chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The original due date was April 13, 2023.  My baby was born 3 pounds nine ounces and 15 inches.  She remains in NICU.   My pregnancy went fine but I did have COVID-19 in November 2022, and one took Paxlovid.  The anatomy ultrasound on my baby after COVID-19 showed she had an enlarged kidney but three weeks later it was normal.  I had a history of mild hypertension before pregnancy, but I lost weight and never needed medicine.  But during my last trimester my blood pressure increased to 130/90s.  February 20, 2023, the night of my booster shot, I sat down on a very low stool that broke and I fell on the ground on my bottom.  The next day I had mild cramping and diarrhea at 1:00pm but then it turned blood about 6:20 pm.  I went to the emergency department in an ambulance and my placenta had erupted.
Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in an elderly female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) was resolving.            The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-070972 (Patient Link).   Reporter did not allow further contact
Quaking chills developed approximately 20 min. after receiving flu vaccine at his employer's health fair. No improvement after glucose and fluids. Vital signs: systolic BP in 140's; heart rate in 110's. C/o abdominal and chest "twinges". Ambulance called - sent to Emergency Dept. Labs, EKG, CT head normal. Received IV fluids and released to home with diagnosis near syncope.
no adverse effects reported; A patient 14 months old was administered GRDASIL 9; This spontaneous report was received from a medical assistant, concerning a 14-months-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 23-SEP-2019, the 14-months-old patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product administered to patient of inappropriate age) 0.5 milliliter (ml), for prophylaxis, lot number 1614897, with an expiration date on 20-SEP-2021 (frequency, route of administration and anatomical location were not reported). No adverse effects were reported.
Moderna 5/19/21, 6/23/21, 9/22/21. Positive on 1/28/22
7 days so far of swollen left armpit gland 7 days so far of morning or evening headache General fogginess
Bells Palsey, 2 wks later, Experincing dull pain behind left ear, 4 days after vaccine, also slight headache.
15FEB- fever, dec appetite, wt loss, cough, nose bleed x 2d, vomiting; Seen 21FEB temp 102.4(R) - otitis.
passed out while riding bike; burns to skin @ rt elbow, lt knee;  abrasion like in appearance; tx Amoxicillin;
Patient is 17 years of age however received the Moderna Vaccine (1st Dose) which is approved for individuals 18 years old and above.
Felt achiness on his leg on the same side; An achy arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Felt achiness on his leg on the same side) and VACCINATION SITE PAIN (An achy arm) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Felt achiness on his leg on the same side). 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (An achy arm). At the time of the report, PAIN IN EXTREMITY (Felt achiness on his leg on the same side) and VACCINATION SITE PAIN (An achy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication was not provided.
pt recvd vax & 2wks p/vax pt devel rash;2wks p/that the sibling broke out in chicken pox;f/u from the nurse indicated that the pt was dx w/hand,foot & mouth disease & not chicken pox;no further details were provided;
1 INCH RED AND SWOLLEN AREA AT SITE OF INJECTION. AFEBRILE
Severe pain in L arm, shooting pain in L shoulder and into neck, numbness & tingling in left hand, weakness in L hand, muscle tightness & pain in most of body, fever, and fatigue.
RASH ON NECK, CHEST, ARMS.  RX: VISTARIL & PEPCID PO.
5-10 min post vaccination patient began to experience the following symptoms: nausea, dizziness, fatigue, intermittent syncope, loss of balance, and shortness of breath. Patient was then provided oxygen via mask 10 L/min with initial vitals of BP:149/91 HR: 81 Temp (oral) 97.9 PluseOx: 100. Member experienced a similar issue one week ago (12JAN2018) due to the medication Topamax and was admitted into the ER. No prior hx of adverse reactions to immunizations. Emergency protocol was initiated at clinic and emergency medical services transported member to a local hospital. PT did not lose consciousness during the encounter. Immunization sites were inspected by physician, prior to transport, with no routine signs of an adverse reaction: NO erythema, pruritus, rash or pain at injection sites.
