chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash at injection site; Itchy at injection site; Warm at injection site; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE WARMTH (Warm at injection site) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 immunisation.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). On 15-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE WARMTH (Warm at injection site). On 09-Jan-2021, VACCINATION SITE PAIN (Soreness at the injection site) had resolved. On 17-Jan-2021, VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE WARMTH (Warm at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Cortisone cream was given as Treatment medication for Itchiness.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up received on 02-Jul -2021: contain No New Information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt has a needle phobia. After getting the vaccine he started sweating and started feeling light headed. He layed down and we gave him some water and some juice. He started feeling better and left after 30 mins
cancer; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was reported to have not started chemotherapy yet and wants to know if he can get vaccine before or after starting chemotherapy for cancer. I was not reported if patient had cancer prior to taking the first dose of the vaccine. The patient has an appointment to get the second dose and was told to bring gatorade and take ibuprofen not acetaminophen. The outcome of the event was unknown.  Information about lot/batch has been requested.
Petechiae type rash on cheeks only - Mom spoke with her private MD office who advised possible vaccine reaction.
My (very) consistent menstrual cycle was 10 days later than normal.  It was also a much heavier than normal flow.
This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccination in a 7-year-old unk patient who received INFANRIX. On an unknown date, the patient received the 1st dose of INFANRIX (injection). On an unknown date, an unknown time after receiving INFANRIX, the patient experienced inappropriate age at vaccination. On an unknown date, the outcome of the inappropriate age at vaccination was unknown. It was unknown if the reporter considered the inappropriate age at vaccination to be related to INFANRIX. Additional information: The nurse reported that a 7 year old received an INFANRIX vaccine. INFANRIX was recommended for children between 6 weeks to 7 years old (prior to seventh birthday). No adverse event reported. No additional information was available. The case was closed.
The patient was administered the tetanus toxoid vaccine as a part of routine immunization care.  Whithin 2 hours after administration of the vaccine the patient displayed difficulty breathing, swelling, and a rash subsequently developed.  The patient was rushed to a local emergency room for treatment in which the patient received treatment with corticosteroids, antihistamines, albuterol inh., and calamine lotion.
Red Rash predominately on face arms and butt however is widespread over body possibly itchy headache a couple days prior and tired
101.6 - 103.7 Fever, chills and rigors, cough, right side pain below arm pit wrapping around to sternum, right side back pain likened to softball size compression
Fever; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (friend). A male patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Lot number and NDC number was not reported) dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Investigation assessment was not provided. The patient medical history and concomitant medication was not reported. On an unspecified date the patient experienced fever. Reported as her friend got their first shot of the  BioNtech Covid 19 vaccine. The day after first dose the patient had started to have adverse reactions. The caller only said he had fever. She  did not provide additional details about the other adverse events.  The patient has had these adverse events since the day after the dose  The clinical outcome of the event was reported as unknown.
Pt was given monovalent vaccine as a pfizer booster instead of the bivalent pfizer vaccine.
I have been having a pain in same section, in same area where the needle was inserted; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), dose 2 via an unspecified route of administration on 31Mar2021 (at the age of 63-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (at the age of 62-year-old) on an unspecified date in 2021 for COVID-19 immunization. Patient stated, I had been having some side effects I believe from the vaccine. I received it from, four months ago but almost every night after a month of it, I had been having a pain in same section, in same area where the needle was inserted on an unspecified date in 2021. It became more intense right now it more intense, every evening when I came home, I was having that serious pain when I go to bed. Patient stated date of first shot "It was 3 weeks before that" and further not clarified. Consumer stated date of adverse event "May be a month after the vaccine (Confirmed as second dose) was administered." Patient again stated, "No, I had not taking any medication for it, I was just concerned every night same problem, we are right now speaking, I was still feeling the same." Patient stated I went to a hospital. It was general hospital, government facility. Patient stated I know persons who are facing the same thing, but they are not family, but they are friends have the same problem. There was no investigation assessment. The clinical outcome of event was not recovered.  Follow-up activities closed. Batch/lot number not available for [Vaccine, BNT162B2].
