chrisvoncsefalvay/vaers-outcomes huggingface dataset:
(Above - for "Dose number in series" I typed "2" because I had the vaccine in May of 2021 and this was the booster I'm writing about now...) I received the Johnson & Johnson booster shot from my Pharmacy on afternoon of December 3rd. My arm was sore Friday night and Saturday I became more sore and had a headache - which didn't necessarily seen too weird since I do get them. But Sunday I was feeling worse. My stomach was hurting - a sharp pain about the level of the belly button. I felt worse as the day went on.  We had family over for dinner in the evening. By that time my stomach cramping was severe, I had nausea and threw up two different times. My headache was super strong. I normally take Rizatriptan with a migraine and most of the time one 10mg dose works. I took that first dose to no avail. So two hours later I took a second dose. It didn't work either. I ended up with a third dose - I NEVER have to do that. It was an awful night. The next couple of days I had bad nausea and the headaches have continued. I'm having migraines nearly everyday, coupled with nausea.
At first, joint in index finger of left hand notes to be swollen, painful, and ROM decreased. A few days later, thumb of opposite hand noted to have the same symptoms to a lesser degree and all joints in hands noted to feeling stiff with no decrease in ROM. Attempted treatment with Tylenol with no effect. Symptoms have continued for a week now.
Minimal soreness at site with injection. Next day had "Flu like symptoms", he stated. Muscles ached all over , chills, and fever. Missed 1 day of work. Better, but still feels achy at present, 5 days post vaccination. Resolving slowly.
Pt c/o rash over body after last COVID vaccine and also with previous vaccine. erythematous rash noted over b/l arms. No tongue/Lip swelling  No other symptoms.  benadryl 25mg given.
This spontaneous report was received from a medical assistant referring to an 18 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 08-MAR-2018, the patient was administered an improperly stored PROQUAD (lot: N025928, expiry date: 18-MAR-2019) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 15 °F to 46°F (32.2°F) for 9 hours, 27 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter. Sender's Comments: US-009507513-1804USA004755.
Information has been received from a physician via a company employee referring to a 12 year old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown. On 28-OCT-2017 the patient received the first dose of GARDASIL 9 (strength, frequency, batch/lot # and expiration date were not reported) intramuscularly for "prevent HPV related conditions". In 2017 the patient had been diagnosed with 'Pain Amplification Syndrome'. The patient had "seen multiple specialists". The outcome of the event 'Pain Amplification Syndrome' was not recovered. The causality between the event and GARDASIL 9 was not reported.
Flu-like body/muscular aches, severe pain at injection site. Continued to worsen for 24 hours. Noticable improvement after 36 hours.
her arm was sore; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 81-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient herself. The patient expected her arm to be sore and adds with the 2nd shingles vaccine her arm was sore, which was received years ago from the date of reporting. She did not had any product or information to provide, lot or expiration date the shingles vaccine.  The patient received Pfizer Covid vaccine and experienced arm hurt, quesy and pasty stools. The 2nd dose was scheduled on 6th February 2021.
felt very weak and winded; felt very weak and winded; an immense amount of pressure in her ears; congestion in her nose; throat began to hurt; throat began to swell; swallowing and speaking became close to impossible; swallowing and speaking became close to impossible; asthma flare up; ear infection; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 29Jul2021 at 10:15 am (Batch/Lot Number: EW0186) (at the age of 18-yrs-old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at the Doctor office/urgent care. Medical history included bronchitis in 2011. The patient has no past drug history and concurrent conditions. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received birth control within 2 weeks of vaccination. On 29Jul2021 at 14:00 (4 hours after receiving the vaccine), the patient's throat began to hurt. As more hours passed, her throat began to swell and swallowing and speaking became close to impossible. It was like this for three days following. On the third day (on 01Aug2021) of her throat swelling, she developed an immense amount of pressure in her ears as well as congestion in her nose. The fourth day after receiving the vaccine (on 02Aug2021), she felt very weak and winded. The fifth day after (on 03Aug2021), she went to urgent care as she was still experiencing these symptoms and was informed that she had an asthma flare up. For context, she hasn't had an asthma flare up since she had bronchitis 10 years ago. She was also informed that she had an ear infection. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment which included Amoxicillin, Benzonatate, Inhaler, and Pseudoephedrine. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for COVID-19 Since the vaccination. The outcome of the events was recovering/resolving.    No follow-up attempts are needed. No further information is expected.~
17 year old daughter received the first dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter received the first dose of the vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter received the first dose of the vaccine). On 26-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter received the first dose of the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 016B21A) with no associated AEs reported.
