chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received 2nd dose of Pfizer vaccine on 1/11/2021. Patient states she had rigor and fever start 14hours later (approx 11pm on 1/11/21). Patient states she had fever up to 102*F up until 1/12/21 at 2pm, when fever resolved. The next AM on 1/13/21, she noticed rash on L deltoid (same site of injection), that spread to her neck area, and then spread to R shoulder area. Pt reported to her PCP that day and was given Rx for Benadryl & Medrol dose pack. Pt states rash resolved by the evening of 1/14/2021.
Vaccine was  prefilled syringe and was activated, cap removed and needle placed, the day before (9/8/22). It was administered 9/9/22 instead of being disposed of on 9/8/22.   Pt endorsed HA for 2 days following vaccination. Unclear if this was r/t the incident or not.
Erythema 6.5"x3.5" with circular area within. Raised blister within circular area. Painful to touch. Ice bag ordered.
Left axilla red, swollen and painful 2 days following tetanus. Low grade fever hand tingling, nausea on and off left arm slightly weak.
round circle around injection site; hives at the site of injection; injection site itchy; soreness of arm; redness at the site of injection; A spontaneous report was received from a consumer concerning a 36-year old, female patient who received the Moderna COVID-19 (mRNA-1273) vaccine and experienced injection site redness, soreness of the arm, injection site hives, injection site itching, and a round circle around the injection site.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient had a sore arm and redness at the site of injection. These side effects resolved after a few days. On 06 Jan 2021, the patient noticed she had hives at the site of injection that was itchy and had a round circle around it. Treatment information for the event was not included.   Action taken with mRNA-1273 in response to the events was not reported.   The events, injection site redness and soreness of the arm, were considered recovered/resolved on an unknown date.   The events, injection site hives, injection site itching, and a round circle around the injection site, were unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
severe facial bullous skin eruption diagnosed as Linear IGA Bullous Dermatosis by biopsy
Initial information received on 08-Aug-2018 regarding an unsolicited valid non-serious case received from Consumer. This case involves a 1 years old male patient who did not want to walk, had slight fever, red dots and given a dose of ADACEL that was expired, while he received vaccine ADACEL and DIPHTHERIA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Aug-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in leg and also received DIPHTHERIA VACCINE. The patient developed a non-serious did not want to walk following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and DIPHTHERIA VACCINE. The patient developed a non-serious slight fever same evening following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and DIPHTHERIA VACCINE. The patient developed a non-serious red dots following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and DIPHTHERIA VACCINE. It was also case of actual medication error due to expired vaccine used. (Other relevant tests included No lab test). Final diagnosis was slight fever, given a dose of ADACEL that was expired, red dots and did not want to walk. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for did not want to walk, as Unknown for slight fever, as Unknown for red dots and as Not Applicable for given a dose of ADACEL that was expired. 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.
Dizzy; This is a spontaneous report from a contactable consumer. A 93-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201, expiration date: unknown), via an unspecified route of administration in right arm on 10Feb2021 at 02:40, second dose via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Feb2021, the patient experienced dizzy. The dizziness would stay as long as she stands up, but if she sat down, she was fine. They did not think much of it and did not really but anything together. She was calling to try and get some help/advice on what to do. They have tried motion sickness pills and called the doctor and has seen the doctor 2-3 times. She cannot think of anything else to do in order to help. She was hoping we would be able to provide some advice and say something that they should do in order to help. The patient's blood was draw, but did not find anything else going on. The outcome of the event was not recovered.
Dose 1 EN6207, 03/20/2021 EN6207, Dose2 04/10/2021 EP7533. I started to see an increase in my eczema creep up after Dose 1 and was prescribed a Steroid cream and by Dose 2, it was increasing in intensity and moving to different location of my body. At this point the treatment plan is not working. By Dose 3, I was prescribed Prednisone.
This spontaneous report was received from an office manager who was working in physician's office. Office manager reported that the office improperly stored GARDASIL (dose, lot number and expiration date not reported). Reporter also stated that she didn't know if any dose were administered to any patients. No adverse events were reported. Additional information has been requested.
Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-056135 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11 May 2021 in which contact information was updated.
Pt administered 2nd dose COVID-19 vaccine this morning at 0937. Similar to reaction from 1st dose, she reported feeling tachycardic and was placed on automatic BP monitor. BP initially 200/115 with HR 135. At 1005 she was given metoprolol tartrate 25mg PO x1. Within a short amount of time BP and HR began to come down and Pt appeared calm and conversational. BP came down to 159/98, HR 104. Pt reported feeling better and decided to leave at 1029.
