chrisvoncsefalvay/vaers-outcomes huggingface dataset:
60 days out from first dose and have not received second dose,greater than 45 days since the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (60 days out from first dose and have not received second dose,greater than 45 days since the first dose) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (60 days out from first dose and have not received second dose,greater than 45 days since the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (60 days out from first dose and have not received second dose,greater than 45 days since the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No medication history information were reported It was reported that it was greater than 45 days since the first dose. Patient lost his vaccination card and was unable to provide the lot number and date of vaccination, but say it was around 15Apr2021 when mass vaccination stared. Stated he might had received the vaccine in his right arm but was not sure.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up information received on 21-JUN-2021 contains No new information
sore neck; chills; sore shoulder where she received the injection; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (sore neck), CHILLS (chills) and VACCINATION SITE PAIN (sore shoulder where she received the injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included ATENOLOL for an unknown indication.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced NECK PAIN (sore neck), CHILLS (chills) and VACCINATION SITE PAIN (sore shoulder where she received the injection). At the time of the report, NECK PAIN (sore neck), CHILLS (chills) and VACCINATION SITE PAIN (sore shoulder where she received the injection) outcome was unknown.            The patient received unspecified concomitant medications. The patient did not take any treatment medication.
I went to the ER on that Sunday and was extremely dizzy. I couldn't walk and I was nauseous. I was having chest pains that felt more like pressure on my chest which I believe was anxiety. Vertigo since vaccine. Been to ER and family doctor. Going to physical therapist. I was given a valium which caused me to go to sleep. I was discharged. I contacted my primary care physician on October 06, 2022. She refilled my Diazepam, Ondansetron and Meclizine. My doctor sent me to a physical therapist the following day. I have seen him 3 tines and I am feeling like I don't have to hold the wall all the time, but I feel dizzy and disoriented.  I am not as bad as I was but I am still pretty much stuck in a chair or in bed.
About 10-12 hours after the vaccination, I came down with severe flu-like symptoms: tiredness then extreme cold and shivering. That lasted for 5-6 hours into the night. . The next day, I was tired, but the other side effects were gone.
Arm feels "heavy, sore, achy, can't sleep if I lay on it" She states it got better after the initial soreness, then approx a week and a half ago became "significantly worse".
Left thigh swelling, redness, warm to touch day after injection 9/25/2014. Increased in size. Pt came into urgent care. BENADRYL and OMNICEF prescribed.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE TRANSIENT CEREBRAL ISCHEMIA RIGHT FACIAL MUSCLE WEAKNESS
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 21Jul2022 at 16:00, outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid was started as treatment on 12Jul2022 and stopped on 16Jul2022. Patient had Rebound on 5th days of finishing treatment. There was no other medication in 2 weeks administered by patient.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Arm started to hurt; This is a spontaneous report from a contactable consumer (patient). A 62-year-old-male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), via an intramuscular route of administration, administered in Arm Right on an unspecified date in Apr2021 (the day after Easter, so April 6th or 5th), at 09:15 in the morning (at the age of 62-year-old), as single dose, for Covid-19 immunization. The patient's medical history was none.The patient did not receive any other vaccine prior to this vaccination and no family medical history. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), via unspecified route of administration, administered in Arm Right on an unspecified date in Mar2021, (3 weeks before like on March 15th or something like that), at 09:15 in the morning (3 weeks before that, so it's like March 15th or something like that) as a single dose, for Covid-19 immunization. The patient's concomitant medications were not reported. The patient got his second shot on the day after Easter and just two days ago his arm started to hurt, on an unspecified date in 2021. It didn't hurt when he got the shot in April, but it just started hurting two days ago (date unspecified). While probing, the patient stated that he was still having the problem and the outcome was not the same. The patient did not receive any treatment for the event. The outcome of the event was not resolved.  Information on the lot/batch number has been requested.
