chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received SPV and anthrax #1 on 31 May '11 in preparation for a trip in late July. He has no chronic medical problems and takes no medications. MOS is combat medic. On about day 8 he developed severe chest pressure/pain that was significantly worse laying down than sitting up. There was mild dyspnea associated with the pain. Chest x-ray and EKG were reportedly normal. He was treated with MOTRIN 800mg tid w/o relief. He was then seen by Cardiology where blood work and echo were also reportedly normal/negative. He was diagnosed with pericarditis unresponsive to NSAIDs and placed on Colchicine yesterday. Today pain continues but maybe a little eased. He is scheduled for an MRI and F/U with Cardiology on the 23rd. Will fu with SM after he is seen.
I have ITP; Platelets dropped to 34 before rebounding to just over 100; I also developed a problem in my ankle & foot requiring prednisone within two weeks of the vaccine, then behind my ear; I also developed a problem in my ankle & foot; I also developed a problem in my ankle & foot; This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 15Feb2021 at 24:00 (Batch/Lot Number: EL3246; Expiration Date: 30Apr2021) as a single dose for covid-19 immunization. Medical history included chronic idiopathic immune thrombocytopenia Purpura, history of cancer and bowel blockage. The patient's concomitant medications were not reported. No other medications taken in two weeks of vaccination. No Covid prior vaccination and not tested for Covid post vaccination. The patient previously took clarithromycin (MACROBID) as antibiotic and experienced drug allergy. On 17Feb2021, the patient had ITP, because she had seen reports of the vaccine triggering the platelet problem, she went to her doctor for a base count a few days before and she was at 84. She went 3 times a week after receiving the shot. Platelets dropped to 34 before rebounding to just over 100. She did not receive the second vaccine. She also developed a problem in her ankle & foot requiring prednisone within two weeks of the vaccine, then behind her ear. She had pictures. No treatment was received. The outcome of the events was unknown.
Spinal stenosis; More anxious; Fever of 101; Rash; Pain in the arm where she got the shot; Feeling clammy and nervous; Feeling clammy and nervous; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number not reported, via an unspecified route of administration on arm from 15Jan2021 to 15Jan2021 at SINGLE DOSE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient previously took trazodone and antibiotics and had problems with them. Caller also stated she might be having withdrawals from a sugar high, has been coming off gabapentin for 2 years. Caller stated she got the first dose of the COVID-19 vaccine on Friday 15Jan2021. Caller reports pain in the arm where she got the shot on Saturday, a rash started Sunday night and fever of 101 started Monday morning, had a fever Tuesday morning and it went away and took more Benadryl for the rash. Caller stated she took Benadryl. Caller states she has been more anxious since Tuesday. Caller states she is feeling clammy and nervous and wants to know if this is normal. Caller had a root canal on Thursday and has spinal stenosis. Could be too much Benadryl or mind over matter issue as she has been reading information online about the vaccine. The outcome of the event fever was recovered; while the other events was unknown.  Information on the lot/batch number has been requested.
Onset of rash and cough/wheezing several minutes after vaccine given. Pt given BENADRYL, ORAPRED, and ALBUTEROL neb treatment. Pt in NAD without dyspnea. Wheezing resolved s/p neb. Rash is papular to BUE. No urticaria unchanged after onset noted.
accidental vaccination of a 16 year old; A spontaneous report  was received from a consumer concerning a 16 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 14 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. The route of administration was unknown. The patient got the first dose of the Moderna vaccine on 14Jan2021.  On 11 FEB 2021, the patient was turned away for their second dose because of their age.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event experiencing accidental vaccination was resolved; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
This spontaneous report as received from a 51 year old female consumer to herself. The patient had none pertinent medical history. The patient had none drug allergies. On 08-MAY-2013 at 11:00 am, the patient was vaccinated with ZOSTAVAX (lot # not reported) (strength and total daily dose not reported). The patient stated that it was given in her upper arm but did not known if it was intramuscularly or subcutaneously. By the evening of 08-MAY-2013, the patient was unable to move her arm and developed a headache, terrible neck pain and a fever of 102 F. And the injection site was hard, hot touch and the area was the size of a baseball. The patient did not seek medical attention. ALEVE was given as treatment. The patient was not recovered. The causality between adverse events and ZOSTAVAX was unknown. Additional information has been requested.
