chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slight soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Slight soreness in arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012120A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (Slight soreness in arm). At the time of the report, VACCINATION SITE PAIN (Slight soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
PATIENT REPORTED TO PHARMACY THAT SHE HAD A SORE RIGHT ARM IN THE MORNING ON 4/18/17. THE SORENESS CONTINUED AND ON 4/19/17 IT WAS WORSE. HER DOCTOR RECOMMENDED THAT SHE SEE A DOCTOR TO GET EVALUATED. THEY ARE SUSPECTING CELLULITIS, BUT THEY ARE RUNNING MORE TESTS AS OF 4/19/17 at 3PM.
A patient received her first Moderna Covid-19 vaccine from expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received her first Moderna Covid-19 vaccine from expired vial) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received her first Moderna Covid-19 vaccine from expired vial). On 07-Jun-2021, EXPIRED PRODUCT ADMINISTERED (A patient received her first Moderna Covid-19 vaccine from expired vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned.  No treatment details were reported.
Information has been received from a healthcare student referring to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On 17-MAR-2016 the patient was inadvertently administered an expired PNEUMOVAX 23 (lot # K010522 with expiration date 25-FEB-2016, dose and route were unknown). The patient's concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
Pt recv vax on 8/31/98; on same day pt exp itchy scattered spots on trunk
pt exp t104.2 w/APAP & was taken to ER & seen by MD who gave Pediaprofin;
This spontaneous report was received from a nurse regarding a 2 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-MAY-2017 the patient (who was 1 year and 7 months old at the time) received the first dose in the two dose hepatitis A vaccination series with VAQTA injection 25/0.5 (lot#, expiration date, route of administration and dosing details were not reported), for prophylaxis. On 25-OCT-2017, the patient (who was 2 years old at the time) inadvertently received the second dose in the two dose hepatitis A vaccination series with VAQTA too early. No adverse were effects reported.
Seen in Emergency Center for "evaluation of fatigue and dry cough ongoing for the past 2 days".  04/14/21 SARS-CoV-2 (COVID-19) by NAA, Micro - DETECTED.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient's friend. The age at vaccination was not reported. The patient got shingles and suffered the rest of her life after she got the shingles vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
This spontaneous report as received from a registered nurse refers to patients of unknown age and gender. On an unknown date the patients were vaccinated with second dose of RECOMBIVAX HB (Strength: 10MCG/1.0 ml 10 standard packages syringe of 1) (Lot # not reported). Nurse reported that unspecified number of patients had received second dose of RECOMBIVAX HB outside of recommended interval and some patients received second dose of RECOMBIVAX HB at month 2 or 3 after the first dose. No adverse effects reported. No product quality complaint was involved. Additional information is not expected. Because the reporter did not wish to be contacted.
mild coughing and tightening of chest.  left vaccine site after 25 minutes. Drove home about a mile, and as I got closer to home the coughing got worse.  Got home after 5 minutes, cough was  a dry hacking cough that sounded like I should be coughing stuff up but nothing came of it.  Had husband drive me to ER about a mile away.  Spent about 3 hours in ER where I received more blood work, and a breathing treatment that broke up the asthma attack.  I was monitored to make sure I didnt get worse or have other effects.  I followed up with my PTP at the Clinic the next week.  All blood work was fine.  I was short of breath all of the time , but still able to work.  At the end of the 1st week after my 2nd shot, I was still short of breath and had developed a constant internal shake, had a light rash on the back of my legs between hip and knees.  My system went into overdrive from the vaccine.I am currently 2 months out and have just began to feel like normal from the 2nd shot.
Chest heaviness, shortness of breath, and dizziness within 10 minutes of receiving the vaccine. I told the clinic staff, and my blood pressure was taken. My normal blood pressure is 110/60, but at that time it was 132/81. I lay down in the exam room for about 10 minutes, and my pressure went down to 122/80. About 9 hours after the shot, I had joint pain. Twelve hours after the shot, I had shivering chills and fever which lasted through the night. My highest fever was 101.4 the morning after the shot. 48 hours after the shot, the symptoms were gone.
Itching 180 degree opposed to the injection site / Itching is subcutaneous; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching 180 degree opposed to the injection site / Itching is subcutaneous) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     The patient's past medical history included Allergic reaction. Concomitant products included VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching 180 degree opposed to the injection site / Itching is subcutaneous). At the time of the report, PRURITUS (Itching 180 degree opposed to the injection site / Itching is subcutaneous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient experienced itching at below the site of the injection and it spreads to the elbow area. Patient was currently itching between his arm within the ribcage region to the elbow, 180 opposed to where the injection was given on the same arm. Patient indicates that he has allergic reaction in the past but this experience does not look like allergic reaction and it is annoying. The itching was subcutaneous. This reaction occurs 99% of the time between 7pm upward.  Treatment details included Aloe Vera helps a little to relief the symptoms.
On 02/25/2001, two weeks after vaccination the patient broke out with less than 10 pox, believed to be chicken pox. Unspecified medical attention was sought. Additional information has been requested.
Patient does not report signs/symptoms of adverse effects; Product experienced a temperature excursion and was administered; Spontaneous information has been received from a physician via a medical assistance regarding a patient of unknown age or gender. Information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.   On 05-JUN-2023, Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) experienced a temperature excursion, and on an unknown date in June 2023, the patient received a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (exact dose, route not reported) as prophylaxis (valid lot # W027449, with expiration date reported on 25-SEP-2024) before they were aware of the temperature excursion. The patient did not report any sign or symptom of adverse effect.; Sender's Comments:  US-009507513-2306USA003878:
Patient developed progressive swelling & tingling of her lips shortly after she received the flu shot. The reaction progressed to swelling of her mouth & tongue she took ATIVAN & a glass of wine, but had progression & presented to the Emergency Room where she was observed to have aggressive angioedema. O2 sat 95%.
Patient complains of pain in shoulder, still occurring, can barely lift arm. Reaching hurts. Can press on back of shoulder on a specific spot and it's painful. Patient believes the needle may have gone into a bursa, maybe not directly into the muscle. Patient has been taking ibuprofen at bedtime which helps but it wears off.
Patient describes going straight home after vaccination about 10 minutes away.  She felt like all the weight of her body went straight to her feet and she crumpled to the floor inside the entrance of her house.  She was not light-headed.  Feet felt very heavy and legs didn't want to support her weight.  She claimed to have laid on the floor for the rest of the day, but later in the conversation mentioned moving about the house.  She made sure she kept her phone with her at all times when getting food or going to the bathroom.  She was completely better the next day. She has been getting the flu vaccine for more than 50 years without any adverse reaction other than sore arm.
Patient  reports difficulty breathing. hives on chest .  patient oxygen level 99% when checked the first time. Patient took Epi-pen at 8;08 am and 2nd dose epi-pen at 8:25 am. Arrival of 911 at 8:29 am. Patient transferred to Hospital.
Broke out in hives; This is a spontaneous report from a non-contactable patient (other health care professional). A 48-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was El3246), intramuscular at arm left on 25Jan2021 19:30 as single dose for COVID-19 immunization. Previously patient received first dose of bnt162b2 as single dose for COVID-19 immunization. Patient did not receive any vaccine in 4 weeks. The patient did not take any medication in two weeks. The patient medical history was not reported. There were no concomitant medications reported. On 25Jan2021 the patient experienced broke out in hives. No treatment was received for the event. The patient did not have COVID prior to vaccination. On 25Jan 2021 the patient did COVID test as nasal swab, PCR test which results negative. Patient had no allergies. The outcome of event was recovered.   No follow-up attempts are possible. No further information is expected.
injection on the knee, and for 3 days they had pains and it was bothering them too; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (injection on the knee, and for 3 days they had pains and it was bothering them too) in a 76-year-old male 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, the patient experienced PAIN (injection on the knee, and for 3 days they had pains and it was bothering them too). At the time of the report, PAIN (injection on the knee, and for 3 days they had pains and it was bothering them too) outcome was unknown.            No Concomitant medications were reported.  No Treatment information was reported.  Patient recalls that after the second Moderna vaccine they were going through therapy for an injection on the knee, and for 3 days they had pains and it was bothering them too, so much they had to skip therapy for a few days.   This case was linked to MOD-2021-372716 (Patient Link).
Pt called hospital system's call center on 3/15/21 stating she had an allergic rxn to 1st dose of Moderna vaccine which she received on 3/1/21.  Reports on 3/2/21 evening, she developed rash on face/neck/ears. A few days later it was on her forearms and hips. Per pt, she called PCP at outside institution 3/3/21 and advised to take OTC allergy medications (allerga, benadryl and topical hydrocortisone) until 3/11/21. Patient was then to start on prednisone taper x6 days.  On the 4th day of steroid taper, pt reports feeling better and improvement in rash.
8 days after 2nd ROTATEQ vaccine had 4 hrs of inconsolable crying at 0830. Then had a "currant jelly stool" at 1630 with resolution of fussiness/inconsolability/crying. No interventions.
Generalized rash, fever, headache. Ibuprofen 400 mg every 4 hours.
As per reported by patients mom, patient complaining of severe arm pain in (L) arm where Pneumovax vaccine was given on 07/09/2013. Patient stated she was also experiencing a headache. No SOB was reported.
Complained of flu like symptoms days after receiving 1st dose of Trumenba; Headache; Sore at injection site; Dizziness; Generalized pain; This is a spontaneous report from a non-contactable consumer via a Pfizer Sales Representative. This consumer reported similar events for four patients. This is the first of four reports.   A patient of unspecified age and gender received the first dose of meningococcal group b rlp2086 (TRUMENBA; lot number AL8468) via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient complained of flu like symptoms, headache, sore at injection site, dizziness and generalized pain. The outcome of the events was unknown. Office said they have seen this in the past where every patient who got a TRUMENBA complained of side effects, then that lot number finished, and they used another lot number and they heard anything from patients about side effects. They were starting to hear more complaints and wonder if it was the vaccines associated with specific lot numbers.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019272004 same reporter, different patient.;US-PFIZER INC-2019272005 same reporter, different patient.;US-PFIZER INC-2019272006 same reporter, different patient.
