chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness of the arm; COVID arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Feb-2021 and was forwarded to Moderna on 07-Feb-2021.    This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Soreness of the arm) and TYPE IV HYPERSENSITIVITY REACTION (COVID arm) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness of the arm) and TYPE IV HYPERSENSITIVITY REACTION (COVID arm). At the time of the report, PAIN IN EXTREMITY (Soreness of the arm) and TYPE IV HYPERSENSITIVITY REACTION (COVID arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up report was possible NNI.
1st day of inj  the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after  receiving the vaccine, at 2 PM started with itching of scalp, arms, legs, rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck.  Took 50 mg Benadryl w/ some relief. 630 PM symptoms reoccur, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER at 830 PM
2 days later, I had fever, fatigue, very bad abdominal pain, couldn't eat, headaches, diarrhea and for 14 days. I felt about 80% better at that time.
Shingles; received the 1st dose of Shingrix on 7Aug2020 / the 2nd dose on 29Sep2020; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 29th September 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 29th September 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. In October 2020, the patient experienced shingles. The patient was treated with antivirals nos. On an unknown date, the outcome of the shingles and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of vaccine and 1 week after developed shingles. The pharmacist told that the patient was currently taking antivirals. The patient received 2nd dose of shingrix earlier than the recommended interval, which led to shortening of vacination schdeule. The reporter consented to follow up.
LUQ Abdominal Pain: Patient reports that he was in his usual state of health until last week when he received his COVID 19 vaccination. He received 1st dose of Pfizer vaccination. Prior to this he was healthy. He reports 10 minutes after injection, he felt a knot/burning sensation in the LUQ of his abdomen. He states that it progressively worsened to the point where he couldn't sleep the following night. Over the weekend, he felt like he was improving. However, last night it was significantly uncomfortable. He feels an achiness/bruising sensation over his LUQ. He reports that there is a baseline discomfort but then it will become so bad that he has a hard time walking. He states that if he gets in a certain position he will feel improved but if he moves the wrong way it feels like it pinches. No changes with food. He reports decreased appetite. No fever, chills, nausea or vomiting. He had diarrhea x 1. No constipation.
1:45 PM flushing with headache  Blood Pressure: 120/64; Pulse 80; Pulse Ox: 98%   1:55 PM Blood Pressure 170/90; Pulse 84: Pulse Ox: 98% Resident up and walking   2:05 PM Slight headache Blood Pressure 130-70; Pulse 78; Pulse Ox: 98%
Severe upper arm pain and should pain , extended swelling, rash that extended down to almost wrist
This spontaneous report was received from a healthcare worker refers to a patient of unknown age who on 12-SEP-2012, was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported) that could not have been improperly stored. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
a now 13 year old initiated GARDASIL 9 series at other institution or facility at the age of 12; a now 13 year old initiated GARDASIL 9 series at other institution or facility at the age of 12; no adverse event; This spontaneous report was received from an office manager and refers to a currently 13-year-old patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date (reported as at the age of 12 years old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.   The reporter was inquiring on behalf of a physician, how to proceed when the patient initiated hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series at other institution or facility. The patient's mother called because a pharmacy would not give her the second dose in the series (inappropriate schedule of product administration and circumstance or information capable of leading to medication error). Caller declined follow-up with physician as the patient's mother reported they were going elsewhere. No additional adverse events was reported. No further information was provided.
has yet to receive the second dose passed 42 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has yet to receive the second dose passed 42 days) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042l20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has yet to receive the second dose passed 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has yet to receive the second dose passed 42 days) had resolved.            Treatment and concomitant medications were provided by reporter.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273, Lot #: 042l20A with no associated AEs.
