chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient also received H1N1 at agency in County (flu clinic?) on 10/26/09 at approximately 5 pm. he had recieved the general flu inactivated shot on 10/22/09 at Dr's office. Per mother he developed some cheek redness and slight puffy lips after the H1N1 inactivated shot given on 10/26/09. On Friday 10/30/09 he developed emesis and was seen in ER on 10/31/09 where he was given prescription for phenergan suppositories. Mother gave 2 suppositories 4 hours apart and did not think he felt better so returned to local ER. There patient noted to be comabative, ataxix, and confused. he was given shot of benadryl. He was admitted to their hospital. he was transferred to ourhospital on 11/2/09 after remaining obtunded with response to pain only. he was admitted to our hospital on 10/2/09 where complete work up was undertaken and is negative to date. he started coming out of his obtundation slowly. he is being discharged today 11/5/09 with close follow-up with his primary care physician. His obtundation is felt to be related to an uknown ingestion.  11/10/09 Medical records and Discharge summary received for DOS 11/2/09-11/6/09.  Final DX: Toxic metabolic encephalopathy, hypertension, elevated TSH elevated creatinine.   Vaccine 1 week before. Facial flushing. H/O steroid therapy. Vomiting. Seen in ED. D/C to home.  Vomiting persisted. Low grade temp. Hypertensive.    Sleepy and unresponsive. Back to ED. Episode of thrashing. Possible Phenergan allergy. Benadryl admin. Completely unresponsive. Tachycardia. Increased WBC.  EEG abn. Patient and family recent food poisoning. Clonidine withdrawal likely cause of hypertension.  Increased creat due to acyclovir. At time of d/c patient responsive, normal tone, moved all extrems. Walking.  12/15/09 ED records received for DOS 10/31/09. Pt. presented with abdominal pain, vomiting. Tx. with phenergan supp. Discharged home. DX: Gastritis
poss sz 15 days p/MMR; multiple brief episodes of crying, rubbing eyes & eyes rolling back; no treatment;
Hives-whole body, non-pruritic tx with OTC/oral Benadryl.
Red, warm to touch, circular area 10cm by 10cm. Prescribed Benadryl 25 mg 1 pill Q6 prn.
Initial information received on 08-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age patient who experienced IMOVAX: administered to pt. that had been reconstituted 24 hrs prior to administration. Pt. on post exposure rabies vaccine series, a 4 dose series and this was 3rd dose/ no adverse event, while he/she received vaccine IMOVAX RABIES. On an unknown date, the patient received a third dose of suspect IMOVAX RABIES (Lot number, expiry date not reported) via unknown route in unknown administration site. Patient received IMOVAX vaccine that had been reconstituted 24 hrs prior to administration. Patient on post exposure rabies vaccine series, a 4 dose series and this was the 3rd dose in the series. It was an actual medication error due to inappropriate reconstitution technique. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
On Aug 12 I had very bad head congestion in nose, eyes, ears, headache which I found out by testing myself the next day was caused by COVID.  I had pain in my left eye and redness and trouble focusing. I went to the doctor who  had done my catarct surgery 2 year s before and he said I  had infamation and some scarring around the cataract that might need laser treatment later. He gave me steroid eye drops which have helped.
possible allergic reaction.  no known link to anything, no known allergies to anything.  previously exposed to many common allergens with no effects.  wanted to register this reaction that occurred so close to recieving vaccinations. 5/20 - 7am noticed body & leg hives        9am fever of 101 registered at Dr. office        5:30pm fever of 102 registered under arm        8pm hives spread to face and arms 5/21 - fever continues throughout day (100-101 under arm)        hives come and go throughout day        6pm notice swelling of hands and feet        8pm hands and feet take on purple tinge give Benedryl on advice from nurse line and swelling reduces slightly.  5/22 - 2am temp of 100 registered(under arm)         7am hives have abated, temp is normal        11am continued clear with residual hives
PATIENT REPORTED THAT DURING 15 MINUTE WAITING PERIOD SHE FELT SHE HAD A LUMP IN HER THROAT. SHE ALSO REPORTED THAT THIS HAD HAPPENED DURING HER 1ST SHOT. SHE TALKED TO HER PCP LAST TIME AND THEY THINK IT MAY HAVE BEEN RELATED TO HER GERD. LAST TIME IT LASTED ABOUT 2 DAYS AND IT HURT TO SWALLOW
Arm was sore; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in 2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm was sore on an unspecified date of 2021. The outcome of event was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Patient with c/o pain  in her rgiht arm, right side of upper back and right hand.  The pain started last night.  She reports not taking any meds for the pain or seeking medical attention at this time.
