chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lower back to ankle pain; could not get out of her bed, can not site down too long; Neck spasm; pain all over (Pain scale 9); Fever; Headache; Chills; lower back to ankle pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back to ankle pain), MOBILITY DECREASED (could not get out of her bed, can not site down too long), MUSCLE SPASMS (Neck spasm), PAIN (pain all over (Pain scale 9)) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sciatica, Asthma, Heart failure and Neuropathy. Concurrent medical conditions included Sclerosis multiple and COPD.    On an unknown date, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced BACK PAIN (lower back to ankle pain), MOBILITY DECREASED (could not get out of her bed, can not site down too long), MUSCLE SPASMS (Neck spasm), PAIN (pain all over (Pain scale 9)), PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and ARTHRALGIA (lower back to ankle pain). At the time of the report, BACK PAIN (lower back to ankle pain), MOBILITY DECREASED (could not get out of her bed, can not site down too long), MUSCLE SPASMS (Neck spasm), PAIN (pain all over (Pain scale 9)), PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and ARTHRALGIA (lower back to ankle pain) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No treatment information was provided.  No concomitant product was reported.
I contracted COVID-19. I had a slight fever for one day. My symptoms included tiredness, a slight sore throat, fatigue, and nasal congestion. I spoke to my doctor and I was prescribed Paxlovid. I started the medication on 11/08/2022.
Rash on her shin; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The patient received dose of Shingrix and had developed a rash on her skin. The reporter consent to follow up.
spotting; uterine cramp; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of HEAVY MENSTRUAL BLEEDING (spotting) and UTERINE SPASM (uterine cramp) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (spotting) and UTERINE SPASM (uterine cramp). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency; LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, HEAVY MENSTRUAL BLEEDING (spotting) and UTERINE SPASM (uterine cramp) 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 concomitant medications were reported.; Sender's Comments: Based on current available information and the temporal relationship between product use and the start date of the events a causal relationship cannot be excluded.
pt recvd vax & devel foot pain & swelling w/ 1 hr, and significant ankle swelling O/N w/pain of wrists, ankles, elbows, knees, hip & shoulder;t100;pain & swelling persisted & pt remains;ESR remain high & pt now has liver funct enzyme inc;
Swelling, redness and tenderness down the arm. Not at injection site cellulitis like reaction.
Covid rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Covid rash on her arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TOLTERODINE L-TARTRATE (DETROL) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Covid rash on her arm). At the time of the report, VACCINATION SITE RASH (Covid rash on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided (after first dose).  The patient was going through menopause. She was having bladder problems before.   This case was linked to MOD-2021-250643 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Non-significant Follow-up included  narrative updated
Swelling of face, dry irritated skin around mouth, nose, eyes started 3-11-2010 Also had crusted pustules around lips when seen today (3-15-10) Treated with 10 mg DEXAMETHASONE IM x 1, Bacitracin Oint. to lips bid, Lysine to lips OTC 3-16-10 improving. Treated with PREDNISONE 10mg and E-mycin Ophth. Oint.
