chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hormonal acne; Skin lesions on torso mostly on back; burning sensation to her face and torso; itching localised; redness/erythema local; hives/urtricaria local; This spontaneous case was reported by a pharmacist and describes the occurrence of SKIN LESION (Skin lesions on torso mostly on back), BURNING SENSATION (burning sensation to her face and torso), PRURITUS (itching localised), ERYTHEMA (redness/erythema local) and URTICARIA (hives/urtricaria local) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PRURITUS (itching localised), ERYTHEMA (redness/erythema local) and URTICARIA (hives/urtricaria local). On 01-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN LESION (Skin lesions on torso mostly on back) and BURNING SENSATION (burning sensation to her face and torso). On an unknown date, the patient experienced ACNE (hormonal acne). On 15-May-2021, BURNING SENSATION (burning sensation to her face and torso) had resolved. On 18-May-2021, PRURITUS (itching localised), ERYTHEMA (redness/erythema local) and URTICARIA (hives/urtricaria local) had resolved. On 21-May-2021, SKIN LESION (Skin lesions on torso mostly on back) had resolved. At the time of the report, ACNE (hormonal acne) 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 considered PRURITUS (itching localised), ERYTHEMA (redness/erythema local), URTICARIA (hives/urtricaria local) and ACNE (hormonal acne) to be possibly related. No further causality assessments were provided for SKIN LESION (Skin lesions on torso mostly on back) and BURNING SENSATION (burning sensation to her face and torso).    No concomitant medications provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received provided patient ethnicity, additional events, suspect dosage details and reporter causality.
On 01/23/2001 the patient developed several itchy and painful papules. On 01/03/2001 the patient presented to her physician's office with a large crusty patch on her left side near her back. The physician indicated she had Herpes Zoster. Additional information has been requested.
Uncomfortable / Swollen lymph nodes on my left collar bone / remained the same size; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Uncomfortable / Swollen lymph nodes on my left collar bone / remained the same size) in a 41-year-old female patient who received mRNA-1273 (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced LYMPHADENOPATHY (Uncomfortable / Swollen lymph nodes on my left collar bone / remained the same size). At the time of the report, LYMPHADENOPATHY (Uncomfortable / Swollen lymph nodes on my left collar bone / remained the same size) had not resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Concomitant medications included birth control pills.  Treatment details were not reported by the reporter.
Seizure; Condition aggravated; This case was received via FDA VAERS (Reference number: 1036286) on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of SEIZURE (Seizure) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included seizure.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, SEIZURE (Seizure) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no known allergies has been reported. the concomitant medications not reported . the patient has the medical history of seizures.  Company Comment: Very limited information regarding the events has been provided at this time.  Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is not expected.
After receiving my vaccine, 2-3 days following I began to feel all over body aches and pains, muscle and joint stiffness and soreness. I was congested beyond belief with an migraine-like headache. I would feel nausea and vomit from the pain.
I received my Moderna booster Tuesday around 11 am.  Fine during the day.  Around 8 pm I started to have chills and kept getting more and more; headache came on around 10 pm.  Went to bed at 11 freezing; couldn?t get warm. Woke sometime during the night to go the bathroom; still freezing.  When I got up I was very dizzy and felt I was going to faint.  I laid on the foot of our bed and can?t say for sure if I passed out.  I was still very light-headed when I woke at 7 (Wednesday, 10th) and felt faint if I tried to get up.  Chills were a lot less. No headache.  By 9 I got out of bed, slight chills but not feeling faint.  Just felt out of it.  Spent the day on the couch sleeping almost all of it.  Tried to make coffee around 10 and instead of pouring water in the pot I poured it on the counter.  Looked at it and left it.  Around 6pm I was feeling better with no more chills.  Thursday (11th) I noticed my left underarm/armpit is very sore.  Feel fine otherwise.
Acute flare of uveitis R eye. Ocular pain, redness, photophobia
Redness and swelling, 4 fingers below top of shoulder and extends in a band from injection site to inner axilla. Pt also reports a fever of 100F. Recommended no further pneumo vacc and caution with TD boosters.
The child was given Moderna COVID-19 vaccine as a booster; Generalized malaise; Diarrhea; Soreness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of MALAISE (Generalized malaise), DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Soreness at the injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The child was given Moderna COVID-19 vaccine as a booster) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer-BNT 10 mcg on 09-Nov-2021 and Pfizer-BNT 10 mcg on 01-Dec-2021. Past adverse reactions to the above products included No adverse event with Pfizer-BNT 10 mcg and Pfizer-BNT 10 mcg.    On 12-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The child was given Moderna COVID-19 vaccine as a booster). In July 2022, the patient experienced MALAISE (Generalized malaise), DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Soreness at the injection site). In July 2022, MALAISE (Generalized malaise), DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Soreness at the injection site) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The child was given Moderna COVID-19 vaccine as a booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history information or past illness for the patient was reported. No concomitant medications were reported. The patient received Moderna-Booster 50 mcg. No treatment medications were reported.   This case was linked to MOD-2022-613069, MOD-2022-613065 (Patient Link).