My palette has radically changed.  Food and drink don't taste good. My body smells like sulfur or vinegar, in a bad way. My urine and poop smells weird, also like acidic.
Patient was Positive for Covid-19 in September 2020, repeat testing in October showed negative result.  Patient was vaccinated on 2/24/21 and 3/17/21 with Pfizer-BioNTech COVID-19 vaccine.  Patient developed COVID 19 on 6/20/21, and was hospitalized for acute respiratory failure.  Patient was intubated and required pressor support with norepinephrine and an IABP.
moderate vaginal bleeding; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 16Jan2021 13:00 (Batch/Lot Number: EL3248) as single dose, dose 2 via an unspecified route of administration, administered in Arm Right on 06Feb2021 (Batch/Lot Number: EL9269) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously experienced drug hypersensitivity. The patient reported that about 12-18 hours after getting the 1st and 2nd shot she experienced light to moderate vaginal bleeding for 2-3 hours and then it cleared up. Both times she was not near her mensural cycle. The patient did not have any other vaccine in four weeks. The patient was not priorly Covid vaccinated. The patient was not tested Covid post vaccination. The outcome of the event was reported as recovered on an unspecified date 2021.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 06-Jun-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 10 microgram. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.).    The route of administration of suspect Moderna bivalent dose 1 and 2 was reported as BI. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case.
Patient is COVID positive 11/16/2021.  Pt is fully vaccinated. Patient presents to ED with chief complaint of cough, chest congestion, headache body aches with intermittent nausea vomiting. She reports she is able to eat small amounts of food and drink small amounts of liquid. Reports last night had a fever 102. Using over-the-counter medications. Patient for she does have some shortness of breath, no chest pain, no back pain.  Patient is satting 98% on room air. Positive for headache. Patient will be discharged with a prescription for motrin, mucinex.  Discussed importance of returning to ED for new or worsening symptoms.
Approximately four hours after administration of flu vaccine (and concurrent pneumococcal vaccine), patient felt flu symptoms.  Within 2-3 hours, full case of flu developed with chills/fever, full-body muscle aching, eye irritation, dry cough, headache, fatigue.  Patient spent next 36 hours in bed.  Fever broke after appox. 30 hours.  Dry cough persists into fourth day after vaccination.  Treatment was bed rest, aspirin, OTC cough suppressant.  Patient is not illness-prone, has not had flu for more than five years prior.  Patient in generally strong health, except for Type II diabetes, which is well controlled by diet, medication, and exercise.  No adverse reaction with any prior influenza vaccination.
Both feet hurt the day shot. As days go by the pain was in lymph nodes on my shins. The pain started moving up my legs as days passed. Fatigue. Headaches. By may 18th the pain was up to my hips, arms, and hands. My joins felt swollen.  Muscle weakness in legs and arms. Difficult to walk.Was admitted to the hospital on the 19th.  For 5 days
sluggish; rash now looks like a Black and Blue Mark; Burgundy dark red rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (sluggish), VACCINATION SITE DISCOLOURATION (rash now looks like a Black and Blue Mark) and VACCINATION SITE RASH (Burgundy dark red rash at injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 004420A) for COVID-19 vaccination.     No medical history was reported by the reporter. .  Concomitant products included IBUPROFEN for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (sluggish), VACCINATION SITE DISCOLOURATION (rash now looks like a Black and Blue Mark) and VACCINATION SITE RASH (Burgundy dark red rash at injection site). At the time of the report, SLUGGISHNESS (sluggish), VACCINATION SITE DISCOLOURATION (rash now looks like a Black and Blue Mark) and VACCINATION SITE RASH (Burgundy dark red rash at injection site) outcome was unknown.            No treatment was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
perniosis; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A male patient of an unspecified age (reported as age of 51) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on an unspecified date on Feb2021, as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient wanted to know efficacy after one dose. Patient reported that 3 days in to it, he developed welts on his feet and hands. He then stated his HCP said it was COVID toe and diagnosed him with perniosis on an unspecified date on Feb2021. Patient stated he does not have COVID. He wanted to know if this could have been caused by the vaccine and if it is safe for him to get the second dose and how long before he has to get the second dose. The outcome of the event reported was unknown.  Information about batch/lot number has been requested.
