chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cough; Runny nose; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), RHINORRHOEA (Runny nose) and NAUSEA (Nauseous) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced NAUSEA (Nauseous). On 27-Oct-2021, the patient experienced COUGH (Cough) and RHINORRHOEA (Runny nose). At the time of the report, COUGH (Cough), RHINORRHOEA (Runny nose) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported. It was reported that the patient received moderna vaccine on 26 Oct 2021 and felt nauseous. On 27 Oct 2021 the patient had a cough and runny nose.
Red swollen area around injection site. Site is fevered. Arm is itching under arm pit. Pain at site.
Possible celluliltis of right arm. Patient came in Sunday am with large part of upper arm red and hot. MD was called and started dicloxacillin 250 4x/day for 1 week with follow up on Monday.
Patient reported feeling flushed 6 minutes after vaccine administration. Vitals at 1513 were: BP 117/60,   HR 74, O2 97%. Patient reported that symptoms resolved about five minutes later. Patient was observed for 25   minutes (she declined to stay longer) and did not develop any new or worsening symptoms. Vitals at  3:24 PM BP 107/56, HR 72, O2 98%. Reviewed s/sx anaphylaxis, advised patient to call 911 if these   occur.
The lymph nodes under my arm swelled and are still tender to this date. I also came down with the Parotid Gland Infection in June and broke out in  a rash which I had never had before on my face and neck. The I came down with the Parotid Gland Infection again in December and the rash came back in the exact same spots but this time blisters popped up. I went to the doctor and was diagnosed with  Shingles. I had to go in for my annual physical less than a week after seeing a doctor with my primary physician, and he said the same thing. I was advised by the first doctor visit NOT to get the booster as it was time to get it and then my primary doctor also said the same thing. I will NOT be getting the booster! I am scheduled to receive the Shingrix vaccine next month. I had had a one shot shingle vaccine when I was 50 but had not received the two dose Shingrix vaccine. I have heard  from different medical persons that shingles is being seen in patients that  have received the Mederna vaccine.
On 26-Jan-2023, the vial was initially stored in the refrigerator and on 27-Feb-2023 administration of vaccine; No adverse event; Patient received expired Bivalent Moderna COVID-19 vaccine beyond 30 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine beyond 30 days in the refrigerator), PRODUCT STORAGE ERROR (On 26-Jan-2023, the vial was initially stored in the refrigerator and on 27-Feb-2023 administration of vaccine) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Feb-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine beyond 30 days in the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 26-Jan-2023, the vial was initially stored in the refrigerator and on 27-Feb-2023 administration of vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine beyond 30 days in the refrigerator), PRODUCT STORAGE ERROR (On 26-Jan-2023, the vial was initially stored in the refrigerator and on 27-Feb-2023 administration of vaccine) 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 (Patient received expired Bivalent Moderna COVID-19 vaccine beyond 30 days in the refrigerator) and PRODUCT STORAGE ERROR (On 26-Jan-2023, the vial was initially stored in the refrigerator and on 27-Feb-2023 administration of vaccine).    The concomitant medication was not reported by reporter. The intact carton vial was used and vial size was 2.5 ml. On 26-Jan-2023, the vial was initially stored in the refrigerator and on 27-Feb-2023 administration of vaccine. The vial did not undergo any temperature excursions. The treatment medication was not reported by reporter.
Per notes: Pt's daughter call around noon and said she got the vaccine Thursday and was dizzy Friday and Saturday.  There were no other side effects but she went to the doctor just to double check.  At ~6pm the grandson answered the phone and stated the pt is at the hospital because she fell.  Tried to call multiple times on Sunday for a follow-up but no answer.  Pt's medical hx is unknown and no list of pt current medications.
symptom milder-some dry heaves; loss of appetite. but not as bad as past shot; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 01Mar2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 10Aug2021 08:30 (Batch/Lot number: unknown) at the age of 82 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6206, Doses: 0.3 mL, Route of administration: Intramuscular, Anatomical location: Upper arm muscle), administration date: 07Mar2021, when the patient was 82 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE , Lot number: NDC 59267-1000-02, Route of administration: Intramuscular, Anatomical location: Upper arm muscle), administration date: 28Mar2021, when the patient was 82 years old, for Covid-19 immunization. The following information was reported: RETCHING (non-serious), outcome "not recovered", described as "symptom milder-some dry heaves"; DECREASED APPETITE (non-serious), outcome "not recovered", described as "loss of appetite. but not as bad as past shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Leg cramps and pain on both legs, Abdominal cramping, severe headache.
pt recv vax 8APR97 & 9APR97 & pt exp a watery blistery rash on rt foot;rash was dx by MD as coxsackie virus;MD felt that coxsackie virus was not r/t therapy w/varicella vax;
Large area of erythema 3 x 4 inches with warmth, woke up with sore on left deltoid. Said was sore night of vaccination.
