chrisvoncsefalvay/vaers-outcomes huggingface dataset:
14 year old patient was given Infanrix instead of Adacel/ NO AE; Initial information received on 21-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional .  This case involves a 14-years-old female patient who received once dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [INFANRIX] (lot number: G5BE3, expiry date: 25-May-2021, via an unknown route in the left deltoid instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number, expiry date not reported) (wrong product administered) on 16-Sep-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, and family history were not provided. There was no history of vaccination prior to this dose.  No concomitant medications or no other vaccines were used.  It was an actual medication error case due to wrong vaccine administered.(latency: same day)  At the time of reporting, no adverse event was reported.  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.
This spontaneous report as received from approximately 79 year old female consumer regarding herself. The patient concurrent condition included drug reactions/allergies to acrylate and methacrylate. The patient's medical history included high blood pressure and Lyme disease. On 07-MAY-2013 the patient was vaccinated with ZOSTAVAX (dose unknown) for prevention of shingles. Concomitant therapies included MAXZIDE, QUINAPRIL HYDROCHLORIDE and levothyroxine sodium (manufacturer unknown). On an unknown date in May 2013, after administration of ZOSTAVAX the patient experienced weight loss, muscle aches and pains, developed a rash, an infection and hives. The patient also stated that after administration, the patient needed to have a dental partial reline performed and developed puffy lips. On an unknown date in 2013 the patient underwent blood work - result unspecified. The patient sought medical attention and had unspecified office visits. The patient was prescribed with unspecified antibiotics (unspecified names, dosages/frequencies and manufacturers) for her muscle pain and aches and a pill (unspecified name) for infection. The outcome of weight loss, muscle aches, rash, puffy lips, hives, an infection and pains was reported as not recovered/not resolved. The outcome of dental partial reline performed is unknown. Additional information has been requested.
chills, muscle soreness, left arm pain/injection site pain. injection site hard started around 7pm 12/28/20, currently 12/29/20 no longer have chills still have generalized muscle soreness, left arm pain/injection site pain, injection site hard
2 days p/vax pt in hosp, had sz; ER M.D. told mom he believes sz was illness induced, however shots may have had something to do with it
Severe chills Severe body aches Severe leg weakness Fever Nausea Blurry vision
The day following the immunization injection site became red, warm to the touch and raised about the size of a golf ball.  recommended patient has examination just in case
Information has been received from a physician via a field employee referring to a male patient of unknown age. The patient was not the physician's patient. The physician heard of the patient. The patient had positive hepatitis A and hepatitis B antibodies. On an unknown date the patient was vaccinated with a dose of hepatitis B vaccine (manufacturer unknown) (dose, strength and route unknown) while he had positive hepatitis A and hepatitis B antibodies. Subsequently on an unknown date the patient developed major arthritis problems. The outcome of the event was unknown. Causality was not provided. Additional information is not expected as the physician refused to be contacted.
local erythema & induration w/warmth w/o tenderness extending over deltoid area; subsequent to DTP vax rxn peaked 27JUN92 & improved 28JUN92 w/o systemic sx imp local DTP reaction;
patient stated she had a red, raised bump, painful, itchy rash on her right shoulder blade and a few spots on arm about a week after vaccination. the reaction resolved in a few weeks and she is completely better.
11/7/18....  reported tiredness 11/8/18.... tiredness ongoing, dizziness started around 6:30pm, passed out, went to ER, all tests run there checked out normal 11/9/18....  tiredness, dizziness, nausea and vomiting, went to Doctor today, given ZOFRAN, better this evening but still "not himself".
On 10/29/2001 at 10:30 AM administered vaccine (flu). By 10:55 AM pt became sick to stomach, weak, diarrhea, no vomiting. By 11 AM weak, warm, diaphoretic, quite pink all over. Unable to hear BP. No respiratory distress, no hives, no localized reaction at site. Poorly responsive. Sent to ER via ambulance.
