chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HIVES ON HIS BACK, TORSO, AND ARMS; This spontaneous case report was received from a nurse (PVX2019-588) on 06-Mar-2019. The report described a 59-year-old male consumer who had hives on his back, torso, and arms following the intake of oral Vivotif for typhoid fever prophylaxis.  The consumer's past medication included Hepatitis A vaccine (only 1 dose) which was taken on 01-Mar-2019.  The consumer's concomitant medication included ibuprofen, Tylenol (paracetamol), Flonase (fluticasone propionate) as needed for unknown indication. He also took medications for blood pressure.   The consumer was allergic to ciprofloxacin and penicillin as a kid. He used to have hives from ciprofloxacin.   It was reported that the consumer took the first dose of Vivotif on 02-Mar-2019. On 04-Mar-2019, he experienced hives on his back, torso, and arms. He did not take the additional doses.  The consumer took one dose of Benadryl (diphenhydramine) for the treatment of hives on 04-Mar-2019 and the hives started to get better. Then on 05-Mar-2019, the hives came back a little bit, but now they were recovering and going away.  He did not expose to any atypical or new environment. He did not have any new food, chemical, or medication exposure. He also did not change his laundry detergent or soap.  The action taken with Vivotif with respect to the event hives on his back, torso, and arms was dosage discontinued.  The clinical outcome of the event hives on his back, torso, and arms was resolving.  The reported causality with respect to the event hives on his back, torso, and arms was possible.  Company's Comment: In this case, it was reported that a 59-year-old male consumer who had hives on his back, torso, and arms following the intake of oral Vivotiff. There seems to be a temporal association between the intake of Vivotif and the event. Hence, the causality of the event with Vivotif was assessed as possible. Additionally, co-administration of Hepatitis A vaccine (only 1 dose) on 01-Mar-2019 also provides a plausible explanation for the reported events.; Sender's Comments: Company's Comment: In this case, it was reported that a 59-year-old male consumer who had hives on his back, torso, and arms following the intake of oral Vivotiff. There seems to be a temporal association between the intake of Vivotif and the event. Hence, the causality of the event with Vivotif was assessed as possible. Additionally, co-administration of Hepatitis A vaccine (only 1 dose) on 01-Mar-2019 also provides a plausible explanation for the reported events.
Within a couple minutes after the injection on 04/15/2021 I had a strong metal like taste. This metal taste/smell increased with each day and is still with me to this very day with no signs of decreasing.  I have a list of foods that I can no longer eat as the taste/smell is so unpleasant.  I have to leave a room when certain foods are being cooked and it is too bothersome. I have tried cleansing my nose, brushing teeth / tongue with multiple brands of tooth paste, mouthwash daily, .. nothing changes the symptom/reaction.
Muscle achiness for 1-2 days post vaccination. Severe headache, nausea, vomiting fever, dizziness, blurred vision, loss of appetite, upset stomach, cold sweats.
Started with dizziness within the first hour. Then started increase arm started hurting really bad.  Shallow breathing, headache, nausea, next day bad swelling in arm and redness and severe pain. I was very cold and very tired. If I got up symptoms got worse. Some ice on spot helped some with swelling the first day but by second day the swelling was much worse. I had the shot on Thursday afternoon. By 6 PM I was so bad I thought I might have to go to hospital. I started drinking  more water and took some Advil. The next morning I had bad fatigue and wasn't able to do anything till afternoon. On Saturday I was feeling better but arm was still hurting very very bad and very red and swollen. Started taking some Benadryl every 4 hours and on Sunday morning the arm has started to loose redness and still some pain and swelling but is beginning to get better. Its Sunday now and not fully recovered but feeling like I am getting better now.
On this date CDC required the Bivalent Booster and this patient was given the COVID-19 MOD 6-12/A Booster
C/O GENERALIZED ITCHING WITHOUT RASH OR WHELPS 6/12/02. BEGINNING 7/6/02 BEGAN RASH, LARGE WHELPS, WITH DIFFICULTY BREATHING, LIPS SWELLING, FEET SWELLING, EYELIDS SWELLING. 7/7/02 WENT TO ER AND WAS TREATED AND RELEASED. 7/8/02 BACK TO ER FOR 5 HOURS.7/10/02 PMD TREATED.RECOVERY PENDING, STILL UNDER TREATMENT.
