chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On October 1st, 2020 I received the flu shot at my work and I was currently 27 weeks pregnant. A couple hours later, I started to not feel so well but I tried to keep something on my stomach and kept working at the office for the rest of the day. That night I took a bath, and tried getting a video of my baby moving in my belly. That was 7:15 pm that night, and that was the last time I felt my baby move. I went to my doctor's appointment 5 days later after realizing I hadn't felt her move in that long, and she had past. I had to be induced that night and my daughter was delivered the next morning at about 10:00 am on October 7th, 2020. She weighed 2 lbs 1 oz.
Symptoms: Severe chest pain, shortness of breath Emergency Room screening, CT Scan, chest x-rays and blood work.  Findings: Pulmonary embolism in the right middle lung.   Treatment: Hospitalization,  24 hour heparin drip for 3 days
some of the medication came out the bottom side of the syringe, no AE; Product came out the bottom side of syringe, leaking during administration, no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 76 years old female patient who experienced some of the medication came out the bottom side of the syringe, no ae and product came out the bottom side of syringe, leaking during administration, no ae, while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ268AA, Exp. 5/10/2020 via intramuscular route in the left arm.  It was a case of actual medication error due to vaccine underdose. It was also a case of syringe leak.  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error  List of documents held by the sender: none
inflammation at the injection site; achiness all over; This case was reported by a consumer via call center representative and described the occurrence of injection site inflammation in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number UNK, expiry date unknown) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site inflammation and general body pain. On an unknown date, the outcome of the injection site inflammation and general body pain were recovered/resolved.   It was unknown if the reporter considered the injection site inflammation and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced achiness all over and inflammation at the injection site. The reporter consented to follow up. This case has been linked with case US2020AMR239268, reported by same reporter for same patient.
Right after the injection, my left arm was hot to the touch, sore at injection site, no discoloration except redness, low grade fever and chills in the evening.   These symptoms got progressively worse and my arm became swollen and hard.   When I turn over at night in my sleep, the pain was so extreme, I would wake up.  My "covid arm" symptoms lasted about 10-14 days and slowly went away.   I did take Tylenol for the pain. I had an annual  appointment scheduled with my doctor so I got him to look at my arm.  He was not concern about it.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-OCT-2016, the patient was inoculated with ZOSTAVAX by a physician as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On an unknown date in 2016, the patient was treated by a health care provider for shingles. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. Outcome of the events was unknown. Causality assessment was related.
I had extreme fatigue and weakness after receiving the vaccine. I was exposed to COVID-19 on 12/23/2022 at a holiday party. I tested positive for COVID-19 on 12/29/2022. I was sick for five weeks and just no energy to do anything. I got up to go to the bathroom and fell down. I managed to get myself up and I crawled to bed.  I also have a really bad cough and at one point I popped a rib. I contacted my doctor, and I got a prescription for Tessalon to help control my cough. I am feeling better, but I still have a cough, fatigue and low energy.
Chills, nausea,  headache, muscle aches. fever took 2 Tylenol fever dropped went to bed all morning
This case was reported by a nurse and described the occurrence of an injection site reaction in a 50 year old male patient who received Hepatitis A vaccine inactivated (Havrix).  The patient's medical history was notable for allergy to Ceftin.  On 01/16/2003, the patient received the first dose of Havrix.  On 12/07/2004, the patient received the second dose of Havrix in the left deltoid.  The recommended interval between the 2 doses of Havrix is 6 to 12 months.  On the same day, the patient received a dose of Hepatitis B vaccine recombinant (Engerix-B) in the right deltoid.  At an unspecified time later the same day, the patient experienced a local injection site reaction manifested by deep muscle pain in the upper left deltoid.  The patient was seen at a physician's office.  The nurse stated that, this patient complains that the pain in the left arm inhibits his ability to sleep on his arm and it also prevents him from using his arm to its fullest potential.  The event was ongoing as of 01/26/2005.  The nurse considered the event to be related to vaccinations with Havrix.
Recurrent hives. Started 04/26/05- seen in office for hives 04/28/05. RX for Claritin and predinisone taper.
Got sick even after vaccine/at the end of the day I still got sick; Got sick even after vaccine/at the end of the day I still got sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Got sick even after vaccine/at the end of the day I still got sick". Clinical course: Reporter's only only thoughts were that she should have never gotten the vaccine at all because at the end of the day she still got sick. The reporter considered that event was caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities was not recovered/not resolved and the outcome of the swelling arm was recovered/resolved. It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The pharmacist reported that a patient received SHINGRIX at their pharmacy either in August or September 2018 and she experienced severe redness and swelling within a day or two of the first dose. The severe redness subsided, however, the patient returned the day of reporting to get the second dose and she still has a red bulls eye mark on her left arm. The pharmacist refused to provide the patient's date of birth. The reporter consented to follow up.
