chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of generalized hives has been received from a Registered Nurse concerning a 12-year-old female, subsequent to FLUMIST. Medical history included attention deficit/hyperactivity disorder (ADHD) and childhood epilepsy. Concomitant medication included methylphenidate hydrochloride. The patient's brother or sister experienced hives with the diphtheria, tetanus, and DTP vaccine at 18 months old. On 19-Oct-2008, the patient received FLUMIST, intranasal administration. She had never received FLUMIST before. One hour post administration of FLUMIST, the patient broke out in generalized hives. The hives progressively worsened over the next two days. No other symptoms were reported. The patients mother treated her with diphenhydramine. The outcome of the event was not reported. Additional information received on 30-Oct-2008 and incorporated into the narrative included in medical history concomitant medication and vaccine information.
Narrative: 69yo M died on 7/23/2021 at home in home hospice care from multiple myeloma and plasmacytoma cancers. Pt had been vaccinated with covid vaccines on 3/5/21 & 4/2/21. Vaccines are not related to pt's death.
got violently ill couldn't even keep water down for at least 36 hours; still not well; This case was reported by a consumer via interactive digital media and described the occurrence of illness in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and the 2nd dose of COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced illness and feeling unwell. On an unknown date, the outcome of the illness and feeling unwell were not recovered/not resolved.   It was unknown if the reporter considered the illness and feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. Reporter stated that her husband had the shingles vaccination 2 1/2 weeks after his second Covid-19 shot. He got violently ill couldn't even keep water down for at least 36 hours. He was still not well after 3 days. The reporter suggested not get the shingles vaccine to close to the Covid vaccination. No further information was reported. It was unknown if the reporter considered the illness and feeling unwell to be related to Covid-19 vaccine.
Itchy red rash developed at vaccination site approximately one week after the vaccination. Applied OTC hydrocortisone twice a day.
neck pain, injection site pain, fatigue Narrative: employee states: after first dose, had neck pain, fatigue, and injection site pain had similar symptoms after 2nd dose that went away after 3 days for the last several days (reported 6/2/2021) had extreme unilateral pain on right side of neck, radiating down the arm. It keeps getting worse instead of better. It wakes her up at night and employee is concerned. It has limited her mobility in her right arm, but does get better after ibuprofen or aleve. Employee intends to seek further medical attention. Employee states symptoms lasted a few days beyond 6/2/21 then subsided.
Narrative: COVID infection following COVID vaccine series 01/23, Pfizer, dose #1 02/16, Pfizer, dose #2 1/15, Pfizer, dose #3 12/29 COVID swab, result: detected 12/28 pt cc: cough, myalgias, rhinorrhea, exposure: unknown 1/4 clinically resolved
numbness tingling and urticaria  fever chills burning headaches bradycardia  emesis
Fever, body aches, nausea for 48 hours. Decreased cardiovascular function for 10 days.
pt recv vax & according to mom-2hr later noted itchiness & rash on abd;bilat arms, rt buttock, no other sx;rx DPH;no diff in breaking;
sick; Initial information was received on 19-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves a patient of unknown demographics who got sick while receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (formulation, strength, dose, batch number and expiry date: unknown) via unknown route in an unknown administration site for prophylactic vaccination (flu). Information on batch number was requested  On an unknown date, the patient got sick (illness) (unknown latency) following the administration of Influenza vaccine.  Action Taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (illness).  At time of reporting, the outcome was Unknown for the event (illness).
From initial information received on 05/14/2004 from a physician regarding an adverse event occurring in the USA, it was reported that following a heel laceration on 04/22/2004, a 40 year old female patient received a TD ADS Adult vaccination, lot number U1019AA, administered intramuscularly in the left deltoid on 04/23/2004.  A couple of days later the patient developed extreme fatigue, muscle aches and couldn't open her jaw for a few minutes.  The jaw stiffness was found to be resolved upon examination on 05/03/2004.  On 05/14/2004 the extreme fatigue and muscle aches were slowly resolving.  It is unknown if the patient recovered completely from these events.  From additional information received on 08/09/2004 from the reporting physician, the adverse event start date was reported as 04/25/2004.  No new medical information was provided.
12:50 pm Td given with no prior memory of adverse events to vaccine.  1:45 pm sharp pains in throat, felt like it was closing. 4:00 pm called to report above syptoms, was told to go to ER, dizzy-SOB- Dr. told her anaphylaxis "prednisone" shot in arm to follow with 5 days of clariton once daily.  to ER #2 pain in back and thighs. 05/03/04 patient is okay now.
just a little soreness; This is a spontaneous report from a contactable consumer (patient's wife). A 72-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 16Feb2021 (Batch/Lot Number: EL9266) as single dose for covid-19 immunization. The patient's medical history was reported as none. The was no concomitant medication. With his first shot he had nothing, just a little soreness. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
High fever 103 for 2 days, irritable for 4 days, difficult to console, he refused his bottle, sleep max 1-2 hours at one time for 4 days.
