chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 02-Dec-2022 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after 4 temperature excursions.  No treatment information was provided.  This case contains information for the 36th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:Master Case
STRONG COUGH WITH PHLEGM; DIARRHEA; SHIVERS; FEVER; HEADACHE; CHEST HURT; STOMACH HURT; NASAL SECRETION; VACCINE ALMOST KILLED ME; UNKNOWN SIDE EFFECTS; IN BED ALL THE TIME; COUGH FOR 10 DAYS AND NOW WITH BLOOD; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was healthy young man with no previous health conditions. the patient was taking antibiotics, inhalers and expectorants. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUL-2021, the subject experienced cough for 10 days and now with blood. On JUL-2021, the subject experienced chest hurt. On JUL-2021, the subject experienced stomach hurt. On JUL-2021, the subject experienced nasal secretion. On JUL-2021, the subject experienced vaccine almost killed me. On JUL-2021, the subject experienced unknown side effects. On JUL-2021, the subject experienced in bed all the time. On JUL-2021, the subject experienced headache. On 08-JUL-2021, the subject experienced strong cough with phlegm. On 08-JUL-2021, the subject experienced diarrhea. On 08-JUL-2021, the subject experienced shivers. On 08-JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, shivers, diarrhea, strong cough with phlegm, cough for 10 days and now with blood, chest hurt, stomach hurt, nasal secretion, headache, vaccine almost killed me, unknown side effects and in bed all the time was not reported. This report was non-serious.
Patient complained of lightheadedness and headache. Patient denies pain, blurred vision, difficulty breathing or chest pain. Initial vital signs at 0921: BP 136/92 P 71 R 22 O2 98% Temp 98.4F. Vital signs at 0951: BP 128/84 P 66 R 16 O2 97% Temp 98.4 F. Patient discharged from post vaccination area.
Shot given on 8/22/03. Red and swollen area observed on 8/24/03. Remains the same on 8/25/03.
Patient received nasal swine flu vaccine at 4pm Wednesday 10/21.  On 10/22 and 10/23 patient noticed unusual fatigue considering she had slept 9 hours each night and was on 200 mg/day Provigil for narcolepsy and had not experienced daytime fatigue since beginning that medication several months ago.  On Saturday 10/24, patient awoke at 8am with a basal body temperature of 98.9 (normal temp 97.8) which rose to 99.9 for the next 24 hours.  Patient also experienced multiple loose stools, and by midafternoon patient experienced five hours of severe watery diarrhea, to the point of producing external hemorrhoids (and potentially internal as well since both bright and occult blood were noted in the stool for the next 24 hours).  The diarrheal symptoms decreased in frequency after the first five hours from bowel movements every 10-15 minutes to every few hours.  Patient also complained of appetite loss and severe headaches, though noted that dehydration is her usual migraine trigger.  Fever, diarrhea, tiredness, and headaches resolved by the evening of 10/25.  The patient lost 1.5 work days due to the severity of her GI symptoms.
Vaccination was given on December 25 on January 1 started noticing redness and itching us at the vaccination site like a hive I just took Zyrtec will continue to monitor
Ten minutes after the shot I felt like I was going to pass out. Felt very similar to an experience I had where I passed out shortly after giving blood. I was dizzy and light headed and called for help. Pharmacist took my BP which was high so paramedics were called.
Was exposed to someone who had COVID-19; started having a sore throat and coughing a lot and had a high fever and couldn't swallow anything; Took home COVID-19 test and was positive; Went to urgent care and was prescribed PAXLOVID; After 1 week tested negative; 3 days later I started having another sore throat and a fever; Took home COVID-19 test and it was positive again; Started coughing up green phlegm; Called doctor and was told to go to urgent care so they could take X-rays because he feared Pneumonia; Doctor said that I had a secondary infection, maybe a sinus infection; Was prescribed AUGMENTIN.
patient was administered two doses of ACTHIB on 21APR2022 with no reported adverse event; Initial information received on 21-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 9 months old female patient who was administered two doses of hib (prp/t) vaccine (Act-Hib) on 21apr2022 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar); diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Dtap); and Rotavirus Vaccine.   On 21-Apr-2022, the patient received 0.5ml doses totaling 1.0 ml of suspect hib (prp/t) vaccine lot U7178AA and expiry date: 30-Nov-2022 (strength, frequency was unknown) via intramuscular route in the left thigh and right thigh for Immunization.Lyophilized powder vial (Lot:UJ614AB Expiration date: 12-Mar-2023) Diluent (Lot: U7178AA Expiration date: 30-NOV-2022)   On 21-Apr-2022, (Latency: same day) the patient was administered two doses of acthib with no reported adverse event (extra dose administered)  Action taken : not applicable.  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.
