chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose 3 years ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had received his 1st dose of Shingrix vaccine 3 years prior to the reporting.) and Covid vaccine (after this vaccine patient got the Covid vaccine).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's comment: The reporter stated that the patient had his first shot of Shingrix vaccine 3 years prior to the reporting and after this vaccine, the patient had got the Covid vaccine. Reporter stated that the patient did not completed his Shingrix vaccine series. No information was provided for the patient (demographics) or about the vaccine. The reporter had consented to follow-up. Additional supportive information: Until the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Breakthrough case of COVID-19: She had a fever of 101.1, body aches, shaking, chills, and felt like pins and needles were poking her body. She did not have an appetite, coughing, sore throat, and coughing up phlegm. She was prescribed benzonatate 200mg and Flonase.
Patient brought to the ED on 10/22 for stroke like symptoms including weakness, slurred speech, and troubles balancing. He was diagnosed with a stroke and admitted to the ICU on 10/22. Additionally his admission screening test for COVID came back positive that day. He required supplemental oxygen due to acute hypoxic respiratory failure likely from COVID-19 pneumonia however was able to be weaned off oxygen. Patient was discharged 11/4 and admitted to inpatient rehabilitation.
Told her to take claritin and tylenol - she had redness and swelling of the arm but no itchiness and no difficulty breathing
injection area became red, swollen, and itching to patient ~ 12-24 hours after injection  recommended benadryl and ibuprofen for both redness, swelling, and itching patient did state that redness and swelling had started to dissipate after 48 hour mark from injection
Information has been received from a pharmacist concerning a 74 year old female with no pertinent medical history and no drug allergies, who on 13-AUG-2010 was vaccinated with a standard dose of ZOSTAVAX (Merck) (lot # 664635/0836Y, SC). There was no concomitant medication. On 16-AUG-2010 the patient developed an itchy rash at the injection site, and the rash was circular and red but not raised. There were no labs or diagnostics tests performed. The patient had called the pharmacist, and had not recovered at time of report. Follow-up information was received indicating that the patient developed local reaction only and resolved in a few days. The vaccine was not administered in the office, so they do not have the data. No further information is available.
L arm upper deltoid and biceps red, warm area non tender. TX; hydrocortisone cream and Benadryl prn.
lupus; scleroderma; RA; Sjogrens; PA; Raynauds; arm just a little sore/sore arm; a little puffy; a little sleepy; tired in a restless way; nauseated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 23Aug2021 (Lot number: FA8448) at the age of 40 years 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:01, Lot: EN6201), administration date: 25Feb2021, when the patient was 40 years old, for Covid-19 immunization, reaction(s): "Felt very tired", "Couldn't keep eyes open from when I got home mid afternoon yesterday till midmorning today", "Injection arm is sore at injection spot", "Pain in my left shoulder blade", "Mouth, throat, eyes and chest felt slightly dryer than usual", "Mouth, throat, eyes and chest felt slightly dryer than usual", "Mouth, throat, eyes and chest felt slightly dryer than usual", "Mouth, throat, eyes and chest felt slightly dryer than usual", "Feet sore (tingly, dry, burning- feeling not looking) as well yesterday- not from walking but from that achy bone muscle feeling", "feet sore (tingly, dry, burning- feeling not looking) as well yesterday- not from walking but from that achy bone muscle feeling", "A little nausea", "Light headache"; Bnt162b2 (Dose:02, Lot: EN6208), administration date: 18Mar2021, when the patient was 40 years old, for Covid-19 immunization, reaction(s): "Sore arm", "Legs felt heavy in a painful way", "Legs felt heavy in a painful way", "Nausea", "Massive headache", "Sleepy in a restless way". The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "lupus"; SCLERODERMA (medically significant), outcome "unknown", described as "scleroderma"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "RA"; SJOGREN'S SYNDROME (medically significant), outcome "unknown", described as "Sjogrens"; PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "PA"; RAYNAUD'S PHENOMENON (non-serious), outcome "unknown", described as "Raynauds"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm just a little sore/sore arm"; SWELLING (non-serious), outcome "unknown", described as "a little puffy"; SOMNOLENCE (non-serious), outcome "unknown", described as "a little sleepy"; FATIGUE (non-serious), outcome "unknown", described as "tired in a restless way"; NAUSEA (non-serious), outcome "unknown", described as "nauseated". The patient underwent the following laboratory tests and procedures: investigation: negative, notes: I've tested negative this whole time.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Pt came in to receive second moderna vaccination. Nurse administered shot did not realize that lot was expired. Pt received shot around 3:15-3:20 on November 29th, 2022. Lot expired on November 27th, 2022. While doing the count.  We noticed that the shot was given even though vaccine was expired. Pt is being notified and Moderna is being contacted to find out what the next steps will be as far as if she needs another dose or how long she should wait.
