chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Zoster within 1-2 days after vaccination/herpes zoster; This case was reported by a physician via sales rep and described the occurrence of herpes zoster in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced herpes zoster. The patient was treated with antivirals nos. On an unknown date, the outcome of the herpes zoster was recovered/resolved.   It was unknown if the reporter considered the herpes zoster to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but the patient was in their 70s. The patient was vaccinated and then developed zoster within 1-2 days after vaccination.  The health care professional did not have patient information available and also did not know the vaccine lot number, expiration or which arm the vaccine was administered in (unknown arm).  The patient had come to health care professional following vaccine administration and was diagnosed with herpes zoster which had resolved later. The health care professional made visual diagnosis but did not confirm with PCR testing.  The patient was treated with antiviral therapy and the herpes zoster episodes resolved without complications. As per health care professional, patient did not have a medical history significant to herpes zoster other than age-patient was in the 70s with hypertension.  Patient was currently not receiving therapy for herpes zoster episode. The reporter consented to follow-up. This case has been linked to US2020AMR214315, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR214315:same reporter,same suspect, same event, different patient
Received injection on 9/1/2017 from a prescription written by Dr. on 8/16/2017. On 9/2/2017 @ around 6 pm spouse called and stated that the patient was experiencing vertigo, fever, and his muscles were beginning to twitch since 4 p.m. When asked if the fever was around the injection site, the answer was, "No, there is no fever, redness, or swelling where the shot was given."  Spouse was told that I was contacting Dr. and if husband gets worse, take him to emergency room or call 911. Called on-call doctor around 6 p.m. then at 6:15 pm called spouse and told her Dr. would be calling, but if worse, call 911. At 6:45 called spouse to see if doctor called her. She stated, 911 emergency was at the house. Follow-up 9/5/2017 and no answer @ 3:45 pm today.
arm is sore; chills; fatigued; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm is sore), CHILLS (chills) and FATIGUE (fatigued) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concomitant products included RSV VACCINE and INFLUENZA VACCINE for an unknown indication.    On 09-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 10-Nov-2023, the patient experienced PAIN IN EXTREMITY (arm is sore), CHILLS (chills) and FATIGUE (fatigued). At the time of the report, PAIN IN EXTREMITY (arm is sore), CHILLS (chills) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No medical history was reported. The dosage text was reported as unknown. This morning the arm was sore. During sleeping the patient also experienced chills this morning and feels fatigued.  No medications or treatments were given. The RX number.
Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Hypertension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: Eye ball rotating
Had Td on 8/7/02. On 8/8/02 developed streaking, discomfort, increased pain and itching, low grade temp, myalgia into neck, flu-like sx. Started on Vioxx 25mg qd on 8/8/02.
Suspicion I had COVID in Feb of 2020.  With second dose of vaccine has exactly the same sysmptoms Uncontrollably shivering and shaking, very strong cough similar to dry heaves, unable to keep eyes open or shut for any length of time, couldn?t sleep or lie still.  Lasted from 5 am to about 3 pm then was over.
4/16/21 Patient presented to ED w/complaint of "fogginess in the head." No dizziness or lightheadedness. Stroke alert was called and pt was placed in observation. Pt screened positive for SARS-CoV-2 in the ED Altered mental status Dizziness Stroke like symptoms CT head-no intracranial hemorrhage or acute findings.  Atrophy with chronic microvascular disease CTA H& N-normal CT of the brain.  No carotid or vertebral artery stenosis in the neck. EKG-normal sinus rhythm.  No significant ST-T wave changes Check A1c, lipid panel Continue aspirin, Lipitor Hold antihypertensives until stroke ruled out with MRI Noted MRI of the brain Consult neurology,PT/OT/ST. Pt discharged to home after assessments  COVID-19 positive Chest x-ray-no acute cardiopulmonary process Patient is not hypoxic No indication for remdesivir or dexamethasone at this time Start patient on zinc, vitamin D, vitamin C
This is in follow-up to report(s) previously submitted on 9/14/2006.  Information has been received from a physician concerning a 23 year old female with no known drug allergies was vaccinated intramuscularly on 18-AUG-2006 at 15:00 in the deltoid muscle with GARDASIL (yeast).  On 24-AUG-2006 the patient developed a rash with itching and minimal swelling on the back of her neck, arms, ribs, back and behind her left knee.  Follow up information stated that the patient was treated with Benadryl, 50 mg and topical hydrocortisone cream.  It was reported that on 24-AUG-2006 the patient had recovered.  Additional information is not expected.