blistered on her cheeks and chin; entire face and chest and neck got all rashed out really severely/rash all over the body and face; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 51-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Jun2021 10:45 (age at vaccination: 51-year-old) as single dose for covid-19 immunization. (Vaccination facility: Pharmacy). Vaccine Administered at Facility: No. Medical history included Seizures ongoing stated states she has been having seizures her whole life. No concomitant medications were not reported. patient did not receive any other vaccinations within four weeks prior to vaccination. Patient had tetanus shot and she never had any reactions to tetanus. It was reported that she got the first shot on the 15th and she got a severe reaction. her entire face and chest and neck all was rashed out really severely and had blistered on her cheeks and chin and she went to the emergency room and the dermatologist and they did not know what to do so they put her on some antibiotics. she was scarring up from this, this was ridiculous. stated yeah its viscious bad, it wont go away. stated her symptoms began 16Jun2021 and are ongoing. went to the emergency room, dermatologist and her primary care just for a minute to get a referral. they put her on doxycycline 100mg twice a day and he gave her a 3 month prescription, also gave medicated antibiotic ointment but she was not using it it because it burns too bad. her face was on fire, it burns, it stings, it hurts. The outcome for the event was reported as not resolved.   Information on the lot/batch number has been requested.
Left shoulder pain and reduced range of motion noted morning of 10/19.  Had lifted weights as normal on 10/17 after injection, but then rested.  Pain and stiffness/ continued/ worsened till 10/31 when presented.  Slight better 11/1/19  with naproxen but referred to physical therapy 11/6/19 and possibly orthopedics.
Pt reported  incident on 11-02-2022. Reported vaccination administration took longer than expected (45 seconds), leaving  left deltoid muscle bruised black and blue and sore. Then after months the bruise went away and left a small white patch on deltoid muscle with some tenderness. Referred pt. to physician for further treatment. Recommended OTC clotrimazole 1% cream if suspected fungal reaction may have occurred.
Admitted to Hospital on Date of Adverse Event [recorded in system] for treatment of Covid-19 Positive following completion of Covid Vaccine Series
Patient states that his arm was very sore the day of injection and became very red, warm and swollen. He did not take anything the night of for symptoms, but did take ADVIL PM two days later. As of now, patient is only experiencing swelling and redness. He states he does not have pain now.
Raised red bump at injection site on 1/24.  Went away after 2-3 days then came back on 1/31.
After getting the vaccine (booster #2) - an hour later the following happened.  Elevated blood pressure, sweating, leg swelling, leg cramps and heart palpitations.   My arm had a tingling sensation and so did my left side of my body.   The swelling on my legs was not intense but I feel it is not getting better.
Sudden onset of fatigue,nausea,& chills approx 6 hrs after vax.  The next am she exp twitching of lt arm,numbness,& tingling progressing to entire lt side w/ eventual involvement of whole body. Describes muscle spasms,visual disturbance,&
sore injection site to first vaccine; low grade fever to first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN and PYREXIA in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN and PYREXIA. At the time of the report, VACCINATION SITE PAIN and PYREXIA 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.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-370295 (Patient Link).
Vertigo feeing, lesions on lower spine and cerebellum.  Unable to walk and loss of balance.   Amount other things.  Treatment - heavy does of Prednizone 1,000 mg IV on September 6th, 2021.  Then 80 mg Prednizone with taper down.  Relapse and repeat after 6 weeks and relapse and repeat right before Christmas of 2021.   Still have major issues.  In the myelitis family.
Patient is >14days post completion of vaccination series and tested positive for COVID-19 on 4/3/2021.  Presented with headache, sore throat, body aches, chills, lightheadedness, and nausea.  Known COVID-19 exposure on 3/31/2021.
