chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had redness and lump at injection site first day with no itchiness.  itchiness started on Sunday 2/14.  calmed down with Benadryl.  On 2/15 at 5 am, itchiness awoke me from my  sleep and had to take 50 mg of Benadryl to calm the overall body itchiness.  there is no full body rash, just redness at the injection site.  Started out as about the size of a tennis ball but now is a bit larger than a golf ball size.
Headache, dizziness, nausea, aches, chills,  fever, sore arm
Saw some sparkles; Red veins arounds her eyes; Hot like burning on the eyes; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Lot Number: ER8727 ), dose 1 via an unspecified route of administration on 19Mar2021 (at the age of 38-years-old) as dose 1, single for covid-19 immunization at hospital. Relevant medical history was reported as None. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none.Concomitant medications were not reported. Patient did not have family history. Prior to vaccinations (within 4 weeks) patient received MMR vaccine three weeks ago for immunization (at the age of 37-years-old). It was reported that vaccine was not administered at military facility.On 19Mar2021, after having the vaccine, patient saw some sparkles for just a few seconds and felt some hot like burning on the eyes just at that moment and then red veins arounds her eyes appeared. Now she was having red veins around the eyes that were not going away. None of the AE required patient to visit emergency room or physician office. Patient was asking for someone to explained to her what happened. she was scheduled to received the next dose of the vaccine on 09Apr2021. The outcome of event for red veins around her eyes was not recovered. The outcome of the rest of the events was recovered on 19March2021.  No follow-up attempts are possible. No further information is expected.
Vaccine given at 9am. Pt. cried all night and awoke at 5:30am with an episode of pallor, shallow breathing and lethargy similar to the episode after the 2mos vaccines.
Redness, swelling, itching, 24 hours after vaccination left thigh 13/cmx17cm.
Arthralgia, NauseaVomting, fatigue, weakness, sweat/chills, soft stools Narrative: Took OTC ibuprofen
vaccines given Friday (8/21/20) in the afternoon. pts arms were sore for a couple days. on sunday (8/23/20) pt developed diarrhea, nausea, and chills (w/o fever). Adverse event was reports Monday (8/24/20) afternoon.
Severe redness, swelling, pain and itching from (L) injection site to the elbow.
legs were discolored, black.; This case was reported by a consumer via interactive digital media and described the occurrence of skin discoloration in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter knew someone who got just the shingles shot years ago from the date of reporting and after that their legs were discolored, black.  That shot sure worked. No contact details were available.
Rash, shortness of breath, swelling tongue and throat, pounding racing heartbeat, dizziness, weakness, itching. Lasted for about a week
with administration felt a slight nerve twinge that went up the right side of my neck near the carotid, after waiting 15 minutes nothing more; after about an hour felt warm at injection site and swelling and tenderness to the right side of my clavicle, joint pain, feeling feverish but temp was wnl, headache and generalized achiness.   At approx. 2300, had chills for about 2 hours; On Saturday, still had swelling and tenderness on the right side clavicle and could barely move right arm;  Sunday still had tenderness and swelling but able to move right arm a little more but still having soreness. Monday still having tenderness and swelling at right clavicle and soreness in right arm.  Did take aleve on Sunday for pain.  On Monday, did notify workplace and my PCP of adverse reactions.
