chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # K020802, exp. date: 31-JAN-2016, subcutaneous, dose, strength, site of administration not reported). On an unknown date the patient experienced knot, forming at the injection site, immediately, after receiving ZOSTAVAX. The knot was described further as a harder nodule, than normal, which lasted a day or two, and resolved in two or three days (date of recovery not reported). The relatedness between knot and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Fever, chills, dizzy, headache  Fever over 101. Symptoms lasted just over 24 hours. Treatment: rest, ibuprofen, cold compress  Same symptoms occurred  after 1st shot as well.
12 minutes after injection patient  got warm, vision blurred, then nausea.  Pt was laid down with cool wash cloth + given juice.  Pt was slowly sat up at different levels until sitting straight over a 10 minute time frame.  Pt warm 15 more minutes then left with self. since she had no more side effects.
On April 13th I developed a rash on my forehead that itched and hurt terribly and got progressively worse.  Sharp shock like pains in my head/brain which lasted for 5 days before subsiding, then the rash  scabbed on my forehead and right eye.  Still itches and as of 4/27 still scabbed.   It has been diagnosed by my clinic as Shingles and I was prescribed Steroids, (which I?m no taking as pain has subsided)
PATIENT RECEIVED PFIZER COVID VACCINE AND WENT TO WAITING AREA. PATIENT COMPLAINED THAT HE FELT FAINT. PATIENT DIAPHORETIC AND SHAKING. CLOSED EYES. APPEARED TO LOSE CONSCIOUSNESS FOR ABOU A MINUTE. GAVE PATIENT COLD WATER. PATIENT REVIVED QUICKLY. MOVED HIM FROM CHAIR TO WAITING AREA TO LAY FLAT. HE WANTED TO RISE TO HIS FEET WITHIN MINUTES.  PATIENT'S MOTHER IS PHYSICIAN AND WAS ON PHONE WITH FATHER ACCOMPANYING HIM.
This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age. Pharmacist reported that unspecified patients frequently experience a small rash at the injection site after vaccination with ZOSTAVAX. The rash only lasts about 48 hours before resolving. No specific patients were mentioned. Additional information is not expected.
Initial report received from a health care professional on 09 January 2014. A 4-month-old female patient, whose medical history and concomitant medications were not reported., received first dose of PENTACEL (lot number: C4555AB, intramuscular in the left thigh) on 7 January 2014 the patient had also received PREVNAR (manufacturer not reported, dose number, route and site of vaccination and dose number was not reported) on an unspecified date.  IT was reported that the patient had experienced injection site tenderness, redness and swelling about a size of a silver dollar. Illness at the time of vaccination and pre-existing physician diagnosed allergies and birth defect was unknown. Laboratory details and corrective treatment was not reported. At the time of this report the patient was not recovered from adverse event. Documents held by sender: none
rash was bigger, swollen, itchy, and extremely painful; Extreme fatigue and a lot of pain on the arm where the vaccine was given; Extreme fatigue and a lot of pain on the arm where the vaccine was given; itching, hot, small rash in the area of where the vaccine was given; itching, hot, small rash in the area of where the vaccine was given; itching, hot, small rash in the area of where the vaccine was given; This is a spontaneous report received from a contactable consumer or other non hcp. A 32-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 09:00 as single dose for COVID-19 immunization. Medical history included asthma and allergies (Penicillin), COVID-19, drug hypersensitivity, hypersensitivity and thyroid disorder (had thyroid issues about 7 years ago but that was resolved and have not had problems with thyroid for years now) from an unknown date and unknown if ongoing. Probiotics were given on every other day. The patient had COVID-19 prior vaccination. On 11Mar2021 patient experienced extreme fatigue and a lot of pain on the arm where the vaccine was given (fatigue and vaccination site pain), itching, hot, small rash in the area of where the vaccine was given (injection site pruritus, vaccination site warmth and vaccination site rash). On 12Mar2021 rash was bigger, swollen, itchy, and extremely painful. The patient visited Urgent case. Treatment was given with Steroid shot, antibiotics and an ointment. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
PATIENT FELT LIGHTHEADED AFTER RECEIVING THE VACCINE, CHILS, EXPERIENCE DIFFICULTY BREATHING. BECAUSE OF THIS. 911 WAS CALLED, AND ONE SHOT OF EPIPEN 0.3 WAS ADMINISTERED TO THE PATIENT. WHEN EMS CAME IN SHE WAS ASKED SEVERAL QUESTIONS AND WAS TAKEN TO A NEARBY HOSPITAL FOR FURTHER OBSERVATION.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 14-JUL-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J007954 and expiry date: 27-JUN-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Hospitalized 4/25/22-4/29/22 child birth via c-section after failure to descend, covid +,  primigravida,  birth weight 2.97kg EGA 38w3d, pt weight 99kg
Redness, swelling and hot to the touch. Redness about 2" in diamiter from shot. Patient's mother informed us on 11/5/10 that the patient is doing just fine.
