chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022; received doses from a vial first punctured the day before the date of administration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from a vial first punctured the day before the date of administration) and PRODUCT STORAGE ERROR (Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses from a vial first punctured the day before the date of administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses from a vial first punctured the day before the date of administration) and PRODUCT STORAGE ERROR (Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received 1st booster dose. Concomitant drugs were not reported. It was reported that 4 doses from 1 vial was first punctured on 14-Jul-2022 at estimation 10:30 AM and were administered on 15-Jul-2022 first administration at 09:30 and last administration at 11:30. The vial was stored in fridge post puncture and did not undergo any temperature excursion. The vial was exposed to room temperature range between 10 minutes and 35 minutes. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-614370, US-MODERNATX, INC.-MOD-2022-614372, US-MODERNATX, INC.-MOD-2022-614373 (E2B Linked Report). This case was linked to MOD-2022-614370 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-614370:Patient 1 US-MODERNATX, INC.-MOD-2022-614372:Patient 2 US-MODERNATX, INC.-MOD-2022-614373:Patient 3
Rash occurred on hand about a week after vaccination, more pronounced rash occurred on elbow started about a week ago, 3/25/19 ish.
PAIN UPON INJECTION ON 12/7/19.  AS OF 12/19/19, IT STILL HURTS TO PUT ON COAT, PANTS, ETC.  PAINFUL AT BEDTIME (COULD NOT SLEEP) ON 12/18/19.  HURTS TO MOVE IT.
sz-arching of back, mucous in mouth, pale lasting 30sec;post ictal period of 20min recovered & observed to have no further problems;
4/09/21 8p.m. fatigue started and patient went to bed with headache 4/10/21 Nausea, vomiting, muscle aches, dizziness, pulse slower than usual, low blood pressure. symptoms continued for days 4/14/21 ER. Dehydration secondary to vomiting. Hospitalized overnight. Received IV fluids, IV potassium, and protonix. Patient reported that her troponin was elevated, her potassium was low, but she felt much better after infusions. Patient left hospital AMA 4/15/21. Patient reports she now feels well, just a little fatigue.
Fatique, Headache, Joint pain, muscle pain, chills, nausea,  dizziness, difficulty breathing
Symptoms included laying around all day no fever during the day and at 8:22 pm he started jerking and was non responsive until emergency personnel got to my home.  (seizure)
24 hours after the injection I had a blood shot patch on my left eye which I believe is a subconjunctival hemorrhage. It has gotten smaller but is still visible today on 4/8/21 , six days after the vaccine.  Additionally,  my lymph nodes under my left arm swelled 36 hours after the injection and were swollen for 4 days. I took two 500 mg of tylenol daily for 4 days. I was very fatigued for 48 hours 24 hours after the injection.
This is from Flu Vaccine.  Could not move or bend left arm was very heavy and in a lot of pain.  Went to emergecy room.  Said to take Motrin.  Symptoms normal and will be better in a few days.
7 cm red rash, burning, warm to the touch 2 days after the 2nd vaccine
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 56 year old (Caribbean) female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 25-MAY-2021) 1 total, dose was not reported, administered on left arm on 21-MAR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for hypothyroidism.  It was reported that, the patient was testing weekly to determine if she had been exposed or acquired COVID-19. On 08-MAY-2021, the patient was tested positive for Ig-G (Immunoglobulin G) but not Ig-M Immunoglobulin M) upon rapid antibody test (confirmed immunological vaccine failure). On 05-JUN-2021, the patient tested again which showed negative for Ig-G and Ig-M.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210612287. This report was associated with a product quality complaint: 90000181865.; Sender's Comments: V0: 20210612254-COVID-19 VACCINE AD26.COV2.S- Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Pt recvd 1st dose of Hep B vax in JUL92 & approx AUG92 devel SOB & bronchitis; pt was hospitalized for 1 day & was treated w/nasal oxygen & Ventolin;
The evening after the shot I felt like a barrier had been broken by something in my brain.  Felt like blood was pushing past something that was closed and then broke through eventually.  What followed was pain in my leg, arm and stomach all on the side of the vaccine.  The next day I had difficulty speaking sentances.  I had a stomach pain that made me yell out in pain as I was blacking out.  Night sweats followed the next two days.  And searing tingling pain occationally was felt up and down my right side.  On my hip, leg, ankle, wrist and elbow.  I have phoned my PCP and they said that because I am now doing fine that nothing can be done, however I am scheduling an appointment where I will request a brain scan.
