chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administration of expired moderna vaccine that were given as booster shot to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the vaccines were stored in freeze and taken out one to two vials and placed in fridge each day as needed.  No treatment information was provided.
No adverse event to report Pt was administered a booster dose as draw #21 out of a Moderna MDV14 vial which should have been discarded after drawing #20 doses.
painful reaction in knees; muscle cramps in her legs; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (painful reaction in knees) and MUSCLE SPASMS (muscle cramps in her legs) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 28-Feb-2021, the patient experienced ARTHRALGIA (painful reaction in knees) and MUSCLE SPASMS (muscle cramps in her legs). On 02-Mar-2021, ARTHRALGIA (painful reaction in knees) and MUSCLE SPASMS (muscle cramps in her legs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-034300 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Significant follow up: Called to obtain email address but consumer declined as she said all the events have resolved after 2 days; Sender's Comments:  MOD-2021-034300:same reporter, different patient and events
At 1145, patient reported dizziness to EMT. Patient reported the dizziness started "about ten minutes after I sat down". Patient stated the dizziness "feels the same when I sat down". Patient denied itchiness, rashes, hives, difficulty swallowing, and difficulty breathing. At 1145, EMT  assessed patient vital signs: blood pressure 156/102 mmHg and pulse 76 beats/minute. Patient reported history of hypertension and took her unspecified blood pressure medication in the morning. Patient offered EMS. Patient denied EMS. At 1150, EMT reassessed patient vital signs: blood pressure 170/114 mmHg and pulse 79 beats/minute. Patient reported she felt less dizzy. Patient reported this blood pressure is "normal" for her. Patient reported feeling anxious. At 1200, EMT reassessed patient vital signs: blood pressure 172/112 mmHg and pulse 79 beats/minute. Patient reported she feels "all better". Patient denied dizziness. RN educated patient on signs/symptoms of when to seek emergency care, to follow up with primary care provider and to sign up on v-safe. At 1210, patient left facility with unlabored respirations and steady gait.
Patient has been experiencing fairly significant arthritic pain in hands and ankles since receiving the smallpox vaccination.(She had no history of arthitis before vaccination).  Patient describes the pain as if "joints are swollen"--although they do not appear to be swollen. Upon awakening in the am-patient must force her hands to move.  After approximately 5 minutes-she is able to move joints appropriately-but she must continue to move them throughout the day or this same feeling of "being swollen" returns.  It is the same situation in the ankles-although not as severe.   The day before she was vaccinated-she experienced what she thought was an insect bit to her thigh.  She thought it most likely to be a spider bite.  Although the area has completely cleared up.  Dr is completing an arthritis workup.
About a day or so after the shot, patient spiked a 103 degree temp, followed by shaking in the night and febrile like seizures.  Since this day, about every 3 days or so, she has continued to have a yo-yo fever, and at night she sometimes shakes.  She has not been sick or had any other isolated events except the MMR vaccine, which is why I think there is a high possibility for the cause.
Hospitalized long term for multiple issues. Pt positive for COVID 19 on  10/31/2021.
Immediate nausea, hot flash and heart palpitations at time of injection, soreness for 3 days, and on the 4th day I had a general feeling of malaise, which worsened until I developed a fever. Severe fatigue and constant fever as high as 105 for three days, and finally went to the ER. Immediately treated for sepsis. Full blood panel, blood cultures, x-ray and CT scan. Also ran some additional cultures for respiratory  pathogens. The Dr?s had a tough time determining what it was. They saw a very small area which they called pneumonia, however, I?ve had pneumonia and this was not what it was. Final discharge paperwork stated Systemic Inflammatory Response Syndrome.
no energy; she felt lethargic; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy) and LETHARGY (she felt lethargic) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced ASTHENIA (no energy) and LETHARGY (she felt lethargic). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 08-Oct-2021, ASTHENIA (no energy) and LETHARGY (she felt lethargic) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient reported that she does not take any regular medications. No treatment details were reported. Patient reported that she experienced lethargic with no energy after first shot which was unlike her.   This case was linked to MOD-2021-373431 (Patient Link).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine at a physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, she was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
it was improper administration technique / needle leaked during administration of shingrix; needle leaked during administration unknown dose got it and rest leaked; This case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in product usage process in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number ap545, expiry date 25th January 2023) for prophylaxis.   On 9th July 2021, the patient received the 2nd dose of Shingrix. On 9th July 2021, unknown after receiving Shingrix, the patient experienced wrong technique in product usage process and incomplete dose administered. On an unknown date, the outcome of the wrong technique in product usage process and incomplete dose administered were unknown.  Additional details were provided as follows: The reporter stated that, needle leaked during administration of Shingrix, unknown number of vaccine dose got in and rest leaked, which led to incomplete dose administered and no product complain it was improper administration technique, which led to wrong technique in product usage process. The reporter consented to follow up.
