chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to an unspecified number of unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. Since an unspecified date in May 2015 (exact date unspecified, approximately in 2015), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # K008877, expiration date 24-FEB-2017, dose and route not reported). Information regarding concomitant medications was not reported. No adverse effected reported. This is one of several reports received from the same source. Additional information has been requested.
Since 2 February she has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body, especially where her skin is scraped or scratched. Lesions last less than 24 hours, affect her palms and soles, and resolve without post-inflammatory changes. She also notes increased lesions when she was stressed or with increased body heat/sweating (such as exercise or a hot shower). She denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with exercise, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 22 January, 11 days prior to onset of symptoms. She has used oral antihistamines with benefit. She denies constitutional symptoms. UCT score today is 9 (1, 2, 0, 2, 0, 0, 2, 2). No history of adverse reactions to prior vaccines.
No adverse effects; inadvertently administered an expired dose of ROTATEQ; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender.   The patient's concurrent conditions, medical history, drug reaction/allergies or concomitant medications were not reported.  On 07-JUN-2019, the patient was inadvertently administered an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally as prophylaxis (dose and frequency were not reported) (lot number R003148 with expiration date 05-JUN-2019). No adverse effects were reported nor temperature excursion.
Aches; Weakness; Arm soreness; Pain in back; Pain in neck; Fever; chills; Pain in shoulder getting worse /Pain in knees; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), ASTHENIA (Weakness), PAIN IN EXTREMITY (Arm soreness), BACK PAIN (Pain in back) and NECK PAIN (Pain in neck) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A, 032821A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE, TIMOLOL, GLYCERYL TRINITRATE (NITROSTAT), AZELASTINE HYDROCHLORIDE (ASTELIN [AZELASTINE HYDROCHLORIDE]), IPRATROPIUM, CLOPIDOGREL, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, DICLOFENAC, OXYCODONE, DIAZEPAM, GABAPENTIN, METAXALONE and METOPROLOL for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Aches), ASTHENIA (Weakness), PAIN IN EXTREMITY (Arm soreness), BACK PAIN (Pain in back), NECK PAIN (Pain in neck), PYREXIA (Fever), CHILLS (chills) and ARTHRALGIA (Pain in shoulder getting worse /Pain in knees). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Aches), ASTHENIA (Weakness), PAIN IN EXTREMITY (Arm soreness), BACK PAIN (Pain in back), NECK PAIN (Pain in neck), PYREXIA (Fever), CHILLS (chills) and ARTHRALGIA (Pain in shoulder getting worse /Pain in knees) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8 (High) 100.8 Degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-400086 (Patient Link).
Initial report received from healthcare professional on 23 September 2014. A 66-year-old female patient, who has no relevant medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (batch number U5019AA, intramuscular in left deltoid) having expiry date 4 October 2015 on 22 September 2014. It was reported that on 22 September 2014, in the evening after receiving FLUZONE HD vaccine, the patient's fingers of left hand were swollen. The patient was going to take BENADRYL as a corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none.
Had ROTAVIRUS vaccine on 8/18/16 and developed blood stools (hemoccult (+)) - was fussy but it resolved-symptoms started 8/19/16
On January 4, 2023 I had a dry cough, I awoke the next day with the cough still there a fever. I called my doctor to have a telehealth visit, she prescribed a Z-PAK. This did not help, I went to the emergency room, they administered a breathing test, and sent me home with steroids. This seemed to get rid of the cough and the fever. Once I finished the steroids, the cough and fever came back, I called my doctor to have another telehealth visit, received another round of antibiotics. The cough and fever started to go away but as the medication was finished the cough started again. My doctor ordered a chest x-ray, she saw something on it, she referred me to a Pulmonologist. The Pulmonologist ordered a CT scan, this came back as scar tissue. My pulmonologist prescribed a WIXELA inhaler for me to use.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had pain in extremity (little arm pain), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Follow-up (Aug 23, 2021): A contactable female consumer (patient) reported: Patient information. Follow-up (Oct 4, 2021): This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
RED WATERY EYES; A LITTLE ITCHY EYES; IRRITATED EYES; REDNESS TO BOTTOM OF EYE LIDS; INFLAMMATION TO EYE; FEVER; This spontaneous report received from a patient concerned a 51 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 ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced red watery eyes. On 09-APR-2021, the subject experienced a little itchy eyes. On 09-APR-2021, the subject experienced irritated eyes. On 09-APR-2021, the subject experienced redness to bottom of eye lids. On 09-APR-2021, the subject experienced inflammation to eye. Laboratory data (09-APR-2021) included: Body temperature (NR: not provided) 100.3. Treatment medications (dates unspecified) included: naproxen sodium, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, red watery eyes, a little itchy eyes, irritated eyes, redness to bottom of eye lids, and inflammation to eye on 09-APR-2021. This report was non-serious.
