chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient's left upper and lower eye lids were red and swollen.; the patient's left upper and lower eye lids were red and swollen.; This spontaneous report was received from a nurse concerning a 9-week-old male patient. The patient's concurrent conditions included gastrooesophageal reflux disease (GERD), umbilical granuloma and poor weight gain. There were no known allergies. Concomitant therapies included diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (PEDIARIX) and pneumococcal 13v conj vaccine (crm197)(PREVNAR 13).      On 23-JUL-2020, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (mL) (strength was unknown; valid lot # S030968, expiration date reported as 16-APR-2022), intramuscularly in the right thigh; and rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 mL (strength was unknown; valid lot # S025595, expiration date reported as 13-APR-2021) orally for prophylaxis.   About 4 hours after receiving the vaccines, the patient's left upper and lower eye lids were red and swollen. The mother of the patient watched the patient overnight, and the swelling and redness resolved on its own the next day 24-JUL-2020. No treatment was provided for the redness and swelling. The mother brought the child to the office the following day. The patient was seen by the physician on 24-JUL-2020. The relationship between the events and suspect vaccines was not provided.
Had varivax on 8/17/00. Suspected outbreak of varicella on 7/16/01.
Headache Body Aches Narrative:  Pt reported Body aches, headache on day after dose #2 of covid vaccine. Pt treated with tylenol.
This spontaneous report was received from a nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates in the years 2015, 2016 and 2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. There were multiple temperature excursions but the temperature and the time frame were unknown by the reporter. No data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA005342: US-009507513-1705USA005384: US-009507513-1705USA005385: US-009507513-1705USA005386: US-009507513-1705USA005388: US-009507513-1705USA005389: US-009507513-1705USA005390.
Patient is a minor who received the Moderna COVID 19 vaccine. Patient was seen today at a COVID testing event requesting a 2nd dose, and this is when the error was discovered. Patient reported no adverse signs/symptoms.
about 7 hrs p/vax pt became disoriented, dizzy, poor balance, nausea, joint aches all over didn't have breathing difficulty but felt like was having breathing difficulty, very anxious; lasted aprox 8 hrs; doesn't feel 100%;
On day 5 after the shot, that evening got chills, headache, diarreah.  On day7 injections site became more tender than it had been, the injection site became red and the redness grew.  injection site somewhat swollen, hard and hot to the touch
Felt like something was in her eye / annoying feeling; Ophthalmologist diagnosed her with a conjunctival cyst/Pink bump in the corner of her eye / It might be a little less red/bubble in the eye; not as irritating as it was on Saturday; This case was reported by a consumer via call center representative and described the occurrence of eye discomfort in a 76-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number Z59N7, expiry date 8th October 2022) for prophylaxis.   Concurrent medical conditions included glaucoma, drug allergy and latex allergy (for years (affecting different parts of her body such as her ear and her elbow, example like after receiving dental work)).   On 5th November 2020, the patient received Boostrix (intramuscular) .5 ml. On 7th November 2020, 2 days after receiving Boostrix, the patient experienced eye discomfort, conjunctival cyst and eye irritation. On an unknown date, the outcome of the eye discomfort and eye irritation were unknown and the outcome of the conjunctival cyst was not recovered/not resolved.   It was unknown if the reporter considered the eye discomfort, conjunctival cyst and eye irritation to be related to Boostrix.  Additional details were reported as follows: The patient herself reported the case. The age at vaccination was no reported. The patient received the Boostrix 0.5 milliliter intramuscularly in the right deltoid at pharmacy. On 7th November 2020 at afternoon, the patient felt like something was in her eye. The patient said it was not painful but it just was an annoying feeling as if there was an object in her eye(especially when she blinked). The patient lifted her lid and saw that there was a pink bump in the corner of her eye. The patient sent a picture to her ophthalmologist who diagnosed her with a conjunctival cyst. The physician instructed the patient to treat it with artificial tears. The patient said that about 36 hours later she stopped feeling the sensation that something was in her eye. On 11th november 2020 the cyst was about the same size. It might be a little less red. The patient was wondering if her conjuctival cyst could be a result of the Boostrix. he patient mentioned that the tip caps contain latex and she has been allergic to latex. On 13th November 2020, the patient reported that there was still a big bubble in her eye but it was not as irritating as it was on 7th November 2020. The reporter consented to follow up.
administered expired Daptacel to patient; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2019SA150840, 2019SA150850, 2019SA150851, 2019SA150852 and 2019SA150853 (same reporter).   This case involves a 24 months old female patient who was vaccinated with a 0.5 ml dose 4 of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C52028A and Exp. Date 17-May-2019) via unknown route in the right arm on 18-May-2019.  The patient's medical history not reported and concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB),  HEPATITIS A VACCINE (HEPATITIS A) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation  It was an actual medication error case due to expired vaccine used.  It was unknown whether the patient experienced any adverse event post vaccination.  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.  Outcome of the event was reported as unknown.  List of documents held by sender: none.
