chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cough; A spontaneous report was received from a Healthcare professional concerning a 67-year-old, female who received Moderna's COVID-19 vaccine and experienced cough.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020 prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number:026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 04 Jan 2021 she experienced cough.    On 05 Jan 2021 she woke up feeling better. Treatment for the event including inhaler.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event cough was resolved on 05 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
CONGESTION IN NOSE; TROUBLE BREATHING; RASH ALL OVER BODY; BRUISE ON LEG; BODY ACHES; CHEST CONGESTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 05/MAY/2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination in left deltoid. No concomitant medications were reported. On 13-MAR-2021, the subject experienced congestion in nose. On 13-MAR-2021, the subject experienced trouble breathing. On 13-MAR-2021, the subject experienced rash all over body. On 13-MAR-2021, the subject experienced bruise on leg. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced chest congestion. Treatment medications (dates unspecified) included: prednisolone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash all over body, bruise on leg, trouble breathing, body aches, congestion in nose and chest congestion was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Pain near injection site.  Pain has continued since my first injection.  I continue to have trouble getting dressed and many other simple tasks.  I had no adverse symptoms from my second injection.
I had my first dose on 11/23/21. No adverse effects.  I had my second dose on 12/14/21. No adverse effects. Just minor fatigued and body aches.  On 12/29/21, I visited the ICU ward of the hospital to visit my unvaccinated father-in-law who had contracted covid earlier in the month. This was my first contact with him since Thanksgiving week. We were crying, so I was wiping my eyes, but wearing a mask and likely contracted covid at the hospital. On 1/2/22, I began coughing and on 1/3/22, I began self-isolating. I had a PCR test on 1/6/22 and it came back positive for covid on 1/8/22. I have been in quarantine since testing positive with plans to take another test on 1/13/22. My symptoms have been fairly mild; the first 2-3 days included fatigue, body aches, chills, a low grade fever, headache, and nasal and chest congestion. Within 4 days, I had lost my senses of taste and smell almost entirely. Over the past few days, my fever broke and my senses are slowly returning. I continue to have a cough and tickle in my upper airways. Because of my history of asthma, I sought care from an urgent care doctor on 1/10/22. He prescribed an oral steroid for 5 days and albuterol (nebulizer) as needed.
10 MINUTES after the injection, I became very hot and flushed, with headache, palpitations, weakness, and shortness of breath. I sat down, my heart rate was 110 on my I watch. I was breathing heavy and feeling sweaty. The healthcare providers had me lie down on a stretcher and gave me oxygen with my feet elevated. After about 20 minutes, I felt better. Later that day, I came home and slept for 2 hours. The next day, (today) I came home early from work because I feel very tired and having difficulty concentrating. But the other symptoms have gone away.
Left arm was a bit tight after first dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Left arm was a bit tight after first dose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015N20A) for COVID-19 vaccination.     The patient's past medical history included Broken leg (The patient  broken leg and broken ankle, since 2 years. so, she is in a wheelchair.) and Broken ankle (The patient  broken leg and broken ankle, since 2 years. so, she is in a wheelchair.). Concurrent medical conditions included Spinal fusion and Type 1 diabetes mellitus. Concomitant products included INSULIN for Type 1 diabetes mellitus, VITAMINS NOS and OXYCODONE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TIGHTNESS (Left arm was a bit tight after first dose). At the time of the report, MUSCLE TIGHTNESS (Left arm was a bit tight after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-294374 (Patient Link).
Left middle cerebral artery infarct with cerebral edema and right sided hemi-paresis.
Later Thursday night, I started to get headache, chills, fever and nausea. This continued all throughout the night and into Friday. The headache was so bad, anytime I moved, it seemed like someone was stabbing my head right in the front. I was hot due to the fever but I never got the temperature. The chills were dramatic, as I was laying on the floor shaking like it was -10 degrees while it was room temperature. I never threw up, but it was hard to drink anything. I couldn?t sleep that night as I was shaking so bad and the head ache hurt. Friday was the same, if Thursday night was a 10, Friday was a 9, so it got some what better. I had to drive and did so with out accidents, but it was t the smartest idea. Couldn?t eat Friday night, but I didn?t throw up. Saturday, everything is almost back to normal, headache is minor, no fever and little nausea, but the first 30 ish hours were the absolute worst in my life.
