chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm a little sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm a little sore) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 007B21A and 022M20A) for COVID-19 vaccination.     It was reported as patient never had COVID positive test or diagnosis and no other vaccines given within one month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Warts (5 years ago patient had 18 warts and on 20-SEP-2021 warts turned black and after one or two weeks disappeared.). Concurrent medical conditions included Drug allergy (Patient is allergic to cipro), Diabetes (since 3 years ago No change in status such as improvement or worsening), Asthma (since she was 50 years old No change in status such as improvement or worsening) and Blood pressure high (since she was 30 years old blood pressure for a couple of days after 1st and 2nd dose). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (esophageal), METFORMIN for Diabetes, LISINOPRIL for Hypertension, ESCITALOPRAM OXALATE (LEXAPRO) and INSULIN for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced PAIN IN EXTREMITY (arm a little sore). On 12-Dec-2021, PAIN IN EXTREMITY (arm a little sore) had resolved. Patient height reported as 5'6 and it was reported patient did not experienced similar event in past and AE doesn't cause patient seek medical care (office visit, Urgent care, ER, hospitalized). It was reported that the patient was not tested positive to COVID-19.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  It was also reported as Insulin recent medication, she was not taking it when warts disappeared. No treatment information were reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-629204, US-MODERNATX, INC.-MOD-2022-629199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-629204: US-MODERNATX, INC.-MOD-2022-629199:
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 16-FEB-2013 the patient was vaccinated with 0.65 ml ZOSTAVAX (19400 PFU) subcutaneously. It was reported that 22 vials of ZOSTAVAX (lot number H012138, expiry date 25-SEP-2013) were exposed to 70F for 5 minutes and called to assess temperature stability on 01-NOV-2012. They were determined to "must be used within three months 1 vial of ZOSTAVAX administered to the patient of 16-FEB-2013, no adverse effects noted. It was unspecified if the patient had sought medical attention. Additional information has been requested.
This spontaneous report as received from a consumer refers to a female patient of unknown age. On 2006 the patient was vaccinated with PROQUAD lot reported as 0770R expiration date 04-AUG-2006 for prophylaxis. Other suspect therapies included M-M-R II. On an unknown date the patient experienced wrong drug administered and no adverse event. The outcome of wrong drug administered and no adverse event is unknown. The reporter considered wrong drug administered and no adverse event to be not related to M-M-R II and PROQUAD.
Systemic: Dizziness / Lightheadness-Mild, Systemic: feet tingling-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild
BODY ACHES; STOMACH WOES FLARED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination.The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced stomach woes flared. The action taken with covid-19 vaccine was not applicable. The outcome of the body aches and stomach woes flared was not reported. This report was non-serious.
No adverse events; Expired vaccine used; This spontaneous report was received from a pharmacist refers to a patient of unknown demographics.The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 19-SEP-2019, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dosage information, route of administration and anatomical locations were unknown) of lot # N034512 with an expiry date of 13-SEP-2019 for prophylaxis (expired product administered). No adverse events reported. The outcome of expired product administered was unknown. No product quality complaint (PQC) reported.
Chills x 4 weeks; fatigue x 4 weeks. Initially given Tamiflu.
Pt administered Pfizer dose to right deltoid. Pt received moderna first dose 3/11/21 at Walgreens. Pt denies any signs and symptoms of adverse reaction. Pt observed 30mim post injection, given information on reporting to state of Az health services. VAERS filed for incident by  vaccination charge. Pt educated on sign and symptoms of severe reaction and when to seek medical care upon exiting POD. Advised pt to contact  for advice on vaccination status. Pt left in POV on own accord.
This non-serious spontaneous case, initially received on 03-Jan-2018, reported by a pharmacist, concerns a female patient of an unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date, after the vaccination (duration unspecified), the patient developed a little yellow blister. The pharmacist inquired, if the FLUCELVAX vaccine contains any egg products and reported that, she did not know whether the patient was allergic to egg. At the time of this report the pharmacist stated that, the patient was fine (recovered). Non-significant follow-up received from the pharmacist on 08-Feb-2018: No additional information was available; hence no changes were made in the narrative.
