chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received 1st dose of Moderna vaccine instead of Pfizer 2nd dose of vaccine; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MEDICATION ERROR (Received 1st dose of Moderna vaccine instead of Pfizer 2nd dose of vaccine) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE on 18-Mar-2021.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced MEDICATION ERROR (Received 1st dose of Moderna vaccine instead of Pfizer 2nd dose of vaccine). On 07-Apr-2021, MEDICATION ERROR (Received 1st dose of Moderna vaccine instead of Pfizer 2nd dose of vaccine) had resolved. Not Provided      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.; Sender's Comments: This report refers to a case of Wrong product administration for mRNA-1273, lot # 032B21A with no associated AEs.
Acute onset large clot and profuse first time nose bleed (posterior potentially from sinuses which hurt), petechiae
felt very weak; felt dizzy; nauseous; Laid down and couldnt even move head as room was spinning.; vomited; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 09:45 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no allergies to medications, food or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN). 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 27Mar2021 at 12:30, after 2 hours of vaccination, the patient felt dizzy and nauseous. The patient did lie down and couldn't even move her head as room was spinning. The patient tried to get up but made her more nauseous and vomited. The patient stayed in bed all day and at and the next day on 28Mar2021, the patient still had little nausea and felt very weak. By evening the patient was able to eat. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events dizziness and nausea which included treatment with DRAMAMINE. No therapeutic measures were taken as a result of the events head spinning, vomited and felt very weak. The clinical outcomes of the events dizzy, nauseous, laid down and couldn't even move the head as room was spinning, vomited and felt very weak was recovered on an unknown date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On 10/22/2201 he began to have body aches, coughing, diarrhea, and he felt very tired. As it developed, he got a sore throat, so he couldn't swallow and then he got chills. He never had a fever with it. We took him to urgent care for testing. 3 kids from his school are also home sick as well. I was told to give him acetaminophen. I also gave him Mucinex that has acetaminophen in it as well. He still has a cough and sore throat. He had chills last night, but they are gone today. He is getting better. We still don't have a diagnosis for it.
Intense sharp shoulder pain around joints of left should and constant pain in deltoid muscle.i cannot lift left arm15 degrees above shoulder without pain. I feel great pain lifting left arm 30 degrees above shoulder. Unable to lift arm more than 45 degrees above shoulder. Any movement of left arm up, down, forward, back caused great pain. Cannot rest elbow on chair arm without great pain. Cannot lie on left shoulder in bed without great pain. Cannot hold objects in left hand without hand shaking perfumery. Symptoms worsening. Visit to Healthcare facility and scheduled visit to orthopedic.
This spontaneous report as received from a medical assistant refers to a 15-year-old patient of unknown gender. No information about the patient's medical history and concomitant conditions were reported. On 06-JAN-2016, the patient was vaccinated with an improperly stored, the third dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, injected in the left arm (dose and route of administration were not reported). Concomitant therapy included influenza virus vaccine (unspecified). Administered doses were exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
Within a few weeks of getting her two month shots, my daughter basically went silent. She stopped cooing and talking, she seemed very withdrawn. She stopped rolling. She was doing very advanced things for her age and just stopped. She then developed a bright red, dry and scaly rash that started on her elbows and was spreading with each day over most of her body.