Information has been received from a company representative. She was told by a consumer that hsi son was vaccinated with varicella vaccine. It was noted that the child was exposed to chicken pox and subsequently developed a "serious" case of shingles. The child was seen by his physician. Additional info has been requested.
A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicating that 12 month old female vaccinee was inadvertently administered Fluvirin IM on 14Nov02. The vaccinee experienced no adverse reaction. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200805, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200805, PJP200200876, PJP200200877.
Soreness in shoulder; In bed for a while; Swelling; Redness; Temperature; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Soreness in shoulder), BED REST (In bed for a while), BODY TEMPERATURE INCREASED (Temperature), SWELLING (Swelling) and ERYTHEMA (Redness) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038KZ0A and 00ZBZ1A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DILTIAZEM, FLECAINIDE, HYDROCHLOROTHIAZIDE, METHIMAZOLE, OMEPRAZOLE, RIVAROXABAN (XARELTO) and ATORVASTATIN for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Soreness in shoulder), BED REST (In bed for a while), BODY TEMPERATURE INCREASED (Temperature), SWELLING (Swelling) and ERYTHEMA (Redness). At the time of the report, ARTHRALGIA (Soreness in shoulder), BED REST (In bed for a while), BODY TEMPERATURE INCREASED (Temperature), SWELLING (Swelling) and ERYTHEMA (Redness) outcome was unknown. Not Provided          Treatment information included ice. Action taken with mRNA-1273 in response to the event was not applicable.
Onset of symptoms 2/14 itching and rash rapidly spreading from back of neck/forearms to entire body over the course of a week.
Nausea; dizzy; feels like burn from shoulder up to the elbow.; L arm swelling; L arm extremely itchy; Arm is red as the day when she got the injection; fever low grade; immediate fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), BURNING SENSATION (feels like burn from shoulder up to the elbow.), INJECTION SITE REACTION (L arm swelling), INJECTION SITE REACTION (L arm extremely itchy) and INJECTION SITE REACTION (Arm is red as the day when she got the injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gastrointestinal disorder NOS, Migraine and Allergy NOS. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Gastrointestinal disorder, ALPRAZOLAM (XANAX), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), VORTIOXETINE HYDROBROMIDE (TRINTELLIX) and BACLOFEN for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (dizzy), BURNING SENSATION (feels like burn from shoulder up to the elbow.), INJECTION SITE REACTION (L arm swelling), INJECTION SITE REACTION (L arm extremely itchy), INJECTION SITE REACTION (Arm is red as the day when she got the injection), PYREXIA (fever low grade) and FATIGUE (immediate fatigue). On 04-Mar-2021, the patient experienced NAUSEA (Nausea). At the time of the report, DIZZINESS (dizzy), BURNING SENSATION (feels like burn from shoulder up to the elbow.), INJECTION SITE REACTION (L arm swelling), INJECTION SITE REACTION (L arm extremely itchy), INJECTION SITE REACTION (Arm is red as the day when she got the injection), PYREXIA (fever low grade), FATIGUE (immediate fatigue) and NAUSEA (Nausea) outcome was unknown.            Additional concomitant medications included loinzeff for gastro issues and migraines medicines (once a month) which was stopped on 03 Feb 2021.  Treatment for the event included diphenhydramine (Benadryl) and acetaminophen (Tylenol). The patient took the medicine when she felt bad.
04/01/23 presents to EC ED for "respiratory distress". PMHx of "DM, HTN, OSA, asthma, COPD"
This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma attack on Saturday night), PYREXIA (Low grade fever) and BREAST PAIN (Breast pain on same side as the shot) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 032B21A) for COVID-19 vaccination. Concomitant products included METFORMIN from 26-Jun-2021 to an unknown date and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) from 26-Jun-2021 to an unknown date for an unknown indication. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced ASTHMA (Asthma attack on Saturday night). On 02-Jul-2021, the patient experienced PYREXIA (Low grade fever) and BREAST PAIN (Breast pain on same side as the shot). At the time of the report, ASTHMA (Asthma attack on Saturday night), PYREXIA (Low grade fever) and BREAST PAIN (Breast pain on same side as the shot) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications were not provided by the reporter. Action taken with mRNA-1273 in response to the events were not Applicable. This case was linked to MOD-2021-245563 (Patient Link).
