chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 12-May-2023, the patient experienced PRODUCT ADMINISTRATION ERROR (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION ERROR (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml).    This case contains information about the 17th patient out of 27 patients as described by the reporter.  All the patients were over the age of 65 years.  No concomitant medications were reported.  The first booster dose of vaccine was administered in the deltoid site.  On 10-May-2023, 27 patients received 0.25 ml booster dose of the Moderna bivalent vaccine instead of 0.5 ml dose.  On 11-May-2023, 26 patients were contacted, and on 12-May-2023, 18 patients received an additional 0.25 ml booster dose, 2 patients made appointments to receive the following week and 1 declined to receive the additional 0.25 ml dose. A husband and wife pair stated that they would go to the clinic to receive the additional dose but gave no specifics and one patient was mailed a letter as he was not able to be contacted by phone.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case
TERRIBLE MIGRAINES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced terrible migraines. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of terrible migraines was not reported. This report was non-serious.
pt recvd vax;to er 2 days p/ vax;Dad said T up to 103;unable to get T down;meds given;
Received first vaccine at 17; A regulatory report () was received from a consumer concerning a 17-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  while the product was found to be administered at an inappropriate age.   The patient's medical history were not provided. Concomitant were not reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  It was observed that the patient received first dose of vaccine at 17 (product administered to patient of inappropriate age).  Treatment information were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event was considered to be resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
taste in her throat; bad headache; pins and needles sensation on the lower portion of her face and tongue; Itchy; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot Number: EN6198,Expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 25Feb2021 16:15 as 1ST DOSE, SINGLE for covid-19 immunisation,(Age at vaccination-68 years). Medical history included ongoing food allergy, ongoing drug hypersensitivity(Does not do well with Penicillin or Sulfa), blood pressure abnormal, thyroid atrophy,drug hypersensitivity (Does not do well with Penicillin or Sulfa) from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (TIROSINT) taken for an Thyroid, amlodipine taken for an blood pressure, zolpidem tartrate (AMBIEN) taken for an sleep ,unspecified start date and ongoing. On 25Feb2021 The patient experienced taste in her throat, bad headache, pins and needles sensation on the lower portion of her face and tongue, itchy. The patient had not received any other vaccine within 4 weeks. The patient visited emergency room/ physicians office. The clinical outcome was recovered.   No follow-up attempts are needed. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 21 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pre-existing autoimmune disease" (unspecified if ongoing); "congenital heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: Nasal swab; (Dec2022) Negative, notes: for three days; (Dec2022) Negative, notes: for three days; (Dec2022) Negative, notes: for three days. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a certified medical assistant (C.M.A) referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L001316 with expiration date 10-NOV-2016, dose and route were unknown) oral. No concomitant therapy was provided. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Soreness at injection site and fever of 99.8°f. As well as muscle aches and fatigue.
Patient received influenza vaccine at hospital employee health (she is a student nurse). Traveled by car to health services. Once on campus noted severe whole body pruritus and redness to left arm/chest. No other rash or urticaria, no anaphylaxis, no breathing difficulties or mouth/eye edema. Treated with diphenhydramine and monitored. Relieved a great deal. Sent back to vaccine administrator and PCP for follow-up.
I tested positive for covid 19 on aug, 19th 2021 Coughing  Headache  Chills  Fever Body aches Shortness of breath Extreme fatigue Loss of smell and taste
General malaise; Vaccination site pain; patient never received the second dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (General malaise), PRODUCT DOSE OMISSION ISSUE (patient never received the second dose) and VACCINATION SITE PAIN (Vaccination site pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient never received the second dose). On an unknown date, the patient experienced MALAISE (General malaise) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, MALAISE (General malaise) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (patient never received the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by the reporter  It was reported that the patient did not take any medications to treat the symptoms Patient was taking concomitant medications but refused to provide the information The patient reported that the symptoms lasted for about 3 to 4 days   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Live-follow was received contains no new information
COVID 19 Treatment; COVID 19 Treatment; 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 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 15:00 as dose number unknown (booster), single (Lot number: GH9693) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mixed connective tissue disease" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE, start date: Jun2010; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE], start date: Jun2010; EFFEXOR, start date: Jun2012. Past drug history included: Sporanox, reaction(s): "known allergies: sporanox", notes: known allergies: sporanox. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (04Feb2023) Negative, notes: I tested negative for COVID in the morning of 04feb and 05Feb but tested positive this morning, 06Feb; (05Feb2023) Negative, notes: I tested negative for COVID in the morning of 04feb and 05Feb but tested positive this morning, 06Feb; (06Feb2023) Positive, notes: I tested negative for COVID in the morning of 04feb and 05Feb but tested positive this morning, 06Feb.  Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.