This spontaneous report was received from a Nurse refers to a patient of an unknown age and gender. The patient's relevant medical history and concurrent condition were not reported. On 03-APR-2018, the patient was ordered to receive a dose of M-M-R II and a dose of VARIVAX. Inadvertently, the patient received a dose of PROQUAD therapy type; rHA, (Lot number: N015621, Expiration date: 15-JAN-2018) subcutaneously (dose not reported) for prophylaxis and a dose of VARIVAX (Lot number: M049125, Expiration date: 15-DEC-2018) (dose not reported) for prophylaxis. Other concomitant therapy included sterile diluent (MRK) (lot#, expiry date and dosage details were not reported). No adverse effects reported. No product quality complaint (PQC) was involved.
Blisters appeared on old Ceasarean scar. Looked like a bad burn across a 3/4 wide by 4 inch long area. Applied triple antibiotic cream and bandage until 04/12/2015. Then went to urgent care who gave antibiotic and antibiotic cream. The on 04/27/2015 I went to Dr. who sent me to a wound center for treatment. Treated as a 3rd degree burn for 4 weekly visits by scraping dead tissue and applying "Santyl" collagenase Ointment and applying daily with new bandages. Until May 26th when the wound finally closed .
Injection site reaction - arm swelled, reddened, and had elevated temp. Patient became ill; returned to pharmacy 2 days after shot. She was recommended to see Dr - site was infected and treated with ABx.
Sore throat  Pfizer-BioNTech COVID-19  Vaccine EUA
Extensive erythema 15 centimeter by 11 centimeter, warmth, and induration, not tender (right thigh)
got tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (got tired) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (got tired). At the time of the report, FATIGUE (got tired) outcome was unknown.            No concomitant medication was reported.  No treatment details were reported.   This case was linked to MOD-2021-277162 (Patient Link).
myoclonic sz 24 hrs p/vax adm to hosp nl EEG w/resolution of sx;
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 09-AUG-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally (dose, lot#, expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 11 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA007465: US-009507513-1708USA007464: US-009507513-1708USA007466: US-009507513-1708USA005855:
This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 30-OCT-2013 at 14:45 the patient was administered with M-M-R II (lot number J002867, expiry date 08-MAR-2015) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date the M-M-R II was exposed to approximately for 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17:14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13:26 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
6AUG95 pt was being carried on parent's back & became limp & plopped off;started crying instantly;not wanting to walk;taken to hosp ER same day, examined & referred to PMD;saw MD 7AUG95 who suggested a recheck in 48hrs;not walking still
Started at 1 am with chills, followed by 38.3 temperature. At 3 AM, fever sank to 37.4 and tachycardia with up to 125 bpm began. Blood pressure 160/74. Rash covered face and neck. Treated with Aconitum D30 (homeopathic medicine), lowered pulse rate to the 90's. Still suffered orthostatic peaks of 125. With stable higher blood pressures of 145/80, at 6 AM took 1,25 mg bisoprolol. This took the pulse down to the 80's. Orthostatic elevated pulse continued throughout the day and into the evening. In the evening, normal blood pressure, pulse and temperature. Rash was gone.
Information has been received from a physician concerning an 84 year old male pt, who was vaccinated in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine.  The physician reported the pt developed an inflamed injection site reaction and swelling to the elbow. The adverse event resolved within 48-72 hours and no treatment was necessary. No other info is available. There was no product quality complaint reported. The pt recovered from the adverse events, inflamed injection site reaction and swelling to the elbow. Unspecified medical attention was sought. Additional info has been requested. The reporter also mentioned another pt who had a similar experience following vaccination with the dose of pneumococcal 23v polysaccharide vaccine.
Patient said that got Moderna vaccine on Thursday in her left arm and that on Sunday night she started have pain on the left side of her head. She described the pain as a throbbing pain with a "boom" that would come every few seconds. It was painful to touch that side of her head. The discomfort kept the patient disoriented for a few days where she was only just today (05/12/21) able to report the pain. She said as time has passed that the duration between the throbbing (or "booming") seemed to get longer and she thinks it is getting better. Tylenol has provided some relief.
2:00 am I woke up with diarrhea and vomiting.  I vomited again at 4:00 am.  I vomited again at 5:00 am.  I had diarrhea again at 8:00 am. I was not able to eat anything all day.  Very ache and weak all day. Slight headache. Slept most of the day. Hardly able to stand in shower. Woke up the next day (4/17/2021) feeling only a slight headache.
