chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 11:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, start date: May2010; DYAZIDE, start date: May2010. Past drug history included: Compazine, reaction(s): "known allergies Compazine", notes: known allergies Compazine; Phenegran, reaction(s): "known allergies phenegran", notes: known allergies phenegran. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Dec2022) Negative, notes: After testing negative on 25Dec2022; (28Dec2022) Positive, notes: Tested positive on  28Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 17Dec2022 to 22Dec2022..
Painful Swollen lymph node on side of breast/under armpit  on third day after receiving the vaccine.
Swollen armpit  thats sensitive & painful  noticed swelling starting 3/14/2021 recommended following up w/MD
shaking; bad headache; chills; fever; nausea; aching muscles; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea) in a 73-year-old male patient who received mRNA-1273 (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced TREMOR (shaking), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and MYALGIA (aching muscles). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TREMOR (shaking), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and MYALGIA (aching muscles) outcome was unknown.             No concomitant medication provided.
Swelling, redness at site of injection day of vaccination in left arm. Next day the reaction spread from shoulder to elbow. Continues to be painful, hot and skin is tight as of 01/15/2003 at 09:20 MD saw the pt at the medical center-s/s indicate celllitis. MD advised further diagnosis. Too soon for cellulitis reaction.
Rigors, Chills, Headache, Lethargy for 18 hours after symptoms started.
Patient feeling very anxious before and after vaccination. Described having difficulty swallowing water shortly (~15 min) post vaccination. Patient was tearful but breathing normally. Walked under her own power from the pharmacy down to the Emergency Room for anxiety over anaphylaxis. Given dose of Vistaril in ER.
Approximately 5 months after my 3rd dose vaccination I contracted COVID-19 and experienced the following symptoms: Body aches, Mild fever, Sneezing, Cough that would trigger a chest pain, Sore throat and fatigue. I took Advil cold and sinus which helped with the majority of my symptoms to get better  and Most of the symptoms lasted for 2-3 days except for the cough which has not improved even after 10 days, . I decided to see a doctor regarding this because there were instances that I was feeling out of breath because of the cough. The Doctor and initially prescribed me with a cough suppressant but it didn't really help me as much. So I went back and they gave me another prescription of  Albuterol Inhaler and Prednisone which has helped me feel so much better. I can't say that i'm a 100 percent back to normal but I have been feeling better ever since.
ER - chest pain, ER - small bowel obstruction. Hospital admission. These visits were within 6 weeks of receiving the COVID vaccine.
Feeling very cold; Anxiety / Covid19 symptoms similar to anxiety; Hands cold feel like ice packs; Trembling / little shaking; Twitching; Shortness of breath; Migraine; Fever 96 F, 98 F, then 96.6 F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 215M20A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included LORAZEPAM, LEVOTHYROXINE, MAGNESIUM GLYCINATE, PARACETAMOL (TYLENOL EXTRA STRENGTH), CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]), FISH OIL, VITAMIN B12 [VITAMIN B12 NOS], VITAMIN B2 [RIBOFLAVIN] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). On 02-Mar-2021, CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Did not get the 2nd dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose of Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose of Moderna COVID-19 vaccine). In 2021, PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose of Moderna COVID-19 vaccine) had resolved.            No relevant concomitant medications were reported. Patient moved and didn't get the second Treatment information was unknown.   Reporter did not allow further contact
pt c/o taunt muscles, low fever 99, throbbing h/a, all joints hurt, chills/fever, & knee's & ankles feel swollen/warm/hot but are not swollen;
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 38 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no illness at the time of vaccination, no past history of similar events, no adverse event after any previous vaccination, no history of allergy to vaccine drug or food, no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, with cause, no family history of any disease (relevant to vaccination) or allergy, not pregnant at time of vaccination and not currently breastfeeding. The patient previously received covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, intramuscular and batch number: 201A21A, expiry: unknown) dose was not reported, 1 total, administered on 22-May-2021 on left (location unspecified) for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, and batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, 1 total administered on 23-DEC-2021 on left (location unspecified) for prophylactic vaccination. No concomitant medications were reported.  On 23-DEC-2021, the patient received expired vaccine administered (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382, 20220261039, 20220261092, 20220261063, 20220260967, 20220261043, 20220261022, 20220261030, 20220261000, 20220261048, 20220261014, 20220260995, 20220261024 and 20220261042.
the patient was noted to have a "cyst localized on the left upper limb"; the patient developed a "1.5 centimeter lump" at the injection site on an unspecified date.; Information has been received from a healthcare business professor(HBP), referring to a 17 years old female patient. Information of concomitant therapy and pertinent medical history was unknown. The patient was allergic to benzyl peroxide and minocycline (reported as monocycline).  On 06-MAY-2019, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot # R010596, expiration date: 11-DEC-2020, strength, dose, frequency and route were unknown) for prophylaxis.   On an unknown date in 2019, the patient developed a "1.5 centimeter lump" at the injection site. On 11-JUN-2019, the patient was noted to have a "cyst localized on the left upper limb" when seen by the physician. It was unknown if  treatments were given for the events. No lab diagnostics or studies were performed for the events. The outcome of the events was unknown. The causality assessment was not provided by the reporter.