Evaluation on Day of Discharge: Stable for discharge   Hospital Course:  Patient was evaluated for sharp reproducible chest pain and shortness of breath. He was evaluated by cardiology who suggested MSK in nature. He started lifting weights earlier this week.  His cardiac work up included EKG with NSR, CXR no acute process, troponin neg x3, inflammatory markers negative. He did have significant dyslipidemia and was counseled on importantance of healthy lifestyle, diet modification and importance of taking statin. Patient was treated with OMT with moderate improvement of symptoms and was rx'd muscle relaxer for a few days to help with muscle spasm. He is to follow up with cardiology and get a repeat lipid panel in 3 months as well as follow up with PCP for stress echo and EGD if sx persist.
Initially a sore arm for a few days, the next day felt a bit sleepy.  Third day feeling of euphoria and relief.  I hesitate to mention this because it may be unrelated but I swear my cell signal strength went up a bar as well.  The sore arm went away after a few days, I took a nap, but the euphoria and relief hasn't passed two months later. I'll learn to live with it.
A little over a week after the First vaccination, I developed two blood clots in my leg; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 via an unspecified route of administration, administered in the left arm on 18Mar2021 as SINGLE DOSE, for covid-19 immunization  (at the age of 67 years-old). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 2 via an unspecified route of administration, administered in the left arm  on 14Apr2021 as SINGLE DOSE. The patient was not pregnant at the time of vaccination.   The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. Medical history included peripheral arterial occlusive disease from an unknown date and unknown if ongoing and bad circulation. There were no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient developed two blood clots in her leg on 28Mar2021 a little over a week after the first vaccination. There was no treatment provided for the blood clots. The outcome of the blood clots was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 20-SEP-2014 the patient was vaccinated with improperly stored dose of PNEUMOVAX 23, 0.5 ml, intramuscular (lot number not reported). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Woke up feeling acute soreness, unique, not fibromyalgia. Started to develop 2 large hives about 1.5 inch on inside of upper arm by armpit. Were hot swollen and itchy. Treated with Loratidine and hydrocortisone. 3 days from vaccination from 2nd knuckle to the nailbed became swollen hot and red. Localized to an infection to skin before cuticle. Soaked it and used hydrocortisone and the peroxide, used collaidal silver (liquid form)-most responsive redness down then.
I received the Moderna Shot in My R arm on Wednesday 4/28/21. My R arm stayed sore ( not at the injection site ) but up in the shoulder joint. It was stiff and sore with abduction or any rotational movements. On may 10th I noticed that the injection sit was showing signs of irritation. Ove the next 2-3 day lesions formed at the posterior aspect of the shoulder joint and in the crook of the R elbow. By the end of the week lesions began to form on the anterior forearm 2 inches below the elbow joint and 1/2 way down the anterior forearm. A small Lesion also formed 3 inches above the wrist on radial aspect of the forearm and another small lesion on the bas of the R hand just below the wrist.  I started on proteolytic enzymes, L lysine and an anti viral 3x a day and acupuncture. Now  on 5/27 the lesions are mostly gone and the pain in the shoulder is almost gone also
fever; joint pain; neck hurts; hurts to swallow; This is a spontaneous report from a contactable consumer (reporting for mother). This female consumer of 55 (unit not specified) received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: unknown; Expiration date was not reported) via unspecified route of administration on 05Mar2021 as DOSE 1, SINGLE for covid 19 immunization. The patient's medical history and concomitant medications was not reported. On 06Mar2021, the patient had fever, joint pain, her neck hurts and it hurts to swallow. The patient (mother of the reporter) received Pfizer vaccine last Friday and started experiencing side effects on Saturday. The reporter seeking treatment recommendations to manage side effects and assistance for her mother. The outcome of the events was reported as un-known.  No follow up attempts are possible. Information about lot/batch number cannot been obtained.
