chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient that more than likely got the incorrect dose of pentacel with no reported adverse event; did not receive both vials mixed with no reported adverse event; Initial information received on 16-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2023SA254858 (Cluster).  This case involves a 8 months old female patient who more than likely got the incorrect dose of diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)] and did not receive both vials mixed with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Aug-2023, the patient received 0.5 mL dose of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine, suspension for injection (batch number: UJ876AA; expiry date: 19-Mar-2024) via intramuscular route in the left thigh for Immunization, more than likely got the incorrect dose and did not receive both vials mixed with no reported adverse event (incorrect dose administered) (single component of a two-component product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the 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 the 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.
While in observation area, patient started to feel dizzy/lightheaded, sweaty/numbness to hands/feet, "static" vision. BP after laying supine: 107/68, Pulse 58, repeat BP 10 minutes later after rest/hydration/snack: 120/83, Pulse 84.  last meal/snack/drink: 2.5 hours prior to vaccine- fruit smoothie Prior history of syncope from tooth extraction/flu illness Patient gradually recovered after rest/hydration/food.
Client has a history of some allergic reactions to medications. (Did not indicate this on form) Rc'd  vaccine in a drive thru clinic and with in minutes delt flushed in his eyes and cheddls. He proceeded to Recovery area and was seen by Dr. No SOB or respiratory distress but had overt facial flushing and mild swelling. Client given 50 mg of PO  Benadryl and observed  x 30 minutes w/o improvement and worsening flushing. Transported by EMS to local hospital.,RN per Dr written vaers form and incident report form.
Case number PHEH2013US026655 is an initial spontaneous report received from a consumer on 30 Dec 2013. This report refers to a 45-years-old female patient. She was bitten by a dog and was concomitantly taking OMNICEF. She began vaccination with post-exposure RABAVERT (batch number: not reported) series on 29 Nov 2013. It was reported that she had her third dose of RABAVERT (batch number: not reported) intramuscularly on 07 Dec 2013. On the same day, sometime after the third dose she experienced difficulty in swallowing and a very dry throat. She also had tightness and pain under her left breast and ribs as well as tightness and pressure in the back and front of her head. It was reported that the dog eventually tested negative for rabies. The outcome of the events was reported as condition unchanged. No further information was provided.
Pt recv vax on 2/24/99; on 2/26/99 pt exp left thigh swollen
Swelling on my neck shoulder axillary and chest on same side as injection site along with swelling and pain at the injection site And under my arm.  I have also had insomnia.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A 75-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "he has received both the first and second dose of the Pfizer COVID-19 Vaccine and one booster dose from Pfizer. He also received a second booster of the Moderna COVID-19 vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "at home test and that too came back positive". Question: Received call from (Name given) with Paxlovid Call Center. Caller was a 75-year-old male consumer who stated he has received both the first and second dose of the Pfizer COVID-19 Vaccine and one booster dose from Pfizer. He also received a second booster of the Moderna COVID-19 vaccine, he states all at the appropriate intervals. He was at a wedding this past Friday and Saturday, he has no symptoms but he thought it would be intelligent of him to test since he was around a lot of people with no masks, dancing, eating. So he took a self at home antigen test and it was negative, he then got an email from his Nephew saying that he tested positive for COVID. So the caller thought it would be smart to take another test, which he did and even though the line was faint it was positive, so 30 minutes later he took another at home test and that too came back positive. So he went to his urgent care center, at which he is a patient and they performed a PCR test, to which he will get that result back tomorrow, but they also gave him a prescription for Paxlovid, so he took it and got it filled at the pharmacy. The pharmacist told him he should take it right away, but he was reading in the insert that it said Paxlovid is for the treatment of minor symptoms of COVID, and he currently does not have symptoms, so his question is should he still take the medication or is it okay to wait till he gets the PCR test result to see if he does in fact have COVID. E-transmitting for AE of positive COVID testing, forgot to offer transfer at the end of the call. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: he took a self at home antigen test; positive, notes: even though the line was faint it was positive; positive, notes: 30 minutes later he took another at home test and that too came back positive; unknown result. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
23 yo female who stated she started feeling palpitations after the vaccine was administered.  On EKG was noted to have frequent PACs.  Does not have a history.  Was sent to the nearest facility by EMS.
Swelling of tongue & throat tissues; Difficulty swallowing; lung congestion; dizziness/shaking.
Severe heartburn with acid reflux - started approx. 10 hours after vaccine. Tums and Rolaids momentarily relieved. Increased in severity after eating meals. Tried Pepcid and Milanta. Temporary relief until eating another meal, then severe symptom returned. Clinic doctor prescribed omeprazole. Acid reflux and minor heartburn continue to be experienced 4 days after.  Body aches - started 10 hours after vaccine. Took Tylenol every 4-6 hours to relieve symptom. Lasted until 34 hours after vaccine. Chills - started approx 11 hours after vaccine.  Fever - started approx 12 hours after vaccine. lasted 6 hours.  Headache - occasional and moderate, from 12 hours after vaccine to 34 hours after.