05/23 I had pressure in forehead and cheek as well as discolored discharge from nasal cavity. This is common for me as the weather changes or stress causes my sinusitis to flare up. I rinsed and used my antihistamine for about a week before deciding to seek medical assistance. Talked with NP and got  Augmentin to clear up sinus infection and it worked. No follow-up and was recovered by 06/07. No other issues to report.
Notified Dr. to check on patient.  Notified Dr. of past history of flu vaccine and 1st dose of Pfizer vaccine. Ten minutes post vaccine (Pfizer), patient starting feeling throat getting itchy. 8:45 am: Pt. took own Benadryl 15 minutes post vaccine140/80 84 19 99% 97.7; 8:55am 146/70 72 18 100% ; 9:10am 128/70 81 99% 18.
Patient developed  dizziness, chills, fever, body ache, sore throat, difficulty breathing, and stopped eating beginning April 26,    The adverse effect is the belief that a breakthrough case of Covid-19 will be less severe if you had the shots.  A false sense of security.
Complaining of pain to R deltoid muscles following administration of the flu vaccine and ever since. Has tried Ibuprofen and cold pack without success.
flu-like symptoms; sleepy/eyelids are so heavy she wants to close them and sleep/hasn't slept like this since she was a newborn baby; exhausted; her joints are hurting; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), SOMNOLENCE (sleepy/eyelids are so heavy she wants to close them and sleep/hasn't slept like this since she was a newborn baby), CHILLS (chills), FATIGUE (exhausted) and ARTHRALGIA (her joints are hurting) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     The patient's past medical history included Arteriovenous malformation (spinal cord) in 1990. Concurrent medical conditions included Nerve damage, Allergy, Wheelchair user in 2001 and Smoker. Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Allergy, GABAPENTIN, BACLOFEN, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), TIZANIDINE, CLONAZEPAM, AMITRIPTYLINE and ROPINIROLE for Nerve damage.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced CHILLS (chills). On 31-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), SOMNOLENCE (sleepy/eyelids are so heavy she wants to close them and sleep/hasn't slept like this since she was a newborn baby), FATIGUE (exhausted) and ARTHRALGIA (her joints are hurting). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), SOMNOLENCE (sleepy/eyelids are so heavy she wants to close them and sleep/hasn't slept like this since she was a newborn baby), CHILLS (chills), FATIGUE (exhausted) and ARTHRALGIA (her joints are hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's medical history included abnormal veins wrapped around her spinal cord, one of them ruptured and bled. From then on, her waist down went totally numb and she lost her ability to walk. Patient also stated that without the concomitant medications she take, her legs would be shaking and spasmatic No treatment was received by the patient
On 2/26/02, the pt received Engerix-B (lot ENG5242A4) and Havrix (lot VHA69A6). It was not known if she had received previous injections of Engerix-B or Havrix. On 2/27/02, 1 day post vax, the pt was hospitalized with a dx of pneumonia. The reporter indicated that the pt received Havrix (lot VHA69A6); however, this is not a valid lot number.
This case was reported by a consumer and described the occurrence of an injection site reaction in a pt who received Pediarix. The relationship of the consumer to the pt was not provided. A physician or other health care professional has not verified this report. On an unspecified date on or before 4/26/05, the pt received a dose of Pediarix (dose number not provided). The site of the injection of Pediarix was not provided. At an unspecified time following the administration of Pediarix, on an unspecified date on or before 4/26/05, the pt experienced an injection site reaction reported as, "a small hard lump near the injection site" of Pediarix. The outcome of the injection site reaction was not reported.
a patient received an expired Adacel/ NO AE; Initial information received on 20-Apr-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of an unknown demographics who was administered with an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number and expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination on 17-Apr-2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  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.  There will be no information available on the batch number for this case.
experienced pain for only 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (experienced pain for only 2 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (experienced pain for only 2 days). At the time of the report, PAIN (experienced pain for only 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Fever (102 degrees F) lasting 36 hours. Chills on 4-11-09 pain in both deltoid muscles radiating into neck area. Dr visit on 4-12-09 given RX for ibuprofen. Pain in arms and neck slowly decreasing.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Severe, Additional Details: patient reported filling shortness of breath and chest pain. I checked blood pressure it was 174/103 with a pulse of 95 bpm. I gave patient a benadryl and called 911.  911 instructed me to give the patient a 325mg of aspirin.
This spontaneous report as received from a 80 years old female patient refers to herself. The patient was vaccinated with ZOSTAVAX (Lot #, dose/frequency, route and duration were unspecified) in July 2011. No other co-suspects were reported. Concomitant medications included: atenolol. The patient stated that after she received ZOSTAVAX in July 2011, she got shingles in February 2012. The patient had sought medical attention via office visit. No treatment was given for the event. At the time of reporting the outcome of shingles was unknown. Additional information is not expected.
