chrisvoncsefalvay/vaers-outcomes huggingface dataset:
maybe she is just stressed.; she has constant headaches at night; nausea; chest pain; dizziness; mild abdominal pain; This is a spontaneous report from a Pfizer sponsored program. A contactable 50-year-old female consumer (patient) via medical information team. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 01Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter was a consumer who received the 1st dose of the Pfizer-Biontech COVID19 vaccine on 01Jul2021 and six days after was still experiencing side effects which include headache that happens mostly at night, nausea, chest pain, and sometimes dizziness, as well as mild abdominal pain. She said that her main concern was the headache in which she takes Tylenol extra strength at 500 mg but it only works temporarily. She was not sure if the vaccine was causing the headache or maybe she is just stressed. The reporter was asked if it was normal for day 6 of being vaccinated to be having side effects. Medical questions were addressed by this program forwarded/referred to medical information. The outcome of the events was reported as not resolved.  Information about lot/batch number is requested.
Pt, a resident in a long-term care facility, devel flu-like resp sxs 18 days p/being administered influenza vax; This necessitated a MD visit;
This spontaneous report as received from a nurse refers to unknown number of patients of unknown age and gender. On an unknown date unknown number of patients was vaccinated with PROQUAD (dose, route of administration and anatomical location unknown) which underwent an unsupported temperature excursion. Pertinent medical history and concomitant medications of patients were unknown. No adverse effects reported. The outcome of the events was unknown. No further information provided. This case is linked to case # 1407USA005729, 1407USA005730, 1407USA005295, 1407USA005736 via same reporter link. Additional information has been requested.
Patient stated that she had hives in arms and legs about 3 days after , she got the first dose on 07/11/23. She did not contact pharmacy at the time. She said , she called her physician , who prescribed an ointment to treat.
Initial swelling; tired; napped; woke up with increased swelling, red, warm to touch; middle of the night woke up and it was redder, more swollen & itchy; by the time I got to work it was a bright red, very warm to the touch, quite itchy -- welt was 9 inches long & 3 1/2 inches at the widest point and began about a half inch beneath the injection and extended to my elbow.  When I got home that evening my husband took a picture and that was emailed to my doctor.
Myalgia inj site swelling, pain; chills, body aches, tired Narrative:
Blood clot (DVT) left leg.  Prescribed blood 30 Mg of blood thinners daily for life.
A bit tired; Headache; Arm hurt a few hours after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm hurt a few hours after vaccination), HEADACHE (Headache) and FATIGUE (A bit tired) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RAMIPRIL for Blood pressure high, ATORVASTATIN, VITAMIN D3, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), FISH OIL and BRASSICA NAPUS, FISH OIL, GLYCINE MAX SEED, GOSSYPIUM HERBACEUM SEED, UBIDECARENONE, ZEA MAYS (OMEGA 3 & COQ10) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE PAIN (Arm hurt a few hours after vaccination). On 16-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced FATIGUE (A bit tired). On 16-Jan-2021, INJECTION SITE PAIN (Arm hurt a few hours after vaccination) and HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (A bit tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Tylenol as treatment.
As soon as I woke up the morning of 4/28/21 I felt like my heart was beating fast. I was going through my day normally at home, and it seemed like it was going even faster in the afternoon and I decided to go into urgent care (around 3pm). I wear a fitness tracker, and about the same time it started alerting me that my heart was having abnormal beats. In urgent care they took an EKG, chest Xray, and ran a lot of bloodwork that all appeared normal. I was given IV fluids and rested there for a while for observation. When I left my heart rate was still elevated. It took a few days for my heart to get all the way back to usual (according to my fitness tracker).
Covid symptoms started 04/25/22; tested positive on 04/27/22. Symptoms were stuffy nose, congestion, coughing, sore throat, and slight headache. I went to doctor on 04/26/22 and got antibiotic's and coughing pills. Symptom's lasted for a week and a half. I do still have sinus drainage and coughing. First vaccine was J&J 03/2021.
