chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt so cold; Teeth chattering; Fever ranging from 101-103.6F for a couple of days; Has been sick all weekend; Arm started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Has been sick all weekend), PAIN IN EXTREMITY (Arm started to hurt), FEELING COLD (Felt so cold), PYREXIA (Fever ranging from 101-103.6F for a couple of days) and CHILLS (Teeth chattering) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.   The patient's past medical history included No adverse reaction (No reported medical history.).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION COMPLICATION (Has been sick all weekend), PAIN IN EXTREMITY (Arm started to hurt) and PYREXIA (Fever ranging from 101-103.6F for a couple of days). On 09-Jan-2021, the patient experienced FEELING COLD (Felt so cold) and CHILLS (Teeth chattering). At the time of the report, VACCINATION COMPLICATION (Has been sick all weekend), PAIN IN EXTREMITY (Arm started to hurt), FEELING COLD (Felt so cold), PYREXIA (Fever ranging from 101-103.6F for a couple of days) and CHILLS (Teeth chattering) was resolving.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 antibody test: Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Reporter did not allow further contact
Patient's left arm became red and swollen past his elbow and warm to touch. No fever.
This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On 08-JUN-2014, the patient was administered MMR II INJ, 0.5 mL, subcutaneously (lot number not provided). The nurse reported that the MMR II expired on 17-MAY-2014. No adverse effect reported. Additional information is not expected.
fever (102.F), flushed cheeks, leg/arm pain, weakness in legs, nausea, poor appetite x 2 days
Getting her second dose of the COVID vaccine which caused her to be ill; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Malignant neoplasm of lower-outer quadrant of right female breast" (unspecified if ongoing). Concomitant medication(s) included: IBRANCE taken for breast cancer female (ongoing). Vaccination history included: Bnt162b2 (Dose number 1,single), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Getting her second dose of the COVID vaccine which caused her to be ill".  Additional information: It was reported that, the patient missed one dose of Ibrance over the last couple of weeks. She told that, this was mainly due to her getting her second dose of the COVID vaccine which caused her to be ill. Overall, she was very adherent to her medication and she told that, she has not missed any of her doses otherwise. Stated that, the date the patient started the medication (Ibrance) was unknown. Stated that, the date this pharmacy first filled the medication (Ibrance) was on 15Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Delayed type hypersensitivity reaction at the injection site. Site was inflamed, raised, and itched considerably. No treatment. Symptoms abated somewhat over the next few days but are ongoing particularly with exertion of that arm.
Exactly two days after my vaccination, I had runaway blood pressure that exceeded 200/100. That lasted about two hours.
This case was reported by a physician, via GSK representative, and described the occurrence of turned blue in a 7-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), HIB and (non-gsk) PREVNAR. On 2 December 2009 the subject received unspecified dose of PEDIARIX (details unknown), unspecified dose of HIB (details unknown), unspecified dose of PREVNAR (details unknown). On 2 December 2009, during the night and less than one day after vaccination with HIB, PEDIARIX and PREVNAR, the subject experienced turned blue. It was reported that the subject turned blue during the night, but he was aroused and okay and did not appear to have any other effects. This case was assessed as medically serious by GSK. At the time of reporting the event was resolved. After the next vaccination with PEDIARIX the event did not recur.
fever 102 & bodyaches;MD gave meds for sx;in bed x 2 days;
10/16/09 35 year old woman receiving immunizations for imigratt purposes received flu and PNUPS. 4 hrs later c/o pain, tingling and itching progressively worse. Seen in ER 10/18/09. Impression: acute cellulitis. Started on KAFLEX, VICODIN and MOTRIN. Abx increased to CAFTVIACORE 1gm IM then CLENTAMYCIN 300mg PO w/improvement by 10/22/09.
Rash and nonspecific eruption red base in multiple stages, typical folliculitis sized scatter on face, torso and all 4 extremities.
sore arm after the vaccine soreness was in the injection site arm; This is a spontaneous report from a non-contactable consumer or other non-hcp (patient himself). A 71-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm and soreness was in the injection site arm after the vaccine on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number is requested.
