chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptom; Drug interaction; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptom), DRUG INTERACTION (Drug interaction) and COVID-19 (COVID-19) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products IBRUTINIB (IMBRUVICA) tablet for Lymphocytic leukemia and REMDESIVIR for COVID-19.    Concurrent medical conditions included Lymphocytic leukemia (Small lymphocytic leukemia).   In 2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 280 milligram once a day. In 2022, IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 280 milligram once a day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and REMDESIVIR (unknown route) at an unspecified dose. In February 2022, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptom), DRUG INTERACTION (Drug interaction) and COVID-19 (COVID-19). In February 2022, INFLUENZA LIKE ILLNESS (Flu like symptom), DRUG INTERACTION (Drug interaction) and COVID-19 (COVID-19) had resolved.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
A flu vaccine, and Td vaccine were ordered to be performed. In error, two flu vaccines were administered. One high dose, and one normal dose.  The Td vaccine was not administered.  The patient did not have any adverse reactions.
Hives developed on 5/5/2021, 4 days after receiving first dose of Covid vaccine
Noted redness, swelling, pain and itching of right arm on 12/13/07.  Swelling, itching, pain and redness extended from right shoulder/chest to below elbow on right arm.  Patient had self-medicated with Benadryl.  Seen by physician for evaluation and treatment.  Per follow up report - normal ROM, without neuro/vascular deficit issues.  Prescribed ice, elevate, Prednisone 10 mg and Tagamet 400 mg.  12/21/07 subject reports all symptoms resolved.
About 17 hours after immunization given in immunization clinic mother noted redness and swelling persisted to today 07/25/02 visit had 3.5x4cm induration right thigh with mild overlying redness and warmth. Diagnosed with cellulitis and treated with Augmentin.
Severe heartburn, followed by itchy from head to toe, followed by severe hives and rash neck to toe, followed by trouble breathing.
Started off very itchy, lasted about 3 days. Redness/rash covering large portion of upper arm lasting about 1 week. No other symptoms.
Fever- 103 for 12 hours, chills, severe muscle aches throughout body, fatigue
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) by a pharmacist for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
PREVNAR & PENTACEL given in (L) leg. Injection sites only 1/4 inch apart. Red, swelling warmth started approximately 12 hours later. Seen approximately 36 hours later in office - only 1 in x 1/2 in red warm swollen area - Tx with warm compress.
cold; Initial information received on 15-Sep-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of an unknown age and gender who experienced cold after receiving Influenza Vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (strength, expiry date, formulation and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date the patient developed cold (nasopharyngitis) (unknown latency). It was unknown if the patient experienced any additional symptoms/events.  Reportedly: we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: it works for me. Yes I know about the flu shots. Same here, I got one cold after another taking my last one in 89. They became mandatory   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Fatigue sent in @ 8:00 pm.  Soreness at site of injection, chills, over all muscle/body ache & headache set in around 1:00 a.m. 1/29.  All five symptoms persisted throughout day of 1/29, relieved w/ x-strength Tylenol (1000 mg) & ibprophen (400 mg) taken simultaneously  2x that day.  1/30, injection site cont. to be sore and experienced general "logey" feeling all day.  1/31, injection site still sore, but no other malaise.
On Sunday May 30th, about 9 days after my 2nd does of Moderna I noticed some bumps on the left side of my torso that I thought were bites. The bumps got worse and turned to more of a rash. About a day or 2 after Sunday May 30th, I started to have bumps on the right side of my torso as well. Sunday June 6th, I went to the Care on to have the rash on both sides of my torso examined. Diagnosis is Bilateral Symmetrical Shingles. I have been given Triamcinolone Acetonide Cream UPS and Valacylovir HCL 1 Gram Tablet. The physician that diagnoses and provided treatment. It was explained that Bilateral Symmetrical is very rare. It is also believed that the rash is a reaction from the 2nd COVID-19 vaccine. It is believed that the immune system was overworked and reacted.
Vaccine given IM in left deltoid -> "instantaneous" syncope or near-syncope. Pt guided down to lie on exam table. VS, O2 Sat - monitored for 50 minutes. Pt alert and able to respond appropriately to questioning. Bradycardia: 44/m -> low 50's. Finally 911 called, and pt taken to Hosp ER where he was monitored x 2 hr and given IV fluids before being discharged.