colapsed to the ground; it was very serious / very serious reaction; just a little bit of a sore arm / just a tiny tiny of a sore arm; passed out cold with no warning / suddenly she blacked out; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out cold with no warning / suddenly she blacked out), FALL (colapsed to the ground), VACCINATION COMPLICATION (it was very serious / very serious reaction), PAIN IN EXTREMITY (just a little bit of a sore arm / just a tiny tiny of a sore arm) and MYALGIA (Myalgia) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (Myalgia). On 06-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out cold with no warning / suddenly she blacked out). On an unknown date, the patient experienced FALL (colapsed to the ground), VACCINATION COMPLICATION (it was very serious / very serious reaction) and PAIN IN EXTREMITY (just a little bit of a sore arm / just a tiny tiny of a sore arm). At the time of the report, LOSS OF CONSCIOUSNESS (passed out cold with no warning / suddenly she blacked out), FALL (colapsed to the ground), VACCINATION COMPLICATION (it was very serious / very serious reaction), PAIN IN EXTREMITY (just a little bit of a sore arm / just a tiny tiny of a sore arm) and MYALGIA (Myalgia) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-328631.; Sender's Comments: This case concerns a 77-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of loss of consciousness among other non-serious adverse events. The event occurred on the same day after the second dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable since the event occurred exclusively after the second dose. The age of the patient could be a potential confounder to the event. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Case seriousness downgraded due to lack of evidence of seriousness from a regulatory or clinical standpoint according to source document
Headache; Body ache; Sore throat; Nausea; Coughing; Wheezing; Extremely ill; very tired and Completely wiped out; Scary sick; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN (Body ache), OROPHARYNGEAL PAIN (Sore throat), NAUSEA (Nausea) and COUGH (Coughing) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery (patient had 2 back surgeries). Concomitant products included OXYCODONE, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and LEVOTHYROXINE for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (Headache), PAIN (Body ache), OROPHARYNGEAL PAIN (Sore throat), NAUSEA (Nausea), COUGH (Coughing), WHEEZING (Wheezing), MALAISE (Extremely ill), FATIGUE (very tired and Completely wiped out) and ILLNESS (Scary sick). At the time of the report, HEADACHE (Headache), PAIN (Body ache), OROPHARYNGEAL PAIN (Sore throat), NAUSEA (Nausea), COUGH (Coughing), WHEEZING (Wheezing), MALAISE (Extremely ill), FATIGUE (very tired and Completely wiped out) and ILLNESS (Scary sick) 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.   Treatment medications were not provided by reporter.
Patient's sperm count decreased by approximately 79% after second dose of Covid vaccine.  Average before vaccination was 78 million.  Average after vaccination was 16 million, below WHO reference value for fertile semen.
FORGOT TO TAKE THIRD DOSE; This spontaneous case report (PVX2019-2622) was received from a consumer on 21-Oct-2019. It described a 22-year-old adult female consumer who "forgot to take third dose" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer received first and second dose of Vivotif on 16-Oct-2019 and 18-Oct-2019 respectively however, she forgot to take the third dose that was scheduled on 20-Oct-2019.  Action taken with Vivotif with respect to event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "forgot to take third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take third dose" was considered as not applicable.
Client received Prevnar 20 vaccination on 6/8/22, data base was not updated, and client was given a second dose of Prevnar 20 on 10/27/22.
Sore muscle; Soreness at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore muscle) and VACCINATION SITE PAIN (Soreness at injection site) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     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 10-Feb-2021, the patient experienced MYALGIA (Sore muscle) and VACCINATION SITE PAIN (Soreness at injection site). On 11-Feb-2021, MYALGIA (Sore muscle) and VACCINATION SITE PAIN (Soreness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-355999 (Patient Link).
?Pulled? hamstring muscle for no reason.  Unable to stand or bend leg for days   On day 3 and finally improving. Did nothing different to strain the muscle other than get a vaccination. The only thing I did differently that day.
Unable to left arm beginning within 2.5 hours after injection. Continued deltoid discomfort and poor sleeping. Continued symptoms to date 02-03-2021
Tinnitus spike second day after injection.  Has not gone down to baseline prior to injection.  Waiting for a doctor's appointment to see if I should get the second dose.  But next available opening is 8/23/21.
Client felt nauseated and weak, vomited off and on all night.  Had chills, and Headache.  Felt weak the next day.
This case was reported by a nurse and described a subject (age and gender unknown) who did not respond to immunization to Engerix-B. On an unspecified dates, the subject received Engerix-B. On an unspecified date before 12 May 2006, a hepatitis B antibody titer was negative. It was reported that the titers were taken from one to five months after the third dose of Engerix-B was received. No adverse events were reported.
