chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 13 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 23-APR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/7/2021 CKD STAGE 4 (GFR 15-29) J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 12/7/2021 CKD STAGE 4 (GFR 15-29) J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/7/2021 ELEVATED TROPONIN I J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 12/7/2021 ELEVATED TROPONIN I
DTAP given 10/14/2003. Developed progressive swelling and itching of right arm in the ensuing 48 hours.  Arm is non-tender, no fever.  Full range of motion shoulder/elbow.
Patient related complaints of burning sensation in her right hand and fingertips.  119/77, 99.4, 18, 88, 98% on room air.  Patient was observed for 45 minutes and stated that she felt fine.
Fever up to 102 degrees; muscle pain all over; Chills; sweats; Headache; tiredness; feeling unwell; injection site soreness; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old male patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN 62 OV, expiry date 30Jun2021) at right arm via an unspecified route of administration, on 20Feb2021, 11:45 at SINGLE DOSE for COVID-19 immunization. Patient was diagnosed with COVID-19 Prior to receiving vaccination. The concomitant medications were not reported. On 21Feb2021, the patient experienced fever up to 102 degrees, muscle pain all over, chills, sweats, headache, injection site soreness, tiredness, feeling unwell. Since the vaccination, the patient not been tested for COVID-19. It was reported that the patient not received treatment for the events. At the time of this report event outcome was recovering.
Blinding head ache; Slept two hours last night; All the symptoms listed on the website; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th November 2019, the patient received Shingrix. On 26th November 2019, less than a day after receiving Shingrix, the patient experienced adverse reaction and sleep decreased. On 27th November 2019, the patient experienced headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the adverse reaction, headache and sleep decreased were unknown.   It was unknown if the reporter considered the adverse reaction, headache and sleep decreased to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per the vaccine indication. The patient had all the symptoms listed on the website.  The patient slept two hours the previous night. One day after receiving Shingrix, the patient had blinding headache. It was reported that Tylenol did not help at all.
4-17-07 Pt received Pneumonia vaccine. LDIM. Arm began hurting that night. Redness and swelling developed. Painful at site. Pt to see on or 4-20-2007. Told pt that it was localized reaction. Have doctor report to us if any further diagnosis.
40 minutes after vaccine:  Mom called office, she stated baby shaking all over, over the course of 2 minutes, no eye rolling but seemed "out of it".  The next day had fever, then developed URI.
feeling tingling in my lips & face.& tongue; feeling tingling in my lips & face.& tongue; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:EL0140) via an unspecified route of administration at the right arm on 19Dec2020 08:30 at a single dose for covid-19 immunisation. Medical history included allergies to medications: sulfa drugs. Concomitant medication included zinc, magnesium, calcium phosphate, colecalciferol (CALCIUM+D), ascorbic acid (VITAMIN C) and clarithromycin (CLARITIN). On 20Dec2020 21:00, the patient felt tingling in her lips, face and tongue. The patient reported that she took diphenhydramine (BENADRYL) orally, 25mg when she got home as treatment. Outcome of events recovered on an unspecified date in Dec2020.
This spontaneous report was received from a patient's boyfriend refers to a female patient of unknown age who approximately in 2011, "about one year ago" was vaccinated subcutaneously with a dose of ZOSTAVAX 0.65 ml. No other co-suspects were reported. No concomitant medications were reported. The patient's boyfriend reported that the patient experienced shingles "about one-year" in approximately 2012, after getting ZOSTAVAX vaccination. The patient's boyfriend disconnected the call and no additional information was provided. Patient's outcome was unknown. Action taken was not applicable. Additional information is not expected.
sore arm, nausea, fatiguesymptoms disappeared after 24 hours; sore arm, nausea, fatiguesymptoms disappeared after 24 hours; sore arm, nausea, fatiguesymptoms disappeared after 24 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Mar2021 14:30 (Lot number: 3247) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, lot_number=3247,, lot_unknown=False,, administration_date=24Feb2021,, administration_time=02:00 PM,, vaccine_location=Right arm,, dose_number=1), administration date: 24Feb2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious), NAUSEA (non-serious) all with onset 18Mar2021 09:00, outcome "recovered" (2021) and all described as "sore arm, nausea, fatiguesymptoms disappeared after 24 hours". Therapeutic measures were not taken as a result of fatigue, pain in extremity, nausea.  Additional information: Adverse event sore arm, nausea, fatigue symptoms disappeared after 24 hours. No covid prior vaccination. Not tested covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Administered vaccine to patient below recommended age for the combination vaccine when should have administered vaccines separately, will be calling parent to notify and schedule follow up visit with provider.
