chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received 26 October 2009 from a health care professional. A six year old female patient who is a part of a cluster of two patients complained of blistering all along the arm, had swelling, and was hot to touch at the left deltoid 48 hours after receiving FLUZONE (lot number UT3252AA) intramuscularly in the left deltoid on the morning of 22 October 2009. The patient had a doctor's visit and was treated with ORAPRED. The patient was not recovered. List of Documents held by Sender: none. The other patient from this cluster has been captured in case number 2009-04493.
Stroke range hypertension, increased sinus congestion, cough. Antibiotic for sinus and cough. Cardiologist is monitoring  blood pressure.
Dry mouth; needed help to move; Fever; neckache; Strong body pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN , PAIN (Strong body pain), DRY MOUTH (Dry mouth), MOVEMENT DISORDER (needed help to move) and PYREXIA (Fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 01-Jun-2021, the patient experienced NECK PAIN, PAIN (Strong body pain), MOVEMENT DISORDER (needed help to move) and PYREXIA (Fever). On 10-Jun-2021, the patient experienced DRY MOUTH (Dry mouth). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Jun-2021, PYREXIA (Fever) had resolved. At the time of the report, NECK PAIN and MOVEMENT DISORDER (needed help to move) outcome was unknown and PAIN (Strong body pain) and DRY MOUTH (Dry mouth) had not resolved.            No concomitant medications were reported.
Left upper arm with baseball-sized red, raised and swollen area with bumps or "blister-like" things. Itched but denies fever. Treated with antibiotic; cephalexin and over the counter cortisone cream.
Rash; Swelling; Redness; Burning down to her hand; severe Pain shooting down her arm / arm continues to be Painful; This case was reported by a consumer and described the occurrence of rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 6th January 2021, less than an hour after receiving Shingrix, the patient experienced rash, swelling, erythema, burning sensation and pain in arm. The patient was treated with ibuprofen, steroids nos (Steroid (Not Specified)) and antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the rash, swelling, erythema and burning sensation were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the rash, swelling, erythema, burning sensation and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of Shingrix on 6th January 2021 in her right arm. Approximately twenty to thirty minutes later, the patient had severe Pain shooting down her arm and Burning down to her hand. The patient also reported a rash, redness and swelling. The patient went to the emergency room, and received a recommendation for ibuprofen. On 7th January 2020, the patient went to an urgent care and received steroids, and an antibiotic. The patient was also taking ibuprofen. Her arm continued to be Painful. The reporter consented to follow up. Emergency room visit required.
Heart flutter, pain in lymphnodes, sore throat, stuffy nose, headache, heartburn, loss of smell.
Throat is soar 2 days after shoot; 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 OROPHARYNGEAL PAIN (Throat is soar 2 days after shoot) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OROPHARYNGEAL PAIN (Throat is soar 2 days after shoot). At the time of the report, OROPHARYNGEAL PAIN (Throat is soar 2 days after shoot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Urticarial lesions on neck, chest, arms and legs X 18 hours after vaccines. Cleared after 3 days. Treated with Benadryl.
ACHINESS; CHILLS; REDNESS/SWELLING AT INJECTION SITE; FEVER; PAIN AT INJECTION SITE; NIGHT SWEATS; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies or comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced night sweats. On 10-APR-2021, the subject experienced pain at injection site. On 11-APR-2021, the subject experienced achiness. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced redness/swelling at injection site. On 11-APR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.5 degrees F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, night sweats, chills, and fever on 11-APR-2021, and had not recovered from pain at injection site, and redness/swelling at injection site. This report was non-serious.
Vaccinee experienced "non responder" following a 3rd Hepatitis B vaccination (? first dose of Engerix-B).
We were administering vaccines to both siblings in the exam room. Patient received the wrong vaccines that were supposed to be given to her sibling.
First shot I only had a sore arm, second shot, I had the normal fever around 4/9/21 at 12 am, around 11:15 am I started to break out in hives and I?m never allergic to anything so it led me to believe it?s due to whatever component is in the vaccine. I took a benadryl and took a nap around 1pm woke up at 4 pm with more hives. I bought Allegra and put calamation lotion on the hives and tried to sleep them off for the next day, on 4/10/21 when I woke up I had severe hives all over my body except for my stomach area, I went to the urgent care and the dr recommended I go to the ER which I was prescribed Prednisone and Hydroxyzine and to take Benadryl when needed. The ER doctor suggested it could be good, detergent, or a different shampoo. But I have never been allergic to anything in my life and have not changed anything and it just so happens I get hives after getting the vaccine.  Now today on 4/20/21 I broke out in mild hives around 2:30 am, took an Allegra and it seems to be gone for now. I hope this is not a reoccurring symptom..
