chrisvoncsefalvay/vaers-outcomes huggingface dataset:
That evening right arm was flush red (like a sunburn), ached and sore. Five days later, my lymph nodes in my right arm swelled up like I had a hard boiled egg under the skin.  One under the right armpit, one just below elbow, several smaller ones near right breast, neck causing painful earache.
Chest tightness 2 hrs after vaccine administered.  18 hrs and after chest pain exacerbated by light physical activity. Pain becomes sharp immediately after moderate physical activity such as brisk walk/jog.  Same symptoms experienced when sick with assumed COVID-19 in October 2020
Fever, anorexia, vomiting and crying developed about 4 hours after Fluzone administration (first dose). Symptoms continued for about 48 hours and then completely resolved by 72 hours (Fever max was 102).
This case was reported by a consumer via GSK/market research programs and described the occurrence of rash in a infant patient who received Rotavirus vaccine. On an unknown date, the patient received Rotavirus vaccine at an unknown dose. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced rash. The subject was treated with probiotics (nos) (Probiotics). On an unknown date, the outcome of the rash was unknown. The reporter considered the rash to be possibly related to Rotavirus vaccine.
Patient came in today and mentioned that they had a black and blue mark from here Tdap vaccine that started at the deltoid and ran down to her elbow. She said that it is healing up quite a bit now and only has slight pain if she touches the spot.
Pt fainted, hit back of head against desk leg and had a 10-15 second seizure.
became pale, lethargic, w/thin high pitched faint cry w/in 1 hr; later devel sterile abscess & required rx, still has permanent scarring @ inj site of MMR;
Hyperpigmented rash over entire trunk with pruruitis. Right axillary lymphadenitis with fatigue.
Began a heavy period December 17th in the early morning. Period was two weeks early, heavy, and painful. Every two weeks since the first vaccine I have had a period. Got hormones checked, labs, pelvic ultrasound. All normal. Four months later I am still bleeding.
Information has been received from a medical assistant referring to a 4 month old female patient. No relevant medical history or concurrent conditions were reported. On 17-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322.  Additional information has been requested.
No adverse event; Dose administered after Manufacturer Date of Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 06-Sep-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Sep-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The 2.5mL vial was initially stored in the refrigerator on 05-Sep-2023. The 2 doses from 1 vial didn't underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 2 out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739608 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739608:Patient 1
This spontaneous report as received from a registered nurse refers to a currently 30 years old female, non-pregnant patient. Her concurrent conditions included migraines (since unknown date) and allergy to penicillin. On an unspecified dates in 2010, for school purposes, the patient received series of hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as "unspecified Hepatitis B series"), (exact dates, doses, dose numbers, route and sites of administrations, lot# and expiration dates not reported). Concomitant therapies included NEURONTIN, LAMICTAL, ZYRTEC, ZANTAC, AMERGE, acetaminophen, NORCO and COMPAZINE. On an unknown date, after hepatitis b vaccine (recombinant) (manufacturer unknown) was administered, the patient had titers drawn and the results were negative. The reporting nurse also stated that the patient's mother believed that the patient received unspecified Hepatitis B series as a child (dates unspecified), but there was no documentation of the first series being administered. The patient did not seek medical attention and received no treatment. The outcome of the adverse event was unknown. Relatedness between use of hepatitis b vaccine (recombinant) (manufacturer unknown) and the negative result of titers was not reported. Additional information has been requested.