Hives on the armpits and the cheeks of the buttocks; Sweating; Hotness; Itches; Very high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on the armpits and the cheeks of the buttocks), HYPERHIDROSIS (Sweating), FEELING HOT (Hotness), PRURITUS (Itches) and BLOOD PRESSURE INCREASED (Very high blood pressure) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced URTICARIA (Hives on the armpits and the cheeks of the buttocks), HYPERHIDROSIS (Sweating), FEELING HOT (Hotness), PRURITUS (Itches) and BLOOD PRESSURE INCREASED (Very high blood pressure). At the time of the report, URTICARIA (Hives on the armpits and the cheeks of the buttocks), HYPERHIDROSIS (Sweating), FEELING HOT (Hotness), PRURITUS (Itches) and BLOOD PRESSURE INCREASED (Very high blood pressure) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received the first dose and started experiencing hives on the arm pit and the cheeks of the buttocks, sweating, hotness, itches and a very high blood pressure. Patient inquires if will be the second dose worse or is safe to take it anyway, and is afraid of getting an anaphylaxis
Received Moderna vaccine on 5/14/21. The morning of 5/15/21 the patient awoke with a pruritic rash on the trunk, which spread to the upper and lower extremities, and face. Patient went to emergency room and was given oral Benadryl x1, oral Prednisone 40mg x1, and sent home the same day with a topical steroid cream. Seen again at my office on 5/28/21. Rash had mostly resolved, but pruritic rash still present on lower back and buttocks. Rash has resulted in small open wounds due to scratching, with surrounding cellulitis. Currently treating with 7-day course of Bactrim for cellulitis. No evidence of anaphylaxis.
Patient's Psoriasis flared up, he had itching , redness of the healing , very extensive
Case number PHEH2013US020199 is an initial combined spontaneous report received from a nurse via sales representative on 25 SEP 2013, with a follow-up received from a physician on 25 OCT 2013. This report refers to a 16-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number A12118, expiry date: 30 AUG 2014) at a dose of 0.5 ml subcutaneously into left upper arm on 13 JUN 2013 at 11:54 AM. It was reported that two days after injection, he started complaining of nausea, fatigue, dizziness and headache that lasted for three to four days. He also had flu like symptoms and neck swelling. The patient consulted physician on 15 JUN 2013. It was reported that on 01 JUL 2013, he had sore throat with swelling in right side of neck which became more of an issue and received some injection (unspecified). On 03 JUL 2013, the physician called him back to the office and it was reported that the patient looked better during the visit, but he had fatigue and dizziness at that visit. The patient's mother did not report any other serious event. Blood tests like erythrocyte sedimentation rate, complete blood count and C-reactive protein were done at the end of JUL 2013 and the results were reported as normal. His mother stated that he was fine now and outcome of th4e events was completed recovered. The physician did not believe  that the event was due to the vaccine, but was concerned as the administere4d MENVEO lot number was recalled after the vaccination.  follow up was received on 25 OCT 2013. Patient demographics, vaccination date, vaccination route (wrong route of vaccine administration), vaccination dose and outcome of the events were updated.
Patient reports generalized itching beginning on 5/17/08 PM. Itching has increased daily and became much worse 5/19/08 PM. Taking Benadryl without relief. Patient did start taking Mucinex and Z-Pack on same date as immunization. No rash noted. Did expreience some redness at injection site.
Patient received second dose 6 days after first dose; A spontaneous report was received from other health care professional concerning a 44-years-old, female patient who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) 6 days after first dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 012A21A) on right arm for prophylaxis of COVID-19 infection. On 18 Mar 2021, 6 days after vaccination, the patient received their second dose of mRNA-1273 (Batch Number: 029A21A) on left arm for prophylaxis of COVID-19 infection.  On 18 Mar 2021, the patient received second dose 6 days after first dose.  No treatment information was provided.  The patient received both the doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   The outcome of the event, patient received second dose 6 days after first dose was considered as resolved on 18 Mar 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 029A21A for second dose) with no associated AEs reported.
Pt @ 4 mo of age on 6Jun91 recvd DPT/OPV/HIBV.There were no reported fever, anaphylaxis, sz but pt died of SIDS on 7Jun91 evening.Found dead in basinet by mom
Rash started on rear of left leg and progressed daily with itching and redness. Diagnosed as shingles on Jan 08.  Started treatment of valacyclovir HCL 1 gram twice a day.  Rash/itching has continued.  Minimal pain so far two weeks into the shingles.  We shall see.
