chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her approximately 12 month old granddaughter with nuts and seeds allergy and no pertinent medical history who in approximately 2007 (about a year old), was vaccinated with "1/8 of a cc" of MMR II (route and lot# not reported). There was no concomitant medication. Subsequently the patient's "arm blew up". The patient received the full dose of MMR II (route and lot# not reported) when she was 17 or 18 months old. The patient went from a lively young child who was starting to talk to not talking at all. The patient was silent. The patient saw a physician. After received early intervention and the patient was now doing great and talking a lot. Upon internal review, aphonia was considered to be an other important event. This is an amended report. Upon review of the file, the AE code of taciturnity was changed to aphonia. Additional information is not expected.
Post vaccination reports feeling nauseous w/associated syncopal episode lasting approximately 1 min; recovers w/full orientation status; medical monitoring x 30 min. w/vital assessment: BP 110/74 P 86 RR 19, rest w/ po hydration and snack.  All symptoms resolve w/ no complaints. Released from facility w/husband.
Pt developed symptoms around est 7/22 and pt recievedbooster a month prior. Pt states his skin was yellowing.
Pt devel sz infantile spasm; abn EEG & thin corpus collosum; pt has developmental delay & poor weight gain;
Chills started within five minutes then within an hour fever of 104.  Patient taken by ambulance to  Hospital and patient diagnosed with sepsis and cellulitis and shortness of breath
30 minutes after vaccine developed itching and hives on chest, back, stomach, arms. An hour after hives developed chest tightness, slight cough, slight wheezing/no shortness of breath and heaviness/numbness/tingling down left arm; however, no pain at injection site of left arm.  Took 25mg of Benadryl about one hour after onset of first symptoms.  Hives and itching resolved 2-3 hours after starting; chest tightness/arm discomfort continued randomly but had improved from initial onset until about 1800. All symptoms had resolved by 1800 and no further complications noted.
This is a spontaneous report from a contactable consumer or other non hcp. A 75-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot #: EL9262), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing Verbatim: Asthma, hypertension from an unknown date and unknown if ongoing Verbatim: High blood pressure, blood cholesterol increased from an unknown date and unknown if ongoing Verbatim: High cholesterol, drug hypersensitivity from an unknown date and unknown if ongoing, headache from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took halothane and experienced drug hypersensitivity, nitrous oxide and experienced drug hypersensitivity. The patient experienced constant headache on 28Jan2021. The patient underwent lab tests and procedures which included investigation: normal. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was not recovered.
Mother stated patient developed hives along her collarbone. Mother stated "it was a line of hives along her collarbone and then one bigger hive." Mother stated child did not seemed bothered by the hives. Mother did give a dose of BENADRYL (dosage was given by her pediatrician). Mother stated in the morning the hives were gone.
MEDI0004267 is a Not Serious Spontaneous case from a physical therapist in the USA involving joint stiffness. The reporter causality is not provided to FluMist. On 12/8/2005, she began to complain bilateral muscle pain and joint stiffness. The pain began behind the kneecaps when going from sitting to standing. He took naproxen which relieved the pain. However, the pain returned whenever naproxen was not taken. The pt saw his primary care physician sometime at the end of 12/05, and was given naproxen. After a day of starting Naproxen, on 1/6/06, he developed soreness of the muscle, bilateral muscle pain and joint stiffness. Oxiproxin was discontinued. This event is ongoing.
Woke up the day after with headache, nausea, diarrhea, sore throat Tested negative for COVID on 3/19 and 3/20 Developed raised lesions all over body on 3/17 Differential: Phlebitis vs reactive lymph nodes vs angiolipomas vs lipomas vs other
Pt reported muscle pain in (L) arm that developed after vaccine administration 3/1/16. Pain has persisted per report at last visit 6/21/16.
Mom reports infant has been crying since Tuesday evening (06/06/06) after having received shots on Tuesday morning (6/6/06). Mom reports fever of 102 degrees at 7 PM Tuesday evening and treated fever with infant Tylenol every 5 hours for past 2 days and continues to cry now.
This spontaneous report as received from a pharmacist refers to a 71 years old female patient with no drug allergy or pertinent medical history. The patient was vaccinated Subcutaneously with a dose of ZOSTAVAX (lot # reported as H011333, Exp Date 08-SEP-2013) on 06-OCT-2012. There was no concomitant medication. On an unknown date after she was vaccinated a dose of ZOSTAVAX, the patient developed redness around the injection site which included a red lump. The pharmacist reported that the patient did call and then stopped by the pharmacy. There was no lab diagnostics performed. No treatment was given. The outcome of redness around the injection site which included a red lump was reported as not recovered/not resolved. Additional information has been requested.
