chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got my only flu shot on 1969 got the only case of flu I ever had shortly there after; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 03-DEC-2020.  This case involves a patient of unknown age and gender who reported that  got my only flu shot on 1969 got the only case of flu I ever had shortly there after (Influenza), while he/she received vaccine Influenza Vaccine.   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, unspecified time after receiving the vaccine, it was reported that the patient got the only flu shot on 1969 got the only case of flu the patient ever had shortly there after. The patient will never take another flu shot!!!!! (Influenza).  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
Vaccinated 9/25/21 Malaise & fatigue within 24 hours Mild cold symptoms 3 days later Ringing in left ear within 5  days later Vertigo treatment at ER 8 days later
Moderna COVID-19 Vaccine EUA :  Experienced side effects beginning 3.5 hours after receiving injection and that lasted about 36 hours, including fever of 100.9 degrees, chills, headache, body/joint aches, fatigue, shaking (from chills), sleeplessness.
has hot erythema in a 3x3 inch patch at the site of injection /  it is red, hot and a little raised; has hot erythema in a 3x3 inch patch at the site of injection /  it is red, hot and a little raised; has hot erythema in a 3x3 inch patch at the site of injection /  it is red, hot and a little raised; fatigue; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st December 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site warmth, fatigue and headache. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were not recovered/not resolved and the outcome of the fatigue and headache were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with 1st dose of Shingrix on right arm. On same night of vaccination, the patient had hot erythema in a 3x3 inch patch at the site of injection, it was red, hot and a little raised. The symptoms were ongoing at the time of reporting. The patient also had fatigue and headache. Fatigue and headache were resolving. The reporter did not consent to follow up.
Pt became hypotonic 4 hrs p/immun; Limp, pale, apnea for 15-20 seconds, elevated temp 102 R & tired for 30-40 minutes; Occurred approx 4 hrs post dose;
1/25/16 left leg has 4mm indentation w/had 4mm nodule. Parents have rubbed area and given warm baths. This is smaller than what parents said site was previously. Has not been in pain.
pt recv vax fussy w/inconsolable cry cont off & on thru today 14AUG98;instructed mom to call MD;rt leg sl puffy & child pulls up leg when touched;cont to be fussy;
heart felt funny and her heartrate was 135 to 140; This is a spontaneous report from a contactable consumer (patient's husband) via Medical information Team. A 37-year-old female patient (reporter's wife) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included anxiety (takes a low dose of Xanax). Concomitant medication(s) included alprazolam (XANAX) taken for an unspecified indication, start and stop date (couple times a month) were not reported. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunisation. The patient experienced heart felt funny and her heartrate was 135 to 140 (non-serious) on Apr2021. The caller stated his wife, got the second dose of the vaccine last Wednesday, 21Apr2021. She ate well and was in good shape. She was 5 foot 4 inches and 135 pounds and has never had any heart issues ever. She wore an apple watch and the morning after the vaccine her heart felt funny and her heartrate was 135 to 140. She has anxiety and takes a low dose of Xanax maybe a couple times a month but did not take anything daily for this. She went to the urgent care and they ran tests and could not figure anything out so they sent her to the emergency room. At the emergency room they ran tests and couldn't figure anything out and weren't seeing anything and said it must be a reaction to the vaccine and said it should go away in a couple days. Now it was going on 8 days and when she woke up her heartrate is about 130. She has contacted her primary care provider and is about ready to go back to the ER. He asked if there is any advice or if anyone else has reported this. He was looking for any information at all on this. The caller stated he already reported this with safety; e-transmitting potential duplicate AE details. The patient underwent lab tests and procedures which included heart rate: 135 to 140 on Apr2021, heart rate: 130 on Apr2021, laboratory test: couldn't figure anything out and weren't seeing an on Apr2021. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I skip period on birth control pills for half a year now, so I don?t get my period at all. After the first dose, I?ve been spotting everyday. It?s not a lot that I need a pad. It?s enough whenever I wipe after peeing, I see a little spot of blood. After the second dose, the spotting continues but start to become heavier. A week later after second dose, the spotting is a bit heavier that I need to wear a panty liner.  This spotting been going for a month now since my first dose.
