chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she had a headache; felt dizzy; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for herself that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that she had a headache and felt dizzy when she got her first dose last 08Apr2021. She said symptoms became better after. She was due to have her second dose on 29Apr2021. The outcome of the events was recovering.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
Patient received vaccination, and continued to remain seated after injection. After a few minutes, patient began feeling dizzy, which made her nauseous. She had to remain sitting for at least 15 minutes before she no longer was dizzy or nauseous, and was able to walk out and leave the store. She has had no problems since.
Patient was given dose 1 from the wrong vial.  Patient was administered 0.2ml from the 0.2ml/10mcg vial.  Patient should have received 0.25ml/25mcg based on age and previous vaccination status.
The large red patch began and spread with finger like things coming from it and it was hot. The doctor said I had a bacteria infection and prescribed an antibiotic. Patients should be made aware that the vaccine is mixed on site i.e the powder and the liquid. There must have been some slip between the cup and the lip.
Instantly red and whelped at injection sites. Watched for 10 min. 2" whelps at injection sites. Given BENADRYL.
I just realized that I got my shot on the 20th, not the 19th, got my days wrong my bad. about five hours after I got my booster shot, I started having severe muscle pain, especially in my back. as the night progressed, i started to not be able to control my neck muscles to hold my head up, and the pain in my arm was so severe i could not lift it more than 45 degrees. Since about 6:30 pm on the 20th, I have been extremely cold and unable to warm up, accompanied with shivering. On the morning of the 21st, I was throwing up as well.
Upon receiving the first dose of the vaccine I seemed to be clear of a chronic condition I have suffered with for 8 years. That condition was Pressure Induced Chronic, Idiopathic Urticaria; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pressure Induced Chronic, Idiopathic Urticaria" (unspecified if ongoing), notes: Pressure Induced Chronic, Idiopathic Urticaria; "painful hives" (unspecified if ongoing), notes: unable to wear tight fitting clothing or anything with elastic in it without breaking out into painful hives; "painful rash" (unspecified if ongoing), notes: have not had one instance of hives or a painful rash since my first dose of the Pfizer vaccine; "Hyperlipidemia" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing), notes: Hypothyroid; "Benign hypertension" (unspecified if ongoing), notes: Benign hypertension. There were no concomitant medications. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 20Feb2021 12:00, outcome "unknown", described as "Upon receiving the first dose of the vaccine I seemed to be clear of a chronic condition I have suffered with for 8 years. That condition was Pressure Induced Chronic, Idiopathic Urticaria". Therapeutic measures were not taken as a result of therapeutic response unexpected. The patient have been unable to wear tight fitting clothing or anything with elastic in it without breaking out into painful hives. She could not wear a bra as the area most effect was anterior chest, from just below breasts to navel. She have not had one instance of hives or a painful rash since her first dose of the Pfizer vaccine. She was now able to wear a bra. This may seem like a trivial condition, but it greatly effected the quality of her life. Se hope this is a long lasting effect.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366871
After a week of getting the vaccine I had overcome the soreness from the shot and feeling ill. I was woken up to intense pain in my left shoulder, neck and arm. The pain was at a 9. I took four 200mg ibuprofen and after 45 minutes the pain subsided.  The following day I began to experience the pain again. With the pain this time I noticed muscle spasms in my bicep and also arm weakness. This subsided after taking four ibuprofen. That evening I experienced this pain again and extreme fatigue in the arm. This did not go away after taking ibuprofen. It eventually subsided later on that night. I haven't experienced the pain or weakness again.
