chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 66 year old female nurse practitioner concerning herself with penicillin allergy, sulfonamide allergy, and COMPAZINE allergy and chronic obstructive pulmonary disease and a history of breast cancer, who in September 2004, "6 years ago" was vaccinated with the first 0.5 ml dose of PNEUMOVAX 23 (Lot # unknown) and on 24-SEP-2010 was vaccinated SC with a second 0.5ml dose of PNEUMOVAX 23 (Lot No. 664864/1365Y). Concomitant therapy included ARIMIDEX, montelukast sodium (MSD), CLARITIN, multivitamins and fish oil. On 25-SEP-2010, the day after administration of her second dose, she experienced erythema and soreness at the injection site. On 26-SEP-2010 she felt like she had the flu. She had a fever of 102F, could barely stand up, felt "like she was going to die", coughing, pain in her arm, and the erythema was about the size of an orange. She was not able to get out of bed. On 27-SEP-2010 she felt much better, she did not have fever and was not hurting as much. The area on her arm was still very red. She was able to return to work. The patient sought unspecified medical attention. There were no Lab diagnostics/studies performed. At the time of the report, the patient was recovering. Additional information has been requested.
Vaccine given 4/11/02. On return (5/13/02), pt reported that for 3 days after injection entire left side of body was numb. Not reported to office until 5/13/02.
Within a few minutes of receiving vaccine, patient got pale and was sweating. He was fading in and out of consciousness and closing his eyes. He also appeared as if he was going to vomit. I immediately called 911 and they were here within minutes, checked him out and he waited an additional 20-30 minutes before leaving.
After receiving vaccine, patient's arm swelled from the shoulder to the bend of elbow covering most of the surface with linear hives.  Also had linear hives on neck and on back. The hives started the evening after he received the vaccine
Patient was due for a Dtap.  A Pediarix vaccine was given which also contained Hep B and IPV.  No adverse reactions.
I was completely zapped of energy; a fever of 100.9.; dizzy whenever I tried to stand up; felt sick to my stomach; heavy sweat all day and into the night.; had a buzzing in my head; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received second dose of BNT162B2, (solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration, administered in left arm on 17Feb2021 09:15 (at the age of 70-year-old) at single dose for covid-19 immunisation. Medical history included CLL. The patient had previously took first dose of BNT162B2 (lot number: EL9261) on 29Jan2021 at 09:15 am in right arm for Covid-19 immunisation. Concomitant medication included calcium, green tea extract. The patient had a past drug of ciprofloxacin and had known allergies: ciprofloxacin. 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 received the second shot on Wed, 17Feb2021. By Thursday morning she was completely zapped of energy and had a fever of 100.9. She took an aspirin and went back to bed where she slept all day because she did not have the strength to get out of bed. She had a buzzing in head and felt very dizzy whenever she tried to stand up. She also felt sick to my stomach, but did not vomit. She had very heavy sweat all day and into the night. By Friday morning she was starting to feel a little better and by Friday afternoon her temperature was back to normal. Her energy level started to return and by Saturday morning, she was back to normal. Now she felt better than she had in a long time. The patient did not receive treatment apart from fever. The events occurred on 18Feb2021 at 12:00 AM. The outcome of the events was recovered on 20Feb2021.
Headache; Achy legs; This is a spontaneous report from a contactable other healthcare professional. A 60-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), intramuscularly in left arm on 23Feb2021 at 08:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included diabetes, asthma, known allergies: Penicillin. Concomitant medical included diabetes meds plus other medicines prescribed by my doctor, received within two weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), intramuscularly in left arm on 02Feb2021 at 14:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. No COVID prior vaccination. The patient has not been tested for COVID post vaccination. On 24Feb2021 at 06:00, the patient experienced achy legs, headache, only lasted the next morning until about noon. No treatment medications was received for the adverse events. The outcome of the events was recovered on 25Feb2021.  No follow up attempts are possible; information on Lot/batch number cannot be obtained.