7 months after vaccination developed superficial thrombophlebitis which is a clotting event.  No previous history of issues. No previous Covid-19 Infection.
-developed rash (mild case) after the patient received the shot. on 12-16-19. -rash continued to get worse over the week. (rash all over the body) - patent also developed joint pain.
Pt recv vax on 10/13/98; on 11/3/98 pt exp fever (102.6F), diarrhea, stomach cramps
Patient reported redness, swelling, and itching at the injection site.  She also described induration as big as a "baseball".  She took Benadryl after which all of her symptoms got better or disappeared completely.   This patient reported her experience so that we could have this information.
ringing in the ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Mar2021 13:15 (Lot number: EN6208) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 23Mar2021, outcome "not recovered", described as "ringing in the ears". The event "ringing in the ears" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional Information: History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the Pfizer Suspect both were none. Adverse event(s) following prior vaccinations were none. Reportedly, the patient got vaccinated Monday (22Mar2021; Dose: 0.3 IM injection) at clinic and she developed ringing in ear Tuesday (23Mar2021) when she was waking up. She had no prior symptoms, and she was still having it today. She was getting a little worried especially reading everything about it. She stated she was sorry the ringing in the ear was throwing her off. She didn't have a primary care, but she had seen 2 doctors already this morning. She asked was this a common thing was it happening to other people. She has seen 2 doctors this morning, one was virtual and then she went to a MD walk in clinic. She was prescribed Zyrtec for a possible allergic reaction. Prior Vaccinations (within 4 weeks) was none, she had been at home for a year. She would like to speak to someone with medical information, she doesn't know and can't get any information of if this is going to be permanent, if it was going to continue. Emergency Room, Relevant Tests and investigation assessment was none.    No follow-up attempts are possible. No further information is expected.
Itching and hives developed on the left side of my face near my eye.  My left leg became itchy in my inner thigh.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 10-NOV-2012 07:54, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient stated she needed to go to hospital for adverse reaction of pain in leg.  After asking MD to check her leg, they discovered a blood clot per patient. She is now doing well per her.
I am entered in Menopause and I have not had any period for 11 months but I am having Menstrual bleeding after my Covid shot; almost 4 periods it's really weird; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0202) via an unspecified route of administration on 11Jun2021 as dose 1, single for COVID-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0187) unspecified route of administration on 02Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 25Jun2021, the patient experienced I am entered in Menopause and I have not had any period for 11 months but I am having Menstrual bleeding after my Covid shot; almost 4 periods it's really weird. When probed for event start date, consumer stated, 25Jun2021 and then I had Doctor Appointment but not a gynecologist but for regular checkup she told my Doctor that I am entered in Menopause and I have not had any period for 11 months, I met and Gynecologist. I had my second Covid shot and then Sunday I start little worse and then on Monday, Tuesday, Wednesday and today it's almost 4 periods it's really weird. When probed for any treatment for the problem, consumer stated, No, what would I take for that. When probed for any laboratory work, consumer stated, I went through my Physical Exam and my regular Doctor had. I went to see her a couple of days after later she had the lab report I had to the lab work she said your chart are text book perfect. The clinical outcome of the event was reported as unknown.  Follow-up attempts are needed. Information on Lot/Batch number was available.
local reaction: red, sore, swollen approx size of an orange. Reaction reported by RN family physician.
Developed a skin condition resembling psoriasis on my arms and legs and groin 2 weeks after my second shot that has never gone away since (now 2023).
Cellulitis to (L) arm at injection site, 4 inches in diameter, warm to touch, occured within hours of injection, treated with prednisone.