Situation: Patient, 28 yrs old, had an appointment for 1st dose Moderna  Lot# 007C21A today. Pt felt anxious prior to vaccination. As a precaution, pt was placed on a gurney and he received the vaccine while on the gurney. RN was bedside during the process. Pt started feeling shaky and dizzy 5 mins post vaccination. . Juice and crackers provided. Pt stated that he ate and drank liquids prior to coming in. Encourage to relax and take slow deep breaths  Background: . He informed the vaccinator upon arrival that he has a hx of syncopal episode during vaccinations. Pt had a syncopal episode when he got the TB Test. Pt felt anxious prior to vaccination. Allergies: PCN and other abx, unable to state rest of allergies Hx: Asthma, MVA last April 2021, head injury, L wrist surgery Accompanied by mother  Assessment:  1020 ? Pt c/o being more dizzy, queasy to throat and chest, lightheaded and started to look pale. VS 99.0F, 65, 98% RA, 97/40 (62), 22. Clear speech noted.  1030 ? VS 105/49 (67), 72, 99% RA, 26. Paler, diaphoretic, increased dizziness, nausea, numbness to hands, anxious, shaky. Mother at bedside, comforting patient. Encourage to take slower deep breaths and continue to lie back.  1034 ? VS 114/61 (74), 72, 100% RA, 22, color is better 1038 ? VS 106/65 (77), 65, 100% RA, 18. Pt is more relaxed. Tightness to throat is better. Clear speech. Can speak complete sentences.  1043 ? VS 103/65 (79), 64, 100% RA, 18. Color has improved. More color to lips, hands are less numb. Pt stated that he is back to ?almost normal.? 1044 ? Called Dr about pt. MD was expecting that pt will be better in a few minutes. If pt is worse or if his symptoms come back while at home, pt need to go to ED or call his doctor. Relayed MD?s recommendation to patient and mother. Both verbalized understanding.  1045 ? VS 102/61 (72), 74, 18, 94% RA 1050 ? VS 116/70 (80), 74, 16, 95% RA. Moved patient and mother to room 6. Pt stated that he is ?feeling way better.? Mother at bedside. Report given to RN 1100 ? VS 103/63, 68, 98% RA semi fowlers on the gurney? conversing with mother.        VS 111/67, 72, 100% RA - sitting       VS 116/68, 85, 100% RA standing. Denies any dizziness upon position changes.  1110 ? VS 97/65, 67, 95% RA. Pt stated that he feels okay. Drank juice. 1120 ? VS 109/65, 72, 95% RA. Able to stand and walk to wheelchair.  1125 ? ambulated to bathroom. No problems. 1130 ? wheeled to car. Denies any symptoms.   Recommendations:   Dr was called about pt and expected that pt will be better in a few minutes. If pt is worse or if his symptoms come back while at home, pt needs to go to ED or call his doctor. Relayed MD?s recommendation to patient and mother. Both verbalized understanding. Pt was wheeled to the car and went home with his mother.
flu-like symptoms; sweats; fever; chills; body aches; This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 022B21A) for COVID-19 vaccination.     The patient's past medical history included Skin cancer and Chemotherapy in 2018. Concurrent medical conditions included High cholesterol. Concomitant products included ROSUVASTATIN for High cholesterol.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 26-May-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 INFLUENZA LIKE ILLNESS (flu-like symptoms), HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Shortness of breath at night followed by severe headache - every night after vaccine; headache; This is spontaneous report from contactable consumer (patient).  A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, in Arm Left on 22Apr2021 11:15 (Batch/Lot Number: Er8735) as single dose for covid-19 immunisation at Pharmacy or Drug Store. The patient medical history was not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ew0150) on 01Apr2021 04:30 PM (at 33 years old) in left arm for covid-19 immunisation. Concomitant medications included iron (IRON) taken for an unspecified indication, start and stop date were not reported and vitamin supplements. The patient experienced shortness of breath at night followed by severe headache - every night after vaccine on 22Apr2021 20:00 with outcome of not recovered. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a registered nurse and refers to a 22 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 23-NOV-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown), lot # M015735 with expiration date of 30-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 57 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
No adverse event; Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 25-May-2023, the patient experienced UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) 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 UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. It was reported that patient had their monovalent and a previous booster dose of bivalent vaccine. Treatment medications were not provided.   Treatment information was not provided.  This case contains information about patient 18th out of 20 elderly patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Patient no 1
No additional AE reported.; Medical assistant reported that a patient was administered an expired dose of VAQTA. Caller stated the administered VAQTA expired on 28MAR2022, but was administered to a patient today, 30MAR2022.; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-MAR-2022, the patient was inadvertently administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) 1 milliliter, lot # T034003, expiration date on 28-MAR-2022 (dose number, route of administration and anatomical location were not provided), for prophylaxis. It was reported that the vaccine had no temperature excursions. No adverse event reported.
Patient called over the weekend of 8/28/21 to report that she has had pain and a bump on her neck near her collar bone a day after her vaccination.  She was advised to call and urgent care or ER to seek help if any swelling near throat.  She was not able to be seen at urgent care so went into the ER.  During the ER visit patient reported that the medical team said it was swollen lymph nodes and that they would resolve after time.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On unspecified dates in 2014, the patients were vaccinated with a dose of RECOMBIVAX HB (dose, route, lot and expiration date were not reported) that were exposed to 52 F for 12 hours in February 2014. No adverse effect reported. It was also reported that the vaccine was supported via "in house" stability data. This is one of several reports from the same source. Additional information has been requested.
After both vaccines was sent for chest CAT scan for another issue.  CAT scan showed "groundglass densities along anterior aspect of both upper lobes of lungs".  Have never had this issue before and still dealing with this issue.
Severe generalized urticaria, dermatographia, appears to be a delayed hypersensitivity reaction. After one week of monitoring and anti-histamine use, has completed a medal dose pack with some improvement but continues to have some dermatographia and is currently 4 weeks post-vaccination. This patient did have a delayed local urticarial reaction at the injection site following dose 2 in the series as well (10 days after the 2nd dose).  This patient has never had a problem with hives before the vaccination.