Moderna COVID-19 Vaccine EUA Took vaccine at 2:45 pm Shoulder was getting sore that night before going to bed Next day woke up and shoulder was sore but felt fine.  As the morning progressed, started feeling worse.  By 11:00 am, reached peak severity of side effects.  Side effects lasted from 11:00 am till I woke up the next morning.  Woke up feeling fine except shoulder was still a little sore.  Side effects were (listed by order of severity):  fatigue, body aches, feeling spaced-out. Tylenol and Advil did seem to lessen those effects.
viral meningitis; vertigo; dizziness; headache; vestibular neuritis; This is a spontaneous report from a non-contactable consumer (patient's daughter). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown), via an unspecified route of administration on 25Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient developed vertigo, vestibular neuritis, dizziness, and headaches. She is currently in the hospital for viral meningitis, all on an unspecified date in 2021. The reporter found a website where five other people reported this. Outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness in left upper arm for 4 weeks without resolution.  Hard to move left arm, painful
Numb upper lip. Lasted 12 hours. Bendryl may have helped.
This spontaneous report as received from a pharmacist refers to a two patients of unknown age and gender. On an unspecified dates in 2014 (also reported as "since 07-AUG-2014"), two doses of improperly stored ZOSTAVAX (dose, route of administration, lot numbers and expiration dates were not provided) was dispensed to patients. No adverse effects were noted. Additional information has been requested.
Every time I got it I got the flu; Initial information was received on 30-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves Adult patient (unknown gender) who experienced "every time I got it I got the flu" (influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious every time I got it I got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  It was reported "I quit getting a flu shot years ago. I got the flu shot for about 7 consecutive years due to my kids being young. Every time I got it I got the flu. Before getting the flu shot and after stopping to receive the flu shot I haven't got the flu. Im 44 and for 37 years never really got the flu. maybe twice when I was a kid so I never be convinced the majority is in need of a flu shot".  At time of reporting, the outcome was Unknown for the event.  There will be no information available on the batch number for this case.
Vaccine given 7 days too early. 1st dose given 9/8/2021 2nd dose given 9/22/2021.
On 11am 02/14/2002, redness; warmth; swelling of interior aspect of left upper arm deltoid approximately 2-3 inches above elbow.
Description: Had febrile illness within 24 hours for both vaccines.  1st episode required hospitalization.  Developed chronic headaches after 2000 dose and also chronic fatigue, arthralgias.  This developed into full CFS that has persisted to the present.  See full summary.  Symptom:  Joint Pain, multiple joints.  Symptom:  Headache, general.  Symptom:  Insomnia.  Symptom:  Fatigue.  Symptom:  Cognitive deficiency.  Symptom:  Neuropathy.  08/24/09 Received medical  & vaccine records. FINAL DX: chronic fatigue syndrome Records reveal patient experienced the following after the initial anthrax vaccine & aggravation of symptoms after subsequent vaccinations: alterations in memory, difficulty concentrating, muscle cramps, joint pain, chronic fatigue, paresthesias of left arm/leg, sleep disturbance, decreased sexual drive, erectile dysfunction, intermittent blurred vision, migraine HA, intermittent tinnitus, alternating constipation & diarrhea, pulmonary nodules, chronic rhinitis, C6 radiculopathy, chills, night sweats, extreme fatigue, . Multiple consults done. Follow-up: Was still symptomatic as of December 08 but have lost contact now.
Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL) 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 assessment was provided for ACCIDENTAL UNDERDOSE (Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL).    No concomitant product was reported.  No treatment information was reported.  This case contains information for the 3rd of 9 adult patients described by the reporter.
Patient had dark urine and high CK level and was diagnosed with acute rhabdomyolysis. Patient received IV fluids and nephrology was consulted. Patient was discharged home when stable.
pt recvd vax; exp dizziness, sl n & flushing p/ 1st vax;
Slight nausea about 4 hours after dose Fever with chills about 8 hours after dose. Very thirsty. Lasted 12 hours General unwell feeling from about 12 to 36 hours after dose
Fever; Chills; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced fever and chills.  The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1 of 3 pts immunized from the same lot (360917) who exp adverse event; pt vaxed 29JUN94; woke up next morning unconsolable high pitch cry & was rigid; hospitalized; afebrile; no neurological sx; only significant finding was a WBC of 48,000;
mild Discomfort; This is a spontaneous report from a contactable consumer reporting for himself from a Pfizer Sponsored Program. This 74-year-old-male patient received at 14:00 13Jan2021 first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EL2418) at the age of 74-years in right arm  as a single dose for COVID-19 immunization. Medical history included COPD. Concomitant medications included ivermectin on 19Jan2021 and fluticasone propionate, salmeterol xinafoate (ADVAIR) for COPD, start date not provided. Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) was given in right arm at 9:00 04Feb2021 Lot: EL9264 for COVID-19 immunization. In 2021, around the end of Febr2021 beginning of Mar2021 he had an antibody test done and it showed 23 antibodies. He then did another antibody test on 03May2021 which showed only 5, so he was saying it was negative. The patient on 14Jan2021, in the morning, had a mild discomfort. It lasted a couple of hours. No events occurred after second dose. No follow-up attempts are needed. No further information is expected.
Headache, watery diarrhea, constant nausea, fever, severe fatigue, sneezing, clear runny nose, edema, itching, hives on torso.