Worse Itching; itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Worse Itching) and PRURITUS (itching) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. P5M2P0A) for COVID-19 vaccination.    Co-suspect product included mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. P25A21A) for COVID-19 vaccination.    The patient's past medical history included No adverse event.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 25-Feb-2021, the patient experienced PRURITUS (itching). On 11-Mar-2021, the patient experienced PRURITUS (Worse Itching). At the time of the report, PRURITUS (itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-056587 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056587:CROSS LINKED for Dose 1
Only the adjuvant was used; Only the adjuvant was administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number dj455, expiry date 26th January 2024) for prophylaxis.   On 16th December 2022, the patient received Shingrix. On 16th December 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-Dec-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient was administered only the adjuvant vial of SHINGRIX instead of the reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Localized redness 6x5 cm at injection site 48 hours after injection. URI cough/fever 100.5 degrees 48 hours after injection. Rash 7d after injection.
an expired dose of PROQUAD that was accidently administered to a 4 year old patient today, 1/27 /21.; This spontaneous report was received from a nurse and refers to a 4-year-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JAN-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) lot # S022917, expiration date: 19-JAN-2021, 0.5mL SQ x 1 dose (formulation, strength, frequency, route of administration were not reported) for prophylaxis. On 27-JAN-2021, an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was accidently administered to the patient.
1 of 2 pts vaxed from the same lot exp an inject site react; pt devel local redness & induration 21 x 17 cm; no systemic sx;
Fever, chills, aching, nausea, vomiting, wheezing, constant croupy cough persistent for 3 days, symptoms still present.
Two episodes of syncope close together, 2nd episode resulted in fall with head hitting a wall, diarrhea/loose stools after 2nd episode  Treated at ER with fluids, CT scan of head, chest x-ray, ECG all normal
Fatigue; Muscle aches; Fever around 99-100; Chills; Nausea; Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 13:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had food allergy which included allergy to bell peppers. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 08:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 17:30, the patient experienced fatigue, muscle aches, fever around 99-100 (unspecified units), chills, nausea and injection site soreness. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events fatigue, muscle aches, fever around 99-100, chills, nausea and injection site soreness were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pain in shoulder; Knot around collarbone; This is a spontaneous report from a contactable healthcare professional, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fc3180) via an unspecified route of administration in the left arm on 09Aug2021 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications taken within two weeks of vaccination included phentermine (ADIPEX) from unknown date for unknown indication. The patient previously took first of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fa6780) via an unspecified route of administration in the left arm on 19Jul2021 at 15:30 (at the age of 29-years-old) as a 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 10Aug2021 at 13:00, the patient experienced pain in shoulder, knot around collarbone. The events resulted in emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the events pain in shoulder, knot around collarbone was unknown at the time of this report.
they mixed the ACT-HIB with sterile saline instead of using the diluent provided with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and a consumer via Global Medical Information (Reference number: 00721749) and transmitted to Sanofi on 12-Aug-2021.  This case involves a 12-months old female patient for whom it was reported that they mixed the HIB (PRP/T) VACCINE [ACT-HIB] with sterile saline instead of using the diluent provided (product preparation issue).  Past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) for and concomitant medication PARACETAMOL (HEPA [PARACETAMOL]).  On an unknown date, the patient received 0.5 ml total dose of suspect HIB (PRP/T) VACCINE (lot number: UJ522AAA and expiration date: 06-Aug-2022) via intramuscular route in right thigh for prophylactic vaccination.  It was case of potential medication error due to inappropriate preparation of medication (latency: same day).  No adverse events were reported at the time of this report.  At the time of this report, outcome of the event was reported as unknown.  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 the 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.
