chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 10/3/12, pt reports she felt burning/itching around her belly button. She noted no rash. On 10/6/12, she still had the burning/itching around belly button and also developed itching under her left arm, also with no rash. By 10/8/12, all symptoms had stopped. Pt did not go to MD or receive any medications for her symptoms.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 at 13:00 as dose 1, single (Lot number: EN6206), in left arm, on 04Apr2021 at 13:00 as dose 2, single (Lot number: GW0150), in left arm, on 19Oct2021 at 19:00 as dose 3 (booster), single (Lot number: 3203080), in left arm and on 19Apr2022 at 18:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LATANOPROST, start date: 01Jan2015; ATORVASTATIN, start date: 01Jan2008; FINASTERIDE, start date: 01Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 05May2022.  No follow-up attempts are possible. No further information is expected.
The pts prostatic enlargement worsened. The pt sought unspecified medical attention. Follow-up from a registered nurse indicated that on 3/1/00, the pt's dermatitis and prostate conditions worsened and continued to worsened for 4-5 days, then improved slightly for approximately 1 month. The pt started a no yeast, no sugar diet and approximately 7 weeks post onset, the pt returned to prior vaccine status. The pt recovered 7 weeks post onset.
Patient noticed redness at site where she received ZOSTAVAX about 24 hours later. Noted that it felt inflamed and hot. She came to the pharmacy on the next day 12/15/17 and showed it to pharmacist and it looked very red and was about 2 inch x 2 inch patch on back of left arm at site of ZOSTAVAX. She also went to her MD and was told to ice and monitor.
DIZZY, HEADACHE, TIREDNESS, JOINT PAIN, NAUSEA, FEELING UNWELL, DIARRHEA,
Pt says she began menstruating the evening she was vaccinated. Menstruation was heavy. She says she has not menstruated in months, but denies going through menopause. No known hx of contraceptives.
I had chills in the middle of the night. It was cold sweat. My body ache and I had a huge head. I went to the ER. They gave me Tylenol then an hour later they gave me Motrin. They put an IV of fluid because I was dehydrated and had fever of 102.  They let me go until fluid was done and fever went down after 4 hours.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 30-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Received Engerix B 3rd series, that day onset of lt arm itch & redness & swollen, pruritus, limited range of motion
I95.9 HYPOTENSION 10/28/2022 ALTERED MENTAL STATUS, UNSPECIFIED I95.9 HYPOTENSION 10/28/2022 ANEMIA OF CHRONIC DISEASE
24 hours after injection began to have arm swelling and pain.  seen in clinic at 48hrs. with arm swelling about 6cm with injection site at center mild hue of erythema.  Treated with benadryl and ice to site. Patient to call if any increase in erythema, pain, or fever.
After my Covid vaccine my left armpit became swollen and sore from the lymph node, that subsided after a few days.  About 10 days after the vaccine I was giving myself a breast exam and noticed what appears to either be a swollen lymph node on my left breast on a cyst.  Along with the lump I have weird nerve sensations around that area.  I have no history of anything breast or nerve related in that area.
Headache, Sore Arm, swollen and red arm on and near the injection, chills, body soreness.
Generalized erythematous maculopapular rash with skin induration around and distal to injection site. Reaction occurred about 5-6 hours, post vax. Rash persisted with Benadryl 24 hours later. No other immunizations given.
Missed dose; All over body rash; A spontaneous report was received from a physician concerning a 41-year old, female patient who received Moderna ' s COVID-19 vaccine (mRNA-1273) and experienced an all over body rash and missed second dose.   The patient's medical history was not provided. Concomitant medications were not provided/unknown.   On 04-JAN-2021, approximately 24 hours before the onset of the event, the patient received their first of two planned doses of mRNA-1273 (batch number 026220A) intramuscularly for prophylaxis of COVID-19 infection  ,  On 05 Jan 2021, the patient experienced an all over- body rash. The patient reported being out of the country and missing her second dose.   Treatment for the event included cetirizine hydrochloride.  Action taken with mRNA-1273 in response to the events was not unknown.   The outcome of the event, all over body rash, was considered recovering and resolving.  The outcome of the event, missed dose, was considered recovered/resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of rash, a causal relationship cannot be excluded.  The causality for the event of missed dose is assessed as not applicable.
infections from h.pylori; This spontaneous case was reported by an other health care professional and describes the occurrence of HELICOBACTER INFECTION (infections from h.pylori) 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.     It  was unknown if patient  received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     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 HELICOBACTER INFECTION (infections from h.pylori). At the time of the report, HELICOBACTER INFECTION (infections from h.pylori) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that patient had infections from h.pylori and was going to take some herbal supplement with the active ingredient thymoquinone and active biological substance of Nigella Sativa in Black Seed Oil.   This case was linked to US-MODERNATX, INC.-MOD-2023-724906 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724906:90 Year Old Patient)
Information has been received from a physician concerning a 6 day old patient who was intended to receive RECOBIVAX HB, was inadvertently administered a 0.5 ml dose of VAQTA, IM, on 03-OCT-2008 due to human error. No adverse symptoms noted. No product quality complaint involved. Additional information has been requested.
pain jumping around body, from hip to shoulder to other hip to back back up to shoulder where shot was given. Burning sensation going down the vaccinated arm to fingers tingling.   This morning woke up with pain throbbing from shoulder and side of back on side where vaccine was given. This is almost a week of pain in the fourth week after the shot.