Mild erythema, some induration; cold compresses every 2 hours. 1 day after injection.
Severe pain, fever, hallucinations, dizziness, spasms loss of balance lasting until now ( 3/8)
FAINTED/PASSED OUT; NOT FEELING QUITE RIGHT; VERY TIRED; This spontaneous report received from a parent concerned a white and Not Hispanic or Latino female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included faint, and concurrent conditions included seizure, non-alcohol user, and non-smoker. The patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with erythromycin, and ketamine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A201A, expiry: UNKNOWN) dose was not reported, 1 total, administered on right arm on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  It was reported by the patient' parent that, on 12-APR-2021, within 5 minutes after vaccination the patient had fainted/passed out. On the same day, the patient was not feeling quite right and was very tired.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fainted/passed out, very tired, and not feeling quite right. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422792-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Fainted/Passed out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Bell's palsy; This is a spontaneous report from a contactable consumer (patient's wife). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 02Feb2021 at 11:00 at a single dose on left arm for COVID-19 immunisation. Medical history included ongoing systemic lupus erythematosus (Lupus), ongoing hypertension (High Blood Pressure), ongoing gout and hip arthroplasty from Dec2020 to an unknown date; all diagnosed about 20 years ago. Concomitant medications included allopurinol, atorvastatin, benzonatate, chlorthalidone, apixaban (ELIQUIS), hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN), hydroxychloroquine, iron, loratadine, losartan potassium, mycophenolate mofetil, omeprazole, paricalcitol, prednisone, spironolactone and valacyclovir [valaciclovir] and vitamin D NOS. The reporter's husband had a reaction to the vaccine. She was wondering if it is ok to have the second dose. He got paralysis, Bell's Palsy on 14Feb2021. She clarified vaccine as COVID19 Vaccine. She would like any information available about second dose after having Bell's Palsy with the first dose. The outcome of the event was not recovered.
5 or 6 migraines over the next 6 weeks, about 1 every week starting when I had the 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 08:00 (Lot number: ER8735) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 02Apr2021, when the patient was 55 years old, for COVID-19 Immunisation. The following information was reported: MIGRAINE (non-serious) with onset 22Apr2021, outcome "recovered with sequelae" (2021), described as "5 or 6 migraines over the next 6 weeks, about 1 every week starting when I had the 2nd dose". Therapeutic measures were not taken as a result of migraine.  Additional information: Migraines now about every 2 months. The patient did not receive any other vaccines within 4 weeks  prior to the COVID vaccine. The patient did not receive any other medications in two weeks. The patient did not had covid prior vaccination or tested post vaccination. There were no known allergies or other medical history.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to a 14 year old patient of unknown gender. On 29-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L027282 with expiration with expiration date reported as 29-JAN-2016). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had an injection site reaction on (R) arm. Site for inflamed, she went to urgent care and receive RX for Cephalexin 3x/day for 10days. Reaction happened 2 days after shot was administered.
From telephone contact with the reporting nurse it was stated that a 29 year old male patient received an IPOL, a TD Adult, a Yellow Fever and a Hepatitis A vaccination on 5/18/01. Ten days after the vaccinations, the patient developed generalized red rash over body, except face. Further information is requested. From mailed correspondence received on 7/2/01 additional vaccine, vaccine administrator and responsible physician information was provided. From additional correspondence received on 9/7/01 it was reported, reviewed, no additional information at this time. This case is closed.
Patient was given the incorrect dose for their age. Patient was given a Pfizer 6mo - 4yr dose instead of the 5 - 11y dose.
Telephone call 9/17 reporting complaints of slight swelling of RA without hardness, redness at injection site.  Reports fever of 101 9/16 relieved by Advil x 1.  Fever has returned today with pain in injection arm, described as sharp.  Recommend MD eval if fever not relieved by antipyretic - Advil/Tylenol and gone after today.  Plan to return call 9/22 & complete VAERS.  9/22 - phone call:  no response; 10/6 - phone call:  resolved in 48 hours.
