chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NEGATIVE SIDE EFFECTS; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: UNKNOWN) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced negative side effects, and was hospitalized (date unspecified). The number of days of hospitalization was not reported and it was unsure if the patient was discharged from the hospital. It was reported that, "Hey my wife got the vaccine and immediately had negative side effects, which required hospitalization and thousands of dollars in medical bills. Can you help us out". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of negative side effects was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20221101633- negative side effects. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Papular rash appeared 2 days ago on trunk now starting to look more vesicular-parent was unable to report staging of rash. Rash appears as "crop" or single papules neck and thru.
received the Moderna Monovalent Booster instead of the bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     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, the patient experienced WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine).    Concomitant medications were not reported.   The patient received Moderna Covid-19 vaccine monovalent instead of the bivalent dose for their booster dose. This happened  because the monovalent vaccine with the purple border is labeled booster doses.   Treatment medications were not reported.
FEVER 102.5 R STATUS GRAND MAL SEIZURE ACTIVITY WITH SUBSEQUENT ORAL ENTUBATION, SEIZURE CESSATION WITH VALIUM RECATL/IV; CRITICAL CARE ADMISSION TO PICU
3/11/21 Left side of face went numb, jaw pain, felt like electric bolts through head, involuntary muscle contacting in face (both sides), Jittery, Eye twitching, headache. Ear pain.    3/12 -3/13/21 Face numbness got worse, left side started to droop. Muscle soreness in left arm, headache, tired.  3/14/21 ER visit to rule out Stroke. Diagnosed with  Bells Palsey.  3/15-3/17/21 Left side of face still numb, pain/muscle spasms come and go.  3/18/21 Woke up with skin hypersensitive- feels like I have a severe sun burn from my neck to waist area, swollen glands,  eye twitching, lips, tongue and throat swelled up. Severe jaw and ear pain, trouble breathing. Face still tingly/numb. Legs became extremely sore and heavy feeling, hard to walk. Called Dr- put on Prednisone (60mg and decreasing) and an anti-viral.  3/19/21 Same symptoms as previous day plus stomach area began to hurt/burning sensation- like all my organs were inflammed. Uncomfortable pain in my right side.  Took first dose of meds this am.  3/20/21 Extreme jaw/ear pain, clenching feeling, loss of strength on the left side of my face  Symptoms tapered off  fir a few days, face numbness decreased and swelling seemed to improve.  3/25/21 Woke up with Skin burning again and glands in neck swollen. Called Dr- placed back on a higher dose of Predisone . At night, throat  and tongue swelled up 3/26/21 Tongue and throat swelling, still facial tingling and numbness
Warmth, redness, tenderness, pain, inflammation. The left arm, from elbow to shoulder. Dr diagnosed Cellulitis. Prescribed Levofloxacin, Mupirocin and LOTRISONE.
Information has been received from a physician concerning an approximately 17 week old male who was vaccinated orally with a 2 ml second dose of ROTATEQ. Subsequently the patient experienced intussusception. Unspecified medical attention was sought. On 11-MAY-2009 the patient was admitted into the hospital. At the time of reporting, the outcome was unknown. Additional information has been requested.  6/12/09 Hospital records and DC summary received DOS 5/11/09 t0 5/12/09. FINAL DIAGNOSIS: Intussusception. Post vaccination abdominal pain, emesis, decreased oral intake. No BM for 2 days. Crying, fussy. Successful reduction with barium air contrast enema. ICD-9 Codes: 5600, 53081
not feeling well today; back pain/Tried swimming in pool today and got back pain.; This is a spontaneous report from a Novartis. A contactable 74-years-old male consumer (patient) received bnt162b2 (COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 06May2021 (at the age of 74-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  It was reported that patient received second Covid vaccine on 06May2021 and not feeling well today or back pain in 2021. Tried swimming in pool today and got back pain. The outcome of events was unknown.  Information on the lot/batch number has been requested.
5pm started with chills, followed by headache and rapid heart rate and fever. Syncope upon standing.  Heart rate stayed elevated for over 5 hours. Fever came down with Tylenol amd Motrin.
large area of erythema and hardness81/2" erythema and 3"X 41/2" induration.  treatment consisted of warm compressess, motrin massage and move arm. call prn
No AE/PQC reported; received is first ROTATEQ dose at 15 weeks old; This spontaneous report as received from a patient's mother refers to a 15-week-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.    On 13-OCT-2021, reported as yesterday, the patient was vaccinated with his first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (exact dose, lot # and expiration date were not reported) for prophylaxis. No adverse event was reported.