Throat issues; I am having congestion and allergies after receiving the vaccine.; I am having congestion and allergies after receiving the vaccine; Patient does not plan on getting the second dose of the Moderna COVID-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Throat issues), NASAL CONGESTION (I am having congestion and allergies after receiving the vaccine.), HYPERSENSITIVITY (I am having congestion and allergies after receiving the vaccine) and PRODUCT DOSE OMISSION ISSUE (Patient does not plan on getting the second dose of the Moderna COVID-19 vaccine.) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (history of allergies for too many things including medals and antibiotics.), Allergic reaction to antibiotics and Allergy (Medals).    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat issues), NASAL CONGESTION (I am having congestion and allergies after receiving the vaccine.), HYPERSENSITIVITY (I am having congestion and allergies after receiving the vaccine) and PRODUCT DOSE OMISSION ISSUE (Patient does not plan on getting the second dose of the Moderna COVID-19 vaccine.). At the time of the report, OROPHARYNGEAL DISCOMFORT (Throat issues) and NASAL CONGESTION (I am having congestion and allergies after receiving the vaccine.) had not resolved, HYPERSENSITIVITY (I am having congestion and allergies after receiving the vaccine) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient does not plan on getting the second dose of the Moderna COVID-19 vaccine.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Patient reported adverse event kyriad ever since he received the maternal COVID-19 vaccine   The patient have allergies too many things including medals and antibiotics. Throat issues previously treated with steroids.
One to two days after getting the PREVNAR-13 shot, patient developed moderate to severe bruising, swelling, pain, and hematoma approximately 1 to 1.5 inches around the injection site on right arm.
4 hours after vaccination severe difficulty breathing, fever 102, sore throat (like razor blades when swallowing), face so hot-felt like a mask.
now after getting the second shot she had antipsychotic symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administration date 26Jan2022 (Batch/Lot number: unknown) at an unspecified age as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, 1st Dose), for COVID-19 Immunization. The following information was reported: PSYCHOTIC SYMPTOM (medically significant) with onset Jan2022, outcome "unknown", described as "now after getting the second shot she had antipsychotic symptoms". Additional information: the patient stopped the medication of antipsychotic drugs for 9 months. After getting the second dose of Pfizer COVID-19 vaccine, the patient had antipsychotic symptoms. They were still waiting to hear from the patient's doctor. Now, the reporter was asking for any drug interactions for antipsychotics and Pfizer COVID-19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Breakthrough case admission after 3 vaccines Moderna 3/12/21 lot# 044A21A;  Moderna 4/19/21 lot# 025B21A;  Moderna 12/7/21 lot# 069H21A
The patient came into pharmacy 2 days after vaccination was given and had a bright red, softball sized area of cellulitis.  It was very warm to the touch, and slightly swollen.  She said it began on 7/1/2008 with a small red bump, and then progressively got larger.  She visited her doctor and was given a Cephalexin.
Starting the day following vaccination, the patient reported severe chills, body aches, and headache that lasted at least 10 hours.
Patient states that headache developed shortly after dose #1 of pfizer Covid vaccine. Patient states that headache has not gone away. Patient has not taken any medications to help with headache. Counseled her on potential side effects of vaccine and how to treat. Suggested that patient follow up with PCP.
she experienced soreness; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (she experienced soreness) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis and Psoriatic arthritis. Concomitant products included APREMILAST (OTEZLA) for Psoriasis and Psoriatic arthritis.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (she experienced soreness). At the time of the report, PAIN (she experienced soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 18-MAR-2021 patient took DOSE-2 Moderna vaccine having batch number 001B21A. No treatment information were reported.    This case was linked to MOD-2021-339523 (Patient Link).
eruption looks like Herpes Zoster; pain around his back; skin reaction; This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number 3454N, expiry date 23rd August 2022) for prophylaxis.   On 16th October 2020, the patient received the 1st dose of Shingrix. On 21st October 2020, 5 days after receiving Shingrix, the patient experienced vesicular rash, back pain and skin reaction. On an unknown date, the outcome of the vesicular rash, back pain and skin reaction were not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash, back pain and skin reaction to be related to Shingrix.  Additional information was provided as follows: The patient experienced skin reaction, the eruption that looked like herpes zoster and pain around his back after receiving the 1st dose of Shingrix. The reporter consented to follow up.
This case was considered medically important. Information regarding Prevnar was received from a consumer regarding a 16-month-old male patient who developed autism. The patient received the second dose on 07-Jun-2006. Reporter denies patient has any other past medical history. Concomitant medications were not reported. The patient developed autism in Nov-2006. The outcome is unknown. Laboratory test (results: revealed high "porforin" levels) and hair metal test (results: revealed arsenic) were done in Jan-2008. No additional information was available at the time of this report.
