chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In my first Moderna shot (on March 4th, 2021) I received it in my left arm. By Saturday March 13th, 2021 I started to experience a severe rash on and around the injection site. This was raised, red, warm to the touch and burned. This initially was the size of a baseball in circumference and then it expanded to wrap all the around my arm and down to my elbow.  By March 16th, 2021 I communicated with a supporting  doctor via a telehealth meeting and shared with her photographs that I took of the arm.  I was given the diagnosis of CELLULITIS and was prescribed Cephalexin (KEFLEX) 500 mg Oral Cap (for 10 days).
No additional adverse event reported; Expired Pneumovax23 was administared; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.      On 29-SEP-2021, the patient was vaccinated with 0.5 milliliter of an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T010293, expiration date 30-AUG-2021 (route was not reported) for prophylaxis (expired product administered). No additional adverse event and no product quality complaint were reported.
Patient complained of overall feeling of warmth about 30 min after injection-became increasingly dizzy with vision disturbances-double vision and blurred vision. Sent to hospital where fluids were administered and patient observed. Atypical allergic reaction diagnosed at hospital.
I have misplaced my  COVID-19 Vaccination Record Card.  On March 8, 2021 [ same date & time as my husband had his ]   I was given the Moderna vaccination on my right arm.  Within a day or 2.  I asked my husband to look at the right side of my next b/ c it hurt really bad.  He noticed my neck, towards my shoulder, towards my back, my chest above my breast & my collar bone were really swollen & feels squishy.?.  Still swollen.  My collar bone looks weird. It has been 4 months since I had my first Moderna shot.  No issues or reactions on my left arm/ my left side where I had my second dose of the Coronavirus/
LOCAL REACTION: REDNESS, HEAT, SWELLING, YELLOW DRAINAGE L DELT. SYSTEMIC: C/O FATIGUE, MUSCLE SORENESS TO CHEST AND ARMS
Arm soreness since injection(expected)  General fatigue, made better by Ibuprofen
Immediately after the flu shot the patient noticed significant pain. Patient has had increasing pain in her arm since the vaccine. This morning (12/17/18) she woke up with severe, uncontrolled pain. Patient denies any swelling or redness. Reports numbness in her fingers once in a while.
The day after vaccine pt c/o intense arm pain w/red rash spreading down the arm in the shape of an "S".
pt fainted, falling off exam bed and hitting head on floor.  Cool compress applied to knot at forehead, pt to be referred to ER for further evaluation
Pt came into clinic for dr appt, provider ordered covid bivalent booster, pt received covid monovalent vaccine
Left sided neck muscle spasm, pain, radiating down left arm beginning 48 hours after injection and lasting several days.
Did not get the full 0.5ml dose; A spontaneous report was received from a physician concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine but did not get the full 0.5ml dose.  The patient's medical history was not provided.  Concomitant medications were not reported.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273, intramuscularly for the prophylaxis of COVID-19 infection.  On an unknown date, the patient did not get the full 0.5ml dose, but however received only 0.35 to 0.4 ml of the vaccine due to a syringe malfunction. No treatment information was provided for the event.  Action taken in response to the event was not reported.  The event did not get the full 0.5ml dose was considered to be resolved on an unreported date.; Reporter's Comments: This report refers to a case of Incorrect dose administered for COVID-19 vaccine, mRNA-1273. There were no reported AEs associated with this case of Incorrect dose administered for COVID-19 vaccine, mRNA-1273.
24 hours after vaccination, pt complained of redness, pain and swelling in injection site, generalized. RX: hydrocortisone cream.
Rash all over body, headache, low-grade fever, all symptoms started 6 days after vaccination.