In Oct90 10 out of 59 pts were found to have insuff or neg antibody levels during post serology testing for anti- HBs.  (see EBU910168 - EBU910173 - EBU910175 - EBU910177)
Narrative: 71yo male with hx of degenerative lumber spinal stenosis, osteoporosis, hypothyroid, basal cell carcinoma of skin, DM type 2, barretts esophagus with dysplasia, HDL, renal transplant, COPD, carcinoma of lung, colon polyp, HTN had received covid vaccines on 1/7/2021 & 2/4/2021. Pt's wife informed facility patient passed away at outside hospital on 6/8/2021. No information available regarding patient's death at outside hospital. Likely not related to covid vaccines given > 120 days prior to death.
Male and I got our second shots (Moderna) yesterday about 3:00 p.m.  By that evening I was feeling "off."  When I went to bed I began to experience constant severe chills.  I put on more pajamas, warm socks, and extra blankets.  No improvement.  I slept fitfully, shivering with cold in a room that was 74 degrees.  I finally got up around 4:00 a.m. and took my temperature.  Normal.  I began to have diarrhea and in a few minutes, I was nauseous and began vomiting.  It was a rough night, and I just assumed I had picked up some intestinal bug.  I happened to have an appointment today with a new doctor I am trying out to replace my former primary care doctor.  The moment I mentioned my symptoms, he said it was the COVID booster.  He has a specialty for geriatric patients and has seen this already.  His own mother had the same reaction to her second booster shot.  Naturally, male had no trouble at all!
next day 100 degree temp - day 3 urine turned dark orange - day 4 urine dark orange - day 5 urine a thick white color - on 11/03/2022 I was able to see Dr and was given Antibiotics - after finishing the antibiotics the UTI came back - I have had this UTI come back three times. It has been two weeks now after the last antibiotics (01/8/2023) and so far the UTI has not returned.
I had a small red rash that appeared at injection site 24 hours after the shot. It faded fairly quickly and was gone by February 17, one week after injection. February 18th I awoke (8 days after injection) to another red rash that is hot to touch, swollen, red and itchy. It's gotten a lot bigger today February 19th just since 9am.
pt. developed an injection site rxn with blotchy redness, warmth and burning pain. Pt recovered after 2 days.
pt recv vax & exp swelling & itching @ the inj site;no other info provided;
Had rash-all over body started on stomach-had her soak in oatmeal.  Vomited-just gave her water.  Shot on Saturday-symptoms on Wednesday.
Received flu shot at work. About 2 am, I was awoken with tingling and pain in both my thumbs and index fingers. By 6 am, it had spread to all 10 fingers. Difficulty with fine motor, using an utensil etc.  By 6pm, I had red splotches on both hands and throbbing pain with use and at rest.  Consulted with employee health and agreed to wait and see.
Nerve ending irritation in forearm and shoulder  followed by constant tingling (pins and needles feeling) in my left hand.  This tingling and forearm irritation has continued since this second dose of the Moderna vaccine in March 2021.
Patient presents for ER follow-up. He was seen in clinic on 1/22 for his WCC and received Tdap and MENACTRA. He developed swelling and itching at the site 24 hours later. No fever. Was seen at medical center on 1/24 for pain and swelling. He was diagnosed with cellulitis and placed on Clindamycin and BENADRYL q8 hours. The swelling and pain is much improved. Per notes from medical center he presented to the ER 3 days after receiving vaccinations. Exam was notable for "large area of erythema, warmth, induration and tenderness to palpation to left upper arm over deltoid. Small scab to center from injection. No fluctuance. No drainage. Small nodule palpable to anterior aspect of axilla. Tender to touch." Ultrasound was performed with impression: Cellulitis without abscess.
Severe Vertigo, Fever 102.6, Body aches, Hard chills, nausea, mild headache, sore and rigid deltoid muscle, lymph glands on left side (neck to waist) swollen and painful. Fell and injured back because of vertigo
Developed shingles the day following vaccination.  Patient reports having rash to side of face, neck, chest, shoulder, back of head and upper back.  Patient states having continued nerve pain and itching with some blistering reappearing on back of head and neck.
Narrative:  COVID infection following COVID vaccine series 01/16, Pfizer,  dose #1 02/06, Pfizer, dose #2 10/14, Pfizer, dose #3 09/01 COVID swab, result:  detected 09/01 pt cc: loss of taste or smell, myalgias, productive cough exposure: unknown 09/01 SARS-COV-2 LINEAGE result: B.1.617.2 09/01 SARS-COV-2 CLADE result: 21 J (DELTA)
30 to 40 minutes after vaccine a numbness creeped up the left side of my shoulder, then the left side of my throat/neck, then the left side of my face. It felt slightly numb, but was not paralyzed and i was able to see fine. It started to wear off after about 4 to 5 hours. Woke up in the morning and face seems back to normal.
pt devel an extreme local reaction @ inject site & fainted following Hep B vax in 1988; exp described as anxiety reaction;
Client's father requested Pfizer 0.3 mL first dose. Client received Moderna 0.5 first dose instead. Client was observed for 30 minutes by RN. Client did not present with any signs or symptoms of an untoward response or reaction to the Moderna first dose.
