chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LOW BACK PAIN; LEGS FELT VERY HEAVY; WALKING VERY SLOW; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (LOW BACK PAIN), LIMB DISCOMFORT (LEGS FELT VERY HEAVY), GAIT DISTURBANCE (WALKING VERY SLOW) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product OCTREOTIDE for Acromegaly.    The patient's past medical history included Hypertension since an unknown date, Acromegaly since an unknown date, Borderline diabetes since an unknown date, Hypersensitivity since an unknown date, Constipation since an unknown date and Back disorder since an unknown date. Concomitant products included CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE, PANTOPRAZOLE and DENOSUMAB (PROLIA) for an unknown indication.   On 26-Mar-2021, the patient started OCTREOTIDE (unknown route) 20 mg. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced BACK PAIN (LOW BACK PAIN), LIMB DISCOMFORT (LEGS FELT VERY HEAVY), GAIT DISTURBANCE (WALKING VERY SLOW) and FATIGUE (Fatigue). At the time of the report, BACK PAIN (LOW BACK PAIN), LIMB DISCOMFORT (LEGS FELT VERY HEAVY), GAIT DISTURBANCE (WALKING VERY SLOW) and FATIGUE (Fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomittant: unspecified high blood pressure medication, an unspecified medication for allergies, unspecified vitamins,
Moderna COVID-19 Vaccine   Explosive diarrhea within the hour.  That lasted all night.  I had a severe headache for two days requiring lots of aspirin.  Sensitivity at injection site lasted for approximately two days.   That's it.
Pt called on Sunday, May 19 at 11:30ish to report an adverse reaction to her shingrix shot received on May 16.   Pt stated the night after getting her shot, she suddenly felt feverish, sweaty, achy after supper, then better before bedtime.  Upon awakening the next morning, pt stated she removed the bandage, noted area to be red, hot and "pus-y" looking.   Over the course of the day, she stated the swollen area continued to grow and went around her arm.  She stated that it continued to feel hot, and noted two white dots appeared near where the shot was administered.  Today, she reported the red area seems to be lightening in color, and is no longer growing and seems to begin shrinking
This spontaneous report as received from a female patient of unknown age refers to herself. The patient was vaccinated with ZOSTAVAX (lot number, dose, route and injection site were not reported) on 11-OCT-2012 for prevention of shingles. No other co-suspects were reported. NO concomitant medications were reported. On 15-OCT-2012 the patient started flu-like symptoms. She had pain in her muscles in her back, a headache and some blurred vision (for distance only). There was no treatment given for adverse events and no laboratory diagnostics study performed. The outcome was unknown at the time of report. The patient had seen the health professional on 15-OCT-2012 for medical attention. Additional information is not expected.
Pt. developed generalized hives, swelling of face, eyes, lips & ears. Vitals stable afebrile. Rec'd Dexamethasone & BENADRYL.
Arm was terribly sore; Initial information was received on 12-Oct-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care professional.   This case involves a patient (unknown demographics) who had arm was terribly sore (pain in extremity) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious arm was terribly sore (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
On 7/20 began having a dull tightening pain on right side of chest, also had pain radiating down right arm, seen by MD RX with Advil site has 3 inches of induration with swelling and erythema on 7/25/06.
Friday coughing; Sneezing runny nose; Sneezing runny nose; Pain at night in left arm; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: EP6955), via an unspecified route of administration in the left arm on 18Mar2021 at 09:15 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. Prior to the 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 4 weeks prior to the COVID vaccine. The patient had no known allergies to medications, food, or other products. The patient experienced pain at night in the left arm on 18Mar2021 at 18:00. The following day, Friday, on 19Mar2021, the patient experienced coughing, sneezing and runny nose. The patient did not receive any treatment for the reported events. The clinical outcome of the events painful left arm, coughing, sneezing and runny nose was recovering at the time of this report.   No follow-up attempts are needed. No further information expected.
There was not an adverse reaction but reporting that this dose of vaccine was given from a bottle stored beyond the 31 day refrigeration time.  It was given a day after said noted expiration date of refrigeration.
PENTACEL was prepared incorrectly.  Instead of mixing the powder with the liquid, Dtap and Polio and Act-Hib all separately, no AE; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves patient of unknown age who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number and expiration date not reported) that was prepared incorrectly, that is instead of mixing the powder with the liquid, DTaP and polio and Act-Hib all separately via unknown route in an unknown  administration site for prophylactic vaccination (PT: product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate reconstitution technique (same day latency).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
pain in his right arm; shingles; This is a spontaneous report from a contactable consumer.    A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter stated they know one fella who on an unspecified date had pain in his right arm after the Covid shot, shingles was being affected from the shot. Outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report was received from a 74 years old male consumer reporting on himself with a history of heart problems and no drug reactions or allergies, who on 11-JUN-2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. Concomitant medications included TOPROL XL tablets, CRESTOR, PROTONIX, ZESTRIL and ferrous. The consumer stated that about a week ago, on approximately 01-AUG-2012, he still developed shingles. DOMEBORO was given as a treatment for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The relatedness for patient still developed shingles was unknown of ZOSTAVAX. Additional information has been requested.
