chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Three days after the second dose of the vaccine I had a flare up of my Asthma and my Fibromyalgia. I was having trouble breathing and my Asthma was more severe than normal. I went to my doctor and I was given a new inhaler and some Steroids.  It was difficult to breathe for one week after that. I also had some nerve pain and my bones felt like they were throbbing. It was a flare up of my Fibromyalgia and I was given some Alpha Lipoic Acid 600mg and it has really helped with my nerve pain. My fibromyalgia normally flares up a couple of times a month.  This time it was much worse and I was bedridden for two days. It started three days after the shot and lasted for three days.
Headache, NauseaVomiting, Fatigue Narrative:  Employee called out of work for fatigue.
Information has been received from a registered nurse (R.N.) concerning an 18 year old female patient with a family history of cervical cancer who on 27-JUL-2007 was vaccinated IM with a 0.5 ml first dose of GARDASIL (lot number 654885/1424F). On 03-OCT-2007, the patient was vaccinated with a 0.5 ml second dose of GARDASIL (lot number 654885/1424F). On 05-FEB-2008, the patient was vaccinated with a 0.5 ml third dose of GARDASIL (lot number 654885/1424F). Nurse reported that the patient had a PAP Smear test done in 2009 and the result came negative. Approximately on 13-MAY-2010, the patient had another PAP Smear and the result came in as positive HPV and Cervical Intraepithelial Neoplasia II (CIN 2). The patient sought for unspecified medical attention. Additional information has been requested.
experiencing bleeding from gums; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL BLEEDING (experiencing bleeding from gums) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS) and AMLODIPINE BESILATE (NORVASC) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GINGIVAL BLEEDING (experiencing bleeding from gums). At the time of the report, GINGIVAL BLEEDING (experiencing bleeding from gums) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
7APR92 recvd 1st dose of Engerix-B & felt tired & dizzy following inject; resolved in 3 days; 19APR92 devel red itchy rash on body, chest & heels of feet;
Pt. is 3 years of age. She was scheduled to receive her first dose of MMR, Varicella (Chicken Pox), and Hepatitis A vaccines. The Screening Checklist for Contraindications was reviewed. Pt. experienced a fever of 103?F after vaccines when she was an infant. It was treated with Tylenol. There were no other contraindications for vaccines today. Pt. was given the MMR vaccine SQ and the Hepatitis A vaccine IM in her Right Arm. The Varicella vaccine was given SQ in her Left Arm. Approximately 3 minutes after the vaccines were given, two pink raised areas approximately 3 mm diameter were noticed on her upper medial Left Arm.  They both resembled pimples with a raised bright pink/red area in the center and fully surrounded by a flat pink area. She also had a few raised areas behind her Left Ear, one 3mm pink raised area on her upper left chest and back. She did not complain of any itching or discomfort. Pt. was monitored for 30 minutes. The raised area on her chest and area behind her ear resolved. There was another 5mm x 3mm area noted on the lumbar spine observed 20 minutes later. Mom was instructed to follow-up with her doctor regarding administration of an antihistamine. Pt. was not in any respiratory distress and mom was instructed to call EMS if she had any swelling of her lips, tongue, difficulty breathing. Mom verbalized understanding and left at 3:45 p.m. with symptoms improving.
Information has been received from a licensed practical nurse concerning a 14 year old female who on 26-JUL-2007 was vaccinated with a first dose of Gardasil. Subsequently, the patient felt achy which resolved after one day. On 04-OCT-2007 (also reported as 05-OCT-2007), the patient was vaccinated with intramuscularly with a 0.5mL second dose of Gardasil (lot 658282/0929U). On 05-OCT-2007, the patient experienced dizziness, wheezing, headache, eyes puffy, nausea, chills and shortness of breath/difficulty breathing. The patient went to the emergency room for treatment. The nurse reported that she did not think the patient was treated with intravenous medication. Subsequently, the patient recovered. The nurse felt that the patient's wheezing, dizziness, headache, eyes puffy, nausea, chills, shortness of breath/difficulty breathing were considered serious as other important medical events. Additional information has been requested.