Pt received her 2nd COVID vaccine on 3/19 on 3/24 she had her 1st Injectafer infusion to treat IDA. IV was started on (L) hand (site of vaccine) and shortly after the infusion began, she developed itchiness / rash to (L) FA, hand radiating to chest & scalp.  Infusion was stopped. Unsure if any contraindications between iron infusion & COVID vaccine.
Pt was administered COVID19 vaccine prior to screening question and answered yes to the vaccine in the last two weeks having a pneumonia vaccine on 4/14/21
Monovalent vaccine was administered in error when bivalent vaccine should have been. No harm to patient. No adverse effects from vaccine. Potential for errors is greater with multidose vials that look alike. Recommending changing the vials, creating single dose syringes that can be scanned to prevent errors.
This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also posted on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main thought was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse events because he had already reported the events. This is 1 of 13 cases, reported by the same reporter for the patients who experienced adverse events after receiving SHINGRIX.
Developed vomiting on the morning of 7/23/19. Pt become pale, limp, and nonresponsive. Diagnosed with intussusception by ER as well as Hospital. Pt was kept over night for observation
chest pain that she describes as severe, constant, in the breast tissue, hard to move, hard to pick things up, hurt constantly; chest swelling; monthly cycles have been very effected and are still 'pretty bad'.; chest swelling that her doctor thought might be relayed to lymph node issues and under her arm lymph nodes; chest swelling that her doctor thought might be relayed to lymph node issues and under her arm lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Lot number: FH8027) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 01, Lot number: unknown), administration date: Apr2021, for COVID-19 immunization, reaction(s): "chest pain that she describes as severe, constant, in the breast tissue, hard to move, hard to pick things up, hurt constantly", "chest swelling might be relayed to lymph node issues and under her arm lymph nodes", "monthly cycles have been very effected and are still 'pretty bad'", "chest swelling might be relayed to lymph node issues and under her arm lymph nodes"; Bnt162b2 (DOSE: 02, Lot number: unknown), administration date: May2021, for COVID-19 immunization, reaction(s): "chest pain that she describes as severe, constant, in the breast tissue, hard to move, hard to pick things up, hurt constantly", "chest swelling might be relayed to lymph node issues and under her arm lymph nodes", "monthly cycles have been very effected and are still 'pretty bad'", "chest swelling might be relayed to lymph node issues and under her arm lymph nodes". The following information was reported: CHEST PAIN (medically significant), outcome "unknown", described as "chest pain that she describes as severe, constant, in the breast tissue, hard to move, hard to pick things up, hurt constantly"; COSTOCHONDRITIS (non-serious), outcome "unknown", described as "chest swelling"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "monthly cycles have been very effected and are still 'pretty bad'."; SWELLING (non-serious), LYMPHADENOPATHY (non-serious), outcome "unknown" and all described as "chest swelling that her doctor thought might be relayed to lymph node issues and under her arm lymph nodes".
The following day, wife says her husband's rights side of his face was swollen.  No changes in diet, products used, and does not believe he  was bitten by anything.  Lips, tongue were not affected, no difficulty swallowing.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIARRHOEA (diarrhea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-073992 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073992:
No adverse event; Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022) and NO ADVERSE EVENT (No adverse event) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2022 at 2:25 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-May-2022 at 2:25 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022).    Patient's race was reported. No concomitant medications were reported. The event did not cause the patient to seek medical care. The patient did not have any adverse effects from this vaccine.  The dates of the first two doses was unknown. It was unknown if any other vaccines were given in the 4 weeks prior to COVID-19 vaccine. It was reported that determine course of action when COVID vaccine given past expiration date. 6 doses administered on 07 May 2022 from lot number 033H21A with a published expiration date of 25 Mar 2022. Health care professional stated that they were the 1st boosters.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-714990.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714990:patient S-E
Immediate - same day Sept 21: swelling, pain and redness which continued throughout the day Later same day Sept 21: : body aches started as well as fever and chills. Red raised welts, rash grew from the original injection site and spread from upper right arm to elbow. Difficulty sleeping, night sweats Next day: Sept 22: body aches continued, fever was 101.5 with Tylenol. Chills and rash continued. The upper arm was hot to touch and feel, with pain which prevented movement. Kept hydrated, ate fruit, alternated Tylenol and Aleeve for 4 days. Fever broke on Saturday morning (sept 23)  (48hurs) but the arm pain, redness and swelling didn't end until Sunday, Sept 24.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
arm is red; swollen; hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm is red), PERIPHERAL SWELLING (swollen) and FEELING HOT (hot to touch) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced ERYTHEMA (arm is red), PERIPHERAL SWELLING (swollen) and FEELING HOT (hot to touch). At the time of the report, ERYTHEMA (arm is red), PERIPHERAL SWELLING (swollen) and FEELING HOT (hot to touch) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. No Relevant concomitant medications was reported. Treatment information was not provided.
