chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menactra was exposed to 27 Farenheit for more than 3 hours due to the temperature in the refrigerator was manually changed and also the vaccine was administered to 11 year old male patient, no AE; Initial information received on 01-Jul-2020 regarding an unsolicited valid non-serious case from other health professional.  This case is linked to cases 2020SA172973, 2020SA172697, 2020SA174880, 2020SA174885, 2020SA174941, 2020SA174940, 2020SA174906, 2020SA174932, 2020SA174911, 2020SA174910 and 2020SA173110 (same reporter).  This case involves a 11 year old male patient who was vaccinated with the MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] that was exposed to 27 Fahrenheit for more than 3 hours and the excursion occurred due to temperature of the refrigerator was manually changed.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.  On 18-May-2020, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6565AA and expiry date: 28-Mar-2021) via unknown route in unknown administration site as prophylactic vaccination.  It was an actual medication error case due to Product storage error temperature too low.  At the time of report, no adverse event was reported  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 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.
pt devel rt hand muscle spasm/twitching;then went into tonic generalized sleepiness-pt was given valium;02 sat 95%;
sickness from Covid-19; sickness from Covid-19; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sickness from Covid-19) and COVID-19 (sickness from Covid-19) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 18-Mar-2021, the patient experienced ILLNESS (sickness from Covid-19) and COVID-19 (sickness from Covid-19). At the time of the report, ILLNESS (sickness from Covid-19) and COVID-19 (sickness from Covid-19) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she is under few medicines.
Information has been received from a Licensed practical nurse concerning 5 female patients aged 14-15 who were vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patients fainted, this "happened at all doses not just one particular". Unspecified medical attention was sought. All continued with the therapy. The patient recovered, "all were ok".
Patient reported he had a reaction to the second shingles vaccination within a few hours of receiving the shot. He ended up with a hive like rash on his torso (front and back) that was itchy. That evening he began to feel unwell, with a headache, fever, chills and later feelings of nausea which lasted for the next 24 hours.
4-18 Arm developed red, tender 3" L x 2" wide area with hard center.  Looked like a large hive, lasted about 5 days.  On day 3 also became itchy.  4-23 Symptoms started to subside.  4-24 Arm is just pale red, no swelling.
Dizziness, Myalgia, UrticariaPruritus, Swelling, fatigue Narrative:
had the first dose of the pfizer covid 19 vaccine and both experienced arm pain; had the first dose of the pfizer covid 19 vaccine and both experienced arm pain; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of unknown age (Age: 72; Unit: Unknown) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on an unknown date as DOSE 1, SINGLE for covid-19 immunization. The patients medical history was not reported. Concomitant medications were not reported. It was reported that that the consumer and his wife had the first dose of the pfizer covid 19 vaccine and both experienced arm pain. Caller stated that his wife takes doxycyline daily. Stated that his wife was due to get a botox injection prior to her second dose of the pfizer covid 19 vaccine. The outcome of the events was unknown.     Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
25min p/vax pt exp facial paralysis & numbness & tingling in the arm;
Pt noticed localized reaction left deltoid today. 6/17/04: quarter-sized erythematous, swollen area and increased itchy and warm to touch. No other symptoms noted.
Pt states that after taking her second typhoid capsule she noticed a pustule on the trunk of her body.  After taking the third capsule, the pustules multiplied to cover the entire trunk.  The pustules were dime size, with a pus-filled center.  Pt stated that she did not develop a fever but the pustules were itchy.  The pustules are just now dried up and starting to resolve.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 29-JAN-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 17-MAY-2016, the patient was treated and was diagnosed with painful herpes zoster, or shingles. She was later diagnosed with peripheral neuropathy secondary to shingles. As a direct and proximate result of the ZOSTAVAX vaccine, 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 has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
w/in 13 days post inj pt devel (probable) angioedema-diffuse;rx zyrtec, prelone;resolved;
10 days after varicella vaccine client suddenly noticed pain at site of injection; 1) sore, bruised at site; 2) burning and itching at site Lasted 7 days
severe weakness to point of not being able to walk, nausea, chest pain, dizziness immediately after vaccine given; rapid response team was called and then taken to ED; had shortness of breath and chest tightness, severe weakness, severe body aches. Fever up to 100.7 about 19 hours post vaccine; at 28 hours post vaccine continues to have severe weakness, chest tightness with SOB at times,  slight cough with wheezing, diarrhea X3
Began with soreness at the injection site and tiredness about 16hours post injection. Then I had body aches headache and low grade  fever  (99-100 degrees), about 18 hours after the injection.  I had a rough night waking intermittently but all symptoms were gone when I woke at 10:30 am on 4/7/2021.
dry cough on and off; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough on and off) in a patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (dry cough on and off). At the time of the report, COUGH (dry cough on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were reported.  No treatment was reported.