This case was reported by a nurse and described the occurrence of dehydration in a 26 month old male pt who received Havrix. On 1/20/04, the pt received the first dose of Havrix, in the RA (lot VHA777A2). Approximately, 2 days following the administration of Havrix on 1/22/04, the pt experienced nausea and vomiting, dizziness, diarrhea, dehydration and "had a rash". The pt was seen in an ER. Additional info received from Mfr on 8/11/04, indicated that the pt "was hydrated" in the ER. The events resolved on an unspecified date.
w/in 15min of vax pt started breaking out w/a rash & w/in 45min rash was all over body;seen by PP;DPH given;MD felt like child allergic to component in vaccine;
pt recvd vax & woke up & vomited 17JUN94-3x a/1020; pt had had nothing to eat or drink; no other sx; no one else sick; MD questions flu/virus because several other children had same sym;
they had administered the fluzone qiv-np tp 6 patients prior receiving the email with no reported adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced who was administered the Influenza Quadrival A-B Vaccine [Fluzone QIV] prior receiving the email with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot number, strength, expiry date not reported) via unknown route in unknown administration site as immunization prior receiving the email with no reported adverse event (poor quality product administered) (unknown latency).  It was reported that vaccine was shipped on Saturday, 23-Sep-2023 and was received on Tuesday, 26-Sep-2023. The vaccines are not suitable to use due to a shipping excursion was received on 27Sep2023.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a 68 year old female patient with no allergies and no pertinent medical history who in July-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Dose, route and Lot# not reported). Concomitant therapy included EFFEXOR, CELEBREX, HCTZ/triamterene, omega-3 marine triglycerides and baby aspirin. The consumer stated that in August 2010, a month after having ZOSTAVAX (Merck) experienced cold sores on one side of her face and cold sores all over her body. There were no laboratories diagnostics performed. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unspecified. On 24-DEC-2015 the patient was vaccinated with an expired third dose of GARDASIL (strength, dosage, frequency and route unspecified. The physician was not able to provide the lot#/exp. for the expired GARDASIL that was administered as well as the dates of administration of previous doses. No adverse symptoms was reported. Additional information has been requested.
Patient started the evening of vaccine with erythema surrounding site which spread for 3 days, measuring 10 cm x 6 cm when seen for visit 11/05/19, tender with central nodule - Treated for cellulitis with doxycycline 100 mg BID for 10 days, ice.
Erythema 50mm x 25mm noted by mother 08/10/05. States applied cool ice compresses and gave Tylenol. Mild slight swelling noted when presented in office. Child has no difficulty moving arm. Advised to administer Benadryl cream or cortisone cream to sight, or give oral Benadryl and or Tylenol for discomfort.
Patient developed shortness of breath and fast heart since receiving vaccine.  No tachycardia in the emergency room.  Blood pressure = 153-92
Urticaria (mild). MR received  revealing a 9 month old in for well-baby exam with only c/o mild diarrhea-resolving, otherwise normal. Flu shot given and infant developed hives that evening on face/trunk/back.  Seen 2 days s/p vax. because infant seemed uncomfortable, and was having trouble sleeping. DX: Urticaria, likely 2' to influenza vaccine, treated with Atarax PRN itching.
2 days p/inject lt arm was very swollen & red & sore; Swelling extended to elbow; Upper arm had many welts; Seen in ER; rx Celdane & all sx subsided w/in 4 days;
pt recv vax 2DEC98 & 2 1/2hr post vax pt exp a sz & a rapid rise in temp & was taken to ER;pt was sent home w/oral antibiotics 9DEC98 pt devel a viral rash, had another sz, fever 104 taken to ER;sz considered an other med event;
Discomfort at site of shots-Aggressive behavior which occurred 24-36 hours after admin and lasted 10-14 days
He said he had just started having muscle pain in his leg; This is a spontaneous report from a contactable consumer (patient).   A 36-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection, Batch/Lot Number: ER8729; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Left on 09Apr2021 (at the age of 36-years-old) 09:30 as 2ND DOSE, SINGLE for covid-19 immunisation. The patient had no medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection, Batch/Lot Number: EN6206; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Arm Left on 19Mar2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Patient had no prior vaccinations (within 4 weeks). No additional administered Vaccines. On 04Jun2021, the patient experienced muscle pain in leg. Patient stated that he wanted to know if this was still associated with the vaccine and heard of people who had side effects 1 week or just 24 hours after receiving the Pfizer-BioNTech Covid-19 Vaccine. He wanted to know if there had been reports of people having side effects almost 2 months after receiving the vaccine and had tried to find out if the side effect he was having from the Pfizer vaccine. He has a primary care doctor but declined to provide HCP information and he just put ice on it. Patient had not visited emergency room and physician office. The patient had no relevant tests. The outcome of event was not resolved.