SARS-CoV-2 RdRp Resp Ql NAA+probe~COVID-19 rapid diagnostic test (nucleic acid amplification test NAAT) performed on 7/13/2021. Test came back positive. Case investigation interview with patient has not been conducted as of time of this note.
My 3-year-old daughter got a H1N1 vaccine of nasal spray preparation on 11/07/2009 at the doctor's office. Medimmune is the manufacturer of the vaccine. She developed a slight fever of 100.2F at night and had a stuffed nose. She could fall asleep after being given half spoon of liquid MOTRIN -J and J product-. The next day, she did not have fever and running nose but looked less active and energetic than usual. She had cough with little production. At the following two nights of 11/08 and 11/09, she continued to have fever of about 100.2 - 100.3F with stuffed nose. We  took her to see a doctor on 11/12. The doctor found her body temperature of 100.2F without other bothers. No actions taken by the doctor. Since then. My daughter has been getting better and almost back to normal today 11/18.
Red spots and itching at injection site about 1 wk after injection and continuing but better. Using witch hazel for itching.
bumps, pussy; small red bumps; small red bumps; chicken pox; rash, small red bumps, ankles and feet; itching around both ankles and tops of both feet; This case was reported by a consumer and described the occurrence of chickenpox in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox).   On 22nd July 2022, the patient received the 1st dose of Shingrix. On 25th July 2022, 3 days after receiving Shingrix, the patient experienced chickenpox, rash, pruritus, papular rash and red rash. On 26th July 2022, the patient experienced pustular rash. On an unknown date, the outcome of the chickenpox, rash, pruritus, pustular rash, papular rash and red rash were unknown.   It was unknown if the reporter considered the chickenpox, rash, pruritus, pustular rash, papular rash and red rash to be related to Shingrix.     Additional Information: GSK receipt date: 31-Aug--2022 Reporters comment:  The patient developed a rash (small red bumps) and itching around both ankles and tops of both feet.  The next day, the patient emailed his/her doctor because some of those bumps had grown and looked a bit pussy. The  doctor said he/she had chicken pox and should quarantine until the bumps were not pussy. What she could not tell him/her was whether should get the second dose of the Shigrix vaccine. Chicken pox was not listed as a possible side effect of the vaccine and yet had them. The reporter attached pictures at the end. The reporter wanted to know did the first dose had the desired effect. Should attempt to get the second dose with the possibility that he/she would develop chicken pox again and need to quarantine.     .
Patient reported feeling very debilitated, weak, fatigued she felt out of it and could not think well. She lost track of periods of time, and cannot remember much of that night. Chilled, shakes and body aches. This lasted until am of 3/28/19 when she felt better but still shaky and weak. She felt too sick to go to the Doctor's office or hospital.
5 1/2 x 4cm eryth. mild swelling on lt deltoid area. Mild tenderness some warmth.
Sneezing; Runny nose; Runny eyes; One of the worst allergy attacks in awhile; A spontaneous report was received from consumer concerning a male patient who received Moderna's COVID-19 vaccine and experienced an allergy flare up, sneezing, runny nose and runny eyes.    The patient's medical history included unspecified allergies. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient describes his reaction as "one of the worst allergy attacks in a while." The patient experiences sneezing, runny nose and runny eye. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event(s)  allergy flare up, sneezing, runny nose and runny eyes were unknown.; Reporter's Comments: This case concerns a male of unknown age who experienced NS events of unexpected sneezing lacrimation, increased, rhinorrhoea and expected hypersensitivity.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on 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.
Chills, hot flashes, weak, fatigue, lightheaded, headaches. Bump under R axillary.
Patient was given 0.2ML of the 30 mcg formula instead of 0.2ML of the 10mcg formula.
Patient has experienced ringing in her ears ever since the day after she received her PREVNAR vaccination.
Pt has no previous history of skin issues 10 days after 2nd Moderna vaccine developed bullous lesions which gradually worsened until over most of 4 extremities
Pt. was given expired Tdap vaccine, no adverse reactions reported, new non-expired vaccine was given.