she didn't feel well; woke up with aches and pains; she is also a little tired; she began having a headache; This is a spontaneous report from a contactable consumer and via Regulatory Authority. This 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Feb2021 (at the age of 73-year-old) at dose 2, single for COVID-19 vaccination. Medical history included migraines. Concomitant medication was not reported. It was reported that she received her second dose of the covid vaccine yesterday. She was experiencing a headache this morning (12Feb2021) and took 15 mg of Ibuprofen. The consumer said that she is generally healthy adult on no medications other than for occasional migraines. She says she walk 4-5 miles every day but did not today because she didn't feel well. She says she got her second dose of the COVID-19 vaccine yesterday on the 11th and today (12Feb2021), she woke up with aches and pains. She is a migraine person, and her doctor told her she could take Advil and Imitrex after it, which she has only took Advil, but she wanted to hear from the company that she could take Imitrex. She clarifies that she took two Ibuprofen at 06:00 AM today for her aches and pains which worked great, but she still has a headache and she is worried about it escalating into a migraine. She says that she is also a little tired. Caller says after her first dose of the vaccine she had no reaction whatsoever. The therapeutic measures were taken in response to the events aches and pains and headache. Outcome of the event headache was not recovered and for other events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information is expected.
I am 20 weeks, 4 days. I am due may 20th, 2021. I got the vaccine at work and felt fine. I was getting in my pajamas for the night and my husband noticed a weird rash on my body. It did not itch or hurt. I took a shower and a Tylenol and went to bed. I woke up at 5am the next morning and it was completely gone.
Lymph node swelling in left armpit, fatigue,  injection site pain, redness and swelling
patient was given the liquid part of Pentacel and not the powder part, no AE; Upon Internal review a signification amendment was performed on 04-Jun-2021, to change the product code of Pentacel from 242 to 520  Initial information was received on 20-Oct-2020 regarding an unsolicited valid non-serious case from other health professional in the United States.  This case involves a 10 months and 2 weeks old female patient who was given 0.5 ml liquid part of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Batch number: UJ349AAA and expiration date: 22-Jun-2021, DTAP-IPV- Lot: U6841AA, expiry date: 22-Jun-2021, and ActHib- Lot: UJ349AA, expiry: 22-Jun-2021) and not the powder part via intramuscular route in the left thigh for prophylactic vaccination on an unspecified date (PT: product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique (same day latency).  No adverse event reported at the time of reporting.  The medical assistance (MA) stated the nurse gave the liquid part of Pentacel with the blue top and not the powder part with the green top, the ActHib. The Caller was asking what to do if they only gave the liquid part of Pentacel and not the powder. Can they mix it with anything other than 0.4% NaCl (sodium chloride), what about water or they have 0.7% NaCl, where do they get the 0.4% NaCl. Can Sanofi supply it and how much 0.4% NaCl will they have to use. The caller was told that since the liquid part was 0.5ml they will have to use that much to reconstitute the powder.  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.
Breakthrough covid December 24.  Fever, aches, chills, cough, congestion.  Took Paxlovid as soon as I tested positive , had no fever on Day 3, but then fever and other symptoms returned Day 9.  Day 11 no fever and feeling better, but still testing positive.
lmost passed out, almost blackout; woke up and broke out in sweats all over her body; restless was tossing and turning; symptoms hit her like a ton of bricks; threw up could not keep any food or water down; headache (throbbed with every heartbeat); Nausea; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (lmost passed out, almost blackout) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (lmost passed out, almost blackout) (seriousness criterion medically significant), HYPERHIDROSIS (woke up and broke out in sweats all over her body), RESTLESSNESS (restless was tossing and turning), FEELING ABNORMAL (symptoms hit her like a ton of bricks), VOMITING (threw up could not keep any food or water down), HEADACHE (headache (throbbed with every heartbeat)) and NAUSEA (Nausea). On 26-Mar-2021, LOSS OF CONSCIOUSNESS (lmost passed out, almost blackout), HYPERHIDROSIS (woke up and broke out in sweats all over her body), RESTLESSNESS (restless was tossing and turning), FEELING ABNORMAL (symptoms hit her like a ton of bricks), VOMITING (threw up could not keep any food or water down), HEADACHE (headache (throbbed with every heartbeat)) and NAUSEA (Nausea) had resolved.            No concomitant medications were provided No treatment medications were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-071431 (E2B Linked Report).; Sender's Comments: This case concerns a female adult with a serious unexpected event of loss of consciousness, and nonserious unexpected feeling abnormal, hyperhidrosis, restlessness, and expected nausea, vomiting, headache. Based on 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. MODERNATX, INC.-MOD-2021-071431:Crosslinked case
Developed itching, swelling, redness on left forearm after receiving varicella and hepatitis B vaccine.