Headache; Sore arm; This is a Spontaneous report from a non-contactable consumer (patient). A 48-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer covid-19 vaccine, Lot number: EN6199, Expiration date: 05Mar2021), via an unspecified route in the left arm on 05Mar2021 at 15:45, as a single dose for Covid-19 immunization. Medical history included diabetes. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within four weeks. The patient did not take any medications within two weeks. Since the vaccination, the patient had not been tested for COVID-19. The patient had not been tested for COVID-19 post vaccination.On 06Mar2021 at 09:00, patient experienced headache and sore arm. The clinical outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Rash on arm; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on arm) and MYALGIA (Body aches) in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash on arm) and MYALGIA (Body aches). At the time of the report, VACCINATION SITE RASH (Rash on arm) and MYALGIA (Body aches) outcome was unknown.            No concomitant medication details was reported.  No treatment medication details was reported.
pt had vax 26AUG92 late AM by evening felt unwell et didn't wan to eat; started vomiting 1AM; vomited until about 8AM; afebrile; parent called MD the following day improved, but has increased warmth et lump 1"x2" @ inject site;
Patient complained of uncontrolled spasms in shoulder, arms, legs 8-9 hours after getting flu shot. Lasted for 8-10 hours.  Also, got chills, headache, body aches.  Went to see Dr on 9/5/19 to make certain he was OK.  Dr said the adverse events are likely due to flu shot.
pruritic rash starting in the left shoulder region and spreading more diffusely over time to side and right side of back.  He was seen in ED and 03/07/21, given IV Solu-Medrol and prescriptions for Medrol taper plus Pepcid.  Reportedly he is seen his primary care provider several times in the interim but presented back to the ED on 3/29/21 for a pruritic rash.  He was admitted for 48 hours during which time he underwent nondiagnostic skin biopsy, and was discharged home on steroids and the proton pump inhibitor.  Within 48 hours of discharge she was readmitted with a mild lactic acidosis and persistent rash.
Erythema multiforme Reaccuring rash over body Treatments have been Steroids
little sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (little sick) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ILLNESS (little sick). At the time of the report, ILLNESS (little sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.   This case was linked to MOD-2021-325371 (Patient Link).; Sender's Comments: This case concerns a 50-year-old female patient with no relevant medical history, who experienced the unexpected event of Illness. The event occurred on an unknown date after receiving an unknown dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. The case is initially reported as serious however based on available information and medical judgement, the case is non serious as the outcome of the event is not hospitalization.
aching that started in the knees & then all over the body by Sunday (2 days later); not weak, but was painful upon movement; 12ARP93 better s/tightness in hands;
This spontaneous report was received from a lawyer regarding a case in litigation concerning an adult patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On or about 03-JAN-2013, the patient was inoculated, in a Medical Center, with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the long-term prevention of shingles (strength, route, anatomical location, dose number, lot/batch # and expiration date were not reported). On or about 07-AUG-2015, the patient was treated in Urgent Care for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered significant medical expenses, and pain and suffering, and other damages. At the time of reporting, the outcome of vaccination failure, herpes zoster, emotional distress, injury and pain was unknown. The reporter considered the events to be related to ZOSTAVAX.
The day after the vaccine was administered the patient had a large vomit and then had a blood stool.  Only one episode of bloody stool.  The patient was also fussy and her stools have been green and mucus.
Cellulitis to (R) thigh, red swollen, painful. Evaluated at Urgent Care.
Patient came in after receiving MMRV in the right leg on 7/18 with an area of induration and redness at sight of injection: redness 4 1/2 cm by 4 1/2 cm, induration: 6 cm by 5 cm.  Patient describes only itching. No pain/drainage/fever/other rash.
Nine days after the vaccine, the patient awoke from her afternoon nap with a fever of 103.5F. The patient was taken to the dr and nothing was found to be wrong. The next day she was fine.
back ache; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): 20220407295(0.0) (Janssen).  A 41-year-old female patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "back ache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient height and weight were not reported. Patient was health care professional. No past medical history or concurrent condition were reported. The patient received Covid-19 vaccine av26.cov2.s (dose number in series 1) (Suspension for injection, route of administration not reported, Batch number: 1805018, expiry: Unknown) Dose was not reported, 1 total administered on left arm on 05Mar2021 for prophylactic vaccination , No concomitant medication were reported. It was unknown weather patient had any adverse events following vaccination with covid-19 vaccine ad26.Cov2.s (Dose number is in series 1). The patient additionally received non-company suspect vaccine Pfizer biontech covid-19 vaccine (Dose number in series 2) (Form of admin not reported, rote of admin, batch number: Unknown, dose was not reported, 1 total administered on 28Oct2021 for prophylactic vaccination. On an unspecified date, the patient experienced back ache (dose number in series 2). On 03Apr2022, Laboratory data included: SARS-COV-2 rapid diagnostic test (NR: Not provided) negative. This report was non-serious. Causality as per reporter and Causality as per Mfr. for the event back pain with Janssen Covid-19 Vaccine (Covid-19 Vaccine Ad26.Cov2.S) was possible. Causality as per reporter and Causality as per Mfr. for the event back pain with Pfizer Biontech Covid-19 Vaccine (Tozinameran) was not applicable  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Blacked out, sweating, dizzy immediately after vaccine, called 911 patient recovered in 10 minutes.