My first vaccine was in 8/2008. The last was at the public health clinic. After my first vaccine my menstrual cycle became intermittent. For the past three years it had been basically nonexistent only 3 to 4 a year maximum. Which is not genetic. I have failed at conceiving naturally. I also am extremely tired all of the time no matter how much I work.
Information has been received from a medical assistant concerning a 6 year old female patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #659155/1366U). Subsequently, the patient developed an injection site reaction described as injection site swelling and injection site itching. The patient sought unspecified medical attention. There was no product quality complaint. This report is one of several from the same source. Additional information has been requested. Follow up information has been received from a medical assistant on 24-MAR-2008 concerning a 6 year old female patient with an allergy (hives) to amoxicillin who on 29-JAN-2008, was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (lot #659155/1366U) (dose unknown), subcutaneously in the left thigh. It was also reported that the patient had no illnesses at the time of vaccination. Other vaccinations received on the same day included hepatitis A virus vaccine inactivated (MSD) (lot number 657307/0442U), intramuscularly in the right thigh and hepatitis B virus vaccine rHBsAG (yeast) (MSD) (lot number 652882/0106F), intramuscularly in the right thigh. On an unspecified date, the patient experienced redness/swelling with pain over varicella virus vaccine live (Oka/Merck) site. No itching was noted. On an unknown date, the patient recovered. It was also reported that the patient's siblings experience an adverse event on varicella virus vaccine live (Oka/Merck) (MDS) WAES 0803USA00596). No further information is available.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No relevant medical history of the patient was reported. On 13-JUN-2014 the patient was vaccinated with RECOMBIVAX HB (dose number, dose, route of administration and lot number were not reported). Expiration date was reported as 02-MAY-2014. No concomitant medications were reported. The patient was administered with a properly stored dose of RECOMBIVAX HB on 13-JUN-2014 that had an expiration date of 02-MAY-2014. No adverse effects were reported. There was no product quality complaint (PQC) involved. The outcome was unknown. Additional information has been requested.
A report was received from a healthcare professional on 10/17/2003 concerning a 33 year olf female vaccinee who experienced a reticular, blanching rash over the entire body on the same day as receiving Fluvirin on 10/16/2003. ON 10/16/2003 the vaccinee experienced a reticular, blanching rash over the entire body sparing only the face and the palms of the hands.  The vaccinee did not report any fever, shortness of breath or itch in relation to the rash.  It was the vaccinee's first exposure to the influenza vaccine.  The outcome of the event was not reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/24/2003 Follow up information received from a healthcare professional indicated that the vaccinee also experienced epigastric pain and joint aches.  The event resolved on an unspecified dated. The reporter considered there to be a temporal relationship between the Fluvirin and the adverse events.
5 weeks post Vax experienced headache, listlessness, muscle aches, shivering,  night sweats, temp 101.5 (oral). Lasted 36 hours.
A week later after my left arm bruised up I now have a mild rash at the injection site about 3? in diameter. It?s not bothering me actively but I wanted it documented. After the first shot that I had a week ago I also had an upset stomach.  I believe that the red itchy arm is already improving and will resolve in a few days.
received my second dose of moderna 7 days early; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received my second dose of moderna 7 days early) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received my second dose of moderna 7 days early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received my second dose of moderna 7 days early) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
pt recvd vax 6FEB95 & on 9FEB95 was taken to MD w/red swollen area on the rt anterior thigh (where ACTHIB was given); MD reported had a poss cellulitis on RAT;
States he got hot from head to toe; very pale and increased BP. Reported by EMS. I called the family later that day, grandmother said he was fine and did not go to doctor. This happened about 30 minutes of vaccination.
