chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered PNEUMOVAX 23 that underwent a temperature excursion; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 22-FEB-2021, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot # T024557 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 15-MAR-2022 (route of administration, anatomical location were not provided) for prophylaxis.  The temperature excursion was 75 degrees Fahrenheit (F) for 4 hours and 30 minutes. There were no previous excursions reported. The digital data logger was not involved.
Headache; Nausea; fever; Chills; This is a spontaneous report from a contactable consumer (patient himself). A 65-yers-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, formulation: solution for injection, lot number: EN6201, expiry date: unknown) via un-specified route of administration, in left arm on 16Feb2021 11:30 (age at vaccination: 65-years) as dose 2, single for Covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3302, expiry date: unknown) via unspecified route of administration, in left arm on 27Jan2021 (age at vaccination: 65-years) as dose 1, single for Covid-19 immunisation. Facility type vaccine was hospital. Patients medical history and concomitant medications were not reported. Patient had no known allergies. No other vaccines in four weeks was administered to patient. On 16Feb2021 11: 30 PM, patient experienced headache, nausea, fever, and chills. No treatment was given as a result of the adverse events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of events was recovered on an unspecified date in 2021.   Follow-up attempts completed. No further information expected.
First dose of Pfizer COVID-19 shot felt a bit dizzy than about 10 minutes after I had already waited the allotted waiting time and was on my way home my lips began to tingle, I started to have trouble swallowing  my tongue felt heavy my voice became very hoarse.  I had a bad headache.  Was treated with an IV of Steroids and Benadryl  and later given Claritin and Allegra for 3 days.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # K020215, expiration date 15-MAY-2016, exact doses and route of administration were not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Fever, chills, muscle pain, swelling and redness on injection site. Took Aleve 2 tablets next day, fever and chills alleviated.
High fever up to 104 degrees lasting 24 hours and improved down to 100 degree x 2 more days then resolved
profound fatigue and dyspnea when in the shower, cold like symptoms starting 12/15/21
Absolutely healthy and active pre-varicella immunization shot was administered. Shot was given following a physical exam which revealed no abnormalities. Patient began throwing up 1 hour after shot, had no fever but was very fatigued and slept a lot. She threw up 3 times in 4 hours, a call made to Doctor was NOT returned. Initially nurse said to take her to Emergency room, but changed her mind saying the Doctor would call back. She slept through night fine, but was fatigued all morning and not eating well. Not sure what we should do, nurse said it was probably a coincidence and she probably had flu?
(R) facial cheek swelled and slight swelling of eyes. Denies itching, hives, difficulty breathing. Lasted 2-3 days. Took BENADRYL -> initially on "old box" and bought new at pharmacy which he feels helped. Thought he might have slept wrong on it.
Patient become sweaty, weak, had a loss of hearing and passed out. Happened within 2 minutes of receiving vaccine.
Patiennt was administered a Moderna covid vaccine with expiry 10/15/2021.  Patient tolerated the injection well and was observed after injection for 15min in the office. No complications or adverse events were noted.
We are reporting another incident of a 3 year old receiving a dose of H1N1 (Novartis) that is licensed only for persons 4 years of age and older. The child received 0.5 mL intramuscularly of H1N1 (Novartis MDV) at one of our health department community clinics. The dose was given on XX-XX-2009 but wasn't discovered until XX-X-2009. We have not received any reports of adverse reactions from this error. We will again be re-educating our staff to prevent this error from happening again. We have not received any reports of adverse reactions from this error.
emergency cancer treatment; has not gotten second dose in 42+ days; This spontaneous case was reported by a pharmacist and describes the occurrence of NEOPLASM MALIGNANT (emergency cancer treatment) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced NEOPLASM MALIGNANT (emergency cancer treatment) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (has not gotten second dose in 42+ days). On 02-Jan-2021, PRODUCT DOSE OMISSION ISSUE (has not gotten second dose in 42+ days) had resolved. At the time of the report, NEOPLASM MALIGNANT (emergency cancer treatment) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant details were provided. No treatment details were provided.  Company Comment: 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.; 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.
1ST DOSE OF SHINGRIX GIVEN 5/16/18 AND 2ND DOSE 6/29/18. INTERVAL WAS LESS THAN 2 MONTHS BUT GREATER THAN A MONTH.
