chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient received GARDASIL (lot: J005925, Expiry date: 27-NOV-2015) on 03-AUG-2013 at age 18 years old and received  GARDASIL 9 (lot M036059, expiry date: 03-JUN-2019) on 06-JAN-2017. The patient did not receive a 3rd dose of GARDASIL or GARDASIL 9. No adverse effects reported. Additional information is not expected as consent to contact physician was not provided.
off label benefit; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (off label benefit) and VACCINATION SITE PAIN (soreness at injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (severe allergic reaction to poison ivy). Concomitant products included FISH OIL (OMEGA 3 [FISH OIL]), ESOMEPRAZOLE, MAGNESIUM, MULTIVITAMINS [VITAMINS NOS], COLECALCIFEROL (VITAMIN D3), UBIDECARENONE (COQ10 [UBIDECARENONE]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On an unknown date, the patient experienced OFF LABEL USE (off label benefit). At the time of the report, OFF LABEL USE (off label benefit) and VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not reported for mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.   This case was linked to MOD-2021-213422 (Patient Link).
Received 1st dose Moderna Covid Vaccine 1/29/21 and received Janssen Covid Vaccine 5/18/21.
Nosebleeds after nasal flu vaccine. Also with cold, runny nose, cough, conjunctivitis (eye infection) (suspect adenovirus).
This spontaneous report was received from a consumer referring to her daughter, an 11 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient received the second dose of GARDASIL route subdermal (incorrect route of drug administration) (anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unknown date, reported as after receiving the second dose of GARDASIL, the patient started experiencing severe leg cramps. At the time of the report, the outcome of the event was unknown. The causal relationship between severe leg cramps and GARDASIL was not reported. Additional information has been requested.
12 year old patient received 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient received 1st dose) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient received 1st dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient received 1st dose) had resolved.            Concomitant product was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Follow-up information received and contains no new information On 10-Sep-2021: Non-significant follow up appended. Contains no new information. Added contact details for reporter as it was not captured in previous version. On 11-Oct-2021: Non-Significant follow up received contains no new information
Pt seen at the clinic with macular red spots, trunk face and extremities.  Pruritic on 11/21/03. Diagnosis: Rubella from immunization.
Patient was admitted to medical center.  Abdominal CT was performed.  Patient diagnosed with intussusception. 1/29/09-records received for DOS 1/11-1/13/09-DC DX: Intussusception. History of hypothermia (34C), obtundation and hematochezia with clots. Lethargic, dehydrated and minimally arousable to tactile stimulation with bright red blood per rectum, left lower quadrant mass felt.
significant redness, swelling and pain at the site of injection (IPV) on the right arm (8 cm X 5 cm) No streaking, afebrile
patient experienced intense bone pain, joint pain which was ongoing 4 days later on 2/26/21 and was improving but still present on 3/1/21. Fever & chills lasted through Wednesday 2/24/21. patient had sought the consultation of an allergist prior to receiving the vaccine because of her prior reaction to Tdap. I advised notifying her doctor of this reaction.
Shingles - Started with ear pain in right ear followed by rash on right face.  Was given Amoxicillin for ear infection, Valacyclovir HCL  for Shingles  and Gabapentin for severe pain of the head, ear, neck as well as tingling on face.    Shingles rash dried up and scabbed over, however, severe pain continues along with numbness of the face.
This spontaneous report was received from a registered nurse refers to a 19 year old female patient with unspecified penicillin allergy. No medical history was reported. The first dose of RECOMBIVAX was administered on 15-AUG-1994. The second dose of RECOMBIVAX HB (invalid lot # 1368A2, Expiry date unknown) was administered on 13-SEP-1994. The third dose of RECOMBIVAX HB (lot # 613621/1162A, expiry 27-JUN-1997) was administered on 23-FEB-1995. No concomitant medications were reported. Serological testing was performed approximately on 17-MAR-2014 (reported as on an unspecified date about a week from today, 24-MAR-2014) showed that patient did not had immunity to hepatitis B. Patient sought medical attention-went to physician's office. The patient was then administered another dose of RECOMBIVAX on an unspecified date in order to begin a new RECOMBIVAX HB series. The outcome of the event was unknown. Causality was not reported. Additional information has been requested.
1/31 - rash on her chest, no sob.  Wasn't seen for it. Still has the rash on her chest, but no sob, no swallowing difficulties. Rash hasn't spread since the 1/31.  Today can see a black spot lower forearm.