joint pain on the injection site from the right upper arm up to in between her elbow; Very uncomfortable; Muscle pain on the injection site from the right upper arm up to in between her elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT PAIN (joint pain on the injection site from the right upper arm up to in between her elbow), DISCOMFORT (Very uncomfortable) and MYALGIA (Muscle pain on the injection site from the right upper arm up to in between her elbow) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B2HA and 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Drug allergy (allergies to Benadryl) and Sulfonamide allergy (allergies to Sulfa drugs). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and LORATADINE (CLARITIN [LORATADINE]) for Asthma.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced VACCINATION SITE JOINT PAIN (joint pain on the injection site from the right upper arm up to in between her elbow), DISCOMFORT (Very uncomfortable) and MYALGIA (Muscle pain on the injection site from the right upper arm up to in between her elbow). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Muscle pain and Vaccination site joint pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE JOINT PAIN (joint pain on the injection site from the right upper arm up to in between her elbow), DISCOMFORT (Very uncomfortable) and MYALGIA (Muscle pain on the injection site from the right upper arm up to in between her elbow) outcome was unknown.
5 days after my injection of my first pfizer covid vaccine, I began to have a shingles flare up that started with upper back pain/ache to electrical like nerve pain through the area of my previous shingles outbreak from 2 years ago which at that time I had taken anti virals that made me extremely sick.
white spots in vision, peripheral vision disturbances, slight tunneling vision, then headache over Left eye for several hours (8-10 hours)
Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0171) via an unspecified route of administration in the left arm on 20Apr2021 at 10:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included subclinical hypothyroidism and known allergies to almonds. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/ norethisterone acetate (JUNEL), bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium (LEVOXYL) and liothyronine sodium (CYTOMEL); all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received omeprazole (MANUFACTURER UNKNOWN), for unknown indication from an unknown date and experienced drug allergy. On 21Apr2021 at 04:00, the patient experienced vomiting and diarrhea. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events vomiting and diarrhea was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt presented to ED 1/12 complaining of shortness of breath and nonproductive cough which onset approximately 8 days ago. Tested positive for COVID. Remains admitted for management of COVID.
pt recvd vax; swelling in site, in lymph node under arm & all muscle in arm & in under arm w/ constant pain; unable to lift arm above head x 4 days;tx w/ warm compress; strong smelling urine;
Severe Tinnitus, no treatment.  Has subsided SOME, but still faint and persistent.
Began to develop rash a few hours after flu vacc. (hives-type)... took BENADRYL to help with itching aches and headaches developed for 3 days - no BENADRYL taken 01-14-14 - Hives returning and to occ. health.
Spoke with patient a few hours after finding out I gave her moderna vaccine when she was under 18 years old. She so far has no side effect from the vaccine. I told her to call me if she experiences any side effects.
Rash on face,arms, hands; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on face,arms, hands) 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.   In March 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash on face,arms, hands). At the time of the report, RASH (rash on face,arms, hands) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Arm swelling began the day after administration. Family applied local cold. By day 2 swelling had increased to entire upper arm and shoulder warm to the touch and firm, mild erythema. Had an office visit 9/17. Possible early cellulitis. Cephalexin prescribed. They will be following up with us.
I am not sure if related on not. This event was 13 days after my COVID-19 1/2 immunization. Otherwise, I am a very healthy physician, normal BMI, I have also been tested 5-6 times negative for COVID. I do get exposed in my job, but wear proper PPE.  Viral infection in FEB that was like COVID-19 sx, I did AB test as soon as it was available, and negative.  ---The Event: Monday morning (1/4/21), after getting out of shower, I was talking to my husband (who is MD)and started having BROCA's aphasia sx (could not get words out coherently), then fell into bed and started right wrist and right foot posturing. This lasted 10 min. I have non-memory of it, but my MD husband witnessed it. After 10 minutes, I was back to normal, except shaky and some word finding difficulties. After 30 min, totally back to normal.
Pt rec'd imms 3/27/08 and at time denied pregnancy. On 4/10/08 home pregnancy test (+). Pt has no PCP and no OB/GYN MD. Advised husband to find PCP or OB/GYN and have confirmatory blood test for pregnancy.
Child received prevnar injection on Left thigh on 09/16/03.  Brought in by mother today 09/18/03.  Left thigh with approx. 100mm circular area red, warm and firm to touch.
Redness/pain at site of injection, fever, chills, loss of appetite, dizziness, extreme tiredness, headache, and high blood sugar.