Developed fevers to 107 deg R per ER exam 10/6/02 vomited 2 times. ER evaluation, tests, antibiotic IV po for diagnosis of rule out UTI. Urine culture negative.
A nurse reported that a 33-year-old female did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. The pt's medical history, concurrent conditions and concurrent medications were unknown. The pt received injections of Engerix-B on 08/04/1998 (lot # not provided), 03/25/2002 (lot ENG5257A4) and 05/20/2002 (lot ENG5257A4). The vaccine was not administered according to the recommended schedule of 0, 1, and 6 months. Six months after the 3rd injection of Engerix-B, on 11/20/2002, an unspecified titer was "less than 2". In December 2002, the pt received her 4th injection of Engerix-B. Comment: The reporter indicated that 4 additional subjects did not achieve protective antibody titers following immunization with Engerix-B. Please see reports A0400568A, A0400569A, A0400570A, and A0400571A.
pt recvd vax 530PM & approx 1 hrs later started abdo cramps, heaviness in chest & difficulty breathing; h/a started & then coughing; 1:05 AM less cramping but has numbness in rt hand & heaviness in chest & difficulty breathing;
Swelling to left side of face after waking from nap which I was laying on my left side, and received my injection to my left arm. Lasting 3.5 days.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Specifics regarding the patient's cause of death are not documented in chart. When contacted to schedule 2nd COVID-19 dose, wife reported on 3/11/21 patient was hospitalized on a ventilator and passed away that day. Comorbidities included T2DM, HTN, HLD, spondylosis, obesity, 50 year smoker
11:40- pt asked if her hands and face should be itching 11:41- gave Benadryl 50 mg PO and checked O2 she was at 96% on room air  11:45-  pt started saying her throat felt tight O2 92% face was red and could see signs of distress so she was given an EpiPen, ambulance was called  11:50- did vitals BP 140/78, HR 103, O2 93% pt stated she felt like she was going to pass out and it was still hard to breath 11:55-  pt still struggling to breath O2 92% voice muffled, face visible red, signs of distress 2nd EpiPen given  12:03- ambulance arrived  pt never lost consciousness
This case was reported by a pharmacist via call center representative and described the occurrence of varicella-like rash in a 97-year-old female patient who received SHINGRIX (batch number C7B9P, expiry date 27th February 2021) for prophylaxis. On 27th August 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced varicella-like rash and pruritus. On an unknown date, the outcome of the varicella-like rash and pruritus were unknown. It was unknown if the reporter considered the varicella-like rash and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right deltoid (time of shot was not specified). The patient developed an itchy chicken pox type rash which had been there for 2 months on and off. The reporter asked in what part of the body itchy chicken pox type rash was developed and she stated that she did not know. The reporter consented to follow up.
Irregular Vaginal bleeding; Nausea; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ENG206; Expiration date were not reported), via unspecified route of administration in the left arm on 10Mar2021 03:15 PM (at the age of 50-years-old) as second dose, single dose for COVID-19 immunisation at a School or Student Health Clinic. Medical history included asthma and thyroid from an unknown date and unknown if ongoing. The patient was taking other medications in two weeks. The patient previously took Vitamin B12 (reported as B12) and experienced drug allergy. The patient was previously vaccinated with BNT162B2 (Batch/Lot Number: ENG201) in the left arm on 09Feb2021 03:15 PM as first dose, single dose for COVID-19 immunisation. Patient was also previously vaccinated with Tetanus vaccine in the left arm on 20Jan2021 as first dose for tetanus immunization and experienced Shingles. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. On 10Mar2021, the patient experienced irregular vaginal bleeding and nausea. No treatment was given as a result of the events. The outcome of the event was not recovered  No follow-up attempts are possible. No further information is expected.
I had no trouble after receiving the vaccine. I had a stuffy nose and a sore throat for a couple days before testing for COVID-19. I tested positive for COVID-19 on 12/21/2022. I contacted my doctor, and they didn't provide a prescription but recommended taking over the counter medication. I later developed an ear infection.
Three days after vaccine was feeling short of breath, bounding increased heart rate, and frequent palpitations {PVCs).  Four days later these symptoms persisted, but started having chest discomfort and bilateral lower leg and feet numbness, tingling, and needle like pain.  Eight days later as the aforementioned symptoms persisted , had to visit a hospital ER for chest pain.  Was placed on Metoprolol to control heart rate and rhythm.  Now three weeks post 2nd COVID19 vaccine and symptoms persist, but somewhat controled with Metoprolol.  No history of these problems pre-vaccine.