12:45-eyes itchy, grainy, vision blurred, eyes red and swollen. 1:15-Mouth tingly with metallic taste. 1:45-burning and itching inside ears. 2:30-red itchy blotches on face.Throuout evening pt was diaphoretic. Tx with Benadryl, Prednisone.
vomiting, chills, rapid heartrate and high blood pressure, dizzy faint, achy
Fully vaccinated with Covid vaccine x 3 (pfizer). Tested positive for Covid on 01/24/2022. Admitted to hospital on 01/24/2022. Expired on 01/25/2022 while still hospitalized.
Immediately after injection (per parents) started with redness, induration and swelling around site. Has not changed in two days.
varicella type rashes; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or around 30-OCT-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered varicella type rashes. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of rash vesicular was considered to be disabling.
The cases were received on 21 March 2014 at GPV. Initial misuse report received from a health care professional on 16 September 2013. This case was linked to case # 2014SA040026 (same vaccine same reporter). A 9-year-old patient had received FLUZONE Intradermal. It's an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none
Patient developed a localized reaction with a large amount of swelling and erythema.  Patient also complained of pain.
SVT Tachycardia lasted 10 minutes. 43 hr post injection.
Started getting chills on second night, shivering and then woke up in a pool of sweat.
pain; hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), 0.3 ml single (Lot number: EW0187) at the age of 70 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "she had cancer" (unspecified if ongoing), notes: She had cancer that had spread to the lymph nodes in both arms; "lymph nodes were removed", start date: Nov2019, stop date: Nov2019, notes: The lymph nodes were removed Nov2019; "Estrogen blocker prevent cancer coming back" (ongoing), notes: Estrogen blocker prevent cancer coming back; "Heartburn" (ongoing). Concomitant medication(s) included: LETROZOLE taken for prophylaxis (ongoing); ESOMEPRAZOLE MAGNESIUM taken for dyspepsia (ongoing). Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 12Oct2021, outcome "recovered" (16Oct2021), described as "hives"; PAIN (non-serious), outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  Additional information: Caller mentioned that she had Pfizer for all of her previous COVID-19 vaccine shots. She had her lymph nodes removed. She is afraid of experiencing lymphadenopathy. She mentioned that she is currently on physical therapy and still experiences pain. Her family care doctor told her to contact Pfizer and tell her if she should still get another booster.
Information has been received from a registered nurse concerning a 6 year old female with no known medical history or allergies who on 12/10/1999 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. Concomitant vaccination that day included an IM first dose of hepatitis B vaccine, recomb Engerix B in the left arm. There was no illness at the time of vaccination. On 4/11/2005 the patient developed a few vesicles and blisters on abdomen, back and groin. Unspecified medical attention was sought and symptomatic treatment included Avena Aveeno bath and diphenhydramine hydrochloride Benadryl. No relevant diagnostic test were performed. There were no adverse events following prior vaccination. Subsequently, the patient recovered. Additional information is not expected.
(+) erythematous, warmth, inflamed with small crust of vesicles formation Amoxicillin/Benadryl liquid
7:00pm started severe itching all over body and red rash, lasting 30-45 minutes.  The itching and rash resolved with Benadryl 25mg po.
Patient is 16 year old female who is hospitalized with VZV Meningitis; This spontaneous report was received from a physician referring to a 16-year-old female patient. The patient's past medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot/batch, expiry date not reported) when she was a child for prophylaxis. The physician reported that the patient was in hospital with VZV meningitis (varicella zoster virus meningitis (herpes zoster meningitis)) documented on polymerase chain reaction (PCR) with a rash on her left arm for several weeks that was painful. The physician believed that VZV meningitis was not classic, but vaccine associated zoster. The patient was having an immune work-up. The physician was planning to test the cerebrospinal fluid (CSF) and see if this was a wild type or vaccine strain. The outcome of the event herpes zoster meningitis was not reported. The reporter considered the event herpes zoster meningitis to be related to varicella virus vaccine live (Oka/Merck)(VARIVAX).  Upon internal review, the event herpes zoster meningitis was determined to be medically significant.
The patient presented to the ED on 4/3/23 with fever, cough, shortness of breath, body aches, and headaches. She tested positive for COVID-19 at home the morning of her visit to the ED. Notably, she was found to be tachycardic and mildly hypoxic in the ED. Repeat COVID-19 PCR test performed in the ED also resulted positive. Ultimately she was admitted 4/3/23 - 4/4/23 for observation. Discharge diagnosis included COVID. Of note, she has received the primary COVID vaccine series and one booster.
Patient stated that 5 days after the injections, he started feeling pain not at the injection site, but it's an aching pain in his bone and radiate to his shoulder. He feels more pain when putting pressure on the shoulder.