sinus infection; Breast cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 52 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy to many antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: ER8730, Anatomical site of injection: Left arm, Route of administration: Intramuscular), administration date: 23Mar2021, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: ER8729, Anatomical site of injection: Left arm, Route of administration: Intramuscular), administration date: 13Apr2021, for COVID-19 Immunization. The following information was reported: BREAST CANCER (medically significant) with onset 27Nov2021, outcome "recovered" (30Dec2022); SINUSITIS (non-serious) with onset 24Mar2022, outcome "not recovered", described as "sinus infection". Therapeutic measures were taken as a result of breast cancer, sinusitis. Clinical course: Completed treatment for Breast Cancer 30Dec2022 included chemo, radiation + immunotherapy + surgery (double mastectomy). Benadryl taken for corrective treatment of sinus infection, orally, Start date: 01Dec2022, ongoing. Patient received BNT162b2 (BNT162B2), on 10Nov2022 as dose 4 (booster), single (Lot number: GH9693) intramuscular, in right arm for covid-19 immunisation.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300101355 same patient, different drug and different event.;US-PFIZER INC-202300101367 same patient/product, different dose/event;
CHILLS; A LITTLE BIT OF HEADACHE; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: explosive gallbladder, and atrial fibrillation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the patient experienced chills, and a little bit of headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and a little bit of headache on 20-MAR-2021. This report was non-serious. This case, involving the same patient is linked to 20220217599.
A few hours after we got home, patient spiked a fever. It went up to 104 at one point. Once the fever broke he lost all eye contact, stopped talking, started banging his head on things, started screeching so loud it would make your ears ring, had terrible diarrhea daily, lined up toys instead of playing with them, and just lost all emotion. We have had him in speech therapy, occupational therapy, a special teacher all once a week. He goes to the chiropractor twice a week. Weve tried many many other remedies as well. Vitamins, b12 shots, etc. He is coming around a little bit. But not as much as we had hoped.
Patient inadvertently received an additional dose within 12 hours with no adverse event.; Initial information regarding an unsolicited valid non-serious was received from other health professional (Reference number- 00532090) and transmitted to Sanofi on 23-Mar-2021.  This case involves a patient with unknown demography who inadvertently received an (one dosage form) additional dose DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number and expiration date were not reported) via unknown route at an unknown administration site (extra dose administered) for prophylactic vaccination within 12 hours.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   It was actual medication error due to extra dose administered (on same day).  It was reported that patient received a dose in the emergency department and then inadvertently received an additional dose when the patient arrived to the unit at the hospital. Reporter had questions on potential adverse reactions.  At the time of report, the patients experienced no adverse event.  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.  There will be no information on the batch number for this case.
After receiving Gardasil vaccine - pt became nauseated, dizzy and c/o head swirling, severe headaches. Symptoms gone after about 15 mins.
PATIENT'S DATE OF BIRTH WRITTEN AS 1/20/2009 AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS FATHER. CHILD IDENTIFIED IN  IMMUNIZATION REGISTRY AS HAVING ANOTHER BIRTH DATE WHICH WOULD MAKE CHILD ONLY 11 YEARS OLD AT TIME OF THIS FIRST VACCINE ON 7/27/2021.
I had a "drop attack:  on 3/8/21. suddenly went limp and fell to the ground, conscious, but not dizzy in advance.  When comfortable, I walked into another room to get my BP cuff, and the same thing happened. I fell limp to the ground, unhurt.  Then unable to get up because  limbs felt like spaghetti for about an hour. I had a PET scan which was unremarkable on 4/9/21, with some hypoperfusion neurophalm exam unremarkable 4/16 3rd attack,  falling backwards, unharmed 4/24 sudden transientbinocular diplopia.. 4/30 a cardiac loop placed.  Afterwards, BP  180/98 and transient aphasia.  Followed by chest pain.  Hosp overnight. MI r/o.