Immediate dizziness, 1 hour later extreme malaise, extreme tiredness, sleepiness, extreme ill feeling.
Approximately 5 hours after receiving my 2nd Pfizer Covid shot, I started to get diffuse abdominal pain & back aching. Seen in the ED 1/8/20 - Negative US, Normal labs - returned to ED 12 hours after D/C for worsening abdominal pain. 1/9/21 - CT showed Appendiciticitis
A week after he received his first dose of Pfizer, he developed SOB and went to urgent care. He was told that this was a common vaccine reaction and sent him home. His symptoms subsided. After his second dose of Pfizer, he again developed SOB and went to urgent care. He was again told that this was a common reaction and was sent home. He went to the ED because his symptoms worsened and he developed back pressure as well as RLE swelling/pain. He also developed on and off sharp chest pain that would only last a couple of seconds. He was admitted to ED obs at Strong and was Found to have extensive bilateral PE on CTA chest. US doppler of the BLE showed DVTs in RLE. Echo showed some RV strain and his troponin was in the 100s. He was started in Eliquis 10 mg BID. He finished his 7 day course of 10 mg BID and is now on the 5 mg BID regimen.    Today he says that his symptoms have improved. His SOB is better and the back pressure and RLE swelling/pain has resolved. He and his mom were wondering if any follow up was needed in terms of imaging. I said that he would likely get a repeat US of his legs in 3 to 6 months given the unclear nature of the etiology of his PE/DVT. It could be due to the vaccine or it could be unprovoked. They asked about activity and I said it was fine, but if he is feeling tired or more short of breath to back off. He is ok to travel.    provider note from follow up visit 8/2/2021)
Pt was very sleepy very fatigued w/ any activity was not sweaty. Myalgia and weakness, fatigue, terrible (L) arm ache mid deltoid.
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 22-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    Concomitant product use was not provided by the reporter. More or less 170 - monovalent and 20 bivalent doses had been administered which were beyond the 30 day beyond use date. Vaccine administered on 23-Feb-2022 with lot number 042J21A after 30 days BUD date which was 17-Feb-2022. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live follow up has been appended.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
- light headedness, headache started later Some itchiness but did not last BP - 118/84 Headache not resolved
Severe muscle aches, shaky, goosebumps all over despite layers of clothing, fever of 101, swelling from my shoulder down to my elbow along with red splotches that were scaly and itchy, my arm is hot to the touch and extremely painful, flank (kidney pain, left side)
For two days my only side effect was pain at the injection site. Exactly one week after the vaccine dose 1, I was doing yoga and lying on my right side when I experienced nystagmus. It lasted about 20 seconds and then I had some dizziness related to visual issues, my eyes feeling like they were floating, slow to land on objects. I had a very mild headache for two days. The nystagmus has continued every day (now 11 days past the first event), but only when I first sit up after lying down on my right side. It subsides completely in a few minutes and has no other triggers that I've found, and I am able to go about my normal activities which include driving and riding a bike, as well as reading and computer use.
Redness in the area, according to the patient presented with welts in the vaccinated arm like shingles. From the deltoid to the forearm. This is the second dose and the patient is immunocompromised due to a medical condition.
One 5mm autoinoculation. Site approximately 5 cm distal to primary vaccination site.
Swelling, erythema, pruritus (L) deltoid - BENADRYL and CEPHALEXIN X 1week
Sore Arm, Redness and swelling at site of injection lasting  starting day of injection lasting 5 days, 2 Days fever ranging from 99.6 to 101.6
Chest pressure; Episodess of sob, chest pressure, and tiredness that started the day after 2nd injection and has continued every 2 or 3 day since last episode was 4/14 during the night.; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm right on 18Mar2021 at 13:15 hours (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and diabetes. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and metformin hydrochloride (METFORMIN) from unknown date and for unknown indications. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the arm right on 25feb2021 at 13:15 hours (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Prior to the 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. On 19Mar2021 at 09:00, the patient experienced episodes of shortness of breath, chest pressure, and tiredness that started the day after 2nd injection and has continued every 2 or 3 day since last episode was 14Apr2021 during the night. Therapeutic measures were not taken as a result of these events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events shortness of breath, chest pressure, and tiredness was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Constant Feeling as if I was going to die because my heart was going to explode; Constant Feeling as if I was going to die because my heart was going to explode; Rapid irregular heartbeat Between 106 and 140 bpm; Increased diastolic and systolic blood pressure 158/114; Increased diastolic and systolic blood pressure 158/114; Shortness of breath; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received bnt162b2 (BNT162B2), first single dose via an unspecified route of administration, administered in arm left on 26Jul2021 at 12:00 (Batch/Lot number was not reported) for covid-19 immunisation at age of 30-year-old. Medical history included penicillin allergy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced rapid irregular heartbeat between 106 and 140 bpm, his normal pulse was about 70 bpm; experienced Increased diastolic and systolic blood pressure 158/114, his normal blood pressure 105/65- 120/75; experienced shortness of breath and fatigue and constant feeling as if he was going to die because her heart was going to explode; all events were on 28Jul2021 at 12:00. The events resulted in: Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome and treatment were unknown. The events reported as non-serious.   Information on the lot/batch number has been requested.