This is a spontaneous report received from a contactable consumer or other non HCP). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history included being COVID-19 positive (unspecified if ongoing), and severe fatigue (ongoing), notes: due to COVID-19 infection. The patient's concomitant medications not reported. Vaccination history included the 1st dose of the COVID-19 vaccine (manufacturer unknown), for COVID-19 immunisation. The patient experienced an unexpected therapeutic response (the patient was no longer fatigued upon receiving the second BNT162B2 dose), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021157711 same reporter, suspect drug, event; different patient.
pt recvd vax w/in 24-48 hrs devel fever, elevated WBC, petechiae over stomach & groin area;
Diplopia Narrative:  Patient contacted by primary care team. BP has been elevated which may be cause of headache, blurred vision rather than vaccine.
Tolerated first vaccine one month prior without incident. Today, developed 10/10 headache with photophobia starting five minutes after recieving the injection. Developed a cough and then crushing chest pain. Initial blood pressure and heart rate were within normal limits, and continuous pulse oximetry showed consistent Oxygenation of 98%. Patient was able to speak in full sentences although unable to take a deep breath. Pain was physically limiting, and patient was transported to ER, for immediate evaluation and treatment. At the ER, pateint was normotensive and nontachycardic. He received IV epinephrine and dexamethsasone. Per paramedic report while in ER, patient shortly afterward developed hypotension with left
Patient complained of soreness and stiffness at injection site to upper arm. She claims she had decreased range of motion to her left arm by 5pm that day. She followed up with her pcp and then Dr  who did an xray and claims she has bursitis and is in phtsical therapy 3 days a week.
Hypeventilation - required O2 and close observation O2 Sat 100%
Swollen lymph node (or unknown lump) behind the left collarbone; painful on it's own and painful to touch. Lymph node swelled up to about the size of a cherry and has stayed that size. Began at about 11 AM on 2/8 and has continued through now (~4 PM 2/9).   Intense muscle aches, worse two days after the vaccine, instead of just one day after. Aching of the muscles around the eyes (the ones you would use to squint and the top of the cheeks), the scalp, neck (the base of the skull and trapezius), biceps, aching around the wrist joints, hip flexors, quadriceps, and ankle joints. Found relief with 500 mg acetaminophen throughout the day.
Severe vomiting, body aches, fever, headache  Prescribed zofran (Not sure of the type of  vaccine received, Pharmacy did not indicate the type)
The day after the 2nd Moderna vaccine I developed 2 blisters on right ankle...they started out red, itchy, and burning & in less than 24 hours they got really inflated.  2 days later they popped by themselves &  slowly started to drain.  Today is day 5 after the vaccine,
Patient reported to clinic for second Monkeypox vaccine. Patient noted to have purple, raised area that looks like keloid at site where first dose was administered.
Individual were administered Moderna vaccine booster dose after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
SM developed generalized myalgias within 30 minutes of receiving each of his eight anthrax shots. Muscle aches lasted approximately one week. Motrin helped to keep pain tolerable. Was on quarters only once for muscle aches.
Low Grade Fever; Aches; Chills; This is a spontaneous report from a non-contactable consumer. A 49-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6200, Expiry date: unknown, at the age of 49 years), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 14:45 dose 2, single for covid-19 immunisation at Workplace clinic. The medical history was not reported. Concomitant medication(s) included tetanus vaccine, administered in Arm Left on 18Feb2021 for immunisation. Historical vaccine included BNT162B2 (Batch/Lot number: EL9261, Expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 20:30 as dose 1, single for covid-19 immunisation. Covid was not tested prior to or post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced low grade fever, aches, chills on 25Feb2021 16:00. The patient did not receive any treatment for the events. The reporter assessed the events as non-serious. The outcome of the events was recovered on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021262467 same patient/drug, different dose/event
Patient received first dose of Moderna COVID-19 vaccine on 4/7/2021. After vaccine was given, patient complained of pruritus and was given Benadryl 25 mg po x1. Patient was observed for 30 min and sent home.
Pt recv vax on 3/15/99; on 3/22/99 pt exp fever (101),headache, stiff neck, joint &muscle pain of legs/arms,numb legs,diarrhea, vomiting; on 3/24/99 pt exp itchy/blotchy rash over body,poor appetite; tx=Benadryl,Epinephrine,Atarax,Decadron
Pain on left foot - feels like a small bump; Pain on left foot - feels like a small bump; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced pain on left foot - feels like a small bump on 31Mar2021. The event was reported as non-serious. The patient did not receive any treatment as a result of the event. The clinical outcome of pain on left foot - feels like a small bump was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
About 12 days post  first dose of Moderna at around 9:00 pm, I experienced an acute, stroke like event.  I experienced derealization, inability to think, blurred vision,  pins and needles / tingling in extremities and face,  leg heaviness,  and then proceeded to have a severe, 9/10  headache.  For the following two weeks, I was couch ridden and continued to experience severe, chronic headaches, blurred and double vision, pins and needles / tingling in extremities and face, exhaustion, derealization, and intense brain fog.   Two years later, I am still experiencing chronic brain fog, blurred / double vision, pins and needles / tingling in my extremities, twitching, and headaches.