The shot was painful when administered. The left arm is now unusually weak and sometimes painful to do things like removing a shirt or lifting anything with that arm. My doctor says it is a rotator cuff injury and now I will need some physical therapy and time for it to get better.
Positive SARS COV-2 Rapid antigen test; Positive SARS COV-2 Rapid antigen test; Feeling sick, like a head cold; Head cold; Ears are clogged too, her brain is clogged; Ears are clogged too, her brain is clogged; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer sponsored program. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot Number: EN6204) via an unspecified route of administration, administered in Arm Left on 25Mar2021 (age at vaccination 60-years-old) in morning as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration, administered in Arm Left on 20Apr2021 at 09:30 (in the morning) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. No other vaccinations was administered within four weeks prior to the first administration date of the suspect vaccine. On an unspecified date in Jul2021, the patient ears are clogged too, her brain is clogged. When querying her ears and brain feel clogged, she clarified she started feeling sick with a head cold on Sunday. Feeling sick, like a head cold on 25Jul2021. On 28Jul2021, the patient experienced positive sars cov-2 rapid antigen test. Went to a wedding Saturday night and thought she had a head cold. Can she tell if she has the delta variant from that test? Advised caller to follow up with primary care physician. Difficult to provide product information from the patient record card stating it is handwritten. She had not used any medication to treat a fever. Has had no fevers. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Jul2021. The outcome of the event (malaise, nasopharyngitis) was recovering and other events were unknown.
pain on the left shoulder and muscle started 9.1.2021 Pain makes me unable my left arm  to raise , lift and limit certain ROM  Today 9.2.2021 , level of pain is at 7/10 this morning. Need help dressing up and putting my hair up.  Took 1000mg tylenol this morning.
At 0100 on 12/29 woke up with severe arm and neck pain.  Treated at that time with Ibuprofen and heating pad.  By 0900 developed a fever, body aches, headache, chills, and skin burning.  Fever persisted until 0100 on 12/30.  Mild residual body aches 12/30 and fatigue.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: After vaccine, pt bled slightly at injection site.  She saw the blood and started to feel faint, tingly lips, flushed and then lost color in her face.  I instructed her to deep breath and elevated her feet since she felt she couldn't move to be laid down.  Finally she was able to stand up, I assisted her to the floor the pharmacy, elevated her feet, and she improved immediately in the supine position w/ feet elevated.  She recovered 100 percent without fainting or losing consciousness.
Extreme fatigue, generally unwell, body aches, headache, abdominal pain, nausea, ear fullness. Near syncopal episode the morning after the vaccine.
Swelling, redness and muscular pain in left arm. Pt used ice but still having pain and swelling more than 24 hrs later.
Brain fog x 6 hrs 1/2 First 12 hrs-mild arm pain 1/3Then low grade fever, myalgias, Anorexia-mild 1/4 Awoke AM brain fog, difficult to work teaching in clinic. Suddenly cleared around noon. About 46 hours after shot, all good.
Within 24 hours after vaccination developed reddened, warm area below armpits x 10 days. Doctors visit to MD inconclusive. Resolved without problems.