Administered  Pfizer-BioNTech COVID-19 Vaccine (Orange Cap) 0.2ml IM prior to dilution. LOT:  FL0007.  Manufacture date 09/2021 with Expiration date of 05/31/2022 and a beyond use date from Pharmacy of 04/28/2022. Notified provider - FNP, Pharmacist, PHN. Pharmacist also aware. Notified patient's mother at 11:50  AM.  States child is doing OK so far and is running around and playing.  Asked about giving him Tylenol and Motrin.  Either OK per Pharmacist and FNP.  States will be needing more Tylenol and will pick up today at Pharmacy.
pt felt cold, shaky & devel hives & itching; sx relieved w/Methylprednisolone & DPH;
This case was reported in a literature article and described the occurrence of scid (severe combined immune deficiency) in a 4-month-old female subject who was vaccinated with Rotavirus vaccine (manufacturer unspecified). On an unspecified date the subject received 2nd dose of Rotavirus vaccine (unknown). At an unspecified time after vaccination with Rotavirus vaccine, the subject experienced gastroenteritis, cough and diarrhea and later was diagnosed with scid (severe combined immune deficiency ADA mutation). The subject was hospitalised. Relevant test results included stool testing positive rotavirus for vaccine strain. At the time of reporting the outcome of the events were unspecified. Stem cell transplant was pending. The Food and Drug Administration (FDA) has licensed two rotavirus vaccines: ROTATEQ, licensed in February 2006, and ROTARIX (GlaxoSmithKline), licensed in April 2008. VAERS report dates from February 3, 2006 (the licensing date of ROTATEQ) through January 15, 2010; MedDRA (Medical Dictionary for Regulatory Activities) preferred term (PT) " combined immunodeficiency" (which included the lower level term "severe combined immunodeficiency") and/or any report text field (including fields for symptoms, laboratory/diagnostic tests, pre-existing conditions and illness at time of vaccination) with the term "SCID" or "combined immunodeficiency". Additionally, exploratory queries for other immunodeficiencies were performed to ascertain whether individuals with these conditions might be at risk from rotavirus vaccine. The research was expanded to include all MedDRA PTs available in the database for acquired and congenital immunodeficiency nine reports of SCID and rotavirus vaccination in five female and four male infants, with ages at presentation ranging from 3 to 9 months. Seven had received ROTATEQ, one ROTARIX and one an unspecified rotavirus vaccine; two reports originated outside of country. All cases required hospitalization that ultimately led to a diagnosis of SCID after at least one dose of rotavirus vaccine. Of the seven infants, none completed the vaccine series prior to the SCID diagnosis. All reports documented stool testing positive for rotavirus (EIA antigen, viral RT-PCR, or unspecified method), and vaccine strain rotavirus was specifically identified in a six cases. Seven reports also described prolonged rotavirus shedding, lasting from 1 month to at least 7.5 months (median of at least 5.5 months). Bone marrow transplantation was reported as completed in four cases and pending in four additional cases. One report listed the outcome as unknown. No deaths were reported. The author's conclusion stated: The aforementioned labelling changes were warranted given the risk posed by live rotavirus vaccine to individuals with SCID, as illustrated by these VARES cases. Although congenital, SCID was not diagnosed in these infants until after rotavirus vaccination. Earlier identification of SCID (e.g., from expanded newborn screening of heightened clinical vigilance) could prevent inadvertent live rotavirus vaccine administration and also potentially result in earlier life-saving stem cell transplants.
This spontaneous report as received from a nurse referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 01-MAR-2017, the patient was vaccinated with a dose of M-M-R II that was reconstituted with sterile water (reported as "which was not a DILUENT of Merck") (product use issue) for prophylaxis, (dose, frequency, route, lot number and expiration date were not provided), therapy type (HSA). No adverse effect were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Pt. complained of the left arm being black and blue and complained of arm hurting. Resulted in doctor's visit.
9/3/19y- arm was sore, felt tired,  hot, by the time I got home from work had fever (~101,7) 9/4/19- arm still sore, tired, nauseous,   9/5/19- arm sore, pain in my armpit, some digestive issues  9/6/19- nauseous,  arm sore,  armpit sore,  tired 9/7/19- tired soreness
PT C/O DIZZINESS AT 9:10 AM. DENIES ANY OTHER PROBLEMS OR SOB.  BP 104/64 HR 78 O2 98% PT STATES HIS SYMPTOMS WERE RELIEVED AND LEFT THE OBSERVATION SITE AT 9:15 AM.
Tested positive for COVID-19 on November 10, 2022 using a home test.  This was after serving as an election clerk for 8 hours on Election Day with no mask. Normally, I wear a mask due to being immunosupressed due to taking Enbrel but didn't wear a mask that day.  Symptoms were not too bad - slight sore throat, slight fatigue, sinus congestion, cough Started Paxlovid on November 12, 2022
patient was receiving 2nd dose of series, during the administration of dose, there was leakage from syringe and needle. Pharmacist proceeded to administer an additional dose without conversion with patient. Concerns regarding potential overdose.