chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within two days of vaccine, shortness of breath on light exertion (talking, walking), ?revved up? like on steroid or medrol. Anxiety, increased resting HR, abdominal cramping, diarrhea, agitation, palpitations, fatigue, dazed, premenstrual spotting.
Headache; Body aches; Light headed; Loss of energy; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Pfizer er8730, Expiration date: unknown) via an unspecified route of administration on 22Mar2021 at 13:00 on left arm at single dose for COVID-19 Immunization. Medical history included Chrones. The concomitant medication was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 16:00 (24-hour clock), patient experienced headache, body aches, Lightheaded and Loss of energy. The patient did not receive any treatment for the events. The reporter assessed the event as non-serious. The events were not recovered.  No follow-up attempts are possible. No further information is expected.
Subjective fever, ears ringing, sore throat and neck "feels" swollen. Also have a decreased appetite and increased sleep.
Second vaccine inadvertently administered too early.  Was given one week apart instead of 3 weeks, no adverse reactions noted.
Patient received Fluzone 11/10/03. Presented to health unit 11/12/03 with left facial paralyses temperature 98.4 Refresh eye drops for lubrication. THe medical record received on 4/5/04 states headaches, and twitching of left eye.
On 7/21/19 I just started feeling bad and I took 2 Tylenol before going to bed.  On 7/22/19 when I got up about 8:00 AM I had a fever of 100 degrees and I was aching all over.  After breakfast, I took 2 Tylenol every 6 hours all day.  I also had a red area around the shot site.  I measured the redness on my arm today 7/23/19 and the redness measures 1 3/4 inches across and 3 1/2 inches long.  My arm has been sore from the beginning and it is still sore today.
Client states pain in joint of right index finger starting 3/11/11 evening, and swelling of bilateral hands at joint starting morning of 3/12/11. Has only taken ibuprofen. States no fever, SOB, difficulty breathing. May have had pain prior to vaccine, but swelling started after. Describes pain as arthritic-type, but says didn't have arthritis in hands before.
PATIENT RECEIVED ZOSTAVAX AND PREVNAR AND 3 HOURS LATER SHE HAD A SEVERE RASH ON HER FACE, NECK, AND ARMS. SHE ALSO COMPLAINED OF HER NECK BEING SWOLLEN. SHE WENT TO THE HOSPITAL AND THEY PRESCRIBED BENADRYL AND PREDNISONE BUT DID NOT ADMIT HER. 12 HOURS LATER SHE FEELS FINE EXCEPT THE RASH ON HER ARMS.
Side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Side effects). At the time of the report, VACCINATION SITE REACTION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Pt recv vax on 10/16/98; on 10/16/98 pt exp tenderness at vax site; on 10/17/98 pt exp upset stomach and achiness, fever, nausea.
Fever; Soreness in arms; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as vaccine for COVID. Medical history included did have COVID early on. Concomitant medications were not reported. The patient experienced fever, soreness in arms on unspecified dates. She had a vaccine on Wednesday, and she did have a typical side effect- two days of fever and soreness in arms, the typical. Her question was, "Now, if you have the side effects, the first go around. When I am going to get the second go round, well, how did they go out on the study? Did most people that got them on the first go around get them both?" She had COVID early on; one would think her body would already have what it needed to, that's why she was surprised that she was getting side effects. The outcome of the events was recovered.    Information on the Lot/Batch Number has been requested.
Pt received MMR and influenza shots at approx. 7AM, then reported to work as LPN at medical center.  At approx. 11AM he experienced sudden onset of a burning sensation in his mouth and throat and shortness of breath.  He was on his way to the ED when he experienced diaphoresis.  A medical alert was called and he was given epinephrine 0.3 mg SQ.  He was awake and alert, but complaining of difficulty breathing when the ED physician arrived on the scene.  He was tranported to the ED where he received Benadryl 50 mg IV and SoluMedrol 125 mg IV.  He was observed for 3 hours before being discharged to home.