The day after my second shot, I felt like I was having a heart attack. My chest got tight around my heart and it came in waves. My heart/lungs in my chest in that area felt very heavy and in severe pain. It was hard to breath. I felt like someone was squishing me. I have a high tolerance for pain but this pain I thought I was dying.  This started about 10:30 in the morning, my husband ran me to the hospital but had to pull over because I was screaming in pain and couldn?t breath while I was in the middle of a ?wave? of pain. He called 911, they met us in the parking lot. They gave me 4 aspirin and then took me to hospital. By the time I got to the hospital, the aspirin had helped. This aspirin saved my life. I was then discharged with ?chest pain unspecified type?
Client awoke at 0400 AM on 9/11/03 with sudden onset of fever 101.3 F, headache and shortness of breath. Was seen at health center at 10 AM 9/11/03. Fever reduced with Tylenol.
Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15May2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; manufacturer unknown), for COVID-19 Immunization.  The following information was reported: CHILLS (non-serious) with onset 15May2023, outcome "unknown".  Additional information: Reporter's wife had the shot today and she had got chills and she was having a reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approx 50 minutes after vaccination pt had itchy eyes and throat. Mother had him take 50 mg Benadryl. Reaction continued with chest pain, throat swelling, hives. Paramedics treated with epi, steroids then observed in ER. Has hx of egg/chicken sensitivity but takes flu vaccine without difficulty.
Following the initial injection the muscle was sore for about 36 hours. A week later, the injection site became tough and warm to the touch. The area surrounding the muscle became splotchy and red, developing an itchy rash that is painful to scratch.
On 11/1/19 in PM had episode of clammy and generalized weakness. Same type of episode happened on 11/3/19 @ approx. 12 noon but took about 30 minutes to recover from extreme generalized weakness & clammy skin. On 11/5/19 sitting @ Work at desk. Right arm started hurting at level right above the elbow. Pain increased in about 10 minutes to 8/10 on pain scale. Painful and numb feeling. Felt like tourniquet left on arm too long. Notified coworker. Went to ED. Work up ruled out stroke. Was asked if I had taken the flu shot and in what area. Was told by Dr. and Dr. that I needed to follow up with PCP for reaction to flu vaccine and heave documented.
About 5 mins. after immunization, pt. developed erythematous, urticarial rash face, chest, back, arms, thighs. Pt. also vomited x1. BENADRYL 25 mg given. Observed for 45 mins. No resp. issues.
UNABLE TO REACH PATIENT NO KNOWN ADVERSE REACTION AFTER 3RD DOSE.
This case was reported by a healthcare professional and described the occurrence of a large, raised knot at the injection site in a 34-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  There were no concurrent medications.  On 24 October 2007 at 14:00 the subject received unspecified dose of Flulaval at 0.5 ml in the left arm.  On 24 October 2007, 30 minutes after vaccination with Flulaval, the subject developed a large, raised knot (the size of a fist) at the injection site.  The injection site was also warm to the touch and red.  The subject was treated with Benadryl and Tylenol.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.
Red welp at injection site, tingling in hands/arm on 03/22/2021 to current time
Brief feeling of dizziness and and Increases heart rate. The dizziness left quickly the elevated heart rate lasted for about 30 min.  I was wearing an Apple Watch and noticed the BPM went from about 65 up past 130; after waiting for 25 min it went down to 90. Then stayed elevated for a few hours before returning to normal for me.
