chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bladder leakage during the night time; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN8732) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history.  Concomitant medications included simvastatin (MANUFACTURER UNKNOWN); taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 27Mar2021 at 14:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient previously took ampicillin and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Jun2021 at 23:00, about a month after the second shot, the patient started having bladder leakage during the night time. The patient had never had this happened and did not know if it was a side effect. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of the event bladder leakage during the night time was not recovered at the time of this report.
Pt. seen in ER and orthopedic surgeon for arm pain following influenza vaccination.
Within 10 minutes I was sweating and I felt hot all over - even my hands.  Within a few hours I had a terrible sore throat and headache. That evening i still had a fever. The next day the headache and sore throat was worse and now congested  I was having a hard time breathing.  I went to the doctor the 3rd day with the same symptoms.  They tested me for strep and mono - both were negative.  I terrible sore throat and congestion lasted about 9 days, I also got an ear infection, so the doctors finally gave me an antibiotic and steriods  - within a couple of days I felt better.
pain in arm; fatigued; painful headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), FATIGUE (fatigued) and HEADACHE (painful headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in arm), FATIGUE (fatigued) and HEADACHE (painful headache). On 26-Mar-2021, PAIN IN EXTREMITY (pain in arm) had resolved. At the time of the report, FATIGUE (fatigued) and HEADACHE (painful headache) outcome was unknown.            No relevant concomitant medications provided. No relevant treatment information provided
12/24/19 -1/29/20  Severe chest pain on several occasions.  Went to urgent care on 1/29/20 to make sure it was heartburn and not a heart problem.  Diagnosed with elevated d-dimer and right bundle branch block.  Confirmed heartburn.  Weaned myself off of spore-based probiotics and symptoms went away as I decreased the probiotics. Spring of 2020  Noticed declining digestion and developing food sensitivities.  Symptoms could include stomachaches, nerve pain, fatigue.  Chronic constipation, which continues to now.  Other symptoms controlled by very restricted diet.
Abnormal heavy menstrual flow, severe menstrual cramps started on 9/21/21 following the morning after the vaccination.
getting pain on my upper left side; Took the Booster by Pfizer on 05Jan2023/ Is bivalent=False; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2023 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "degenerative disk disease" (unspecified if ongoing); "osteoarthritis in hips" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Flagyl, reaction(s): "Allergy". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown, Route of administration: Unknown , Location of injection: Leg Right), administration date: 05Apr2022, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "prev dose vaccine location=Right leg"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown, Route of administration: Unknown , Location of injection: Leg left), administration date: 07Apr2022, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "prev dose administration date=07Apr2022", "prev dose vaccine location=Left leg". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 05Jan2023 at 12:00, outcome "unknown", described as "Took the Booster by Pfizer on 05Jan2023/ Is bivalent=False"; PAIN (non-serious) with onset 05Jan2023 at 12:30, outcome "not recovered", described as "getting pain on my upper left side". The event "getting pain on my upper left side" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain.  Additional Information: Patient was vaccinated with Pfizer booster dose and started getting pain on his upper left side. He visited ER twice where they couldn't figure it out. Then patient visited her gastroantologist and have done many tests but couldn't find the cause of pain. The pain comes and goes throughout the day until present. The pain was constant and the patient was sure that it was caused by booster shot. The patient didn't receive any other vaccine within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccine. Since vaccination, the patient hasn't been tested for COVID-19  The information on the batch/lot number for BNT162b2, 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-202300113635 same reporter, same patient, same product, different dose, different AE;US-PFIZER INC-202300111373 same reporter, same patient, same product, different dose, different AE;
First shot was on 7-27-21. I had very few side effects- mostly just typical side effects- sore arm, slight headache for a day or so, a little fatigue- but more concerning was the blood pressure increase and heart palpitations.  On 8-24-21 I got the second shot and my side effects were much worse. Immediately after the shot- like within 1 minute- I swear I could taste a strong metallic/astringent taste through my eyeballs. No joke. But i just brushed it off as it dissipated rather quickly. Side effects started off rather typical- sore arm primarily, but this time it started twitching constantly. But almost exactly 12 hours after the 2nd shot- I awoke from a dead sleep with severe joint and muscle pain, cold shivering sweats, headache and debilitating fatigue. The joint pain was severe, followed closely by the muscle pain and fatigue. I ran a 102 temp for about 24 hours and was unable to judge time at all. I don't want to sound like a wuss, but I had not felt this bad in decades! The most severe aspects of these side effects lasted for approx 48 hours. However, mild joint pain and extreme fatigue has continued, along with weakness in my arm, continual twitching of my left arm and constant twitching of my left eye now for over 6 weeks. Increased blood pressure and heart palpitations have remained as well. I do not feel like my battery ever recharges to 100% anymore- only to about 60% at best. I am overtaken by waves of fatigue- so that by 2 in the afternoon I am done, followed by waves of headaches so that by evening time, all I want to do is set in a chair and do nothing. I don't even want to fix dinner. The best I hope for anymore is to just muddle through the day so I can go home and not sleep because it hurts so bad and I have a headache.... And the constant twitching is driving me crazy!