An order for Infanrix (DTAP) was placed by PA-C on 8/10/23. The patient arrived with her father on 8/15/23. The medical assistant collected ordered vaccines including PCV13 and Hep A. The MA grabbed Adacel (Tdap) without realizing the difference between DTAP and TDAP. The correct vaccine, Infanrix (DTAP) was not available at the time of incident. The patient was brought into the medical lab with her father for vaccine administration. After administering one vaccine, the MA came to the provider for assistance administering the other two vaccines. The provider inadvertently administered Adacel (TDAP) to the patient's right deltoid while the patient sat on her father's lap. The MA was also present in the lab at time of administration. The vaccine was partially administered as some of the vaccine was left in the syringe upon the patient pulling away. The mistake was realized when documenting the vaccines in the chart. The refrigerator was checked for the correct vaccine at which time the correct vaccine was not available. The provider informed the parent that the incorrect vaccine was administered and that the patient will need subsequent doses to complete the DTAP  series. The parent and the provider agreed to administer the correct, needed vaccine at time of next visit after patient turns 4 years old.
pt recvd vax; devel rash behind knee & elbows; 31aug93 f/u: minor erythema at inject site;
Strong phantom smell and sinus pain 2 days after second dose of Pfizer. Started 10/10/21. Shot received 10/07/21
Shot 10/21/2005 - Terrible pain down shoulder/arm after injection - felt like going to fall off.  Aching still going on - 12/28/2005, can't use right arm, very painful.
2 hours after injection - Swelling, hives, fever, nausea, dizzyness & fatigue /cold / hot spells  5 days later  - still bad swelling, extreme redness and site reaction to injection plus underarm swelling and hard enlarged lymph node swelling, still having nausea - dizzyness and fatigue - cold / hot spells - soreness and pain has radiated up the left shoulder to the shoulder and neck area .  Taking Tylenol, benedryl to ward off the hives - cool and warm compresses
Throat "tickling" clearing; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 37 year-old male patient received bnt162b2 (BNT162B2), administration date 08Apr2021 11:45 (Lot number: EP7533) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Product: COVID 19, Lot unknown: False, Differential Diagnosis: Anaphylaxis (dyspnea, stridor, drooling, tongue swelling), 11:30 Vitals: BP 138/89, HR 81, O2 96%.), for COVID-19 Immunization, reaction(s): "Drooling", "Dyspnea", "Stridor", "Tongue swelling"; Bnt162b2 (Dose number: 1, Product: COVID 19, Lot unknown: False, During his 30 minute waiting period after the injection, the patient began to experience throat tightness and tongue swelling., 11:30 Vitals: BP 138/89, HR 81, O2 96%.), for COVID-19 Immunization, reaction(s): "Tongue swelling", "Throat tightness"; Bnt162b2 (Dose number: 1, Product: COVID 19, Lot unknown: False, 1st Pfizer vaccine patient had facial/throat swelling after the 15 min waiting period while driving home. No medical treatment, self resolved with Benadryl at home., 11:30 Vitals: BP 138/89, HR 81, O2 96%.), for COVID-19 Immunization, reaction(s): "Facial/throat swelling", "Facial/throat swelling". The following information was reported: OROPHARYNGEAL DISCOMFORT (non-serious) with onset 08Apr2021 12:00, outcome "unknown", described as "Throat "tickling" clearing". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (08Apr2021) 141/89; heart rate: (08Apr2021) 68; oxygen saturation: (08Apr2021) 97 %.  Additional information: Lung sounds clear, no visible swelling.  No follow-up attempts are possible. No further information is expected.
