chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in injection site; A spontaneous report was received from a consumer concerning 53-year-old, female patient, participating in the Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  experienced   pain in the injection site.  The patient's medical history, is not provided by the reporter  Concomitant medications were not reported.   The patient received their first of two planned dose of mRNA-1273 on 18Jan2021.The patient received their first of two planned doses of mRNA-1273 in(Lot number: 030L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Experienced Pain In the injection site.    No lab data is reported by the reporter.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events, Pain on injection site is unknown .   The reporter did not provide an assessment for the events.  Since no Seriousness criteria is reported , hence the case is considered to be Non-serious.
WARMTH AND TINGLING ON LIPS; WARMTH AND TINGLING ON LIPS; HEALED COLD SORE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced healed cold sore. On 08-APR-2021, the subject experienced warmth and tingling on lips. On 08-APR-2021, the subject experienced warmth and tingling on lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warmth and tingling on lips, and warmth and tingling on lips on 08-APR-2021, and the outcome of healed cold sore was not reported. This report was non-serious.
Swelling and pain at injections site starting at 4:45pm on 3/16/2021. Woke up at approx 2:30 am with severe diaherra, sweats, malaise, nauseous.  dizziness, headache, lymph nodes in armpits, breasts, and stomach cramps.  This lasted until Friday, March 19th.
bruise the size of a quarter with lump underneath on arm at injection site/the bruise has started to turn colors so she would say, yes, it is improving; bruise the size of a quarter with lump underneath on arm at injection site/the bruise has started to turn colors so she would say, yes, it is improving; This is a spontaneous report from a contactable consumer, the patient. A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: ER8733) via an unspecified route of administration, administered in arm right on 01Apr2021 at 14:00 as dose 2, single (at the age of 48-years-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6204) via an unspecified route of administration, administered in arm left on 11Mar2021 as dose 1, single for covid-19 immunization at the age of 48-years-old). It was reported that after receiving the second dose of vaccine on 02Apr2021 in the afternoon the patient experienced the bruise the size of a quarter with lump underneath on arm at injection site. She reported that the bruise has started to turn colors so she would say, yes, it was improving. After the patient first dose she had no side effects, it was fantastic. The patient had not underlain health conditions. The patient did not visit emergency room and physician office for the adverse events. The outcome of the events was recovering at the time of report.  No follow-up attempts were needed. No further information was expected.
More localized pain at the injection site than is usual for a vaccine; This is a spontaneous report from a contactable physician (patient). This physician reported similar events for herself and one patient (her nurse). This is the first of two reports. A female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date at a single dose for Covid-19 immunization. Medical history included blood group O+. Concomitant medications were not reported. It was reported that the patient experienced more localized pain at the injection site than is usual for a vaccine. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021085284 same reporter, same drug, same event, different patient
fatigue; muscle pain; joint pain; Sore arm; headache; nausea; vomiting; dizziness; Metallic Taste; light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DYSGEUSIA (Metallic Taste), DIZZINESS (light headedness), NAUSEA (nausea) and VOMITING (vomiting) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles in 2020.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (dizziness), DYSGEUSIA (Metallic Taste) and DIZZINESS (light headedness). On 06-Mar-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headache) and INJECTION SITE PAIN (Sore arm). On 13-Mar-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Mar-2021, DIZZINESS (dizziness) and DYSGEUSIA (Metallic Taste) had resolved. At the time of the report, DIZZINESS (light headedness), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown and HEADACHE (headache) and INJECTION SITE PAIN (Sore arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Tempt 101.5, high blood pressure  swollen arms redness hot to touch Hospital gave me saline
Case number PHEH2013US005300 is an initial spontaneous report received from a medical assistant on 28 FEB 2013 with a follow up received on 25 MARCH 2013. This report refers to a 16-year-old female patient. She was vaccinated with MENVEO (batch number: M11051 and expiry date: 31 MAR 2014) intramuscularly at a dose of 0.5 ml on 07 FEB 2013. This vaccine had  undergone temperature excursion. This first temperature excursion took place on 23 JAN 2013 and the vaccine reached 54 degree Fahrenheit for less than four hours. MENVEO was not re-constituted at the time of excursion. Reporter stated that, the MENVEO had a temperature excursion. She did not experience any adverse events as a result of the temperature excursion. She would be revaccinated. No further information was reported.   Follow up received on 25 MARCH 2013. Updated reporter comments.
