chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 virus test positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 virus test positive) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and Psoriatic arthritis.    No known allergies.  Concurrent medical conditions included Crohn's disease (moderate to severe adult) and Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19 virus test positive). At the time of the report, COVID-19 (COVID-19 virus test positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was reported that the primary reporter contact for lot number information was unsuccessful. It was reported that the Humira was taken as a solution for an injection in pre-filled pen. No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter causality for the event of COVID positive was no reasonable possibility for Humira. No treatment medications were reported. Company comment-This spontaneous case concerns an elderly male patient of unspecified age with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 (with positive SARS-CoV-2 test) that occurred in the context of mRNA-1273 vaccination. Latency can not be assessed as event onset date nor vaccination date was provided. No further information on risk factors, investigations, treatment of the events was available in the report. Outcome of the event was not resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns an elderly male patient of unspecified age with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 (with positive SARS-CoV-2 test) that occurred in the context of mRNA-1273 vaccination. Latency can not be assessed as event onset date nor vaccination date was provided. No further information on risk factors, investigations, treatment of the events was available in the report. Outcome of the event was not resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement.
Herpes keratitas in left eye, treated with valacyclovir 3 times per day for 7 days, Lotamax Ophthalmic Gel Drops 2 times per day for 14 days
CHRONIC LEFT ARM PAIN AND UNABLE TO SLEEP OR LEAN ON LEFT SIDE ATTEMPTED TO TREAT WITH SALONPAS PAD, TYLENOL, ADVIL X2 WEEKS - NOT EFFECTIVE CALLED DOCTOR AND RECOMMENDED TO USE HEAT PAD - NOT EFFECTIVE
Information has been received from a licensed practical nurse (LPN) concerning an 18 weeks old male infant with a history of formula interolance and reflux (treated with LEVSIN) drops and ZANTAC)), who on 11-DEC-2007 was vaccinated IM in the left thigh with the first dose, 0.5 ml, of PedvaxHIB (lot #656522/0437U). Previous vaccination in the series on 18-OCT-2007 was indicated to be from another manufacturer. Concomitant therapy included DTaP-IPV and Prevnar. On 11-DEC-2007, 3 hours after vaccination, the child developed a fever of 102.9 F. On 12-DEC-2007 the child developed 5 separate bouts of diarrhea. On 13-DEC-2007 the child had watery stools, vomited twice and was cranky and irritable when examined in the physician's office. At the time of this report, the child was recovering from the events. The physician did not feel the events were related to PedvaxHIB, other than on a temporal basis. Additional information has been requested.
the swelling came back and his hands started to swell as well; patient says his lips started to swell the night he received the dose; This is a spontaneous report from a contactable consumer.  A male patient of unspecified age received first dose of bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced that his lips started to swell the night he received the dose, so he went to the emergency room. Therapeutic measures were taken as patient was treated with steroids for five days. After he was discharged the swelling came back and his hands started to swell as well. He went back to the ER. The reporter wanted to know if the side effects the patient had been common with the PFIZER covid-19 vaccine. The outcome of both the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 2 minutes of receiving IM TDAP in left deltoid, patient complained of feeling faint, was eased to the floor experiencing a very brief syncopal episode. She responde to verbal stimuli immediately and once her color returned she was hepled to an examining table, given po fluids, vital signs monitored (stable at 90/70 p-90) and observed for 30 minutes. She left ambulatory in no distress with her husband who drove her home. On follow up the next day she reported feeling fine.
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 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 at 11:45 as dose 1, single (Batch/Lot number: unknown), in left arm and on 24Apr2021 at 08:45 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FOLATE; D3 +K2. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (10Jul2022) Negative; (11Jul2022) Negative; (12Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial case was received on 16 September 2010 from a healthcare professional. It contains information for a cluster of 5 unidentified patients. Five unidentified patients received on 15 September 2010 an injection of FLUZONE (lot number U3568AA). Approximately 24 hours later on 16 September 2010, the 5 patients all complained of a severe headache, body aches, and fatigue. No further information was provided. As of this report, the patients had not recovered. Follow-up information was received on 12 November 2010 from a healthcare professional. The reporter provided individual patient identifiers for each of the five previously reported unidentified patients. The information for the initial case (2010-05065) now contains information for the first of five patients. A 44 year old female received the previously reported injection of FLUZONE (lot number U3568AA) on 15 September 2010 in her left arm. She had no pre-existing medical conditions. On an unspecified date, she started with coughing and wheezing, and experienced a low fever, severe headache and body aches. On day 2 (date not reported), she was very tired, and had "bit of aches" and headache. On day 3 she was feeling better. Following prior vaccinations the patient experienced "feeling a bit tired if anything". The patient recovered on an unspecified date. The reporter for this case (2010-05065) is the same reporter for cases 2010-06445, 2010-06446, 2010-06447 and 2010-06448. Documents held by sender: None.