Patient was inadvertently administered intramuscularly only the liquid (dtap-ipv) component of the pentacel vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 23-Jul-2021 from a Pharmacist.  This case involves a two-month-old female patient while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] reported that she inadvertently administered intramuscularly only the liquid (dtap-ipv) component of the pentacel vaccine with no adverse event (product preparation error).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 22-Jul-2021, the patient received 0.5 ml (total) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ434ABA (box) and expiry date 08-Mar-20222] (unknown latency) via intramuscular route in unknown administration site for prophylactic vaccination.  It was reported that, "Pharmacist stated that yesterday (22 Jul 2021), the patient was inadvertently administered intramuscularly only the liquid (DTaP-IPV) component of the Pentacel vaccine, and not the lyophilized (Hib) component of the vaccine.  Pharmacist did not have information on where on the body the vaccine was administered, did not have information on whether any concomitant vaccines were administered, and did not have information on which dose in the series this was. Product used: Used. Still using product: No".  It was a case of actual medication error due to active ingredient not added to diluent (latency was on same day).  At the time of reporting, patient had no adverse event.  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.
Tingling in feet that progressed to hands. This began sometime in December of 2007 (cannot remember exact date).  Did NOT require hospitalization. Saw Dr. (neurologist) at hospital who diagnosed GBS based on EMG, nerve conduction study. Is recovering, still has some tingling in feet. Neurology note dted 2/207-Impression clinical and electrodiagnostic studies document the presence of mainly sensory polyneuropathy. Involving both motor and sensory fibers coming on relatively abruptly and reaching a plateau after just 1-2 wekks and then stabilizing is strongly suggestive of mild form of Guillain-Barre syndrome. C/O paresthesia in left foot and migrating to right foot and then into the hands.
Chills, extreme body/joint aches, very sore arm, fatigue starting the evening of the vaccine , lasting yet today 3-26
2 days after vaccine, started with pain at injection site, extreme fatigue, flu like symptomology. Pain began to radiate down arm, into muscles around neck over next few days. One day, pt. could not lift self out of bed in an normal way. Couldn't do "curl" r/t extreme pain. Recovered after 8 days.
Brief unresponsiveness per mother, duration about 1 minute, then self-recovered, no abnormal movements.
Patient had lightheadedness, disoriented, flushed, ears warm. "foggy", shaky. Paramedics were called and patient escorted for further evaluation
High fever after first shot; Chills; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High fever after first shot), CHILLS (Chills) and VOMITING (Throwing up) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (High fever after first shot), CHILLS (Chills) and VOMITING (Throwing up). On 15-Mar-2021, PYREXIA (High fever after first shot), CHILLS (Chills) and VOMITING (Throwing up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-407988 (Patient Link).
Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 73 years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (lot number-UJ052AA and expiry date- 09-Jun-2019) on an unknown date at Oct-2018. It was reported that the patient was also vaccinated with a 0.5 ml dose of the same vaccine (lot number and expiry date was not reported) in the right deltoid via intramuscular route on 05-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given the same visit. It was a case of actual medication error due to extra dose administered. At the time of reporting, the patient had no adverse events. 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. List of documents held by sender: none.
This spontaneous report as received from a nurse refers to a 18 year old female patient. The patient's concurrent conditions included penicillin allergy. On 18-MAY-2010, the patient was vaccinated with her first dose of GARDASIL (route, lot number and expiration date not reported). ON 30-JUN-2014 the patient was vaccinated with her second dose of GARDASIL (route, lot number and expiration date not reported). No concomitant medication or pertinent medical history were reported. On 01-JUL-2014, the patient presented nausea, felt sick to her stomach and "clammy". On 02-JUL-2014 the patient fainted while taking a shower and then fainted again when getting dressed. Patient did not have fever and was eating and drinking well. No treatment was given for the adverse event. The patient sought medical attention. At the time of the report the outcome of the events was reported as not recovered. Additional information has been requested.
shoulder pain; feels like the muscle/tendon coming off; feels like the muscle/tendon coming off; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2020). Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 14th June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, between 3 and 4 months after receiving Shingrix and less than 6 months after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced shoulder pain, tendon discomfort and muscle disorder. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the shoulder pain, tendon discomfort and muscle disorder were not recovered/not resolved.   The reporter considered the shoulder pain, tendon discomfort and muscle disorder to be possibly related to Shingrix.  Additional details were provided as follows: The patient reported himself. The reporter stated that he has received dose 1 of Shingrix (around Feb 2020) and dose 2 of Shingrix  (on 14th June 2020 as then later a flu shot.  The reporter did not have the exact dates of the shots but did provide the pharmacy's phone number so that we could obtain the dates of the injections, lot number/exp date, and confirm if they were given intramuscularly. The reporter did not specified the brand name of the flu shot.  The reporter stated the most recent Shingrix shot was given intramuscularly in the deltoid. He said it was given in the top left muscle of the arm but he was not sure if it was given intramuscularly or subcutaneously. The reporter informed that he felt like it went just into the skin but he was not sure.   A few weeks ago (almost 2 months ago) the patient begin experiencing shoulder pain. It feels like the muscle,tendon coming off, has tried using ice and massage but it has not been helping (The left arm was the arm where he received the second Shingrix shot). This has not resolved. It had been lingering, and it had been over 30 days. The reporter said he was wondering if this was due to the Shingrix shot. The reporter consented to follow up. This case was liked with case US2020236577 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020236577:same reporter.
Soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in her arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 05-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness in her arm). At the time of the report, VACCINATION SITE PAIN (Soreness in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the 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.; Reporter's Comments: Based on the 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.
extreme fatigue, dizziness, low grade fever (99.9 degrees F), right arm soreness symptoms lasted for a full 24 hours (4/5 9pm to 4/6 9pm)
severe inflammation throughout the body; This is a spontaneous report from a contactable consumer (patient's friend). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On unspecified date patient experienced severe inflammation throughout the body after taking the vaccine. There was no seriousness of Life Threatening, Intervention/Medically Important, Disabling/Incapacitating, Congenital Anomaly/Birth Defect, Hospitalization Required, Death, Hospitalization Prolonged, Other for the reported event severe inflammation throughout the body with BNT162B2. Outcome of event was unknown.  Product Complaint: There is no product complaint associated with this case.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Feel terrible; Tiredness; Headache; Muscle pain; Chills; Fever; Swollen lymph nodes; Cough; Sneezing; Runny nose; Sore throat; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0217 and expiration date was not reported), second dose via an unspecified route of administration on 24Jun2021 single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported), first dose via an unspecified route of administration on unspecified date as single for covid-19 immunisation. On an unspecified date the patient had other symptoms that was listed on website tiredness, headache, muscle pain, chills, fever, swollen lymph nodes. Patient also had cough, sneezing, running nose, sore throat. The outcome of the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Patient received the first COVID vaccine elsewhere and did not bring their card with to receive their second dose and did not tell us his first dose was the Pfizer vaccine until after administering the Moderna. Patient showed no reactions, but received the incorrect second dose.
patient missed their scheduled dose, patient has received her second dose on 03Aug2023 and forgot to follow up on her succeeding doses with no reported adverse event; Initial information received on 16-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient and reporter reported patient missed their scheduled dose of Rabies (Hdc) Vaccine [Imovax Rabies], patient has received her second dose on 03aug2023 and forgot to follow up on her succeeding doses with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Aug-2023, the patient received  Dose 2 of suspect RABIES (HDC) VACCINE Powder and solvent for suspension for injection (with an unknown strength, lot number and expiry date) via unknown route in unknown administration site for immunization.   On an unknown date, the reporter reported reporter reported patient missed their scheduled dose of Rabies (Hdc) Vaccine [Imovax Rabies], patient has received her second dose on 03aug2023 and forgot to follow up on her succeeding doses with no reported adverse event (routine immunisation schedule incomplete) (unknown latency).  It was reported, A nurse asks about the recommended dose scheduling adjustment for IMOVAX if the patient missed their scheduled dose, patient has received her second dose on 03Aug2023 and forgot to follow up on her succeeding doses; Agency provided information; patient information unavailable. No additional information. This is reported as a medication error due to a patient missing a scheduled dose from the IMOVAX series. No additional information.  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.
Approximately, 4-5 hours post vax, this pt experienced nausea, vomiting four times, stomach cramps, sweating, and fever of 101 degrees F. The pt was also very tired. She took Pepto-Bismol, Tylenol, and used ice for her symptoms. She recovered on 04/10, two days post onset. The pt had no symptoms post first two doses. Another pt was reported with a similar experienced post vax with the hepatitis B vaccine recombinant. No further information is available.
Fever began within 9 hours, vomiting began 6 hours later and lasted thru the night (mostly dry heaves). Fever peaked at 103.5 by mouth. Next was mostly aches in most muscles and yes, the testicles. Arm that received the injections could not be lifted and has a rash running from the top of shoulder down midway to elbow (better by day 3 & 4 but still has rash on day 4). Second day required trip to local ER for IV therapy and nausea medications to stop vomiting.
Left upper arm redness, pain and swelling began, within several hours worsened. Seen on 1/21/18 by provider. Location upper arm. Some body aches. No rash elsewhere. No right arm symptoms.
Initial misuse report received from a healthcare professional on 05 August 2013. A 09-year-old patient was administered PENTACEL vaccine instead of Td vaccine. No other information was provided. No adverse event was reported. Documents held by sender: none.
Pt. received MMR at noon time on 11/14/11. That evening pt. reports a swollen throat (uvula) and developed hives all over body. Symptoms treated with BENADRYL. They lasted for 12 hrs.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) in a 9-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 23-May-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse 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 adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.).    Patient received dose 1 monovalent Moderna vaccine 25 micrograms on 23-Feb-2023. Batch number AS1417B. The route of administration of suspect Moderna bivalent dose 2 was reported as BI. Concomitant medication was not reported. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
10-12 hours after injection experienced redness, inflammation and warmth at injection site. Lasted about 2 days. Did not seek treatment but site remained itchy 3 days later. No issues in past.