presented to the emergency department complaints of shortness of breath.  Patient reports that she was her usual state of health until approximately 1 week ago when she started noticing increased shortness of breath.  Patient reports that ever since then, her symptoms have continued to worsen.  Patient has had multiple episodes of fevers and chills.  Reports that she has had loose stools as well.  Her appetite has been very poor and her oral intake has been minimal over the past 2-3 days.  Patient reports that typically, she is able to get around and do her day-to-day activities however, has been unable to even go to the bathroom and back without significant shortness of breath.  Was found to have acute hypoxem respiratory failure, secondary to sepsis in the setting of COVID-19 pneumonia.  Chest x-ray negative for any acute findings. Lab work consistent with leukocytosis 12.3, lactic acidosis 6.4, erythrocytosis 18.6, hypochloremia 97, hyperglycemia 117, uremia 47, acute renal failure, and hypoalbuminemia 3.4.  Initial troponin 49 and BNP 6200.  EKG independently reviewed and negative for any acute ST elevations or depressions.  T-wave inversions noted in V6.  Patient hospitalized for COVID-19 treatment.  Discharged 1/27/2022.    Pfizer 9/15/21 & 10/16/21
Patient received a third HPV vaccine after already completing 2-dose series. Third dose was not needed.
Coughing; Sore throat; This case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   In September 2022, the patient received Flu vaccine. On an unknown date, less than a week after receiving Flu vaccine, the patient experienced cough and sore throat. On an unknown date, the outcome of the cough and sore throat were not recovered/not resolved.   It was unknown if the reporter considered the cough and sore throat to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she was agree with he/she was not paying 95.00 dollars. The patient told his/her doctor if he/she got it doctor brings it up everytime he/she go plus the pneumonia shot. The patient received flu shot about a week ago and he/she was been coughing 3 days after sore throat. The patient stated that it was hard to trust these shots anymore. Follow-up would not possible as no contact details were available.
Kinrix adminstered to a 9YO; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th November 2022, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 14th November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Dec-2022 Reporter's comment: The reporter consented to follow-up via email. The case is for 1 of 2 linked patients reported by same reporter. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2022185121:Same reporter
accidentally vaccinated with Fluzone Quadrivalent vaccine that expired on 30-Jun-2019 with no AE; Initial and live follow-up (on the same date) information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA293059.  This case involves a 35 years old male patient who received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE prefilled syringe (lot UJ049AB, expiry date: 30-Jun-2019) via intramuscular route in the right arm on 18-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used. It was reported that the nurse accidentally vaccinated a male patient with Fluzone Quadrivalent vaccine that expired on 30-Jun-2019.  At the time of reporting, the 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.
Patient got ZOSTAVAX vaccination. Had injection site reaction. The area around injection was red, swollen, and painful.
experiencing gastrointestinal issues; 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 female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "experiencing gastrointestinal issues".  Additional Information: I had the covid shots thru this manufacturer and so did my husband in Apr2020. We both started experiencing gastrointestinal issues and at times severe issues. Never had these issues prior. Could. this be an alternate side effect of covid shots and booster shots.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
fever; chills; This case was reported by a other health professional via sales rep and described the occurrence of fever in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were reported as follows: The reporter was a physician assistant. The age at vaccination was not applicable as this report. The patients had experienced fever and chills following a dose of Shingrix. The reporter did not consent to follow up.
24 Hours after receiving the vaccine my arm was sore from my bicep all the way up to my lower neck.  I noticed two bumps near my clavicle, as well that area is swollen.
No adverse event; Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose) 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.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .3 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose).    No concomitant medications were reported. It was reported that administrations occurred over the course of approximately 1 month. Patient had no reported symptoms, no additional doses or treatments.  This case was for the 1st patient out of 5 adult patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-682550, US-MODERNATX, INC.-MOD-2022-682547, US-MODERNATX, INC.-MOD-2022-682548, US-MODERNATX, INC.-MOD-2022-682546 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682550:same reporter US-MODERNATX, INC.-MOD-2022-682547:same reporter US-MODERNATX, INC.-MOD-2022-682548:same reporter US-MODERNATX, INC.-MOD-2022-682546:same reporter
Per history pt received Moderna vaccine on 1/7/21 at an outside vaccination facility (lot # 025L20A). However when pt presented at our urgent care, she reports " receiving  Moderna  dose on  01/11/2021. Denies any symptoms 3 days after receiving vaccination.  Started with persistent headache on 01/19/2021.  Also reports chills and lightheadedness. Not better with Ibuprofen at home. patient was given ketorolac 30mg x1 during visit but provided no adequate relief. Patient advised to go to ED for additional work-up. Patient verbalized understanding. Patient offered assistance to call ambulance but she refused and would go to ED by herself. She states she was not dizzy at the time and stated she was stable to drive herself to ED.