has severe all body muscle ache for 4 days after vaccination. and  1-2 weeks after vaccination, developed intense palpitation and episodic chest pain, wake up from sleep. has to do  a stress test to r/o cardiac ischemia
Blotchy skin, "itching" scattered small red dots 4 hours after influenza vaccine. Rx with BENADRYL every 12 hrs. Office visit x2.
Redness, soreness, swelling and itching as well as some pain Started on second day after vaccine given for Shingles
05/11/2021: Day of vaccination second dose I had an extremely sore arm after the vaccine. Right after the administration of my vaccine I started to become dizzy. After these symptoms receded I then went home. I did then have a fever, cold and flu symptoms after wards. I did have a headache as well and the fever went away after a few days. I still had the flu like symptoms and about 5 days post vaccine I did start to have chest pains and pressure build up. I then contacted Dr. regarding chest pain, I was told to go into Urgent Care and then the ER due to the chest pain conditions. They did an EKG and did not find anything abnormal. They did an x-ray as well which did not show anything abnormal. I was given an Iv injection due to dizziness that was persisting. They sent me home the same day. No prescriptions given and symptoms persisted for a while and they did minimize. The chest pain wouldn't allow me to take deep breaths and I did have chest flutters as well and it has increased since then. Dizziness is not as bad however it does come and go often. Flu like symptoms have gone away however I am still experiencing migraines to this day. As of now I am also still experiencing fatigue going on.  Because of the increase in consistency with heart palpitation I did go in for an exam and a heart monitor for 14 days. The doctors stated that there was nothing that they could do at this point and to check in every couple of months.
Chest pain so bad thought I was having a heart attack; Pain in the arm; Headache; Nausea; Vomiting; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain so bad thought I was having a heart attack), PAIN IN EXTREMITY (Pain in the arm), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057620A) for COVID-19 vaccination.     Concurrent medical conditions included Endometriosis. Concomitant products included OXYBUTYNIN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), MULTIVITAMINS [VITAMINS NOS] and PROBIOTICS NOS for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced CHEST PAIN (Chest pain so bad thought I was having a heart attack), PAIN IN EXTREMITY (Pain in the arm), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, CHEST PAIN (Chest pain so bad thought I was having a heart attack), PAIN IN EXTREMITY (Pain in the arm), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
0.3ML COVID-19 VACCINE administered IM left deltoid AT 11:50AM today 4/20/2021                                                                       at 11:55 AM patient complained of Dizziness, patient was visibly Flushed,  Pale looking;  Sweating profusely,  Water 4oz  given to him.   AT 12:04, he complained of DIFFICULTY BREATHING, 12:05 EPIPEN 0.3mg one dose administered (left thigh); 911 ACTIVATED; PARAMEDICS ARRIVED AT 1211pm                BP  87/55   at 11:55am;  87/57 at 12:00pm;  Epi-pen 0.3mg at 12:05pm; 12:10pm BP: 114/75 Pulse 51; 12:55pm 90/58; one bottle of Pediatric Electrolyte plain 32oz given, patient declined EMS pick up.  1:00PM bp 100/63; Pulse: 51.  O2 sat at  99 the whole time period .  Patient went home with mom.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier (s): MOD22-013231. A 67-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 2, single (Lot number: EL9262) for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZOLPIDEM; AMITRIPTYLINE; LISINOPRIL; METOPROLOL; MONTELUKAST; SENNA [SENNA SPP.]; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN B3; LUBRICANT. Vaccination history included: BNT162b2 (Dose: 01, Batch Number: EL3246, Route: Intramuscular), administration date: 17Jan2021, for COVID-19 Immunization. The following information was reported: BLINDNESS (medically significant) with onset 2021, outcome "recovered" (2021), described as "he lost eye sight for 3 months". Patient had his first Pfizer COVID-19 booster vaccine (lot number: 301348A) on 26Sep2021 at the facility in contact 4 and stated he blew a blood vessel in the left eye after this. No follow-up attempts are possible. No further information is expected.