Chills, fever, bodyaches, nausea, photosensitvity; Hypersensitivity to touch
1 of 4 pts who recvd vax exp fever & inject site rxn; pt had fever of 103 & inject site rxn consisted of pain, redness, swelling & inability to move arm; seen in ER:
They administrated the Moderna booster shot to 2 patients, Vial was moved from Freezer to fridge on 10Sep2021 and were used yesterday 30Oct2021, More than 30 days in the fridge; Vial was moved from Freezer to fridge on 10Sep2021 and were used yesterday; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They administrated the Moderna booster shot to 2 patients, Vial was moved from Freezer to fridge on 10Sep2021 and were used yesterday 30Oct2021, More than 30 days in the fridge) and PRODUCT STORAGE ERROR (Vial was moved from Freezer to fridge on 10Sep2021 and were used yesterday) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (codeine) and Allergy (Anaphylaxis to Iodine).   On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They administrated the Moderna booster shot to 2 patients, Vial was moved from Freezer to fridge on 10Sep2021 and were used yesterday 30Oct2021, More than 30 days in the fridge) and PRODUCT STORAGE ERROR (Vial was moved from Freezer to fridge on 10Sep2021 and were used yesterday). On 30-Oct-2021, EXPIRED PRODUCT ADMINISTERED (They administrated the Moderna booster shot to 2 patients, Vial was moved from Freezer to fridge on 10Sep2021 and were used yesterday 30Oct2021, More than 30 days in the fridge) and PRODUCT STORAGE ERROR (Vial was moved from Freezer to fridge on 10Sep2021 and were used yesterday) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: follow up added Allergies On 02-Nov-2021: Follow up  contain no new information
I have hypopigmented macules on my hands and face; This spontaneous case was reported by a patient and describes the occurrence of MACULE (I have hypopigmented macules on my hands and face) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023021A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MACULE (I have hypopigmented macules on my hands and face). At the time of the report, MACULE (I have hypopigmented macules on my hands and face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient don't had personal nor family history of vitiligo, autoimmune disease and no other pigmentary disorders. No concomitant medications was reported. No treatment information was reported.
Child developed fever in the evening of 5/24/12 to 101 degrees F. Friday 5/25/12 temp was as high as 103 degrees F. Dr. office was contacted - advised to watch for worsening symptoms - schedule appt if not better. Pox marks appeared 5/25 Friday & Saturday 5/26 on face, neck, side and leg - several small pox rash on trunk & legs decreased appetite, increased drooling fever subsided by 5/27 pox are fading.
Pt reports rash all over her body. Rash started on 1/8/22. She is reporting that her mother developed the same type of rash following immunization on the same day. The pt reached out to her medical provider. She has taken Benadryl at home without any relief.
I received the first dose of COVID-19 (Pfizer) on 10/8/2021 at 11:05 a.m. at the 377th Military Treatment facility. Symptoms started about an hour later with severe head fog, followed by extreme fatigue and a headache that has persisted. On 10/10/2021 I developed chest pain with a racing heart that continued to become more noticeable as a couple days went on. I decided to make an appointment with my Military PCP. I was seen on 10/15/2021. He decided to put in a cardiology referral and ordered basic labs be drawn. All labs were within normal limits.  On 10/19/2021 I was at my desk and felt what I would describe as a near syncopal episode coming on. I felt cognitively off which was accompanied
Inflammation and stiffness and swelling in right leg, lots of all over body pain.  Went to see a rheumatologist who confirmed I had a recurrence of PMR and probably from the vaccine.
Large round, inflamed, itchy area around injection site gradually appearing after injection. Instructed patient to try Benadryl 25 mg.
Pt experienced swelling, and redness in left thigh which was hard, and nontender. Pt was prescribed Benadryl and instructed to watch for worsening symptoms.
Swollen thigh, sore to walk; physical exam performed by MD advised to use Benadryl 12.5/5ml 1tsp Q6 hours. No cellulitis, + wt. bearing.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. In May 2011 the patient was vaccinated with the first dose of GARDASIL, injection, (lot #, expiration date, dose and route unspecified). In January 2013 the patient was vaccinated with the second dose of GARDASIL, injection, (lot #, expiration date, dose and route unspecified). No adverse effects reported. Additional information has been requested.
Extreme lethargy, swollen head and neck, extreme body aches, trouble balancing on feet (fell 3 times when going to bathroom), trouble keeping head from falling sideways when attempting to sit up, extreme loss of appetite for food or drink (lost 10 pounds within 4 days).
bumps all over head, arms, legs, back which looked like mosquito bites with minor irritation; Felt a little ill; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt a little ill), VACCINATION SITE PAIN (Sore arm) and URTICARIA (bumps all over head, arms, legs, back which looked like mosquito bites with minor irritation) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.  On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 20-Feb-2021, the patient experienced MALAISE (Felt a little ill) and VACCINATION SITE PAIN (Sore arm).   On 23-Feb-2021, the patient experienced URTICARIA (bumps all over head, arms, legs, back which looked like mosquito bites with minor irritation).   On 25-Feb-2021, MALAISE (Felt a little ill), VACCINATION SITE PAIN (Sore arm) and URTICARIA (bumps all over head, arms, legs, back which looked like mosquito bites with minor irritation) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication were provided by the reporter.   No treatment information was provided.