We cked out of Dr. office at 201 pm took elevator down 2 floors she was laughing/joking and just as about to walk through - to have blood drawn (came back normal) said felt dizzy - Lab tech she doesnt like shots - said dizzy she drew blood by 205 she shut her eyes after blank cold stare, and yawned several times - cold clammy - so still like frozen - her BP was 121/63 in appt when left office was - 88 about. BP was 121/63 when cked in Dr. office - shot was given - Patient asked- if suppose to hurt ? - was laughing and planning lunch and afternoon plans and just like that she stopped and said "I feel dizzy - really dizzy" - lab teach OR your fine - I explained something is wrong she is not afraid of shots - (grew up in hospitals) he proceed and as taking off rubber strip about 204 pm patient was like frozen and staring out at nothing - just as fast she shut her eyes and the lab tech put her head back she kept yawning - and then just stopped - perfectly still - cold and clammy you couldn't even tell if she was breathing - I told please call code help me move her she was like frozen in the chair  couldn't move her - she came too about 235-240 pm - said felt dizzy still and like she was out off her body - taken back up
Itchiness, started around 1300 8/6/2020.  Hives appeared on arms around 1400 Still itchy took Benadryl and a shower. went to ER. Hives were on arms, torso, got med to help. next day hives got worse spread to legs, arms, thighs, chest. went to ER due to  chest tightness. given Benadryl IM, steroids
APPROXIMATELY 26 MINUTES AFTER ADMINISTRATION OF VACCINE, PATIENT BEGAN EXPERIENCING THROAT SWELLING, FACIAL AND MOUTH/TONGUE NUMBNESS.  POD OBSERVATION STAFF WAS NOTIFIED AND 50 MG (1 ML) OF DIPHENHYDRAMINE WAS ADMINISTERED IM BY APN STILL PER PATIENT REQUEST OF NOT WANTING THE FULL 2 ML AT ONCE. 5 MINUTES LATER APN STILL ADMINISTERED 2ND DOSE (50 MG/1ML) OF DIPHENDYDRAMINE.  AFTER 2ND DOSE, PATIENT REPORTED ALL SYMPTOMS RESOLVED.  PT WAS CLOSELY MONITORED FOR ADDITIONAL 30 MIN PRIOR TO EXITING THE POD SITE VIA PERSONAL VEHICLE (AS PASSENGER).
Within one day patient has extreme muscle weakness and pain both legs and back and lasted > 1 week. CK up. ESR up.
24 hours post (4/11)  n/v, chills, fatigue;   4/14 numbness/tingling  R arm (opposite);    chest tightness.  local site small swollen, red area;
devel diabetes; p/MMR vax devel myalgias, arthralgias, approx 6 wks later had diabetic sx & blood glucose of 440; cont to have diabetes; No prev hx; No family hx;
The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 29Feb2016, this case now contains all required information to be considered valid. This is a spontaneous report from Pfizer-sponsored program Pfizer.com General Company information. A contactable consumer reported for herself. She was a 76-year-old female consumer and received PREVNAR 13, via an unspecified route of administration on 25Sep2015 at single dose. Medical history included hypertension from 1982 and ongoing, hypothyroidism from 1965 and ongoing, drug hypersensitivity, to sulfa from 1947 and ongoing. Concomitant medication included levothyroxine ongoing ar 1.12 mcg one per day for thyroid since she was in her 20s, EDARBI ongoing at 80 mg once a day for high blood pressure from about 2.5 years ago, nifedipine ongoing at 30mg twice a day for high blood pressure from about 4 years ago, TEKTURNA ongoing at 300 mg once a day, for high blood pressure from about 10 years ago and metoprolol ongoing at 50mg tablet; 1/2 tab per day for keeping heart from fluttering from about 5 years ago. The patient experienced on 26Sep2015 right arm so sore could not lift until next day and trouble breathing, on 27Sep2015 felt like was going to pass out and no energy this lasted for about 3 months after shot. She had real bad muscle pain all over body and felt like a rag doll, completely worn out and experienced itching. The patient recovered from pain in arm on 27Sep2015, recovered from the event muscle pain on unknown date in Feb2016. The outcome of the event worn out was recovering. The patient received BENADRYL and trouble breathing resolved. Follow-up (21Mar2016): additional information received from a contactable consumer includes date of vaccination. Events asthenia and itching added. Following (20May2016): Follow-up attempts completed. No further information expected.
This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 72-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included arthritis and shingles. On 25th August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, wrist pain, shoulder pain, chills, tiredness, weakness, nausea and joint inflammation. On an unknown date, the outcome of the influenza-like symptoms, wrist pain, chills, tiredness, weakness, nausea and joint inflammation were unknown and the outcome of the shoulder pain was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, wrist pain, shoulder pain, chills, tiredness, weakness, nausea and joint inflammation to be related to SHINGRIX. Additional details were reported as follows: The caller reported that she experienced flu like symptoms that have persisted. She had been seen by her doctor twice by the reporting date to try and determine what was causing the symptom and she had blood work done. Her WBC was at 11,000 and that neutrophils were elevated as well. The caller also reported that her left wrist joint had been painful and feeling like it was inflamed. The caller reported she had history of arthritis and thought it might be related to that or could be from the vaccine shot since it was on the left side as well. The caller preferred any communication regarding this report go through her since she was a medical professional. The healthcare professional further defined flu like symptoms as chills, felt tired and week, and experienced nausea. She also stated she had shoulder pain but that it resolved. She was not sure if the shoulder pain occurred before or after receiving SHINGRIX.
