chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna Dose Number 4. Pfizer / BioNTech Dose Number 3; Treatment of COVID-19; Treatment of COVID-19; 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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL330), in left arm, on 08Feb2021 as dose 2, single (Lot number: EL9265), in left arm and on 30Nov2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 64 years, in left arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 21Apr2022 as dose 4 (booster), single (Lot number: MOD / 001M) and on 30Sep2022 as dose 5 (booster), single (Lot number: MOD / AS7162B), in left arm for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna Dose Number 4. Pfizer / BioNTech Dose Number 3"; COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, vaccination failure. Additional information: The patient had no treatment and no known allergies. No chronic health conditions or illness.
Redness and swelling to injection site of left thigh, 3cm induration, 2cm redness. Hesitant to walk.
Patient also reported having hives and eczema all over the body after her second dose of the Pfizer Covid-19 vaccine in April 2021 three days after injection which resulted in neck, face, and whole-body hives which took 10 days of prednisone to clear but then afterward she started having severe eczema which she had not ever had before and still continues to be an issue. Patient reported having bad hives again in her arms when she was infected with Covid-19 in July 2022. Again, she had to be on oral steroid for 7 to 10 days for the hives to resolve.
I got My flu shot and got the flu; Initial information received on 27-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient of unknown age and demographics who developed got my flu shot and got the flu  after receiving vaccine Influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  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 Influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient developed non-serious i got my flu shot and got the flu  (influenza)  (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
No adverse event occurred; The caller said the patient inadvertently received PROQUAD on the same day as VARIVAX, on 7/12/2023; This spontaneous report was received from other health professional concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions and allergies were not reported.  On 12-JUL-2023, the patient was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (Lot number w031810 has been verified to be a valid lot number, expiration date reported and validated as 05-OCT-2024), and with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (therapy type recombinant Human albumin [rHA]; lot number X011979 has been verified to be a valid lot number, expiration date reported and validated as 18-JUL-2024), both as prophylaxis (Accidental overdose) (Strengths, doses, route of administration, vaccination schemes and anatomical locations were not reported). Nevertheless, it was confirmed that no adverse event (AE) occurred.
6 days post immunization, patient develops vision issues, numbness in extremities. Hospitalized on 01/03/2013. Moved to IC on 01/06/2013. Released from hospital 01/28/2013. Followed up with in home physical rehab. Diagnosis (via patient) was Guillan Barre.
Crying unconsolable for 4 hours. Legs blue for 15 minutes per mom.
1/7/04 mom phoned and stated that child had rash on diaper areas, no other symptoms. 1/8/04 mom phoned and stated that child broke out more on stomach, chest, back, upper arms, face, balla of ears finger and diaper areas. 102 deg temp at 8 pm. Mom took child to ER. ER MD told mom that has adverse reaction to varicella vaccine. Child also had ear infection. Amoxicillin prescribed. Mom also gave child Tylenol for fever. Mom also stated that child had a little bit of diarrhea since 1/7/04.
arm feel like someone shot me!; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included back surgery (Family History) (the patient mother had 2 back surgeries), fractured hip (Family History) (the patient's mother had broken hip), renal failure (Family History) (the patient's mother had kidney failure) and pain (Family History) (the patient's mother had shingles that was most pain). Previously administered products included Shingrix (first dose received on an unknown date).   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 Information: GSK Receipt Date: 27-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the first dose of Shingrix that was uneventful.  The patient received second shot and caused arm to feel like someone had shot me. The patient was thinking if the pain was from shingles, then the patient would take 2 more shots to prevent it. The event was over in a day and all was well.  The patient's mother had 4 children naturally, 2 back surgeries, a broken hip, and kidney failure. The mother said shingles was the most pain.  The patient was very thankful that we have a vaccine for it. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Tinnitus: started about an hour after injection and lasted several hours. no prior history of tinnitus.  Body aches, fatigue, dizziness, fever, chills, weakness  Nausea and vomiting: started about 24 hours after injection. severe throughout the night, then gone after sleeping.
Upon waking the day after the shot, Vertigo started. Incapacitated me for the entire day with nausea and intense dizziness with intermittent nystagmus upon movement such as to rise to go to toilet. Symptoms lessened by AM on the 30th, though still present. Nystagmus not present on  the 30th.