2 days after the 1st shot upper body, arms, and thighs developed itchy rashes/hives.; A number of tiny blood red dots on skin; 2 days after the 1st shot upper body, arms, and thighs developed itchy rashes/hives.; skin inflammation; The rashes slowly faded, but left a few dark color skin marks; This is a spontaneous report from a contactable consumer, the patient. This is first of two reports. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Feb2021 at 10:30 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Patient had no medical history and had no known allergy to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 19Feb2021 at 12:00, 2 days after the 1st shot, the patient experienced upper body, arms, and thighs developed itchy rashes/hives and a number of tiny blood red dots on the patient's skin. The rashes slowly faded, but left a few dark color skin marks. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with antihistamine Allegra D, but it wasn't effective and 10 days later he saw his doctor and was prescribed triamcinolone acetonide cream, which helped to calm the patient's skin inflammation. The clinical outcome of the events upper body, arms, and thighs developed itchy rashes/hives and a number of tiny blood red dots on the patient's skin was recovered with sequelae on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
28FEB97 recv vax 2PM around 11PM that noc;mom stated devel a fever of 104;mom gave APAP;3-4AM;started vomiting x 4;pt had welts on face that started w/fever & inc in size & redness;rt leg red & swollen;inc irritability;
Right arm swollen day after immunization. Fourth and fifth fingers turned purple with numbness and tingling.  Radiating electrical shock throughout right arm.  Developed a contracture in right hand pinky finger.  Decreased grip stength of 26 pounds in right hand and decreased feeling.  Loss of range of motion in right arm. Currently receiving nerve blocks for pain and going through occupational therapy to try and regain strength in right arming.
Patient requested second shingrix vaccine at dropoff. After administering, patient stated she meant pneumonia 23 vaccine so she was administered a third dose of shingrix. Last shingrix dose was 9/2019/
2 minutes after injections (MMR and Varivax) in seperate thighs-patient had urticarial welts on both thighs which resolved with Benadryl liquid.
Smelling cigarette smoke when there is none since first dose. Smell has been constant since second dose.
First dose in January 2021 and wanted to know if I need to start over; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose in January 2021 and wanted to know if I need to start over) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose in January 2021 and wanted to know if I need to start over). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose in January 2021 and wanted to know if I need to start over) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Child was sitting in chair after his vaccinations at 1145.  As he arose he paled and fell into the chairs with a vasovagal reponse.  Child awake, but not repsonive to voice commands, HR 45 RR 10.  Not responsive to sternal rub.  Called 911 1258 HR 90 RR 15,  EMT arrived 1300, child still not responsive to voice, but awake.  Mother informed EMT's child had not eaten breakfast. VS taken with BS 68 Sats 99%, HR 100.  Child does not take medications and has no significant history other than mild asthma. Child showed moderate improvement and able to communicate at 1320  Mother declined transport to ED.  Mother to follow up as needed.
She is not feeling well; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "She is not feeling well".  Additional Information: Reporter said, that she has today her appointment to get the second dose of the Pfizer covid vaccine and she is not feeling well so she would like to change her appointment. PQC was not present. AE Present was reported as yes. Case was reported as non-serious. Possible AE.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
vaccine given to oncology patient under the age of 65, no AE; vaccine given to oncology patient under the age of 65, no AE; Initial information was received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown demographic patient who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number not reported via unknown route in unknown administration site on an unknown date.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing neoplasm malignant.  It is an actual medication error case due to overdose and inappropriate age at vaccine administration.  It was reported that the vaccine given to oncology patient under the age of 65.  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  Information on the batch number was requested.
My throat swelled up like a balloon; This is a spontaneous report from a contactable consumer (patient) and other HCP. A 73-year-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in the left arm on an unspecified date (at the age of 73 years old) as dose 2, single for COVID-19 immunisation at hospital. Patient was not pregnant at the of vaccination. Medical history included cardiac and kidney issues, Known allergies: Yes. Patient previously took bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in the left arm on an unspecified date (at the age of 73 years old) as dose 1, single for COVID-19 immunisation and experienced sore arm, swelling at shot site. Other medications were given within 2 weeks. No other vaccines were given within 4 weeks. On 01Apr2021 12:00, the patient experienced my throat swelled up like a balloon. The patient underwent lab tests and procedures which included ultrasound scan as doctor ordered ultrasound to be sure it was nothing else. Therapeutic measures were taken as a result of my throat swelled up like a balloon and included with treatment 2 different ultrasounds to check thyroid and gland. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. AE resulted to doctor or other healthcare professional office/clinic visit. The clinical outcome of the event was reported as recovering.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Headache from 2/23 until 2/ 26       and fever 101.9  for 4 days
completed series, titer testing was negative; This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a female patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   Linked case(s) involving the same patient: US2022043704  Additional details were provided as follows: This case was reported by the medical assistant. The age at vaccination was not reported. The patient completed the series of Engerix B but titer testing was negative, which led the patient to be therapy non-responder. Engerix B series was being re-administered, for tolerance of Engerix B 10 received by the patient, refer case US2022043704. This case was linked with US2022018153, reported by same reporter for different patient. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022018153:Same reporter, different patient US-GLAXOSMITHKLINE-US2022043704:Same patient, same reporter
Narrative:  Patient experienced chills, fatigue, muscle aches, and headache after receiving the first COVID-19 vaccination dose.