Client received 2nd COVID dose @ 12:50 pm, complained of feeling anxious and "heavy head" feeling at 1:00pm.  Client reports history of anxiety.  Denied shortness of breath or difficulty breathing,  Placed in zero-gravity chair, given water to drink.  Client was offered Benadryl, decined.  Client denies medical issues or allergies, not taking medications.  Client observed for 30  minutes, vital signs stable.  Able to walk out of observation area at 1:32 pm with steady gait, aunt is present with her.  Educated on when to call 911 and to follow up with primary care.
The pt had no concurrent medical conditions; specifically, she had no known allergies. She was taking no concurrent medications. She received an injection of Infanrix on 12/1/00. Within 24 hours, she developed a large, raised area of firmness, redness, swelling and warmth at the injection site. She was seen by the physician, who noted that the injected thigh was 5cm larger in circumference that the contralateral thigh. The injection site swelling did not extend to the hip or knee. The pt was treated with loratadine (Claritin) and warm compresses to the injection site. She recovered by 12/4/00. The reporter indicated that 2 pts experienced injection site reactions following receipt of Infanrix lot DTPA972A2. However, only 1 pt was identified.
Pt mom called Friday 8/24/07 stating patient's left shoulder and arm at shoulder muscle is red, raised and hot, size of shoulder muscle and pt. arm is stiff and hard to move. PHN advised mom to call pt. pediatrician for follow up and PHN will call back to complete VAERS. 8/27/07 PHN called to pt mom and pt seen at doctor's office 8/24/07. Pt placed on Keflex 1tsp x 2 daily (250 mg/5 preparation). Pt has another reddened area above shots. Today pt. to follow up with doctor today. Antibiotics completed x 3 days. Area on left shoulder reddened, swelling has decreased.
I was exposed to COVID. I started getting symptoms of sore throat. I had a positive COVID-19 test. Then my symptoms progressed to congestion, tiredness, and low grade fever. I had an O2 meter that at the lowest was 92. I was having tightness in my chest. I also have a cough as well. I called my doctor and was prescribed Paxlovid. I do have a telehealth visit tomorrow due to the tightness in my chest.
This spontaneous report as received from a registered nurse refers to about 6 patients of unknown age. The reported stated she had about 6 international students that she drew titers on that failed to seroconvert to either the measles or other components of the M-M-R II vaccine. Nurse stated students were vaccinated in their country, beginning at 9 months of age. It was unknown if the patients had sought medical attention. The outcome was unknown. Additional information is not expected.
Pain at injection site first 4 days.  No fever or swelling.  On day 5 there was intense itching and a band of raised, red, warm-to-the-touch irritation appeared.  Benadryl helps to ease the itching.  It looks like a gigantic hive.
Developed blood clots in both legs, than severe muscle pain in both calf and thigh muscles. I have been in and out of the emergency room several times and the doctors said that they could fine nothing wrong. I am still in severe pain as of this date 9/6/2021. It is so severe at times that I cannot walk or get up and down from a chair.
Information has been received from a medical assistant concerning an infant who was vaccinated PO with an incomplete dose of ROTATEQ because the patient vomited during or after administration of the vaccine.  It was unknown whether medical attention was sought.  The outcome was unknown.  There was no product quality complaint.  No further information is available.  This is one of several reports from the same source.
Approx. 3 weeks after older brother broke out with chickenpox (exposure at school), 2 younger brothers now have red rash, fluid filled vesicles not popping; no fever; no itching.
The next morning  I woke up with intense muscle aches, which lasted for 24 hours.  It felt like Flu symptoms. Mild headache. The next day I was fine, but I have had some swelling in my Lymph glands, which still persists off and on. My first shot only gave me a sore arm.