Indurated arm; Red Arm; Arm started itching; Arm Inflamed; Warm Arm; This spontaneous case was received on 20-Oct-2023 from other health professional (Nurse, Patient) via agency (reference number: SEQW23-03616) and concerned a 71-year-old, female patient.  The patient's concurrent conditions included intestinal problems, allergy to penicillin, sulfur and dairy (milk protein). The patient's concomitant medications included Xarelto (Rivaroxaban), Calcium, unspecified vitamins, Singulair (Montelukast sodium) all used for unreported indication and low dose Ciprofloxacin used for intestinal problems.  On 18-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration, anatomical location, and indication: not reported). The batch number reported was 371640 with expiry date: 30-Jun-2024.  On the same date, five minutes after receiving Fluad Quadrivalent vaccine, the patient had a local reaction and her arm started itching. The rest of the day it started to get inflamed.  On 19-Oct-2023, the patient observed that, the arm was red and indurated.  On an unspecified date in Oct-2023, the patient's arm was warm.  On 20-Oct-2023, the patient's arm was still red however it was slightly less warm.  The outcome of the event inflammation localized, induration, erythema of extremities, localized itching was not reported.  At the time of initial reporting, on 20-Oct-2023, the patient was recovering from the event skin warm.  The reporter assessed the case as non-serious.  Company comment: A 71-year-old patient experienced localized inflammation, induration, skin warmth, arm erythema, and localized pruritus within two days after receiving the suspect product influenza vaccine. Based on suggestive temporal relationship and the absence of confounders, causality for the reported events is assessed as probably related.; Sender's Comments: A 71-year-old patient experienced localized inflammation, induration, skin warmth, arm erythema, and localized pruritus within two days after receiving the suspect product influenza vaccine. Based on suggestive temporal relationship and the absence of confounders, causality for the reported events is assessed as probably related.
Chest pain beginning 24hours after vaccination. EKG suggestive of pericarditis
Dizziness, lightheaded, off balance, nausea after second shot.  This lasted for about 4 weeks or longer.
IPOL was given in error. 0.1ml into (L) forearm intradermal. Was supposed to receive 0.1ml TB intradermal test.
gave monovalent moderna covid booster. The state had not yet issued us the bivalent covid vaccine.
one hour following, wanted to vomit. two hours later, lie down, head hurt, could not focus. Headache continued for 6 HRS until I could walk and function. Presently, my sinuses bother me, mucous and headaches. year 2018, I refused senior flu shot and got regular shot. This year 2019, I made mistake and got senior shot. I weigh 102 lbs I should not have to take a shot that is 5X stronger.
Nausea, Vomiting, Migraine with temp of 99.8. Symptoms resolved on 01/07/2021
Hives; This is a spontaneous report from a contactable consumer. A female patient (daughter) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was unknown and expiration date was unknown), via an unspecified route of administration, administered in Arm Left on 27May2021 as 1st dose, single dose for COVID-19 immunization. Medical history was none provided. The patient's concomitant medications were not reported. The patient did not receive any other vaccines prior to the vaccination (No, she was not there yet, she was going to get next vaccine next week). On May2021, patient experienced hives. Reporter stated, just wanted to know about the reaction that my daughter had with the first dose. Reporter stated, I just want to talk to somebody just to clarify before we get the second dose. Reporter again stated, 5 hours later, I just want to know about the reaction she had was normal, that's all. No, she had a reaction and wanted to know if that was an okay reaction and normal. Reporter stated, No, she did, I mean she was just taking systemic antihistamine does not like, because she has hives. Reporter stated treatment for hives was No. The outcome of event was unknown.  Follow up attempt needed; information about lot/batch number has been requested.
