chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A little bit of headache; A little muscle aches; Pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (A little bit of headache), MYALGIA (A little muscle aches) and VACCINATION SITE PAIN (Pain at the injection site) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 019821A or 0198Z1A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, SILODOSIN (RAPAFLO), BUPRENORPHINE, OXYCODONE HYDROCHLORIDE, PARACETAMOL (OXYCODONE AND ACETAMINOPHEN), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and TESTOSTERONE (TESTIM) for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced HEADACHE (A little bit of headache), MYALGIA (A little muscle aches) and VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, HEADACHE (A little bit of headache), MYALGIA (A little muscle aches) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.            The patient is not currently taking anything to treat adverse effects, but would like to take Tylenol.  Action taken with mRNA-1273 in response to the event was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: The patient stated that he was feeling fine.
Redness, itching and about a golfball sized, hard area. Condition still exists as of this date, 6/8/13, but to a lesser degree.
Had 1st dose of Moderna COVID-19 vaccine at outside  facility. Patient reported he had a rash/flushing with 1st shot and CDC  advised him not to take the second shot.
Tendonitis; Joint pain; 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 TENDONITIS (Tendonitis) and ARTHRALGIA (Joint pain) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDONITIS (Tendonitis) and ARTHRALGIA (Joint pain). At the time of the report, TENDONITIS (Tendonitis) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported.
Night after vaccine severe chills, muscle aches. When waking in morning, had neck pain and muscle spasms. Was in severe pain in neck with difficulty swallowing.  Went to urgent care and was given muscle relaxers. Pain continued for 3 weeks after, severe still. Began chiropractor visits, no improvement. Had MRI completed, showed golf ball sized lymph node swelling in neck on side of severe pain. Went to ENT for course of steroids with mild improvement. Still having mild to moderate neck pain everyday and it has been 2 months since vaccine. Would never get this type of vaccine again, and I am a medical professional who usually trusts them.
LOSS OF APPETITE; NAUSEA; DIARRHEA; VOMITING; HEADACHE; COLITIS ATTACK; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis, and other pre-existing medical conditions included: Patient had no known allergies and had no relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on JUN-2022 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 40 mg, 1 time every 2 weeks, therapy dates were not reported for moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. No concomitant medications were reported.  On 25-JUN-2022, the patient experienced colitis attack, and headache. On 26-JUN-2022, the patient experienced loss of appetite, nausea, diarrhea, and vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from loss of appetite, nausea, diarrhea, and vomiting, and the outcome of colitis attack and headache was not reported. This report was non-serious.
Localized skin reaction within muscle of upper extremity.  Arm swelling and pain.  Full pulses.  No blistering of skin.  No numbness of hand.  Patient called physician on call who recommended ice and one dose of Benadryl.  Will monitor.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 55 years old patient of unknown gender. Information regarding medical history, concurrent conditions, or concomitant medications was not provided. On or about 20-AUG-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified), for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
Right after patient left I realized that vaccine was given IM instead of SQ when complete injection site on vaccine administration record and informed consent form. I called Merck to check for effectiveness and adverse effects or needs to re-vaccination might have cause due to wrong route of administration. I received a verbal and fax from Merck to confirm no needs for re-vaccination or  any side effects due to intramuscular injection.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: EP7533), in left arm, on 19Apr2021 as dose 2, single (Lot number: EW0164), in left arm and on 26Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 46 years, in left arm for covid-19 immunisation. The patient had no relevant medical history and no known allergies. Concomitant medication(s) included: BUPROPION; CHLORTHALIDONE. The patient did not received any other medication in two weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 04Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 04Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (31May2022) Negative; (01Jun2022) Negative; (04Jun2022) Positive. Therapeutic measures were not taken as a result of covid-19.  Clinical course: It was reported that after testing negative on 31May2022 and 01Jun2022 using at home rapid tests, patient tested positive on 04Jun2022 using at home rapid tests.
Patient hospitalized;  Positive for COVID-19 (after being vaccinated)   BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider at Discharge: None Physician, MD None   Admission Date: 8/23/2021 Discharge Date: 8/27/2021    Active Hospital Problems   Diagnosis Date Noted POA ? MRSA UTI 08/27/2021 Yes ? Renal colic 08/24/2021 Yes ? UTI (urinary tract infection) 08/24/2021 Yes ? Ureterolithiasis 08/24/2021 Yes ? Renal colic on left side 08/24/2021 Yes Resolved Hospital Problems No resolved problems to display. DETAILS OF HOSPITAL STAY: 58-year-old man presenting to our institution with left-sided flank pain.  Reports that this pain felt similar to previous kidney stones he experienced in the past.  Pain was present for 4-5 days prior to admission, social with poor appetite, nausea and significant vomiting, likely secondary to pain.  No fevers or chills associated.  He presented to an outside emergency department, with urinalysis showing 2-5 red blood cells, CT showed obstructing 6 mm urolithiasis at the left ureteropelvic junction.  He was discharged home for supportive care.  Patient presented back, with worsening flank pain.  The emergency department his identified to have sodium of 128, urinalysis showed 73 WBCs.  Renal ultrasound showed mild left-sided hydronephrosis.  Patient also was identified to have COVID-19, the setting of vaccination, having received to Johnson Johnson vaccine in March 2021. Patient was admitted to the general medicine service.  He was seen in consultation with Urology.  He was felt inappropriate candidate for surgical intervention due to acute infection.  The patient underwent placement of a left ureteral stent on 08/25/2021.  Urology is planning an outpatient ESWL in 2-4 weeks.   Urine culture revealed MRSA.  This is unusual organism in the setting of a community acquired pyelonephritis.  Blood cultures were obtained x2 as Staph aureus bacteria can be associated with bloodstream infection, and culture results negative after 3 days.   Patient will discharge on oral Bactrim to continue while the stent is in place. In regards to his COVID-19 infection, patient developed some mild cough.  Chest x-ray was obtained which showed no evidence of an infiltrate.  Patient was treated with Regeron monoclonal antibody infusion on 08/24/2021.  Remained on DVT prophylaxis throughout the hospitalization. Patient has acute kidney injury which was present on admission, resolved with hydration.