Pt. was checking out after vaccine given and became faint. Skin dry, no pallor noted. BP 100/52. After remianing in office for an additional 15 minutes, felt fine and left office, Will return in 4 months for last injection.
Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot # 009482, expiration date 06-MAR-2017, dose and route were unknown) which were exposed to 33F for 0.5 hours. No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Breakthrough case admission after two doses Moderna 5/4/21 Lot# 016C21A Moderna 6/1/21 Lot# 002C21A
No additional AE reported; PROQUAD was administered after a temperature excursion; This spontaneous report was received from a healthcare business professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot # W017570, expiration date: 29-NOV-2023, administered for prophylaxis (strength, dose and route of administration were not provided) (product storage error).  On 24-AUG-2022, administered dose of vaccine experienced the temperature excursion of 5.7 degrees Fahrenheit for 30 minutes; it was also reported that on 18-JUL-2022, there was previous temperature excursion of 6 degrees Fahrenheit for 1 hour and 8 minutes.  No additional adverse event was reported.
tenderness in lymph nodes under the arm of the arm that received the shot; This is a spontaneous report from a contactable consumer reported for herself. A 60-year-old female patient received second dose of bnt162b2 (Lot Number: ER8732) via an unspecified route of administration in left arm on 29Mar2021 13:15 as single dose for covid-19 immunisation. Medical history included asthma, NAFLD (Fatty liver), high blood pressure, high cholesterol. Patient was not diagnosed with COVID-19 prior to vaccination. Patient not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, with unspecified medications the patient received within 2 weeks of vaccination. Patient received first dose of bnt162b2 (lot number: EN6205) on an unspecified date in Mar2020 10:15 PM in left arm. On 30Mar2021 09:00 AM, patient experienced tenderness in lymph nodes under the arm of the arm that received the shot. The event outcome was recovering. No treatment received. Patient had not been tested for COVID-19 since the vaccination.  No follow-up attempts are needed. No further information is expected.
fever; Injection site has a ring; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On 12th May 2020, the patient received Bexsero. In May 2020, less than a week after receiving Bexsero, the patient experienced fever and injection site reaction. On an unknown date, the outcome of the fever and injection site reaction were unknown.   It was unknown if the reporter considered the fever and injection site reaction to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The patient received vaccine and developed fever and the injection site had a ring around it. No other information was reported.
patient reports noticing a lump below right clavicle.  It is not tender but is slightly warm to touch.  It has not changed since patient noticed.
The first shot, I just had sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8736, Expiration date: Jul2021) intramuscularly on the right arm (shoulder) on 23May2021 (at the age of 58-year-old) as single for COVID-19 immunization. Medical history of the patient included rheumatoid arthritis (2010- not clarified), and asthma, it might have been, patient haven't had wheezing and it might have been about 2 weeks ago. Concomitant medication included Diclofenac Sodium Topical Gel, 4 times a day (1%, Atopic cream) taken for rheumatoid arthritis, Prednisone 5 mg once a day taken for rheumatoid arthritis, Hydrocodone 10 mg taken for rheumatoid arthritis, Albuterol (Salbutamol) taken for asthma. Patient did not receive any prior vaccinations within 4 weeks. On an unspecified date, the patient had sore arm after the first dose. Patient did not receive any treatment for the event. The outcome of the event was unknown.
Patient reports redness and swelling at site of injection 3 days post vaccinations. She also reports itching and low grade fever 99.6. However, she admits that fever has been present prior to vaccination.
severe reaction; was in bed for 3-4 days.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe reaction) and BEDRIDDEN (was in bed for 3-4 days.) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (severe reaction) and BEDRIDDEN (was in bed for 3-4 days.). At the time of the report, VACCINATION COMPLICATION (severe reaction) outcome was unknown and BEDRIDDEN (was in bed for 3-4 days.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient has concomitant medications but the reporter did not have the list. No treatment medications were reported.   This case was linked to MOD-2021-409907, MOD-2021-409908 (Patient Link).
Started with flu shot in 2014, happened each flu shot thereafter. Pain in shoulder for 5 mo in 2014, could not raise shoulder, 2015 pain for 3 months, 2016, could not sleep on arm for 1 yr.
Cellulitis-left arm swelling c/o pain since shots 8/24. Area of redness/warmth since 8/25. Hives to chest and back 8/25 pm. Vomited x 1 on 8/25. Diarrhea x1 on 8/26.