Fever, rash, increased fussiness, starting evening of vaccination, local reaction erythema. Mom had been putting warm, compresses on injection site, when switched to cool compresses pain and redness resolved.
For 6 hours after shot I had pain and numbness in my right arm. Woke up at Midnight with a fever and non stop shivering and extreme dry mouth and pain.  That lasted for 10 hours. For 36 hours I had extreme weakness and fatigue and body pain. Pain in all body parts. After 24 hours I have a large red hot raised area inferior to where the shot was given   48 hours and still having arm pain and body pain. The fever and weakness has mostly passed.
Facial tingling and numbness, left side of face (same side as shot). Lasted for several hours.
I was sick with nausea, vomiting, headache, muscle aches, extreme exhaustion, and feeling extreme hormonal changes like extreme night sweats. Worse than anything I ever had during menopause. I was in bed for 1 week, and feeling sick for 2 weeks. I am still suffering with extreme night sweats almost 2 months later.
Patient presented with 3-4 days of increasing shortness of breath/chest pain. Was found to have a pulmonary embolism. started on Heparin drip, transitioned to apixaban after 24 hrs and DCed home
Patient was given 3 doses of the Shingrix vaccine on 7/26/22, 9/30/22, and 12/8/22
Localized redness and itching after 2 days, followed by generalized itching with diminished redness at injection site. Patient called their physician practice and were prescribed a 3 day course of Prednisone.
I experienced light-headedness, fatigue, and nausea. I called my PCP and was advised to go to the ER immediately. I ended up going to the ER because my vision was blurry, nausea, and couldn't stand up along with a feeling feverish. I was very dehydrated, and the doctors were not sure if the symptoms were associated with the vaccine. My blood work came back normal, and I was advised to hydrate myself while they worked to get my heartrate down since it was very high. I was given to units of IV fluids while there.  I was only able to consume rice cakes and it took a full 5 days before any food could he held on to my stomach without feeling like vomiting.
This spontaneous report was received from a nurse and health professional and refers to a 4 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a physician refers to an unknown number of patients with unknown gender and greater than 26 years old. The physician reported that on an unknown date the patients were vaccinated with GARDASIL injection (lot # and expiration date unspecified) (dose, route and anatomical location unspecified). The physician mentioned since the approval for GARDASIL, she had been giving GARDASIL on unknown dates, to an unknown number of patients who are greater than 26 years old. No adverse effect reported. This is one of two cases from the same source. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Tachycardia-Mild, Systemic: Vomiting-Mild, Additional Details: about 15 min after shot, she said felt warm and felt heart rate increases, when i took bp 135/90, hr 78, she said only last a few minutes
Woke up at 0700 with fever that fluctuated between 103-106 and would not come down with Tylenol, tepid shower, and cold compress. Nausea, dizziness, headache and could not sit up without vomiting. Could not hold down liquids 0700 to 1030. Passed out at 1030 and woke up at 1400 with fever holding at 100.1-100.2. Called Urgent care for advise on treating. Got it to dip for an hour (1830-1930) to 98.9 with increased Tylenol. Slept and woke at 2000 with fever of 100.2 that is holding steady at time of writing. No nausea and can hold down fluids. Reported symptoms through online Covid symptom tracker.  Will go in once clinics open at 0800 if still running fever to have this checked out.
pt recvd vax;1jul94,fever, 3pm lethargy; t of 101.5 in the pm; v; listless;2jul94,fever of 104.5,listless,stiffneck,dehydration,febrile sz,adm to hosp for 10 days;tx pcn IV for meningitis;
He had a fever, arm extremely sore, red swollen (half dollar coin size), very warm to the touch.
Headace, nausea, couldn't sleep, severe pain of muscles and joints (head, neck, back, knees, elbows, left foot, some fingers).  Bedridden 06/16/2001.  Put on Celebrex, Vioxx, Tylenol.  Now left with fibromyalgia, left foot and knee pain, head, neck, and back pain.