March 12- 3 a.m. Muscle & joint pain with low grade fever. 8:00 pm swollen lymph gland on left side above  collar bone - size of an egg. This is March 14 3:00 pm  soreness & fever is gone but swollen gland is not.
redness at the injection site; swelling at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided.  Treatment medications was not provided.   Reporter did not allow further contact
Increased heart beat and an odd cough - lasted about 1/2 hr but cough went into asthma and lasted about 1 week and have never had a reaction to any flu vaccine.
Hives brought on by exercise began 4 days after vaccine. Various incidences of the same reaction have occurs over the last month.  Today, 27 days since vaccination, hives began during exercise all over the body, including swelling of lips and eyes. The reaction has improved, but eye swelling and upper lip swelling are still present one hour later.
Fever of 102 orally checked by patient, pain of 4/5 to left deltoid, swelling at injection site, per patient.
non immunocompromised got 3rd dose (full dose) of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (non immunocompromised got 3rd dose (full dose) of the Moderna vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Overweight, Arthritis (long before she got the Moderna Covid-19 vaccines) and Pain NOS. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]), IBUPROFEN (ADVIL [IBUPROFEN]) and TRAMADOL for Pain management.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (non immunocompromised got 3rd dose (full dose) of the Moderna vaccine). At the time of the report, ACCIDENTAL OVERDOSE (non immunocompromised got 3rd dose (full dose) of the Moderna vaccine) outcome was unknown.            Patient stated that she already got a 3rd dose (full dose) of the vaccine long before Moderna has been authorized for the 1st booster dose. Lot number reported as (013(?)(?)0Afor 1st dose. No information on treatment medications was reported.   Reporter did not allow further contact
Arm was really sore started about 1pm, I started to get cold and couldn't get warm to the point I was shaking about 7pm,  on 5/5/2021 I woke up with body aches really bad around my joints and muscles and headache and fatigue.  5/6/2021 I have pain still in my joins but manageable more in joints I have had surgery on or had injury to in the past.
Patient experienced localized reaction.  Area is red and swollen x2 weeks accompanied by pain.  Hyperpigmentation is currently present.
Three days after vaccine had a really high fever, took COVID-19 test and it was negative. Tested the next day and it was positive. Saw Dr and was prescribed Paxlovid and slowly feeling better.
This spontaneous report was received from a consumer of unknown age and gender regarding himself/herself. Information regarding the patient's medical history and concurrent conditions were not provided. On an unknown date the patient was vaccinated with GARDASIL when she requested to be vaccinated with GARDASIL 9 (product name confusion). No adverse effects were reported. No product quality complaint (PQC) was involved. No laboratory tests were reported. The outcome of the events were unknown. No further information was provided. Additional information is not expected, no contact details were provided.
had shot when it first came out. Got shingles 3 times/ Suspected Vaccination failure; Got shingles 3 times; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported. The patient got the Shingrix shot when it first came out and got shingles 3 times.  The patient said never again. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset were unknown.
This spontaneous report was received from a pharmacist referring to a 66 year old patient. On 16-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 dose 2, lot # N010106, for prophylaxis.  No adverse event reported.
Headache, Myalgia, lethargy/fatigue Narrative:  Other Relevant History:
Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Getting booster soon
I became dizzy within a week of receiving the injection. I'm not sure the first date of dizziness, but had a severe case on 4/20/18 after having shot on 4/13/18. I am still having dizzy spells as of 6/1/18. I have been to my primary care physician, an ear, nose and throat doctor and the clinic. I am now going to a vestibular therapist.
Client complained of nausea and vomited into trash can at 1026. Client stated that she was feeling anxious before receiving her vaccine, and that she is prone to having anxiety events. Vital signs were taken at 1030 (Blood pressure 156/84 HR 105, O2 99%).  Client offered water and she accepted and drank some. Vital signs taken at 1035 (Blood pressure 144/92 HR 118). At 1038 client stated that she was still feeling slightly nauseas but calmer. Vital signs taken at 1045 (Blood Pressure 141/80 HR 92), and again at 1052 (BP 133/82 HR 77). Patient stated that she was feeling better.  She left with her brother at 1053 with no assistance and with a steady gait.
Very deep fatigue. It feels like the life force is drained out of me. I'm not able to function and spend most of my time in bed. Sometimes I can sit up on the couch and watch TV.  I have trouble concentrating and even talking to someone on the phone is exhausting. My brain is not functioning like it usually does.
"COVID arm" itchy, slightly painful to the touch rash started 3-5 days after initial vaccine
After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 68-year-old, White, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 68-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting Out of specification product use.