pt recv vax;devel pain & tenderness at inject site;devel palpable nodule which MD felt was a sterile abscess;x-ray revealed no abnormalities;sx persisted,was tx w/ physical therapy;
Overall muscle body aches. What makes it different than arthritis and stress related pain is that I have aches/pain in my arms and leg muscles as well. I've never had this before. NSAIDS are effective in relieving the symptoms. It's an overall body ache that still persists. It hasn't gotten worse or better. Its persistant & annoying! I haven't felt the need to see my doctor because I can control the symptoms. That and my life has been consumed with dealing with my Mom's Estate, & I have no interest in going into the clinic & potentially exposing myself to COVID due to my Asthma and Diabetes. My daugter was hospitalized with COVID pneumonia & pulmonary embolisms & was sick for 3 mo.  UPDATE:  Aug 15 no symptoms
administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number unknown, expiry date 2nd January 2023) for prophylaxis.   On 9th January 2023, the patient received Engerix B. On 9th January 2023, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's Comment: The nurse reported that the patient received a dose of Engerix B which was already expired. No additional adverse event details available per healthcare professional.  The reporter consented to follow up. Additional Supportive Information: The use of Engerix B dose, which was already expired on 2nd January 2023, which led to expired vaccine used.
Started with a bad headache, then had chills so bad I was shivering. Later that night, I started throwing up and had diarrhea. Took my temperature, it was 101. Had hot sweats and then cold chills. The throwing up and diarrhea lasted til the next morning. But the headache, chills and fever lasted most of the day. Took Tylenol and some pepto. It is now Friday the 21st and I am feeling pretty much back to normal today.
IM injection given at 1 pm on 10/26.  Approximately 8 pm sharp pain abruptly began at injection site along with oval red rash,  initially 1" in size then enlarged to approximately 3.5" in length. Domed swelling at and around injection site, very sensitive to touch. Swelling and pain gone by 10/28, red rash began to fade on 10/28 and continued fading through 10/29.  No fever, nausea, vomiting, aches or other systemic symptoms occurred.
1320: arrived in 30 minute observation. 1350 notified she had waited 30 minutes and if feeling well she could leave. Patient stated she had had some left lateral hand numbness since just after the injection that now is feeling more like tightness than numbness, a new tickle in the throat and tongue which felt "puffy" like "taking up some more space than normal. Denied any other symptoms. 1400: VS 135/90, pO2 98-99%, HT regular at 84,  stated throat tickle dissipating, tongue puffiness resolving and left had less tight.  1410: Patient asked to go to BR and returned without complaint. 1420: Patient drank small bottle of water without difficulty, "felt normal to swallow." Patient stated her symptoms had resolved and there were no new symptoms.  Patient stated she felt normal and comfortable to drive home.
Rash to (R) arm 24 hours after vaccine. Blister at site of injection 8mm in size.
Pain in arm, frozen shoulder, bicep synovitis Left arm. Tx PT, can't take anti inflammatory meds, Pain and immobility continues.
Information has been received from a registered nurse, concerning a female baby whose 26 year old female mother with no known allergies and no pertinent medical history, on an unspecified date in June 2010, was vaccinated with GARDASIL (lot number not reported). Her LMP was not reported. There was no concomitant medication. The registered nurse reported that on 11-FEB-2011 the mother delivered vaginally a female baby, with a congenital cardiac anomaly (specific type of anomaly was unknown), at 39 weeks of gestation. The baby's weight 7 pounds 11 ounces. The registered nurse stated the baby had cardiac surgery within a week of delivery an outcome of neonate's surgery was reported in record as favorable. Cardiac anomaly was considered a congenital anomaly by the registered nurse. Upon internal review cardiac surgery was considered to be an other important medical event. The mother's experiences were captured in WAES1008USA03991. Additional information has been requested.