Fell forward, tense.  Pale initially.  Mom caught her.  Stiff when 1st fell; Attempted to sit upright.  Pale initially.  We kept her.  Patient pinked up after 5 minutes; sat upright at 530 PM.  Stood upright - pt reported legs wobbly.  Sat her down.  No food since lunch.  Crackers and juice provided.  Released to leave at 545 PM.
pt stated her left arm was sore and warm to the touch after getting the vax.   On the next day she developed a fever of 101-102 along with  fatigue, nausea, weakness, so she slept all day.  Third day her fever was 99.8, she still had fatigue and arm was hot to the touch at the injection site.  She now has a rash an inch below the injection site and is about 3x4 inches in size.  Pt has not contacted her PCP at this time.
About a week after receiving the vaccination, her arm began to ache. She states that it has not improved and seems to be getting worse.
This spontaneous report as received from a medical assistant refers to 1 of the two different patients of unknown age and gender. The patient's concurrent conditions, concomitant medications, historical conditions and historical drug allergies/reactions were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dosing regimen and frequency unknown) (lot number and expiry date unknown) for prophylaxis. On an unknown date within minutes after receiving the GARDASIL 9 the patient experienced arm pain. The action taken with the therapy with GARDASIL 9 was unknown. The outcome of pain in extremity was unknown. The relatedness of the events to the therapy with GARDASIL 9 was unknown. There was no product quality compliant reported. This is one of the two reports from the same source. Sender's Comments: US-009507513-1803USA004279.
hydrocephalus; cranial bleed; no bladder control; rash on back; shingles on back; pain; confusion; difficulty walking; encephalitis; severe muscle pain (left leg); redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 2nd November 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema (serious criteria hospitalization). On 8th November 2019, the patient experienced muscle pain (serious criteria hospitalization). On 12th November 2019, the patient experienced rash (serious criteria hospitalization), shingles (serious criteria hospitalization), pain (serious criteria hospitalization), confusion (serious criteria hospitalization), walking difficulty (serious criteria hospitalization) and encephalitis (serious criteria hospitalization and GSK medically significant). On 15th November 2019, the patient experienced bladder incontinence (serious criteria hospitalization). On 30th November 2019, the patient experienced intracranial hemorrhage (serious criteria hospitalization and GSK medically significant). On 13th January 2020, the patient experienced hydrocephalus (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the injection site erythema, muscle pain, rash, shingles, pain, confusion, walking difficulty, encephalitis, bladder incontinence, intracranial hemorrhage and hydrocephalus were unknown.   It was unknown if the reporter considered the injection site erythema, muscle pain, rash, shingles, pain, confusion, walking difficulty, encephalitis, bladder incontinence, intracranial hemorrhage and hydrocephalus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experinced injection site erythema, muscle pain in left leg, rash, shingles, pain, confusion, walking difficulty, encephalitis, no bladder control, intracranial hemorrhage and hydrocephalus. The patient went to the emergency room on on 15th November 2019 and was admitted to the hospital the same day. on 5th February 2020 the patient was discharged from the hospital.  Reporter consented to follow up
Moderna COVID-19 Vaccine EUA Headache, fever, body aches, chills the night of the first injection
vision loss; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 18-JAN-2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route and lot # not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).               On an unknown date "shortly after" receiving zoster vaccine live (ZOSTAVAX), the patient experienced vision loss. As a direct and proximate result of the defective Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. The patient 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. The outcome of vision loss was considered as not recovered.   The event was considered to be related to zoster vaccine live (ZOSTAVAX).    Vision loss was considered to be disabling by the reporter.  Upon internal review vision loss was considered to be medically significant.