Recurrent fever, body aches, Upper respiratory, ear, sinus infections, hearing loss and surgery for collapsed Eustachian tube. Required recurrent treatment of antibiotics.
hurts more than with the first two; Shoulder is more sore muscularly speaking; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (hurts more than with the first two) and ARTHRALGIA (Shoulder is more sore muscularly speaking) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), FLUOXETINE and PRAVASTATIN for an unknown indication.    On 06-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 PAIN IN EXTREMITY (hurts more than with the first two) and ARTHRALGIA (Shoulder is more sore muscularly speaking). At the time of the report, PAIN IN EXTREMITY (hurts more than with the first two) and ARTHRALGIA (Shoulder is more sore muscularly speaking) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment details were reported.   This case was linked to MOD-2021-396244, MOD-2021-396352 (Patient Link).
Patient is an active, healthy 63-year-old man, not on medication and has never smoked. Received J&J 4/7/2021. Received Moderna booster 10/23/2021. The patient developed L femoral DVT and massive saddle pulmonary embolus on 10/30/2021. He was in cardiogenic shock and R heart failure initially, with ECHO showing severe R heart strain. Patient received TPA and then clinically improved. Able to be discharged to home on oral anti coagulation. Autoimmune work-up negative.
5yr old female s/p KINRIX immunization left deltoid last week, and mom noticed redness, swelling of left upper arm. Treatment-application of warm compress and non-steroidal anti inflammatory for pain.
Information has been received from a health professional concerning a 41 month old male with a history of ibuprofen allergy (causes tongue swelling) who on 11/20/01 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot 05772). The patient's mom called to report an outbreak of vesicles that started on 5/7/04. No blood work or tests were done and the patient was not seen in the office. It was reported that at the time of vaccination the patient had no fever-just rash. No other information was reported. Follow up information indicated that the lot number was not available. Additional follow up indicated that the patient recovered on 6/25/04. Additional information is not expected.
While sitting in a pub, the bar tender told me his ex-wife had a Pfizer vaccine then miscarried her child.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), 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: ABORTION SPONTANEOUS (medically significant) with onset 16Apr2022, outcome "unknown", described as "While sitting in a pub, the bar tender told me his ex-wife had a Pfizer vaccine then miscarried her child.". It was unknown if therapeutic measures were taken as a result of abortion spontaneous. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt was a transfer from Hospital with an intracranial bleed as well as compression fracture of T10 and L4-L5. Pt was found to be COVID positive with no symptoms present.
NOT FEELING TOO WELL; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, and batch number were not reported), 1 in total, dose was not reported, for prophylactic vaccination. It was unknown whether patient had any adverse event following covid-19 vaccine from unspecified manufacturer. (Dose series in number 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. (Dose series in number 2) On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced not feeling too well. (Dose series in number 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feeling too well was not reported. This report was non-serious.
Child seen due to febrile seizure that evening (the night after administration of vaccines). No fever and no other symptoms reported by mother.
Lymphangitis, tender nodes, malaise and muscle aches. Treated with Motrin 800mg tid.
second dose not administered past 42 days; diagnosed with Covid 19 infection; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose not administered past 42 days) and COVID-19 (diagnosed with Covid 19 infection) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was reported.     On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced COVID-19 (diagnosed with Covid 19 infection). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose not administered past 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose not administered past 42 days) and COVID-19 (diagnosed with Covid 19 infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
Vaccines were given to patient. Patient walked out of the room with no problem after a few min. Pt. C/O of feeling dizzy. Per Dr. possible vasovagal. Patient was taken back to the exam room and we had him lay down. Vital signs were checked. Patient was observed and left the clinic feeling well.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an adult male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles.  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unspecified date, the patient was treated at a hospital emergency room for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
02/10/22 presents to ED for " Fever, Diarrhea". PMHx of "CLL on PO chemo, HTN, CAD, GERD, and gout"
Infant received first set of immunizations on 11-22-06 with the exception of having received his first Hepatitis B at birth. His appointment for his second set of immunizations was scheduled for 01/31/07 and it was at that time that the mother reported that the infant had cried for 4 hours straight after receiving his immunizations on 11-22-06. Mother reported that the child "felt a little warm but not feverish" but denied checking his temperature with a thermometer. She stated the infant "turned a bright plum color and was sweaty" from crying so much. Mother also reported that infant was kicking and hysterical during the 4 hour crying period. She stated that the crying started immediately after he received his immunizations. Denied any whelps, hives, or seizures. The infant refused to breast-feed or take a bottle that day. On day 2 the child was fussy but his appetite was better. Day 3 showed more improvement with his appetite and fussiness and by Day 4 he was back to normal. Instructed mother to consult with MD and get permission to receive immunization and bring record from MD with permission to administer immunizations.