pt recvd vax on 16APR92 & 28APR92 devel 1 episode of bloody diarrhea followed by severe epigastric pain, palpitations, diaphoresis, flushing, abdo cramps, agitation, paresthesia, elevated SGOT, & elevated SGPT; seen in ER;
Fever; Headache; Chills; cold; Muscle weakness; muscle weakness; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (cold), MUSCULAR WEAKNESS (Muscle weakness), MUSCULAR WEAKNESS (muscle weakness), the second episode of PYREXIA (Fever) and the second episode of HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced MUSCULAR WEAKNESS (muscle weakness), the first episode of PYREXIA (Fever), the first episode of CHILLS (Chills) and the first episode of HEADACHE (Headache). On 09-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING COLD (cold), MUSCULAR WEAKNESS (Muscle weakness), the second episode of PYREXIA (Fever), the second episode of HEADACHE (Headache) and the second episode of CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 04-Mar-2021, MUSCULAR WEAKNESS (muscle weakness) had resolved. On 09-Apr-2021, FEELING COLD (cold), MUSCULAR WEAKNESS (Muscle weakness), the last episode of PYREXIA (Fever), the last episode of HEADACHE (Headache) and the last episode of CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 103 (High) 103.         Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-MAY-2021. ADR form was received. Added patient details and medical history.
Since I got the vaccine my menstruation is super painful and the blood flow is too much. They are also longer. I feel extreme tiredness and blackouts.
Flu symptoms, achy, feeling like I got hit by a truck.  Followed by a cold.
Pt recvd vax 15NOV92 & 5 days following vax pt exp h/a, dizziness, nausea & abdo pain; No further details were provided;
Pt. received flu shot and for 4 or 5 days after shot pt had pain at inj. site and lasted until Dec. 11 when pain radiated down to elbow then hand and shoulder blade and hard to get up several times at night to ice that area.
This spontaneous report was received from a pharmacist regarding a 85 year old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. The pharmacist reported that on 14-SEP-2016, the patient might have received ZOSTAVAX (strength, indication, expiry and lot# were not reported). The pharmacist also reported that on 13-OCT-2016, the patient had received a possible second dose of ZOSTAVAX lot# L044528; expiry on 09-FEB-2017. No adverse events were reported. There were no product quality complaint involved. Additional information has been requested.
Patient c/o of dizziness, nausea after receiving J&J vaccine. Pt reports just got her COVID shot and started to feel lightheaded, cold hands, anxious and nauseated.
Insomnia; Cough; his body start jerking; This is a spontaneous report received from a contactable consumer. A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on 03May2021 (at the age of 40 years) and second dose of BNT162B2 on 26May2021, as a single dose for COVID-19 immunization. The patient medical history included Ventricular tachycardia and concomitant medications included Amiodarone used for Ventricular tachycardia on an unknown date. Reporter stated that he took the highest dose in that medicine, yes the highest, I do not know what the highest is that he is taking I know it is the highest since they said they cannot give him anything now". Reporter stated, "My son might be having a reaction to the Pfizer vaccine and he has a test in the morning, but he already been into the emergency room and all these and I need to ask or talk to somebody that can medically give me some advice before his test specifically we do not know he can actually have this test now. Reporter added, "Now do you need to know his side effects that he is having from the vaccine that came from the vaccine. Okay the side effects he is having started right after his first vaccine on 03May2021 he started getting the sleep apnea well not sleep apnea sorry about that he started getting insomnia and he cannot sleep and he ended up getting a cough so when he went back to his second vaccine his insomnia started getting worse, he is like he cannot sleep at all and when he does fall asleep its only for 2 hours and he gets so tried, his body start jerking and makes him wake up. Report-er stated, "They are worsening". The patient underwent laboratory test and procedures which included chest X-ray, Nuclear test on Friday and have not got results for that test. Outcome of events was reported as unknown.  Reporter seriousness for Insomnia, Cough, his body start jerking was unspecified.
Right middle cerebral artery stroke-left hemiparesis, admitted to hospital. Rx: ASA, supportive care.
Fever - 100 degree D. Diarrhea. Stomach upset. Dizziness.
erythema nodosum, on shins and ankles, one finger and upper right arm It is being treated with prednisone (Pediapred)
NO ADVESRE EFFECT; improperly stored vaccine administered; This spontaneous report was received from a medical assistant refers to a 5-year-old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 15-MAY-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R030801 and expiration date 22-APR-2020) (dose, units and frequency were not reported). The temperature excursion was at -14 c to -10 c (-14.4 degree centigrade (c)) for 15 minutes. The previous temperature excursion was at -9 c to -8 c (-3.2c, -7.6c) for 4 hours and 29 minutes. Data logger was no involved. No adverse effects were reported. No PQC (product quality complaint) was reported.