Information has been received from a registered nurse concerning a 5-year-old female with no pertinent medical history and no drug reactions/allergies who on 25-MAY-2001 was vaccinated with a dose of Varivax (Oka/Merck) (Lot # 637663/1602K). There was no illness at the time of vaccination. There was no concomitant medication. It was noted that on 24-AUG-2001 and 13-OCT-2004, the patient was vaccinated SC in the left arm with doses of MMR II (Lot # 639517/0592L and Lot # 648471/0321P, respectively). On 04-APR-2006 the patient developed a breakthrough case of varicella. She had about 25 lesions on her face, arms, and abdomen. They were itchy and the doctor prescribed diphenhydramine hydrochloride (BENADRYL). She had no other symptoms and has recovered. There were no lab diagnostic studies performed. There was no product quality complaint. Follow up information received from a registered nurse indicated that on 04-APR-2006 the patient developed varicella disease. On 10-APR-2006, the patient recovered. No additional information is expected.
She got her vaccine, was feeling fine when she walked out of the office and they were sore.  She got home and was doing her normal routine, went to work Saturday.  She felt tired and weak, drowsiness.  She worked 8 hours, went home, ate and laid down.  She got back, got some water and said it was time to go to bed around 8-9:00 PM.  She took her medicine and went to bed.  Around 1:30 she woke up in sweat, gasping for air, and sweating like she was going crazy.  She made it up the store and went to the bathroom, and felt like she needed to throw up, and felt like she was going to fall out.  She knew she could not make it back down to stairs, and laid down on the couch.  Her daughter woke up, asked her if she was OK, told her she was nauseous, feeling bad.  She wanted to call 911 but she calmed down and everything working out for her.  She was still tired, nauseous and got up around 5:30 and went downstairs to her bed.  She called her work and told them that she was not feeling well, and was scaring the whole family and was trembling like she was going to faint and fall out.  She got to use the bathroom and laid down as she was very weak and tired.  She was scared to take anything for it other than her high BP medicine, and her regular medicines.    Today, she is feeling much better, she is very tired like she needs to take a nap.  The nausea is gone, and can finally eat something and does not feel like she is going to throw up.  She has made an appointment for her to see her doctor tomorrow.  She is not breaking out into a sweat, just hot.
Covid test result=Positive; Covid test result=Positive; feverish; cough; laryngitis; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 27 year-old female patient received bnt162b2 (BNT162B2), administration date 16Nov2021 (Lot number: FF2589) at the age of 27 years as dose 3 (booster), single, administration date 26Apr2021 (Lot number: EW0171) as dose 2, single and administration date 05Apr2021 (Lot number: EW0151) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Mar2022, outcome "unknown" and all described as "Covid test result=Positive"; LARYNGITIS (non-serious) with onset 07Mar2022, outcome "unknown", described as "laryngitis"; PYREXIA (non-serious) with onset 08Mar2022, outcome "unknown", described as "feverish"; COUGH (non-serious) with onset 08Mar2022, outcome "unknown", described as "cough". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) unknown  results; sars-cov-2 test: (08Mar2022) positive, notes: Unknown.  No follow-up attempts are possible. No further information is expected.