Feeling feverish; Arm hurt a lot; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling feverish), VACCINATION SITE PAIN (Arm hurt a lot) and CHILLS (Chills) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling feverish), VACCINATION SITE PAIN (Arm hurt a lot) and CHILLS (Chills). At the time of the report, MALAISE (Feeling feverish), VACCINATION SITE PAIN (Arm hurt a lot) and CHILLS (Chills) outcome was unknown.            No Concomitant medication information was reported. No Treatment medications were provided As per the narrative in source document, the patient is female.
Client presented at the vaccination site on 12.23.21. Client reported he received first dose of Moderna COVID vaccine on 03/27/21 and received second dose of Moderna COVID vaccine on 04/24/21 both at the facility. Client reported with first dose of Moderna COVID vaccine, he had neck pain, body pain, and weakness 12 hours after received the vaccine lasted eight to 10 hours and with the second dose of Moderna COVID vaccine on 04/24/21, he had the same neck pain, body pain, and weakness 12 hours after received the vaccine lasted six hours. Client reported he took Tylenol with help with both doses. He denied any known allergy. Client told he has HTN controlled with Losartan and arthritis controlled with pain medication (unknown name). Client is requesting for the booster dose of Pfizer COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator, requesting to proceed with the booster dose of Pfizer COVID vaccine. Per the doctor, approval to proceed with the booster dose of Pfizer COVID vaccine was obtained via text message from clinical project coordinator. Client received the booster dose of Pfizer COVID vaccine, LOT#: FL3197 on 12/23/21 at 1530 by RN. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1400 unassisted and with a steady gait.
Patient stated that vaccination caused extreme pain during administration. Shortly afterward she developed a large blister at the injection site with persistent pain interfering with the ability to sleep. Woke up the next morning with pain, swelling, and redness covering a large portion of the upper arm that was warm to the touch. Patient contacted her primary physician who advised her to apply ice and seek medical attention at the immediate care center if swelling continued. Patient was advised to 1) mark the area of redness & return if it continues to spread. 2) apply cool compresses several times daily avoiding direct skin contact; 3) ibuprofen 600 mg every 6 hours PRN; 4) BENADRYL 25 mg PO nightly x 3 days; 5) follow up with PCP in 3 days if symptoms have not resolved.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received SHINGRIX (batch number D9474, expiry date 30th September 2021) for prophylaxis. Concurrent medical conditions included glaucoma and fruit allergy (for Avocado and Banana). Concomitant products included ALLEGRA. On 21st March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2019, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site induration and injection site discomfort. The patient was treated with non-drug therapy (Ice Pack (No Medication)) and TYLENOL. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site induration and injection site discomfort were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site induration and injection site discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX at left deltoid. The patient experienced redness, warmness, firmness and discomfort at the injection site. The redness was approximately 4 inches wide and 2 inches long. The pharmacist advised patient to use ice at the injection site and to take TYLENOL for discomfort.
This spontaneous report as received from a registered nurse refers to a 8 week old patient of unknown gender. On 05-AUG-2013 the patient was inadvertently vaccinated with one dose of GARDASIL (lot number was not reported) 0.5 ml, intramuscular. Concomitant medication were not reported. No adverse effect reported. Additional information has been requested.
Patient with history of CKD, diabetes, and lung adenocarcinoma with metastasis to bone.   She was seen in the ED on 11/19/22 for evaluation of a cough for the past several months, however the day prior, her cough began to worsen. COVID-19 PCR test was done that day which was positive. To note, the patient also recently had COVID-19 in September 2022. Ultimately, patient was admitted 11/19/22 - 11/25/22. Discharge diagnosis included acute hypoxic respiratory failure secondary to COVID-19 pneumonia and COVID-19 pneumonia with superimposed pneumonia. During admission, she developed hypoxia and required supplemental oxygen, however her respiratory status improved. At discharge, she was on room air.