Sinus, head cold congestion. Mild fever at times - it didn't last long. Biggest thing has been fatigue. I had a cough - the cough didn't last very long. I didn't have trouble with breathing.  I did several doctor appts over the phone. No treatment. They gave me antibiotics but that was before I knew it was COVID - I am still taking those antibiotics and I am taking vitamin supplements. I am still tired - it is getting better every day. I still have some sinus stuff.
Nausea/vomiting for 2-3 hours started about 14 hours after vaccine was administered. Headache, body aches, and fatigue constant all of 5/13/21.
headaches; fast heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program Support. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heart rate". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient got her 1st dose and she experienced headaches and a fast heart rate for like a day or two. And the fast heart rate scared her. She's scheduled to get her 2nd dose on 5Apr2021, and she wants to know if the side effect will be the same or will there be a more intense side effect. She wants to know the severity of the side effect of the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient has had a fever for almost 48 hours ranging from 99 to 102 degrees with no other symptoms immediately after shot.
Had swelling of that and numbness in lips and stomach started hurting and only took 10 mins after shot.Then the people admitted ephi into my leg..03mg.And then fire department got called and got 50 cc of liqard benadryl into me and iv and it was off to the hospital and got some prednisone and and was in hospital for 8 hrs
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history was unknown. The reporter stated that on an unknown date the patient was affected with MMR II (dose, route of administration and anatomical location was unknown). Concomitant medications were unspecified by reporter. Action taken with MMR II was not reported. The outcome of the event was unknown. The causal relationship between the event and MMR II was not reported. No further information was provided. Additional information has been requested.
Extreme vertigo...has 3 sessions of vestibular therapy which did not resolve symptoms. Still have debilitating vertigo and cannot drive or even leave my house. Feel drunk constantly.
Husband of the patient called and stated this morning patient has "flu like symptoms" such as chills, body aches and nausea but no fever.
High grade fever, chills, severe headache, severe joint pain (whole body), nausea, left armpit swollen lymph node, fatigue. Lasted over 36 hours. Treated with Tylenol.
The pt's mother states that she called the doctor on 11/28/01 to report concerns of redness and swelling in right arm and received instructions to apply warm heat and to call back with any problems. The signs and symptoms increased and the child was taken to see an MD at 14:00 on 11/28/01 with increased swelling and redness. He was dx'd with infection at the vaccine site. He was rx'd with antibiotics (1st dose given at 16:00). Mom took child to ER at 22:00. She states the swelling had spread to his shoulder, chest and neck. He was admitted to the hospital X 2 days and dx'd with cellulitis of the right upper extremity. Phone call on 12/3/01 to mom states the child had a fever of 101.8F-102.8F on 12/2/01. PMD is aware. Temperature on 12/3/01 was 99F.
Headache, Arthralgia, Fever, chills, leg cramps Narrative:
2 days of dizziness, nausea, blurred vision. Treatment was rest and fluids with electrolytes and sugar
Patient came up to the observer during her 15 min wait after her injection. she complained of a metallic taste in her mouth, throat feeling tight and flushed.  Rn obtained her vitals and stated that they were Blood pressure: 117/79, Oxygen 98-99%, Pulse 102 and then went down to 88. Her lungs were clear, was given juice water and 50mg of benadryl. She was feeling better and was told to contact her primary provider regarding her 2nd dose.
This patient had 3 - 4 cm red, raised area with complaints of discomfort to touch, and the area was warm to touch.
11/5/2021 I felt a lump in my right breast. After a few days I called to get a mammogram. I was told I could not have one for 90 days after my COVID vaccine. I had a mammogram on 1/19/2022. I was told I had cancer.  On 3/17/2022, I had a lumpectomy. On 5/31/22 until 6/21/22, I had radiation every day. I saw the Oncologist on 7/20/22 and was prescribed anastrozole and started taking it on 08/3/2022. I have been taking the anastrozole ever since. I am still in treatment. The cancer is all gone.
Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 12-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2015, strength, dosage and frequency unspecified (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter.  Additional information has been requested.
s/s started 9NOV93 sore throat, body aches, low grade temp, h/a & chills; no hospitalization;
On February 13, 2021 at 4pm, my 87 year old mother received her initial COVID injection. Early the following morning, approximately 14 hours afterward, she suffered from sudden-onset uncontrollable diarrhea. She visited her doctor and was prescribed diphenyloxylate/atropine to combat.  She received her second dose four weeks later and the condition reappeared and lasted a good five months. She was additionally prescribed another round of diphenyloxylate/atropine, as well as ciprofloxacin.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 20Sep2023 to 25Sep2023. Clinical course: Patient had no known allergies.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314687 same patient, different drug/events;
no adverse event; My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .) and NO ADVERSE EVENT (no adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .).    Concomitant medication was not provided.  Treatment information was not provided.  This case contains information for the 1st patient out of 4 pediatric patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-712819, US-MODERNATX, INC.-MOD-2023-712821, US-MODERNATX, INC.-MOD-2023-712822 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712819:Patient 2 US-MODERNATX, INC.-MOD-2023-712821:Patient 3 US-MODERNATX, INC.-MOD-2023-712822:Patient 4
Pt began to feel lightheaded and dizzy.  He did pass out while sitting in chair.  Quickly came back, woke back up and was able to answer orientation questions.  He did report that this always happens to him when he takes antihistamines.  Observed for a period of 5-7 minutes and felt / looked better.  Told him we would observe him for a period of 30 minutes.  Within 5 minutes, he had the exact same reaction.  Patient passed out, was pale and diaphoretic.  Blood pressure was 65/39 with HR 45 (3/16 @ 1430).  At that time, he was moved to a gurney and placed in Trendelenburg position.  Patient observed. repeat blood pressure at 1435 was 104/64 with HR 68.  Patient continued in Trendelenburg position.  Patient observed until 1455.  Repeat blood pressure at 1452 was 105/69 with HR 73.  Patient looked and felt better.  He refused to go to ED.  Wife to stay with patient and observe this evening and afternoon.
I had been eating and drinking water. I took a nap. About 20 minutes after waking, as I was sitting up in bed, my hearing turned into a cracking sound like a TV and I lost consciousness briefly during the ringing in my ears. After lying down for a few minutes I was okay. I continued to feel extremely soar all over my body.
sweating like a pig; hair is falling out in chunks,when she touches her hair it comes out in clumps, bald in a month; no control over her body; hair is falling out in chunks,when she touches her hair it comes out in clumps, bald in a month; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating like a pig), the first episode of ALOPECIA (hair is falling out in chunks,when she touches her hair it comes out in clumps, bald in a month), COORDINATION ABNORMAL (no control over her body) and the second episode of ALOPECIA (hair is falling out in chunks,when she touches her hair it comes out in clumps, bald in a month) in a female 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 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 HYPERHIDROSIS (sweating like a pig), the first episode of ALOPECIA (hair is falling out in chunks,when she touches her hair it comes out in clumps, bald in a month), COORDINATION ABNORMAL (no control over her body) and the second episode of ALOPECIA (hair is falling out in chunks,when she touches her hair it comes out in clumps, bald in a month). At the time of the report, HYPERHIDROSIS (sweating like a pig), COORDINATION ABNORMAL (no control over her body) and the last episode of ALOPECIA (hair is falling out in chunks,when she touches her hair it comes out in clumps, bald in a month) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was reported.    This case was linked to MOD21-077234 (E2B Linked Report).; Sender's Comments:  MOD21-077234:
This is 1st booster of Bivalent pfeizer. The day of the vaccination 2/4/23, pt had bruise at the site of injection. The following  day on 2/5/23, pt experienced severe stomach cramp, painful upon urination, no energy, lethargic, lost of appetite, but no fever. Pt then went to see her primary care and they obtain the urine. The urine showed there are blood in the urine.
After the injection mild symptoms of pain at the injection site began. Then progressive Muscle fatigue and weakness along with a headache occurred within 4 hours of the vaccine. These symptoms were mild.   Was awoken 12 hrs after vaccine administration with sever chills and fatigue, fever (peak 101.2 F).  Took Tylenol with mild relief.    Still with intermittent chills and ongoing fatigue.
pain in the right TMJ joint But has a sharp pain toward the right forehead, cheek and chin Not a numbness Just a pain Improves when not chewing and opening jaw, feels fine. No fevers or chills Denies any tooth/gum pains.  This occurred after taking the covid pfizer shot, 2nd does, didn't really notice  Didn't really notice his face was swollen until today. No heat/itch.
Positive COVID-19; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history has been provided.     On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced COVID-19 (Positive COVID-19) (seriousness criteria hospitalization, medically significant and intervention required). The patient was hospitalized on 16-Apr-2021 due to COVID-19. At the time of the report, COVID-19 (Positive COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test positive: Positive.     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.   The patient was administered monoclonal antibodies on 16-Apr-2021 as a treatment of the event. The reporter stated the patient has recovered and inquired if it is advisable to give the second dose of the vaccine. His clarification request was promptly answered by an agent, confirming the second dose is safe to administer if the patient has recovered completely. It was further specified that the second dose should be given within the recommended interval and no later. Concomitant medications have not been specified.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.