05/16/2022 I had vaccination. On 07/16/2022 I was traveling that evening. I drove home from feeling a little out of sorts. On 07/17/2022 my temperature was 102. 07/18/2022 I took a COVID-19 at home test and it was positive. On 07/19/2022 I sought medical attention and was prescribed Plaxovid. I started the medication that evening and for the 5 day period. I am feeling reasonably good presently.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age. Current conditions and medical history was not reported. Between 26-OCT-2014 to 29-OCT-2014, the patients were vaccinated with RECOMBIVAX (dose, lot number and frequency were not reported), intramuscular. Concomitant medications were not reported. The patients received RECOMBIVAX that was improperly stored. RECOMBIVAX was exposed to 11.1 Celsius for 1 hour 18 minutes (all doses supported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
COVID vaccine breakthrough case. Moderna 5/4/21 025B21A, 6/1/21 025B21A and boosted 12/22/21 030H21B
5 min after injection to my right arm: redness and swelling to the left side only of my face. 8 min after injection to my right arm: sharp chest pains over my heart. 10 min after injection to my right arm: mild chest and throat tightness, mild shortness of breath. After 30 min: no shortness of breath, no chest tightness, no chest pains. After 2 hours: swelling and redness to face disappeared. 2 weeks after injection: red, hot, raised, itchy area to right arm at injection site. Disappeared after about 2 weeks.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed full blown chickenpox with too many lesions to count. The lesions covered his entire body from his scalp to his feet. The pt presented to a physician and was afebrile. the pt was treated with Motrin and Benadryl.
pt recvd vax 3PM & started crying @ 10PM; mom went in & checked pt; pt began to have a sz lasting 1 min; called 911;
Systemic rash, dry cough (causing cough); 650mg Tylenol every 6; 50mg Benadryl to start then 25 mg every 6, Pepcid 20mg every 12 hours; rash is slowly resolving; throat still very dry with dry cough
1st dose 4-5 years ago, 2nd not yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received first dose 4 to 5 years ago on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 4-5 years ago, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-MAR-2023 The reporter reported that a patient received their first dose of Shingrix four or five years ago.  The second dose has not been given yet.  The reporter declined to have contact stored and declined to provide additional information. The reporter did not consent to follow-up. At the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Client received PNEUMOVAX 23 to right upper arm on Monday December 17, 2012. Client presents today with c/o reddened, swollen, warm, painful area to under side of upper arm. Client reports taking ibuprofen ATC for discomfort. Denies running any fever. Dr examined client. Dx of local reaction to PNEUMOVAX 23.
7 days following vaccination, patient lost eyelashes and had compromised immune system.  Was ill for 9 weeks following vaccine with severe cough, body aches, fever.  Was seen in the clinic on 12-20-19 and was prescribed steroids, antibiotics, inhaler, and cough syrup.
Large swollen lymph node under left armpit on injection site side. Sore lump found approximately 1.5 inches in size with swelling around it. Extremely painful with sharp pain and burning at times. Took ibuprofen to help with discomfort. Lasted 4 full days.
Pfizer Moderna COVID?19 Vaccine EUA  Chronic urticaria beginning 8/1/2021, resistant to any medications, steroids or topical solutions.  Hives are whole body, red, swollen and itchy.
Administered hiberix without the diluent; Administered hiberix without the diluent; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Hib (Hiberix) (batch number 335N9, expiry date unknown) for prophylaxis.   On 26th April 2022, the patient received Hiberix. On 26th April 2022, unknown after receiving Hiberix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-May-2022 Reporter's Comments:  Registered nurse reported that, there were 3 vaccines that were administered hiberix without the diluent. She was unaware of how these vaccines were reconstituted so were unable to give any information. The reporter consented to follow up. Additional Supportive Information:  The patient received Hiberix without the diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR076035:Same reporter. US-GLAXOSMITHKLINE-US2022AMR076036:Same reporter.