She felt nervous all over; Has not received the second dose (>36 days after first dose); Still having tingling in her legs; Heart Pounding; Leg Cramps; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Leg Cramps), NERVOUSNESS (She felt nervous all over), PARAESTHESIA (Still having tingling in her legs) and PRODUCT DOSE OMISSION ISSUE (Has not received the second dose (>36 days after first dose)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Walking pneumonia (Patient had walking pneumonia 3 years ago. Patient was given a quinolone (antibiotic). It has affected nervous system in legs and back and got better after a year.) in 2017.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced MUSCLE SPASMS (Leg Cramps) and PARAESTHESIA (Still having tingling in her legs). On an unknown date, the patient experienced NERVOUSNESS (She felt nervous all over) and PRODUCT DOSE OMISSION ISSUE (Has not received the second dose (>36 days after first dose)). At the time of the report, MUSCLE SPASMS (Leg Cramps), NERVOUSNESS (She felt nervous all over) and PRODUCT DOSE OMISSION ISSUE (Has not received the second dose (>36 days after first dose)) outcome was unknown and PARAESTHESIA (Still having tingling in her legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up document was received. Additional events were  added. It contains significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Soreness; puffy face; headache; flu-like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4541469 (RA).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OCREVUS. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Soreness"; SWELLING FACE (non-serious), outcome "unknown", described as "puffy face"; HEADACHE (non-serious), outcome "unknown", described as "headache"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms".  Additional information: Patient's concurrent condition was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sweats; Coating in mouth; Permanent crick in the neck from the injection site up to the neck; Tender injection site; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (Sweats), COATING IN MOUTH (Coating in mouth), MUSCULOSKELETAL STIFFNESS (Permanent crick in the neck from the injection site up to the neck), VACCINATION SITE PAIN (Tender injection site) and FATIGUE (Fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     Concomitant products included TRIAMTERENE for Blood pressure, ROSUVASTATIN for Cholesterol, VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced HYPERHIDROSIS (Sweats), COATING IN MOUTH (Coating in mouth), MUSCULOSKELETAL STIFFNESS (Permanent crick in the neck from the injection site up to the neck), VACCINATION SITE PAIN (Tender injection site) and FATIGUE (Fatigue). At the time of the report, HYPERHIDROSIS (Sweats), COATING IN MOUTH (Coating in mouth), MUSCULOSKELETAL STIFFNESS (Permanent crick in the neck from the injection site up to the neck), VACCINATION SITE PAIN (Tender injection site) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
Elevated blood pressure 1) 172/107 2) 156/92 (normal for her is around 127/85 per patient), wave of fatigue, felt a lump in throat, rash across opposite arm and chest, felt heat sensation. Symptoms improved after 20-30 minutes of monitoring and patient went home with instructions to seek medical attention if symptoms begin to worsen.
Myocarditis, trouble breathing, extreme body ache, high fever, chills, no appetite for 1 week
No additional AE reported; Nurse reports improperly stored PROQUAD was administered.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.   On 05-JAN-2023, the patient was vaccinated with improperly stored (temperature -14 degree Celsius up to-10 degree Celsius  (-13.7 degree Celsius), time frame 5 hours 15 minutes 0 seconds, no previous temperature excursion) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) subcutaneous injection, lot #W012730, expiration date: 16-OCT-2023, administered for prophylaxis (strength and route of administration were not provided) (product storage error). No additional adverse event reported (no adverse event).  This is one of several reports from the same reporter.
Pain and swelling at injection site; headache, chills, fever (100 degrees F). Still continues at time of reporting. Muscle and joint aches all over body, headache, dizzy, tired; symptoms lasted 36 hours from time of injection; unable to perform normal tasks or go to work. Stayed in bed for close to 36 hours.
pt recv vax 17APR98 & 23APR98 pt exp h/a;pt was seen in ER 20APR98& had various test performed;3JUN98 pt to chiropractor c/o h/a, numbness & tingling in hands & arms, dizziness, muscle weakness & stiffness in neck;dx paresthesia & cervical
TWO BRUISE (ONE ON EACH LEG); This spontaneous report received from a consumer concerned a 20 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, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced two bruise (one on each leg). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from two bruise (one on each leg). This report was non-serious.
The pt experienced swelling at the area of right deltoid, 1.5 inch diameter, red, warm to the touch, tender. The pt was seen my an MD on 8/29 and the symptoms remain except for tenderness.
Information has been received from a consumer concerning her 12 month old son with a history of bronchitis and no drug reactions or allergies who on 17-OCT-2005 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 20-OCT-2005 the patient experienced a cough, congestion, low grade fever and 3 bumps around the injection site. It was noted that the patient's mother is 3 months pregnant and she has not had a reaction. No labs or diagnostic tests were performed. At the time of this report, the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved.  Additional information has been requested.
This spontaneous report as received from a physician refers to a patient of unknown age and gender who within the last 2 weeks in 2013, was vaccinated with GARDASIL (dose, lot # and route not provided). The Physician stated he use to give GARDASIL vaccinations all the time, even to his own children. However, within the last 2 weeks in 2013, a patient developed severe headache, weakness and muscle aches all over the body. The patient sought medical attention and was seen in the physician's office. Physician states he walked that patient over to the Neurologist. The outcome of severe headache, weakness and muscle aches all over the body was unknown. The relatedness adverse events was unknown for GARDASIL. This is one of several reports from same source. Additional information has been requested.
I was going to my nephew's wedding. I thought I may be having allergies issues not only being in a different area but also maybe because of the dogs that I was around. I was coughing, I had a sore throat, chills, I was able to breath but I was also having a lot of phlegm and I was coughing so hard that it was making it hard to breath but that was really due to the buildup of phlegm, my throat was raw and sore from the coughing. I ended up taking a COVID-19 home test and it was positive. I called my healthcare provider back home since I was out of town and he sent me an RX for PAXLOVID. Sleeping has been hard I did not get the medication until Friday but since being it on it has been helping. I am still testing positive and I am still tired but my cough is better.