devel hives & ankle swelling & not walking-48hr later seen in ER given DPH;
Myalgia fatigue, itching at site Narrative:  After #1 dose 3 d itching swelling pain after #2 dose fatigue myalgia chills for 3 d
38 year old male presents to clinic for all over body rash. PT states that over the last 2 weeks he noticed a rash that began on the left side of abdomen and as well on left foot. Pt states that he thought it was a ingrown hair on the abdomen. Pt states that he noticed then he started to spread all over to the rest of the body except for the neck and the face. Pt states that he has tried OTC antihistamine and topical steroids to minimize the rash with no help. Pt denies any pain with the spots but states that it does itch. Pt states that he thought that it was a heat rash. Pt states that it was at it is not getting any worst. Pt denies any new changes done in  the last 2 weeks. Pt denies any new detergents, lotions, creams, ect. Pt reports receiving the Covid19 vaccine 2 days prior to onset of sx. Pt states no difficulty breathing or swallowing.  Pt prescribed antihistamine for hive control  topical steroid cream to control itching  Pt educated on red flag sx and advised to f/u w/ PCM or ER if sx worsen  Pt should be reassessed prior to receiving second dose of vaccine in 2 days.
Pt. complained of stomach pain 10-15 min after the vaccination administration and tingling in her arms. pt. vomited at 10 am emt and fireman arrived at 9:57am and notied spots on her back not sure if its from vaccine injection sight was normal the pt. reported no sob was advised to go with the emt to er and was transported to er by emt at 10:12 am
Information has been received on 08-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a physician's office as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 26-SEP-2016, the patient was treated by a physician at a physician's office for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient was prescribed gabapentin for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information on patient's medical history and drug reactions or allergies was provided. On 03-APR-2015, the patient was inadvertently vaccinated with an expired M-M-R II expiration date 30-MAR-2015 (dose, route, anatomical location, lot # were not reported). Concomitant therapy was not provided. No adverse effects were reported. Additional information has been requested.
Left thigh mildly swollen, erythematous rash, 2 x 6 cm. Left anterior aspect skin warm no tenderness no induration
Tingling, numbness in hands and feet. Feeling of numbness and pins and needs/heat
Sleepy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy) and HEADACHE (Headache) 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 14-Mar-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 14-Mar-2021, the patient experienced SOMNOLENCE (Sleepy) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Sleepy) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
I contracted COVID-19 on 07/11/2022 with symptoms of cough, mild headache, body aches, runny nose, and congestion. I was prescribed PAXLOVID on 07/12/2022. I was ill for 3 days before my symptoms began to resolve. I was feeling feeling recovered, but as of 7/18/2022 my symptoms returned and my cough has worsened.
began w/h/a 6AUG92, rash began 9AUG92 cont to worsen, seen by MD 8SEP92 recvd inject began 21 dose sequence of Pred on 9SEP92; this allevaited itching & urticaria; throat swollen & extremely sore; seen by MD again;
Seven days after the first dose, rash developed on left arm near the injection site and lasted about 5-7 days. Itchy and warm. Did not like sunlight.   Three days after second shot, rash developed on the left arm near the injection site and lasted 3-5 days. Itch and warm. Did not like sunlight.
Observed blood in bottom of my left eye, morning following booster shot. Eye was also slightly painful and felt irritated. I also had a decent headache, that seemed to be felt primarily above and behind both eyes, but was worse on left side. I called my primary doctor, who advised me to go to eye doctor. I saw Dr. at local location. I was diagnosed with a subconjunctival hemorrhage in my left eye. No treatment to be had.
This spontaneous report as received from a healthcare student refers to a female patient of unknown age. Medical history, drug reactions or allergies were not reported. On 10-MAR-2014, the patient was vaccinated with a dose of ZOSTAVAX (LOT#, expiration date and dose not reported) subcutaneous. Concomitant medication was not reported. On 11-MAR-2014, the patient experienced rash and redness with no pustule near the ZOSTAVAX injection site. No laboratory diagnostics were performed. The outcome of rash and redness with no pustule near the ZOSTAVAX injection site was reported as not recovered/not resolved. The patient sought medical attention by visiting the pharmacist. Additional information has been requested.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 28-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L011846, expiration date 16-JUN-2017 (strength, dose and route of administration were not provided). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
7/21/16-got PREVNAR 13 shot-7/22 bad sore throat, draining nose, cough-7/23 condition worsened-7/24 felt better-7/25 well, as if nothing happened. 8/8/16 virus, bad sore throat, draining nose, gut-wrenching cough, kept getting sicker. 8/15 to Urgent Care at my own Drs. office-chest x-rays diagnosis of pneumonia (viral) taking Levofloxacin, Prednisone, Albuterol Sulfate. 8/22 finally feeling better/to see my family Dr. on 24th to figure out what's next.