pt recv vax 29APR96 & w/in 4hr pt w/temp to 101.8R & extreme irritability;sx persisted x 2 1/2 days;
Arm pain at injection site, slight fever of 100.4, body pain, chills, loss of energy.
feeling crappy; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling crappy) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    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 an unknown date, the patient experienced FEELING ABNORMAL (feeling crappy). At the time of the report, FEELING ABNORMAL (feeling crappy) had resolved. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient received one booster dose of the Moderna COVID-19 vaccine previously. Patient could not provide the lot numbers for the previous doses at this time. With the previous shots, had 2 days of feeling "crappy" and it was over after that. Patient didn't want to do anything for those two days but felt better after that.
Positive case of covid; Positive case of covid; MARKETING NAME NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4246404-00.  A 65 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Apr2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single and intramuscular, administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single and administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "upper respiratory infections", start date: 2018, stop date: 2018, notes: In 2018, the patient experienced upper respiratory infections. In 2018, event resolved.; "sick", start date: May2021, stop date: May2021, notes: Event sick occurred in May2021 and resolved in May2021. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "recovered with sequelae" and all described as "Positive case of covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2021) positive, notes: Positive. On unknown dates, the patient experienced upper respiratory infections and non-fda approved indication for enteropathic arthritis. in 2018, the patient experienced upper respiratory infections. in 2018, the upper respiratory infections resolved. in May2021, the patient experienced sick. In May2021, the sick resolved. In Nov2021, the patient experienced positive case of covid. On unknown dates, positive case of covid resolved with sequelae and non-FDA approved indication for Enteropathic arthritis resolved. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Apr2021, patient received 1st dose COVID-19 Vaccine manufactured by Moderna. In May2021, patient received 2nd dose COVID-19 Vaccine manufactured by Moderna.    The reporter causality for the event positive case of covid was Not Reported with BNT162B2.  The reporter causality for the event positive case of covid was Not Reported with covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE)   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
First dose of vaccine was administered to patient in the face of a known contraindication.  Patient reported having received another vaccine within the prior 14 days.
swelling of the lymph node and under the armpit; pain at the injection site, tenderness at the injection site; body ache; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling of the lymph node and under the armpit), VACCINATION SITE PAIN (pain at the injection site, tenderness at the injection site), MYALGIA (body ache), HEADACHE (headache) and NAUSEA (nausea) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced LYMPHADENOPATHY (swelling of the lymph node and under the armpit), VACCINATION SITE PAIN (pain at the injection site, tenderness at the injection site), MYALGIA (body ache), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, LYMPHADENOPATHY (swelling of the lymph node and under the armpit), VACCINATION SITE PAIN (pain at the injection site, tenderness at the injection site), MYALGIA (body ache), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient reported using warm showers as treatment.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up document is received doesn't have any new information
The pt developed hives three hours post-vaccination with sore throat. Applied hydrocortisone cream and reports she's fine. Denied further symptoms.
Pain on the left arm with some discoloration and swollen at the site of the injection., tired, weak, sleepy, headache, freezing cold.
swollen injection site; super itchy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE PRURITUS (super itchy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE PRURITUS (super itchy). At the time of the report, VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE PRURITUS (super itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was provided.
This spontaneous reprot as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 08-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Hives onset > 24 hours after receiving .25 pediatric pre-filled flu vaccine. Instructed to take BENADRYL and hives resolved in 1 1/2 days after administration.
pt brought to ED from facility with sacral wound, found to have UTI and is dehydrated; O2 supplementation; IV fluids given; wound care; pt dc'd back to facility; on day of discharge pt tested positive for COVID; pt passed away in the facility.