High Blood Pressure & high vitals. Dizziness. Fatigue. Diagnosis was Myocarditis. Treatment is a Beta Blocker. And only mild exercise for at least 6 months.
The vaccine triggered an asthma attack for 3 days. My arm swelled with a lot of pain Headache
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX (batch number 3S354, expiry date 4th July 2020). Concomitant products included BOOSTRIX. On 4th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site pain and injection site swelling were not recovered/not resolved. The reporter considered the injection site erythema, injection site warmth, injection site pain and injection site swelling to be related to SHINGRIX. Additional information was reported as follows: On 19th March 2018, the patient received a dose of BOOSTRIX (intramuscular, batch number; 9PD92, expiry date: 30th March 2020) in left arm. The patient received SHINGRIX on right arm. On the date of reporting, the patient came to the pharmacy to report that, she had redness on her right arm at the injection site. The healthcare professional described this redness as large and approximately 3 inches in diameter and irregular in shape. The healthcare professional also stated that, the red area was pretty tender and warm to touch. The patient had been putting an ice pack on the area.
On 1/17/21 i had a heart attack 10 days following the second Pfizer dose.  Was hospitalized in a coma for 8 days, had a stent implanted, but ultimately recovered.
Pinkish rash on face, neck, chest, arms and hands. Lasted 3 days after first vaccine, after second dose - autoimmune kidney disease. Started feeling protein in urine, gained 30 lbs water weight
got the shingles vaccine then got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional details were reported as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The reporter's husband got the shingles vaccine then got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
This spontaneous prospective pregnancy report was received from a registered nurse and refers to a female patient of unknown age. No relevant medical history of the patient was reported. On an unknown date in October 2014 the patient was vaccinated with RECOMBIVAX HB dose 2 (lot number, expiry date and route of administration were not reported, therapy type was unspecified). There were no concomitant medications reported. The patient became pregnant with last menstrual period (LMP) on 08-OCT-2014 (number of weeks of pregnancy at the time of the report subtracted from the date of the report) and estimated date of delivery (EDD) of 15-JUL-2015 (reported as became pregnant on an unspecified date 18 weeks prior to 12-FEB-2015). The date of conception was estimated to be 22-OCT-2014. The patient experienced no adverse effect. There was no product quality complaint involved. The pregnancy outcome was pending at the time of the report. Additional information has been requested.
Nose bleed; This is a spontaneous case from a contactable lawyer. This lawyer reporting for a female consumer. This is the second case out of the two cases. An unspecified age of non- pregnant is unknown female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: not provided), via an unspecified route of administration on unknown date at single dose for covid-19 immunisation. The patient had no family history and medical history. The patient's concomitant medications were not reported. It was reported that on unknown date I was talking to my daughter and she has a friend whose mother lives in the same area and had her first Pfizer vaccine (Unspecified Vaccine, Pfizer) and had a small nosebleed right afterwards and then when she has second vaccine, she had another, a very bad, I had no nose bleed like this before like my husband is a Physician that I never had anything like this before, this is very serious kind of situation to happen, and this after the very first vaccine that I had. So, that's what I wanted to tell you that is going on, I am not going to take second. How long I am going to wait, how long I am going to test my antibody and see that I don't have any more antibodies and go take 'Moderna'. Have you heard anything like this?". The outcome of the events was "Unknown". Information for lot/batch number was requested.
Acute disseminated encephalomyelitis - numbness in extremities, dysarthria, dysmetria, truncal ataxia.
Headache, Myalgia, Fever, NauseaVomiting, malaise, chills Narrative:
Diagnosed with Hashimoto's Disease - treatment is to stay on levothyroxine and continue to monitor levels - symptoms are joint pain, lethargy, sleepiness, muscle aches, sensitive to cold
Vaccines received Wednesday morning. On Friday night, patient noticed pruritic, red rash to right arm. Took Benadryl with relief. No further issues.
tested positive for COVID-19; tested positive for Covid-19; This is a spontaneous report from a non-contactable consumer via Medical Information Team. A 35-years-old male patient (Son) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: Not reported) via an un-specified route of administration on an unspecified date as single dose for COVID-19 immuniza-tion. The patient's medical history and concomitant medications were not reported. On an un-specified date, patient experienced tested positive for COVID-19. On an unspecified date, pa-tient underwent lab tests and procedures which included sars-cov-2 test positive: positive. Re-porter wanted to know if her son should still receive the 2nd dose after 21 days or wait until he has recovered before receiving it. Reporter also wanted to know if it would be safe for her pregnant daughter to receive the Pfizer-BioNTech Covid-19 Vaccine, if there are recommenda-tions on what time it would be best for her daughter to receive the vaccine and how her daugh-ter could sign up for the clinical trials for pregnant women and the Pfizer vaccine. Outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.