This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction at vaccination site, after second dose of the vaccine), PRURITUS (Started itching right away) and VACCINATION SITE ERYTHEMA (A hot redness of the size of an orange) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination.  No medical history was provided by the reporter. Concomitant products included VITAMINS NOS for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PRURITUS (Started itching right away) and VACCINATION SITE ERYTHEMA (A hot redness of the size of an orange). On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergic reaction at vaccination site, after second dose of the vaccine). On 02-Mar-2021, PRURITUS (Started itching right away) had resolved. At the time of the report, ALLERGY TO VACCINE (Allergic reaction at vaccination site, after second dose of the vaccine) and VACCINATION SITE ERYTHEMA (A hot redness of the size of an orange) had resolved. On 25 Feb 2021, the patient received second dose of Moderna Covid-19 vaccine and experienced an allergic reaction in the injection site and the reaction was a hot redness of the size of an orange.  The patient also reported that they also experienced itching which lasted for 5 days. The patient recovered after 3 weeks. Concomitant medication reported also included Blood pressure drugs. No treatment medications were the by the patient. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-085317 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up received on 26 May 2021 contains patient demographics, additional event information, and event date.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-085317.
About 1 week after the injection, the injection area began swelling, itching, becoming on to the though, and very red. It a little bit larger than the size of a quarter.
patient reported rapid palpitations following the first vaccination. sometime between 05/07/21 and 05/10/21 he started having muscle pains in various places that kept moving around. winded easily. Came into the ED on 05/21/21 with complaint of left calf pain x2 weeks. no cause found. patient followed up in another facility on 5/26/21 where bloodwork was unremarkable, but was prescribed 6 day course of tapering steroids. symptoms improved, but returned as steroids tapered. patient developed right calf pain on 6/6/21. bloodwork showed elevated d-dimer and was sent to the ED for evaluation. no lower extremity or pulmonary emboli found. suspected that patient has COVID myocarditis and sent for follow up with cardiology. patient was prescribed steroids again on followup. patient presented to ED again on 06/25/21 with headache, chills, SOB and weakness. there was concern for vasculitis and sent to higher level of care.
Fever of 104 degrees, diffuse rash, hives, nickel sized flat red marks, and splotches on her chest. Treated with Tylenol and Motrin.
Information has been received from a registered nurse concerning a 14 year old female patient with seasonal allergy and no known pertinent medical history who on 17-SEP-2008 was vaccinated with first dose of GARDASIL (Lot # 659184/0843X) 0.5ml, intramuscularly. The patient's last menstrual period was 10-NOV-2008. The patient was in the office to received the second dose of GARDASIL and she mentioned she was 10 days late getting her period. The second dose of GARDASIL was not given to the patient. Although the patient's urine HCG test was negative the physician instructed the patient to wait 1 or 2 days to see if she gets her period. If the patient does not get her period she was instructed to call the office to arrange for blood test for pregnancy. On 17-DEC-2008 the patient was treated with Clindesse for bacterial vaginosis. At the time of report on 17-DEC-2008 the patient was not recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2009. Follow up information has been received on 09-JAN-2009 from a Registered Nurse who reported that the patient was never received GARDASIL. Additional information is not expected.
She received Zostavax 6-8-07 awoke next day with blurred and double vision.  7/24/07 Received office note of 6/11/07 which reveals patient awoke w/double vision day after vax.  Exam revealed no abduction right eye.  Double vision worsened w/right gaze.  Pt dx w/6th nerve palsy right eye.
Vaccinated with TD 3/2/07 on 3/5/07 presented with redness, warmth and with tissue swelling.
reports symptoms of Other: shortness of breath. Writer has observed that patient had no difficulty breathing, no adventitious sounds were coming from patient, no wheezing, patient was not winded. Treatment/intervention vital signs at 1408: BP:139/87, SpO2: 98% as high as 100%, Pulse:84.  Ice pack and water was given to patient, writer directed patient to sit up straight, and gave her permission to pull down her mask. Patient insisted to writer and other staff, multiple times, that she was comfortable to leave and that she did not need to stay to be observed any longer.  Writer educated patient that she is to come to the emergency department if symptoms or reaction worsened.
Patient was given 1 ml instead of 0.5 ml. Patient was contacted and made aware of the error. Patient was feeling in adverse effects at this time. Was made aware of potential side effect and asked to call if any appeared.
Patient reports 2 days post injection she developed wheezing and coughing after taking a long walk. These sx persisted while exercising for 2 months. Wheezing lasted 10-15 mins post exercise, cough 30-45 mins post exercise. Saw allergy/asthma specialist. No wheezing, but continued to cough.
Pt report feeling light headed, dizzy, blurred vision, nauseated,  loss of hearing, and tingling in the fingers in both hands.
On 8/7/22 around 10:30 am, the father requested for a second dose of Pfizer.  Pfizer 0.2ml was given on the left arm. RN then noticed when filling out the vaccination card that the patient was given Moderna as the first dose. The site lead was immediately notified. It was explained to the father that Moderna was administered as the first dose, not Pfizer. The father was asked to wait 30 minutes for the patient to be observed. The patient did not show any reaction while waiting.  The parent?s information was taken for following up by the site lead. The parent was encouraged to continue monitoring the patient for any reaction and to report to the child?s doctor. The father was contacted by the site lead around 8;45pm. The father responded that patient seems great and had no issues that he could see.
