chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I've been trotting back and forth to the bathroom since 6 am this morning. I'm not sure where this liquid is coming from.; Stated that it is like she is drinking beer; 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 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Apr2023 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: POLLAKIURIA (non-serious), outcome "unknown", described as "I've been trotting back and forth to the bathroom since 6 am this morning. I'm not sure where this liquid is coming from."; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Stated that it is like she is drinking beer".  Additional information: Patient had been trotting back and forth to the bathroom since 6 am this morning. she was not sure where this liquid was coming from. The only thing that changed was that she had shot. This was her fifth one. she reported yesterday's was slightly different.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Here on 7/15/04. Client refused second (Hep B vaccine) stating "when I took my first shot on 01/06/04, my arm felt numb for a day or two." No doctor or ER visit was made, pt is doing fine.
pt recvd vax;inc T,anorexia,irritability;apap;to clinic w/ warm but not hot to touch rt deltoid;mom reports pt restless,would not eat supper,feels hot;local rxn to pertussis per clinic MD;d;mom unsure if pt had virus from school or vax rxn;
A report was received of itchy rash coincident to FluMist. An eight year old female received FluMist vaccine sometime between 12/29/2005 and 6/02/2006. In the evening of 1/4/2006, the child developed a rash and was seen by a physician on 1/6/2006. The rash was described as an itchy, erythematous, maculo papular rash primarily located on the upper and lower extremities and the trunk. The child had no fever, cough or congestion and no history of suspicious allergies or similar rash in the past. Physical examination revealed a scattered erythematous fine papular rash on the trunk proximal arms, and the lower extremities. The parents had applied hydrocortisone cream to the rash prior to presentation to the physicians office. Event outcome was not reported. The reporter assessed the causality of the event to FluMist as unrelated.
DIZZINESS, LIGHTHEADED,  PALE,  ICE PACK, WATER
Right deltoid edema, induration, pain (injection site). Started night of 25 June. (2) "Rash" over neck, ant and post thorax - started 30 June 07 AM. Pruritic - was indurated by ED,told by nurse to take diphenhydramine and Ranitidine. (3) C/O something stuck in my throat, no dyspnea, chest respirations dysphonic on exam on 2 July - Right deltoid still indurated, tender. Difficult to move c/o pain - only cluster of papules in packed area - seen the other eruptions. No signs of pharyngeal closing 9 July 2007.
had mild anaphylactic/an allergic reaction to the Covid vaccine; felt like she had a lump in her throat; tongue felt weird; or an adverse reaction; This is a spontaneous report from a contactable consumer or other non-hcp (Patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 16Jul2021 as dose 1, single for COVID-19 immunization. Medical history included COVID-19 infection from Mar2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date the patient experienced had mild anaphylactic, felt like she had a lump in her throat, tongue felt weird. Caller is reporting an allergic reaction to the Covid vaccine. She had the vaccine Friday, and it was the first dose. After the vaccine, it felt like she had a lump in her throat and her tongue felt weird. She called the doctor the next day and he said that she had mild anaphylactic or an adverse reaction and was recommended to not get the second dose. She is not an anti vaxxer or anything but, she definitely likes to read about everything. Caller states that before her son was born, she read the vaccine book and chose to do the vaccines for him. But with the Covid, she was nervous because it felt like she didn't know enough, like she couldn't get enough information. It felt like the pros outweighed the cons. She is a schoolteacher and is getting ready to go back to full capacity. In the fall, it is going to change. The same with her son, they both had Covid last Mar2020, and had no symptoms but both tested positive. Her son had the fever. States that her students are coming back but, wanted to ask if she did have a reaction, would that warrant not getting the second dose; if she would it be like just going in and taking Benadryl or bring an Epi Pen. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive in Mar2020. The clinical outcome of the events was unknown.  Information about lot/batch number has been requested.