Pediatric nurse practitioner stated they gave some pediatric 6m-5y after the BUD; Vial was initially stored in the refrigerator 23-Dec-2023 and dose was administered after BUD; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner stated they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2023 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event) in a child 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. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner stated they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2023 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner stated they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2023 and dose was administered after BUD) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner stated they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2023 and dose was administered after BUD).    No concomitant medications were reported. Total 42 Dose were administered after 30-day Use By Date. Vaccine was administrated on 26-Jan-2023, 27-Jan-2023, 30-Jan2023, 31-Jan2023, 2-Feb-2023, 6-Feb-2023,8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. Vial size was reported was 0.4 ml per vial. Vial did not undergo any temperature excursions. No treatment information was provided.  This case was reported for patient 17 of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:patient no. 01 (Master case)
Patient called the pharmacy at 7:00pm to inquire about the possible side effects of the Shingrix and Boostrix vaccines. She reported that since waking up that morning around 8:00am, she had extreme lethargy, a fever of 100.4 degrees Fahrenheit, moderate pain in arm where vaccines were administered, body aches and chills, headache, and a "tingly" sensation throughout her body. Patient stated that she felt "worn down" and compared it to a severe case of the Flu, Mono, or Strep Throat and had been home in bed all day.  Patient said she took "a few" Tylenol ER 650mg tablets to help with the fever. She said she was going to take Benadryl for the "tingly" sensation after she got off the phone but it is unknown whether patient took medication.
4 inch diameter reddened, raised area at injection site ON RD. Fever 99.4 F, stomach ache, malaise.
Less than 24 hours following Td vaccination, our 15yo son developed significant pain an edema at the vaccination site and then developed nausea and temperature elevation of 100.3 with malaise and generally feeling ill.
Patient said the area of shot is red/purple and warm to touch. I informed her to take ibuprofen or TYLENOL and ice it down, and if that doesn't help to see the doctor.
1) on eve of vaccine 1/21/21 I had a slight headache, stuffed nose, stiff neck, malaise, slight stomach upset.  Drank plenty of water. 2) next day 1/22/21 I had a feeling of being poisoned or having undergone chemo therapy (which it was). Overall poor body feeling/ malaise. Had a 1st of 5 scintillating scotomas at 9:45 a.m. For 4  days following the vaccine, I had 5 scintillating scotoma/ocular events lasting 22 minutes each on 1/22, 1/24, 1/26 & 1/27. On 1/24/21 at 1 p.m., I had an optica/visual kaliedoscopic focus (dysfunctional vision)  lasting for approx. 30 seconds followed by a scintillating scotoma at 4 p.m. TOO MANY UNUSUAL SCARY OCULAR EVENTS!
Started with hives on wrist, itching all over body; swelling right arm @ Y.F. vaccine site; tenderness R side of face, neck, ear.  BENADRYL PO & ZANTAC 75 mg PO Q6 hours X 3 d.
rash is still there; chills; fever; big red spot on her arm; really sleep/slept all day yesterday; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (really sleep/slept all day yesterday), RASH (rash is still there), CHILLS (chills), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (big red spot on her arm) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2021, the patient experienced SOMNOLENCE (really sleep/slept all day yesterday), CHILLS (chills), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (big red spot on her arm). On an unknown date, the patient experienced RASH (rash is still there). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (really sleep/slept all day yesterday), CHILLS (chills), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (big red spot on her arm) was resolving and RASH (rash is still there) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.   Patient experienced chills, fever, was really sleepy, and had a big red spot on her arm where she got the shot , 30 minutes after receiving the second dose. Her temperature was taken and it didn't increase over 100. She slept all day yesterday. Today she feels a little better, and is not as tired, but her rash is still there. She has taken some Tylenol, used ice on her arm, and drank lots of water which all seemed to help.; Sender's Comments: This case concerns a 92-year-old, female patient, with no disclosed medical history, who experienced the non-serious, unexpected events of somnolence, and expected events of chills, pyrexia, rash and vaccination site erythema. The events occurred on the same day after second dose of Moderna vaccine. The rechallenge is unknown as no details were given about the first dose. The benefit-risk relationship of Moderna vaccine is not affected by this report.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/28/2021 CANCER METASTATIC TO BRAIN J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/16/2021 CANCER METASTATIC TO BRAIN J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/28/2021 CANCER METASTATIC TO BRAIN J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/16/2021 CANCER METASTATIC TO BRAIN
Itching around waistline 30 minutes following vaccine which developed into a full, splotches red, itchy body rash by 2pm- neck, chest, backs and front of hands, abdomen, fronts and backs if thighs, forearms, face, chin, neck. No rash near vaccine site
Information has been received from a medical assistant refers to an unspecified number of patients who on unknown dates were vaccinated with ZOSTAVAX (dose, lot #, route not provided) that were improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.