I was fine for about 2 months then I noticed I had no taste while I was eating. It?s still this way as of today. Loss of taste.
This patient has soreness of the left arm and left scapular region 20 minutes after vaccine to present. Redness at the injection site, left deltoid. The patient states she felt sluggish, over tired 1 hour after the shot and she been feeling the same since.
pt recvd vax & felt flushed & SOB x 30-40mins p/vax; came to ER; has 2 hives near site of inject; doing fine otherwise; ER MD reported hx of ? react to TD vax 3-4 yrs ago;
Patient complained of dizziness, migraine headache and tingling in her right arm immediately following vaccination.
After getting  second shot of the vaccine, they developed swelling of the face; Afyter getting their second shot of vaccine vaccine, they developed hives of the face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (After getting  second shot of the vaccine, they developed swelling of the face) and URTICARIA (Afyter getting their second shot of vaccine vaccine, they developed hives of the face) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, 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 experienced SWELLING FACE (After getting  second shot of the vaccine, they developed swelling of the face) and URTICARIA (Afyter getting their second shot of vaccine vaccine, they developed hives of the face). At the time of the report, SWELLING FACE (After getting  second shot of the vaccine, they developed swelling of the face) and URTICARIA (Afyter getting their second shot of vaccine vaccine, they developed hives of the face) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was reported getting knee replacement on 12-APR-2021. Patient consulted emergency room  for treatment but treatment data was not provided.
Pt. stated: pain, soreness at inj. site & entire arm, rash turning into raised, malaise, fatigue over last 24 hours, told patient to see MD at clinic, MD saw patient and treated for infection ?.
Immediately after receiving my first vaccination, I felt tingling from my arm up to my face. Then my face was numb, cheeks, chin and tip of my tongue. It lasted for 2 and a half days. I went to my doctor and they recommended that I go to an allergist and states it was a peg allergy. They recommended I get the second shot, so when I got the second shot they put it in my leg instead of my arm. I had no complications with the second one.
Tingling (B) hands, papular rash forearms, itching arms, soreness (B) shoulders noted 10/26/11, improved 10/29/11.
Complained of tingling/numbness left side of face and felt as if something was penetrating her left ear canal. Sent to urgent care.
Patient stated after going home from getting vaccine she had a headache experienced memory loss and had trouble texting on her phone.
Fussy after 2 mo imms. No fever. Seems uncomfortable. Not inconsolable.
Day 8 post vaccine: red, warm, slightly swollen ( slight plateau) itchy 2x2? area appeared, just distal to injection site (NOT exactly on the site). It grew over 5 days to 3x5?.  Slightly darker red around the perimeter. Continued to itch. Then faded over the next 5 days.  Gone now 1-26-21
This case was reported by a consumer (also the subject) and described the occurrence of increased blood pressure in a 78-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Co-suspect medication included ADVAIR 250/50 mcg. multi dose powder inhaler. There were no concurrent medications. On 20 August 2010 the patient started Fluticasone propionate+salmeterol xinafoate (inhaled) at 1 puff(s) twice per day. Approximately 7 days later, on 27 August 2010, the patient experienced increased blood pressure. Treatment with Fluticasone propionate+salmeterol xinafoate was discontinued. On 30 August 2010 the subject received unspecified dose of Flu vaccine (details unknown). On 30 August 2010, less than one day after vaccination with Flu vaccine, the subject experienced increased blood pressure of 140/60. The subject stated that her blood pressure was usually around 110/60. At the time of reporting the event was unresolved. Patient was prescribed ADVAIR by her doctor to help with her breathing. She was not specifically diagnosed with asthma or COPD. Patient stated she took the medication as prescribed for a one week and then discontinued it because she experienced an increase in her blood pressure. Today, August 30th, 3 days after discontinuing ADVAIR, patient received a flu shot, manufacturer unknown. Patient's blood pressure is usually around 110/60 and today it was slightly elevated to 140/60. Patient is not sure if the increase in her blood pressure may be due to the flu shot and/or ADVAIR. Follow-up received on 23 September 2010 from the consumer: The lot number for ADVAIR was provided as R472217; expiration date was not reported.