Information has been received from a 74 year old male patient with cardiac disorder, sulfonamide, LEVAQUIN and mycin allergy who on 29-NOV-2010 was vaccinated with a 0.65 ml dose subcutaneously of ZOSTAVAX (Merck) (Lot # not reported). Concomitant therapy included influenza virus vaccine (unspecified), LIPITOR and aspirin (manufactured unspecified). The consumer reported that on 29-NOV-2010 while he was recovering from pneumonia he received the ZOSTAVAX (Merck) dose. He believed that he was recovered from pneumonia because he had finish with his antibiotic therapy and felt better. Then, 18 hours after receiving the vaccine, he started to experienced pneumonia-like symptoms such as coughing, yucky feeling and feeling sick. At the time of the report, the patient had not recovered. No laboratories were performed. The patient did not seek medical attention. No further information is available.
pt recv vax 5SEP95 & 29MAR96 pt devel chicken pox w/numerous open lesions;By 8APR96 pt had recovered;
I had brief episodes of atrial fibrillation lasting about 30 seconds; I woke up with tachycardia of a heart rate about 130 to 140 beats per minute; my arm had some swelling; I felt a little fatigue; This spontaneous case was reported by a physician and describes the occurrence of ATRIAL FIBRILLATION (I had brief episodes of atrial fibrillation lasting about 30 seconds) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 250202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ATRIAL FIBRILLATION (I had brief episodes of atrial fibrillation lasting about 30 seconds) (seriousness criterion medically significant), TACHYCARDIA (I woke up with tachycardia of a heart rate about 130 to 140 beats per minute), PERIPHERAL SWELLING (my arm had some swelling) and FATIGUE (I felt a little fatigue). On 28-Feb-2021, ATRIAL FIBRILLATION (I had brief episodes of atrial fibrillation lasting about 30 seconds), TACHYCARDIA (I woke up with tachycardia of a heart rate about 130 to 140 beats per minute), PERIPHERAL SWELLING (my arm had some swelling) and FATIGUE (I felt a little fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter. Patient received vaccine in left non-dominant deltoid.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
pt was seen in ER the noc following the inject for febrile sz; mom states fever was 101 7PM; recvd 2nd dose of APAP t99; woke up 1255 & had sz lasting approx 10 mins;
Nerve Pain from neck to finger tips. I have been on prednisone and now Lyrica, for the pain.
swollen testicles for a few days (blueballs); could not walk right for a few days; second vaccination gave me only slight feeling of body imbalance; 10 or so hours after receiving it my testcles ached; Just an ache, making me uncomfortable; This case was received via Regulatory Authority(Reference number: US-irms-MOD21-145833) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TESTICULAR SWELLING (swollen testicles for a few days (blueballs)), GAIT DISTURBANCE (could not walk right for a few days), BALANCE DISORDER (second vaccination gave me only slight feeling of body imbalance), TESTICULAR PAIN (10 or so hours after receiving it my testcles ached) and DISCOMFORT (Just an ache, making me uncomfortable) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Testicular swelling (40 years ago), Blood pressure high since 2008 and Non-consummation. Concomitant products included METOPROLOL from 2008 to an unknown date and AMLODIPINE from 2008 to an unknown date for Blood pressure.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced TESTICULAR SWELLING (swollen testicles for a few days (blueballs)), GAIT DISTURBANCE (could not walk right for a few days), BALANCE DISORDER (second vaccination gave me only slight feeling of body imbalance), TESTICULAR PAIN (10 or so hours after receiving it my testcles ached) and DISCOMFORT (Just an ache, making me uncomfortable). In 2021, TESTICULAR SWELLING (swollen testicles for a few days (blueballs)) and GAIT DISTURBANCE (could not walk right for a few days) had resolved. At the time of the report, BALANCE DISORDER (second vaccination gave me only slight feeling of body imbalance), TESTICULAR PAIN (10 or so hours after receiving it my testcles ached) and DISCOMFORT (Just an ache, making me uncomfortable) outcome was unknown.            Treatment medications was not reported. The patient received the first dose of Moderna COVID-19 vaccine 2-3 months ago. He also received the second shot of Moderna COVID-19 vaccine about 2 months ago. The patient was not sexually active now. The patient did not have any history of prostate problems.   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow up contains significant information of patient history, concomitants, new events and patient demographics.