8/7/21: DEVELOPED FEVER, HEADACHE.  8/9/21: TESTED POSITIVE FOR COVID-19
18days p/vax pt devel fever & hosp w/pneumonitis, pt devel generalized rash approx 100 lesions. Pts condition has improved.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (incorrect product storage) (lot # L029472, expiry date 08-AUG-2017 (lot # L045953, expiry date 17-NOV-2017) (lot #L041207, expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. It was reported that the VARIVAX experienced a temperature of 12.1 degrees centigrade for a time frame of 1 hour, 38 minutes. It was reported that the VARIVAX was back in range. It was reported that the VARIVAX experienced no previous temperature excursion. This case was reported due to a data logger. The action taken with the therapy with VARIVAX was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
pt recvd vax & exp fever of 104-105 w/ apap & sponge bath;
It has been 3 years I have been struggling with shingles / yes I had both shots because it can come back again / checked with my doctor and the pharmacist/ suspected vaccination failure; struggling with shingles / on my left side of my forehead and head area; itch; nervous pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and nerve pain. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and nerve pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and nerve pain to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient had been struggling with shingles for 3 years and also had nervous pain and itch. The reporter stated that, he or she had shingles luckily on the left side of the forehead and head area and luckily did not have the rash and spray areas as some people had but 3 years were just too much. The patient received both the doses because shingle could come back again and had already checked with his or her doctor and the pharmacist. This case was considered as suspected vaccination failure as details regarding the laboratory test confiding Shingles and time to onset for Shingles were unknown at the time of reporting. The case had been linked with the case- US2021AMR081522, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR081522:same reporter
I had flu like symptoms. I had really bad migraine/headaches. I also had fever, nausea, fatigue. It all lasted for about two weeks. I do suffer from migraines but these were worse. I took Excedrin and it either wouldn't go away or go away and come back.
dizzy, faint, blood pressure 90s/60s. Currently on OCPs, denies chest pain or SOB
Pt recv vax on 6/26/97; on the same day pt exp fever (104) after Tylenol &Advil tx.  Pt went to Dr who advised no more pertussis vax.  Pt was irritable.
One day later, I suddenly had severe muscle spasm in the middle of my back, with nausea.  Simultaneously all my teeth ached.  it lasted for about 15 minutes.  Since then, in the following 6 months, I have the same symptoms, but less severe intermittently at least every other day, and sometimes twice a day.  It only lasts for 5 to 10 minutes now.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic for follow-up with neurology. Approximately ten to fourteen days after immunization patient reports developing paresthesias in arms and legs and left side of face, cramps, weakness, and muscle spasms. Patient was prescribed diazepam which helped symptoms. Patient diagnosed with ADIP/Guillain-Barre syndrome, underwent physical therapy, and has gradually improved.
Heart palpitations, brain fog, confusion, difficulty with speech, headache, weakness, dizziness, extreme fatigue, moving slow,  .palpitations are worse with activity.
On March 20th I received the J&J covid-19 vaccine shot.  Starting on March 21st I begin to experience symptom such as fever, chills and body aches. That lasted for about 2 weeks.  The week of April 5th- I been to experience struggling the ability to breathe. I was having serious pain in my left side of my chest and in the lower left side in my back. It was so severe, I went to the hospital on April 8th and at the hospital the Doctors discovered I had blood clots in my lung. I was in the hospital for 2 days. Iam currently on blood thinners inhaler and and oxygen.