L deltoid, warm-red. No fever, area of redness, 8 cm x 3 cm.
Patient was given a fourth Pfizer COVID vaccination. She received her booster (3rd dose) on 10/4/21 at a different pharmacy and received another one at this location (4th dose)
Information has been received from a nurse concerning 8 patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. From 04-NOV-2015 to 25-NOV-2015 the patients were each vaccinated with an improperly stored dose of GARDASIL (0.5 ml, intramuscular). Lot number (L021620) is an invalid lot number for GARDASIL. No adverse reactions reported. No product quality compliance (PQC) was reported. Additional information has been requested.
Started running a fever over 100.4 within 7 hours of the receiving the vaccination.  Fevers ended within 24 hours. Right arm at injection is still sore 2 days later.
freezing; her migraine went away; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (freezing), THERAPEUTIC RESPONSE UNEXPECTED (her migraine went away) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic migraine.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced FEELING COLD (freezing), THERAPEUTIC RESPONSE UNEXPECTED (her migraine went away) and PYREXIA (fever). At the time of the report, FEELING COLD (freezing), THERAPEUTIC RESPONSE UNEXPECTED (her migraine went away) and PYREXIA (fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications reported include unspecified allergy medications used for migraines.   No treatment information was provided.
Pt states he experienced myalgias and neck pain; went to ER on 10/14/2020
after a couple of days I felt dizzy, not all the time, but time to time, also like funny feeling on the jaws, neck head, goes away and comes back like a facial nevraly
Breakthrough case of COVID-19; Breakthrough case of COVID-19; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 (Lot number: ER8732) at the age of 36 years as dose 3 (booster), single, administered in arm left, administration date 19Apr2021 (Lot number: ER8731) as dose 2, single and administered in arm left, administration date 29Mar2021 (Lot number: ER8732) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergy-Allergic to Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. It was reported that patient not received other vaccine in four weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 post vaccination. The following information was reported: IMMUNISATION (medically significant) with onset 20Oct2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovering" and all described as "Breakthrough case of COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 rna: (31Dec2021) positive, notes: Nasal Swab; sars-cov-2 test: (31Dec2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Infant in clinic for first health check. Patient healthy and growth chart shows gaining weight, gaining length. During the health check, I inadvertantly administered required 2 month vaccines to a 22 day old infant. I did not utilize the recommended immunzation schedule for children and adolescent guide before administering the immunizations listed above. Upon my mistake, I contacted the parents reporting the error and to check on the health of the infant. Mother reports no adverse reaction at the time of phone call. Advised to call with questions or concerns.
Case number PHEH2014US019179 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 42 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).
COVID 19 Treatment; COVID 19 Treatment; vaccine brand=Other, vaccine brand other=Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 04Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Sep2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Heart condition" (unspecified if ongoing), notes: Heart condition. Concomitant medication(s) included: LIPITOR, start date: 01Aug2008, stop date: 27Mar2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Sep2022 at 12:00, outcome "unknown", described as "vaccine brand=Other, vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. COVID symptoms returned 4 days after completion of antiviral medication. Tested positive for COVID. Symptoms include fever, runny nose.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
hives and itching; hives and itching; This spontaneous report was received from a physician via company representative regarding a 11-year-old female child patient. Information on patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-MAY-2019 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) via unknown route for prophylaxis (also reported as for prevention of HPV: Human papilloma virus), strength, dose, frequency, lot # and expiration date were not reported.On 03-MAY-2019, the mother of the patient called the physician's office to report that her child (patient) had developed hives and itching (urticaria and pruritus) on 02-MAY-2019. It was not specified if events had occurred at injection site or elsewhere on the body. Patient had not recovered from the events urticaria and pruritis. Causality assessment was not reported. There was no involvement of product quality issue (PQC).   This is one of the two reports received from the same source.