I received my injection on Thursday at 2:00 PM.   Upon waking the next day, around 8AM, Friday, I had a bad headache, body aches, weakness, could not get warm.  I laid on the  couch all day and didn't eat anything until 4 in the afternoon, a little soup.  Later in the day I got a fever and was so weak I could barely walk, I fell when trying to get up, fortunately I fell onto the couch, I made it to the bed and didn't get up until about 8 the next day.   Saturday.  I felt much better then but am still weak.
flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu shot (patient received yearly flu shot) and Shingrix with an associated reaction of influenza like illness (patient received 1st dose on an unknown date and experienced flu-like symptoms, refer linked case US2021192911).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   The reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported but it could be 61 or 62 years old. Two years before the reporting date, the patient had got the Shingix two-shot series and experienced flu-like symptoms for a couple of days. The reporter stated that the side effects were expected and had recovered after a day or so. The reporter did not specify if side effects occurred after dose 1 or dose 2 or both. The reporter did not consent to follow-up and stated that she was certain that her husband did not want GlaxoSmithKline to contact his doctor. This case has been linked to US2021AMR193160 and US2021192908, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192911:same reporter,same patient, same suspect, different dose (1st dose) US-GLAXOSMITHKLINE-US2021192908:same reporter US-GLAXOSMITHKLINE-US2021AMR193160:same reporter
Initial information received on 07-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 9 months old male patient who received unstable vaccine IPOL which was in temperature excursion (open) and temperature maximum was 11.5 degree C for 1 hour 46 min. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication received Hep B and HIB. On 24-Aug-2018, the patient received a dose of suspect IPV (VERO) lot N1J45 expiry date: 05-Oct-2019 via intramuscular route in the left thigh. It was a case of actual medication error due to incorrect product storage and deteriorated drug administered. It was not reported that if any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient received Pfizer vaccine at 1054am  Reaction started at 1105am. Patient stated blurred vision, diaphoretic, salty mouth, and nauseous. RN requested help and patient was laid back down on the ground. Cold washclothe applied to neck and forehead. 12.5/5ml Diphenhydramine given oral solution   After about 20 minutes, patient verbalized she felt better - she was brought  inand iupright postion and seated in an chair w/o issue.    Blood pressures taken at time of incident and through out monitoring - Vital unremarkable.   Rn called patient mother , who was able to come to the clinic to pick up patient. At time of pick up patient started to feel additional reaction, CF team at medical facility called for additional intervention. FNP from CF team advised to get orthostatic BP and record. Ortho Static taken with a drop in BP from laying to standing.   BP was as low as 50/30 P:66 O2: 98 on RA     911 activated as patient conitnued to have sudden decrease in BP. Patient went to the hospital via EMS. Patient parents and twin sister with patient.   Admin notified - chart documented.
Menactra was given early--should not have been until she turned 16. Pt went into anaphylaxis within 15 minutes after vaccines and first depo-provera injection were administered.  She was given an Epi-Pen and monitored in the office while EMS was activated.  They arrived 7 minutes later and pt was taken to the ER.  She was monitored there for 4 hours and did not go back into anaphylaxis and was released.  She had fevers off and on for the next week and significant fatigue, and followed-up in my office on 9/15/21, 9/17/21, 9/22/21, 10/1/21, 10/4/21, and 10/21/21 for symptoms thought to be related to be the episode.
Information has been received from a consumer her approximately 5 year old son who was vaccinated with VARIVAX (Merck) in "2000" 0.5 mL. After getting VARIVAX (Merck) the patient developed sudden body pains. The patient sought unspecified medical attention. At the time of reporting, the outcome was not reported. No further information is available.
