chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Child received 2nd dose from from a vial left out for 16 hours) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On 27-Jul-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Child received 2nd dose from from a vial left out for 16 hours). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Child received 2nd dose from from a vial left out for 16 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Child received 2nd dose from from a vial left out for 16 hours). Concomitant medication was not provided. It was reported that a doctor called on behalf of a parent and parent reported that the pharmacy called parent on 28-Jul-2022, to advise that needed to come back to repeat their 2nd dose, because the vial used was left out for 16 hours. Doctor did not have any product information such as lot number, storage and stability information on the vial (unpunctured, punctured). Treatment information was not provided. Reporter did not allow further contact.
rash on back only; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on back only) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash on back only). At the time of the report, RASH (rash on back only) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications includes Letrovole 2.5mg daily. Medical treatment was provided around 25Mar2021 for topical ointment use( 1st dose).   This case was linked to MOD-2021-106967 (Patient Link).
I was around someone on Sunday who ended up testing to positive for COVID-19. They called and told me, and I then started feeling chills, was shaky, I had a fever, I was achy and had pains. I took a COVID-19 home test and it was positive and I went into my doctor, and they tested me as well and it was also positive. They put me on Paxlovid and about after 24 hours I was feeling better.
Volunteer administered 10 mcg instead of 30 mcg.   Notified mother of child. Left voicemail as she works M-F 8-5 and we could only communicate by VM.  CDC allows repeat, dosing per clinical judgment.  Child is under-vaccinated for age.  Recommended repeat dose on 2/4/2022.
Approximately 12 hours after receiving vaccines patient had 103 degree fever, dizziness and nausea. Symptoms had already resolved and patient was well before mother contacted me.
Information has been received from a physician concerning a "young" female patient who "last week", on approximately 12-MAY-2010 was vaccinated with a pediatric dose of VAQTA (lot number not reported). "Last week, after getting the vaccine", on approximately 12-MAY-2010 the patient experienced a 104 degree fever. Unspecified medical attention was sought. No lab studies were performed. The outcome of the patient was not reported. Additional information has been requested.
p/vax pt devel redness from the shoulder to elbow, w/inflammation & soreness;approx 2-3 days p/onset pt recovered;
Patient received flu and pneumonia shot on 11/6/02. At 10PM that night, right arm red and swollen. Came to health department 3:30PM 11/7/02 for evaluation; sent to ER, private MD notified by CFNP. told to take Benadryl by mouth and put cold compresses on site.
I got it and within that short period of time I really just didn't feel well. My heart was racing and not racing, blood pressure was up and down.
For her feeling like she was going to pass out, patient states that she was probably dehydrated; Right sided Neck Pain and Right sided armpit pain; Right sided Neck Pain and Right sided armpit pain; right side neck swelling; Felt like going to pass out; Felt light headed like she was going to pass out; Nausea; Vomiting; Upset stomach; Body chills and aches; Body chills and aches; Headache; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: 31Mar2021) solution for injection, via an unspecified route of administration on right arm on 11Jan2021 at a single dose for Covid-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient was not pregnant. Patient reported she got the first dose on 20Dec2020 and on an unknown date in Dec2020, she experienced right side neck pain, right side armpit pain, arm pain where she received the vaccine on the right side, right neck swelling, tenderness, and lymph node thing. Patient reported that on 11Jan2021, she got the second dose at 9AM and by 5-6 PM she felt the symptoms. Then by 7:30PM felt terrible and had to have her sister come get her, she felt like she was going to pass out. She experienced the nausea before 7:30PM on 11Jan2021. The vomiting happened on 11Jan2021 at night 12 hours after the vaccine, she vomited the next day also around 10 in the morning on 12Jan2021. The upset stomach started 11Jan2021. Patient confirmed that she did not actually pass out but she felt light headed like she was going to pass out, it started on 11Jan2021 and went into 12Jan2021 she was just light headed and not well. The body chills aches started 11Jan2021 around the 5-6PM time, she felt fine most of the day but it was that evening she was achy. The headache started 11Jan2021 at night continued to 12Jan2021 and was still ongoing today. The right sided neck and armpit pain started yesterday 12Jan2021 and she still has it at the moment. She stated that she was probably dehydrated and still feels like she was recovering. She had right side neck swelling on 11Jan2021 and right sided under armpit pain on 12Jan2021. She has never been tested for Covid or had any antibody tests. She has had no issues with vaccines in the past. Outcome of the events 'Felt like going to pass out', 'Nausea, Vomiting', 'Upset stomach', 'Body chills and aches' was recovered on 12Jan2021; 'Headache' and 'dehydrated' were recovering; 'Right sided Neck Pain and Right sided armpit pain' was not recovered; 'dizziness' and 'right side neck swelling' were unknown.  No follow-up activities are needed. No further information is expected.