REDNESS ON  ARM; PAIN AT INJECTION SITE; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Batch number was not reported has been requested.No concomitant medications were reported. On 12-APR-2021, the subject experienced redness on arm. On 12-APR-2021, the subject experienced pain at injection site. On 12-APR-2021, the subject experienced swelling at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, swelling at injection site, and redness on arm. This report was non-serious.
Received call in PHN office from mother on 11/5/09 @ 11:21. Mother stated pt. received flu shot during POD exercise on 10/28/09 at school and had a reaction. Pt got off the school bus at 16:20 and complained of his neck itching and it felt warm. Pt developed hives on the front of his neck. Mother treated with hydrocortisone cream. In few days the hives had resolved. Pt did not go to ER. Instructed mother to have pt see provider prior to next administration of vaccine.
Information has been received from a registered nurse referring to a patient of unknown age and gender Information about medical history and concurrent condition was not reported. On 24-FEB-2015 the patient was vaccinated with improperly stored PNEUMOVAX23 lot # K010465 with expiration date of 23-MAR-2016; dosage and route unspecified (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Extreme chills, fever, extreme fatigue, body ache, extreme soreness around shot site, swelling of gland under arm that received the shot, headache, 2 days later a red welt appeared along with a knot that has been at the shot site.  I alternated Tylenol and Advil, drank lots of fluids, rested ALL DAY the day after the shot, applied ice to shot site.  Took Benadryl at night after red welt appeared.
Temp 100.4 -> 100.8. No site soreness or redness.
5 hours after vaccine I began to feel as if a RA flare was beginning.  I was totally exhausted, joints in my hands began to swell and so painful that I needed to wrap them in heating pad.  It was painful just lifting a cup of tea.  By the time I went to bed my neck was also hurting.  Woke several times due to pain.  By morning I just feel drained and want to rest.  Site of injection is sore but nothing bad.  I wish I had known this would be causing such a severe RA reaction.  I doubt if I will be getting the 2nd dose.
Congestive Heart Failure; zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 69-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 11-JUN-2013, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiration date were not specified), by a pharmacist at the pharmacy, for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the patient was treated by a physician for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: congestive heart failure and zoster-related conditions. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of congestive heart failure was determined to be medically significant.
Information has been received from a 22 year old medical assistant who was given the second dose of GARDASIL "subcutaneously instead of intramuscularly" by a worker in their office. The medical assistant reported she had a "plump" area under her skin after it was given since it was given wrong. At the time of this report, the patient was recovering. Additional information has been requested.
Bilat shoulder pain, diffuse myalgias and arthralgias. Treated with prn acetaminophen of ibuprofen, cool compresses and later warm compresses.
Patient received her first dose of the Pfizer vaccine in March 2021.   A few days later, she noticed a sudden onset of bilateral, intermittent tinnitus.  She received her second dose of the Pfizer vaccine in April and noticed an immediate increase in the severity of the tinnitus, at which time it became constant.  On   November 10th, she received her booster COVID19 vaccine and noticed another increased in the severity of her tinnitus, which began on November 12th.  It has now increased to the point where it will wake her from her sleep and she has a hard time falling asleep again.
Sore arm-swollen and red; Sore arm-swollen and red; tiredness; Headache; body aches; Sore throat; She also had a sore arm; This is a spontaneous report from a contactable consumer. A 75-year-old female patient reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 15Mar2021 (at 75-year-old) in right arm, as dose 2, single for COVID-19 immunization. The patient's medical history included allergies- rag weed seasonal allergies spring and fall. The patient's concomitant medications were not reported. The patient had not received other products and did not have any investigation assessment. On an unknown date Sore arm-swollen and red and tiredness. On an unknown date in Mar2021 the patient experienced headache, body aches, sore throat, she also had a sore arm. The outcome of Sore arm-swollen and red and tiredness was unknown. On an unknown date in Mar2021 headache, body aches, sore throat, she also had a sore arm recovered.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
have R A and am on imusupresent meds; 4th case of shingles; shingles are very painful.; This case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis in a 85-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant), shingles and pain. The patient was treated with immunosuppressants nos (Immunosuppressant Drug (Nos)). On an unknown date, the outcome of the rheumatoid arthritis and shingles were not recovered/not resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the rheumatoid arthritis, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 06-JUN-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient currently had 4th case of shingles.  The patient had 1st shingles shot but delayed second because he/she had rheumatoid arthritis and was on immunosuppressant medicine.  The patient requested, if you were able please take shots, as shingles were very painful. Additional Supportive Information: Follow-up could not be possible as no contact details were available.