Patient's mother informed clinic on 02/28/09 that daughter had received MCV4 vaccination prior to going to college and has been experiencing swelling (chicken egg size) with itching prior to and during swelling near injection site every 1 to 2 months.  No other symptoms presented per clients mother.  Swelling lasts only 1 to 2 hours, with itching prior to and after.
Two days after receiving my third Pfizer dose my left shoulder, left hand and left hip became painful, inflamed and swollen.
infant went into a "trance" spell for 6 seconds and would not respond to any form of stimulus.
pt recvd vax & devel acute demyelinating encephalomyelitis & was hospitalized;MD reported another pt w/the same rxn;
Didn't realize it was a reaction to flu shot until dermatologist did biopsy 12/10/10. Reaction started as small red bumps on left ankle - as number of bumps increased over the next weeks - they went further up both legs - progressed to weeping sores then crusty sores. Used topical treatment - with first bumps used Triamcinolone cream 1% - washing with HIBICLENS - as spots progressed to weeping - added Mupirocin ointment 2%. Was given Rx for BACTRIM by Dermatologists after 9th day on BACTRIM - had urticarial outbreak on torso. Stopped BACTRIM and added CIPRO & doxycycline - biopsies of left calf and left axilla taken on 12/10/10. Results indicated urticarial allergic reaction for left axilla (BACTRIM) while lower left leg - (lesion is crusted - lesion is impetiginized) was called "subacute spongiotic dermatitis" - doctor noted drug reaction (this was following flu shot). Flu shot manufacturer - Sanofi Pasteur - PA. Sores cleared over 3 month period.
bloody nose; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En7534) via an unspecified route of administration in the arm left on 01Apr2021 at 14:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm left on 04Mar2021 at 14:45 (at the age of 37-years-old). On 04Mar2021, (after receiving first dose of Covid-19 vaccination), the patient experienced first episode of a bloody nose and was resolved on an unknown date. On 01Apr2021, (after receiving second dose of Covid-19 vaccination), the patient experienced second episode of a bloody nose. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient does not normally had bloody noses at all. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome for the second episode of the event bloody nose was resolved on 01Apr2021.     No follow-up attempts are needed. No further information is expected.
Upon her Janssen COVID vaccine administration at 12:30 patient complained of throat tightness, dry nagging cough, and a headache. Patient was able to speak in full clear sentences and able to drink water. She drank 5 water bottles to clear her dry mouth but was still dry. Patient airway patent, no presence of rash. Clear lung sounds. Patient given 25mg p.o benedryl at 1252. Patient was concerned about her throat tightness and agreed she wanted to seek EMS. EMS arrived and assessed her. Patient was discharged with paramedics.
2/3/21 - tested positive for COVID19 3/16/21, 10:30AM: Vaccination was administered  3/17/21, 1:17AM: Experienced severe chills and fever. soreness at injection site. 3/17/21, 1:17AM - 8:00AM: experienced restlessness, sleeplessness, muscular agitation 3/17/21, all day: Full body soreness, fatigue, nausea, headache, soreness at injection site, lethargy 3/18/21, 1:00AM-9:00: Sleeplessness, full body soreness, shallow breathing 3/18/21, 9:00: sharp nausea, muscle pain, lethargy, soreness at injection site.
This case was reported by a other health professional via sales rep and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient's age group was taken based on the product indication as no other patient details were provided. The age at the vaccination was not reported. The reporter said a patient was given SHINGRIX last month and was reporting a case of the shingles at the time of reporting. The reporter was directed to speak with Medical Information via the SHINGRIX GlaxoSmithKline response center. The sales rep would follow up with the reporter for more information.
9 days post injection, the site of the injection and surrounding area became red swollen and itchy. This took about a week to subside.