Act hib was reconstituted with MMR/VZV diluent instead of diluent that is packaged with Acthib and administered to pt. As per annual follow up report No adverse reaction. Med error.
Information has been received from a health professional concerning a 17 year old female with no allergies who on 23-APR-2007 was vaccinated with a second dose of 0.5mL subcutaneous varicella virus vaccine live (Oka/Merck) (Lot# 653305/0438F). On 24-APR-2007, the patient experienced pain, swelling and induration at the injection site. The patient was instructed to mark the area of swelling and induration and it was found that the area increased in size the following day. At the time of this report, the patient had not recovered and no further information was available. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Cluster headaches that are increasing in frequency and intensity. Muscle and joint stiffness in limbs. Lower back pain with disruption in sleep and restlessness.
The next morning I was standing and passed out.  Was sat down and passed out again and while down I was advised I developed a rash that moved up my neck, chest and face and was really tingly which did go away on its own later that day.  My BP an HR went extremely low  also
Several hours after the shot I felt a pain in the left arm which went away after a day or so. A week later after no symptoms I felt the pain again. Since then I have intermittently felt the pain in my arm, as well as a general weariness and aching, which seems concentrated in the left side of my body. These effects disappear for three or four days at a time, only to reappear. At times it's no more than a pinch in my arm, at other times, there's a general feeling of weariness. The symptoms have generally been mild and have not interfered with my daily routine. I have full mobility of my arms and all other parts of my body and do my daily workout as usual.
This spontaneous report as received from a consumer via FDA (Agency number: 2014-2020) refers to a female patient of unknown age who is the consumer's daughter. On an unknown date the patient was vaccinated with GARDASIL (manufacturer unknown) (dose, route, indication and lot # not reported). On an unknown date the patient experienced adverse reaction. The consumer requested a copy of a VAERS report that was file don the patient behalf after she had an adverse reaction to the HPV vaccine. The outcome of adverse reaction was unknown. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a 4 month old male who on 06-NOV-2007 was vaccinated SC with a 0.5 mL dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) instead of Rotateq due to error with the order.  Other concomitant therapy that day included PREVNAR, PEDIARIX, and PEDVAX HIB (OMPC) (MSD).  No adverse symptoms were noted.  No additional information was available at the time.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Headache, Myalgia, Arthralgia, NauseaVomiting, Tachycardia, hypotension Narrative: Employee states: After the first dose she experienced: local injection pain and mild myalgia After second dose: she ended up in the local ED with SEVERE myalgia/ arthralgia/ headache/ tachycardia/ low BP/ low sats, vomiting treated with Toradol and Phenergan today on 1/26/21 she states she is still ill with horrible arthralgia and horrible headache not feeling well
A patient received last years flu vaccine no AE; Initial information regarding an unsolicited valid non-serious case was received from Other Health Care Professional via a consumer/non-health care professional via Global Medical Information (GMI) (Reference number- 00825045) and transmitted to Sanofi on 22-Oct-2021.  This case is linked to cases 2021SA355038 and 2021SA356217 (same reporter).  This case involves a11 years old female patient who received last years INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered) by mistake.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given to the patient.   On 22-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (once, lot UJ562AA, expiry: 30-Jun-2021) via an unknown route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "Caller states that 3 patients received last years flu vaccine by mistake and would like to know how to proceed?"  At the time of reporting, no adverse event was reported and the outcome was unknown for the reported event.   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.
had very little arm soreness with the first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 10:00 (Lot number: EN6204) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Stroke", start date: 2014 (unspecified if ongoing), notes: The first was in 2014.; "blood thinner" (unspecified if ongoing); "Stroke", start date: Dec2018 (unspecified if ongoing), notes: The second was Dec2018.; "She had a MRI to confirm" (unspecified if ongoing). Concomitant medication(s) included: XARELTO taken for blood disorder, start date: Jan2019 (ongoing). Past drug history included: Eliquis for blood thinner, reaction(s): "couldn't deal with Eliquis very well", notes: For 2.5 years after the first stroke; Eliquis for blood thinner, reaction(s): "made her feel like she was dying", notes: For 2.5 years after the first stroke. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 04Mar2021, outcome "recovered" (05Mar2021), described as "had very little arm soreness with the first dose". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.