I have fever and chills since April 1st until today (April 8th, 2021)
STROKE; BACK OPERATION; ANKLE OPERATION; KNEE OPERATION; ANEURYSM; HAND SWELLING; JOINT SWELLING OF HAND; This spontaneous report received from a patient concerned an adult female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry was not reported) dose was not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. Age at time of vaccination 59 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Non-company suspect drug included: upadacitinib (form of admin unknown, oral, batch number and expiry was not reported) dose and frequency and therapy dates were not reported, ongoing treatment for moderate to severe rheumatoid arthritis. On an unspecified date, the patient experienced stroke, back operation, ankle operation, knee operation, aneurysm, left hand shaking, hand swelling, and joint swelling of hand (Knuckle swelling). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of upadacitinib was not changed. The patient was recovering from stroke, and aneurysm, had not recovered from hand swelling, and joint swelling of hand, and the outcome of back operation, ankle operation and knee operation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220860405- covid-19 vaccine ad26.cov2.s -Stroke, Back operation, Ankle operation, Knee operation, aneurysm. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Itchiness at the site; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the site) and DIARRHOEA (Diarrhea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 12-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the site) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included serum derived bovine/protein isolate for diarrhea.  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.   Reporter did not allow further contact; 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.
Date above approximate as no exact date given.  Received H1N1 Flu mist at County clinic.  2 days later developed sudden left eye crossing with subsequent 6th CN Palsy dx.  Seen by ED and then  Opthalmology.  MRI done and normal.  Previous hx of Left 6th nerve palsy at 9 months of age which resolved spontaneously. Mild amblyopia of Left eye also dx'd by Ophthalomologist.  Patching of eye treatment being done.  Peds Neurologist saw and felt dx was isolated and neuropathic.  Doubted any intracranial pressure.  Felt it would resolve over the next several weeks.
Red, raised rash and soreness around injection site appeared more than one week after shot was administered.
Pt did not respond to series of Recombivax (2 doses) & Engerix-B (1 dose);  Recv Engerix-B booster dose & lab values continue to show no titers.  04Feb91 titer neg. 26Feb91 recv 2nd booster dose.
I dont have details of the shot given but it was a general flu shot.   Sever reaction on my face,  Nose enlarged,  Left eye swollen,  half way closed, itchy,  All around the eye was affected.  in addition a few small spots on left upper leg, right finger.
Pt recvd 1st Engerix-B vax & 1 1/2 hrs post vax exp dizziness (room spinning); event resolved in 20 min w/o any treatment;
Information has been received from a physician concerning a 7 year old female no pertinent medical history and no known drug reactions/allergies who in 2001 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 27-DEC-2006, the patient was vaccinated with the second dose of varicella virus vaccine live 0.5 ml (Oka/Merck) (Lot # 654806/1065P) SQ. On 02-APR-2007 the patient experienced mild case (6-7 lesions) of chicken pox. The patient's mild case (6-7 lesions) of chicken pox persisted. No diagnostic laboratory studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
After booster she had a sore arm, a little touchy when she rolled on the right side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After booster she had a sore arm, a little touchy when she rolled on the right side) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 029L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX and FLU VACCINE VII.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-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 PAIN IN EXTREMITY (After booster she had a sore arm, a little touchy when she rolled on the right side). At the time of the report, PAIN IN EXTREMITY (After booster she had a sore arm, a little touchy when she rolled on the right side) outcome was unknown.            Concomitant medication also included a lot of medication which are not specified by the reporter. No treatment information was provided.   This case was linked to MOD-2021-361527, MOD-2021-361511 (Patient Link).
She got her vaccine, had a very very painful arm, swelling and redness around the site.  No fever, nothing like that and was fine othewise until Tuesday.  On Tuesday she woke up with a cough just feeling really bad, sore throat.  She took Dayquill for cough and cold, which did not help her.  She called the doctor and was given Prednisone and an antibiotic and felt that it was viral and she did not take the antibiotic.  The prednisone did help her.  She is still very very weak, dizzy and just does not feel good at all.  They started getting better after the Tuesday outbreak and the next Saturday came up and she was just weak all day and she tested her husband and herself and they were both positive for COVID.  This is the first time she has had COVID.  She is a go getter for her age and cannot do anything at this time.  She called her doctor today to see if she could do blood work and is waiting for them to call back.
Cardiac arrest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, This man was boosted, he had all three doses), for Covid-19 immunization; Bnt162b2 (Dose 2, This man was boosted, he had all three doses), for COVID-19 immunization. The following information was reported: CARDIAC ARREST (death, medically significant), outcome "fatal". The patient date of death was unknown. Reported cause of death: "Cardiac arrest". It was not reported if an autopsy was performed.  Clinical Course: It was reported that caller just read a case report about an older man who died of cardiac arrest after his Pfizer COVID-19 Vaccines. This man was boosted, he had all three doses. Caller does not have any further information about this man to provide. For his COVID-19 Vaccines are unknown. States this was from a article and the first case reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Cardiac arrest
Lethargy, erythema at site, fever to 104.2, loss of ability to stand or walk, confusion, reduction in speech ability.  Symptoms started during the evening of 3/30/21 after vaccination.  PCP was contacted on 3/31/21 and we were told the effects would only last 48  hours.  Fever was reduced with Acetaminophen 1000 mg q6h x 2 doses, oral fluids, and icing the axillary.  911 was called on 4/1/21 when pt lost ability to stand and and was minimally vocal but alert.  Pt was hospitalized and remains in that situation at this time.