After 24 hours exp chills,, fever an dreallytire. I had a CT scan on my neck had lymph nodes on right side. I'm not certain if it was related to vaccine. I have had several tests since then to rule out malignant in the lymph nodes.
Information has been received from a physician concerning a 62 year old female who on 06-JUN-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck) (Lot#656606/0033U).  On 10-JUN-2007 the patient developed a diverse "herpes/zoster/chicken pox lesion" on her body that was spreading to other parts of the body.  Unspecified medical attention was sought.  At the time of the report the patient had not recovered.  No other information was provided.  There was no product quality complaint involved.
Initially felt fine. Got lightheaded, nauseous, dizzy. Brain felt foggy. Wanted to lie down but kept her upright. Doesn't recall ride to emergency department. Next recalls her husband in ER and physician pushing on her chest (sternal rub). Extreme exhaustion
soreness at site of shot; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient of an unspecified gender received BNT162B2,  intramuscular, administered in Arm ,at the age of 63 year old, on 20Jan2021 22:30 (Batch/Lot Number: EL3247) as dose 1, single and on 20Feb2021 14:30 (Batch/Lot Number: EL3247) as dose 2, single for covid-19 immunisation.  Medical history included, blood pressure and thyroid. Prior vaccination included Prevnar, shingles and Mery. Concomitant medications included ongoing telmisartan for blood pressure and  levothyroxine for hyperthyroidism, both from 09Jan2021. After each shot 1 and 2, on 20Jan2021 and 20Feb2021, 4 hours later, patient experienced soreness at site of shot. No relevant tests were done. The outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.
swollen lymph nodes; swelling under my arm; This is a spontaneous report from a contactable consumer(patient).  A 23-year-old male patient received the second dose of bnt162b2 (BNT162B2, Lot Number unknown), via an unspecified route of administration on left arm on 28Mar2021 at single dose for COVID-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. Patient stated, "I have like Pfizer vaccine on Sunday my second dose and I don't know if this is the right place to ask but it says the side effects is swollen lymph nodes. Should I be concern if it goes pass like its day 4 and still have like swelling under my arm, I saw that it's a side effect I am just wondering, it's been like 4 days so (incomplete sentence)." The patient stated the onset date of the events was the day after so it was 24 hour later on 29Mar2021. No treatment was received for the events. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
soreness swelling at injection site and pain to site of shot and arm pit. also vey strange that i wet the bed last nite. I am 56 yrs old and have not wet bed in 50 yrs i dont drink alcoho or do street drugs l so just very strange that it happened the night after getting shot. dont know if two are tied but very very strange. I do take a water pill but did not take my meds yesterday.
Has been sick ever since the 2nd day after the shot - malaise, lethargy, low-grade fever, headaches, nausea, back pain, fatigue.  Had localized swelling, soreness & tenderness for about 3 days.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing); "known allergies: strawberries" (unspecified if ongoing); "known allergies: apples" (unspecified if ongoing); "known allergies: nectarines" (unspecified if ongoing); "known allergies: peaches" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Nirmatrelvir, ritonavir (PAXLOVID) was given as treatment of COVID-19 from 19Sep2023 to 24Sep2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received her covid vaccine, while waiting for 15 minutes to be observed the patient fainted. Her mom noticed her eyes rolled back and started calling for help. We called 911 . Patient was placed on the ground carefully as we awaited for EMS to arrive. The patient was breathing, but had low blood pressure when EMS arrived. EMS took the patient to the hospital.
Patient received booster dose on 11/5. Calls today to report gland swelling and painful near . Also reports glands in left arm are swollen.
On the way home, above stated person experienced a swelling of throat. He stated that that it was difficult to swallow and was painful. He considered visiting the emergency room for treatment of symptoms. Symptoms subsided around 30 minutes from time of event. He just arrived at his home.
Presented with shortness of breath and altered mental status. Found to have severe acidosis, circulatory shock. Required CRRT and triple pressors. Developed severe thrombocytopenia and also found to have subacute cerebellar stroke concerning for VITT.
Patient states she started having severe pains in her neck 3 days after receiving the flu shot. The next day the pain spread to her shoulder blade and down to her wrist. She states the pain was severe however she didn't lose any motor function of her arm or her shoulder. The pain mostly resolved about 2 to 3 weeks after it began. She says she still has a little pain in the back of her arm in the mornings.
About 24 hours after her vaccination with Shingrix, Patient became breath, had severe pain in her arm and felt very tired. She visited her pulmonologist and I/ID said she had interstitial markings and granular areas in her lungs. MD said it was probably from the Shingles vaccine and they want to re check her in 4 months. Patient has gradually started feeling better.