slightly swollen and redness around site of shot. soreness in arm at site of shot full body aches constant low-grade headache fatigue
injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2019, the patient received Shingrix. On 9th December 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was resolved with sequelae.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received vaccination in right deltoid. The patient had injection site pain for 4 days. The reporter consented to follow up.
Information has been received from a registered nurse concerning a 5 year old male with no pertinent medical history who on 30-MAR-2004 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot #647521/1108N) in his left thigh SC. There were no illnesses at the time of the vaccination. On 14-APR-2008 the patient was seen in office with a four day history of a rash (onset 11-APR-2008). They were found to be diffuse papules of varying sizes, mostly on trunk, extremities with several overlying vesicles crusted over. The number of lesions was more than 50. There were no diagnostic or laboratory tests performed. As of 22-APR-2008 the rash was still ongoing. Additional information has been requested.
Swelling at injection site, lymph node swelling left arm, fever, chills, achy joints all over, tired
Headache and fever on 3/9. Diarrhea 3/11 or12 for 4-5 days
Woke up the morning after my shot with my left middle finger hurting really bad. Went to Dr. Took a medrol dose pack, didn't help, took exray. Went on to hand Dr. Discovered arthritis in all of my fingers. Put me on celebrex. That pain is still there but it still hurts. Took my 2nd booster on Friday 5/13/22. Woke up the next morning and my same left middle finger was killing me for about 2 days
10:00 PM: hives on chest 11/10/03. 6:00 AM 11/11/03: hives on back, neck, chest, face.
Presented after being found at home poorly responsive in bed after vomiting and w/ lethargy. In ED hypoxic and hypotensive. Found to have septic shock. Tested Covid +. Cause of death was progressive hypoxemic respiratory failure secondary to aspiration pneumonia and COVID19 pneumonia.
pt recvd vax & 5 days following vax pt devel a temp of 102 & a raised, defined, dissimilar looking rash on trunk that spread to the rest of body; No further details were provided;
Patient went to physician's office complaining of swelling in the upper left arm. The physician diagnosed the patient with cellulitis and gave her an IM antibiotic and oral antibiotic. The patient believes the pharmacist gave her an infection. The patient presented to me to what seemed to be an adverse reaction to the injection. According to the physician documents given to the patient, the patient was afebrile and other signs were shown to be in the normal ranges. Patient was discharged with self-care instruction. Her outcome is unknown at this time.
suspected vaccination failure/ had it now; had it now; already vaccinated 3 times; Pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In AUG-2023, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced pain (Verbatim: Pain). On an unknown date, the patient experienced vaccination failure (Verbatim: suspected vaccination failure/ had it now) (serious criteria GSK medically significant), shingles (Verbatim: had it now) and extra dose administered (Verbatim: already vaccinated 3 times).  The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the vaccination failure to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the shingles and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the vaccination failure to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 17-Sept-2023 The case was received from the patient's children via interactive digital media. The patient had it now and she had already been vaccinated 3 times. The reporter stated that it was unbelievable that the patient got it.  The physician said that the vaccine was 80 percent effective but she fell into the 20 percent  that was not. Poor thing, she had pain for 3 weeks now that would not go away. The patient received shingles vaccine, which led to extra dose administered. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history were reported. The nurse stated that, on an unknown date, the patients were vaccinated with a dose of GARDASIL (route, lot# and expiration date were not reported) intramuscular, which was stored improperly. Concomitant medications were not reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
pt recvd vax; approx 2 hrs after vax pt devel red, sore & "welty" arm, stomach pains w/ belching, dizziness, lightheadness, a "stupid feeling"; pt was hot & felt like passing out & was very tired;
Pt was underdosed at 25 mcg.  No ill effects occurred, pt was given a full dose on 11/8/22 following guidance from CDC.