From initial information received on 10/10/03, from a health care professional regarding an adverse event occurring in the USA, it was reported that a 42 year old female patient received a dose of Fluzone, lot number U1139AA, administered intra-muscularly in the left arm on 10/07/03. Two days later, the patient developed a 2 inch red area, swollen and warm at the administration site as well as fever, nausea and vomiting. During this event, the patient was also taking Glucophage, Acupril and HCTZ. The patient's recovery status is unknown.
Fever of 101 for three days, high pitched scream (one that I have never heard from her before) for hours at a time for the majority of the day and night started on 7/7/16 and lasted for three days, less screaming and fussiness on 7/8/16, but still present, naps and nighttime sleep greatly disturbed, wakes screaming instead of happy as usual, refused bottles for three days starting 7/7/16 and wouldn't breastfeed either on  7/10/16, ate almost nothing that day, lack of appetite for solid food as well, as of today, she has only had one bowel movement since immunization (regularly goes every day), clumsy on 7/9/16 and fell much more than usual, rash appeared on trunk 7/10/16 and is still there, gassy and seems to have digestive pain starting on 7/10/16 which is still ongoing.
Patient started to feel faint and nauseous within a couple minutes. His lip started to swell. EpiPen Jr. administered. He responded. Ambulance came and patient taken to ER to get checked-out.
covid arm - red itchy swollen 3" circle just under injection site on left arm,  began 6 hours ago
Cramping; Extreme fatigue; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramping), FATIGUE (Extreme fatigue), HEADACHE (Headache) and NAUSEA (Nausea) in a 63-year-old male patient 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 MUSCLE SPASMS (Cramping), FATIGUE (Extreme fatigue), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, MUSCLE SPASMS (Cramping), FATIGUE (Extreme fatigue), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up information received and Outcomes updated.
In 07/21/05 requesting 4 mo shots however reported following events after 04/12/05 vaccines. High fever 102.9 digital thermometer immediately after shots, infant screamed off and on all night long. Quit breathing at 09:00 and taken by ambulance and then shipped out.
chills, fever, aching evening of immun; rash on elbows, body 5JAN94 next AM; 6JAN93 rash covered body; 3FEB94 has recovered;
12 hrs later bleeding for nose, coughed up a blood clott,  about 8 hrs after that went to the bathroom and had a little blood in toilet.  During the next few days sore muscles and pressure in my sinus eye area, and little ache on top of my head.
sore throat; congestion; fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 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: NASAL CONGESTION (non-serious) with onset 08Sep2022, outcome "unknown", described as "congestion"; FATIGUE (non-serious) with onset 08Sep2022, outcome "unknown"; HEADACHE (non-serious) with onset 08Sep2022, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset 08Sep2022, outcome "unknown", described as "sore throat". Additional information: The patient received the Covid-19 booster 06Sep2022. Two days later I had sore throat, congestion, fatigue, headache. Did not have these symptoms with first vaccines. Took the vaccine so patient could safely travel to see daughter. Trip was ruined along with expenses changing flight. Patient feel Pfizer didn't explain the severity of the vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Severe pain in both arms.  I had the shot split because of injection site issues in the past.  The next day I had a racing heart.  The next day the racing heart got worse.   It was painful..I also had a tightness in my chest that lasted several weeks.
Extreme nausea, cramping in hands and feet, cold sweats, stomachache lasting about 10 mins. Was taken to the Emergency room due to hyperventilation, low blood pressure (90/50), and general weakness.
This spontaneous report as received from a pharmacist refers to several patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX23 (lot #, dose, frequency and route were unknown). On an unknown date the patients experienced fever, achiness, cough, "felt sick", sore arm, redness and swelling from elbow to shoulder of left arm. The outcome of the events was unknown. This is one of two reports from the same reporter. The other report is MARRS#1409USA006595. Additional information has been requested.
Approximately 42 hours after getting the vaccine I woke up in the morning covered in deep painful hives, within an hour my top lip started swelling. I went to urgent care and got a steroid shot (decadron 10mg) intramuscular in my right buttocks/hip and was given 50mg of benadryl.  Was discharged and followed up with my primary. I was given instructions to continue benadryl every 4-6 hours as needed and start a steroid (prednisone) 20mg twice a day for 5 days. I took my first dose of steroids Monday evening. I have been using steroids and benadryl since with small improvements. I am now trying Pepcid 20mg twice a day and will continue to taper off of the steroids for a week due to guidance of my primary care.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with varicella virus vaccine live (Oka/Merck). It was indicated that on an unspecified date, the patient developed chicken pox. Medical attention sought and current patient status was not reported. A product quality complaint was not reported. This is one of two reports from the same source. Additional information has been requested.