Nurses administered 9 shots, at least 8 were to patients under the age indication.; Initial information regarding an unsolicited valid non-serious case received from other health professional on 22-Oct-2020.  This case involves patients of unknown demographics who were administered 9 shots, at least 8 were to patients under the age indication (product administered to patient of inappropriate age), while he/she received vaccine INFLUENZA VACCINE.  Concomitant medications were unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer via unknown route at an unknown administration site (lot number: UT7081NA and expiry date: 30-Jun-2021) for prophylactic vaccination.  On an unknown date, (unknown latency) it was stated that the nurses administered 9 shots, at least 8 were to patients under the age indication (product administered to patient of inappropriate age).  It was not reported if the patient received a corrective treatment.  There will be no information available on batch number for the case.
This solicited report was received from a 53 year old male patient, as part of a market research, referring himself. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. On unknown date, the patient got sick from the vaccination (malaise) when he was in army and he did not want to get sick from the vaccination again. The outcome of malaise was unknown at the time of reporting. The relatedness between the malaise and therapy with PNEUMOVAX 23 was not reported. Additional information is not expected, because the reporter contact details were not provided.
pt recv vax & devel an exaggerated inj site rxn described as cellulitis;
Moderna COVID-19 Vaccine   Patient reported the following via an email following vaccination: "I had the vaccine on Saturday and only had a slight sore arm but last night my tongue is slightly swollen and very sore and the roof of my mouth ? kind of like I after you burn your mouth on something and the aftermath."
All night so far: Severe headache, body aches, excessive vomiting throughout night, dizziness, almost passing out, confusion, weakness
HER ARM IS SWOLLEN AND SHE SAYS SHE HAS SHOOTING PAIN DOWN BY HER BREASTS.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 24-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" which had a lot number of K007828 and expiration date on 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had two temperature excursions; one for 712 hours with lowest recorded temperature of 33 F (0.555555556 celsius) and other one for 216 hours with lowest recorded temperature of 32 F (0 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
I had my vaccination on 09/20/2022. On 09/22/2022 I woke up at 4AM and had a rash on the left side of my body on the front and back. I called the mobile urgent care and diagnosed with Shingles. Started on steroids and antiviral medications. I did a consultation with my dermatologist to skip injections until Shingles has resolved.
Redness and induration developed night of 7/11/07 (got vaccines on 7/11/07) and seen 7/13/07 for 10 x 8.5cm redness by 5cm x 5cm induration - treated for cellulitis.
Mother calls facility reports child might have had a reaction. Reports fever. 01/10/2012 0900 Mother reports fever persists. 01/11/2010 0900 Mother reports fever broke over night. 01/11/2012 0900 Mother reports fever 101.0 after Tylenol instructed Mother to consult provider. 01/12/2012 0830 Mother reports taking child to provder and diagnosed with ear infection and sinus infection.
L deltoid red @ injection spreading down + around arm measuring 15 x 16 1/2 cm. Parent stated fever previous night up to 101.
This spontaneous report was received from a pharmacy student refers to a male patient of unknown age. The patients medical history included history of previous cold sores. The patient had no drug reactions or allergies. on 08-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number was J00494, expiry date was 04-APR-2014, route was not reported). On an unknown date in MAY-2013, the patient had an outbreak of cold sores after receiving ZOSTAVAX. There was no treatment rendered for the event. The outcome of outbreak of cold sores was reported as not recovered. The patient sought medical attention (contacted pharmacy). Additional information has been requested.
Flu Shot administered on 10/3/18 at approximately 4:30pm. On 10/4/18 at 5:30am first adverse reaction event occurred. After having a bottle of milk, Patient began screaming in pain for approximately 30 minutes until he could be calmed. TYLENOL was provided at this time to help him with the pain. Throughout the day Patient's nanny and father noticed slight swelling in of the left side of his face and neck. By 8pm swelling of the left face and neck was extremely significant. At the swelling location it was red and hot. At that time Patient was brought by his parents to Hospital's ER. Patient was treated by MD. Dr. ordered an ultrasound of Patient's left face/neck. The ultrasound showed swelling of the left Parotid Gland as well as surrounding lymph nodes. Dr. prescribed TYLENOL, MOTRIN, and AUGMENTIN for the diagnosis of Parotitis. 3ml of AUGMENTIN to be taken twice a day for 10 days. On 10/5/18 Patient's swelling increased on his left side of face/neck. 10/5/18 Patient was seen by Dr. (primary pediatrician office), no new medications or directions prescribed. 10/6/18 swelling subsided.