7-8 days after dose 1 of the Moderna vaccine, I ( a 54 y.o. female with no known allergies, and taking no medications) experienced intense itching at injection site (upper left arm). Injection site swelled up like a mosquito bite with a rough surface, about the size of a silver dollar.  Itch persists at the moment.
PATIENT CALLED REPORTING A BRIGHT RED AND WARM NODULE AT THE SITE OF IMMUNIZATION. A NURSE AT THE SCHOOL SHE WORKS AT DREW A CIRCLE AROUND IT YESTERDAY AND THE RED HAS EXTENDED BEYOND THE CIRCLE. Pt FEELS LIKE THE NODULE GOES UP TO HER SHOULDER. SHE ALSO REPORTED FEELING OVERALL UNWELL TODAY.
started breaking out in a red raised rash all over body w/in a few hrs p/being vaxed; very itchy & uncomfortable; no breathing problems; rash was noted on bottom of feet & hands covered w/rash; given DPH in ER; hands & feet also swollen;
Pain at injection site and irritability in the hours following vaccination; the following morning, several instances of vomiting.
few hours later patient had severe dizziness and nausea and had to leave work.  called today (3/7) and still has both with achiness and fever
I got the shot within a minute I could feel in my neck, my jaw, my throat and my ear felt like it was getting big, and my mouth felt like it was full of cotton and I couldn't swallow. A few days after that my blood pressure was going lower than normal and I felt dizzy, so I reduced my blood pressure medication and kept an eye on it. I also had a huge a lump in my arm and my whole arm was sore. It was red and hot to the touch.
Swelling/burning at injection site - over 24 hours got nurse.  Went to ER.
(R) back of arm where MMR given became reddened, which we expected but within 24' her whole upper arm swollen & reddened with heat. Pictures sent to Dr. Benadryl cream & oral taken by patient & she did fine. #2 not given.
Vertigo with nausea Increase in blood pressure Partial hearing loss in right ear due to increased tinnitus
I got real lightheaded, cold, clammy and had a fever of 100.9. The school nurse checked my blood pressure which was elevated. She also checked my blood sugar because she thought that it may had been dropping and gave me orange juice to drink. The nurse followed my home and next day I had high fevers and body racking chills that lasted for exactly 36 hours. I woke up on Wednesday feeling fine. I took Tylenol for the fevers and had no appetite. I mainly slept for those 36 hours.
The day after the vaccine I had fatigue and body aches. Then on 12-23 fevers of 101.4, chills, body aches, diarrhea, vomiting, productive cough, and profuse sweating. Jan 1st I was in the shower and was dizzy with a headache. Loss of consciousness almost happened and that is when i got out of the shower and laid down. Went to the ED and was diagnosed with bilateral pneumonia
1st dose - 05/22 11:30 AM - Pain in arm, mild feverish, tiredness and mild chest pain. 2 nd dose  - 06/12 10:30 AM - Pain in arm, tiredness more pulling pain in chest
INJECTION SITE WAS HOT TO TOUCH WITH GOLFBALL SIZE KNOT AT SITE.
Fever of 105°F; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 105°F) and FATIGUE (Tired) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L2UA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020. Concomitant products included INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PYREXIA (Fever of 105°F) and FATIGUE (Tired). At the time of the report, PYREXIA (Fever of 105°F) and FATIGUE (Tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Body temperature: 105.0 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Fever ad fatigue are consistent with the known safety profile of the vaccine.; Reporter's Comments: Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Fever ad fatigue are consistent with the known safety profile of the vaccine.
Patient received two Pfizer vaccines in 2021:  11/20/21 and 12/11/21. Patient contracted COVID-19 disease in January 2022. Patient was hospitalized in March 2022 with signs and symptoms consistent with MIS-C complications. Symptoms included fever, joint pain and rash over two weeks.