Information has been received from a nurse concerning a 12 month old male child who on approximately 01-APR-2008 was vaccinated with VARIVAX (Oka/Merck) (lot # 659726/1772U). It was reported that the patient was at the doctor's office and soon after having blood taken he received the VARIVAX (Oka/Merck) (lot # 659726/1772U) vaccination. Subsequently, after the injection was given the patient stopped breathing, he was stiff, he turned blue; and he was not crying for about 20-30 seconds. It was noted that there were two nurses there, one nurse picked the patient up and started to pat and rub him, while the other nurse also tried to stimulate the patient. The patient finally started crying, and appeared to be fine. It was also reported that the doctor assessed the situation. The patient is due to come back next week for the next set of shots because on that day he was to get some other shots, but they decided to delay them because of the reaction he had. The patient's mother was called later that day and it was reported that "as of right now the child was fine." There was no emergency room visits. Upon internal review "stopped breathing" was determined to be an other important medical event. Additional information has been requested.
Patient states her arm is red, swollen and warm to the touch from her shoulder down to her elbow.
After her 2 mo vaccines, Mom reported she was jittery, crying and had a fever. She then gave Tylenol which helped the fever and crying but she was jittery the night of vaccines
Having cold sores for an extensive period of time.; Extremely painful; Unable to eat; Dose received 3/ dose number=3; This is a spontaneous report received from a contactable reporter(s) (other healthcare professional). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 08Oct2021 (Lot number: FF8839) at the age of 44 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Allergic reaction to antibiotics" (unspecified if ongoing), notes: Known allergies: QUINOLONES. Concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "Drug allergy"; Quinone, reaction(s): "Drug allergy". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EL9261, Anatomical Location: Left arm), administration date: 01Jan2021, when the patient was 43 years old, for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE, Lot Number: EN6201, Anatomical Location: Left arm), administration date: 09Feb2021, when the patient was 43 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 08Oct2021, outcome "unknown", described as "Dose received 3/ dose number=3"; ORAL HERPES (non-serious) with onset 04Nov2021, outcome "recovering", described as "Having cold sores for an extensive period of time"; PAIN (non-serious) with onset 04Nov2021, outcome "recovering", described as "Extremely painful"; FEEDING DISORDER (non-serious) with onset 04Nov2021, outcome "recovering", described as "Unable to eat". The events "Having cold sores for an extensive period of time, extremely painful and unable to eat" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of oral herpes, pain and feeding disorder.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Therapeutic measures were taken as a result of oral herpes, pain and feeding disorder and included treatment with unspecified medication. Since the vaccination, the patient had been tested for COVID-19.
Cellulitis in deltoid with seroma formation; requiring hospitalization & surgical incision & drainage.  Pt developed large area of redness at injection site.
Patient received first dose of the Pfizer-BioNTech COVID-19 Vaccine EUA at 17:48 on 12/20/20. At 17:58, patient complained of eye irritation, eyes were red and itchy. No complaint of difficulty breathing, increased heart rate or dizziness.  Pharmacist provided diphenhydramine 25mg tab and patient was observed for an additional 15 minutes. Irritation resolved and patient had no complaints at end of the observation period. Discharged to home.