left foot is numb, have had meeting with primary doctor and blood work - then an EMG which is super fun.
-1.5 hours after shot, intractable vomiting for 14 hours, could keep nothing down, not even ice chips,- ended up treating with ondansetron 2- 5 mg doses-no appetite for at least 4 days and resultant weight loss of 6-8 lbs -balance impaired, vision blurred about 12 hours after-lasting 12 hours -confusion from about 12 hours post vaccine until 24  hours post vaccine -weakness, and hand and leg diskinesia about 12 hours after -lasting 12 hours -sore throat, phlegm  48 hours after for 12 hours -hyper alertness and unable to sleep almost 48 hours -twitching during sleep (throughout body, arms and legs) and in evenings which lasted 6 days, slowly abating over time -headache  -multiple hot flashes 3-4/hour first 2 days mostly at night, way more than I normally have (I usually have 2-3 a night and 1-2 during the day-4 days/week)  Shot on 2/8/21 and finally felt back to normal, resumed all normal activities including exercise 2/14/2021
Nausea; vomiting; dizziness with vertigo; dizziness with vertigo; headache; fever; severe body aches in lower back; fatigue; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246), via intramuscular on 07Jan2021 11:45 at single dose in left arm for covid-19 immunization. Medical history included asthma, hospitalized with pertussis related bronchiolitis/hypoxia in Apr2020. The patient's concomitant medications received within 2 weeks of vaccination included multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had allergies to medications, food, or other products included erythromycin and pancuronium bromide (PAVULON). The patient previously received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), via intramuscular on 17Dec2020 17:00 at single dose in right arm for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The patient experienced nausea, vomiting, dizziness with vertigo, headache, fever, severe body aches in lower back and fatigue from 36 to 50 hours post vaccination on 09Jan2021. The patient did not receive any treatments. The outcome of the events was recovered in Jan2021.
arms are swelling/swollen arm; starting to itch; where the shot was put in and is turning red; This is a spontaneous report from a Sponsored Program  from a contactable consumer (patient). A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2, via an unspecified route of administration, on an unspecified date as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162b2 on an unspecified date for COVID-19 immunization. The patient reported that she thinks she is having some reactions to the second dose. Her arms are swelling and starting to itch and it's like it is already swollen which you can see where the shot was put in and is turning red. The clinical outcome of the events arms are swelling/swollen arm, starting to itch and where the shot was put in is turning red, was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Information was received on 29-JUN-2017 from a registered nurse, concerning an unspecified adult patient (age and gender unknown). No medical history or concomitant medications were reported. The nurse reported that the unspecified adult patient received pediatric doses of VAQTA on unspecified dates (also reported as 29-JUN-2017). No adverse effects reported. No other information was provided. Additional information has been requested.
On 03/03/2021 I received my Covid-19 vaccine and i started feeling tired and sore arm. On 05/24/2021 my hemoglobin went down .6 points. On 10/27/2021 I received my next booster and on 04/05/2022 my hemoglobin was tested and decreased 1 point to 10.5 points.
The patient received his first COVID-19 vaccine on 2/23/2021 upon which he received the Moderna brand of vaccine.  On his return visit to receive his second dose on 3/23/2021 he received the Pfizer brand of the vaccine.  Upon speaking with the patient other than concern about receiving two different brands the patient has not experienced any adverse effects.  The patient was told that although not ideal he was done with his vaccination course and would not require any additional vaccinations.
On 02/19/2003 Pt showed signs of redness, pain, swelling and hardness at injection site on right arm. On 02/20/2003 these symptoms increased.