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of erythema in a subject of unspecified age and gender who was vaccinated with KINRIX, (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of KINRIX (.5 ml, route unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced erythema, hardness injection site, swelling injection site and injection site warmth.  At the time of reporting the outcome of the events was unspecified.  The healthcare professional reported that 15 subjects experienced the same events in the same time period after vaccination with KINRIX.  At the time of reporting, no additional information was available.  This is case 8 of 15 (see case IDs A0860669A, A0860688A, A0860690A - A0860694A, A0860696A - A086702A for the other reports).
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown demographics. The patients concurrent conditions or medical history were not reported. On an unknown date, the reporter stated that the patients received a dose of an improperly stored VARIVAX (Merck) (dose, route, anatomical location, lot number and expiration date not reported). No adverse effects were reported. Additional information has been requested.
Patient stated that she developed a red, itchy rash, that felt warm (feverish) at the injection site and the surrounding left deltoid starting a couple days after the injection.  Vaccine administered on 4/22 and patient presented on 4/30.
face becoming numb as well as numbness in her fingers and legs; This is a spontaneous report from a contactable other healthcare professional. A 57-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date was not reported), via an unspecified route of administration on 13May2021 as dose 1, single (at the age of 57-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 13May2021, immediately after having the first dose, patient started having complaints of her face becoming numb as well as numbness in her fingers and legs that lasted approximately thirty minutes then resolved. The outcome of the event was recovered on 13May2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Swelling, redness, heat, unbearable itching, pain. Unable to lift arm or have anything on site for a radius of 2 1/2" around injection point. Initial treatment-Hydrocortizone cream (did nothing to make the symptoms subside). Redness and swelling expanding around site, pain and itching still occuring as of 08/20/2010.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (parent). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Jan 8, 2022, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had COVID-19 (tested positive for COVID-19 virus), onset Jan 15, 2022, with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. Additional information: The patient had the first dose of the Pfizer COVID-19 vaccine on Jan 8, 2022. Last Saturday the patient contracted the COVID 19 virus and tested positive. He described it as horrible, terrible, very ill, chills and headache. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-202200111998 same reporter/product/event, different patient.
Information has been received from a registered nurse (R.N.), concerning an unspecified number of patients of unknown ages and genders. The patients pertinent medical history and concurrent conditions were not informed. It was reported that on unspecified dates, the patients were administered doses of improperly stored VARIVAX, lot # L018001, expiration date 19-MAY-2017, (dosage and therapy route were not provided). No adverse effects were reported. Concomitant therapies were not informed. No product quality complaint (PQC) was involved. This is one of two reports from the same source (MARRS # 1609USA014852). Additional information has been requested.
PAIN IN BOTH SHOULDERS AND BOTH ARMS, AND HEADACHE THAT BEGAN DAY FOLLOWING VACCINATION AND WORSENED DAILY.  PAIN IS ACUTE AT NIGHT AND INTERFERES WITH SLEEP. LOSS OF STRENGTH AND MOBILITY IN BOTH ARMS AND CONTINUOUS PAIN IN JOINTS, MUSCLES, SHOULDERS AND BACK.
STROKE; SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and diabetes type 2.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 04-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On unspecified date, the patient had sore arm. On 28-MAR-2021, the patient's right peripheral vision was gone and went to emergency room and diagnosed with stroke. The patient got hospitalized. At hospital, alteplase was administered as the treatment medication for stroke. Patient was discharged on 02-APR-2021. The magnetic resonance imaging (MRI) has shown small spot (stroke confirmed) while Computerized axial tomography scan (CAT) scan did not show the stroke. The patient was hospitalized for 5 days.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke on 02-APR-2021 and the outcome of sore arm was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0;20210518127-covid-19 vaccine ad26.cov2.s-Stroke. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
TOOK UNREFRIGERATED DOSES OF VIVOTIF; This spontaneous case report (PVX2019-2701) was received from a consumer on 30-Oct-2019. It described a 29-year-old female consumer who "took unrefrigerated doses of Vivotif" (PT: Product storage error), while being on Vivotif for typhoid fever.  Case report: The consumer took all doses of Vivotif that was unrefrigerated. She took the last dose on 25-Oct-2019.   Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: The causality of the event "took unrefrigerated doses of Vivotif" was considered as not applicable.; Sender's Comments: Company Comment: The causality of the event "took unrefrigerated doses of Vivotif" was considered as not applicable.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: cough-Mild
Pain at injection site within hours of vaccination.  Continued and radiated into neck for 2 weeks. No redness or swelling.  After 2 weeks pain subsided began having vertigo which has continued.  Today 1/27/10 developed numbness in face.