Patient found dead in bed the next morning.  Attributed to likely heart attack (history of MIs) secondary to ESRD, DMII, but did occur day after vaccine administration.
fever 101.00 large & painful lesion @ inj site nearly inconsolable crying;
headache; tiredness; Vaccine exposure during pregnancy; a little sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), VACCINATION SITE PAIN (a little sore arm), HEADACHE (headache) and FATIGUE (tiredness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-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. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 11-May-2021. On 19-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and VACCINATION SITE PAIN (a little sore arm). On 20-Apr-2021, the patient experienced HEADACHE (headache) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 19-Apr-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (a little sore arm), HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown.            No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-058276, US-MODERNATX, INC.-MOD-2021-058563 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058276:Case for dose 2 US-MODERNATX, INC.-MOD-2021-058563:cross linked case (case for mother)
I started getting symptoms of chills, sweats, body aches, and congestion. On the 4/10/2022 I had a fever with fatigue, no appetite, and loss of sense of smell. I got a negative COVID-19 test on 4/9/2022 then positive COVID-19 test on 4/10/2022. My symptoms lasted about 10 days but then after 14 days I still felt feverish and had fatigue. I tested negative on 4/26/2022 with a positive outcome. My husband is a physician and was prescribed medications. I still have congestion and bronchial spasm. I would have pains in my ribs and chest that would last for minutes and then it would go away.
Cannot talk; Patient's worsening condition; Nausea; Out of balance; Like someone drunk; Woozy; face is tightening; Leg is agitating and tingling; Chest tightening; Leg is agitating and tingling; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Out of balance), FEELING DRUNK (Like someone drunk), DIZZINESS (Woozy), MUSCLE TIGHTNESS (face is tightening) and LIMB DISCOMFORT (Leg is agitating and tingling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced BALANCE DISORDER (Out of balance), FEELING DRUNK (Like someone drunk), DIZZINESS (Woozy), MUSCLE TIGHTNESS (face is tightening), LIMB DISCOMFORT (Leg is agitating and tingling), CHEST DISCOMFORT (Chest tightening), PARAESTHESIA (Leg is agitating and tingling) and NAUSEA (Nausea). On an unknown date, the patient experienced APHASIA (Cannot talk) and CONDITION AGGRAVATED (Patient's worsening condition). At the time of the report, BALANCE DISORDER (Out of balance), FEELING DRUNK (Like someone drunk), DIZZINESS (Woozy), MUSCLE TIGHTNESS (face is tightening), LIMB DISCOMFORT (Leg is agitating and tingling), CHEST DISCOMFORT (Chest tightening), PARAESTHESIA (Leg is agitating and tingling), APHASIA (Cannot talk), CONDITION AGGRAVATED (Patient's worsening condition) and NAUSEA (Nausea) outcome was unknown.            concomitant medicines was not reported by reporter   Treatment information was not provided
Information has been received from a nurse practitioner concerning a 21 year old white female student with no pertinent medical history who on 13-MAR-2007 was vaccinated intramuscularly, into the left deltoid, with a second dose of Gardasil (lot #).  On 15-MAR-2007 the patient developed a rash on her face, she "wanted to sleep all day and for some reason wanted to cry."  Unspecified medical attention was sought.  On approximately 18-MAR-2007, the patient recovered.  There were no laboratory or diagnostic tests performed.  It was noted that the night before the second dose of Gardasil was administered, the patient had eaten shellfish.  Although there was no history of shellfish allergy, there was a family history of shellfish allergy.  No further information is expected.
Redness at injection site & swelling. Itching in some parts of body mainly injection site. Tenderness at injection site. Ice, BENADRYL cream.
Severe swelling and redness down arm of where flu shot given. BENADRYL.
Joint and body aches are the symptoms I experienced with all 3 diagnoses of covid. I tested positive recently on 02/03/2023 and i was experiencing body aches and a low-grade fever. The doctor prescribed me Paxlovid the same day and I took that for 5 days and still developed a cough after that round that I had experienced chest pains as well and the doctor advised to get a chest x-ray on 02/06 and they could see the start of pneumonia forming.
Patient received Pfizer Monovalent vaccine instead of Pfizer Bivalent vaccine booster
Injected arm started throbbing. Woke up out of sleep twice that night to take NSAIDS to try and make it bearable. Still 3 weeks later not able to push or pull with arm, drive care, or lift with left arm-including taking off shirt, without pain. Able to pinpoint exact place injection was given and pain associated when pushing spot. Taking NSAIDS all day long to be able to move.  Finally after 2 1/2 weeks made general physician appt because it is crazy how long and how  bad my arm hurts. At that time still not able to lay on left arm or lift over head. Have been to chiropractor 3 time to help relieve shoulder/muscle pain.