Hard time sleeping, restlessness, sore shoulder and stiff neck. Weakness, sluggishness.
nausea, vomiting, fever, severe site pain-onset 6hrs p/vax lasted 6-8hr duration
45min p/vax pt felt fullness in ears, going down throat-eyes felt funny-no trouble swallowing epi given w/good effects;rescue called taken to ER;
Sore arm at injection site for 3 days. Heavy fatigue for 2 days after injection.
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient started shaking about 5 minutes after COVID shot. He was sitting next to his dad and the dad called for help immediately. Patient did not fall or lose consciousness. We layed the patient down on the bench and put his feet up. A retired paramedic helped until 911 arrived. Patient seemed ok when he left with the ambulance, but dad wanted to make sure it wasn't a seizure.
Patient experienced stomach upset and achy joints (all joints) 15-20 minutes after receiving Moderna booster (boosting her first 2 Pfizer doses) and Fluzone HD. She says the joint pain/discomfort has improved but continued since then (15 days). I advised her to follow up with her primary care provider.
This issue might/might not have impacted this individual. We identified a possible storage and handling issue of one particular vial of vaccine might have made the vaccine less potent on June 16, 2022. Doses from this vial were given to 9 children on the date June 16, 2022. 17 children vaccinated that day. We have been unable to identify which 9 children received doses from the vial that was impacted. The vaccine was reconstituted and replaced in the refrigerator for what inadvertently became too many hours before it was used. We did extensive research with Pfizer and etc. We received documentation back from the correct medical unit at the company Pfizer, who researched this vaccine being out of range for possibly 2 additional hours than what they had data for as of June 2022. Each of the 17 children are being offered an additional dose now, 8 or more weeks after the possibly "invalid" dose administration. Encouraged to discuss this with their pediatric primary care provider, who have also been notified. We suggested the 8-week delay to potentially reduce the risk of side effects including myocarditis in children after an mRNA if another dose was given sooner. It has now been more than 8 weeks since that clinic.
This spontaneous report as received from a registered nurse refers to a 37 year old female patient. Patient's concurrent conditions included Kidney stones. The patient's medical history included unspecified broken arm (on unspecified date) and measles titer resulted low. The patient received a Measles shot on 15-DEC-1990 and Rubella shot on 05-MAR-1997. On 05-FEB-2014, the patient was vaccinated with MMR II, albumin status HSA, 0.5 ml, subcutaneous (lot # J006995, expiration date: 14-JUN-2015). On an unspecified date in February 2014 (also reported as "5-6 days ago") the patient experienced rash on her chest that was "blistery" and itchy". The reporter stated that the rash spread to the patient "back and arms and down to her genitals". On 15-FEB-2014 (also reported as "two days ago"), the patient was treated with VALTREX (manufacturer unknown). The reporter also reported that prior to receiving the MMR II, the patient had a titer drawn on 03-FEB-2014. She stated that the patient's measles titer results was "low" but that the patient was immune to mumps. No drug reactions and allergies were reported. The outcome of the events were reported as not recovered/not resolved. Additional information has been requested.
pt recv vax 15APR98 & devel fever of 104;pt was seen in ER where no treatment was given;
On 7/16/2021, I woke up with heavy breathing,  My BP was 190/103.   My breathing continued to worsen and my BP did not change.  I decided to go to the ER. They took blood work and EKG . The blood work indicated blockage and I was admitted for sugery and they placed 5 stents. I was in the hospital for 4 days and discharged with instructions to follow up with cardiologist, lifestyle changes,  new medications. , and I am wearing a life vest.   I will be starting therapy soon  and I have not been back to work yet.
Migraine headaches, nausea, sneezing, conjested,  ear ache, body ache, tired
patient c/o of feeling itchy at 4:10 PM; c/o chest tightness and heaviness 4:20 PM. Patient given Benadryl 50mg p.o. 4:12 PM; lungs were clear, O2 Sat:
high pitch screaming for 3-4 hrs, irritability for 2-3more hrs; low grade fever;
He had PCR +; He had PCR + with covid symptoms; dose_number=3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Nov2021 (Lot number: FF2589) at the age of 47 years as dose 3 (booster), single, intramuscular, administered in arm right, administration date 25Feb2021 (Lot number: EL3247) as dose 2, single, and intramuscular, administered in arm left, administration date 01Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported IMMUNISATION (medically significant) with onset 23Nov2021, outcome unknown; VACCINATION FAILURE (medically significant) with onset 28Dec2021, outcome unknown; COVID-19 (medically significant) with onset 28Dec2021, outcome unknown. The event he had pcr + with covid symptoms was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures sars-cov-2 test (28Dec2021) positive, Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The case was reported as serious.  No follow-up attempts are possible. No further information is expected. Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure is expected. The case will be reassessed further upon receipt of additional information.