This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 40-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 7754S, expiry date 30th June 2016). Concurrent medical conditions included drug allergy (a lot of medicine allergies). On 15th September 2015, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 15th September 2015, several hours after receiving FLULAVAL QUADRIVALENT, the patient experienced extensive swelling of vaccinated limb, injection site cellulitis, injection site warmth, injection site tenderness and injection site erythema. The patient was treated with clindamycin. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site tenderness were unknown and the outcome of the injection site cellulitis and injection site warmth were recovered/resolved and the outcome of the injection site erythema was recovering/resolving. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site cellulitis, injection site warmth, injection site tenderness and injection site erythema to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. On 15th September 2015, the patient received FLULAVAL QUADRIVALENT, at left deltoid, at 8:30. By dinnertime on the night of 15th September, after receiving FLULAVAL QUADRIVALENT, the patient experienced swelling, redness and was diagnosed with cellulitis. Her arm looked like she had a blood clot and there was a 5x5 inch area on her left arm of warmth, tenderness and focal area swelling with no streaking. These events were noted when the patient was seen at the doctor office on the 16th September 2015. The patient required an emergency visit. The patient was seen again on 17th September 2015, and it was noted as a local reaction to the flu shot but the patient was not allergic to the immunization. There was also no cellulitis, upper arm was normal temperature, there was slight redness around the injection site and it was tender to palpate with full range of motion. Pulse, movement and strength were normal. The patient was sent for an ultrasound and given 20 tablets of clindamycin 300 mg every 6 hours. This case was linked to case US2015134386, as it concerned with the same reporter. The reported batch number was 77546, which does not exist and was updated to be 7754S as per sales database.
CHEST PRESSURE/PAIN 5/10, BP 175/90, HR 90, INTERMITEENTLY PALPITATIONS, EMESIS X1, DIAPHORETIC. PARAMEDICS PROVIDED ASA AND NITRO X3, CHEST PAIN NOW 3/10, TRANSPORTED TO HOSP.
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 65-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: 3 days after completion of 5 day anti-viral medication regimen. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No other medications was received within two weeks. Patient developed what I though was a bad cold (no other symptoms) 4 days after completing medication.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a nurse refers to an 11 months and 9 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
mom c/o lump to rt thigh; mom observed lump approx 2 wks p/vax given; no drainage or discharge to area;
5/20-Vaccine, 5/21-Fever-aches, 5/22-numbness in face/Left, 5/23 and 24 - loss of words/memory, speech, 5/24-Emergency Rm sent by Physician-CT scan, 5/25-MRI, 5/25-5/31-symptoms progress, 5/31-neurologist appt., 6/2-symptoms get worse hospital-4 days.
10 days, post vax of flu vaccine, employee had enlarged lymph nodes in armpit (L) and left side of neck swollen. Swelling did not subside until 11/22/00.
This spontaneous report as received from a healthcare worker refers to a 5 year old patient of unknown gender. On 02-APR-2014 the patient was vaccinated with (Oka/Merck) VARIVAX, lot # J006114, expiration date 19-MAY-2015, 0.5 ml once, subcutaneous (dose in series unspecified) that was improperly stored at 11.5F due to defrost cycling for an unspecified time frame. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Myalgia, Arthralgia, Fever, ErythemaMultiform,  chills, fatigue, injection site pain/arm pain, swelling at injection site, rigors Narrative:    Other Relevant History: