chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose on 20Sep2022, expiration date of 18Jun2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 42-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 20th September 2022, the patient received Havrix. On 20th September 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.      Additional Information: GSK receipt date: 22-SEP-2022 Reporter's comment: Pharmacist reported that a colleague had administered a dose of Havrix to a patient on 20th September 2022, which had an expiration date of 18th June 2022. At the time of reporting, the dose had not been repeated.  The reporter had consented to follow-up. Additional Supportive Information: The patient received a dose of Havrix which was already expired, which led to expired vaccine used.
Pt developed hives on torso, legs, arms and buttocks. Mother gave 2 tablets of Benadryl. Hives have completely gone this AM. JEV given at 11:15 on 07/10/02. Hives developed at 6:30pm on 07/10/02. Benadryl given 10:30pm on 07/10/02.
Given second Hepatitis A dose on 6/5/2017. Presented at school wellness center on 6/8/17 reporting facial swelling, erythema, and warmth that began the prior evening. treatment included Prednisone, Zantac, Benadryl and referral to PCP for continued management and follow up.
sneezing; chills; nerve sensation limbs; pain at injection site (left); Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of PARAESTHESIA (nerve sensation limbs), SNEEZING (sneezing), EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), CHILLS (chills) and VACCINATION SITE PAIN (pain at injection site (left)) in a 44-year-old female patient (gravida 4, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage in November 2017, Allergy (decreased injections) on 01-Jan-2017, Pregnancy (healthy live, full-term birth) on 16-Sep-2016 and Pregnancy (healthy live, full-term birth) on 09-Aug-2019. Concomitant products included VITAMIN D NOS for Hypovitaminosis, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Aug-2020 and the estimated date of delivery was 22-May-2021. On 27-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and VACCINATION SITE PAIN (pain at injection site (left)). On 28-Jan-2021, the patient experienced PARAESTHESIA (nerve sensation limbs) and CHILLS (chills). On 27-Feb-2021, the patient experienced SNEEZING (sneezing). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 27-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. On 29-Jan-2021, PARAESTHESIA (nerve sensation limbs), CHILLS (chills) and VACCINATION SITE PAIN (pain at injection site (left)) had resolved. At the time of the report, SNEEZING (sneezing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. In 2021, Blood glucose: normal normal. In 2021, Ultrasound scan: normal normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The date of positive pregnancy test on 15-Oct-2020 and estimated date of conception was 15-Aug-2020. The patient has an established prenatal care.   This case was linked to MOD-2021-031546 (Patient Link).
Monday administration, dizziness for 30minutes (rapid heart). Itching and soreness and redness. Chief complaint redness increasing in size.
Moderna - 1st Shot - 02-20-21- left arm - lymph nodes sore, developed Covid arm on 03-28-21  Moderna - 2nd shot - 03-21-21- right arm, got side effects for 2 days, fever, aches, headache, nausea.  I am writing as my right arm(2nd shot) is still sore and the lymph nodes on both sides next to my arm pits are very sore. Not sure if this will go away and if I should do anything about it?   Also reporting that my daughter-in-law developed pleurisy a week after receiving the J&J shot as diagnosed in the ER. Sounds related to me.
Pt has a past medical history of nonischemic cardiomyopathy and DM type II, along with being status post renal transplant in 2012.  He comes to the hospital with worsening shortness of breath and was found to be COVID positive.
This case was reported by a consumer via call center representative and described the occurrence of nausea in a 73-year-old female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced nausea, fever and shingles. Shingrix was discontinued. On an unknown date, the outcome of the nausea, fever and shingles were unknown. It was unknown if the reporter considered the nausea, fever and shingles to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that a friend had first dose of Shingrix sometime earlier this year and experienced nausea and fever and then several days later developed shingles. The patient's doctor advised her against getting the second dose.
Injection site looked hemorrhaged. The injection site was dark red whith what looked like blood underneath the skin. The patient did not experienced pain despited this.
VIVOTIF was taken on 10/14/17, 10/16/17, 10/18/17, and 10/20/17. Adverse reactions started on 10/28/17. They were an abrupt onset of lower abdominal cramps and constipation, and dizziness and shakiness right before, during and after defecation. Patient tried to alleviate constipation with laxatives. At present (1/3/18), the dizziness and shakiness have subsided, but the abdominal cramping and constipation persists.
After administering influenza and Gardasil vaccines, labs were immediately drawn from the child. After removal of the needle for blood collection, the patient fell to her left side, a cabinet breaking her fall. A nurse was able to stop her from falling onto the floor. The patient completely lost consciousness for about 30 seconds. She awoke with no recollection of the incident, feeling as though she had just fallen asleep. BP immediately following the incident was 60/30, within 20 minutes repeat BP was 101/66, HR 70. Mother obtained juice and candy for the child to eat. No bruises or araisions noted. Left office about 30 minutes later feeling well.
I got the 2nd vaccination of Moderna on  4/28/2021 approx. 130 pm.  No reaction during the 15 minutes wait.  All was well and went to bed and woke up the next day, 4/29/2021 approx. 530 am.  Feeling the following, tiredness, motionless, headache, arm and body soreness and some upset stomach.  Took a sick day as I felt no energy to move about.  Couldn't drink a 2nd cup of coffee and my normal eating routine was off somewhat as it was not normal.
Varicella - Information has been received from a physician concerning a 5 year old caucasian female patient with a penicillin allergy who on 09 Mar 1999 was vaccinated in the right anterior thigh with a first dose of varicelle virus vaccine live (lot 626149/1125h).  It was noted that there were no illnessess at the time of vaccination.  On 19 Mar 2000 the patient developed chickenpox.  On 10 Mar 2000 the patient was examined in the physician's office.  It was confirmed by a physician that the patient had chickenpox consisting of approximately 50 lesions scattered on the patient's face, trunk, extremities and vulva.  Additionally, it was noted that the patient was afebrile.  Follow up information reported that the patient had no adverse effects from varicella rash and subsequently recovered.
R arm with erythema and swelling from elbow to shoulder. Erythema extends to chest. Positive warmth, tender, taught. R arm 22cm. fever 102 that day.
Systematic outbreak of maculopapular rash noted in clusters over most of body. Very itchy  Onset of rash was on day 4-5 of receiving vaccine. Onset was not immediate.  Still presenting hives 1 week after outbreak.
She was in her usual state of health yesterday. when she received her third dose of Pfizer Covid vaccine.  That evening she had dinner with her daughter which did include some salmon and a few walnuts in the salad.  Later that evening she had a feeling of mouth/throat dryness and tightness so she ate a plum.  Her daughter is clear that she thinks the symptoms began before patient ate the plum.  Then she woke around 2:30 in the morning with a feeling of shortness of breath and throat tightness/swelling and came to the ED.  She was found to have angioedema affecting the root of her tongue and epiglottic area based on CT.  She was treated with IV solumedrol, IV benadryl, racemic epinephrine, IV pepcid, direct laryngoscopy by ENT specialist.  Did not require intubation.  Airway swelling improved with the above treatment.  Admitted to ICU stepdown unit for observation.  I believe the event was related to eating walnut or salmon, rather than the vaccine because the onset of symptoms was more than several hours after the vaccine, whereas, the onset was within two hours of eating walnut/salmon which is more typical for angioedema or other allergic reaction.
First night: awoken at night due to arm pain. Able to work following day 1/7: evening: low grade fevers 99.0. Tolerated with tylenol 1/8: ongoing low grade fevers 99.0. Tolerated with Tylenol 1/9: Fevers slowly increasing to 100, with chills, alternating with sweats. Began difficulty tolerating with Tylenol q6h 1/10: fevers increasing to 101. Chills and sweats ongoing. Not controlled with Tylenol q6h. Began adding ibuprofen q6h alternating. Arm pain continued with now noticing severe erythema, warmth and edema around incision site. Began with macular rash around trunk anterior and posterior 1/11: 1:30 am began having chest heaviness that was not subsiding. Tmax 103.4. Went to ED. EKG, CBC, CMP, UA, CXR all WNL. BC ordered - unknown results. COVID PCR negative. Rash continued spreading to limbs as day progressed. some now raised and tender on arms and flank. Given keflex QID. 1/12: Fevers and chills continue 103. Not controlled with Tylenol and ibuprofen alternating q6h. Now with canker sores/ulcer in mouth and several in genital region. Difficult to ambulate and to urinate secondary to severe pain from ulcers. 1/13: Fevers and chills continue. 103. Still not controlled but slightly improved. Rash appeared stable. Now with central blind spot in right eye. Went to see ophth and found to have had a blood vessel rupture. Ulcers continue to be severely painful requiring sitz baths to urinate 1/14: fevers slowly declining. Rash stable. blind spot unchanged 1/15-1/19. Fevers eventually resolved. Continuing keflex. Ulcers improving, though still somewhat painful. Able to ambulate. Blind spot unchanged.
Information has been received from a registered nurse concerning a  26 year old black female  healthcare worker with no known allergies who was vaccinated with a first, second, and third dose of Hepatitis B virus vaccine rHBsAg(yeast)on 05/05/2004, 06/02/2004, and at 3 pm in her left deltoid on 11/03/2004 (lot#648123/0596P)(thimersol-free). There was no illness at the time of vaccination. On 11/03/2004 the patient experienced a knot at the injection site, pin pricking sensation with pain, swelling and ithching at the injection site and redness in the area of injection site. There were no systemtic reactions. It was reported that the previous vaccinations in this series were well tolerated and that there were no adverse reactions to other previous vaccinations. The patient stated that the symptoms lasted until 11/07/2004. The nurse saw the patient on 11/08/2004 and her arm was feeling better, and there was no knot or redness. There were no relevant diagnostic tests/laboratory data. On 11/08/2004 the patient was considered to be recovered. There was no product quality complaint involved. No furhter information is available.
Left deltoid area became red, swollen 3"-4" long, painful. Seen by PCP.
Patient awoke the day after vaccination covered in hives. Presented at Health Center with a low B/P (72/49) and urticaria. Was given .5cc Epinephrine 1:1000 and 50mg BENDARYL PO. EMS was dispatched for transport to hospital.
Chicken pox after 1 dose of varicella vaccine. Date of vaccine 10/4/99.
Arthralgia, CoughWheeze, Chills, injection site pain and swelling  Narrative:
Patient called Sat. 09/18/10, afternoon, stating arm with flu shot is fine, & pneumonia shot is very sore, red & hot to the touch. I told her to put cold compress on it & to call her MD or go to facility. I called her back after we closed on Sat to check on her & again Sun am. She said facility MD put her on Clindamycin & drew around it & told her if it gets any bigger, go to ER. Sunday morning she said it is getting smaller & feeling better.
Child received 2nd dose of varicella vaccine on 4/7/00. Unknown to nurse, the previous dose was given 1/28/00. There was no record of this in pt's chart nor was it indicated on 4/7/00 at 11:03 for us to verify receipt of vaccine, nor did mother advise nurse of same, prior to administration of vaccine. Mother produces "pink" immunization record which indicated prior dose after 2nd dose given. Parent informed of 2nd dose given.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Aug2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Pennicilin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Patient experienced a rash and swelling in the throat and mouth shortly after receiving the vaccine. She took benadryl and used her ProAir inhaler which resolved the symptoms. Pt's husband is an EMT, so she did not feel it necessary to go to a medical facility for treatment.
I have a mild sore throat with congestion and drainage and a fever between 102-99.
Initial reaction was slight pain at injection site.  6 days later (Jan. 24) developed itching around site of injection along with redness and hard lump (size of lemon) under the skin with fever at the site area on arm.  Called Health Dept. and talked with .  She suggested hot compresses on area.  She gave me your number to call.  I used the compresses along with benedril cream several times a day from the 24th to present (Jan. 28).  Itching has just about stopped and lump and redness have gone.
Cold; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) and MYALGIA (Body aches) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold) and MYALGIA (Body aches). At the time of the report, NASOPHARYNGITIS (Cold) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication provided by the reporter. No concomitant medication provided by the reporter.
RN was asked to assess pt after the administration of the vaccine. Pt complained that her head felt like it was going to explode. The nurse took pt. vital signs which were 180/11 97% on 4 L NC (BL), 101, and 20 RR. Pt stated she "sometimes has right sides weakness". Pt had unequal smile, with weakness to the right. Pt also had unequal hand grips with right sided weakness and was unable to raise her eyebrows and had blurry vision. Pt was unable to state "No ifs ands or buts" to this nurse as well. Vaccine clinic staff called an ambulance after this nurses initial assessment of the pt. Medics arrived and took over care of the pt. Unknown disposition of patient.