Severe Uveitis in both eyes.  Treatment included 1 drop of Cyclopentolate in each eye 3 times daily for 4 days; 1 drop of Durezol in each eye 6 times daily for 4 days; for the next 10 days treatment included 1 drop of Cyclopentolate in each eye 1 time daily and 1 drop of Durezol in each eye 4 times daily; for the next 5 days 1 drop of Durezol in each eye 3 times daily; for the next 5 days 1 drop of Durezol in each eye 2 times daily; For the next 5 days 1 drop of Durezol in each eye once a day.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Pertinent medical history and concomitant medications were unspecified by reporter. On an unknown date unspecified number of unspecified patients vaccinated with PNEUMOVAX 23 (route of administration, anatomical location, dose and lot number was unknown) that were exposed to temperature outside of the proper storage range (stored temperature were unspecified by reporter). No adverse effect reported. The outcome of the events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Itching; Weakness; This is a spontaneous report from a contactable consumer or other non-hcp (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date in 2021 (Lot Number: FA7485, Expiry date: Unknown) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced itching and weakness. The outcome of the event was unknown.
Patient is a 50 y.o. male pancreatic cancer admitted 9/28/2021-10/6/2021 for abd pain and elevated bilirubin GI consulted and underwent EUS/ERCP on 9/29 - found to have stricture in neck of pancreatic duct which could not be passed, underwent IR guided PTC on 10/1, presented to OSH with pain and subsequently transferred due to coiled PTC, s/p IR replacement of PTC on 10/9.  Denies missing doses of Eliquis. Notes new CP and SOB overnight 10/11-10/12. Also should be wearing oxygen but current is not. Is getting out of bed to use the restroom but has significant fatigue and decreased mobility. Denies previous hx of VTE or bleeding problems.   50 yo male with PMH of pancreatic cancer admitted 9/28/2021-10/6/2021 for abd pain and elevated bilirubin GI consulted and underwent EUS/ERCP on 9/29 - found to have stricture in neck of pancreatic duct which could not be passed, underwent IR guided PTC on 10/1, presented to OSH with pain and subsequently transferred due to coiled PTC, s/p IR replacement of PTC on 10/9.   1. PE/DVT -9/30/21 U/S: Acute deep vein thrombus within the left popliteal vein and portions of the posterior tibial and peroneal veins. PTA Eliquis 5mg BID. (was hospitalized when diagnosed).  -10/12/21 CT C/A/P: Small bilateral lower lobe segmental and subsegmental pulmonary emboli without evidence of right heart failure.  -had been on Lovenox 70mg BID 10/9-10/11, changed to Eliquis 5mg BID -covid vaccines 9/13/2021 and 10/6/2021, i do not  lot numbers for 9/13/2021 but the lot number for the 10/6/2021 covid vaccine pfizer is EW0169   2. Pancreatic adenocarcinoma  -diagnosed 3/2021 -03/2021 EUS/MRCP: 2 cm mass or 2.3 cm mass in his pancreas -03/2021-07/2021: pt was treated w/ Folfirinox, and pt did have some mild improvement in his markers; however, pt was not able to tolerate sx (extreme fatigue, wt loss, n/v) -07/2021-current: Pt transferred care to Dr. (as it was closer). He was started on Gemzar and Abraxane (07/2021-current; last treatment was 09/14. He is on 3 weeks on weekly infusion, followed by 1 week break). When last seen, pt was told that he has not been responding well to Gemzar and Abraxane (and he had also been having very bad neuropathy associated w/ medication). - 9/28/21 CT a/p- slight increase in pancreatic head malignancy. Small peripancreatic and periportal LNs. Moderate intrahepatic and extrahepatic biliary ductal dilatation with abrupt tapering in region of pancreatic mass. Multiple small hepatic mets. -plan to start Larotrectinib as soon as available from specialty pharmacy  -will follow with Dr.    3. Obstructive jaundice  -PTC replacement 10/9   Recommendations: -Discussed CT with radiology, and although PEs could be subacute (we have no CT chest to compare it to within the last month) he endorses new CP and SOB overnight so favor failure of Eliquis.  Recommend changing to Lovenox, ok with once daily dosing of 1.5mg/kg.  -Will arrange f/u with Dr. in 3 months to discuss duration -daily CBC
I was very tired. I also had some pain in my left hip and my sciatica flared up on my left side.  Not sure if just a coincidence