BROKE OUT IN A RASH ON FRONT OF BODY LEGS AND BACK. TREATMENT:IV, EPI 0.3CC, SOLU MEDROL 125MG, PEPSID 20MG, BENYDRYL 50MG.
Arm pain x 3 days fever 104 degrees F ear, swelling and redness around vaccination site, warm to touch.
mom reports pt devel hives last noc;this morning a foot was swollen to the point could not put a shoe on or bear weight;knee & elbow started to swell;mom reported sx vary from hives to rash;
infection in her eye brow; eye is swollen; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration on unspecified date of Jan2021 single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date of 2021 the patient experienced infection in her eyebrow and eye is swollen. Patient clarifies that she was taking antibiotics and a steroid for a possible spider bite. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt staying in hospital; admitted on 12/17/21; had a positive COVID test on 1/27/22; planned to stay through quarantine period, but pt expired on 2/5/22; DC and med records being sent to info@vaers.org
Patient developed nephrotic syndrome including hypertensive emergency, acute renal insufficiency, peripheral edema, acities, fatigue, marked albuminuria, hypoalbuminemia, marked elevation in cholesterol.  No cause has been found.
6/17/23 during the night she woke up with a strider cough and was wheezing. She had a low grade fever off and on and was a little grumpy. On 6/18/23 she tested positive with an at home COVID test. She was given an oral steroid at the urgent care. She had some MOTRIN because she was a little grumpy.
Progressive weakness and tingling of both legs and arms and difficulty in speaking and swallowing.  Dr.'s question that it may be Guillain Barre.  Treated with Gammagard x3 days. Lumbar Puncture was negative however.  Stayed from 10-12 to 10-15.
pancreatic insufficiency; a rise in this condition since COVID 19 vaccine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient in her high 60's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for Covid-19 immunization. The following information was reported: PANCREATIC FAILURE (medically significant), outcome "unknown", described as "pancreatic insufficiency"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "a rise in this condition since COVID 19 vaccine". Patient with preexisting IBS developed pancreatic insufficiency. Her doctor was unsure if it was from the vaccine but had seen a rise in this condition since COVID 19 vaccine was administered. After COVID vaccine she never had COVID prior to diagnosis. The events "pancreatic insufficiency" and "a rise in this condition since covid 19 vaccine" required physician office visit.  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.
Patient developed fever overnight on 11/11/22, with subsequent simple febrile seizure. Brought by EMS ED, where patient was found to be stable and symptoms fully resolved.
Incontinence urinary, ache: bones joint, muscles neuropathy, skin: sores in throat and mouth, dizziness, high cholesterol.
Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 06-NOV-2012, the male patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (Lot number, dosage and route of administration not provided). On or about 08-MAR-2017, the patient was treated by a physician (dermatologist) at a dermatology office for the following injury resulting from his ZOSTAVAX use: Shingles. The patient claims damages as a result of:  injury to themselves, loss of consortium, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
A non-serious spontaneous report of "received FLUMIST on two consecutive days" has been received from a nurse concerning a five-year-old. During the flu vaccination program at the local School District, the patient received FLUMIST on two consecutive days, 05-Oct-2009 and 06-Oct-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
I had a really bad headache, deep crackling cough, short of breath. labored breathing a stuffy nose, fever. When I blew my nose nothing would come out. I hurt more than when I had open heart surgery. I got home from work on June 1, 2022 and took the COVID-19 test and it was an immediate positive. I went to the county drive through testing PCR COVID-19 test, I received my positive results on June 2, 2022. On June 2, 2022 I went to the Emergency Room because I was so short of breath and I had just had open heart surgery at the end of 2021. I was prescribed Paxlovid for my positive COVID-19 test results I started taking it that evening and am feeling better.