After 3 days, developed urticaria on neck. Spread over a week to lower chest, increased itchiness. It's has been 4 weeks, decreased in itchiness and faded in numbers and color, but there are still faded rash present on neck and chest.  After 4 weeks, severe dizziness with nausea, which is lasting a week. Had to take time off of work because when I read or focus, or bend down, I get severe nausea and motion sickness. Not pregnant. Never experienced debilitating dizziness and nausea before.
rigors, nausea, lightheadedness, fatigue, back ache lasted 1-2 days rx APAP;
The patient received the vaccine at 11am and about 11:05am became very dizzy and light headed. He was lowered to the ground to keep from falling. We put him in a chair to relax and gave him some water. The patient was coherent but very pale and sweaty.  we did call an ambulance and the patient was taken to hospital. The patients mom said they just did observation with no additional treatment and was discharged
sore @ inj site;scratchy, sore throat, tired, runny nose, had to take a nap;extremely tired;losing voice;
On 19May22 I came down with COVID-19; On 19May22 I came down with COVID-19; I was diagnosed with diverticulitis and psoriatic arthritis on my (R) hand; I was diagnosed with diverticulitis and psoriatic arthritis on my (R) hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIVERTICULITIS (medically significant), PSORIATIC ARTHROPATHY (medically significant) all with onset 30Mar2021, outcome "unknown" and all described as "I was diagnosed with diverticulitis and psoriatic arthritis on my (R) hand"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "unknown" and all described as "On 19May22 I came down with COVID-19". The events "on 19may22 i came down with covid-19" and "i was diagnosed with diverticulitis and psoriatic arthritis on my (r) hand" required emergency room visit. Therapeutic measures were taken as a result of covid-19.On 30March the patient went to the ER where the patient was diagnosed with diverticulitis and psoriatic arthritis on the right hand. The patient did not have anyone in  family who ever suffered from diverticulitis. On 19May22  came down with COVID-19, and was prescribed Paxlovid for 5 days. The patient had diarrhea, bad taste in the mouth and vomiting and when finished it, got diverticulitis (more serious > the 1st).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Temp to 104, febrile seizure  4/10/07 Rceived medical records from hospital which reveal patient experienced shaking. pallor, coldness, lip cyanosis, eyes fixated lasting approx 5 min & was admitted 3/27/07.  In ER, temp 103.2.  Sepsis w/u done.  Tx w/IVF & antibiotics. Admit DX: Sepsis, meningitis (bacterial/mycobacterial), SVT or congenital heart disease. FINAL DX: none stated.  Letter faxed to hospital to request D/C summary. 5/7/07 Received D/C summary which reveals admitted 3/27-3/28/07 w/ Final DX: Fever, shaking s/p vaccination; and TB exposure, started on INH prophylaxis.  To be seen by PCP on 3/29.
Started cephalexin for a bad foot infection..had taken it in past with zero issues...within 30 minutes had horrible lung on burning clenched up fire, gasping and coughing for breath, hives all over me reaction.
Severe headaches; Nauseous; Could not  sleep due to the severity of the headache; This is a spontaneous report from a contactable nurse. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the arm left on 08Mar2021 at 14:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the arm left on 29Mar2021 at 13:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to food, medications, or other products. 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. The patient did not receive any medication within two weeks of vaccination. On 08Mar2021 since the vaccine, the patient experienced severe headaches that would not go away and make her nauseous.  She suffers from the headaches day and night and could not sleep due to the severity of the headaches. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events severe headaches, nauseous and could not sleep due to the severity of the headache was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Vial was initially stored in the refrigerator on 4Jun2022 and administered on 05Jul2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 4Jun2022 and administered on 05Jul2022) and NO ADVERSE EVENT (No adverse event) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 4Jun2022 and administered on 05Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 4Jun2022 and administered on 05Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 4Jun2022 and administered on 05Jul2022).    No concomitant medications were provided by the reporter.  Date the vial was initially stored in the refrigerator was on 04-Jun-2022.The vial did not undergo any temperature excursions.  No treatment medications were provided by the reporter
Patient reports throat swelling after first vaccination. He states he did not have trouble breathing but he felt like it was swelling. It went down after 30 minutes and patient was not administered epinephrine.
Hypo-osmolality and hyponatremia Acute kidney failure, unspecified Epistaxis
Patient reported to this professional that she began to experience generalized swelling of her hands and face approximately 45 minutes after she recieved her second COVID booster dose (4th dose). The patient denied trouble breathing, throat tightness, dizziness, nausea, tachycardia, hives, itching, stridors or cough. The patient refused the offer to receive an oral dose of benadryl from this professional upon presentation and instead agreed to be monitored periodically for the next few hours while at work. The patient later commented upon follow up that she took a dose of Benadryl once she returned home from work. Per the patient's report, the swelling in her face and hands gradually subsided over the next few days.
her periods have not returned to a typical cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]. Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, Unknown manufacturer), administration date: 2021, for COVID-19 immunization, reaction(s): "periods are coming every 6+ weeks". The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 01Jan2022, outcome "not recovered", described as "her periods have not returned to a typical cycle". The event "her periods have not returned to a typical cycle" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination. The patient periods were coming every 6 plus weeks and really severe after the first booster in 2021. She had multiple boosters now and her periods have not returned to a typical cycle. The patient was COVID tested post vaccination. This report is not serious  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.