Increase in hand and fingers joint pain, swelling, and decrease in strength and range of motion; foot and ankle pain ; will be seeing doctor due to increase pain and loss of strength
Sometime in the night after receiving the Shingrix vaccine at 1 pm on May 31, I developed at fever and large, hot swollen site.  June 1: The swollen site was approximately the size of my thumb, red and very hot, quite raised up, and hard. I had a fever and chills June 1 - June 4/5 and was mostly bedridden with little energy.  The fever was over 101 during that time period. Reached 102.1 on June 4.  Was feverish that night but had no fever by 7 am on June 5. On June 6th, the swollen part of the welt was about 3 by 4 inches while the hot, red, hard part was approximately 2 by 2 inches.  One month later at June 31st, the area was no longer hot; however, I had about 5 hard nodules under the skin at the shot site.  Now August 12, all symptoms are gone except my skin is still slightly discolored. After a shower, looks like like small very light bruises.  I told my primary docto and allergist; both would not make a call on whether I should get my 2nd shingles shot.
MOC brought child to clinic 7 days after shots she had viral exanthem & hives.  Present to allergist for final dx & recommendation.
Red spot right buttock, right wrist, both ankles, left elbow; Rash left arm and shoulder; This spontaneous case was reported by a nurse and describes the occurrence of MACULE (Red spot right buttock, right wrist, both ankles, left elbow) and RASH (Rash left arm and shoulder) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 025B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]), PREDNISONE, POTASSIUM and LOSARTAN for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced MACULE (Red spot right buttock, right wrist, both ankles, left elbow) and RASH (Rash left arm and shoulder). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, MACULE (Red spot right buttock, right wrist, both ankles, left elbow) and RASH (Rash left arm and shoulder) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-211568 (Patient Link).
Client came to be vaccinated accompanied by her father on Saturday January 23, 2021. The greeting table in the front was very busy and a lot going on. The client had registered online and had her paper to prove it when she was escorted to he next tables to be registered. There was nothing adverse about her registration form. Date of birth was listed, however, it was not caught that she was less than 18 to receive Moderna. We advertise that it is the Moderna vaccine that we have. Father never said anything and stood off to the side waiting for her to be observed for 15 minutes. On Monday, January 25, I spoke with client who answered phone, to explain what happened and to see if she was OK. States her arm at injection site hurt a little, but nothing else. I said I would call each day to make sure she was OK. Later in the day, she left a message to call her. I called and she wanted to know what vaccine she would get as her second dose. I said it would not be Moderna and that I could find some information and call her back. Then she states she has a lawyer and to whom should she address it to. I said the Health Officer at the city.
Information regarding influenza virus vaccine, (manufacturer unknown) was received from a consumer, regarding her 79-year-old mother, who experienced flu-like symptoms following receipt of the influenza virus vaccine (2002-2003 Formula) when she was 78 years of age. Medical History: Relevant medical history was not provided. Product Details: Indication for Flu Shield (2002-2003 Formula) was immunisation. Product was administered on a unspecified date. Dose regimen was not provided.  Concomitant Therapy: Concomitant therapy included Lipitor (atorvastatin). Event Details: The patient experienced flu-like symptoms (influenza like illness) following receipt of the influenza vaccine 2002-2003 when she was 78 years of age. Related Case(s): See related case(s): HQWYE512824 (adverse event, non expedited). No additional information was available at the time of this report.
Information has been received from a physician concerning a 34 year old male who had a splenectomy five years prior who on 06/18/2001 was vaccinated with varicella virus vaccine live (site unknown). On 07/10/01, the patient developed a rash. On 07/12/01, the patient was seen in the physician's office with 20 to 30 papular vesicles on trunk, extremities and face. It was reported that the patient was afebrile. It was also noted that the patient weighs approximately 400 lbs. The patient sought unspecified medical attention. Additional information has been requested.