pt had fever to 106 & had 5' febrile convuls w/in 1hr p/vax;pt had a mild viral GE several days a/;seen p/sz & LP done neg;
(first 24 hours) extreme fatigue, severe headache, photosensitivity, nausea and loss of appetite, muscle aches, joint pain, neck and back aches, swollen/puffy eyes, loss of color, sudden and extreme feelings of being cold and unable to warm self, extreme shacking /muscle spasms, shooting pain like lightning in feet when moved, labored breathing, 102 temperature,  (next 24) severe headache, major fatigue, loss of appetite, body, muscle aches, Joint pain. loss of color (next 12) feeling hot and sweating, headache, inability to be comfortable to sleep, color loss
This spontaneous report as received from a medical assistant refers to an adult patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JAN-2017, the patient was vaccinated with two pediatric doses of VAQTA, strength reported as 25/0.5 (no unit was provided), lot # M031806, expiration date 30-MAR-2018, intramuscularly (dose was not reported). There was no adverse effect reported. Additional information has been requested.
330 PM had feeling of lump in throat; 630 PM not feeling well, lump in throat causing some coughing. Had increase nausea in the evening and his eye were "burning & turning red. " At 10 PM he vomited violently, repeatedly and his eyes "turned blood red." He had fever that night, malaise, HA & weakness 10/17 & 10/18; felt better 10/19.
day 1-3: take 4 Advil for pain for one day day 4-6: start swell ( red) and itch. Use ice pack day 7: minimum pain and  itch remain.   Much less adverse events  than first time.  One week after vaccine, I have no problem to do house work.
Blotches and rash on arms and upper chest. Triamcinolone cream applied twice daily. Blotches and rash have gotten slightly better and treatment has to stop this Sunday night. Going to see PCP 12/5/2017.
99.4 fever erythematous rash on left arm and face. Tx given Benadryl 25mg TID.
Patient developed sever nausea, chest tightness, blurred vision, and one episode of vomiting. Patient stated requested that we call 911 and he wasn't able to stand up.
This case involves Infant and unknown gender patient who experienced menquadfi was administered to a patient post-excursion with no reported adverse event and temperature excursion due to a power outage and refrigerator malfunction, reports temperature excursion was 0.06c, total time of excursion was 1 hour with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot U7218AC via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event, "menquadfi was administered to a patient post-excursion with no reported adverse event" (poor quality product administered) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE. On an unknown date the patient developed a non-serious temperature excursion due to a power outage and refrigerator malfunction, reports temperature excursion was 0.06c, total time of excursion was 1 hour with no reported adverse event (product storage error) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE. It was reported, "MENQUADFI experienced a temperature excursion due to a power outage and refrigerator malfunction; reports temperature excursion was 0.06C; total time of excursion was 1 hour. Pediatrician states MENQUADFI was administered to a patient post-excursion." Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable. It was not reported if the patient received a corrective treatment for the events (MENQUADFI was administered to a patient post-excursion with no reported adverse event, temperature excursion due to a power outage and refrigerator malfunction, reports temperature excursion was 0.06C, total time of excursion was 1 hour with no reported adverse event). At time of reporting, the outcome was Unknown for the event menquadfi was administered to a patient post-excursion with no reported adverse event and was Unknown for the event temperature excursion due to a power outage and refrigerator malfunction, reports temperature excursion was 0.06c, total time of excursion was 1 hour with no reported adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. 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.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in an 81-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported. The reporter stated that because their facility has not been able to download the digital data logger, they have been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the State was made.  There had been no power outages that would have impacted the Moderna vaccine. However, she reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion.  Reporter stated that no adverse reactions were reported by any patients.
EE is fully vaccinated as on 1/27/2021 with Pfizer and contracted COVID, tested PCR positive on 9/08/2021