Pt vaccinated with DTP within several hrs after experienced low grade fever and extreme irritability, high pitched, screaming cry, was inconsolable lasted up to 24 hrs.
Fever, heavy sweating began (with both 1st in November 2022 & this 2nd dose) approximately 6 hours after administration. Vomiting commenced approximately 18 hours following administration. Vomiting ceased after 2 instances 2nd dose, after about 3 hours 1st dose. Both followed by extreme fatigue/full day of sleep. Fever subsided approximately 40 hours after vaccine administered.
Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse by phone. This case is linked to cases 2019SA071898, 2019SA073917 and 2019SA073919 (same reporter). This case involves a 82 years old patient (gender not reported) who was accidentally vaccinated with 0.1 ml dose of FLUZONE (batch number: UI998AD and expiry date: 30-Jun-2019) via intradermal route in right forearm, instead of TUBERSOL on 13-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to wrong vaccine administered. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by the sender: none.
2- 3 weeks after HPV & VARIVAX given (given on 10/4/10), hair loss of occipital & frontal hairlines - growing back after one month. Hair loss extended half way occipital.
Patient received PNEUMOVAX 23 in left deltoid on 10/11/10 within a few hours left bicep became red, inflamed and warm to the touch. The symptoms continued and were reported on 10/13/10. The inject site was unaffected. Pt was advised to see MD.
Pt called to describe a headache and 101 degree F temperature. Headache resolved with TYLENOL but came back again.
Patient has a temperature of 103-104 degrees, eight days after vaccine administration. Fever began in the middle of the night and lasted 12 hours. No other symptoms. No other ill effects.
Patient complained of severe redness and swelling and itching at the injection area for over 10 days.
fever; headache; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th January 2022, the patient received the 2nd dose of Shingrix. On 16th January 2022, 1 days after receiving Shingrix, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were not recovered/not resolved.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. On the day of reporting, the patient had a fever of 101.8 degree F and a bad headache The patient asked that how he/she treated it. The follow-up would not possible as no contact details were available.
My face and lips began to swell within 45 minutes of the injection. My lips also became very tingly. Face and Lips felt very numb like they had been injected with novocaine.  My blood pressure also spiked and my heart was racing.  Have been very fatigued for the past 24 hours. Headache and body aches.  Sore throat. Restlessness in my legs.
starting 1 hour after shot, dizziness and brain fog.  Starting 4 hours after shot: lethargy, chills. Starting at time of bed until morning (11pm - 7am): significant itching left arm and shoulder. All symptoms except itching stopped after 48 hours. Itching remained every night for 8 nights, then became sporadic averaging 2 nights per week and still continues. Treatment of itching entails OTC anti-itch cream ArniCare with Arnica Montana 1X HPUS-7%, and OTC 4% Lidocaine patches from Target which take approximately 2 hours to ameliorate itching.
Upon injection into the right arm, blood started to pour out of the injection site. Bleeding stopped once the nurse administered pressure. There were no immediate side effects present, other than soreness at the injection site. Approximately 17 hours after the vaccination, the following symptoms started: nausea, malaise, fever (102.3), chills, headache, and lower back pain. The onset of side effects was intense and required that I immediately stop what I was doing and rest.
Initial case was received on 18 October 2010 from a healthcare professional. It contains information for a cluster of three unidentified female patients. The first of three patients who is over 65 years of age (specific age not reported) received on 09 October 2010, a deltoid intramuscular injection of FLUZONE HIGH-DOSE (lot number U3601AA). On 09 October 2010 she experienced dizziness, chills and felt "out of it". The patient had no illness at the time of the vaccination. Her pre-existing medical conditions and concomitant medications were unknown. She had no known allergies. The symptoms lasted about 24 hours. The patient recovered on an unspecified date. The reporter for this case (2010-05999) is the same as for case 2010-06000 and 2010-06001. Documents held by sender: None.