Complaints of right arm pain, numbness and tingling after flu shot. Rx of Percocet and Ibuprofen and told to rest. Missed several days of work due to could not lift arm. Referred to neurologist. Dx of ? fascitis. Ordered PT with iontophoresis, Relafen, Protonix, Neurontin. Also scheduled EMG study. Patient now on Celexa. Thinks shot was given too high.
hives and redness and itching at the site on the left arm/ about 24 hours later.
I got flu shot yesterday at 1000. I was fine all day until when at the end of the day at around 5:00 pm, I noticed my eyes were itching, teary, and swollen, my hands & feet were swollen and itchy, the injection site was sore, and my throat was also itchy. I took Benadryl right away & fell asleep. When I woke up, my eyes are still swollen & itchy and my hands are swollen. My feet are fine. I was sent by charge nurse to Employee Health.
Palpitations; Chest discomfort - some tightness; Extremely high pulse rate; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), CHEST DISCOMFORT (Chest discomfort - some tightness) and HEART RATE INCREASED (Extremely high pulse rate) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3832B) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypothyroidism and Cholesterolosis NOS (Takes statin for cholesterol.).    On 29-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 02-Oct-2023, the patient experienced PALPITATIONS (Palpitations), CHEST DISCOMFORT (Chest discomfort - some tightness) and HEART RATE INCREASED (Extremely high pulse rate). On 02-Oct-2023, PALPITATIONS (Palpitations), CHEST DISCOMFORT (Chest discomfort - some tightness) and HEART RATE INCREASED (Extremely high pulse rate) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2023, Heart rate: 150s, extremely high.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient takes statin for Cholesterol. Patient called her cardiologist who said that the event could have been due to dehydration or due to the vaccine. She took fluids and it was resolved. She was told to consult again if this recurs. Patient feels overwhelmed but not lethargic and very worried. Her vaccination details are as follows: First dose on18Jan2021 with lot number 012L20A, Second dose on 15Feb2021 with lot number 006M20A, third dose on 11Sep2021 with lot number 050E21A, Fourth dose on 08Apr2022 with unreadable lot number, Fifth dose on 29Apr2023 with lot number AS7144B.   Reporter did not allow further contact
Swelling at vaccination site spreading to full upper arm from shoulder to elbow. Slight hacking cough, rapid heartbeat, miscellaneous pangs around body, earaches, edginess, swollen feet and face. Started about 4/06/21 and beginning to subside around 04/11/21
Extreme pain when moving, unable to sleep due to pain. Lymph node so swollen it feels like a golf ball, and it?s very hard to use my left arm. Fever and sweats and shaking as well. I haven?t cried from pain in years but it is that bad currently.
fatigue; headaches; 5 episodes of micro fainting spells; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534), via an unspecified route of administration on 18Mar2021 at 16:00 at a single dose in the left arm for COVID-19 immunization. Medical history included blood pressure, cholesterol, GI, and anxiety (as reported, for clarification). Patient also experienced some positional and vasovagal fainting spells from Jan2020 to an unknown date (also reported as every 6-8 weeks and had tapered off then on 06Mar2021, had 7 episodes and many near misses, pending clarification). Concomitant medications included metoprolol; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); polycarbophil calcium (FIBER); escitalopram oxalate (LEXAPRO); simvastatin (ZOCOR) and unspecified supplements. The patient previously took the first dose of BNT162B2 (lot number: EN6202) in the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. It was reported that patient had 5 episodes of micro fainting spells since 02Apr2021. On an unspecified date, the patient experienced fatigue and headaches. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of 5 episodes of micro fainting spells was not recovered; while the other events was unknown.
Pt presented to clinic with an insect sting and thinks she is allergic to stings and was given TD. Pt returned to clinic, 3 days later, with swelling, induration and itching at site of injection.
WITHIN THE SAME DAY STARTED WITH RIGHT ARM SWELLING, REDNESS, WARMTH, AND ITCHING AT INJECTION SITE. TAKING IBUPROFEN AND ICED AREA. GOT BETTER AFTER A FEW DAYS AND STARTED BACK UP AGAIN, WORSE THAN BEFORE.