Thank  you for the ability to receive the vaccine,  I am reporting this for your documentation.  11:00   very tired , followed by chills and body aches especially chest pains.  2:00 pm  upset stomach , 6:00 pm  started throwing up for 90 mins.  Tuesday still had chills and body aches  foggy thinking could eat later in the day.   I have a big bruise on my arm  still 10 days later and a line of 4 blood blisters  at my injection site .   I have pictures  did not see where I could up load  them. My partner  (67) was great on Monday after the shot.. did 5 miles on the treadmill. Tuesday  he had a low grade fever  101,  severe chills and body aches.  Wednesday  we were both still a little foggy .  Other than than great
Limited arm movement; chills; achy joints; This is a spontaneous report from contactable consumer (patient) and consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced limited arm movement, chills and achy joints on 03Apr2021.  Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
got a breakthrough COVID PCR+ infection; got a breakthrough COVID PCR+ infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "got a breakthrough COVID PCR+ infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
rash all over his back, and chest; redness; rash all over his arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over his arm), RASH (rash all over his back, and chest) and ERYTHEMA (redness) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced RASH (rash all over his arm), RASH (rash all over his back, and chest) and ERYTHEMA (redness). At the time of the report, RASH (rash all over his arm), RASH (rash all over his back, and chest) and ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Pt devel 4 large hives on lower abdomen 20 min p/vax inject @ diaper line; no other sx inject site clear; DPH given p/hives were noted;
Patient has reported a shingles-like rash from the left lower abdomen traveling up to the left shoulder; extremely itchy. Still seeking treatment to determine if it is definitively shingles.
Varicella vaccine breakthrough diagnosed with varicella 4-24-07 7 lesions. No fever. Exposed 2 wks prior to this.
This spontaneous report was received from a physician refers to a 4 year old patient with no drug reactions/allergies. There was no pertinent medical history. On an unknown date in 2007, the patient was vaccinated with either PROQUAD, (lot number, expiry date was unknown) or VARIVAX, (lot number, expiry date was unknown), subcutaneously in the left thigh. No concomitant medications were taken. The physician could not confirm which product was administered. Approximately on an unknown date in 2007, 48 hours after vaccination the patient experienced 20 typical varicella type lesions cascading to the leg and tremendous pain at location of lesions cascading down left leg described as pain associated with shingles. The patient sought medical attention. The patient was hospitalized for an unspecified length of time and was treated with fluids and intravenous pain medications. On an unspecified date, the events were recovered. Additional information has been requested.
Patient was due to receive 5th dose in Dtap series. By accident, Tdap was administered to patient. State Immunization Registry notified and clinical nurse with IR informed me that no adverse events are to be expected. Tdap given to patient accidentally counts as 5th Dtap and no repeat is needed. Mother of patient notified.
11 weeks at time of injection.  Sore arm day of and day after but cleared up no other apparent symptoms. 8 days later woke up and injection sight was sore and itchy. Didn't see anything but didn't really look. At night  while in the shower my injection sight was burning like a sun burn. When I looked in the mirror there was a large rash around injection site about 3 inches wide and 6 inches long. Itchy and sore to the touch.  Estimated delivery date is Sept. 7th, 2021.
From fax correspondence received from reporting physician, it was reported that a 29 year old female received her 1st dose of Imovax Rabies on 5/7/01 and her 2nd dose on 5/10/01. One week after receiving the 2nd dose, the pt developed urticaria, angioedema and swelling of MCP (metacarpophalangeal), PIP (proximal interphalangeal) and DIP (distal interphalangeal) joints. Treatment of antihistamines and steroids were given for serum sickness. The pt recovered from these events.
Stomach cramping and diarrhea for 10 days following administration of a flu shot.