given the adjuvant portion only.; given the adjuvant portion only.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number D4PA4, expiry date 10th February 2023) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The clinical coordinator reported that, the patient received the adjuvant portion of Shingrix only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021180796, US2021180799, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021180796:same reporter US-GLAXOSMITHKLINE-US2021180799:same reporter
Dose 1 given 3/17/2021 lot # 040A21A Moderna  Pt was hospitalized with Covid 19
My skin is itchy all over but not too itchy that it creates a rash. The itch is very slight but all over my body; This is a spontaneous report from a contactable consumer (patient). A 21-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 09Mar2021 13:45 (at the age of 21 years old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication received within two weeks of COVID vaccine included acetaminophen (ACETAMINOPHEN), etonogestrel (NEXPLANON), cyanocobalamin (VITAMIN B 12 [CYANOCOBALAMIN]), and iron supplements, all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 12Feb2021 16:45 (at the age of 21 years old) as single for COVID-19 immunisation. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced my skin is itchy all over but not too itchy that it creates a rash. the itch is very slight but all over my body on 09Mar2021 14:30. No treatment given for the event. Patient did not tested for COVID post vaccination. Outcome of the event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
MOTHER STATES--  when boy woke up this AM reports ---fever of 99.1  body aches all over.  feels nauseated
Received immunizations Wednesday, 8/22/18. Wednesday night noticed arm "a little swollen, but child not complaining of pain. The swelling continued and on Friday morning noticed significant more swelling, red, and warm to touch, still no complaints of pain. Friday, 8/24/18, child presented in clinic with Right Deltoid swollen, red, and warm to touch. Diagnosed as Cellulitis and treated with Cephalexin 250mg/5ml 1 tsp bid x 7 days.
Persistent tinnitus  in both ears two months after Pfizer Covid booster shot. Event started one day after receiving the booster shot. No alteration or event in the patient life around this time.
On 5/9/02, mom called and reported redness and swelling the size of a golf-ball, warm to touch and a fever of 100F-101F. On 5/10/02, seen in office with a fever of 100F, increased redness and some swelling. Still able to move in all motions and still warm to touch.
pt says the next day after taking the vax her right arm has become sore and red from the elbow up to the shoulder.  The arm has a lump around the injection site and is warm to the touch.  As of today 5/4/21  the redness is gone but it is still warm and sore.  Pt has been taking Tylenol but has not helped any.  Pt will call her PCP for medical advice.
Right arm locked up for 6 weeks, could not raise above head for 7 months. X-ray and MRI. Shot was given to me out of surgery for ACDF neck.
sick at my stomach; sick at my stomach; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 21Feb2022 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; COVID-19 vaccine (Dose 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious), ABDOMINAL DISCOMFORT (non-serious) all with onset Feb2022, outcome "unknown" and all described as "sick at my stomach". Additional information: The patient stated, "Yes, I am calling about some of the side effects that I am having to see if that is was it is?" The patient then stated, "I had the, I took my booster, I had the, I am fully vaccinated, and I took my booster shot Monday." (Clarified the product name as Pfizer COVID-19 Vaccine).  When clarified if the patient was experiencing side effects after taking the booster of Pfizer COVID-19 Vaccine, the patient stated, "Yes, that's what I want to." The patient stated, "Yes, I have a doctor my primary doctor. I don't understand you. I'm not getting the straight of it. Well, listen thank you for helping me and I will try to get in touch with them tomorrow. I have been sick at my stomach (incomplete sentence)."  The lot number for bnt162b2 was not provided and will be requested during follow up.
my arthritis is 100% worse; My pain is debilitating and has been since I received the vaccinations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRITIS (non-serious), outcome "unknown", described as "my arthritis is 100% worse"; PAIN (non-serious), outcome "unknown", described as "My pain is debilitating and has been since I received the vaccinations".  Additional Information: Since patient received Covid 19 vaccinations patients arthritis was 100 percentage worse. In fact, patient had Rheumatologist checking on more information about this and primary. As of the point where patient fear may be disabled at a much earlier age in life. The patients pain was debilitating and had been since received the vaccinations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It itches a little bit in one spot; Rash on the upper arm of the injection site; Extra dose administerd; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (It itches a little bit in one spot), VACCINATION SITE RASH (Rash on the upper arm of the injection site) and EXTRA DOSE ADMINISTERED (Extra dose administerd) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A, 016M20A and 038B2114) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (It itches a little bit in one spot), VACCINATION SITE RASH (Rash on the upper arm of the injection site) and EXTRA DOSE ADMINISTERED (Extra dose administerd). At the time of the report, VACCINATION SITE PRURITUS (It itches a little bit in one spot), VACCINATION SITE RASH (Rash on the upper arm of the injection site) and EXTRA DOSE ADMINISTERED (Extra dose administerd) outcome was unknown.            No concomitants and Treatment medications were reported.