I began to develop a severe tingling/electrical feeling in my left leg on Oct 23rd.  Several days later the same feeling began in my right leg and then by Oct 31, 2015 my arms and legs. In addition pain has developed across all extremities.  Symptoms remain to present day (March 19, 2016). I have been clinically diagnosed with peripheral neuropathy and there appears to be no cure to my current condition.
Intense headaches every day for almost two months now including dizziness, vomiting, confusion, ringing ears....seeing a neurologist and several tests have been done: CT scan, bloodwork, MRI, MRA, and MRV....undergoing more tests due to persistent headaches.  Doing a second MRV on Monday with contrast.
Patient was inadvertently administered COVID-19 Pfizer Adult 0.2mL formulation instead of COVID-19 Pfizer Pediatric 0.2mL formulation resulting in larger dose.
On 7/13, pt had fever of 100F (arm); on 7/16, pt vomited and cranky; on 7/19, pt cranky, limp, lifeless, stopped breathing approximately 30 seconds, hands turned blue and took to hospital; 01/20, to ER for monitoring.
3x3 inch red patch around the injection site which extended down my arm 10 days after the vaccine. Itches
feels like ears are plugged and mouth is dry; admits to feeling anxious prior to vaccine today. VSS. Narrative:  Feels like ears are plugged and mouth is dry; admits to feeling anxious prior to vaccine today. VSS (p67, BP 128/89, rr 16, sat 98%). After 10 additional minutes, pt felt mild nausea; provided water, pt asked for apple juice - provided. 25mg oral benadryl requested from outpatient pharmacy and given to pt; pt agrees to stay for additional observation. VSS (p67, BP 122/85, sat 100%),. Pt stated she felt well enough to leave and return to work after 45" total observation, all sx have resolved at this time.
facial numbness/numbness in her left arm; swelling on the left side of her face; This is a spontaneous report from a contactable consumer reported for her daughter (patient). A 23-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 07Oct2021 at age of 23-years-old as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received the vaccine, and now was suffering from numbness. The patient had the Pfizer vaccine this morning at 10 and she was getting worse with facial numbness and swelling on the left side of her face and numbness in her left arm and she was very concerned. This wasn't showing up or listed as a side effect. Reporter stated they reached out to the doctor but they didn't want her in the ER because of Covid and said to go tomorrow if it gets worse. The outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Lg reddened area approximately 60 mm in circumference at injection site. Slightly sore. No treatment. EE to use warm compresses and ibuprofen at home.
I received the Janssen COVID-19 Vaccine EUA at roughly 2:15pm on Sunday 4/11/21. I waited at the vaccination site for 30 minutes and did not have any adverse effects. I went through the rest of my day without any adverse effects. I went to bed at 9:00pm. I woke up at 11:00pm with body aches and chills. I could not stop shivering. I then became very warm. I alternated between freezing/shivering and burning up all night. I felt very sore and my muscles hurt. It was primarily my upper body that hurt, not my lower body. My arms, torso, back, and neck hurt to move. I was very sensitive to everything I touched. It felt uncomfortable to touch the blankets in my bed or the water when I washed my hands. It did not hurt to do that, it just felt sensitive and uncomfortable. Around 5:00am I got a terrible headache. It felt like my head was made out of a lead ball. It hurt to move lift my head. My face hurt and felt like I had pressure. This lasted all day for Monday 4/12/21. After 5:00pm I slowly started to feel better. My body aches went away. I still had a headache, but it was far less severe. It is approximately 7:00am on 4/13/21 as I am filling this out. I still have a minor but persisting headache. My left arm is sore at the injection site. I am feeling much better than I was.
pt recvd vax & devel red, rough rash; fever of 100 & runny nose;
This spontaneous report as received from a medical assistant refers to a 3 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX 0.5ml, intramuscular (lot # J006358, expiry 23-MAY-2015) that was stored inappropriately. The medical assistant stated there was a power outage on 12-APR-2014 and the (Oka/Merck) VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated (Oka/Merck) VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Mom stated that leg was warm to touch, thigh was swollen 2x the size of the other leg, redness around the injection site and hardness around the injection site as well.
On 9th day after first shot, I had a large red itchy spot on shot site.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Apr2022 as dose number unknown, single (Batch/Lot number: unknown) 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 Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 10Dec2022 to 15Dec2022.     The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Hospitalization for CVA (recovering from COVID diagnosed 1 week prior) on dates 12/23/22 - 1/3/23.  Treated with no COVID-related medications.
8/17/10 approx. 10:30 am child present with mother fainted post vaccination onto chair. B/P taken. 98/60 (L) arm HR=72. Res=14 unlabored, alert & oriented after few secs. EMS contacted arrived after 5 mins VS taken B/P 110/70 P=74 R=14. O2 Sat=97% mother requested EMS transport to ER at hospital, child x1 vomited outside clinic prior to transport. Child Disch from hospital ER at 12:36, F.U call from MOC doing well at home slight upset stomach.
Fever, chills, body aches, fatigue lasting through next day. Treated with OTC ibuprofen and acetaminophen cycles.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-MAR-2016 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # L010596, expiration date 06-APR-2017; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 840, 34 and R; 168, 32 and R. The storage criteria was refrigerator (R).This is one of several reports received from the same source. Additional information has been requested.
exhaustion; red at the injection site/injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (exhaustion) and VACCINATION SITE ERYTHEMA (red at the injection site/injection site was red) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced FATIGUE (exhaustion) and VACCINATION SITE ERYTHEMA (red at the injection site/injection site was red). The patient was treated with Physical therapy for Vaccination site erythema. On 18-Jun-2021, VACCINATION SITE ERYTHEMA (red at the injection site/injection site was red) had resolved. At the time of the report, FATIGUE (exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2021, SARS-CoV-2 test: positive (Positive) positive.         It was reported that her gynecologist scheduled her for exploratory surgery to check for possible cancer. No concomitant medications were reported. Treatment included taking a massage.  Body temperature was taken on an unknown date and the results were 97.6 degrees F   This case was linked to MOD-2021-231139 (Patient Link).
This spontaneous report as received from a Pharm. T. refers to a 4 patients of unknown age and genders. On unspecified date, the patients were vaccinated with PROQUAD (lot #, dose and route not provided). No concomitant medications were reported. The healthcare worker reported that on unspecified date, 4 patients received PROQUAD that was stored at 36-46 degrees F. for possibly 816 hours. No adverse effect reported. The outcome of incorrect storage was unknown. Additional information has been requested.
3" x 4" area of redness without induration on left upper arm. mom noticed redness start the evening of the vaccine. she was seen in clinic 3 days later.
Panic attacks and symptoms, rapid heart rate with palpitations, feelings of faint, dizziness, blood pressure increase, anxiety I saw my family doctor for an evaluation and also contacted my gynecologist I was given a script for an ECG and heart monitor I did the ECG These symptoms lasted 3 weeks
INJURED; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced injured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injured was not reported. This report was non-serious. This case, from the same reporter is linked to 20231022451.
Patient presents to Medical center on 02/01/2022 with nausea and vomiting.  Patient had history of recent renal transplant.  Patient c/o abdominal pain in the area of transplanted kidney.  She stated her blood pressure has been low and felt lightheaded and dizzy in the mornings.  She also c/o nonproductive cough, and reports intermittent SOB.  She was admitted  and placed on gentle IV fluids and IV antiemetics.  On 02/20/2022 patient began to have significant higher oxygen requirements, requiring vapotherm.  Patient became somewhat confused with occasional agitation.  On 02/22/2022 family elected to move to comfort care.  Patient expired on 02/24/2022
not feeling well for a couple of days; throwing up for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well for a couple of days) and VOMITING (throwing up for a couple of days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MALAISE (not feeling well for a couple of days) and VOMITING (throwing up for a couple of days). At the time of the report, MALAISE (not feeling well for a couple of days) and VOMITING (throwing up for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided. Patient reported that her daughter was not feeling well and throwing up for a couple of days after getting the first dose of the vaccine on 12Oct2021.