Patient is 73 years old with past medical history of multiple sclerosis, neurogenic bladder, hyperlipidemia, recurrent UTI, hyperlipidemia presented to the hospital s/p a fall.  Patient fell from the wheelchair and was laying face down when she was found by her husband. Subsequently after patient had 2 episode of nausea and vomiting. Patient denies any syncope.  Otherwise patient has no fever, chills, chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, constipation.  Admits to frequent urination and dysuria.   In the ED, patient was found to have urinary tract infection and was initiated on Rocephin.  She was found to have a positive COVID.  She did receive COVID-vaccine previously.  Prior urine cultures grew E. coli.  Patient had CT of the head and CT of the cervical spine and were both negative.  Patient had a CT of the abdomen and pelvis with IV contrast and was consistent with cystitis.   Clinical Summary   Patient presented to the emergency department due to nausea vomiting and fall at home.  She was admitted to the medical surgical unit for the treatment of urinary tract infection.  Neurology was consulted given her history of MS.  She was found to be at her discharge and neurology recommended baseline and neurology recommended discharge.  She was found to be COVID-positive which could be etiology of her nausea vomiting and weakness. She did not meet criteria for remdesivir.  She had 1 episode of fever at 100.7 which quickly resolved and did not recur.  This is likely secondary to COVID rather than UTI.  After antibiotic treatment her dysuria was resolved.  She is feeling well and requesting discharge.  I discussed case with husband who was in agreement.  She will be discharged to complete course of Keflex x5 days and Paxlovid.  I did confirm no interacting drugs with the pharmacist.  Extensive education with both the patient and husband.   Patient was previously set up for IR placement in 2 days of suprapubic catheter to aid in her frequent UTIs, but this has to be rescheduled due to her present COVID infection.   Discharge diagnosis   Urinary tract infection with sepsis  COVID infection Multiple sclerosis Generalized weakness s/p fall Neurogenic bladder with incontinence Hyperlipidemia
Patient admitted to ICU 11/2/2021 w/COVID-19 PNA (tested positive on 10/26/2021) s/p 2 doses Pfizer on 3/26/2021 & 4/19/2021.
Speech lost and still have residue language issues. 11/23/09 DC summary and hospital records received for dates 11/10/09 to 11/12/09. DX: Status post transient speech arrest/aphasia vs transient alteration of awareness. Chief c/o speech difficulty, pt states aware of what was desired to say, but unable to speak. Pt. admitted for further eval. Upon dc pt speech improved.
Child doing well. R deltoid area with redness and edema x 2 days. ROM intact. 6/8/02 Sx: mild, getting better. Tx: Motrin as directed/cold compress, RTC if Sx not better.
Breakthrough case after 2 vaccines  Moderna 3/2/21 Lot# 015M20A ; Moderna 3/30/21 Lot# 002B21A
pt recv vax in MAY1995 & 1 wk p/vax pt devel an unusual gait while walking & signs of encephalitis; No further details were provided
The side effects didn't all occur simultaneously. Friday evening I noticed severe arm soreness. Later Friday night (about 10 hours after getting the vaccine) I developed gradual onset chills, body aches, and fatigue. Saturday I woke up with a severe headache, body aches, fatigue, and fever. The headache became severe by mid-day, with fatigue also worsening throughout the day.  Sunday was more of the same, though I believe the fever started inching down and the headache lessened. What developed Sunday afternoon/evening took me off guard though. I noticed a sudden drop in heart rate, a feeling of pressure and discomfort in the chest, nausea, and shortness of breath with exertion (consistently - not just once). (I'm a long-distance runner, so this is unusual for me.) At first I debated going to the emergency room, but since I'm so young and in otherwise good condition I thought nothing of it. I had similar symptoms the following day, but I avoided exerting myself until all of my symptoms from the vaccine had ended. I felt groggy and fatigued for several additional days, but by Saturday (8 days after getting the first dose of Pfizer) everything had resolved. I also developed swollen lymph nodes, which returned to normal size within about 3 weeks (before swelling again after the second vaccine).  The second dose of the vaccine caused a more sudden and intense reaction, though I never developed chest pain/slow heart rate with it.  Instead I developed sudden onset severe chills, fatigue, and body aches about 9 hours after getting the shot. A fast heart rate, shortness of breath, and sudden onset fever (temperature jumped nearly five degrees in about 90 minutes) quickly followed. My fever stabilized around 102.2 around 3 a.m. that morning, and slowly crept down throughout the afternoon/evening. Overall, with dizziness, body aches, extreme fatigue, etc., this was the sickest I've been since I had a severe case of the Flu in high school. The fatigue, shortness of breath, and fast heart rate continued for about a week - getting slightly better each day.