This case was reported by a pharmacist and described the occurrence of radiating pain in arm in a 32-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 24 October 2013 the subject received a dose of FLUARIX Quadrivalent (.5 ml, unknown). On 26 October 2013, 2 days after vaccination with FLUARIX Quadrivalent, the subject experienced pain radiating down the back of the arm (triceps) to rib cage and deltoid tenderness. The pharmacist reported there was no redness, but the subject experienced pain radiating down the back of the arm (triceps) to rib cage and tenderness in the deltoid. It was noted that the subject consulted a healthcare professional. The pharmacist considered the events were disabling. At the time of reporting the radiating pain in arm and deltoid tenderness were unresolved.
Marked redness/swelling R upper arm - developed 1 day after IZ's.
patient received moderna after a single J&J dose. Patient received 0.5 ml instead of 0.25
Essential hypertension. Procedures:  1. Robotic sleeve gastrectomy with hiatal hernia repair 2. Laparoscopic wedge liver biopsy Hospital admission for surgery within 6 weeks of receiving COVID vaccine.
FEVER; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 03:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Dose number: 3; Fever; Nausea; This is a spontaneous report received from a non-contactable reporter (Pharmacist).   A 46-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 46 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation and Covid19 vaccine (DOSE 2, MANUFACTURER UNKNOWN, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation.   The following information was reported: IMMUNISATION (non-serious) with onset 12Jan2022, outcome "unknown", described as "Dose number: 3"; PYREXIA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Nausea".   No follow-up attempts are possible. No further information is expected.
2 days after the vaccine, I became very, very sore on all parts of body. My back seemed to feel it the most. I could not get comfortable in any position. This was to the point of crying because SO bad. I slept for about 36 hours without taking anything. I developed a bad cough the next day with a fever. My chest hurt. Horrible headache for about 27-28 hours. Aspirin did not help. Neck sore and injection site very sore although no marks show up.
This case was reported by a nurse and described the occurrence of heart palpitations in an adult female pt who received hep B vaccine (unk manf). On an unspecified date, the pt received the first dose of hep B vaccine. At an unspecified time following the administration of hep B vaccine, the pt experienced heart palpitations and dizziness. The immunization series with hep b vaccine was discontinued. The outcome of the events is unk.
Muscle weakness in both legs; Numbness in both feet; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness lower limb in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced muscle weakness lower limb and numbness in feet. On an unknown date, the outcome of the muscle weakness lower limb and numbness in feet were not recovered/not resolved.   It was unknown if the reporter considered the muscle weakness lower limb and numbness in feet to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received Shingrix vaccine 2 or 3 months ago. The reporter stated that after received Shingrix vaccine the patient experienced muscle weakness in both legs and numbness in both feet.  The reporter stated that it had been progressively getting worse for the past 2 to 3 months and had not resolved. The reporter did consent to follow up.
Severe nerve/arm pain, couldn't lift arm, uncomfortable at all times, and pain worsened in supine position. This continued at the severe level for approximately a couple months, then started to subside slowly month by month. Could not work for 3 months. Took a full year to return to mostly normal. Tried high dose prednisone for 5 days, but pain resumed immediately after course.
Having symptoms of COVID-19; Heavy chest breathing; sore throat; cough; runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Having symptoms of COVID-19), CHEST DISCOMFORT (Heavy chest breathing), OROPHARYNGEAL PAIN (sore throat), COUGH (cough) and RHINORRHOEA (runny nose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Having symptoms of COVID-19), CHEST DISCOMFORT (Heavy chest breathing), OROPHARYNGEAL PAIN (sore throat), COUGH (cough) and RHINORRHOEA (runny nose). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, COVID-19 (Having symptoms of COVID-19), CHEST DISCOMFORT (Heavy chest breathing), OROPHARYNGEAL PAIN (sore throat), COUGH (cough) and RHINORRHOEA (runny nose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
First day following vaccine, very tired. some blurred vision the next few days. on fourth day following vaccination,   blurred vision, unstable walking felt like having Vertigo. Today the 16th, all adverse symptoms are gone
Raised and red rash at vaccine insertion site. Irregular border and shape, the area is itchy.
PHN administered Typhoid Vi without incident. PHN then administered TDaP and within 3 seconds patient stated "oh that hurt, wait a minute..." then became unconscious, pale and unresponsive for approximately 30 seconds. No respirations for approximately 15 seconds. PHN called for assistance and pt. was placed in supine position on the floor. He then became responsive and was oriented x3 but remained very pale and lethargic. EMS was notified and pt was transferred to local ER for evaluation.