C?O numbness in legs, became confused, disoriented.  Transferred to Emergency Department. Diagnosed with CVA event.  Still being treated at this time.
7/25/18: Bright red, warm to the touch (no blisters) rash surrounding injection site. Resolved in approximately 3 days. 7/31/18: Awoke at approximately 2 AM to new onset pounding head pain located in back of right side head. Reported to Urgent care. Blood pressure elevated (178/106). Dr diagnosed Herpes Zoster. Started course of VALTREX 1000 mg. 8/8/18: Follow-up visit with PAC. Blood pressure elevated (167/91). Reported only way to stop the 2 AM headaches was to maintain therapy of MOTRIN 400 mg every 6 hours. Removed MOTRIN therapy and started continual therapy of INDOCIN SR 75 mg. Brain MRI ordered. 8/15/18: Return visit with PAC presenting with new onset vaginal sore and elevated blood pressure (156/92). Sore swabbed for HSV. Test returned negative for HSV Type 1 and 2. Started therapy of HYDRODIURIL 25 mg tabs daily. 8/17/18: Brain MRI conducted. Awaiting results. 8/19/18: Awoke approximately 7 AM to numbness in both hands and dull head pain located in back of right side of head.
temp for a couple of days;10/14 T101 x 2 days;bump on neck then broke out in chickenpox;mainly on trunk;
She received her Flu shot on Wed. She said she had also hit her head on something Wed. On Friday she had numbness/tingling/tightness in her feet/toes. She went to ER on Friday, thinking it was a concussion from hitting head. ER could not find a cause. She saw neuropathy listed on vaccine info sheet and thought maybe it's from the flu shot.
2nd Dose Was Given 3 Months After The First Dose; Received 3rd Dose of Heplisav-B; Initial Report Received on 19-Oct-2022  This is a spontaneous report, received from a nurse in the regarding a female patient who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.  Concomitant medications were not reported.  On 01-Mar-2022, dose 1 of HEPLISAV-B (Lot #935844, expiration date 04-Nov-2022, NDC #43528-0003-01), route not specified, was administered in the left deltoid for hepatitis B immunization.  On 07-Jun-2022, 3 months following the first dose, dose 2 of HEPLISAV-B (Lot #935844, expiration date 04-Nov-2022, NDC #43528-0003-01), route not specified, was administered in the left deltoid for hepatitis B immunization.   On 18-Oct-2022, dose 3 of HEPLISAV-B (Lot #937233, expiration date 11-Mar-2023, NDC #43528-0003-01), route not specified, was administered in the left deltoid for hepatitis B immunization.  Concomitant vaccines administered included a dose of a flu vaccine (Lot # not reported), route not specified, in the right arm.    The 3rd dose of HEPLISAV-B was reported as being administered due to a documentation error. The patient did not demonstrate any adverse reactions.  Action taken with HEPLISAV B was not reported.  The outcome of the adverse event was not reported.  No further information was available at the time of the report.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Splitting headache, pain in back of neck, swollen lymph nodes in left armpit with pain to left breast, muscle aches in every muscle, of my body, extreme lower back pain, freezing in my feet, chills and shakes, and nausea for 2 nights and 1-1/2 days.  Diarrhea started the second day and I still have it.  I literally was flat on my back in bed for 1-1/2 days only able to get up to go to the bathroom and get something to drink.  The only thing that kept me out of the hospital was that I did not have a fever.
I gave the patient a Moderna peds booster instead of the adult bivalent booster; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (I gave the patient a Moderna peds booster instead of the adult bivalent booster) and NO ADVERSE EVENT (No adverse 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)) 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 WRONG PRODUCT ADMINISTERED (I gave the patient a Moderna peds booster instead of the adult bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (I gave the patient a Moderna peds booster instead of the adult bivalent booster) 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 (I gave the patient a Moderna peds booster instead of the adult bivalent booster).    No concomitant medicine were reported. No treatment medicine were reported.
Healthcare provider states improperly stored vaccine involved in a temperature excursion  was administered to a patient. No additional AE reported. No PQC reported.  Names of vaccines involved (including lot/exp): PEDVAX HIB W006595 10/10/2024 Temper; no additional adverse event; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender.   Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot number: W006595, expiration date: 10-OCT-2024; dose and route of administration not provided) (product storage error). The vaccine was stored in temperature 57.49 degrees Fahrenheit for 1 hour 45 minutes. No adverse event was reported.
Exclusively breastfed infant (4 months, 20 days old) began developing raised red bumps on shoulders, back, neck, knees, elbows approximately 2 hours after mother received vaccine/approximately 1 hour after breastfeeding. Bumps have progressively spread to cover all of baby?s body/face as of 1/20/2022. Visited pediatrician at 3:30pm on 1/20/2022 and no cause other than the vaccine was found. Nurse practitioner prescribed Benadryl dosage per baby?s current weight every 6 hours as needed and referred baby to an allergist. Nurse recommended reporting baby?s reaction to agency via reporting system.
This spontaneous report was received from a nurse practitioner refers to a 50 years old patient who on 03-SEP-2012, was vaccinated subcutaneously with a dose of MMR II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1003AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a health professional concerning herself (age unknown) with a family history of "rheumatoid arthritis and neurological disorders after receiving unknown vaccinations" who was vaccinated with a dose of rubella virus vaccine live (Wister RA 27/3) and the patient also stated that she received "the German measles vaccine after delivery of her first child".  Subsequently, for two months after the vaccination the patient's "joints would lock up" and when she was on the floor she was unable to get up.  Subsequently, the patient recovered from joints would lock up.  No medical attention was sought.  No product quality complaint.  No further information is available.
sharp pain devel in lt hand 20mins p/vax lasted 1-1 1/2hrs;lt arm became swollen from fingers to shoulder lastin 1 1/2d;lt side of neck is still stiff
Weakness on the right side of body. Dizziness, tiredness. Occurred the day after taking the vaccine. Had to go to emergency room May 31st after the symptoms worsened . I couldn't move the right side of my body for a week after that incident.
Child dx with varicella dz 11/24/10 was seen 11/15 for rash - dx roseola. Seen 11/17 with scarlet inaform rash (RSS (-)) tx with cephalexin. Seen 11/23 with papular rash on head, face, trunk. Seen 11/24 with papular & vesicular rash spreading, > 50 lesions.
No additional adverse events; Caller is medical assistant who reports administered doses of vaccines to 5 patients following temperature excursion.; This spontaneous report has been received from a medical assistant, concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 15-JUN-2022, the patient was administered vaccine varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose (valid lot number U007478 [expiration date 08-MAR-2023]) for prophylaxis, after a temperature excursion (product storage error) (dose, vaccination scheme, and frequency were not provided).   No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007849: US-009507513-2206USA007701: US-009507513-2206USA007852: US-009507513-2206USA007865:
Diarrhea and fatigue. Swollen lymph node in left arm as well as severe pain and swelling in left arm. Current symptoms are all present  at the time of this report and have been increasing in severity. I cannot fully extend my left arm
Patient was admitted with Autoimmune hemolytic anemia (Hb 5.3) 4 days after 2nd dose of Morena COVID-19 vaccine. He had  elevated reticulocyte count, bilirubin, LDH, positive Coombs test and undetectable haptoglobin at presentation.  He required PRBC transfusions and was also treated with steroids and rituximab, after which his anemia started to improve
cough; This case was reported by a consumer via call center representative and described the occurrence of cough in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced cough. On an unknown date, the outcome of the cough was unknown.   It was unknown if the reporter considered the cough to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that he received dose 1 of Shingrix about 4 weeks before the time of reporting and has been experiencing cough. The reporter did not consent to follow-up. The reporter did not wish to proceed with safety report questions.
Patient experiencing localized reaction to vaccine: single egg-sized wheal over right thigh. The affected area is warm, blanchable, and non-tender. No respiratory distress, generalized rash or hives, or fever: normal behavior, playful, eating, and drinking.  Advised to use over the counter medications and cool compresses as needed.
Pt tested positive for Covid. Pt states she is feeling weak and having a productive cough. Pt does not have any hx with pulmonary disease.
Approximately one week post vax pt developed a sore arm with a bruise from shoulder to elbow. Pt indicated that he did some heavy lifting and felt a "pop".  Arm became really sore and whole upper arm black and blue.
body aches; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The received first dose of BNT162B2 for COVID-19 immunization. The patient experienced body aches which began 12 hours after the second dose on an unspecified date and lasted for around 24 hours. The outcome of event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician via a field representative refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. Approximately in 2014, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot# were not reported). The reporter stated that the patient had recently outbreak of herpes zoster, approximately in 2015. The patient sought medical attention contacting doctor's office. The outcome of herpes zoster was reported as not recovered. The causality between the event and ZOSTAVAX was not reported. Additional information has been requested.
Vaccine given on 3/21/00. On 4/26/00, pt dxed with aplastic anemia. Annual follow states the pt has finally been diagnosed with Acute lymphoblastic leukemia.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination can be 69 or 70 years. The sore arm lasted for a couple of days. This case was linked with case US20181493969 (2nd dose), reported by the same reporter for the same patient.
Patient had vaccines on 6/08/2006 and developed a high fever that night.  Breathing rapidly, he was seen in the ED the next day and admitted for questionable pneumonia.
having ringing in her ears; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Right on 22Feb2021 11:30 as 2nd dose, single for covid-19 immunisation.  Medical history included occasional vertigo on and off, for the past 5-6 years. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Right on 26Jan2021 as 1st dose, single for covid-19 immunization. On 01Mar2021, the patient experienced ringing in her ears which never had that before. Patient said it was annoying but that is the only bad part about it. Patient had no intention to go to her doctor for treatment. She had not visited to emergency room and physician office. Prior Vaccinations (within 4 weeks) was reported as none.   No follow-up attempts are possible. No further information is expected.