he client pain on the back of her neck to EMT. RNs responded. Vitals obtained at 11:25 AM were as follows: HR 83, O2 99%. The client stated the pain started in her arm and radiated to the back of her head and neck. Repeat vitals obtained at 11:28 AM were as follows: BP 109/73, HR 83, O2 99%. The client stated her pain level was at a 3 on a 10 point scale. The client denied any other signs or symptoms of anaphylaxis. The client was offered water, drank some water, and reported that it felt normal to swallow. The client stated the pain on the back of her neck was intermittent and stated that it was improving overall. Repeat vitals obtained at 11:34 AM were as follows BP 94/67, HR 72, O2 99%. The client stated that she ate breakfast this morning around 8:00 AM. The client stated the pain had resolved and reported the pain at a 0 on a 10 point scale. At 11:40 AM the client reported pressure on the back of her head and reported it at a level 2 on a ten point scale. Repeat vitals obtained at 11:44 AM were as follows BP 104/66, HR 79, O2 99%. The client stated the pain was at a level 2 on a 10 point scale. The client was alert and oriented to person, place, time, and situation. At 11:51 AM the client reported pain and pointed to her chest. The client stated the pain was at a level 2 on a 10 point scale. Vitals obtained at 11:51AM were as follows: BP 101/69, HR 72, O2 99%. The client stated that she felt nervous and anxious. The client denied any new symptoms. RN provided education to the client and her mother regarding s/s of anaphylaxis and when to seek EMS. The client and her mother voiced understanding of this education. At 11:55AM the client stated that her chest pain had resolved. The client ambulated unassisted with a steady gait out of the vaccination site at 11:55 AM.
Pt reports having received the shingrix vaccine which caused her arm to swell (from the Inj site to her elbow). She wanted to know if Enbrel could cause this- I advised that the effects of Enbrel might be to stump her immune response to the vaccine, but not really cause swelling as she described. I advised the pt, per CP, that some swelling and itching is normal after receiving the shingrix shot. Pt will also confer with her physician for her perspective on this.
Pt vaccinated /w MMR 2 wks following vaccination pt developed Stevens-Johnson syndrome & was hospitalized. 17Jul90 developed rash on chest,trunk, palms of the hands, face & upper & lower extremities. Low grade fever /w cracked lips & mouth.
Case was admitted to hospital on 04/21/2023 for an unrelated reason. She acquired COVID 19 in hospital and began becoming symptomatic; cough, severe fatigue, weakness and muscle aches. Case tested positive 05/02/2023. Plan is to go to a Rehab facility for 10 days and return to her home.
Lot #042L20A  Patient with no allergy history.     Received Moderna vaccine at 11:23am  Patient began feeling throat tightening approximately 10 minutes later.     She was given epi at 11:45am.   At 11:47am she was given benadryl 50mg IM   11:555 vitals were BP 163/91, HR 68     At 12:01 vitals: BP 156/79, HR 79, O2 sat 98% on RA  At 12:12 HR 98 O2 sat 97%   gave another dose of epi 1:1000 at 12:13pm     12:15 HR 89 Sat 98 BP 174/99  12:16 IV placed by EMS   1218 BS 161   1221 ED Sharp initiated      Stable when departed.
After the shot 2 weeks ago I start feeling headaches, muscle problems in my back, neck and foot and leg left side. Also a circulation problem my veins left leg are affected my left foot sore I can not walk cramps difficulty to breath.
Pt noticed 3 days after vaccine administration a red itchy patch on the inner arm of the same arm the vaccine was given.
itching that started in the arm where vaccine was administered, then traveled up arm to face and then gradually all over body. No rash. Client has had a head ache since the day of the vaccine.
Irritability (onset 12 hours, post vax; duration approx. 48 hours), diarrhea (onset 4-6 hours, post vax; duration 8 hours), fever (onset 12 hours, post vax; 102F axillary; fever remained around 100F for 24 hours). Treatment: diarrhea-diet changes/fluid increase and fever-ibuprofen.