Left Deltoid warm, hard, painful and swollen down to elbow, left arm 3/4 " larger than Right, follow up call on 11/3 and 11/4 improvement in painfulness and other symptoms less each day
received 1st dose in 2021 and 2nd dose on 14-JUN-2023 of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2021).   On 14-JUN-2023, the patient received the 2nd dose of Shingrix. On 14-JUN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received 1st dose in 2021 and 2nd dose on 14-JUN-2023 of Shingrix). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 15-JUN-2023 The reporter who stated that a patient received her second dose of Shingrix the day before reporting which was more than 6 months between the first and second dose. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
p/vax pt w/many lesions on face, neck, trunk, arms & legs;pt had a low grade temp & a few infected lesions;pt had had the lesions about a week when seen;tx w/ceclor for infected lesions;
45 minutes post injection, my body began to panic followed by my mouth becoming numb and my tongue swelled. This subsided after 10 minutes but never fully went away. This happened again 8 hours after the injection and my entire left side of my face began to swell and my eye swelled too. I took Allegra and the symptoms subsided about 10 minutes later.  For the next 5 days (and current) my face has experienced an angry red rash and off and on numbness to my mouth and face.
Shingrix #1 given 11/30/22, 12/1/22  started with body aches, weakness, fever, light headed, nauseated, dizzy.  Went to urgent care 12/3/22 was given med for nausea, cough, antibiotic, prednisone.  Prednisone helped with body aches.  Everything has resolved except for dizziness.  Still has dizziness daily getting in and out of bed.  Has no history of dizziness previous to shingrix shot
Patient received 2 COVID vaccines on 4/20/21, and 3/30/21, and was hospitalized with COVID on 1/10/22, and remains hospitalized today with COVID symptoms for 2 weeks that have led to weakness, emesis, diarrhea, fever and dehydration
One day in January 2023, I woke up with a slight cough and extreme fatigue. I took a home antigen test and got a positive result. I called my doctor, who asked me if I wanted Paxlovid. When she explained the possible side effects to me, I decided not to take it. She instead prescribed me a nasal spray and a steroid. I self-isolated at home for about two weeks. The symptoms were very mild. I never developed any symptoms besides the cough and fatigue, both of which remained mild.
urticarial react 1SEP94 p/receiving 2 doses of rabies vax;
I developed little (pimple size) red spots on my outer lower arms and on my outer upper legs.
COVID breakthrough. Patient presented to the ED on 1/27/22 with generalized weakness for the last day. Tested positive for COVID on 1/27/22.
Significant Asthma attack - coughing, wheezing. I took emergency inhaler (one puff) and it subsided
Shortness of breath; Heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 16Apr2021 at 10:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 19:00, the patient experienced shortness of breath and heart palpitations. Therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shortness of breath and heart palpitations were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Fever 103, sharp shooting pains down legs and arms, nausea, vomiting, migraine
This case was reported by a physician and described the occurrence of fever in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), Diphtheria tetanus acellular pertussis). Concurrent vaccination included unspecified vaccine (manufacturer unspecified) given on 1 October 2008. On 1 October 2008 the subject received 1st dose of ROTARIX at 0.5 ml, intramuscularly and 1st dose of Diphtheria tetanus acellular pertussis. ROTARIX was administered via the wrong route. As indicated, ROTATRIX should be administered orally. Also, within 24 hours of vaccination with ROTARIX and diphtheria acellular pertussis, the subject experienced fever and diarrhea and was seen in the emergency room. At the time of reporting the outcome of the events was unresolved. In the physician's opinion, the events were possibly related to treatment with ROTARIX.
The patient was due for their dose on 1/25/21 and received it early on 1/19/21. Around 10 minutes after receiving the second dose, the patient experienced some syncope which subsided about 10 minutes later and did not leave the vaccination site until she was feeling better. The other side effect that the patient experienced was redness/swelling/irritation at the injection site for about 24 hours after the injection.