Client received a MCV4 vaccine for college entrance requirement.  He left the clinic without any signs/symptoms of distress and drove approximately 15-20 minutes when he stated to his father that he passed out and was involved in a MVA.  Father is concerned that the vaccine caused his loss of consciousness.  The Police and Fire Dept. responded to the accident scene, but the client refused transport to the hospital.  Father stated he sent a text to his girlfriend at 4:11 pm and then another text was sent at 4:28 pm.
Information has been received from a physician concerning about seven patients who on an unspecified date were vaccinated with a dose of PNEUMOVAX 23 (Lot # 665904/0866Z, expiration date on 04-JUL-2011) (also reported as lot# "0868Z"). The physician reported that the patients developed fever the next day that lasted approximately 3 days. The physician stated that she had never seen so many adverse reactions with PNEUMOVAX 23 before. At the time of this report, the patient's outcome were unknown. The physician reported that the patients developed fever 38.5 degrees C - 39.0 degrees C and cellulitis within 12 hours of receiving vaccine. Fever lasted anywhere between 3 to 5 days. The physician did not provide any information on the duration of cellulitis. The injection site reaction extended from the area of the shot to the elbow and two patients were treated with antibiotics. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. A priority lot check has been initiated. Follow up information has been received from the physician who reported that one of the patients was a 45 year old male patient who on an unspecified date was vaccinated with the first dose of PNEUMOVAX 23 (Lot # 665904/0866Z, expiration date on 04-JUL-2011). The physician reported that the patient developed fever of 39C that lasted for 4-5 days and severe cellulitis which had extending form the shoulder to his elbow. The physician did not provide any information on the duration of cellulitis. At the time of the report, the outcome of the patient was not reported. A standard lot check investigation has been finalized. All in-process quality checks for the lot number (665904/0866Z) in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. Follow up information from the physician concerning a 45 year old male (WT: 160, HT: 5' 11') patient with Ankylosing spondylitis who on 27-SEP-2010 was vaccinated with the first dose of dose of PNEUMOVAX 23 (Lot # 665904/0866Z, expiration date on 04-JUL-2011) IM on the right deltoid. Within 12 hours on 28-SEP-2010 the patient developed high fever up to 105, severe cellulitis type reached right upper extremity to the elbow and lasted 7 days. The patient was treated with LEVAQUIN and nonsteroidal anti-inflammatory drug (unspecified) (NSAIDS). This is one of several reports from the same source. No further information is available.
suspected vaccination failure; shingles; pain; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with cyanocobalamin (Vitamin B12). On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that, the vaccine did not help, still got shingles 2 to 3 times after took vaccine. The patient got shingles most recently last week  from the date of reporting. The reporter stated that the best way was keep the medicine at home. The patient advised when you have that feeling, just take the medicine right away. And take B12, it could reduce the pain This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Based on additional information received on 13 December 2015, this report previously considered as non-valid become valid as patient's identifiers were reported. Initial unsolicited report received from a pharmacist on 08 October 2015. This is an invalid case as no patient identifiers were reported. It was reported that Fluzone HD (batch number, dose, dose in series, route and site of administration were not reported) was administered on an unspecified date. Medical history and concomitant medication was not reported. On an unspecified date, following vaccination, the patient experienced adverse event which was not specified. Laboratory investigation and corrective treatment was not reported. At the time of this report, the outcome of the event was not reported. Follow-up information received from a pharmacist on 13 December 2015. The patient was vaccinated with Fluzone HD (batch number: UI44804) in left upper arm. Any other vaccination within 4 weeks prior to vaccination was reported as none. On an unspecified date, following the vaccination, the patient had developed warm, red blotches. The patient was recovered from the events (within 5-7 days). List of documents held by sender: none.
Onset of blister like rash on chest, nipples, waist and legs to knees, with an increase of rash between her legs.  Denies any systemic symptoms.
Rt upper arm skin erythematous raised & desquamating lesion, redness, itchy well defined noted, mother reported fever for one day after vaccine.
Redness spreading from injection site extending to just below the elbow. Outlined, observation recommend, though on antibiotic beginning 10/14/16 for other infection.
No symptoms or signs on the day 1st dose of vaccine was received (2/11/2021).  3 days later,  (2/14/2021) patient experienced chills for approximately 6 hours, followed by severe (visible) chest spasms, and then cardiac arrest.  911 was called upon witnessing chest spasms, but cardiac arrest/death occurred before patient could be transported to the hospital.