Had SHINGRIX 50MCG SUSR vaccination on afternoon of 1/18/18. So weak the next morning I could not get out of bed. Weak and flu like symptoms for several days. Had to cancel appointments and could not get up the strength to get dressed. Went to Urgent Care on 1/24/18 and tested for the flu and strep. Tests were negative but given Rx for TAMIFLU as a precaution. Returned to Urgent Care on 1/26/18 as illness had not abated. Blood work done that day showed nothing unusual. Made an appointment to see my Primary Care provider the following Thursday 2/1/18. Doctor seemed to think that my illness was a reaction to the vaccine and asked me to contact FDA. She is doing the same. I am still very weak but getting a little stronger each day.
PATIENT STARTED SWEATING AND EAR ROBES RED WHEN I GOT NOTIFICATION FROM PATIENT'S WIFE, EVENTUALLY HAD CHILLS.
UNEVALUABLE EVENT; INJECTION SITE PAIN; This spontaneous report received from a health care professional concerned a 73 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced unevaluable event, and injection site pain. The action taken with covid-19 vaccine  was not applicable. The patient recovered from injection site pain, and had not recovered from unevaluable event. This report was non-serious.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient (gravida 1, para 0) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021 at 4:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in November 2020 and the estimated date of delivery was 26-Aug-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.
LUMP AT VACCINATION SITE, LASTING APPROX. 1 MONTH, WAS APPROX 4 INCHES ACROSS AT IT'S PEAK.
This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 27-year-old female patient who received flu seasonal (batch number 2A2KX, expiry date unknown). On an unknown date, the patient received flu seasonal .5 ml. The subject's estimated date of delivery was 7th March 2015. On an unknown date, an unknown time after receiving flu seasonal, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the reporter considered the vaccine exposure during pregnancy to be related to flu seasonal. The reporter considered the vaccine exposure during pregnancy to be not reported if related to flu seasonal. Additional information received on 23 September 2014: Her last menstrual period was on an unspecified date (but calculated on 31 May 2014) and estimated date of delivery was on 7 March 2015. The patient was exposed to the vaccine during unknown trimester.
Patient had nausea for several days following dose #1 and dose #2 She presented on 10/27/2021 with extreme weakness  fatigue, mental fog, increased tremor, neck pain and  recurrent falls Labs- CRP- sodium 127, chloride 94, CO2-21, calcium 10.7 bili 1.3, alk phos 193, AST 46, ALT-35, ferritin 358.8 immature granulocytes 1, absolute lymphocytes 0.8, WBC 3.5 HB-9.1 HCT 25 MCV 109, platelet 128k
Interchange of vaccine products; Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LOVASTATIN, start date: Jan2000, stop date: 28Feb2023; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D 2000. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 02Mar2023 to 06Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300110661 Same patient, different product, different event;
Temperature: 101, decreased appetitie.  VZ in classroom, hundreds of papulo-vesicles from scalp down.
Redness and swelling at injection site, dry cough, body aches, chills, headache. Was ill for ten days. Dry cough also turned into full congested bronchial cough, sir throat no ear pain.
Patient was given booster vaccine of COVID-19 prior to 5 month window. Patient was contacted 48 hours after the event and reports no adverse reactions.
9/14/15 at approx. 1040am mother contacted our office to advise 2 days post immunization patient was noted to have dime sized rash "appearance of baby dime" noted to chest and 1/4 of facial area with fist sized area of a somewhat bigger rash with areas of what appeared to be pustules. Low grade fever of 99 Ax. "Crabby", "not herself", and needy. At time of call mom states pt. sx improved. Offered to schedule for further evaluation. Mom declined. Provider notified.
I have been diagnosed with Lichen Planus.  This has resulted in loss of all nails in my hands and feet.  I am now undergoing painful monthly steroid injections (20 jabs in my hands).  If this works, same will be applied to my feet.  The damage may be irreversible.
Itchy rash; It is itchy and red; rushes on the back of her neck, then on her breast, then the legs and ended with rush all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash), RASH ERYTHEMATOUS (It is itchy and red) and RASH (rushes on the back of her neck, then on her breast, then the legs and ended with rush all over body) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Medication Allergy (unspecified medications).). Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced RASH PRURITIC (Itchy rash), RASH ERYTHEMATOUS (It is itchy and red) and RASH (rushes on the back of her neck, then on her breast, then the legs and ended with rush all over body). The patient was treated with DEXAMETHASONE ongoing since an unknown date at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date at a dose of 40 mg once a day. At the time of the report, RASH PRURITIC (Itchy rash), RASH ERYTHEMATOUS (It is itchy and red) and RASH (rushes on the back of her neck, then on her breast, then the legs and ended with rush all over body) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
VIS given to mother. Verified with provider. Kept tp 10-15 mins.  no a/r.
The patient received 0.2ml of undiluted pediatric covid vaccine on 2/7/22 at 2:45pm. The mistake was found at 9pm that evening. The patient's mother was contacted 2/8/22 at 11am. She said her son had a sore arm but no other side effects from the vaccination. I explained the mistake and that the patient received a higher dose than was recommended. The patient's pediatrician was called at 3pm and everything explained to him. He said he spoke to the mother earlier, would document the event but was not too worried moving forward.