fever; massive headache; body aches; nausea; chills; lack of appetite; desire to drink fluids; swelling in my underarm /  severe swelling in left underarm; muscle pain; This case was reported by a consumer and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 12th January 2021, the patient received Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced fever, headache, general body pain, nausea, chills, appetite absent, excessive drinking, local swelling and muscle pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, headache, general body pain, nausea, chills, appetite absent, excessive drinking, local swelling and muscle pain were unknown.   It was unknown if the reporter considered the fever, headache, general body pain, nausea, chills, appetite absent, excessive drinking, local swelling and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had basically all of the usual symptoms fever, massive headache and body aches, nausea, chills, lack of appetite and desire to drink fluids. The reporter asked was this normal. The patient had severe swelling in left underarm, fever and muscle pain.  The patient spoken with healthcare professional and they recommended Tylenol.  The reporter did not consent to follow up.; Sender's Comments:  US-GSKCCFUS-Case-00946152_AE-56101:FU1
Muscle aches, fatigue, momentary flushing, slight nausea, slight dizxyness for three days.
Pt became very pale, sweating, c/o dizziness and "feeling drunk." USS. Responded well to OJ and hard candy. Had not eaten all day.
Rotavirus series started after 12 weeks of age. Child received 2 doses of Polio vaccine. One in Pediarix and one as a single dose of Ipol. Mother reports child had no ill effects or adverse reaction to immunizations.
the FIRST on 17Apr2021, on right arm it hurt but not too much. The SECOND on 08May2021 on right arm it was sore but not too bad; arm was a little sore / sore arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Apr2021 (Lot number: ER8731) at the age of 67 years as dose 1, single and administered in arm right, administration date 08May2021 14:40 (Lot number: EW0182) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: AXILLARY PAIN (non-serious), outcome "unknown", described as "the FIRST on 17Apr2021, on right arm it hurt but not too much. The SECOND on 08May2021 on right arm it was sore but not too bad"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was a little sore / sore arm.". Therapeutic measures were not taken as a result of axillary pain, pain in extremity.  Additional Information: The patient did not had a visit to emergency room or physician office. No Prior Vaccinations (within 4 weeks). Patient's Medical History(including any illness at time of vaccination) was none. Relevant tests were none. Previous two doses: the FIRST on 17Apr2021, on right arm it hurt but not too much. The SECOND on 08May2021 on right arm it was sore but not too bad. With the Booster dose on 08Dec2021, "Right arm is hurting, with red patches, itching, spread to the bicep, used a cream for the itchiness. But it's not hives. Arm was killing me and couldn't move it. On Friday or Saturday started getting redness and itches.  No follow-up attempts are possible. No further information is expected.
administered 2nd MENACTRA dose only 4 months later with no reported adverse event; Initial information received on 10-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 years old female patient who administered 2nd menactra dose only 4 months later with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination.  On 06-Apr-2022, the patient received a  dose number 1 of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE followed by second dose of 10-Aug-2022 ( lot number not reported) at a dose of 0.5ml twice via intramuscular route in unknown administration site for immunization.  On 10-Aug-2022 ,the patient administered 2nd menactra dose only 4 months later with no reported adverse event (inappropriate schedule of product administration)(latency: 4 months 4 days) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken : not applicable  It was not reported if the patient received a corrective treatment for the event .   Outcome: Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Syncope Forehand abrasion/laceration BP from 152/81 to 132/94  HR 88 to 97 History of Guillen barre syndrome
large local reaction with erythematous, indurated and tender 5c in diameter on Left arm developed several hours after injection given 6/18/08. Itching, spreading red area with warmth, reddness/tenderness after 8 hours. Seen in office 6/20/08 Augmentin given 400mg-1 po bid x 10d. Cold compress and BENADRYL. Later that noc
8/27/2015 received flu and pneumonia injections. Pain in muscles in both upper arms, and upper muscles in both legs. Dr. took blood tests, orthopedic took x-ray, neurologist tested and Hospital tested.
Lightheadedness and dizziness spell about an hour after injection. Nausea all night of first evening.   Day after shot, felt tired and achey. This lasted for about 48 hours.  On the second day, my arm began swelling near the injection site and turned red. It?s now been 7 days since my injection and my arm still has a large knot under the skin and is sore.
8/2/17 (L) AT erythema 9x10cm warm, swollen, 5c, tender nodule.