Hx: Anxiety Allergy: Amoxicillin; Flushing/sweating, BP 104/61; HR 65; RR 18.  Pt c/o "I feel like I'm going to faint".  Pt denies eating x24hrs.  Pt D/C w/ , mother and no c/o @D/C, BP 112/61, HR68, RR16.  Patient stable and released from vaccination site
LITTLE SWOLLEN LEFT KNEE; CALF HURTING ON AND OFF; TINGLING IN BOTH FEET; WEAK PAINFUL LEGS; PAIN WORST IN THE LEFT LEG, LITTLE PAIN IN THE RIGHT LEG WHICH COMES BACK AND FORTH IN THE LAST COUPLE OF WEEKS BUT NOT AS THE LEFT LEG; PAIN MOVING UP FROM THE HIP TO CLOSE TO THE LEFT SIDE OF THE LOWER MIDDLE OF THE BACK, MOST PAIN WAS IN THE LEFT SIDE OF THE BACK; HEART RACING; PAIN IN RIGHT HIP WHICH WENT AWAY (DID NOT HURT ANYMORE) AND SWITCHED TO LEFT HIP AND WENT DOWN TO BOTH LEGS; LIGHT-HEADED; LOWER SPINE STARTED TO HURT WHICH WAS INITIATED BY THE SCIATIC NERVE AREA ON THE RIGHT HIP; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the patient experienced lower spine started to hurt which was initiated by the sciatic nerve area on the right hip. On 14-MAY-2021, the patient experienced light-headed. On 05-JUN-2021, the patient experienced pain in right hip which went away (did not hurt anymore) and switched to left hip and went down to both legs. On 13-JUL-2021, the patient experienced heart racing. On 30-JUL-2021, the patient experienced pain moving up from the hip to close to the left side of the lower middle of the back, most pain was in the left side of the back. On 13-AUG-2021, the patient experienced pain worst in the left leg, little pain in the right leg which comes back and forth in the last couple of weeks but not as the left leg. On an unspecified date, the patient experienced little swollen left knee, calf hurting on and off, tingling in both feet, and weak painful legs. Laboratory data (dates unspecified) included: X-ray (NR: not provided) Spine looked fine. Treatment medications (dates unspecified) included: cyclobenzaprine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from lower spine started to hurt which was initiated by the sciatic nerve area on the right hip on 05-JUN-2021, had not recovered from pain in right hip which went away (did not hurt anymore) and switched to left hip and went down to both legs, pain moving up from the hip to close to the left side of the lower middle of the back, most pain was in the left side of the back, heart racing, and pain worst in the left leg, little pain in the right leg which comes back and forth in the last couple of weeks but not as the left leg, and the outcome of little swollen left knee, calf hurting on and off, light-headed, tingling in both feet and weak painful legs was not reported. This report was non-serious.
Site of the shot is very warm; Although the arm dose not look like the typical Covid arm; Looks little pinkish and itchy; Looks little pinkish and itchy; Also its now moving further down the right arm; Cold sweats; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Also its now moving further down the right arm), COLD SWEAT (Cold sweats), VACCINATION SITE WARMTH (Site of the shot is very warm), VACCINATION SITE REACTION (Although the arm dose not look like the typical Covid arm) and VACCINATION SITE PRURITUS (Looks little pinkish and itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced COLD SWEAT (Cold sweats). On 03-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Site of the shot is very warm), VACCINATION SITE REACTION (Although the arm dose not look like the typical Covid arm), VACCINATION SITE PRURITUS (Looks little pinkish and itchy) and VACCINATION SITE ERYTHEMA (Looks little pinkish and itchy). In April 2021, the patient experienced CONDITION AGGRAVATED (Also its now moving further down the right arm). On 01-Apr-2021, COLD SWEAT (Cold sweats) had resolved. At the time of the report, CONDITION AGGRAVATED (Also its now moving further down the right arm), VACCINATION SITE WARMTH (Site of the shot is very warm), VACCINATION SITE REACTION (Although the arm dose not look like the typical Covid arm), VACCINATION SITE PRURITUS (Looks little pinkish and itchy) and VACCINATION SITE ERYTHEMA (Looks little pinkish and itchy) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-068878 (Patient Link).
The expected side effects on the day after the second shot of headache, muscle aches, chills, fever.  On May 5, 2021, patient suffered a stroke.  Could not control right arm, could not speak.  Called 911, taken to ER, and checked into hospital.