I had to get the vaccine for a new job. So I went to get the J&J at 5pm. Instantly after,  I got an instant adrenaline rush and massive headache. I teared up it hurt so bad. Then my lunges started to burn and my stomach felt nauseous. My arm instantly started to be sore. (This is all within 15 minutes) at 5:30pm I had to train a client and I still felt that bad feeling, my lungs were still burning. I couldn?t lift my arm to demonstrate a Superman. Struggled through my 6:30pm session. Went home took zinc and vit C. Woke up with a sore arm. Went to teach my 9am group and have been declining ever since. I have a bad headache,  102 fever, diarrhea. My lungs don?t burn anymore but I just feel awful. My eyes burn, my tears are so hot, it burns my check. I can?t lay on my arm. My head hurts so bad. I stayed in bed fighting the fever all the next day drinking as much water as I could and still couldn?t shake this massive headache. It is now Thursday and I couldn?t go to work again because my eyes are swollen and it?s effecting my vision. My head hurts and I can?t stand loud noises or bright lights. I woke up in a pool of sweat and have only have a 99 low grade fever. My arm is swollen. I have never felt this bad. I am healthy, workout 5 days a week, and didn?t feel this awful when I had Covid a year ago. Something isn?t right.
Something running on her spine; Felt something cold; Couldn't stand up; Hurt in her waist and her hip; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Something running on her spine), FEELING COLD (Felt something cold), DYSSTASIA (Couldn't stand up) and ARTHRALGIA (Hurt in her waist and her hip) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045521a, 004c21a and 027b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced DISCOMFORT (Something running on her spine), FEELING COLD (Felt something cold), DYSSTASIA (Couldn't stand up) and ARTHRALGIA (Hurt in her waist and her hip). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, DISCOMFORT (Something running on her spine), FEELING COLD (Felt something cold), DYSSTASIA (Couldn't stand up) and ARTHRALGIA (Hurt in her waist and her hip) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-417004, MOD-2021-417005 (Patient Link).
After receiving this shot I had an extremely heavy menstrual cycle. This is odd because I have very very light ones these last few years. This is not a medical emergency but I wanted you to know that it happened just in case it is related and needs to be studied.
Patient received her the influenza shot and went walking around the store. A little while later, her uncle came back to the pharmacy to inform us that she collapsed in the aisle. EMS was called and assessed her condition. She was awake and coherent. Pharmacist spoke with the uncle and he said she has been compliant with seizure medication, but still gets 3-5 seizures per month.  Patient was taken away from store via ambulence.
patient complained of pinching at the site left arm deltoid and pressure to the chest area which lasted for 1 minute. Vital signs taken and EKG done. Sinus rhythm on EKG result. Patient discharged home.
Mom states that 2-3 days after the Vaccine was given the child developed Tachycardia and Palpitations. Parents took child for an evaluation by the Cardiologist and was advised that it was transient and his Cardiac evaluation was negative.
Arm swelled up real bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 4 (booster), single (Lot number: GH9694) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 20Oct2022, outcome "not recovered", described as "Arm swelled up real bad".  Additional information: Consumer stated, when she got the injection, arm swelled up really bad and it has not gone away yet. It was still swollen and had it 20Oct2022. Paraphrased the concern: Reporter stated, she got it, but it was still swollen up and it still kind of hard so, it was probably since 20Sep, and it was swollen up hard. How do we, what can we do about that? Reporter stated, let me say something, Pfizer 30 mcg/0D 3 ml Inj Pfizer. It came through on the shot when she got it (not clarified further).  No follow-up attempts are possible. No further information is expected.
Pt recvd Engerix-B & the next morning following vax pts tongue became swollen; seen by MD; tx antihistimine;
Dyspnea, cough, fatigue, hypoxia 1 week PTA. Admitted 8/29/21 with COVID pneumonia, pancytopenia, AKI & weakness. Her caregiver tested positive for COVID. Patient able to go on room air after 24 hours. Husband recently died, patient depressed. Discharged to home 9/1/21 - readmitted 9/2/21 with altered mental status, fall.
Case number PHEH2015US026863, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 64-years-old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: 1514501 and expiry date: May 2016) in right deltoid on 05 Oct 2015, which was out of temperature range (34 degrees). The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Pt arrived to ED with CVA like symptoms. Positive F.A.S.T. per EMS with left sided weakness and left facial droop.
Came down with fevers and chills by 06/15/2012 and went home not feeling well. On 06/16/2012, she ran a fever of 101F, went to Urgent Care where it was up to 103F. She was told that she had an "infection" as her arm was red, hot and swollen. She felt like she was "hit by a truck". She missed 2 days of work.
he bled from the injection site at the time of injection and that had never happened to him before; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (he bled from the injection site at the time of injection and that had never happened to him before) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer Covid-19 Vaccine (Batch Number Pfizer) on 17-Feb-2021 and Pfizer Covid-19 Vaccine (2nd dose) on 10-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer Covid-19 Vaccine and Pfizer Covid-19 Vaccine.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (he bled from the injection site at the time of injection and that had never happened to him before) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 19-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, VACCINATION SITE HAEMORRHAGE (he bled from the injection site at the time of injection and that had never happened to him before) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.
HAD A SEIZURE APPROXIMATELY 3 HOURS AFTERWARDS. SHE DOES HAVE HISTORY.