Arm weakness; Covid arm ring; Redness; Arm achy/arm tenderness; Arm inflammation; Muscle tension; Arm uncomfortable/arm didn't feel great; Arm on fire; Large big red circle about three inches/big circle on arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Muscle tension), VACCINATION SITE DISCOMFORT (Arm uncomfortable/arm didn't feel great), MUSCULAR WEAKNESS (Arm weakness), VACCINATION SITE REACTION (Covid arm ring) and VACCINATION SITE WARMTH (Arm on fire) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), VITAMIN B [VITAMIN B NOS], VITAMIN C [ASCORBIC ACID], CALCIUM, UBIDECARENONE (QUNOL LIQUID COQ10), VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]), ATORVASTATIN, GARLIC [ALLIUM SATIVUM] and FLAXSEED for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced MUSCLE TIGHTNESS (Muscle tension), VACCINATION SITE DISCOMFORT (Arm uncomfortable/arm didn't feel great), VACCINATION SITE WARMTH (Arm on fire), VACCINATION SITE RASH (Large big red circle about three inches/big circle on arm), VACCINATION SITE PAIN (Arm achy/arm tenderness) and VACCINATION SITE SWELLING (Arm inflammation). On 19-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Arm weakness), VACCINATION SITE REACTION (Covid arm ring) and VACCINATION SITE ERYTHEMA (Redness). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MUSCLE TIGHTNESS (Muscle tension), VACCINATION SITE DISCOMFORT (Arm uncomfortable/arm didn't feel great), MUSCULAR WEAKNESS (Arm weakness), VACCINATION SITE REACTION (Covid arm ring), VACCINATION SITE WARMTH (Arm on fire), VACCINATION SITE RASH (Large big red circle about three inches/big circle on arm), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Arm achy/arm tenderness) and VACCINATION SITE SWELLING (Arm inflammation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Child received varicella vaccine 11/29/02, per mom, fever 11/30/02 and 12/01/02 rash appeared 11/30/02 am, seen in office 12/2/02 with moderate varicella.
patients were given Moderna vaccine more than 6 hours after first vial puncture.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were given Moderna vaccine more than 6 hours after first vial puncture.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No medical history was reported.     On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were given Moderna vaccine more than 6 hours after first vial puncture.). On 08-May-2021, EXPIRED PRODUCT ADMINISTERED (patients were given Moderna vaccine more than 6 hours after first vial puncture.) had resolved.        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.   No Concomitant  information was  provided. No Treatment information was  provided.
A mother reported that her 15 month old son received his fourth dose of Prevnar vaccine on 02/05/2002. That same day, he developed an injection site reaction on his thigh characterized by a "half-dollar size" area of redness, pain and a hard lump. He developed a low-grade fever and since vaccine administration, he had developed four episodes of ear infection and fever. At the date of the report on 03/12/2002, the mother stated that a small hard lump remained at the site of injection. Additional info received from the vaccine provider on 03/25/2002, provided the lot number, site of administration, and history of Augmentin drug sensitivity.
Huge,fatty bump in arm pit; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Huge,fatty bump in arm pit) 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, the patient experienced AXILLARY MASS (Huge,fatty bump in arm pit). At the time of the report, AXILLARY MASS (Huge,fatty bump in arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
12/04/17 clinic note: Report of tetanus shot pain x2 weeks. Pt increased oxycodone/APAP from 1x to 2-3x/week for (R) arm tetanus shot pain. Pain is 4/10 right deltoid injection. Pt was instructed to RTC if pain persisted.
Information has been received from a physician concerning her 12 month old son who on 12Jul04 was vaccinated with a dose of varicella virus vaccine live in his right thigh. On approx 22Jul04 the pt developed a red, warm site reaction, about 5cm in diameter. Unspecified medical attention was sought and the reaction site was treated with ice; it resolved within a day or so. At the time of this report no further information was available and there was no product quality complaint. Additional information has been requested.
when pt made it home felt like she was getting electric shocks in heart, chest pains, weak, shortness of breath, body aches,
One week after injection, I had ?Covid arm.? I had a raised red itchy rash over the injection site and down my arm. The rase was about 3 inches long and two inches wide. I used a topical hydrocortisone cream and took Benadryl. The rash went away in 4-5 days.
Information has been received regarding a case in litigation from a lawyer, and a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 01-JUL-2008, at age 61, the patient was administered the ZOSTAVAX by a physician (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at a hospital for the following injury resulting from her ZOSTAVAX use: Guillain-Barre syndrome. The patient claimed damages as a result of: injury to themselves,  and economic losses. The outcome of Guillain-Barre syndrome is unknown. Upon internal review, Guillain-Barre syndrome was determined to be medically significant. Additional information has been requested.
Persistant screaming X 6-8 hrs. Severe erythema & tenderness of injection site