Extreme vertigo with very, very bad nausea and of-and-on headache. Waited it out without treatment because my doctor and due to them being hacked, I was unable to reach my doctor. I stayed on the couch for approximately 2 days and also slept there, so as to sleep sitting up, as the work vertigo came while I was sleeping in bed. 1st bad vertigo episode: May 4 approx. 3:30 pm.  Next bad vertigo episode May 5 at 6:10 am sleeping in bed with bad nausea. Third/final bad vertigo episode May 6 at 3:20am with bad nausea while sleeping in bed. Vertigo then decreased / leveled off but continued along with nausea until May 6 11:00 pm. May 7, I woke up with no nausea or headache. Very slight vertigo approx. 4 times during May 7.
caused nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 67 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 10Mar2021, outcome "recovered" (11Mar2021), described as "caused nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient received the vaccine on Friday 9/1/2023. Monday 9/4/2023 patient started noticing red circles around her both eyes, but one eye was worse than the other. Red circle around her eye and her eye was very puffy.  The symptoms lasted for 2 days and subsided after that. In a few days the patient started having the same symptoms again. Patient visited her primary care physician and was prescribed some prednisone and Valtrex, also she took Benadryl. The same cycle of symptoms occurred to the patient multiple times. According to the patient she's in the fifth cycle of the same symptoms, which lasts for 2 days and disappears and then reappear in few days.
unable to walk; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (unable to walk) in a 65-year-old male patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (unable to walk). At the time of the report, GAIT INABILITY (unable to walk) outcome was unknown. Not Provided          No concomitant medication was reported. No treatment medication was reported.
Patient vaccinated w/ Moderna #2 on 3/1/21. COVID exposure on 3/13, tested negative for COVID on 3/13. Retested for COVID by PCR on 3/21/21 and was positive.  Had sore throat, anosmia, dysgeusia.
Large local reaction over right upper thigh from DTaP given on 7/7/04. Reaction started afternoon of 7/8/04 at daycare--progressively got worse until Dad brought patient in to doctor's office on 7/9/04 at 1:40pm. Reaction red, mottled at edges, warm to touch. 200 mg Clindamycin given.  To call back if worsens.
patient had back spasms after being given vaccine. She was watched for extra 15 minutes and given Tylenol. She stated she no longer had back pain and left
Severe rash - ring around neck ad up into hair line at back of neck; more mild rash on  both forearms.  Rash had pustules in some areas on neck, resembling "measles".
Received moderna vaccine on 3/10/21 and 4/8/21. Presented to ER on 1/17/22 and found to be COVID positive. Sob onset this afternoon during dialysis. Upon further questioning patient stated that 2 days ago she started having cough, muscle aches, subjective fevers, chills, nausea but no vomiting, loss of taste.  Patient went to her regular scheduled dialysis session this afternoon, at this time she began having shortness of breath.  Patient did not complete dialysis.  Patient denies chest pain, but says that she feels some tightness, she denies loss of smell, congestion.   In the ER COVID-19 positive in the ER, initila temp at 95.5F which later normalized. CBC remarkable for WBC of 3.22, CMP remarkable for CRT 6.2, transaminitis AST 113, ALT 65, Alk Phosphatase 161, elevated d-dimer at 1.71,  CRP 113, PTT elevated at 48, procal elevated at 3.02, normal LA.  ABGs; pH of 7.637, PCO2 of 22, PO2 of 92.1, HCO3 of 21.4. Chest Xray revealed; patchy pneumonia of the right lung. EKG revealed NSR; with first degree AV block. She received rocephin 1g IV in the ER and was admitted for further management of her COVID-19 pneumonia.  Received azithromycin and ceftriaxone. Discharged on 1/22/22
pt recv vax 22AUG97 & 26AUG97 pt reportedly exp meningitis;bacterial & viral cult results were reported as negative;
She started with chronic insomnia 1 week after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (She started with chronic insomnia 1 week after receiving 1st dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced INSOMNIA (She started with chronic insomnia 1 week after receiving 1st dose). At the time of the report, INSOMNIA (She started with chronic insomnia 1 week after receiving 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment reported   This case was linked to MOD-2021-294919 (Patient Link).
Hives; This is a spontaneous report from a contactable consumer reporting for herself. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN9581, expiry date: May2021), via an unspecified route of administration on 30Jan2021 (at the age of 74-years-old) at a single dose for COVID-19 immunization. Medical history included diabetes from an unknown date and unknown if ongoing. Concomitant medication included glipizide, metformin, apixaban (ELIQUIS), flecainide, omeprazole, simvastatin, losartan, lorazepam, hydralazine. The patient received the Pfizer COVID vaccine on 30Jan2021 and ended up getting hives from it on 30Jan2021. The event started three hours after the injection. The patient received CLARITIN at 10 mg one pill as treatment. The patient underwent lab tests and procedures which included basic metabolic panel (where they check your creatinine, check your A1C, they check your kidneys and they check your back and stuff) with unknown results. The outcome of the event was recovered on 30Jan2021.