nausea, dizzy, SOB, severe swelling @ site of vaccine, almost breaking the skin, solid red color all the way down to elbow fever, went to o ER 2-3hr p/inj rxn started now has a rash all the way around site;
weakness; tired; fever of 100f; heart went out of rhythm for 20 min; hard ball at the injection site over 2 weeks; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weakness), EXTRASYSTOLES (heart went out of rhythm for 20 min), INJECTION SITE MASS (hard ball at the injection site over 2 weeks), FATIGUE (tired) and PYREXIA (fever of 100f) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), EXTRASYSTOLES (heart went out of rhythm for 20 min), INJECTION SITE MASS (hard ball at the injection site over 2 weeks), FATIGUE (tired) and PYREXIA (fever of 100f). At the time of the report, ASTHENIA (weakness), EXTRASYSTOLES (heart went out of rhythm for 20 min), INJECTION SITE MASS (hard ball at the injection site over 2 weeks), FATIGUE (tired) and PYREXIA (fever of 100f) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 37.8 (normal) 100F (37.8 degree Celsius).         no treatment and concomitant product was reported. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Received anthrax vaccine left arm on 25 April. Started having problem 25 April - 27 April. Inability to move left arm.  Had alot of swelling.
This spontaneous report as received from a physician refers to a 3 patients of unknown age and genders who within the last 2 weeks in 2013, were vaccinated with GARDASIL (dose, lot # and route not provided). The physician states he used to give GARDASIL vaccinations all the time, even to his own children. However, within the last 2 weeks in 2013, 3 of his patients had adverse effects post vaccination with GARDASIL. 3 patients fainted after getting vaccinated. The patients sought medical attention and was seen on the physician's office. 3 of the patients were female and one was a male patient. The outcome of 3 patients fainted after getting vaccinated was unknown. The relatedness adverse events was unknown for GARDASIL. This is one of several reports from same source. Additional information has been requested.
24 hours after injection my neck above my collarbone on the side of the injection site became swollen (larger than a golf ball) and tender.   Swelling decreased slowly over several days without treatment.  The tenderness is now gone, but the lymph node is still very hard.
Information has been received from a registered nurse concerning a 14 year old female with seasonal allergies who was exposed to roseola on 25-JUL-2006 and had a fever on 02-AUG-2006.  On 03-AUG-2006, the patient was vaccinated intramuscularly with a 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653937/0637F).  Concomitant therapy included loratadine (CLARITIN) and vitamins (unspecified).  On 04-AUG-2006, the patient developed an extensive rash.  The patient discovered the rash at 7 am on the back of her legs.  It was reported that the rash spread to her back and shoulders and had started to spread to her abdomen.  The rash consisted of non vesicular papular single lesions that were slightly larger than a pinpoint and too numerous to count.  The lesions were described as "burning and itchy".  Unspecified medical attention was sought.  At the time of the report, the patient's rash persisted.  Additional information has been requested.
painful outbreak of autoimmune hepatitis; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. In or around June 2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequent to the zoster vaccine live (ZOSTAVAX) vaccine being administered, in 2017 (reported as within weeks), the pt developed a painful outbreak of autoimmune hepatitis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presenting prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages. All damage proximately caused by the aforementioned characteristics of zoster vaccine live (ZOSTAVAX) that rendered the product unreasonably dangerous, arose from the reasonably anticipated use of the product by the pt. The outcome of the events was not recovered. The causality assessment was considered as related by the lawyer.  The event painful outbreak of autoimmune hepatitis was considered to be disabling by the lawyer. Upon internal review, the event painful outbreak of autoimmune hepatitis was determined to be medically significant.
Pt developed severe urticaria over entire body several hrs after administration of several vaccines.  This resolved with BENADRYL & PREDNISONE
Mom called 10/24/02 describing pain, swelling at site of left upper arm. Take Tylenol or Motrin. Client seen 10/25/02--arm warm to touch, minimal swelling, no redness. Continue Tylenol. Return for check up; no firm knot at injection site. Compresses.