Severe arm pain, low grade fever 99.9, generalize muscle aches, fatigue, headache. Started 5:30am the day after the injection and lasting 12-15 hours. Managed with tylenol 500mg taken 3 times (5:40am, 11:00am, and 6:00pm roughly). That reduced pain to manageable level for koisleeping, and reduced fever to within normal range.
Had flu like reactions, fever, nausea, chills, swelling, entire forearm swollen, very sore, etc then hives after fever broke.
Prior to my Covid vaccine I have had a regular period.  During this time I was also on a oral contraceptive.  Two days after my first vaccine I started my period 1 week early. Then 2 weeks later I had another period, then 2 weeks later I had another one.  In a 5 week period I had 3 full and seperate periods.  I contacted my OBGYN, he didn't seem overly concerned about it- he did not think it was related to the vaccine. But am I normally right on time, never that many right next to each other. So then I thought maybe it was the contraceptive.. so I ended up stopping it after that 5 weeks, and I haven't had the problem since then.
Warm, erythematous and tender area 2-3 inches below injection site. Patient states after 2 days it has started to get better.
MISSED THE SECOND DOSE; A spontaneous case report was received from a caregiver on 17-Jun-2019 for four consumers.  Based on the information obtained from the caregiver, four individual case safety reports PVX201906-000505 (PVX2019-1565; 14-year-old male consumer), PVX201906-000506 (PVX2019-1566, 10-year-old female consumer), PVX201906-000507 (PVX2019-1567; 13-year-old female consumer), and PVX201906-000508 (PVX2019-1568; 16-year-old female consumer) were created and cross-linked in the database.  This case describes a 10-year-old female child consumer who "missed the second dose", while being on oral Vivotif (one capsule every other day) (lot number: 3003275) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 14-Jun-2019 and missed to take the second dose, which was due on 16-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the second dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201906-000505:
Narrative: Patient states that he experiences a mild headache for one day after the vaccine. Symptom resolved.  Other Relevant Hx:  Symptoms: Headache Treatment:
Started feeling achy. Woke up the next day with flu like symptoms. Stuffy nose, fever, diarrhea, stomach issues. Injection site is red, puffy and tender.
PATIENT WAS ADMINISTERED TWO INJECTIONS BY A FLOATER PHARMACIST ON 10/15/2108: FLUAD AND PNEUMOVAX 23. PATIENT HAD NO PROBLEMS WITH THE PNEUOMOVAX INJECTION, BUT, EXPERIENCED ALOT OF PAIN AS THE FLUAD INJECTION WAS ADMINSTERED. PATIENT SAID THAT SHE COULD NOT LIFT HER RIGHT ARM, AND VISITED HER PRIMARY CARE PHYSICIAN ON 10/31 AND HIS ASSOCIATE ON 11/7. DR PRESCRIBED DICLOFENAC GEL AND DR PRESCRIBED AMOXICILLIN. BOTH WERE INEFFECTIVE. PATIENT VISITED AN ORTHOPEDIC SPECIALIST, AND ACCORDING TO PATIENT WAS ADMINISTERED TRAMCINOLONE INJECTION WHICH HAS HELPED. PATIENT STATED DR  CONCLUDED THAT THE INJECTION WAS ADMINISTERED TOO HIGH RESULTING IN INJURY.
Pt with generalized itching.  No rash or itching in mouth, or soa.  No other sx reported.  Pt reports same thing happened with first covid shot and resolved after Benadryl.  VSS throughout observation. Pt without improvement of sx after 45 minutes of observation.  Recommended pt to go to er since sx did not resolve.  Pt refused.  Left ambulatory.