AFTER ABOUT 1 MINUTE  AFTER IMMUNIZATION, PATIENT INDICATED THAT HE FELT PAIN AT THE INJECTION SITE AND PROCEDED TO FAINT. PATIENT REGAINED CONCIOUSNESS AFTER ABOUT 15 SECONDS
3 yr old patient presents 1 day after injections with rash on right leg, red, hot and achy.  Patient ran low grade fever x 2 days.
7-19-2011 picked up ZOSTAVAX vial at pharmacy. Went to MD office. LPN gave injection (L) deltoid. On 8/12/2011 shingles posterior rt leg, upper thigh. Had ZOVIRAX 5% ointment from previous shingles. Applied to sterile dsg. taped on area (R) leg. MD contacted 8/17/2011 script for famciclovir. Taken per MD order. 8/23/2011 shingles scabbed. No dsg. 11-7-2011 (flu vaccine MDV) given by LPN. 8/12/2011 Blisters, inflammation, pain, red , swelling.
Information has been received from a physician concerning a 29 year old pregnant female with a medical history of "a heart condition" who on an unspecified date was vaccinated with varicella virus vaccine live. It was noted that the doctor stated that the "heart condition" was present before the pregnancy and it was a "long standing condition". The date of the patient's last menstrual period was reported to be approx. 13Sep2002 or 20Sep2002. The EDD was 20Jun2003, the exact due date was unknown. At the time of this report, the results of an ultrasound were pending. Unspecified medical attention was sought. Follow up information revealed that on 01Jun2003, the mother delivered a female baby with a birth weight of 5 lbs. 10 oz. It was noted that the patient was induced 5 weeks early due to her heart condition because they wanted her to deliver a smaller baby. It was also noted that the baby was "fine" and "all is going well with the baby". No further information was provided. No further information is expected.
11-13-07 Hurt like a tetanus shot - Benadryl (2 doses).  11-14-07 Red swollen from elbow to shoulder, painful to touch, took Benadryl (3 doses).  11-16-07 Went to MD, gave IM antibiotic.  11-18-07 Dr. started Levaquin.
Over night and into next day. Body aches, headache, no energy, nausea, sore arm, amplification of lower back pain, discomfort.
PATIENT WAS GIVEN COVID BOOSTER VACCINE ON 4/26/23 THAT EXPIRED ON 4/17/2023
Second dose- two months from the first shot.   Significant swelling, three days of fever, headaches, nausea
Shortness of breath, dyspnea, itchy throat, sweaty, throat felt tight. Treatment here in the ER was racemic epinephrine, im epinephrine, famotidine, albuterol nebulizer solution, dexamethasone iv, 1L of NS.
Started having red dotted rashes appear on my legs. They started itching really bad, so I went to an Urgent Care. The Urgent Care doctor told me that it actually wasn't a rash and to go to the hospital. Went to the Emergency Room and had bloodwork drawn. Didn't find out the results and told to go to my regular doctor on the following monday. My doctor referred me to a Dermatologist, the appointment is 2 months away. Doctor also wants me to see an Infectious Disease doctor, but I'm waiting for Authorization. The rash on my legs started moving up to my thighs.
pt recvd vax;high fever,ear infect,conjestion,d,sz,jerking,staring spells,semi-coma,running nose,cough;lasted 8-10 days;
Death - the patient was hospitalized after receiving the 1st dose, with CF and other issues, upon entry to RRLC she was in recovery - vitals were good. Her health was improving.  Three days after the second dose in the morning while the aide waited outside, she died on the toilet  - shocking all staff at the facility and the family.
The patient felt headaches and muscle aches , and ran a low fever the day after his second dose and these continued for a few days.  The following week his behavior became somewhat erratic and he developed headaches once again.  After seeing his physician on March 25, it was determined that he should go to the emergency room .  There it was determined that he had a brain hemorrhage and possible pneumonia.
Left sided facial drooping - started 07/03/2021. Patient diagnosed with Bell's palsy 07/07/2021. Treated with acyclovir 800mg (1 tab orally 5 times a day for 10 days) and prednisone 10mg  (7 tabs day 1, decreasing by 1 tab/day until gone)
General muscle ache, mild fever, vomiting, profound fatigue for 3 days.  One week after the vaccine supraventricular tachycardia with low blood pressure.