Patient reported the next morning she had muscle weakness in legs to the point couldn't get out of bed and had to use her arms to move herself around.  Stated it last for maybe 24 hours and she has returned to normal
myocarditis with ekg changes and severe chest pain requiring pediatric ICU stay. Treated with scheduled Motrin and cardiology follow up
Information has been received from a medical assistant concerning a 9 weeks old female patient with no pertinent medical history and not known allergies, who on 28-MAY-2009 was vaccinated orally with a 2 mL dose of ROTATEQ (LOT # 663362/0039Y). On 28-MAY-2009, the patient concomitantly received DAPTACEL, ACTHIB, IPOL, and PREVNAR. On 03-JUN-2009, the patient's mother called to the physician's office because her child was having watery stools, up to 5 times a day, but no temperature. The patient was seen in the office on 4-JUN-2009 because of severe diarrhea and a rash on an unspecified area. On 04-JUN-2009, a stool culture was done in order to identify the presence of ova, parasites, rotavirus and c-diff, which was found to be positive for rotavirus. A hemoccult was done on 4-JUN-2009 and was also found positive for blood. On 05-JUN-2009 the patient was seen in the office for a recheck. The patient's rash was clearing up but the mother mentioned there was a spot on the right hand and left foot. The right hand was swollen and the left foot had a red spot. The patient was sent to the emergency room and was admitted to the hospital. The patient was diagnosed with cellulitis which was treated with IV fluids and IV CLEOCIN. On 7-JUN-2009 the patient was discharged from the hospital and on 8-JUN-2009 she was re-checked in the office for a post hospitalization visit. The patient had increased in weight by 8 ounces and was reported to be "so much better". The patient's hand was recovering and the spot on her foot went away. At the time of reporting the patient still was on CLEOCIN because of the cellulitis of the right hand. A follow-up visit was scheduled for July or August 2009. Follow-up information has been received from a physician concerning the patient with preauricular skin tags and no other medical problems. It was reported that the patient developed watery diarrhea and rash 5 to 6 days after administration of the first dose of ROTATEQ. On day two of illness, the patient became dehydrated, irritable and developed right hand cellulitis. It was reported that the patient was sent to the ER and admitted in the hospital for 2 days. At the time of reporting the patient had recovered. A lot check has been initiated. The reporting medical assistant considered that rotavirus positive, hemoccult positive for blood, watery stools, cellulitis, rash and red spot in the left foot were life threatening and required intervention to prevent other serious criteria. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 75 year old female with a penicillin allergy and an allergy to lima beans (sick to stomach) who on 27-JUN-2007 was vaccinated subcutaneously in the upper left arm with a 0.5 mL dose of PNEUMOVAX 23 (lot 656233/0200U). Concomitant therapy included calcium (unspecified), vitamin D (unspecified) and vitamins (unspecified). On 27-JUN-2007, in the evening, the patient developed pain in the left arm, little redness, and swelling. The patient went to the office on 29-JUN-2007 and was diagnosed with cellulitis. The patient was treated with levofloxacin. The patient subsequently went to the emergency room because her symptoms worsened. The patient was treated with clindamycin IV at the emergency room and was given oral clindamycin to be taken along with the levofloxacin. The patient was seen in the office on 03-JUL-2007 and was recovering. The patient's cellulitis was considered to be disabling because the patient couldn't lift her arm and was in alot of pain. No additional information is expected.
She has an ear infection; 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 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: EAR INFECTION (non-serious), outcome "unknown", described as "She has an ear infection".  Additional information: It was reported that she is scheduled for her second dose of the vaccine on Sunday, 18Apr2021. She has an ear infection and was prescribed an ear drop with dexamethasone. She asked if it was okay to take this now before/with the vaccine?  The lot number for bnt162b2 was not provided and will be requested during follow up.
