chrisvoncsefalvay/vaers-outcomes huggingface dataset:
double kidney infections; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0185) via an unspecified route of administration, administered in left arm on 21May2021 at 14:00 (at 37 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included spine disorders fibromyalgia and allergy to sleeping pill, both from unspecified date. The patient previously took lorazepam and naproxen and experienced allergies on unspecified date. Concomitant medications included pain medications, mirtazapine and desvenlafaxine; all from unspecified date for unspecified indication. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced double kidney infections on 01Jun2021 which was medically significant. The event resulted in emergency room and physician office visit. Clinical course was reported as follows: On 01Jun2021, the patient started having flank pain. The patient thought it was a kidney stone but was diagnosed with double kidney infections (no history of kidney infection or UTI). The patient was given intravenous (IV) antibiotics at emergency room (ER), placed on 7 days on amoxicillin twice a day, did not clear up infection. Then placed on second course of antibiotic, levofloxacin. The patient had 2 days left and the patient still had an infection. Outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021790421 same reporter/drug/AE with different patient
COVID vaccines received on 4/30/21 and 5/26/21.  She was admitted to the hospital on 9/6/2021 with acute hypoxic respiratory failure due to COVID pneumonia.  She was started on dexamethasone and remdesivir.
Right thigh tenderness and red indurated area about 4" diameter; Left thigh with faint light red area ~4"diameter.  Also has headache, fatigue and general aches and pains.
Left facial numbness, left facial hemispasm, and left arm/leg numbness (less than face).  Symptoms rapidly resolving with observation only.
Mother reports emergency room visit due to swelling redness and itching of left arm. She denies any other symptoms except "slowed her down". No treatment given by ER physician, who advised Benadryl orally and report to HD. Left arm has some swelling and mottling. Approx. 4 inches are involved.
53yo pt experienced an inject site rxn which included redness & swelling of the lt arm w/in 3 days p/immun; Tx included warm compresses @ site of inject & Ceprofloxin 500MG/BID;
fever/The temp reached 100.9 on Friday and stayed around 99.5 since Saturday mid day; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 17:30 as dose 4 (booster), single (Lot number: GJ2524), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Macrobid, reaction(s): "Allergy". 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; Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETED: UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 16Sep2022 at 12:00, outcome "not recovered", described as "body aches"; PYREXIA (non-serious) with onset 16Sep2022 at 12:00, outcome "not recovered", described as "fever/The temp reached 100.9 on Friday and stayed around 99.5 since Saturday mid day". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain.  Additional Information: It was reported that, the patient had a fever and body aches since Friday afternoon. The temperature reached 100.9 on Friday and stayed around 99.5 since Saturday mid-day. She had known allergies to Penicillin and Bactria and other medical history: Macrobid. She had no other vaccine in four weeks. She had other medications in two weeks. She did not have COVID-19 prior to vaccination and was tested negative for COVID-19 post the vaccination. No treatment was received for the adverse events.  No follow-up attempts are possible. No further information is expected.
Vial had been removed from deep freezer to cooler for longer period of time than recommended by Pfizer. By time realized, vaccine had been administered to patient (employee). Pharmacy contacted Pfizer and Infection Disease MDs for counsel. Said wouldn't hurt patient, however not able to guarantee effect; stated could offer 3rd dose in 3-4 weeks. Notified Employee; stated did experience expected side effects of fatigue, chilling, body aches and possibly fever (didn't check) and declined 3rd vaccination offer
When patient received the 1st dose of Pfizer, she began complaining of itchiness on her right arm and felt lightheaded. As a result, we provided client with Benadryl. At 15:01, she received 50mg Benadryl by mouth. Her vitals: temp 97.9, pulse 95, R 14, O2 97%, BP 90/60. Injection site: no sign of redness. At 15:15: Temp 97.9; Pulse 82; R 12; 02 99%; BP 100/60. And at 15:15, patient stated she has a history of fainting after receiving vaccines. Still no signs of redness at injection site. At 15:30: Temp 97.9; Pulse 78; R 12; 02 99%; BP 100/60. Patient stated she felt better, and  her daughter can drive her home. At 15:30, we advised if she still doesn't feel well to seek medical attention.