Redness, swelling, crying continously; 26JUN91 clinic w/fever 102F given APAP & normal exam noted; 28JUN91 same care given temp now 99F normal exam noted;
Herpes outbreak 72 hours after second dose; This is a spontaneous report from a contactable consumer or other non hcp (patient reporting for herself). A 46-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in arm right on 16Jul2021 at 16:00 as dose 2, single dose for covid-19 immunization (at the age of 46-years-old). Medical history included ovarian cyst and fibroids from an unknown date and unknown if ongoing and patient had known allergies of gluten, MSG (monosodium glutamate) and quinoa. Concomitant medication(s) included clonazepam (KLONOPIN) taken for an unspecified indication and start and stop date were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19. Since the vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Doctor's office/urgent care. It was reported that the patient experienced herpes outbreak 72 hours after second dose of vaccine on 19Jul2021 at 17:00. The adverse event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received the treatment for the event. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Rash, chest pains, tachycardia , high blood pressure, arm pain, cognitive difficulties.
had a rash that had broken out especially on his scalp, shoulder, back and it itched; had a rash that had broken out especially on his scalp, shoulder, back and it itched; This is a spontaneous report received from a contactable consumer (patient). An 83-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (lot number: ER2613, NDC number: 59267100002) at 10:30 at single dose for COVID-19 immunization. The relevant medical history included thyroid gland not working. Concomitant medications included ongoing levothyroxine for thyroid gland not working. The patient previously received first dose of BNT162B2 on 18Mar2021 at the age of 83 years old for COVID-19 immunization. The patient had a rash that had broken out especially on his scalp, shoulder, back and it itched on 11Apr2021. The patient received treatment included Eucerin cream, used for relief, just put it on, it's a cream, it had ingredient like "Piroctone Olamine" (not clarified) for protection. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a 67-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020). On 21st May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 24th May 2018, 3 days after receiving SHINGRIX, the patient experienced local swelling and erythema of extremities. On an unknown date, the outcome of the local swelling and erythema of extremities were not recovered/not resolved. The reporter considered the local swelling and erythema to be possibly related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that, she had a patient that had SHINGRIX on Monday, 21st May 2018 (discrepant information was reported for the vaccination date which was corrected from 21st May 2008 to 21st May 2018). The patient came the day before the date of reporting to the pharmacy with red lumps on her arm where she received the injection. The red lumps were no tiny bumps, they were actual lumps. They were midway down the arm, not exactly at the injection site. There were about 3 to 4 lumps. The lumps were not itchy. The pharmacist did not want to provide name of medication. She said the patient had been on the same medication for a while. Clarification had been raised for the confirmation of the reporter's qualification (consumer or pharmacist).
Big round circle around the injection site. It was puffed up; Big round circle around the injection site. It was puffed up and red; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number Z5N5G, expiry date 30th June 2021) for prophylaxis.   On 17th September 2020, the patient received Fluarix Quadrivalent 2020-2021 season. In September 2020, less than a week after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were as follows: The age at vaccination was not reported. The patient received Fluarix Quadrivalent 2020-2021 season in her left arm and experienced big round circle around the injection site and it was puffed up and red. The reaction lasted for 1 day. This case has been linked with US2020189720 and US2020189735 reported by the same reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020189720:same reporter US-GLAXOSMITHKLINE-US2020189735:same reporter
About 9:30 pm the evening of the Moderna booster  ( about 10 hours after the booster) I got chills, mild headache, very sore arm at injection site and my heart started pounding.  My headache and chills subsided about 2:30 am but my heart pounding did not slow down until about 5:30 am the next morning.  My heart pounding, mild chest tightness and discomfort has continued off and on since.  I have never experienced this before my booster.  Heart pounding can last about 45 min to 1 hour and it wakes me up at night. Just started propanolol
Mother reports swelling and patient reports pain at injection site- no fever, no drainage from injection site.
Patient received expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The pharmacist thought that vaccine will expired on Jun-2022, however vaccine was expired on 01-Apr-2022.  The frequency was reported as times per. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow-up document received on 29-Apr-2022 included no new information.
Rash on arms that spread to whole body Itching on arms, chest, waist, legs & MS symptoms over 1.5 weeks. Received PREDNISONE and antihistamines.
Patient started with right sided lower facial nerve palsy (bells palsy), eye twitching, elevated BP.
I received my Covid -19 vaccine on 10/10/2022. On 1/06/2023 I suffered a heart attack.  Prior to my heart attack I have not been feeling well for about a month. I've been having feelings of being tired achy and elevated blood pressure.  I got a sharp pain in left arm and extreme pain in my back in the middle of my shoulder blade. On 1/6/2023 after the heart attack I went to the emergency room. Blood test was done and showed elevated heart enzyme. I was admitted into the hospital for two days and prescribed Heprin. I had a procedure done called Left heart catheterization which had no findings. I was discharged on 01/09/2023. and was prescribed Clopidogrel and enteric aspirin.