I got home from my trip on 10/20/2022 from traveling. The next day on Friday, I felt really short of breath all day. About 06:00PM I went to the ER and my oxygen was below 90%. The doctor told me normally we wouldn't keep you but there wasn't any oxygen to send home with me. I was admitted and ended up spending two nights in the hospital. They had me on oxygen and gave me some LASIX to get some fluid off. I was diagnosed with heart failure and a breathing problem. Since then, I've been trying to get down to the bottom of all of this. It seems like I also have COPD. So now I'm on the SPIRIVA RESPIMAT inhaler that I just got yesterday. I was told to follow up with a cardiologist. I do have an upcoming appointment on 04/04/2023.
Large local reaction with swelling, erythema and warmth.  Swelling on lateral side of arm from shoulder to elbow.
I started having slight cold like symptoms on January 26th and by the 27th I felt REALLY bad. I tested positive for COVID19 on January 29th. The next day I called my PCP and they prescribed PAXLOVID. My friend picked it up for me and left it on my porch so I didn't have to have contact with anyone. Symptoms were mostly cold like, blowing my nose non-stop, a little tired, headache. I didn't lose my sense of taste or smell but the PAXLOVID gave a bad metallic taste. I don't remember being really achy, it was mostly just my head. I just did the 5 days quarantine, and 5 days masking.
Nausea , Headache, Chills, Body aches, skin pain, kidney pain, back pain, coughing, fever, joint and muscle pain,
went to get a Fluzone Quadrivalent prefilled syringe (no preservative) vaccine, however the HCP accidentally gave the Fluzone Quadrivalent MDV instead with no reported adverse event; Patient is in her third trimester of pregnancy; HCP accidentally gave the Fluzone Quadrivalent MDV with no reported adverse event; Initial information was received on 17-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional under Global Medical Information (GMI) Inquiry Number: 00862192  This case involves a 38 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] in context of went to get a fluzone quadrivalent prefilled syringe (no preservative) vaccine, however the health care professional accidentally gave the fluzone quadrivalent multi dose vial (mdv) instead with no reported adverse event (wrong product administered) and patient was in her third trimester of pregnancy (exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e,  before pregnancy outcome was known.  Unknown gestation period, the gestation period at onset and gestation period at exposure data needs to be populated, if available.  The date of last menstrual period was not reported.  The estimated due date was 08-Jan-2022.  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.  The patient's previous pregnancy/ies were unknown.   On 10-Nov-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: U7729AC and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported "The caller stated that she wants to enroll in the pregnancy registry for Fluzone. The patient then called her (obstetrician-gynaecologist) OB/GYN who said that it should be fine, however encouraged her to get on the pregnancy registry."  It was a case of actual medication error due to wrong vaccine administered and vaccine exposure during pregnancy (latency: same day).  Relevant prenatal testing after exposure were not known.   Additionally, at time of reporting, the pregnancy was still ongoing.  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 by the regulatory authority. 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 a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with an expired dose of ZOSTAVAX (lot # 669405/1416Z expiration date 21-JAN-2012) subcutaneously on 10-JUL-2012. No known adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # N012840, expiration date 28-JAN-2019, for prophylaxis) (strength, dose, route and frequency were not reported). The temperature excursion was of 47°F to 77°F (54.9 F), during 15 hours. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Fever 104, sleeping all day, mild cough, vomiting. Admitted to hospital for sepsis work up. Blood culture positive in spite of Prevnar 3 doses.
REDNESS, BRUISE, ITCHINESS, SWELLING, SORENESS THAT HAS LASTED 1 WEEK NOT AND STILL BOTHERING HER. SHE TOOK BENADRYL AND THAT HELPED THE ITCHINESS.
Erythema at site of injection lasting up to 5 days. MOTRIN OTC.
I had a facial abscess 9 days after the injection.  It has since on the most part gone away, but it was very odd.  I have not had anything like this.  I am unsure if this was due to the vaccine, but I wanted to report the issue since it was extremely odd and I do not know what would have caused this.