This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 16-JUL-2015, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # J013370, expiration date 03-FEB-2016 and lot number J0110613, expiration date 11-JUN-2015. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
On 9/13/2021 the patient had been sitting in a chair by the pharmacy after his Janssen COVID vaccine for almost 15 minutes and then got up to stand at the counter to ask the tech if he could leave yet. The tech told him he just had a little bit of time left to wait (maybe 3 more minutes?) when the patient fainted and fell to the floor. Another customer thought he hit his head on the way down.  I was alerted by the tech & went to the patient who was lying on the floor unconscious but was breathing and had a strong carotid pulse. I told the tech to call an ambulance. After maybe a minute the patient started to make bending movements upwards with his legs and stretched one arm out  and up. Then he started to lift his head a little and wake up. I told him to stay down on the floor and rest since he had fainted and may have hit his head. He said he was nauseous after another couple minutes. I gave him a wastebasket and he sat on the floor and threw up. After a few minutes the EMS crew came in and took over. They took him to the hospital.
numbness down left leg.; severe pain; tingling; This is a spontaneous report from a contactable consumer (patient).   A 42-year-old male patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0172) via unknown route of administration administered in left arm on 27Aug2021 03:30 PM (at age of 42 years) at single dose for COVID-19 immunisation. Medical history included herniating and protruding discs in 2018 (I have never had this much pain from the disc issues). Concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0175) via unknown route of administration administered in left arm on 06Aug2021 02:00 PM (at age of 42 years) at single dose for COVID-19 immunization and had Back pain. Patient experienced the morning after the second dose woke up in severe pain with tingling and numbness down left leg on 28Aug2021. Events resulted Doctor or other healthcare professional office/clinic visit. Treatment was receievd with meds, steroid shot, physical therapy, awaiting mri. Outcome of the events was not recovered  Follow-up attempts are completed. No further information is expected.
Pt describes reaction as very hot and itchy and site about 8 cm erythema with induration upon exam.
20 min. after injection of varicella, L arm has 2" raised red area. Child very fussy. No other hives, no resp. distress. Administered 0.2ml (10mg) Benadryl, IM. Observed for another 45 min.
COVID break through case. I received my 2nd booster shot on 04/01/2022 and my adverse event started on 05/05/2022. From 05/06/2022-05/08/2022 I had a sore throat, cough headache, congestion, and runny nose. On the night of 05/06/2022 I tested negative for COVID. On the 05/09/2022 I went to the pharmacy and did a PCR test the result was positive. I went to the urgent care for an insect bite they gave me antibiotics. On the 05/09/2022 I went to the clinic because I wasn't feeling well and I had a PCR test done at the pharmacy for COVID. I didn't call my doctor or see my doctor but I took Advil for sore throat and headache and I also took Claritin D. It helped with runny nose. I started feeling better by Friday 05/13/2022 I had less of all of my symptoms.
9/10/21 SEEN IN THE ER   HYPOTENSIVE, COUGH, SOB AND VOMITING. PATIENT  ADMISSION TO HOSPITAL.  9/12/21 LEAVES  9/14/21 RETURNS TO ER AT . ADMITTED TO HOSPITAL WITH  FOOT INFECTION. REPORTS BREATHING HAS IMPROVED . PATIENT DISCHARGED ON 9/22/21 TO HOME
Feels arm full/arm hurts; Diarrhea; Upset stomach; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Feels arm full/arm hurts), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M2UA) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history 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 (Feels arm full/arm hurts), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Feels arm full/arm hurts), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment details included Pain medications.
Patient had a fever on Saturday 1-30-2021, from about Noon until about 8 pm. Highest fever was 101.7. I treated it with Ibuprophen, and that successfully reduced the fever.  The fever had an adverse affect on her Alzheimer's. the condition was temporary, and by Sunday morning, 1-31-2021, she was back to normal.
Information has been received from a nurse concerning a female patient who in "August 2008" was vaccinated with the second 0.5 ml dose of GARDASIL.  In "October 2008" the patient experienced bad muscle twitching.  No lot number was provided.  It was reported that therapy with GARDASIL was discontinued in "beginning of February 2009".  The patient recovered from muscle twitching on an unspecified date.  The patient sought unspecified medical attention.  Additional information has been requested.
Swelling, red, and warm to the touch around injection site, estimated 4.5 inches long by 2 inches wide.  Lasted 2 days.
Pt and spouse state she had been recovering well after Cancer of lung and stomach and returned to work. 4-5 days after getting Flu shot 11/09/2004 she developed progressive weakness which was later DX as ALS. Death from ALS 11/05.  No additional terms added from Discharge Summary rec'd 11/28/2005/sr  Serum Sickness added from Med. Record rec'd 12/07/2005