Pneumovax 23 was given 6/17/09. Within 24 hours, he began to feel some discomfort in that arm and developed a macular red rash around the injection site associated with discomfort. The redness was bigger on day 2.  Saw PCP 6/20/19, It measures 10 x 10 cm prescription for Biaxin 500 b.i.d. for 7 days was given 6/20/09. On 6/21/09 the pt stated "it is less red and getting better"
Couldn't move her legs and had to crawl up her stairs and push herself onto the bed; Could not walk; wilt on the floor; developed extreme muscle pain; joint pain; fever; chills; headache; nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONTROL OF LEGS (Couldn't move her legs and had to crawl up her stairs and push herself onto the bed) in a 74-year-old female patient 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 Crohn's disease, Fibromyalgia, Neuropathy and Osteoarthritis.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced LOSS OF CONTROL OF LEGS (Couldn't move her legs and had to crawl up her stairs and push herself onto the bed) (seriousness criterion medically significant), GAIT DISTURBANCE (Could not walk), VACCINATION COMPLICATION (wilt on the floor), MYALGIA (developed extreme muscle pain), ARTHRALGIA (joint pain), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CAFFEINE, CITRIC ACID, SODIUM BICARBONATE (ALKA SELTZER [ACETYLSALICYLIC ACID;CAFFEINE;CITRIC ACID;SODIUM BICARBONATE]) at an unspecified dose and frequency. At the time of the report, LOSS OF CONTROL OF LEGS (Couldn't move her legs and had to crawl up her stairs and push herself onto the bed), GAIT DISTURBANCE (Could not walk), VACCINATION COMPLICATION (wilt on the floor), MYALGIA (developed extreme muscle pain), ARTHRALGIA (joint pain), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) was resolving.            Concomitant product use was not provided.  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.    She could not walk and developed extreme muscle pain, joint pain, fever, chills, fever, headache, and nausea. She described it as if she had an extreme case of the flu. She couldn't move her legs and had to crawl up her stairs and push herself onto the bed. It was as if she would "wilt on the floor." Tylenol did not help her but Alka Seltzer did provide her some relief. She is improving slowly. Her symptoms were worse this morning but now are better and not as bad as in the beginning.   This case was linked to MOD-2021-051822 (Linked Report).; 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. MOD-2021-051822:1st dose
Pain, redness, erythema below injection site. It was recommended for patient to apply ice to the site and to take oral ibuprofen. The patient was asked to return tomorrow (9/29/2016) to check for resolution of her symptoms.
Pfizer vaccine was not removed from the freezer at the 14 day cutoff when it is supposed to be moved to warmer fridge temperature. This vaccine was kept in the freezer and thawed at the 19 day mark. THe vaccine does not have stability data published after 17 days, but was not yet expired or out of freezer temperature at any time other than to thaw.
- Pneumonia, unspecified organism NAUSEA VOMITING DIARRHEA
10/02/2015- intense itch on both of my legs w/ hives and hashes and heat feeling. Relieved by Benadryl and a cool shower late in the evening 10/03/2015- Hives begin to reappear on both of my wrists around 5:00 pm and intensified by 8:00 pm all over my body hives and rashes and my feet had a very hot feeling. Benadryl offered some relieve. 10/04/2015 rashes still visible in some parts of my body by 1:00 pm spread all over the body and rashes reappear. Went to the emergency room around 4:00 pm and received prednisone & Pepcid and recommended to take Benadryl. Around 6:00 PM hives intensified and spread all over the body. Within an hour and a half  they begin to disappear. 10/5/2015 rashes and hives come and go with intense itching but not heat. Later in the afternoon hash, hives and itching very uncomfortable but less intense than the prior day, medication being used as prescribed by the ER doctor. Prednisone, pepcid and Benadryl.  10/06/2015 primary care doctor appointment schedule.
has not reported any symptoms. No additional AE/no PQC.; a 17 year old was inadvertently administered the adult formulation of VAQTA; This spontaneous report was received from a physician referring to a 17 year old male patient. No information regarding patient's pertinent medical history, concomitant therapy and drug reactions or allergies were provided.  On 23-AUG-2023, the patient was vaccinated with the adult formulation (Incorrect dose administered) of hepatitis a vaccine, inactivated (VAQTA) (strength, dose, route, frequency, anatomical location, lot number, and expiration date were not provided) for prophylaxis.  No adverse events reported.
Severe neck pain with swelling, aspirin for pain, still experiencing with less intensity after 7 days.
This case was reported by a healthcare professional and described the occurrence of blood glucose decreased in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 20 October 2009 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, unknown arm). On 20 October 2009, less than one day after vaccination with FLULAVAL, the subject experienced blood glucose decreased and sweating. The subject was hospitalised. Relevant test results included blood glucose 53. At the time of reporting the outcome of blood glucose decreased and sweating were unspecified. The healthcare professional reported that the subject received FLULAVAL and blood sugar dropped. The subject started sweating. They gave him something sweet to eat but could not maintain a sufficient blood sugar level. The subject's blood glucose was 53 after eating something. The subject went to the hospital on his own. This was one of two cases reported by this healthcare professional; see case A0813416A for blood sugar glucose decreased, sweating, dizziness, light headedness and feeling unwell after receiving FLULAVAL.
1. Sore arm, fatigue and low fever that continued for 2-3 days after the vaccination 2. On Apr 22nd - 11th day after the vaccination, I got an itchy, large red rash at the vaccination spot in my upper left arm.
Symptoms begin a week after 2nd Moderna shot. I noticed discoloration and started seeing a Dermatologist in September 2021 once it begin spreading. The second visit confirmed Vitiligo and Immune positive bloodwork. I then saw a Rheumatologist for autoimmune disorder. She ruled out concerns but stated to go back for follow ups if needed. She is aware this Moderna shot has created issues but stated to get signed letter my Dermatologist. My Dermatologist stated progression on Vitiligo can't be stopped and refused to write note. I then found out I had an enlarged liver after a CT scan for the abdomen. I began seeing a Gastrologist. Bloodwork all came back negative, but no one has figured out cause of liver enlargement that was a sudden onset. Not family history.