On 9-26-18 when shot was administered I immediately commented that the injection was more painful than normal. By 3 PM my upper arm was hot, painful and very heavy feeling. I had to stop working, ice my arm and take pain meds. I could not move my left arm at first, I have tried to keep it loose, but I cannot lift my arm over my head to remove my shirt, nor can I rotate my shoulder or put pressure on my left arm in certain directions without having pain. This continued for a few days until I began to hear about SIRVA from others with frozen shoulders. I knew immediately that I have SIRVA. The symptoms have improved, but remain.
Large red sphere around the injection area developed -- approximately 2".  The areas remains red with an itchy rash. I had no other reactions to the injection.
I received first Moderna dose on 1/15/2021 and then 5 days later (1/20/2021) I woke up with an incredibly sore and swollen lump near my collarbone. I went in to see my primary care doctor on the same day. She referred me to get an ultrasound done (1/21/2021) which confirmed it was 3 swollen supraclavicular lymphnodes, ranging up to roughly 2 cm. The swelling and pain went away in a week however the swollen lymphnodes did not. I got my second injection on 2/11/2021, which did not trigger any changes in the size or swelling of the lymphnodes. It has now been almost 3 weeks since my second dose and the size of the swollen lymphnodes remains unchanged. I have had one follow-up visit with my doctor who advised we check in in 2 weeks if the lymphnodes remain changed.
had fever 102-103;sleeping-when woke was irritable;had a sz-stiffened,clenched hands, stiff feet-eyes rolled back, clonic jerks for 1 1/2-2min-seen by paramedics;
Rash on right arm, has a slight burning sensation and almost looks like mild sunburn. No professional treatment using topical Hydrocortisone.
Pt received TDAP and MENACTRA, Influenza, HPV and PPD vaccines on 02/08/10. TDAP and MENACTRA were given on Right deltoid. Mom noticed pt has swelling and blister on right upper arm since 02/10/10. Pt transferred to Hospital for further evaluation via ambulance.
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA302578 (same reporter). This case involves a 11 years old female patient who was vaccinated with a 0.25 ml (instead of 0.5 ml) dose of FLUZONE QUADRIVALENT (lot UT6262NA via intramuscular route in the right deltoid) on 25-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not It was a case of actual medication error due to vaccine underdose. The patient didn't' t experience any adverse events following the vaccination. 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 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. List of documents held by sender: none.
Severe headache (same day) Friday, June 23, 2023  Rash started on back of neck and right shoulder (same nerve pathway of the severe case of Shingles that I had in April, 2023) Contacted pharmacy where I received the vaccine on Saturday, June 24, 2023. Contacted my PCP Monday, June 26. 2023.  Was seen at Urgent Care.  Prescriptions were refilled for anti-viral medication and for Lyrica (Pregagablin 75 mg) for nerve damage pain.