Initial symptoms of low grade fever (100-101 degrees Fahrenheit) and body chills beginning approximately 8:30 PM the evening of the date of vaccinations. Acetaminophen and ibuprofen  taken PRN. Low grade fever and general malaise persisted intermittently over 48-72 hours following injection. Profound knee/ankle/and achilles tendon soreness began the day following the vaccination administration and persisted approximately 5 days. Two oral aphthous ulcers and approx. 10-15 vaginal aphthous ulcers presented within 24-48 hours after vaccination and persisted for 7-10 days (peak day 4 following vaccination). Vaginal aphthous ulcers were accompanied by a burning sensation with urination and moderately painful bowel movements.  Very minor rectal bleeding with 2-3 bowel movements due peak of vaginal discomfort.
The next evening, I started feeling like my glands on the right side of my jaw/neck were swelling. Also was feeling like my throat needed clearing and experiencing headaches. Then Thursday the symptoms became worse, that evening my right jaw neck was swollen like a golf ball and it was hard to swallow, it felt like my throat was full of marbles. Also noticed a canker sore on the bottom of my mouth under my tongue. This lasted for a few hours, the swelling started going down but didn't return to normal. Friday, the swelling and canker sore were bothersome, plus had a horrible headache, was irritated and felt fatigued plus had a lot of post nasal drip.
fevers starting wednesday night, tmax 103, off and on between 99-103 up until now
Patient has experienced headaches, dizziness, she had a fall at school as well which is out of character of her and which is what got me looking into the vaccine side effects. She is also pale and her head "feels foggy" at times.
Stroke, in and out patient therapy after a Thrombectomy (3/6/2021).  Whole left side was unable to use.
Information has been received from a consumer. Caller stated that the "varicella vaccine" (manufacturer unknown) was causing an epidemic of shingles, and she knows 7 people under the age of 50 who have Shingles, including herself, and that it was caused by an unspecified varicella vaccine (manufacturer unknown) being given to children. She stated she knows of a child who got Shingles, but didn't say the child had received this vaccine. She also didn't stated that she knew whether these people, or herself, had actually received the vaccine at all. This report concerns about 6 patients under the age of 50 (gender unknown) who developed shingles. Patient's outcome were unknown. Additional information is not expected. This report is linked with MARRS cases 1304USA001477 and 1304USA000279 same reporter.
None- vaccine given 12 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-395985 (Patient Link).
Headache, Arthralgia, FATIGUE, CHILL, PAIN/SWELLING INJ SITE, LOCAL LYMPH NODE TENDER/SWELLING Narrative:
No additional AE reported; Customer called and reported that a dose of PROQUAD expired on 02FEB2023 and was administered on 13FEB2023. The product had no temperature excursions. No additional AE reported. No PQC reported. No additional information provided.; This spontaneous report has been received from a medical assistant concerning a 4-years-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 13-FEB-2023, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection as prophylaxis (lot number U024509 has been verified to be valid; expiration date reported and established as 02-FEB-2023) (expired product administered) (strength, dose, route of administration, and anatomical location were not provided). No additional adverse events were reported.
Patient felt lightheaded after the vaccine. She was asked to stay seated for about 15 minutes and then sent home. Once home she progressively had more symptoms including lightheadedness, confusion, fatigue, unconsciousness, expressive aphasia, loss of bladder and bowel control, elevated temperature, increased pulse, increased respirations, increased blood pressure, dehydration, stroke like symptoms with no evidence of stroke, loss of motor coordination
Morning after woke up with body aches, extremely sore neck, shoulder and back on the side of the injection and injection site.   An overall unwell feeling.  Tiredness.  Night sweats and body chills.  Also, swollen lymph glands and tenderness under my right arm pit about the size of half a tennis ball.  It is now 05/24 and I don't have the unwell feeling, but still soreness in neck and shoulder and swollen, tender lymph glands under right arm pit.
Immunization Administration Error - Patient presented to clinic and denied having received any prior doses of COVID-19 vaccines. It was later determined/verified in system that the patient did receive the Johnson & Johnson vaccine in March 2021. The patient denied this at the time of the visit. Now admits that he may have just forgotten that he had gotten the vaccine.