Fever, body aches, inflammation at site of injection. Pt went to emergency room & tx'd with Rocephin and Keflex.
Patient arm was twitching as if she had something under her skin on the vaccine section; arm was red on the vaccine site, also it was extremely itchy; arm was red on the vaccine site, also it was extremely itchy; Left had feels like it gets numb at times; left hand feels swollen; Patient middle finger hurts on her left hand; Alopecia areata; This is a spontaneous report from a contactable other health care professional (reported for herself). A 34-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EWO164/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 13Aug2021 at 08:00 (at the age of 34-years-old) as dose 1, single for covid-19 immunisation at Hospital. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient has no reported allergies. On 13Aug2021 at 08:30, it was reported that, Alopecia areata. Patient got her vaccine on the left arm and 20 min after her arm was twitching as if she had something under her skin on the vaccine section. The next day her arm was red on the vaccine site, also it was extremely itchy. Left had feels like it gets numb at times and also, she noticed her left hand feels swollen, her middle finger hurts on her left hand and her wedding ring fits snug and it happen after vaccination. No treatment was given for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Aug2021. The outcome of the events was not resolved and alopecia areata was unknown.  Follow-up attempts are completed. No further information is expected.
soreness; her bowels were a little iffy; Feeling Ill; rumbling bowels; diarrhea; upset stomach; nausea; vomiting; accelerated heart rate; dizziness; fever; chills; This is a spontaneous report from a contactable consumer. A 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK8730; Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 14:45 at SINGLE DOSE for covid-19 immunisation. Medical history included arthropod sting, hypersensitivity, sinus disorder, hypertension, blood cholesterol, covid-19.C oncomitant medications included fluticasone taken for hypersensitivity, sinusitis; hydrochlorothiazide, lisinopril taken for hypertension, simvastatin taken for blood cholesterol. The patient previously took z-pak. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No visit to emergency room and physician office. No patient's medical history (including any illness at time of vaccination), relevant tests and family medical history. On 25Mar2021, the patient experienced had minimal soreness, no discomfort, 26Mar2021, she awoke with accelerated heart rate, upset stomach, rumbling bowels, and ran to the bathroom and vomited. Then she had diarrhea. Eventually her heart rate slowed, it was elevated for a while and slowed to normal that morning. she had 6-7 episodes of each- the vomiting and the diarrhea. In between those episodes, she had chills, dizziness, then fever. It rolled along, then her heart rate gradually slowed down. Her symptoms stopped after 2-3 rounds of diarrhea episodes. Her chills came on after she experienced accelerated heart rate. The chills stopped after the first or second throwing up/diarrhea episodes. She had brief dizziness following that. She had a couple or one more episode of throwing up and diarrhea. She got warm, calling it a fever and it did not last long. She has a tendency to get dizziness and takes Flonase to keep her allergies at bay. She thinks the dizziness this time went along with her chills and fever. On 27Mar2021, her stomach had a little discomfort, but nothing major. On 28MAr2021, 02:45 she awakened feeling ill and though she might vomit. It ended up being diarrhea and had 3 episodes of that, spaced out. It was over at 09:00. On 29Mar2021, her stomach was queasy and it went away by evening. On 1Apr2021, she had been experiencing tummy aches, taking Tums and her bowels were a little iffy. Therapeutic measures were taken for dizziness with Flonase. The outcome of the events nausea, vomiting, diarrhea, upset stomach, soreness and abdominal discomfort were unknown and events accelerated heart rate, dizziness, fever, chills and illness were recovered.  No follow-up attempts are needed. No further information is expected.
Slightly sore arm; This is a spontaneous report from a non-contactable consumer. A male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 13Apr2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 13Apr2021, the patient experienced slightly sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event slightly sore arm was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tinnitus in one ear on the second day, ringing which made hearing dull in ear for evening. Was gone by morning. of the third day
Complained of tingling at arms and legs. Thick tongue, chills 25 minutes after flu shot, referred to MD.