Narrative: Patient is 70 y/o M with PMH of schizophrenia, hypertriglyceridemia, PAD, iron deficiency anemia, CKD stage 4, insomnia, folic acid deficiency, BPH, HLD, CHF, COPD, glaucoma, B-cell lymphoma, neurogenic bladder, Hep C, Diabetes insipidus, HTN, GERD, DM that was transferred from his nursing home residence to the acute care hospital for suspected aspiration pneumonia failing outpatient treatment. Patient had recent admission to an outside hospital for COPD/CHF exacerbation and UTI. COVID-19 test was negative 4/15/21, the date of his admission. During course of admission, patient respiratory status worsened requiring intubation, mechanical ventilation, and supportive critical care. He developed AKI requiring dialysis and had progression of CHF with EF of 15%. Patient did not have repeat COVID-19 test during his admission. Repeat COVID-19 test at time of discharged on 5/19/21 was negative. However, because of clinical deterioration including multi-system inflammatory syndrome and organ failure with poor response to antibiotic therapy, provider feels that the patient may have had COVID-19 which was clinically diagnosed but not identified on initial COVID-19 test. Provider obtained COVID-19 antibodies obtained at LTAC facility and found to positive without other know COVID-19 infection.
Chronic severe L shoulder pain lasting through present.Seen by ortho specialty. . Rehab therapy and steroid  and nsaid treatment initiated and continued.
Reported by patient: approximately 10 minutes after Varicella vaccine and 5 minutes after Tdap given, patient reported a burning sensation between shoulder blades. At 15 minutes after 1st vaccine (Varicella) patient reported itching to upper chest. Benadryl 50mg IM given to patient at 9:32 AM Patients skin became bright red between shoulder blades and upper chest area. Patient was observed for approximately 1 hour after onset of symptoms with symptoms resolving.
Second shot wiped me out as if I had pretty severe Covid. Not certain how to explain, but it definitely affected me and my ability to work as a lawyer. Best way to describe the feeling was having a very severe flu.
Patient fainted approximately 10 minutes after vaccination. Pharmacist checked blood pressure 140/87, pulse 74. Applied ice pack. Gave patient Gatorade and re-checked blood pressure. Patient stabilized. Wife drove patient home.
tested positive for covid after that he had a Moderna COVID-19 booster shot/So he had covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid after that he had a Moderna COVID-19 booster shot/So he had covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2021.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced COVID-19 (tested positive for covid after that he had a Moderna COVID-19 booster shot/So he had covid). At the time of the report, COVID-19 (tested positive for covid after that he had a Moderna COVID-19 booster shot/So he had covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported No treatment details were reported.  Patient had both Moderna COVID-19 vaccine shots then he contracted covid in September. After that he had a Moderna COVID-19 booster shot and then on 22-Nov-2021 he had another positive test. So he had covid twice now. Patient denied any other information about his case.   This case was linked to MOD-2021-404022 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no relevant medical history, who experienced the non-serious unexpected AESI event of COVID-19. The event occurred in unknown period of time after the third dose of mRNA-1273 vaccine administration. Causality for the event of COVID-19 was not applicable to the product administration. The rechallenge was not applicable since the event occurred after the third dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Face tingling/numbness and stiff jaw for ~2 hours after the vaccination.; Face tingling; stiff jaw; This is a spontaneous report received from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in the left arm on 21Mar2021 at 14:30 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. The patients medical history included hashimotos disease. Concomitant medications were included synthroid (MANUFACTURER UNKNOWN), nature throid (MANUFACTURER UNKNOWN) and junel (MANUFACTURER UNKNOWN) all for an unknown indication and from an unknown date. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. 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 facility where the patient received the vaccine was at a pharmacy or drug store. On 21Mar2021 at 14:30, the patient experienced face tingling/numbness and stiff jaw for approximately 2 hours after the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the events. The clinical outcome for the events face tingling/numbness and stiff jaw was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected
Pain in axilla, swelling in axilla that has went down some, no hardness on palpitation, no treatment
Hives on chest, axillary swelling, tender nodes and 1 1/2 cm visible swelling on the arm and front chest wall. TX Keflex 500mg TID x 10 days.
Received the second dose 18 days later; A spontaneous report was received from a pharmacist concerning a 35-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and received the second dose 18 days later (inappropriate schedule of vaccine administration).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an undisclosed date, the patient received his first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an undisclosed date 18 days later, the patient received his second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection 18 days after his first dose.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, received the second dose 18 days later, was resolved on unknown date.; Reporter's Comments: This report refers to a case of received the second dose 18 days later (inappropriate schedule of vaccine administration) for (mRNA-1273, lot # unknown ) with no associated adverse events.