Right lower lobe lung mass - He will continue Augmentin to complete an antibiotic course for possible pneumonia.  On discharge he had adequate pain/symptom control. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
pt. c/o light headache after 2nd dose - bright vision he said. we can't see - nausea, BP very low.  VS was done and transfer care to the paramedics.  They call the ambulance they came and stabilize him.  He refuses to go the the ER.
Patient received Pfizer Covid 19 second dose at 442 pm.  Patient presented at 518 pm complaining of her throat swelling and it being hard to swallow.  An epinephrine 0.3mg IM dose was administered at 520pm.  Patient improved within 2 minutes of epinephrine dose.  Her blood pressures remained consistent for 3 checks 521 pm 146/90 pulse 64, 524 pm 137/92 pulse 66, 527 pm 144/91 pulse 69.  EMS arrived  525 pm, patient refused hospital transport as she was feeling better at that point, EMS cleared her.
No adverse event; Dose 1 and Dose 2 and administered on 2-Sep-2021 and 1-Apr-2022; beyond 35 days apart; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 and administered on 2-Sep-2021 and 1-Apr-2022; beyond 35 days apart) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 002M21A and 002F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Apr-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 and administered on 2-Sep-2021 and 1-Apr-2022; beyond 35 days apart). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 and administered on 2-Sep-2021 and 1-Apr-2022; beyond 35 days apart) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 and administered on 2-Sep-2021 and 1-Apr-2022; beyond 35 days apart).    Concomitant medications were not reported. Treatment information was not reported.   This case was linked to MOD-2023-722085 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2023: Live followup received with no new information.
Microscopic blood in stool; Rashes around anus; Allergic reactions; This spontaneous case was received on 24-Oct-2023 from a other non-healthcare professional (patient's father) (reference number: SEQW23-03709) and concerned a male patient of unreported age.  The patient's concurrent conditions included allergic to potato, corn, and other foods. The patient was not taking any concomitant medication.  On 10-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration and anatomical location: not reported) for influenza immunization. The batch number was not reported.  On an unspecified date in Oct-2023, reported as within a few days of the shot, after receiving Flucelvax Quadrivalent, the patient was having allergic reactions. Microscopic blood was found in the patient's stool and rashes developed around the anus.   The outcome of the events 'blood in stool', 'anal rash' and 'allergic reaction' was not reported.  The reporter did not provide a causality assessment. The patient had prior history of allergy, but it was not sure if the present one was related to the vaccine.  The events of 'blood in stool', 'anal rash' and 'allergic reaction', were considered to be medically significant by a Physician within Pharmacovigilance Department.  This case is linked to 202305513 (the same reporter).  Company comment: A patient was vaccinated with Flucelvax Quadrivalent. As reported, within a few days after vaccination, the patient was having allergic reaction. Microscopic blood was found in the patient's stool and rashes developed around the anus. Information regarding relevant laboratory findings and diagnostic data was not provided. The patient's concurrent conditions included allergic to potato, corn, and other foods. The patient was not taking any concomitant medication. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events hypersensitivity, haematochezia and anal rash with the currently available information and chronological plausibility.; Reporter's Comments: The patient had prior history of allergy, but it was not sure if the present one was related to the vaccine.; Sender's Comments: A patient was vaccinated with Flucelvax Quadrivalent. As reported, within a few days after vaccination, the patient was having allergic reaction. Microscopic blood was found in the patient's stool and rashes developed around the anus. Information regarding relevant laboratory findings and diagnostic data was not provided. The patient's concurrent conditions included allergic to potato, corn, and other foods. The patient was not taking any concomitant medication. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events hypersensitivity, haematochezia and anal rash with the currently available information and chronological plausibility.
Rash after a week. Burning but not itching. Right after shot dizzy, headaches. I'm allergic to gadolinium and bug bites. Was sick after 2nd shot on 6.16.21 for 2 days- headaches, fatigue, chills, sore
I had pain in my right leg. I sought emergency medical treatment on 10/16/2021. They did an ultrasound and I was placed on a long term blood thinner. I was told I had 3 blood clots in my lower leg, all below the knee. Technically the event is over but I will be on blood thinners for the rest of my life.
Patient had soreness in arm and fatigue the day after first shot. Patient is now 2 weeks post shot, and reports red spots/diffuse rash on left arm, and fatigue.
Pfizer 4/15/21, 5/6/21. Positive on 9/1/22
SWEATS; FATIGUE; INCREASED HEART RATE UP TO 108 AT  NIGHT UP TO 95 DURING THE DAY; CHILLS; This spontaneous report received from a patient concerned a 37 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced increased heart rate up to 108 at night up to 95 during the day. On 06-APR-2021, the subject experienced chills. Laboratory data included: Heart rate (NR: not provided) 108, 95. On 07-APR-2021, the subject experienced sweats. On 07-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increased heart rate up to 108 at night up to 95 during the day, fatigue, sweats, and chills. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
101.6 temperature on day after vaccine with body aches, diarrhea and vomiting Slurred speech, aggressive tremors 4 days after shot administered (Continuing) Symptoms indicative of stroke and seizures