About 1-2 hrs after receiving vaccines, R arm developed a rash to upper arm surrounding the injection site with a total area of about 5 inches.  States had itching the area.  Lasted about 2-3 days.  No fever reported.
her arm hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm hurt".  Additional information: The patient's age was reported as 87, no unit provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392759 Same reporter/drug/AE, different patient;US-PFIZER INC-2021407626 Same reporter/drug, different patient/AE
Unspecified Adverse event.; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Unspecified Adverse event.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Unspecified Adverse event.). At the time of the report, ADVERSE EVENT (Unspecified Adverse event.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.    Reporter did not allow further contact
About 20 minutes after vaccination, started to feel tingly sensation in mouth, tongue.  About 1 hour after vaccination my lips felt numb.  No blue lips, no rash/hive, no swelling of tongue, lips or face, no difficulty breathing or swallowing.  Just numbness in lips and tingling feeling on tongue, all over mouth.   The numbness felt like novacaine shot you would get if you were getting dental work done.  Numbness in lips lasted about 3 hours but gradually reduced to just tingling feeling after.  The tingling feeling in my mouth gradually got better every hour after that.  It still lasted all night.  It did not completely go away until the next morning.  After the morning, numbness and tingling sensation went away.
Case number PHEH2013US009517 is an initial spontaneous report from the nurse received on 25 Apr 2013. This report refers to a patient of unknown age and gender. On an unknown date, the patient was accidentally vaccinated with only Men A lyophilized conjugate of MENVEO (batch number : not reported) reconstituted with a sterile diluent via intramuscular route and did not receive MenCYW-135 liquid component. It was reported that the patient did not experience any adverse event after the mal-administration. No other information was available.
On 10/6/21, pt went to the ED with shortness of breath and chest heaviness that began within 12 hours of vaccine.
After 1st vaccine, I got Moderna arm exactly 7 days after vaccine.  After 2nd dose, 16 hours later I became extremely sick for 3 days.  Then 2 weeks later, I started an itchy rash covering chest. As time went on it now covers my stomach, back, buttocks, legs, and arms.  Started approximately 2 weeks after 2nd dose.  It?s almost 3 months later and I still have the rash.   After having the rash for about 3 weeks, I went to healthcare facility. They told me I?m allergic to something. The doctor prescribed 6 day course of Prednisone, Claritin, and itch cream.  On June 14, I saw another doctor. He prescribed me Prednisone, an oral medicine to help the itch, and an ointment. On July 2 I saw nurse practitioner because rash was still prominent.
Patient felt dizzy, altered hearing for couple seconds, had trouble breathing for couple seconds, looked pale, shaky. Upon questioning pt. stated they had not eaten anything in about 7 hours. She also felt tingling on her hands running up to her elbow. Monitored patient gave some orange juice, almonds and water. Ran hands under warm water. Within about 5 minutes she felt little better. Color came back in about 10 min. and monitored her for about 15-20 min. She felt fine when she left store 1/2 hour after vaccine. On F/U she felt fine and had no other symptoms.
Patient was advised to sit after receiving the shot but instead stood against the wall  there to watch her sister get the vaccine. Within 5 minutes after receiving the vaccine , she slowly fell on the floor, and was tight for few seconds. Patient's father and I lifted her and sat her in the chair and called 911. Over next 2-5 minutes, she felt normal. EMS personnel took her vitals and stated  that all of them are "Perfect", and there was no need to seek additional medical care or transportation required unless the patient's father would like to. Patient's father mentioned that Patient was nervous and did not want to get the vaccine but came to get the vaccine after some convincing on his end.
68-year-old woman with past medical history of high blood pressure and diabetes presents emergency department for evaluation of body aches, generalized malaise, fatigue, diarrhea in the setting of Covid confirmed illness for the past 7 days.  She has one sick contact at home, her son but he has not taken a Covid test.  She has had 2 vaccines and was due to get her third booster this month.  She gets a little short of breath on exertion.  She has no chest pain at this time.  No leg swelling. This patient is a pleasant 68-year-old female with past medical history of coronary artery disease status post a stent was placed about 3 years ago, history of atrial fibrillation on Coumadin, history of diabetes and hyperlipidemia, who resides with family.
(Sunday, Mar 28) Red, itchy, sore bump appeared an inch below the injection site. The bump remained for 3 days and went away. Prior to and during vaccination, had cold sores in mouth. (Wed, Mar 31st) Cold sores remained, developed rash on nose and around the mouth, and additional sores in mouth (clustering). Went to doctors, diagnosed as Oral Herpes breakout. Prescribed and started taking Valacyclovir  (Saturday, April 3rd) Red bump near vaccine injection site reappeared. Very red, itchy, and sore.
Extreme joint and muscle pain; Extreme joint and muscle pain; chills; exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8627) via an unspecified route of administration in the arm left on 07Apr2021 at 09:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included arthritis. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN), cannabidiol (MANUFACTURER UNKNOWN), biotin (MANUFACTURER UNKNOWN), cod-liver oil (FISH OIL) and cyanocobalamin-tannin complex (B12); all from an unknown date for an unknown indication. The patient had no known allergies to medications, food or other products. The patient previously took first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 17Mar2021 at 09:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 16:00 the patient experienced Extreme joint and muscle pain, chills and exhaustion. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event.  The clinical outcome of the events muscle pain, joint pain, chills and exhaustion was recovered on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
severe pain in joints, wrists, elbows, ankles, hips/ ongoing headache behind eyes/nausea-joint pain wakes me from sound sleep, ongoing exhaustion, lack of appetite
mild expected side effects; Nurse administered the 2nd dose and then noticed needle was dull and pulled it out and gave the 2nd dose with another needle; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (Nurse administered the 2nd dose and then noticed needle was dull and pulled it out and gave the 2nd dose with another needle) and ADVERSE REACTION (mild expected side effects) in a 22-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 immunisation.     No medical history was provided by the reporter.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (Nurse administered the 2nd dose and then noticed needle was dull and pulled it out and gave the 2nd dose with another needle). On an unknown date, the patient experienced ADVERSE REACTION (mild expected side effects). On 30-Apr-2021, ACCIDENTAL OVERDOSE (Nurse administered the 2nd dose and then noticed needle was dull and pulled it out and gave the 2nd dose with another needle) had resolved. At the time of the report, ADVERSE REACTION (mild expected side effects) outcome was unknown.        For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up received on 04 JUNE 2021, email added- event updated as mild expected side effects
Intense itching, hives, low grade fever 99.2 - 100.2
Patient reports pain, swelling and fever within 12 hours of injection. Was evaluated in ER and fever documented 101. Admitted due to other co-morbidities.
The pt developed erythema multiforme and three days of low grade fever. Treated with Ibuprofen.
Patient stopped responding to name and verbal commands, stopped making baby talk, and started making high pitch sounds.
the rashes in some parts of the body and somewhat like whole parts of the body; then there was a little hives; itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): -PFIZER INC-202101689586 (Pfizer).  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Nov2021 (Lot number: FK5127) at the age of 10 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "allergy: allergy with the egg" (unspecified if ongoing), notes: allergy: allergy with the egg. The patient took concomitant medications. The following information was reported: RASH (medically significant) with onset 27Nov2021, outcome "recovering", described as "the rashes in some parts of the body and somewhat like whole parts of the body"; URTICARIA (medically significant) with onset 27Nov2021, outcome "recovered" (2021), described as "then there was a little hives"; PRURITUS (medically significant) with onset 27Nov2021, outcome "recovered" (2021), described as "itchy". Therapeutic measures were taken as a result of rash, urticaria, pruritus.  Follow-up attempts are completed. No further information is expected.
administerd only the Liquid Component; administerd only the Liquid Component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number MAXA587A, expiry date 31st May 2023) for prophylaxis.   On 6th January 2022, the patient received Menveo. On 6th January 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: This case was reported by the medical assistant. The age at vaccination was unknown. The patient was inadvertently administered only the liquid component of (MenCWY) of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up.
Patient had unusual heat to site of injection- extremely hot to touch- compared to many other patients with injection site reaction.
Anaphylactic reaction requiring EpiPen 0.3, Benadryl IM and transport to Emergency Department per EMS.
she returned to the clinic complaining of numbness; tingling in her left 4th and 5th fingers; This non-serious case was reported by a other health professional via call center representative and described the occurrence of numbness in fingers in a 44-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2023-2024 season) (batch number 7Z423, expiry date 30-JUN-2024) for prophylaxis.   On 17-OCT-2023, the patient received Fluarix Tetra 2023-2024 season (injection, left deltoid) .5 ml. On 17-OCT-2023, 1 hr after receiving Fluarix Tetra 2023-2024 season, the patient experienced numbness in fingers (Verbatim: she returned to the clinic complaining of numbness) and tingling of extremity (Verbatim: tingling in her left 4th and 5th fingers). The outcome of the numbness in fingers and tingling of extremity were not resolved.   It was unknown if the reporter considered the numbness in fingers and tingling of extremity to be related to Fluarix Tetra 2023-2024 season.     It was unknown if the company considered the numbness in fingers and tingling of extremity to be related to Fluarix Tetra 2023-2024 season.   Additional Information: GSK receipt date: 17-Oct-2023 Nurse practice reported that working at GlaxoSmithKline Clinic giving FLUARIX 2023-2024 SEASON Vaccines.  One hour after administering a vaccine, she returned to the clinic complaining of numbness and tingling in her left 4th and 5th fingers.   The reporter reported that the symptoms 4 hours after administration and symptoms had not resolved.   Vaccine was not listed in SF look up menu.   IT Ticket had been placed and escalated.   The reporter consented to follow-up.
About 18 hours after 2nd vaccine I experienced flu-like symptoms. I had body aches and extreme exhaustion. I slept about 20 hours the day following my 2nd vaccination. I was so cold that I slept with 3 fleece blankets and a weighted blanket. When I woke up I had the sweats but was still cold. When I woke up on 4/14 (two days after my vaccination) I felt groggy and a bit out of it. The body sores and sweats were gone but I now have a slight headache that comes and goes.