No adverse effects reported; Incorrect product storage; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot #R032766, expiration date on for prophylaxis (strength, dose and frequency were not reported). The temperature of storage and time frame of the excursion were above 47°F (92.3° F) for 13 hours 11 minutes and above 47°F (73°F) for 9 hours. There was a digital data logger involved, but there was no previous temperature excursion.   No adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA007468: US-009507513-1907USA007439: US-009507513-1907USA005368: US-009507513-1907USA005362: US-009507513-1907USA010550: US-009507513-1907USA010551: US-009507513-1907USA010552: US-009507513-1907USA010553: US-009507513-1907USA010554: US-009507513-1907USA010556: US-009507513-1907USA010557: US-009507513-1907USA010558:
8/13/10 mom calls Health Dept. & says child had fever of 101.9 orally. Giving ibuprofen every 4 hrs. w/some relief & then goes back up after 3-4 hours. Woke up today w/rash under his armpits extending down to his upper thighs. Denies itching. Loss of appetite. Mom calls physician after talking w/PHN. Has Dr. appt today & was told it is probably strep throat. 8/16/10 PC to mom - rash is gone. Still has fever & now has cough, saw Dr. 8/13/10 & no meds prescribed. Told is probably viral infection.
Telephone call from client that since receiving vaccine she has been having pain in left arm, difficulties with bathing and getting stressed now. She feels a lump in her armpit area. She states she has increased pain when moving her arm and states she has a difficult day at work because of the pain in her L arm. Denies swelling, numbness or tingling of fingers. Instructed and encouraged exercising left arm and to go to PMD, Emergency care immediately.
This spontaneous report was received from a licensed practitioner nurse referring to a 10 month-old child of unknown gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reaction described. The reporter stated that on 29-JUL-2015, the patient was administered an improperly stored dose of LIQUID PEDVAXHIB injection (lot # K026533., with expiration date: 07-AUG-2017; dose, frequency and route were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
I felt pains around my liver, with night sweats, chills, and headache. I had muscle aches all through my body. This lasted 2 days.
stomach ache; Day two past out; bodyaches; vomited; Headache; nauseous; fever; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Ew0151), via an unspecified route of administration, administered in left arm on 05Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Mar2021 for COVID-19 immunization. The patient had no other vaccine in four weeks. It was reported that on day two (06Apr2021), the patient past out and vomited. The patient also experienced headache, nauseous, fever, bodyaches on 06Apr2021; and stomach ache on 10Apr2021. No treatment was received for the events. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The outcome of the events was not recovered.
Severe pain in the arms at injection site. Severe abdominal pain and diarrhea for over 3 weeks after I received vaccination. Headaches, weepiness, and despair.
A flare up of herpes simplex virus in the form of a cold sore on the middle/right side of my lip with a swollen lymph node on the right side as well. No fever, but felt tired and a little fluish for three days after the vaccine.  Treating with Abreva. Not the first time I've had a cold sore, but its the first one I've had in about three years so the timing this soon after the booster (third) shot is suspicious. My other two shots were also Moderna.
I woke up feeling like someone punched me hard in the arm, my entire arm hurt from the shoulder to my elbow and was even worse to the touch.  The next day I started running a fever and slept most of the day.  By day 2 I had a headache only.
First night severe chills, stomach ache, tiredness. 4 days later tiredness and kidneys ached continued left to right kidneys through 3/16/2021.
noticed minor itching and reddness at injection site. Lasted for several days waxing & waning. Can still see a little reddness. Applied Benedryl gel several times
Awoke at 2:30am with sever itching of the arms and legs. Red,bumpy,itchy rash and hives covered my body from head to toe. I tookBenadryl 25mg and when I go up at 6am the itching, rash and hives were gone.
Patient reported having a sore arm where injection was given - it has been over a month & it is still sore.
rash on the top of both hands; This is a spontaneous report from a contactable consumer (Pfizer colleague), reported for a female patient. An adult (47-49 years old range) female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 14Feb2021 at 07:00 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that two days after receiving the first vaccination (Feb2021), the patient indicated they had a rash on the top of both hands. The patient did not receive any treatment. The clinical outcome for the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained
12/29/2020 08:30PM Chills, body aches, headache, fatigue, sleepless, injection site pain. AM 102.4 Fever, body aches,  headache,  fatigue,  nausea.