Patient called on 11/10/2020 around 3:15pm and mentioned that she broke out in rashes in her back. Upon further asking she stated that she stared seeing them on Monday morning (11/9/2020) and the rashes were in the middle of her back and spread on one side of her back. Rashes were red and blistery.
Swelling in area where shot given started the next day after the shot, large 2 cm  wheal with hard central in-duration, slightly elevated, appeared 3 days later with no relief after icing. Pt placed on antihistamines 3x/day and asked to use 1% hydrocortisone on the area. Pt will follow up in 48 hours
80 yr old with recently diagnosed AML on chemotherapy admitted with worsening nausea/vomiting/anorexia for 2-3 days. She denies fevers/chills/ other GI symptoms. She is currently PUI and in isolation. Labs significant for hypokalemia and leukopenia with mild anemia.  tested positive for COVID-19 infectoin
BODY ACHES; CHILLS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a male of unspecified age. 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 08:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F.  On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced nausea.  Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol/ salicylamide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, headache, body aches and nausea was not reported. This report was non-serious.
Patient was in observation for 15 minutes, before releasing patient nurse noticed that patient looked as if they were going to pass out. Nurse pulled patient aside and shortly after patient's eyes began to roll back and started to have muscle spasms an became unresponsive. Nurse layed patient back and gave sternal rub in attempt to awaken the patient. Patient remained unresponsive and nurse administered epi pen 0.3mg to left thigh. Patient awoken after 3 minutes and became alert. EMS arrived and transported patient to emergency room.
4 degree temperature,  body pain from hips up, diarrhea, vomiting, tired.  Symptoms lasted for 5 days. On 2nd day sleeps 26 hours. Day number 5 everything back to normal. No medical treatment.
Soreness next day. 2nd day after vaccine - swelling and redness at injection location, soreness reduced
Patient came in to receive a COVID-19 Booster vaccine. Shortly after receiving the vaccine, pt began to state that her blood pressure was elevated. 911 was called and an ambulance came to evaluate the patient. Patient was found to have an elevated blood pressure of 200/108. Per the clinician vaccinating the patient, she states she has a history of hypertension and takes medication for it. Patient ultimately decided to refuse EMS. Patient signed and AMA form with at Mobile Vax site as well
09/11/06 mother reports, itchy hives over entire body, fever (unknown) irritability (length of time unknown), after varicella, MMR and again with DTaP. Mother also reports that the child reacted with the same symptoms after each one of her previous vaccine.
Loose stools 24 hour after ROTATEQ. Foul liquid stool x 48 hours gassy & irritable x 8 days.
Information has been received from a nurse practitioner referring to 2 patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. Between May 2015 to September 2015 the patients were vaccinated with improperly stored ZOSTAVAX lot # L002424, expiration date 23-APR-2016 (dose, dose #, route of application site were not reported). No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash  on chest, increased HR and BP. Given Benadryl, was monitored and released.  She felt normal from 2/15 to 2/18.  Then on 2/19 she felt dizzy, tongue felt fuzzy, heart rate erratic. Came to the ED.  Had normal labs. Vitals normalized.  Went home. Thereafter from 2/19 to 2/23, felt dizzy, had erratic heart rate, was light headed and was having a hard time focusing. Came back to the ED on 2/23 and had a HR of 135 and BP of 177/108. Got IV fluids and vistaril.  Her HR improved to 119 and her BP improved to 161/98.