I woke up after laying on the arm that was vaccinated, because of the pain in the upper arm and shoulder. Took 2 ibuprofen and went back to bed.
This is a spontaneous report from a contactable consumer, the patient. A 55-years-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route in left arm on Mar2021 at 09:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient was not tested for COVID-19. Concomitant medication included levothyroxine sodium (MANUFACTURER UNKNOWN) 137 mg for unknown indication. On 18Mar2021 at 10:00, the patient experienced arm soar, headache, slight fever, tired and sleepy. Therapeutic measures taken for these events included treatment with Tylenol and sleep. The clinical outcome of the events arm soar, headache, slight fever, tired and sleepy were resolved on unspecified date in Mar2021.   Information about lot/batch number cannot be obtained. No further information is expected.
Pt received first dose of Pfizer and then received second dose of Moderna. Pt walked in and identity was confirmed. Pt stated she is here for her second dose and was given Moderna. Pt was immediately sent to supervisor for observation and escalation. Pt currently being observed and denies any adverse reactions.
Pediatrician ordered KINRIX, PEDIARIX was removed from the vaccine refrigerator and confirmed with the provider. Vaccine was administered. Upon inputting lot in the system I came to notice this was the wrong vaccine ordered. Provider reviewed CDC website and the vaccine does not need to be repeated. Provider cancelled KINRIX order and then ordered the PEDIARIX that was given.
A little over 12 hrs after dose, I noticed how my whole upper left arm was extremely sore starting at the injection site. By 15 hrs after dose, I felt extremely fatigued. All I could think about was sleep. My eyes would not stay open. This was accompanied by a low grade fever.  The fatigue & fever have subsided 40 hours after dose, the soreness around the injection site is still noticeable 40 hrs after dose, but has diminished by about 40% from when it peaked at around 25 hours after dose.
Pt had 4 year vaccine shots, Dtap, IPV, MMR, Varicella. The day after vaccines, patient had fever from 103.5 to 104.7 rectal.
redness; itchiness; Arm on fire; Very weak; Arm turning purple; Unable to do anything; Fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), PRURITUS (itchiness), INJECTION SITE WARMTH (Arm on fire), ASTHENIA (Very weak) and INJECTION SITE DISCOLOURATION (Arm turning purple) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced ERYTHEMA (redness), PRURITUS (itchiness), INJECTION SITE WARMTH (Arm on fire), ASTHENIA (Very weak), INJECTION SITE DISCOLOURATION (Arm turning purple), IMPAIRED WORK ABILITY (Unable to do anything), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). On 10-Mar-2021, ERYTHEMA (redness), PRURITUS (itchiness), INJECTION SITE WARMTH (Arm on fire), ASTHENIA (Very weak), INJECTION SITE DISCOLOURATION (Arm turning purple), IMPAIRED WORK ABILITY (Unable to do anything), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication not provided.  Treatment information not provided.   This case was linked to MOD-2021-047977 (Patient Link).
On 7/27/10 pt was given Hepatitis A I.M. Lt. Deltoid. 7/29/10 mom took pt to Medical Center - Emergency Room with c/o swelling, redness & pain at injection site. Also c/o n/v dysuria - rash.
Starting 11/26/2022, I had body aches, a headache, a temperature and was feeling sick. I took an at home COVID-19 test which was negative. My fever went up to 102.3 and I felt general malaise. The next day, my husband took me to the urgent care, and they did the flu test and I was positive for influenza A. They gave me a prescription for TAMIFLU but I couldn't pick it up until the next day. I started TAMIFLU the next day (11/28/2022). I was nauseous by that time and had a mild dry cough and started vomiting after starting TAMIFLU. I had no appetite and didn't eat for 3 days. I felt extreme illness. After 2-3 days of stopping TAMIFLU, I developed diarrhea and then had a runny nose until about 12/6. Starting around 12/1/2022, I developed a wet mucous cough that lingered until I started feeling better. By 12/7/2022, I started feeling better.
Felt so lousy with headache; Felt so lousy with headache; Every muscle is sore; A lot of chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt so lousy with headache), HEADACHE (Felt so lousy with headache), MYALGIA (Every muscle is sore) and CHILLS (A lot of chills) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt so lousy with headache), HEADACHE (Felt so lousy with headache), MYALGIA (Every muscle is sore) and CHILLS (A lot of chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Felt so lousy with headache), HEADACHE (Felt so lousy with headache), MYALGIA (Every muscle is sore) and CHILLS (A lot of chills) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-417593 (Patient Link).
I spend a miserable day yesterday with soreness, and feeling sick. Today I woke up and my chest is covered in a red rash.