Persistent diarrhea 12-15 x 1 day lasting > 2 weeks All stool studies normal.
palpitations; Heart arrhythmia; Third dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Nov2021 18:00 (Lot number: FE2593) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin, yeast; "Known allergies: yeast" (unspecified if ongoing), notes: Known allergies: yeast. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE , prev dose brand: Pfizer, Batch/Lot No: EW0150, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), administration date: 02Apr2021, when the patient was 28 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE , prev dose brand: Pfizer, Batch/Lot No: EW0165, Location of injection: Right arm, Vaccine Administration Time: 12:00 PM), administration date: 23Apr2021, when the patient was 28 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 15Nov2021, outcome "unknown", described as "Third dose"; ARRHYTHMIA (medically significant) with onset 28Nov2021, outcome "not recovered", described as "Heart arrhythmia"; PALPITATIONS (non-serious) with onset 05Dec2021, outcome "not recovered", described as "palpitations". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Dec2021) negative, notes: Nasal Swab (PCR). Therapeutic measures were not taken as a result of arrhythmia, palpitations.  No follow-up attempts are possible. No further information is expected.
PATIENT RECIEVED A VACCINE THAT WAS 5 DAYS PAST THE BUD 01/23/2023
Pt called on 6/09  stating that she felt awful, and didn't get any sleep due to severe nerve pain on touch and numbness and tingling everywhere, even on the bottom of her feet , She stated that she felt so weak that she could not even "let the dog out" or climb the stairs, Patient ended up calling in sick to work . this started about 6pm on 06/08. Patient ended up going in to the clinic on 06/09 and saw a prescriber. She stated that she had a 100.6 temperature and that her Dr stated that she might have a urinary tract infection.. She was prescribed a sulfa antibiotic for 3 days. I contacted patient at 6pm 06/09 and pt stated that she still felt numbness and tingling all over and felt "awlful" yet .
On 4/19/2021, I received my second dose of Moderna. On 1/17/2022, I began having COVID symptoms. I took an at-home test that day, and the result was positive. This was a breakthrough case. I immediately called my doctor, and I was prescribed dexamethasone. I was sick for about 3 1/2 weeks. I had fever, chills, severe body aches, diarrhea, and vomiting. The fever usually ran about 102 degrees. In addition to the dexamethasone, my doctor also instructed me to take Tylenol and ibuprofen, alternating them every 3 hours. This really helped with the fever and body aches.
Developed cough that progressed to wheezing and decreasing O0 Sat to 90%.
Extreme soreness in upper left arm, painful to lift arm,  approximately 10 hrs after I received the vaccine shot.
Patient received her second dose of Pfizer in her left arm (LOT # EW0179, Exp 04/28/2021 at 1010). Vaccinator, LVN administered this vaccine 2 days early. Vaccinator stated he was counting dates incorrectly and realized after giving the vaccine that he counted the days wrong. Patient was informed of the recent CDC change. Patient did not experience any side effects or adverse reactions while on site.
next morning woke up with bad body aches and headache. Symptoms lasted all day, did not take any medication. i went to bed early and woke.up next day feeling fine. i had no ill effect after first round of shot on 2/17/2021. no ill effects after3/18/2021
pt recvd 1st dose of Engerix-B 4OCT91 & 45 mins p/inject pt exp chest congestion, tightness, nausea, vomiting, tiredness & sweats until 36 hrs p/inject;
pt recvd vax 31OCT95 & 12NOV95 pt devel redness @ inj site & felt chilly;15NOV95 pt noticed varicella-like pox lesions @ inj site which were not open @ the time of the report;reporter stated pt was out of work;
This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles after 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles after 2nd dose). At the time of the report, HERPES ZOSTER (Shingles after 2nd dose) outcome was unknown.            No concomitant medications were provided. No treatment information were provided.   This case was linked to MOD-2021-405216 (Patient Link).
This spontaneous report was received from a physician via a company representative, concerning to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX vial, (dose, route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. On an unknown date, the patient had a zoster rash on the unspecified arm that was the same arm of vaccination with ZOSTAVAX. The patient sought unspecified medical attention. On an unknown date, the patient recovered from the event. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
othostatic Narrative: The patient looked pale, shaking, reported light headed after got the  vaccine for COVID 19. The staff in the clinic put him down the ground with  feet and legs lifting on the chair. Ice bag provided. At that moment (1250), checked his Vss: BP 103/62,HR 75, 02sat 98%, 10 mins later (1355),his Vss BP 120/80, HR70,02 sat 99%. He stated feeling better, face color turned to pink, the patient said no dizzy any more. Juice provided. Last Time (1330) checked the patient VSs: BP 117/77, HR 87,02 98%. The patient reported feeling OK. He has been released to  home.