Headache, Myalgia, Fever, shortness of breath, chills Narrative:
Patient became nauseous & vomited one time. He had the chills & sat in a chair.  He sipped water & felt well enough to walk home within 30 minutes. He has had a bout of light headedness with vaccines in the past.
severe Raynaud's syndrome; high sedimentation rate; severe arthritis; necrosis of index finger; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: RED BLOOD CELL SEDIMENTATION RATE INCREASED (disability) with onset Oct2022, outcome "not recovered", described as "high sedimentation rate"; EXTREMITY NECROSIS (disability) with onset Oct2022, outcome "not recovered", described as "necrosis of index finger"; RAYNAUD'S PHENOMENON (disability) with onset Oct2022, outcome "not recovered", described as "severe Raynaud's syndrome"; ARTHRITIS (disability) with onset Oct2022, outcome "not recovered", described as "severe arthritis". The events "severe raynaud's syndrome", "high sedimentation rate", "severe arthritis" and "necrosis of index finger" required physician office visit. The patient underwent the following laboratory tests and procedures: Red blood cell sedimentation rate increased: (Oct2022) High, notes: high sedimentation rate. Therapeutic measures were taken as a result of raynaud's phenomenon, red blood cell sedimentation rate increased, arthritis, extremity necrosis.  Clinical course: Female plastic surgeon patient with no prior medical history. Within 3 weeks of receipt of Pfizer bivalent COVID-19 vaccine, developed severe Raynaud's syndrome, severe arthritis, necrosis of index finger, high sedimentation rate. No previous illnesses or conditions. The treatment received for AE was Prednisone, considering methotrexate.    The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the causality of the events  raynaud's phenomenon, red blood cell sedimentation rate increased, arthritis, extremity necrosis with the suspect can not be ruled out completely. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Ras, Ethics committees, and Investigators, as appropriate.
The patient was administered 1 shot of Hep B, 3rd in a series. The patient fainted onto the floor immediately went into seizure activity for less than 1 minute, no incontinence, vital signs stable immediately afterwards.
Information has been received from a NP concerning a 15 month old female who was vaccinated SC with a dose of varicella virus vaccine live. Subsequently seven days post vaccination the pt presented with chickenpox. She had approximately 50-70 lesions. There was no product quality complaint involved. Additional information has been requested.
Patient came back about 1 week after vaccine administration and described a 'knot' feeling at the administration site. Arm was sore and hurt for 6 days. 8/11/20 was the first day that her arm felt ok and more normal. Left deltoid muscle was tight, sore, and knotted up for 6 days.
pt recvd vax & devel hot flashes & sweating; recvd 2nd & 3rd dose of vax; labs on 10mar93 showed anti-hbs neg; recvd 2 booster doses; 19jul93 labs showed anti-hbsag pos;
After receiving the vaccine, patient left the clinic room, walked to the reception area and passed out onto the floor.  He was "out" for only about 1 minute.
Patient was given the Booster twice. Patient suffered no reactions. Patient was notified about the incident.
Swelling and pain in left testicle's vas deferens and epididymis. The swelling lasted approximately 6-10 hours.
Expired vaccine used; 0.3ml administered as booster; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and OVERDOSE (0.3ml administered as booster) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .3 milliliter. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and OVERDOSE (0.3ml administered as booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and OVERDOSE (0.3ml administered as booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) to be not related. No further causality assessment was provided for OVERDOSE (0.3ml administered as booster).    It was reported that the patient did not had any adverse reactions.  Concomitant products were not provided. Treatment medications were not reported.