Patient received second dose of shingrix 1 month earlier than he was supposed to. He was due after July 16 but received it June 16. After giving him the shot, he stated that he wanted to make sure he got the second shot as soon as he was eligible (which he mistakenly thought was 1 month after the first), since a family member is very sick with shingles. I verified in his record that he did receive his first shot 1 month ago and therefore he was not really eligible.
patient tested positive for CoVid after first dose; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 05Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received first dose of vaccine on 05Apr2021 and has had covid exposure. She was inquiring if vaccine will show as positive on covid test and if positive should they get the second dose. Also inquiring if patient that tested positive after receiving first dose, if they should continue with second dose. It was further reported that on efficacy, patient tested positive for covid (Apr2021) after first dose. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
(R) deltoid with 6 x 5 cm red, hot area at injection site.
This spontaneous report was received from an office manager and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates reported as "over the past 3 months", the patients were vaccinated with improperly stored doses of M-M-R II lot # L041455 with expiration date: 22-OCT-2017, albumin status: recombinant human albumin (rHA) and lot# L015279 with expiration date: 30-APR-2017, albumin status: recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse experience was reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 21 hours cumulatively over "3 months," on unspecified dates. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA014473: US-009507513-1703USA014472: US-009507513-1703USA014471: US-009507513-1703USA014470: US-009507513-1703USA014469.
Received call from RN, she advised that child received double dose of flu vaccine. She stated that child received one dose of vaccine on the 17th or 18th of October 2021. Child received another dose of vaccine today, 10/20/2021, given by another RN. The child did not inform this nurse that he had already received a flu shot. School nurse, RN reports child informed her of prior dose and she attempted to contact parents but was unable to reach them, but sent child through line to get vaccine. The school nurse did not report to personnel that there was a possibility the child had received a prior dose. The school nurse later received call from parent verifying child did
site reaction with about 2 inches in size/grew larger about 4 inches wide; pain; redness; accidentally received Moderna vaccine age 6; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (site reaction with about 2 inches in size/grew larger about 4 inches wide), VACCINATION SITE PAIN (pain), VACCINATION SITE ERYTHEMA (redness) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally received Moderna vaccine age 6) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included Multivitamins for an unknown indication.    On 15-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced VACCINATION SITE REACTION (site reaction with about 2 inches in size/grew larger about 4 inches wide), VACCINATION SITE PAIN (pain), VACCINATION SITE ERYTHEMA (redness) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally received Moderna vaccine age 6). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 15-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally received Moderna vaccine age 6) had resolved. At the time of the report, VACCINATION SITE REACTION (site reaction with about 2 inches in size/grew larger about 4 inches wide), VACCINATION SITE PAIN (pain) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        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.
Case number PHEH2014US025042, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 50-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 15 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursions began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Radiating sharp pain that started in neck, then went to L  of chest to L upper arm. Evaluated by EMS, cleared.
Complete exhaustion; Total body pain in all my glands and joints; Total body pain in all my glands and joints; Extreme chills; Shaking; This case was reported by a consumer and described the occurrence of chills in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chills, tremor, exhaustion, general body pain and joint pain. On an unknown date, the outcome of the chills, tremor, exhaustion, general body pain and joint pain were recovered/resolved.   It was unknown if the reporter considered the chills, tremor, exhaustion, general body pain and joint pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had extreme chills and shaking lasting 3-4 hours, complete exhaustion, total body pain in all my glands and joints. The insurance would not reimburse for a doctor's visit. For tolerances of 2nd dose, refer case US2020AMR184227, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR184227:same reporter
Patient had COVID in Sept.  Minimal symptoms.  Received 1st dose 1/18 without adverse reactions.  Second dose on 2/8-had complaints of arm soreness several days after then appeared in usual state of health.  On 2/14 @ 2 hours after having lunch, patient was found unresponsive with Respirations 60, pulse 130, PO 84%, blood pressure 105/68.  Patient with lots of white foam coming out of mouth.   Temperature to 101.3.  Patient DNR B and family deferred transfer, wanted comfort measures only.  Nursing received order for MSIR.  Patient continued with temps in 99-100 range with tylenol suppositories.  Patient passed on 2/16.