Developed a similar reaction to the 2nd dose of the vaccine as to the first (also reported through vaers) but with a shorter time course. About a day after receiving the vaccine, developed itchiness at vaccine site. This developed into a tender, warm, swollen, and mildly painful patch within the 2nd day after my vaccine. The pain was mild and well controlled with tylenol and the itchiness was severe and poorly controlled with itch cream and ice. However, the patch did not last as long as the one after the first vaccine and had resolved within about 5 days with severe symptoms only lasting around 2-3 days. The patch was also smaller in size than the one seen after my first dose.
When I sat down, they started giving me the vaccine and the needle broke and my arm started bleeding. The nurse then went and got another dose and gave it. My arm bleeds a little but not too much. Ago a hour later I started to feel nausea and I had diarrhea, and I went home to lay down. I had to contact my doctor to get medication to stop the vomiting. I then started having bad chills. I felt like I had the flu. The doctor prescribed ondansetron the pharmacist didn?t want to fill the medication because I have arthritis medication. The doctor sent me a lower dose, and, in the meantime, I was at home with flu like symptoms and I felt horrible. I started taking the medication and most of the stuff started going away.
Moderna COVID-19 Vaccine EUA - On day 2 post injection swollen lymph gland under right arm.  On day 4 first  fever 100.4 - 101, body aches, very tired and weak, nausea, slight headache for approximately 48 hours.  On day 6 swollen lymph gland under right arm.
She was very forceful with the needle (I almost blacked out). I felt a sensation in my right upper back when she stabbed my left arm  My main concern now, which started two days after the vaccination, is that I am periodically getting warm sensations on my right thigh.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted after receiving shot. Wife caught him and he was laying on the ground for about 20 seconds and woke up. Wife says this happens after he gets shots. He gets light-headed and faints. After 5 minutes he got up and sat in the waiting area and after 20 minutes he felt okay and went home
Periodic Itching at injection site 10 days post vaccination; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 28Feb2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 10Mar2021, 10 days after vaccination, the patient experienced periodic itching at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event periodic itching at injection site 10 days post vaccination was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX vial 19400 PFU, intramuscularly, lot # N020945, expiry date 26-OCT-2017 (exact dose was not provided). There was no adverse effect reported.
Redness, warmth, erythema of arm. Pt given cephalexin and Benadryl.
Patient called back on 10/10/2021. She said the arm where she got the Covid shot in is red and hot to the touch. She also said she has low grade fever and feels sick.  Patient was  informed that the symptoms are in line with some of the possible vaccine side effects but also advised to contact their doctor and if symptoms got worse to seek medical help.  Patient could not give exact time when the symptoms started but roughly referred to them as being later the same day.
No additional AE; expired dose of VARIVAX administered to patient; This spontaneous report was received from a medical assistantand refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-JUN-2023, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter/two dose series, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). The patient was asymptomatic. No additional adverse events were reported.
Next day right eye was really off . After 2nd vaccine on 8/30 the next day could see out of eye and it was extremely cloudy. Patient is now wearing a eye patch .
fever; Flu like symptom for 4 days following receiving the shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown (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: Covid-19 vaccine (Manufacturer: Unknown, Primary immunization series complete), for Covid-19 Immunization; Comirnaty (Dose 3, Second Comirnaty second booster reaction), for Covid-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Flu like symptom for 4 days following receiving the shot"; PYREXIA (non-serious), outcome "unknown", described as "fever".  Additional information: Second Comirnaty second booster reaction. Flu like symptoms for 4 days following receiving the shot, including fever on 3rd day. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to Pharmacy today 03/15/18 which a lateral rash on right arm near injection site. Area is red, minimal inflammation, and no itch. Rash developed several days after vaccine per patient's memory. Advised to apply ice to cool area down and use hydrocortisone to help with inflammation. If doesn't resolve in a few days patient will see her doctor.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, stop date: 04Apr2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: faint red line. Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid from 04Apr2023 to 08Apr2023. The patient has no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HE CLAIMS THE PREVNAR MADE HIS LEFT ARM SORE AND PAINFUL. HE SAYS IT FEELS LIKE THE NEEDLE IS STILL STUCK IN HIS ARM. HE SAYS PAIN SINCE INJECTION HAS BEEN WORSENING.
Fever, chills, extreme fatigue, headache, sore neck, very sore left arm, nauseous, sore/ weak legs., sunburn-like rash on breasts, arm pits, naval, pubic area.
shingles; Information has been received regarding a case in litigation concerning a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On or about 18-SEP-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported), as prescribed and/or administered by a healthcare provider at a hospital for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by a healthcare provider at the hospital for shingles (onset date not provided). As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not reported. The event of shingles was considered to be related to zoster vaccine live (ZOSTAVAX).