36 hour fever to 101F, chills, malaise, body pain, anorexia, headache. Injection site pain, redness, swelling 4inches X 5 inches. Inability to raise arm to shoulder height.
2 hours after vaccine I developed a swelling under my tongue and on my neck. I took Benadryl and the swelling decreased.
soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 29Mar2021, outcome "unknown", described as "soreness".  Additional information: The patient would like to know if it is okay to take aspirin for soreness afterwards.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt ate cereal at home.  Pt received 2nd HPV vaccine and about 2 minutes after patient became diaphoretic/dizzy.  Pt laid down and became very pale.  Gave a few crackers and juice.  Pt c/o severe cramping and vomited.  Pt also had loose stool.  No rash developed but pt remained very pale for over 30 min.  Pt was finally able to drink a 12 oz coke and improved but it took almost 1 hr for symptoms to resolve.  Pt was monitored close in office.
COUGH, HEADACHES, NAUSEA/VOMITING, FEVER/CHILLS
TC from father who said that he was driving home when he noticed that his son's face was swollen.  Says his son says his chest hurts and he is dizzy.  No difficulty breathing.  Advised him to take his son to the nearest Emergency Department at the closest hospital for evaluation. After receiving vaccines they had gone to the mall for a while before driving home. Father said he was going to check with mom before he took him any where.
15 minute observtion period without incident.  But later pt reports feeling hot and dizzy from standing to make 2nd vaccine appointment. Pt reports no breakfast this morning but did take regular medications. Patients waited 10-15 minutes and rested while sitting. no further dizziness. Able to ambulate and walk to exit with  no further concerns.
Breakthrough Case  Patient received Pfizer Booster on 10/30/2021 Lot #FE3590 Local Pharmacy
2 x 2" redness at left upper arm occurring 48 hours post immunization, treated with cold compress, Motrin.
Entire thigh to under knee of left leg swollen 2x's normal size-warm to touch.
Deafness of left ear, being treated with 60 mgm of Prednisone daily for 7 days.
extreme arm pain and swollen at injection site; extreme arm pain and swollen at injection site; collar bone as it was super painful and could feel a lump just above my left collarbone; collar bone as it was super painful and could feel a lump just above my left collarbone; Lethargy; This is a spontaneous report from a contactable Other Health Professional (patient reported for herself). A 30-year-old Adult female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8727, Expiration date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 at 13:30 (at the age of 30-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included Hypothyroidism, Asthma and obesity. The patient had Known allergies to Penicillins and mussels. The patient had no covid prior vaccination. The patient concomitant medications included unspecified medications. The patient had not been tested for covid post vaccination. On an unspecified date in 2021, after the 1st dose of vaccination, the patient experienced extreme arm pain and swollen at injection site, collar bone as it was super painful and could feel a lump just above my left collarbone and Lethargy during those first few hours as well. The patient stated that few days after the first dose thought a dog at work had broken part of her collar bone as it was super painful and could feel a lump just above her left collarbone. Pain eventually stopped and bump did get smaller. The patient received no treatment to treat the events. The patient outcome of the events extreme arm pain and swollen at injection site, collar bone as it was super painful and could feel a lump just above my left collarbone was resolving and the outcome of the event Lethargy was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
pt recv vax;devel GBS;was paralyzed for 3 wk;f/u:devel sx & was hosp,intubated via tracheostomy;sx all resolved;
Patient received flu vaccine at 11:10 AM on 10/6/17. One hour and 15 minutes later, patient face started to tingle and she had a "full/swollen" feeling in her mouth. Patient did not feel that she needed to use her EPI PEN but did not have any BENADRYL with her. 14:01 VS: 132/80, P-94, R-16. PO BENADRYL, 25 mg give. 50 minutes later patient feeling better and returned to work. 4 hrs later at 06:30 PM patient had a rebound reaction and ended up in the Emergency Department, she received epinephrine injection and IV BENADRYL.
EXPERIENCED TINGLING, ITCHING AND BURNING IN A LINE ALONG RIGHT THORAX, APPROX AT T-7 OR 8.   SENSITIVE WHEN CLOTHES TOUCH AREA, AND NO SIGNS EXTERNALLY OF RASH AT THIS TIME. WENT TO MD, PRESCRIBED ACYCLOVIR 800 MG 5X/DAY X7 DAYS.
This spontaneous report was received from a healthcare professional refers to a unspecified number of unspecified patients of unknown age and gender. No medical history and concomitant medications were reported. On an unknown dates, the patients received improperly stored doses of VARIVAX (Merck) (lot # K021932, expiry: 10-NOV-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 22nd of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There was 13, 11, and 6 different doses given. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:Master case