Suddenly sick to stomach; Started throwing up; Had headache when I woke up; like it felt like nerve pains running down my arms/Pain up and down arms + legs nerve like; Still have fever; tired; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 intramuscular, administered in Arm Right on 24Sep2021 13:30 (at the age of 63-years-old) (Batch/Lot Number: EN0167) as DOSE 3, SINGLE for covid-19 immunisation. Medical history included blood pressure abnormal. The patient have had cancer twice but nothing recently, breast cancer stage ii from 1989, breast cancer from 1995, AFib, GERD. The patient received first dose of BNT162B2 on 04Jan2021 (DOSE 1, SINGLE, Administration Date: 04Jan2021, Administration time: 14:00, Anatomical site of Injection: Right Arm, Route of administration: Intramuscular, Batch/Lot number: 651685), and received second dose of BNT162B2 on 25Jan2021 (DOSE 2, SINGLE, Administration Date: 25Jan2021, Administration time: 14:00, Anatomical site of Injection: Right Arm, Route of administration: Intramuscular, Batch/Lot number: FL3246); for COVID-19 immunization. The patient received Influenza on 16Sep2021 (Manufacturer: (Company name withheld) Batch/Lot No. 33090, Route: IM, Anatomical site of injection: RT arm, No. of previous doses: 16Nov2021). Concomitant medications included metoprolol taken for blood pressure abnormal, atrial fibrillation from an unspecified start date and ongoing; omeprazole (PROTONIX [OMEPRAZOLE]) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing. It was reported the patient got her booster shot on Friday afternoon (on 24Sep2021), her third shot. Fell back asleep, woke about 1:30 AM with fever of 102 degree Celsius. Took 2 Tylenol, tired so laid around. Awakened 03:00 25Sep2021 with pain up and down arms + legs nerve like/ pains all over her body like it felt like nerve pains running down her arms (medically significant). About 15:00 25Sep2021, had tea and went to lay down. Suddenly sick to stomach, vomiting repeatedly with headache. The patient had I had some Zofran (intent treatment), so the patient took Zofran under the tongue. "This didn't resolve until 22:30. Slept this thru night feverishly of awakened with fever still. 26Sep fever 101.2 degree Celsius, 27Sep2021 100.3. Then stated to better. The patient underwent lab tests and procedures which included blood pressure measurement: unknown results on 25Sep2021, body temperature: 102 fahrenheit on 25Sep2021 25Sep2021, body temperature: 101 fahrenheit on 26Sep2021 26Sep2021, body temperature: 101.2 fahrenheit on 26Sep2021 degree Celsius , body temperature: 100.3 fahrenheit on 27Sep2021 27Sep2021. Therapeutic measures were taken as a result of like it felt like nerve pains running down my arms/Pain up and down arms + legs nerve like, started throwing up, still have fever, had headache when i woke up. The outcome of the event nerve pain was recovered, Suddenly sick to stomach, Started throwing up, Had headache when I woke up was recovered on 25Sep2021 22:30, fever, tired was not recovered.
Chills; Injection site was pretty big; (Injection site) hurt really bad; Made her very sick; Feel really bad/ it was like having covid all over again; Had body aches; Had 100.1 F/  Fever; Ulcers inside my mouth; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Made her very sick), FEELING ABNORMAL (Feel really bad/ it was like having covid all over again), MOUTH ULCERATION (Ulcers inside my mouth), MYALGIA (Had body aches) and PYREXIA (Had 100.1 F/  Fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2021.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced ILLNESS (Made her very sick), FEELING ABNORMAL (Feel really bad/ it was like having covid all over again), MYALGIA (Had body aches) and PYREXIA (Had 100.1 F/  Fever). On an unknown date, the patient experienced MOUTH ULCERATION (Ulcers inside my mouth), CHILLS (Chills), VACCINATION SITE SWELLING (Injection site was pretty big), VACCINATION SITE PAIN ((Injection site) hurt really bad) and FATIGUE (Very tired). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ILLNESS (Made her very sick), FEELING ABNORMAL (Feel really bad/ it was like having covid all over again), MOUTH ULCERATION (Ulcers inside my mouth), MYALGIA (Had body aches), PYREXIA (Had 100.1 F/  Fever), CHILLS (Chills), VACCINATION SITE SWELLING (Injection site was pretty big), VACCINATION SITE PAIN ((Injection site) hurt really bad) and FATIGUE (Very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were mentioned. Patient stated that Second shot scheduled for 04Sep2021.
Patient received varicella vaccine on 5/30/19 and pt had positive pregnancy test resulted on 5/31/19. There was not a resulted pregnancy at the time of vaccine administration. Pregnancy is contraindicated with receiving live virus vaccine. Pt followed up with ObGYN doctor and referred to specialty clinic.  No signs or symptoms of the disease as of yet.
Temperature Excursion. Vaccine was stored refrigerated (2-8 degrees Celsius) for greater than 10 weeks.  Vaccine was stored for a total of 5 days past its beyond use date in the refrigerator.  Patient did not experience any adverse events.
Lip and eye swelling, hoarseness about 15 minutes, post vax. Treated with Bendryl/nebulizer.
one single bubble of a shingle; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the first dose of Shingrix and was in the window of the second dose but noticed one single bubble of a shingle. The patient enquired if he/she could get the second dose of the vaccine.