Within 5 minutes of receiving vaccine, patient began itching and breaking out in hives on neck , shoulders and behind ears. Benadryl  25mg PO  given  at  10:02
This spontaneous report as received from a physician via company representative refers to a 12 year old female patient with no medical history. Patient's drug reactions or allergies were not reported. On 08-AUG-2014 the patient was vaccinated with the first dose of GARDASIL (route of administration, anatomical location not reported, lot#: K001631, expiration date: 06-NOV-2016). There was no concomitant medication. On 08-AUG-2014, the patient fainted following administration of her 1st dose of GARDASIL. There were not laboratory tests performed. There ws no treatment given for the reported event. The outcome of the patient fainted following administration of her 1st dose of GARDASIL was reported as recovered/resolved (date of recovery: 18-AUG-2014). The relatedness between the therapy with GARDASIL and the reported event was not reported. Additional information has been requested.
Became Dyspneic and lightheaded.  Covered in hives and severely pruritic.
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.   On 23-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Shortness of breath after receiving pneumococcal vaccine.  Oxygen given via NB face mask.  Patient evaluated by physician and taken to Emergency Department for further evaluation.  Discharged from ED.
This case was reported by a nurse via call center representative and described the occurrence on injection site rash in a 5-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9A7JS, expiry date unknown). Concomitant products included MIRALAX, ZYRTEC and Multivitamin. On 3rd October 2016, the patient received 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 3rd October 2016, less that a day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site rash and injection site warmth. In October 2016, the outcome of the injection site rash and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site rash and injection site warmth to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT on left arm. On 5th October 2016, the patient was seen in the office. This was 1 of the 2 cases reported by the same reporter.
This case was reported by a healthcare professional and described the occurrence of seizure in a 24-month-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 17 September 2012 at 08:14 the subject received 3rd dose of HAVRIX (.5 unknown, unknown). On 18 September 2012, less than one day after vaccination with HAVRIX, the subject experienced seizure, leg stiffness, cried all day and extra dose administered. The healthcare professional reported the subject experienced seizures following a HAVRIX vaccination received on 17 September 2012. That day the mother noticed that his legs got really stiff and he cried all day. The next day on 18 September 2012 he had a seizure. He has had a total of three episodes, but the reporter did not know the dates. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the seizure, legs stiff and cried all day were unspecified.
Arm still hurts 3 weeks after shot.  I can't lift up my arm or rotate it outward. I can't sleep on that side.  The pain has been getting worse. Pain felt in the lower deltoid about 5 fingers down from top of shoulder
a)  2 weeks after 1st dose, had dry cough b) after 2nd dose, head ache along with cough c) A week later, low grade fever developed -mostly in the evening along with night sweats. d) Cough and Headache subsided in about 2 months but daily low grade fever continues to this day. e) Started to have lower back pain followed by knee pain, followed by arm pain(unable to lift hands, dress himself, followed by full body muscle/bone related pain which persists to this day. f)  Patient went to India to meet some personal obligations. Had severe body pain, muscle pain, and bone pain and weakness. Not able to walk  and loss of balance. Consulted rheumatologist - repeated several tests along with Bone Marrow biopsy and Light Chain Serum assay  Primary Diagnosis: Still unclear but suspected to by Myalgia & weakness( Some markers for myositis were positive. Secondary diagnosis MGUS.  Steroid treatment started with wait and watch approach for Multiple Myeloma
skin rash around injection site. Skin was red, warm, swollen and raised. The reaction subsided after a few days. Patient did not need medical treatment.
Information has been received from a 66 year old female consumer with no known allergies who on 05-JUN-2008 was vaccinated with one 0.65 ml dose of zoster vaccine live (Oka/Merck) (lot no. not reported) via subcutaneous route. Site of injection was not reported. Concomitant therapy included alendronate sodium (MSD). On 07-JUN-2008 the patient developed flu like symptoms, itchy red spots on her back. As of 25-JUN-2008, the patient's flu like symptoms and itchy red spots on her back persisted. The patient sought unspecified medical attention. Additional information has been requested.
Sick x8 days with headache. Received required booster (I am an RN at a Medical Center) on 2/28/22 per recommendation for health care workers. I had 3 days of body aches, low grade temperature, and 8 days of severe headaches. This required 3 days of sick calls.