p/ pt recv vax approx 15 mo later pt exp severe case of chickenpox w/approx 200 lesions on body. exudate tonsillitis, high fever 102f, pt looked ill & sent MD
Swelling tender to touch and itching on vaccine site. Also really itchy all over body.
Pt recv vax on 10/20/98; on 10/21/98 pt exp red, hot, swollen  & sore vax site w/ streaks( Rt arm);tx=Relafen & heat
Patient is a 15 y.o. male who presents with fever, cough, and chest pain. He was in his normal state of good health until Saturday (6/12) when he received his second Pfizer COVID-19 vaccine around 4pm. Later that night he developed fever which lasted until Monday morning. He also developed a cough that has gradually improved. No runny nose, sore throat, myalgias, chills, vomiting or diarrhea in past 2 weeks. Yesterday around noon he started to develop chest pain. The pain would come and go, lasting seconds to a minute occurring every few minutes. It is described as a pressure in the center of his chest under his sternum. No palpitations, light headedness, no radiation of pain. This pain lasted until he was given ibuprofen in the ED and it has not returned
I have a pain in the left side of my neck. I went to my chiropractor to get help but nothing is working. It is a constant pain. It feels like severe pressure in the back of my neck on the left side.
Nurse calling for TE evaluation states 3 doses of VAXELIS in PFS involved in the excursion have been administered to patients; This non-serious spontaneous safety report reference #02238017/ interaction #02237963 was received by a partner on 01-SEP-2022 from a Nurse, and forwarded on 02-SEP-2022.  Due to the nature of the event, the causality between Vaxelis and the reported event of "Nurse calling for TE evaluation states 3 doses of VAXELIS involved in the excursion have been administered to patients" was not applicable.  Further information is expected.
Tinnitus left ear has not stopped since vaccine. Severe chest pains and heart pounding for 2 days after vaccine. Pain in right leg calf muscle
11-5 pt received vaccine, pt claims pain since shot gotten worse. 12/6 pt came back to pharmacy to report MD had said administered too high in arm. MD recommended physical therapy.
Late second dose / First dose was given on 31Aug2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 31st August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. No further information was reported. The reporter did not consent to follow up.
2+ weeks of on and off side effects including  aches, malaise, fatigue, headache, sore throat, chest tightness, no energy, tiring quickly, joint aches and pains, daily nausea
Wires sensation on her chest; Fever; Headache; Body aches; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Body aches), PAIN IN EXTREMITY (sore arm), CHEST DISCOMFORT (Wires sensation on her chest), PYREXIA (Fever) and HEADACHE (Headache) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Body aches), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and HEADACHE (Headache). On 03-Apr-2021, the patient experienced CHEST DISCOMFORT (Wires sensation on her chest). At the time of the report, PAIN IN EXTREMITY (Body aches), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and HEADACHE (Headache) had resolved and CHEST DISCOMFORT (Wires sensation on her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
He had a low grade fever all day the next day as well, treated with Tylenol. Fever 102 given Motrin in ER. Was chilled upon going to bed. Mother went into room around 11PM or so, due to hearing pt hit the wall. He was thrashing in bed, had a fever high, pulse (140). We were advised to go to the ER due to the pulse by nurse. We had to stay in a room with child on a heart monitor until pulse normalized. Pulse was 170 in ER.  Hopefully, no problems in the future.
Pt was under dosed with 0.2mL vs 0.3mL, no adverse symptoms reported.
Swelling and intense pain in left arm from shoulder to elbow; warm with erythema. Flu-like symptoms.  Referred to physician and patient was diagnosed with possible allergic reaction. Prescribed prednisone 4 day burst and taper and Benadryl  25 mg every 6 to 8 hours.