cause may have been associated with 2nd dose of the vaccine.    Patient called to report that after the 3rd dose on 10/13/2021 3:30 pm (pharmacy), all of the spots disappeared within approximately 6-7 hours after the third dose.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 13-MAR-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K006682 with expiration date of 17-DEC-2015; dosage and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Presented to the Clinic on 8/4/06 with c/o HA, swollen lymph nodes under L arm, sore throat, and myalgia. Also experiencing cramping in legs when running. C/o Diarrhea this am as well. Labs done. L upper arm smallpox vaccination site with swelling and erythema. Diagnosed as Smallpox Vaccination Reaction. Quarters x 48 hours given. Push fluids. Ibuprofen 400mg po qid with food.
Patient reports waking this morning with redness and swelling at injection site. No pain reported.  On examination patient would found to gave 6X6cm area of erythema with swelling. No fever.  Denies pain to site. Advised to monitor and report any increased pain, swelling, redness to area.  Apply ice for comfort and Acetaminophen. Patient will be seen back in the office on Monday for follow up evaluation. Patient advised to contact on call provider for any increase in symptoms.
Reddining of skin from head to toe, difficulty breathing, persistent cough, swelling of joints, panic attack.
Headache, Myalgia, Chills, temp to 99.9 Narrative:
mom states pt seen by MD dx client ashaving an adverse vaccine rxn; DTP given on 21JAN92; pt seen by MD 22JAN92 had inflammed throat & inject site swollen; MD advised IM vax be given in gluteus;
Sudden pain in abdomen, similar to menstrual cramps but worse, followed by bleeding and clotting.
Pt received Rotateq vaccine 4/4/07 Pt had intussusception dx'd 5/15/07 05/23/07-records received for DOS 5/15/07-DX: Intussusception. Surgical repair. HX nausea vomiting no bowel movement for past 48 hours Temp 100.4. PE abdomen soft mild distention with decreased bowel sounds, non tender. no masses.
This spontaneous report as received from a Certified Medical Assistant (CMA) refers to multiple unspecified patients of unknown age. On an unknown date the patients were vaccinated with improperly stored ROTAREQ orally (dose, frequency and lot # were not reported). No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from  the same reporter. Additional information is not expected as the reporter did not wish further contact.
devel asymptomatic fever to 103 5 dasy post shot which lasted for 5 days & events resulted in occassional vomiting, dec appetite, hyponatrem, dehydration w/IV therapy;
The pt experienced a seizure immediately following MMR vax at the age of 1.2 years of age. Hospitalization after valium administration.
PATIENT RECEIVED MORE THAN THE RECOMMENDED DOSES OF COVID-19 VACCINE. THE PFIZER SERIES WAS ADMINISTERED ON 3/26/2021 AND 4/16/2021, THEN THE JANSSEN VACCINE ON 6/12/2021. TREATMENT, OUTCOME, AND SYMPTOMS UNKNOWN.
Sudden fits of rage: unprovoked screaming (never happened before); grabbing head/rocking and blood curdling screaming. Spends a lot more time alone. Decreased eye contact. His skin erupted in the worst "eczema" ever within 1 day of the shot. Fever. Inability to listen/follow directions (He used to be able to follow 5 commands in order without us having to repeat any steps). He developed a sore throat, loss of appetite, diarrhea and abdominal pain (also there was a white nodule in his throat).
After being on Nexplanon for 7 years,  I very rarely get any cramps or period symptoms. After my second dose of the Pfizer vaccine i had terrible, crippling cramps and had a very heavy period for about 5 days. 3 days later i started to bleed again.
Difficulty breathing; Forgetfulness; Anxiety; Insomnia; Chest pain; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Difficulty breathing), MEMORY IMPAIRMENT (Forgetfulness), ANXIETY (Anxiety), INSOMNIA (Insomnia) and CHEST PAIN (Chest pain) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing), MEMORY IMPAIRMENT (Forgetfulness), ANXIETY (Anxiety), INSOMNIA (Insomnia) and CHEST PAIN (Chest pain). At the time of the report, DYSPNOEA (Difficulty breathing), MEMORY IMPAIRMENT (Forgetfulness), ANXIETY (Anxiety), INSOMNIA (Insomnia) and CHEST PAIN (Chest pain) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.   Reporter did not allow further contact
redness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness). At the time of the report, ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
pt recvd vax 26JUL94 area of reddness & induration (5x6 cm) upper rt arm; swollen & painful glands under rt arm & rt elbow; no fever; genl malaise; instructed pt & mom to use ice pack;
5:26 migraine, exhaustion hour later, nausea and chills, muscle aches, fever the next morning
wicked headache, extreme dizziness, abdominal pain, diarrhea, chills, fever, extreme thirst. left wrist pain. Treatment: boneset herbal tea, lots of fluid  Time: started around 9PM, day of injection and all day next day
I went to the local hospital had my 2nd shot. I waited my fifteen minutes and went home. The next day woke up I had body ache and fatigue. I Did not take any medications, these symptoms lasted about two days. After the two day I started feeling better. I don't really remember any other details.