Information has been received from a health professional concerning a 7 year old male patient who on 01/15/1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Subsequently, on approximately 04/09/2004, the patient developed breakthrough chickenpox with less than 50 lesions.  Follow up information indicated that there was not a single report of adverse reaction following varicella vaccination.  The reporter indicated that 49 other patients developed breakthrough cases of chickenpox.  No additional information is expected.
mom states child devel red eyes w/yellow drainage which did not respond to treatment;approx 5wk p/vax still has eye irritation & episode of leg weakness;
No adverse event; Bivalent doses administered after the BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD).    No concomitant medications were reported.  It was reported that, the patient received bivalent doses after the beyond use-by date.  No treatment medications were reported.
Pt said the next day her left deltoid muscle area was swollen, red and itching. The following days the swelling/redness spread to the entire upper left arm. Advised pt to make appt with her PCP ASAP.
Bilateral Pulmonary Embolism (Saddle Embolus), Shortness of Breath, Deep Vein Thrombosis - Left Leg.
Syringe leaked and she thinks she only received half of its dose; A spontaneous report was received from a dentist who was a 28-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced syringe leaked and she thinks she only received half of its dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020 at 11:30, the patient received her first of two planned doses of mRNA-1273  intramuscularly for prophylaxis of COVID-19 infection. During the administration, the syringe had a leakage and she thought she only received half of its dose. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The event, syringe leaked and she thinks she only received half of its dose was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 28-years-old, female patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date- unknown), reporting an unexpected event of Incomplete dose administered. The event of Incomplete dose administered was considered not related to Moderna COVID-19 Vaccine.
Pt was given 0.25 ml of 2nd dose in Primary series of Moderna, No reaction
12:15 -pt sitting, vitals taken before admin Gardasil in LA. pt passed out, approx 3 min pt wasn't lucid. vitals taken again, pt friend stated that this is a normal occurrence when pt receives vaccinations.  physician came in and pt was laid down in the floor at this time and her feet were elevated. vitals were taken in increments at this time per physician request, at approx 12:40 pt tolerated sitting up and the pt was wheeled down to the clinic for observation.
Patient presented to the clinic visit for COVID-19 booster (order placed). Per report, clinic has just received a new shipment of Pfizer COVID-19 booster, but with its Gray cap, it looks just like the monovalent version for the primary series. RN administered the vaccine and discharged patient. Upon entering the information into the system, warning fired for the incorrect product (NDC 59267-1025-1). RN notified manager, and both of them confirmed that they have just given patient the monovalent rather than the bivalent vaccine.  Provider notified. Patient was informed about the error.  No adverse event noted otherwise.
Back pain; Headache; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 13:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to avocado. Concomitant medication include apixaban (ELIQUIS). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, same day after vaccination, the patient experienced arm pain for two days. On 02Apr2021, days 3 and 4 after the shot, the patient experienced headache. On 04Apr2021, day 5 and 6 after the shot, the patient experienced back pain. The events arm pain, headache and back pain resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event arm pain was resolved on 01Apr2021 while the events headache and back pain were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
PATIENT STATES THAT HIS ARM STARTED HURTING THE MONDAY (10/16/23) FOLLOWING THE VACCINE ADMINISTRATION OM 10/13/23.  HE STATES HE HAS PAIN IN THE RIGHT ARM, THE PAIN WAS SIGNIFICANT ENOUGH THAT HE MADE A DOCTOR'S APPOINTMENT.  HIS DOCTOR STATED TO HIM THAT THERE WAS NOTHING TO BE DONE AND THE PAIN HAS SUBSIDED BY 10/21/23.  WHEN ASKED IF THE ARM HAD BEEN RED OR SWOLLEN, PATIENT RESPONDED NO.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient.  A 60-year-old female patient received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ ritonavir (PAXLOVID) from 26Feb2023 to 03Mar2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.