Information has been received from a registered nurse concerning a 4 year old male patient (who is a twin), with a history of intermittent persistent bronchial asthma, who on 4/10/03 was vaccinated with a dose of MMR (lot # 643715/0838M) at the pediatrician's office. Concomitant therapy at the time of vaccination included montelukast sodium. It was reported that the patient was well at the time of vaccination and that no prior skin testing was done. Subsequently, immediately after receiving the vaccine the patient had a hypersensitivity reaction which included a rash, swelling and trouble breathing. The patient was seen in the ER but not admitted to the hospital. The patient was treated in the ER with epinephrine, steroids and diphenhydramine. It was reported that the patient was diagnosed with a systemic allergic reaction and was subsequently started on budesonide inhaler. The reporter stated that the child recovered from the systemic allergic reaction. It was reported that the office was going to have blood testing done on the gelatin component of MMR. Upon internal review, the systemic allergic reaction was determined to be an important medical event (OMIC). Additional information is not expected.  This is in follow-up to report(s) previously submitted on 5/28/2004 Information has been received from a registered nurse concerning a 4 year old male patient (who is a twin), with a history of intermittent persistent bronchial asthma, who on 10-APRIL-2003 was vaccinated with a dose of MMR II (lot # 643715/0838M) at the pediatrician's office.  Concomitant therapy at the time of vaccination included MSD.  It was reported that the patient was well at the time of vaccination and that no prior skin testing was done.  Subsequently, immediately after receiving the vaccine the patient had a hypersensitivity reaction which included a rash, swelling and trouble breathing.  The patient was seen in the ER but not admitted to the hospital.  The patient was treated in the ER with epiephrine, steroids and BENADRYL.  It was reported that the patient was diagnosed with a systemic allergic reaction and was subseqently started on FULMICORT inhaler.  The reporter stated that the child recovered from the systemic allergic reaction.  It was reported that the office was going to have blood testing done on the gelatin component of MMR II (second generation).  Upon internal review, the systemic allergic reaction was determined to be an important medical event.  Additional information is not expected.
Approximately four hours after receiving flu vaccine, patient developed bloodshot eyes, urticaria (generalized) and chest pressure with inhalation. Self-treated with BENADRYL. Provider advised ibuprofen or acetaminophen and fluids.
Improper Storage (wet outer box); This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incorrect storage of drug (Verbatim: Improper Storage (wet outer box)). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 6-Jun-2023 No patient involvement. Adverse event reported after the caller disconnected, did not ask permission for safety follow-up. The pediarix outer box was exposed to condensation in the refrigerator and wet the outer box of the vaccines, which led to incorrect storage of drug.
Moderna COVID-19 Vaccine EUA. Started with extreme fatigue and heaviness, then noticed as the morning went on I developed a red/brown line along my bottom lip that looked like I was wearing lip liner, as morning progressed by noon on 3/30 I was not able to get out of bed, fever of 101. 5, chills, body aches, nausea, headache, and redness/swelling/pain on injection site. On the evening of 3/31/21 I was able to break my fever with use of Tylenol. Line on lip stayed until 4/2/21. Headaches continued until 4/3/21. I did not see my doctor for this illness. Not sure if this is related but since within a week of the vaccine wanted to include, on 4/5/21 extreme fatigue and headache returned, on 4/6/21 experienced SVT and saw a cardiologist on 4/7/21 (SVT has been experienced since teens but this was the longest episode and I have not experienced this in awhile, first diagnosis ever given for PSVT was on 4/7/21).
severe reaction with bruising on her arm; she was really sick for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (severe reaction with bruising on her arm) and MALAISE (she was really sick for 2 days) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (severe reaction with bruising on her arm) and MALAISE (she was really sick for 2 days). At the time of the report, CONTUSION (severe reaction with bruising on her arm) outcome was unknown and MALAISE (she was really sick for 2 days) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.  The reporter was reporting for her neighbor who had the Spikevax Covid-19 vaccine along with a Shingrix shot and had a severe reaction with bruising on her arm. The reporter attributed it to having two vaccines at the same time. The neighbor was really sick for two days.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2023: Live follow-up received. No new information received.
patient receive covid-19 pfizer after 15 minutes upon leaving the store patient faint at the front of the entrance
Lips became numb 30 min after injection and stayed numb for 3 hours. Nothing else besides that happened.
I was violently throwing up for about six hours, sweating, chills, and I couldn't eat for about two days. I was extremely weak. after I recovered from the two days of being miserable, my neck got really swollen and sore. I had mild soreness in my right arm at the injection site as well, but it wasn't as sore as the first shot. I drank a ton of water and took the tylenol muscle soreness medicine.  In addition to soreness on my left arm (injection site) from the first shot, my period also got heavier and I have spotting in between.
Patient received vaccine around 7:15 pm and reports feeling pain around 9:00 pm. Describes pain as all over, at the site of injection, and reports a fever of 102. Says it feels like he received a bullet to the arm. Reports throwing up in the night and still in pain as of 8:30 am the next morning.