11 yr wcc. Pt is a 11 year old female. Source of patient information was mother. Takes BENADRYL 10mL once daily at bedtime for urticaria - seems to help as preventative, is followed by allergist - ordered blood testing, no skin testing, mom has not yet gone for labs.
Ran a fever of 103 degrees for two days after the shot was administered, he was given childrens tylenol as directed by physician before and after the shot was given.  After the shot was administered he lost communication skills (stopped talking), lost eye contact, withdrew from social contact and interactions with others (adults and children), did not respond to verbal prompts and commands.  This occurred from the time the shot was given until present.  He was diagnosed with Regressive Autisism Spectrum Disorder on April 4, 2008.  On April 6, 2008 he began the g.f.c.f. diet.  On June 25, 2008 we (his parents) took oatient to a D.A.N. doctor and the doctor did blood tests and urine tests.  The results showed a high mercury and lead content.  He is on supplements and vitamins to clean the toxins from his system along with other medications. 12/12/08-routine office visit records received-1/30-2/28/08-speech delay, C/O acting as if can not hear, not following directions. Fever 12/28/07.  1/29/2010 Autism.
eczema-like or ringworm-like rash on arms and face; Eczema-like or ringworm-like rash on arms and face; eczema-like or ringworm-like rash on arms and face; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in arm right on 23Feb2021 at 07:00 (at the age of 71-years-old) as dose 1, single for COVID-19 immunisation. Medical history included hypothyroid and diabetes (diabetes type 2). Concomitant medications included Nature Throid, received within 2 weeks of vaccination. The COVID-19 vaccine was administered at doctor's  office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01Mar2021 at 10:15, the patient experienced eczema-like or ringworm-like rash on arms and face. The patient reported that she was experiencing a eczema-like or ringworm-like rash on arms and face. It was started on right arm and then left. Seems to be getting worse, spreading to face. Using eczema cream on it seems to help. Slowing disappearing. The adverse event result in doctor or other healthcare professional office/clinic visit. The outcome of the event was resolving.
Pain at injection site Fatigue  Headache Rash (COVID arm) after first and 2nd dose Fever (102) Chills
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (light headache), DIZZINESS (dizziness), DECREASED APPETITE (loss of appetite), FATIGUE (tiredness) and NIGHT SWEATS (night sweats) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history provided). On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced HEADACHE (light headache), DIZZINESS (dizziness), DECREASED APPETITE (loss of appetite) and FATIGUE (tiredness). On 15-Feb-2021, the patient experienced NIGHT SWEATS (night sweats). On 18-Feb-2021, HEADACHE (light headache), DIZZINESS (dizziness), DECREASED APPETITE (loss of appetite), FATIGUE (tiredness) and NIGHT SWEATS (night sweats) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient has taken Tylenol which subsided the adverse events.
First dose: The evening after my first dose, around 9pm, my left foot quickly became very painful.  It felt like I had broken a bone in my foot, even tho that afternoon I had gone on a walk and had no issues at all until that evening.  The pain was so bad that I took ibuprofen and iced it, hoping to bring down swelling incase it was broken. There was no bruising, however.  I realized later that my foot looked a little distorted, like the muscles were all cramping. After a fitful night's sleep, I got up to go to the bathroom at 3am and the pain was almost gone and I could walk on the foot.  By morning, it wasn't even painful anymore.  I did not corelate this to the vaccination, but thought I had done something maybe on my walk earlier to cause it.  (I received the vaccine in my left arm, and this was my left foot) Second dose:  Within 2 hours of the vaccination, my left foot (same one) was in pain. It wasn't the same, didn't really feel like muscle cramping, and I would put weight on it. However, even with good arch supportive shoes that I wear to work every day, I had to take my shoes off to find any type of comfort.  My foot continued to hurt the rest of the night and into the 2nd day.  Even today (2 days later) my ankle still has a bit of pain, but isn't keeping me from normal events. I am in good shape typically, normal weight.  I definitely think this was a result of the vaccination. So I wanted to report it.
flu like symptoms; bodyaches; sluggish; sore body; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (bodyaches), SLUGGISHNESS (sluggish), ARTHRALGIA (sore body) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included COPD.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced HEADACHE (headache). On 03-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (bodyaches), SLUGGISHNESS (sluggish) and ARTHRALGIA (sore body). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (bodyaches), SLUGGISHNESS (sluggish), ARTHRALGIA (sore body) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information were not provided.
This patient had an injection; 15 minutes after she complained of numbness, tingling feeling in her arm from elbow to fingertips. Then 30 minutes after the injection, the tingling feeling moved up into her shoulder area. Injection site not red or swollen, arm not swollen. The patient called the MD. The doctor stated to the patient to take Ibuprofen and put ice on it. TC to the patient at 2:30, she stated she was feeling better but her arm was sore and slightly swollen at the injection site.