Came to Medical center 48 hours s/p immunization with right deltoid red and swollen 2x3 cm induration, not tender touch. no symptoms of infection. Mottled red in color. Suggested to take Tylenol/Motrin and Benadryl. Follow up in 1-2 days with Medical center or PCP.
Injection site with surrounding erythema measuring 7.3cm x 4.3cm tender to palpation blanches briskly warm to touch.
Dizziness for two days Joint pain for two days Tremors in my triceps for two days
Itching on shoulder near the injection site that lasted 1-2 hrs after shot; hive on right wrist that lasted about 2 hrs; felt shaky for about 30 min
shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.   No treatment information reported.
I started having symptoms on June 11, 2022. I had severe pain on my intercostal nerves that was so bad I could not sleep at night. I had a rash show up on June 13, 2022 that I suspected was shingles. I used BENADRYL antiitch cream until I could get in to see the nurse practitioner on June 14, 2022. On the June 14, 2022 the NP confirmed that it was shingles and prescribed antiviral for me to take. It took 10 days for the rash to completely be gone.
Information has been received from a physician concerning a 6 month old male who was vaccinated PO with his first dose of ROTATEQ. No adverse event reported. There was no product quality complaint. Additional information has been requested.
Fever, chills, vomiting, Arm immobility, Pain and Heat from Chin down to past Elbow on the side where the shot was given,, 2 days Arm and shoulder are still sore on 3rd day but other adverse effects are gone.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 3:10 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 3:10 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products and treatment information were reported.  It was reported that on 19-Nov-2021 Moderna COVID-19 vials went from the super cold freezer to the refrigerator. no vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured and there were no Previous temperature excursions.
30+ days of diarrhea and nausea.  I haven't had a normal bowel movement in over a month.
Dizziness, soreness under both armpits, all around neck ache, fuzziness in jaw, metallic taste in mouth, pressure in back of head, ears plugged/ringing, tightness across chest, sore arm at injection site.
Injection site itchy; Injection site was hot and red; Injection site was red; Injection site was hot; Initial information regarding an unsolicited valid non-serious case was received from pharmacist (reference number-00321543) and transmitted to Sanofi on 19-OCT-2020.  This case involves 65-year old female patient who had injection site was hot itchy and red (Vaccination site pruritus, Vaccination site inflammation, Vaccination site erythema and vaccination site warmth) while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, concomitant medication and family history were not provided.  The patient's past vaccination(s) included flu shots in the past.  On 16-Oct-2020, the patient received dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number: UJ536AA and expiry date: 30-JUN-2021] via an unknown route at left deltoid site for prophylactic vaccination. It was reported that the this was the first time the patient taking HD.  On an unknown date, the patient developed a non-serious reaction which was hot itchy and red (Vaccination site pruritus, Vaccination site inflammation, Vaccination site erythema and vaccination site warmth), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome for reported events was unknown.
4/2/21:   chills, feverish, headache,  fatigue, extreme pain in lower back and lower left abdomen.  No treatment.  Lasted for 24 hours 4/22/2021:   Fatigue; not feeling right.    4/23/2021:  Increased fatigue, headache, weakness and intermittant pain in legs and arms.  Pain in abdomen, left lower quadrant 4/24/2021:  Continued fatigue, headache, weakness in legs & arms.  Pain has increased in arms.  Pain in abdomen continues.   Left side of face feels tender...hard to explain but it hurts near my eye, upper cheek to my ear.    Also have sneezing and ear ache.
I had bumps on my back, kind of going down my spine on both sides. They weren't itchy or burning. I went to urgent care to get it check because I thought it might be shingles. They did a swap and there was a clear liquid that came out. This was the second time in the same place.