4/9- Headache, irritated throat, cough, fatigue. 4/10- Headache, loss of voice, sore throat, loss of voice, deep cough, congestion, fatigue, fever, chills, restlessness 4/11- Headache, scratchy throat, deep cough, congestion, low fever 4/12-Headache, scratchy throat, deep and heavy cough, congestion, hard to catch breath.
I got rashes dime size; Quarter size red rashes all throughout my body. Especially my stomach and legs.; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the patient.   A 33-year-old male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administered in left arm, administration time at 16:00 (Lot number: unknown) at the age of 33 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication included: ADDERALL.  The following information was reported: RASH (non-serious) with onset 28Dec2021 at 16:00, outcome "recovered", described as "I got rashes dime size"; RASH ERYTHEMATOUS (non-serious) with onset 28Dec2021 at 16:00, outcome "recovered", described as "Quarter size red rashes all throughout my body. Especially my stomach and legs". Therapeutic measures were taken as a result of rash and rash erythematous.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient drank a lot of Benadryl as treatment for rash and rash erythematous.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Chills, muscle aches, bone pain, body aches, injection site Pain lasting 36 hours. Scale of 1 to 10, pain was 7.   Itchy bump at injection site 13 days post injection.
Patient received  HPV vaccine and in two weeks later was diagnosed with Mononucleosis - positive for Epstein Barr and  Cytomeglovirus. Patient then subsequently had multiple rashes,fevers and pain.
Sore arm; Fatigue; Chills; Body ache; Headache; Fever 100.4F; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body ache), HEADACHE (Headache), PYREXIA (Fever 100.4F) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body ache), HEADACHE (Headache), PYREXIA (Fever 100.4F) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: 100.4 (Inconclusive) Fever 100.4F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication was provided.
w/in 12 hrs p/vax 20JUL93 pt devel a fever of 102 & an urticarial rash (no erythema multiforme); the rash was generalized-chest, abdo, arms, legs, buttocks & head; some lesions on feet & hands; OPV repeated on 10SEP w/no sequelae;
Information has been received from a nurse referring to two patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, two patients were inadvertently administered GARDASIL (strength, dose, route, lot# and expiration date unknown), which had been improperly stored. No adverse events were reported. This is one of two reports received from the same reporter. Additional information is not expected since the reporter would not like to be contacted.
Shortness of breath; back pain, chest pain; swelling on face; arms; legs; fever; chills; runny nose.
Flu shot administered in left shoulder felt pain which never went away.  The pain grew more and more intense and pain went down my left arm.  I began to lose range of motion in arm. Went to see doctor on 11/13/2014 at that time had xray and was referred to a physiatrist. Appointment was 12/5/2014 received a cortisone shot and prescribed PT. Still in PT as of 2/17/2015.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced full blown chickenpox with fever and malaise and presented to a physician. The pt recovered. No further information is available.
pt recvd vax 16MAR93 & reported elevated fever 102.6 ax; pt given APAP; parents bathed pt in afternoon; pt cried for 1 1/2 hrs; fever 100.6 ax; seen by MD 17MAR93 dx tonsillitis & rx ATB; MD does not feel temp was vax related;
PATIENT REPORTED A BULGE ON HER LEFT ARM 4 DAYS AFTER VACCINATION. NO PAIN OR REDNESS REPORTED.
Not speaking > 1 word. Not eating. No fever or cough, just sleeping. Peed bed. Crying at 2AM. Sleeping all day.
After the 1st and 2nd dose,Patient experience covid like symptoms like fever 102,nausea vomiting and severe body aches for 1 1/2 days. After the 2nd dose (01/20/2021) on the 12th day (02/01/2021 develop Bell's Palsy and went to ER for treatment.
3/19 - started AMOXICILLIN for OM. 3/26 - WC visit, received DTAP, started CLARITIN. 3/28 - developed rash on thighs and over 48-72 hrs, became larger like hives, spread to abd., chest, arms and face. Saw allergist 4/2. See attached letter from allergist.