5 minutes after receiving the 2nd COVID vaccine, patient states she felt a slight flush, lightheaded and heart palpitations. HR was 120-130s but returned back to normal now. She mentions that a couple days after the first shot she had some tingling on the side of her face. The patient was taken to the ED for monitoring . Workup in the ED was negative, and the patient was discharged home.
Arm became sore and itchy at injection site a few hours after vaccination given on 3/5/2021.    Next morning, 3/6/21 woke at 6am, approx. 20 hours after injection, and noticed a lump (swollen lymph node) on left collar bone. I've been a little sleepy today (3/6/2021) but not what I would consider "fatigued" and there have been no other symptoms so far.
Breakthrough Case of COVID-19: I contracted COVID-19, I went to the doctor because I had scratchy throat, congestion, low grade fever, sinuses were swollen. I was prescribed Paxlovid, I did not finish because it because it made me vomit.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.   No treatments medications was reported.
2 weeks after 2nd dose, sudden profound hearing loss in left ear on 2/20/21; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Feb2021 18:00 (Batch/Lot Number: EM9809) as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at health facility. Medical history included diabetes, high blood pressure. Prior to vaccination, the patient was not diagnosed. Concomitant medications included valsartan taken for an unspecified indication, start and stop date were not reported; nicametate dihydrogen citrate (NICAMETA) taken for an unspecified indication, start and stop date were not reported; dipyridamole taken for an unspecified indication, start and stop date were not reported and 'Novartis' product. The patient received the first dose of bnt162b2 (lot number: EL8982) on 15Jan2021 04:30 PM and around the time of the 1st shot, noticeable rapidly deteriorating hearing loss experienced, declining more in right ear according to audiometry test on 12Feb2021. The patient experienced 2 weeks after 2nd dose, sudden profound hearing loss in left ear on 20Feb2021 08:30 AM. Adverse event result in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Treatment received for the adverse event included oral steroids, steroid injections into ear drum. The patient underwent lab tests and procedures which included Covid-19 RT-PCR test: negative on 01Apr2021. The outcome of the event was not recovered.
This case was reported by a consumer via call center representative and described the occurrence of redness gum in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced redness gum, oral pain, gingival discoloration, gum swelling and gingival inflammation. On an unknown date, the outcome of the redness gum, oral pain, gingival discoloration, gum swelling and gingival inflammation were recovering/resolving. It was unknown if the reporter considered the redness gum, oral pain, gingival discoloration, gum swelling and gingival inflammation to be related to SHINGRIX. Additional details were provided as follows: Within a week of having the vaccine, she started to have redness around her gums along with white spots. The patient stated that her gums were inflamed, swollen and her mouth was very painful. The patient thought might be she had brushed her teeth too hard but decided to go to dentist for assessment. The dentist did not think that the patient had any type of gum disease but could not give her a definitive diagnosis. The patient did suggest that she do a few things to help with her symptoms which included rinsing her mouth with salt water. The patient's symptoms were improving but her dentist suggested that she have a biopsy if her symptoms were not resolved. The patient would back to the dentist the day after reporting. The reporter was inquiring if these types of symptoms had been reported and informed that did not see similar symptoms reported but that we would certainly document her experience.
Large left side breast lump, inflammation and redness.  Ultrasound and biopsy pathology and culture.  Tried 3 antibiotics with no change.   Currently talking Prednisone.  Diagnosis of Idiopathic Granulomatous Mastitis has been given.
I live in a household with 2 other people. One of them was diagnosed with Covid on 08/20/2021. On 08/21/2021 I started having the same symptoms he had. I went to urgent department on 08/23/2021 and I got tested for Covid. It came back negative. I was still having the same symptoms, so I called my doctor. I was having some trouble breathing, coughing, and bad headache. They sent me to the ER. I tested positive on 08/27/2021 for Covid. I spent like 12 hours there. They ran every test in the world I think. They came back normal, but I had a urine infection and they gave me Regen-COV. I still have a cough but its not bad.
Information has been received on 15-AUG-2017 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 08-JAN-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 24-MAR-2014, the patient was treated by a physician at a physician's office for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. The patient has been prescribed Acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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.
patient started having swelling and fever up in the night . The next day her lymph nodes were swollen and her fever was 104  and on Wednesday  she had no fever. On Thursday she went to the doctor for the nodes being swollen and had a script for keflex  sent in on 5/4/23 which she picked up today and notified us of the reaction. Patient gave me her phone number so if I needed more information  to fill out this form but she never answered so I do not have any doctor  or other information which I left blank.