"Moderna COVID-19 Vaccine EUA"  Injection day Saturday March 13th no problems at all, everything was good all day.  I woke up on Sunday morning 8am March 14th with a pretty moderate headache. I didn't feel good all day and took several naps unable to lose my headache. About 3pm March 14th I had a slight pain in my left eye and developed "floaters", a lot of them. I decided to take a nap and woke up 1 hour later with less floaters but I had like marble streaks in my left eye vision and about 10 minutes of flashing lights in my left corner eye, not severe though.  My eye looks normal looking in the mirror, nothing looks unusual.  Tonight the same day March 14th, 11pm before bedtime less floaters, I can only see one. The marble streak in my vision appears to be a black streak now when I look down at a white counter top.  I can make it move from left to right when looking at the counter top but I do not have any pain.  I am not sure what to do but I just wanted to let someone know that I encountered a side effect from the vaccine or it could be a coincidence, I have never had this problem before though.
vaccine was accidentally given to a 14 year old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine was accidentally given to a 14 year old) in a 14-year-old patient of an unknown gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine was accidentally given to a 14 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine was accidentally given to a 14 year old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On 1/31/21 it started with a very sharp pain in her lower back, and not feeling good.  Worse than her usual back pain.  A couple of days later she started breaking out in red spots on her back in the same area where the pain was.  She went to the doctor and was told that she has shingles.  She has had all of the shingles vaccines.  Given medicine for the shingles, Valtrex and the shingles have now dried up.   Everything is on the left side of her body where she had the vaccine.  She is now recovered from the vaccine and the shingles as of today 2/10/21.
After receiving the Janssen vaccine, patient's arm bled excessively and started to form a welt. The bleeding was contained with a band-aid. The patient did not want an ice pack. Over time, the welt went down.
Continuous vaginal bleeding outside of normal menstrual cycle, large clots & heavy vaginal discharge related to the bleeding.
Redness around injection site about 5 in diameter, warm to touch, no other symptoms. Redness and warm to touch still on the day of this report
After the shot my throat felt funny. Ache but not to bad, as the day went on it started to hurt more when I swallowed.  The next day my throat was completely swollen and I lost my breathe while sleeping.
I administered the flu shot to the patient in our clinical services room roughly at 3:55PM, the patient stepped outside the room and collapsed roughly at 3:58PM in front of his mother.
This case was hospitalized 4/6 due to bowel issues.  Exposed and developed symptoms in hospital.  Eventual transfer to hospice d/t decline in part d/t pneumonia symptoms.   COVID Positive PCR - 5/3/2021
No additional AEs were reported; Medical assistant reported that a patient received an expired PNEUMOVAX 23.   No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-OCT-2023, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, lot #w007035, expiration date: 20-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
This case was reported by a nurse and described a 32 year old male patient who did not respond to the Hepatitis B vaccine recombinant (Engerix-B) immunization series.  On an unspecified date in 2002 or 2003, the patient received the third dose of Engerix-B.  Approximately 6 to 12 weeks later, a hepatitis B surface antibody titer was negative.  The nurse stated that, "All injections were given intramuscularly in the deltoid muscle with a 1 inch needle.  All vaccine is refrigerated and the temperature is monitored daily.  The nurse considered the event to be probably related to vaccination with Engerix-B.
This spontaneous report as received from a medical assistant refers to 12 patients of unknown age. From 08-JUN-2017 to 24-JUL-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 for prophylaxis, as follow: lot M036059, expiration date on 03-JUN-2019: 2 doses on 08-JUN-2017, 1 dose on 12-JUN-2017, 2 doses on 16-JUN-2017, and 1 dose on 06-JUL-2017; lot N002720, expiration date on 12-MAY-2019: 1 dose on 06-JUL-2017, 2 doses on 11-JUL-2017, 1 dose on 21-JUL-2017, and 1 dose on 24-JUL-2017; lot reported as M047660, expiration date on 02-DEC-2018: 1 dose on 12-JUL-2017. No adverse effect reported. This is one of two reports received from the same reporter. Lot number M047660 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Sender's Comments: US-009507513-1708USA005381.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-FEB-2018, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # M044220, Expiry date: 31-JAN-2018) for prophylaxis (expired product administered). The reporting pharmacist stated that the ZOSTAVAX did not have any temperature excursions prior to administration. No adverse symptoms reported. No product quality compliant was involved.
Tired, no energy, cuticles of my fingers were turning brown.  Dr. treated me for a sinus infection with an antibiotic!!!!