Severe body aches and pain, temperature of 99.7, shakes, chills, hot flashes, could not sleep the first night, overall my body felt terrible, extra fatigue, really felt very poor.  I felt better 48 hours
Got FLUAD shot. Within hours, had high fever and severe chills (made my teeth ache). Shoulder joint of shot arm painful and muscle weak. Within a week, started having problems with other joints. Aching in neck (creating headaches), fingers especially. Overall weakness in muscles. Never had any of these issues before the shot. Never had a bad reaction to a flu shot before. Been getting flu shots for years. How long will these side effects last?
Initial report received on 20 September 2013 from a consumer. This case is one of two cases reported by the same reporter, who each experienced adverse events following administration of FLUZONE HD Lot # UT761AA. The reporter in this case was also the reporter for case # 2013-09719. A 76 year old female was vaccinated on 16 September 2013 with FLUZONE HD, lot # reported as UT761AA (to be confirmed) intramuscularly into the left deltoid. The patient's medical history was reported as allergies to sulfa drugs, hypothyroid and hyperlipidemia. The reporter denied that the patient had any illness at the time of vaccination. On 16 September 2013, time not specified, the patient experienced redness and pain at the injection site. The patient was evaluated by a physician, date not reported and was prescribed CIPRO, dose and route not reported. The reporter stated that the patient's condition has improved. Laboratory tests were not reported. No further details were available at the time of this report. The patient outcome was reported as unknown. Documents held by sender: None
Soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) and FATIGUE (Fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Loss of smell in January 2021 and Loss of taste in January 2021. Concomitant products included MINOXIDIL, CARBIDOPA, LEVODOPA (SINEMET), PROPRANOLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), COENZYME Q10 [UBIDECARENONE], VITAMIN D [VITAMIN D NOS] and DENOSUMAB (PROLIA) from 02-Dec-2020 to an unknown date for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN (Soreness) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Mar-2021, PAIN (Soreness) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: over 100 (Inconclusive) fever over 100.     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.   In Dec. 2021, patient was sick and had some of the COVID-19 symptoms.
Patient was scheduled with siblings to receive COVID booster. After administering the Pfizer 5-11 bivalent booster it was realized that the patient never received her 2nd dose of the primary dose. Reviewed with CDC and was told to treat as her second dose and that she should receive the bivalent booster in 2 months.
wrist/ulnar nerve tenderness; This is a spontaneous report received from non-contactable reporter(s) (Physician).  An adult patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEURALGIA (non-serious), outcome "unknown", described as "wrist/ulnar nerve tenderness". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Very strong pain in my shoulder, especially when making certain movements. Could not sleep. Had to visit my doctor 3 times already. Miss several days of work. As of Dec 3, 2011, took MRI test, waiting for results.
Vaccine administered after vial was punctured and left at room temp for over 2 hours.  Vaccine administered about 3&1/2 hours after initial puncture.
Had IZ's about 09:00. Developed hives about 18:00. No respiratory symptoms or oral lesions. Most of the hives were on left leg, increasingly spread on to whole body. On examination: erythematous wheals on extremities/trunk; CTA (B)-all clear.
6 hrs after injection developed fever, chills, headache, body aches, fatigue, sent home from work went to bed, temperature 101 degrees F.  Symptoms continued through Sunday, fever down between 99-100 degrees F, chills and body aches mild, still fatigue.  By Monday morning around 2am hives developed, spread across body, face, lips and ears very swollen, went to walk-in clinic by 9am Monday morning.  Patient prescribed prednisone and benadryl for relief of symptoms most likely due to vaccination.
Numbness/tingling in fingers and lips within a couple of minutes of injection. Flush face shortly following. All lasting upto an hour.
Severe headache the next day after getting the vaccine, subsided gradually after 12 hours or so.
This case was reported by a pharmacist and described the occurrence of incorrect storage of drug in a patient who received FLUARIX. On an unknown date, the patient received FLUARIX at an unknown date. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced incorrect storage of drug and vaccination error. On an unknown date, the outcome of the incorrect storage of drug and vaccination error were unknown. It was unknown if the reporter considered the incorrect storage of drug and vaccination error to be related to FLUARIX. Additional details were provided as follows: The reporter stated that there university had a temperature excursion of FLUARIX vaccine that was administered to a number of patients, which led to vaccination error. They were wondering as what was the protocol as far as revaccinating the impacted patients, and any possible effects of revaccinating those patients.