Approximately 15 minutes after receiving vaccine, patient noticed she was having double vision. She was trying to focus on a sign we had in the waiting room, and the words started blurring and doubling. BP was normal, heart rate was slightly elevated. With time (about 10 minutes), patient reported it was improving. We got patient to her feet first to ensure balance wasn?t effected and then patient reported she was ok to leave.
It?s 6 days after 2nd shot, pain in arm persists.  Congestion, coughing, achy ness persists.
This spontaneous report as received from a nurse refers to a 19 years old male patient. The patient was vaccinated with the first dose of GARDASIL intramuscularly and experienced numbness, spine pain and confusion on 25-AUG-2012. The patient also got the second dose of MENACTRA on the same day. The patient went to the emergency room. The outcome of confusion, spine pain and numbness was reported as recovered. Confusion was considered to be significant disability by the reporter. Additional information has been requested.
Six hours after flu shot, had bad asthma attack, wheezing, difficulty breathing, chest tightness. Used Ventolin inhaler, 3 puffs which helped. Repeated a half hour later. Eventually the attack passed. Had a flu shot, same location, in 2012. No reaction. However, the flu shot in 2011, same location, resulted in a similar bad asthma attack, again about six hours after the shot. I did not connect the shot/asthma at the time. Coincidence, I thought, as I had been getting flu vaccines for many years.
Flu like symptoms lasting more than 48 hours; This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A male patient of an unspecified age (reported as a "teenager") received meningococcal group b rlp2086 (TRUMENBA, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced flu like symptoms lasting more than 48 hours on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Had rheumatoid arthritis, have had flares before but it's never been that bad; Can't move shoulder, can't move arm half way up; Blistering headache; Pain on her right elbow down to the wrist, now it is upto the shoulder, pain in her knee as well; This spontaneous case was reported by a patient and describes the occurrence of RHEUMATOID ARTHRITIS (Had rheumatoid arthritis, have had flares before but it's never been that bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced ARTHRALGIA (Pain on her right elbow down to the wrist, now it is upto the shoulder, pain in her knee as well). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Had rheumatoid arthritis, have had flares before but it's never been that bad) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Can't move shoulder, can't move arm half way up) and HEADACHE (Blistering headache). At the time of the report, RHEUMATOID ARTHRITIS (Had rheumatoid arthritis, have had flares before but it's never been that bad), MUSCULOSKELETAL STIFFNESS (Can't move shoulder, can't move arm half way up), ARTHRALGIA (Pain on her right elbow down to the wrist, now it is upto the shoulder, pain in her knee as well) and HEADACHE (Blistering headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included injection for rheumatoid arthritis on 27-MAR-2021.  Treatment for the event included prednisone 10 mg start date 01 Apr 2021 and an anti-inflammatory, and it is not helping.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received his first vaccine and approximately 10 minutes later fainted in the immunization area.  911 was called and patient came to about the time EMS responded.  EMS checked all vital signs and they were normal.  Patient was alert as he left pharmacy.  Patient did hit head when he fell so mom decided she wanted him taken to hospital.
Pt was administered Smallpox vaccine as part of the SRP mobilization process, and within 15 minutes of vaccination Pt presented with difficulty breathing, increased heart rate, elevated BP, and swelling in the throat.  Pt completed smallpox screening and had no contraindications to recieving the vaccine.  At time EMS was called and epi and Benadryl was administered.  Pt was transported to Medical clinic for further evaluation.
Previously received flu shot 11/11/16. Duplicate flu shot given 3/17/17. No adverse reaction noted.
Information has been received from a pharmacist referring to a 60 years old male patient. There was no pertinent medical history or drug reaction/allergies. Concomitant therapies included LIPTIOR, DIOVAN HCT and PREVACID. On 29-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, once, lot # M013377, expiration date 25-MAY-2017) subcutaneously. On approximately 30-AUG-2016 (reported as "a day and a half later"), the patient developed redness and itchiness at the injection site which was also swollen, and the reporting pharmacist believed the patient developed blistered at the injection site. It was also reported that the patient went to unspecified urgent care facility on an unspecified day in regarding to the reactions, treatment was given to the event, but there was no lab test performed. As of 15-SEP-2016, the patient was fine. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Chills/sweats, joint pain, headache, severe fatigue started 20 hours after vaccination and lasted 24 hours. Swollen lymph nodes started 24 hours after vaccination and so far lasted 48 hours.
Patient received an additional booster dose of Pfizer COVID-19 vaccine, she was not having any adverse events at the time of the additional shot.
Received vaccine one 12/31/2020 and started with redness, swelling, and warmth to left deltoid on 01/06/2021.   She was started on antibiotic for cellulitis