Yesterday was diagnosed with erythema nodosum / developed joint pain in lower extremities & a rash on shins; a rash on shins; a week ago she developed joint pain in lower extremities; swollen lymph nodes in left arm just above the elbowand in axillary; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA NODOSUM (Yesterday was diagnosed with erythema nodosum / developed joint pain in lower extremities & a rash on shins), RASH (a rash on shins), LYMPHADENOPATHY (swollen lymph nodes in left arm just above the elbowand in axillary) and ARTHRALGIA (a week ago she developed joint pain in lower extremities) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Oct-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes in left arm just above the elbowand in axillary). In November 2021, the patient experienced RASH (a rash on shins) and ARTHRALGIA (a week ago she developed joint pain in lower extremities). On 06-Dec-2021, the patient experienced ERYTHEMA NODOSUM (Yesterday was diagnosed with erythema nodosum / developed joint pain in lower extremities & a rash on shins). At the time of the report, ERYTHEMA NODOSUM (Yesterday was diagnosed with erythema nodosum / developed joint pain in lower extremities & a rash on shins), RASH (a rash on shins), LYMPHADENOPATHY (swollen lymph nodes in left arm just above the elbowand in axillary) and ARTHRALGIA (a week ago she developed joint pain in lower extremities) had not resolved.            No concomitant medication were reported. No treatment information was provided by the reporter.  Shortly after getting the 2nd dose, patient developed swollen lymph nodes in left arm just above the elbow and in axillary. The symptoms continued to get worse and a week ago in NOV-2021 patient developed joint pain in her lower extremities & a rash on shins. Patient was diagnosed with erythema nodosum ON 06-DEC-2021. Patient mentioned of seeing a rheumatologist soon.
Pfizer-BioNTech COVID-19 Vaccine EUA Onset of chills x 7 hours, significant injection site pain 8/10, injection site swelling
Covid-19; Covid-19; This is a solicited report based on the information received by Pfizer (Manufacturer Control No: 21K-163-4066039-00). A contactable consumer (patient) reported a 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, intramuscularly on 04Mar2021 at the age of 63 years old, as single dose, second dose, intramuscularly on 25Mar2021 at the age of 63 years old as single dose for covid-19 vaccination; adalimumab (HUMIRA), subcutaneously from an unspecified date to an unspecified date, at unspecified dose for rheumatoid arthritis. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced covid-19 in Aug2021. The patient underwent lab tests and procedures which included Covid Test: positive in 2021.  The action taken in response to the events for adalimumab was unknown. The outcome of the event was unknown. Causality as per reporter for BNT162 was possible.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and vaccination failure due to temporal relationship.
FEVER; BODY ACHES; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included declined to provide report for medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 04-MAR-2021 for prophylactic vaccination. batch and lot number were not provided hence requested. No concomitant medications were reported. On 04-MAR-2021, the patient experienced headache. On 05-MAR-2021, the patient experienced fever. On 05-MAR-2021, the patient experienced body aches. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 05-MAR-2021, and had not recovered from fever, and body aches. This report was non-serious.
From patient note: 2/19/21 Day of Vaccination - Morning of the vaccination had burning in arm at and around the injection site with severe soreness of arm developing over the day.   After 5 hours faintness, sore neck/shoulders, trembling hands, "super shaky", also headache with stabbing pain in head and neck which continued for several days.  Tight chest developing within 3 hours gradually turning into extreme difficulty breathing by 9pm.  Around 9pm both arms from shoulders to fingertips went numb and tingly "like nerves were TV static".  Throughout night drank about 1 bottle of water per hour, each time getting up and taking a few steps vision would start blacking out, would feel clammy, and would barely make it back to bed before fainting.  Extreme muscle and joint pain made walking difficult for 3 days..  Fever of 99-101 for 3 days. Day 2 - extreme back pain accompanied by heartburn On 2/22/21 reports doing better but continuing to have soreness, night sweats, chills
PATIENT HAD TEMP REPORTED BY MOTHER FOR A COUPLE OF DAYS 103.9 RASH ALL UPPER OUTSIDE OF ARM TO ELBOW AND CONTINUED TO HAVE TROUBLE SWALLOWING TILL SAT PM.
21JUL95 2AM rough, raised, fine red rash over entire body severe itching; no fever; seen in ER hypersensitive rxn to vax; given Vistaril & Atarax; 22JUL95 seen in ER t104 given med; 24JUL95 no problems;