Experienced sudden onset of shaking, sweating, increased blood pressure, shortness of breath, hyperventilating about 45 minutes after injection.  Went to ER, but did not wait to be seen.  States all symptoms resolved within about one hour after onset.
She developed a vasovagal type reaction following the administation .  Additionally she has had lightheadedness, numbness and tingling in her arms since the vaccine administration.  Pt states the symptoms have not improved since the initial adminstration.
Son reports the day after the vaccination, the patient had a stroke while waiting in the pre-op area for a trigger finger surgery. Patient had not been asked about pending surgeries or other medications on day of vaccination. Son reports patient stopped taking blood thinning medication 2 days earlier because of surgery. According to son, patient's symptoms have resolved and patient did return for second dose on 2/26/2021.
2nd COVID19 Pfizer vaccine 5/1/21 lot # EW0167. both vaccines received at pharmacy. 5/24/21 awoke at 0400 with headache and nausea and vomiting. Headache worsened throughout the day and went to  ED where she had syncopal episode and was treated for migraine headache with migraine cocktail and sent home. Symptoms continued and progressed the next day and she went to Hospital ED in where a CTH revealed SDH near her sinuses. She was transferred to Medical Center in for higher level of care. On arrival she had a CTH/CTA which revealed and extensive central venous sinus thrombosis.
Severe deep aching pain in shoulder and upper arm 7-10 days after vaccination.  Weeks later followed by weakness and atrophy in upper extremity muscle groups.
330PM hep B #1 & MMR #2 given & pt c/o feeling drowsy & became unresponsive x 30-40seconds, regain red responsiveness & then c/o nausea;no emesis noted states havent eaten anything x/a poptart;also stated this has happened @ school a/;
Fever of 101-102 with spikes higher with hallucinations from Saturday 3/13 @ 1 pm until Tuesday 3/16 @ 5 am.  Low grade fever continuing through 4/7.  Arm was very hot and would melt the ice packs used between arm and body.  Multiple asthma attacks from Saturday through  3/23.  Tops of feet swelled on Monday 3/15.  Arm pain, rash at injection site, and joint pain began on Sunday 3/21 and has continued through  3/23.  Whole left side of my body is hotter than the right side and is swollen slightly.  Migraine headaches, arrhythmia, and heart palpitations started on 3/13 and still continue just not as often.
Client called to describe shakiness, nervousness and "difficulty breathing-maybe I'm hyperventilating". Able to speak clearly with no apparent dyspnea. Advised ER assessment where she received Ativan 1mgm po and Benadryl 50mgm IV and dx of possible MMR reaction or anxiety.
Significant pain the affected extremity x 3 days - 7/10 pain, enough to wake me from sleep.
Rash torso, ring like rash left arm at site I&D at site. Given Benadryl and Minocycline. Possible erythema multiforme post smallpox vaccination.
Several pt from this facility exp unspecified adverse events p/vax with lot # 448451. No further info.
had some diarrhea; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in the left arm on 13Feb2021 (at the age of 84 years old) as dose 2, single for COVID-19 immunisation. Medical history included high blood pressure. The patient's concomitant medications were not reported. On 22Feb2021, the patient had some diarrhea in the last two days. The patient could not remember if treatment was taken for the event. The patient was recovering from diarrhea.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was seen at for a same day appointment at healthcare facility on 02 November 2023 with a complaint of back pain. He was evaluated and treated; the patient also wanted a COVID-19 2023-2024 Formula vaccine. The vaccine was administered. The patient left the office without incident.  Patient?s daughter  called the vaccinating providers office on 06 November 2023 to report her father (the vaccine recipient) was vaccinated on 02 November 2023. He went to the Emergency Department on 03 November 2023 with a compliant of chest pain & shortness of breath. The Emergency Department evaluated and treated the patient and discharged him to home.
pt recvd vax; began running fever 2-3 hrs p/ shots; T 105.2 12 hrs p/ shots;in er twice;on ATB;lt arm at inject site was warm; lt leg red, warm,hard x 48 hrs 6 days p/ vax; petechiae on lt shoulder & forearm;