having burning pain in lymph nodes under her left arm; having burning pain in lymph nodes under her left arm that is getting worse; pain that radiated into her left leg / having burning pain in lymph nodes under her left arm; pain is so bad; This is a spontaneous report from a contactable consumer or other non hcp (parent) reported for her daughter (patient). A 30-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left on 24Jul2021 as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The reporter reported the patient had left side pain that radiated into her left leg on Sunday but it subsided. Previous day she began having burning pain in lymph nodes under her left arm that is getting worse.  She got the vaccine in her left arm. She fought getting the vaccine because she heard it causes fertility issues but finally decided to get it. She had to leave work because the pain was so bad. The reporter asked was this normal. Had it been reported before and how long would it last. The outcome of the events was reported as not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
PT REPORTED SEVERE BODY ACHES AND TIREDNESS/LETHARGY FOR AT LEAST 3 WEEKS AND STILL HAVING THESE SYMPTOMS. SHE REACHED OUT TO DR ABOUT DIARRHEA AND SAID THEY TOLD HER TO GET A MEDICATION OVER THE COUNTER FOR THOSE SYMPTOMS.  SHE ALSO STILL REPORTS A SORE ARM AT ADMINISTRATION SIGHT
Large redness and swelling in left arm extending under arm to armpit, and itching and tenderness.
Mother stated she noticed the area this AM around 8AM on infants face, arms, legs and hands.  Few on center of chest and upper back.  Arms, hands, and legs broke out heavily.  The areas were around 1/4 - 1/2 cm in size circular and flat in shape and no area touched.  Infant had no temperature and was eating and drinking.
Attendee received dose of Pfizer vaccine at 14:43. Lot# EW0179. Attendee was directed to observation area.   At 14:45 voiced complaints of dizziness.  Attendee's skin was warm and dry.  Attendee's respirations were not tachypneic or dyspneic. Attendee assisted to the cot to lie down, legs elevated.  HR:  72   BP:  98/68   RR:   19   O2Sat%:  99      14:50 - Attendee stated he felt better, no longer diaphoretic, or pale.   HR:  72   BP:  104/60   RR:   19   O2Sat%:  99  15:00 - Care Practitioner educated on home discharge/adverse reaction instructions and attendee was discharged to home with his friend.   Attendee did not have any reported escalation of symptoms and was able to walk out of clinic independently.
I had pain in my right shoulder and ribs when I tried to take a deep breath. It was determined to be a muscle strain. No treatment prescribed, just told to rest and it would improve on its own, which it did in a couple of days.
Aches chills and slight fever similar to a flu response. Slight dizziness and delirium at times
Woke up on the 3rd day (monday) post vaccination with a terrible headache. I took tylenol to help reduce the pain.  The headache continued all week, but was slightly better, sometime manageable with no medication.  I felt in in the front and back.  I saw my primary care on Friday and he prescribed magnesium oxide and aspirin.  I was offered prednisone, but declined.  Intermitent headaches have continued, requiring some meds 2-3 days a weeks to reduce pain.  The last day I took something was 1/16/22
2 1/2 weeks after EACH shot  I experienced a lapse in  short term memory that lasted approximately 30-45 minutes  similar  to transient global  amnesia
5 days after PROQUAD developed fever and staring out. Paramedics called and dx "febrile seizure" possibly. They directed her to the ER but because child recovered she did not go.
Left triceps - 4x4 cm red, edema - 2x2 cm induration and tender (-) oozing
48 hours following vaccination, the patient developed fever, body aches, slight rash on chest. Within the next 48 hours developed a runny nose. All symptoms resolved within the next 48 hours.
Extreme swelling, redness, hardness, bumps, blisters and oozing. Lots of pain resulting in difficulty walking.  Severe itchiness.
Headache, Myalgia, NauseaVomiting, Tachycardia, Fatigue Narrative:
Observed pt. nervous in clinic when receiving vaccines. Asked pt if he felt dizzy or lightheaded before leaving. Pt denied any problems. Advised pt with mother present to take it easy today and rest. Also to reread VIS forms given. Pt and mother verbalized understanding. Pt mother called at 1440 to clinic, spoke with nurse on phones. Pt mother stated to nurse on phone "when we got home he passed out and is acting weird". Mother stated he is awake and breathing. Mother was advised to call 911. Treatment unknown. Made phone call to pt. mother, no answer. Left message for mother to return call.