Patient reported that upon arrival to the observation period he felt "palpitations." The patient stated the palpitations lasted about 30 seconds. The patient denied any shortness of breath, itching, dizziness, or chest pain. Educated the patient and his mother regarding s/s of anaphylaxis and when to seek EMS. The patient stated he was feeling well and denied any persistent palpitations. The patient was drinking water. The patient stated that he was feeling anxious prior to receiving the vaccine. The patient did eat today prior to receiving the vaccine. The patient denies any chronic conditions. The patient does not take any medications regularly. The patient has no known allergies. Vitals obtained at 3:43PM were as follows: BP 119/72, HR 73, O2 98%.
w/in 2-3 hr pt began develop swelling of lips, periorbital swelling, sense of tightening in throat;no wheezing;no dyspnea;responded to epi;
1st night after, looked bruised, then proceeded to red & has remained painful to this date (grapefruit size area of upper left arm).
Metallic taste starting approximately 5 minute after vaccine. It has since lessened but not completely gone.
Ongoing rash since 01/28/2021, high heart rate, fatigue, 100.1 fever
patient was given Menactra in the left deltoid in error, instead of the intended meningococcal B vaccine, with no reported adverse event; Initial information was received on 09-Jul-2021 regarding an unsolicited valid non-serious case from other health professional (GMI Inquiry number: 00675660).  This case involves 18-year-old male patient who was given MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] in the left deltoid in error, instead of the intended meningococcal b vaccine (wrong product administered).  It was a case of actual medication error due to wrong vaccine administered.  On an unknown date, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number: U6690AA, expiry date: 23-Aug-2021] via an unknown route at left deltoid for prophylactic vaccination.  At the time of report, no adverse event reported.  Description: Yesterday, 08Jul2021, a patient was given Menactra in the left deltoid in error, instead of the intended meningococcal B vaccine. o Treatment NA o Dose # if series Yesterday's dose was an accidental, extra third dose of Menactra. The patient's two prior doses of MCV4 vaccine were in 2014 and Jun2020.  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.
Redness extending to 5 inches in radius within 72 hours, small blisters, mild tenderness - expected common side effects - size was reason for documentation.
positive covid test before procedure Narrative: positive covid test, asymptomatic as of 4-19-2021 RN check in
Patient said had shingles rash at site for 7 days. Resolved on its own.
COVID rebound; COVID rebound; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2022 at 03:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: COVID rebound. Therapeutic measures were not taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 22-MAR-2018 and 03-APR-2018, the patient was vaccinated with a dose of GARDASIL 9 injection (strength, dose, lot # and expiration date were not reported) intramuscularly for prophylaxis. No known adverse effects was reported. No further information was provided. There was no product quality complaint (PQC) reported.
? Cough     sx x 3 days  ? Shortness of Breath ? Headache ? Nasal Congestion  -consider use of OTC medications such as DayQuil/NyQuil, Robitussin or Delsym for cough  - OTC nasal spray and decongestants may provide temporary relief. If you have hypertension, diabetes, thyroid disease, or are pregnant you should avoid using these products. - A mix of 1/2 honey and 1/2 lemon juice can be used to soothe the throat and help loosen thick mucus in the throat or use warm salt water gargles.  Use of hard candy, or throat lozenges for sore throat or cough (sugar free if Diabetic) -Steam inhalation by standing in a hot shower or sitting in the bathroom when hot shower is running helps with nasal discomfort. Vaporizers and humidifiers are not recommended due to the risk of burns, bacterial growth in improperly cleaned equipment, and mold formation in the home  -Saline nose drops help loosen secretions. Commercial or homemade may be used (1/4 tsp. salt dissolved in 8 ounces warm water distilled or boiled water, discard solution after 48-72 hours)  -Consume extra fluids, maintain a nutritious diet, get adequate rest  -Take Tylenol as needed for pain and/or fever.
That evening my eye was itchy. The next morning I woke up and my eye was swollen. I put warm compress on. The next day Friday my eye was leaking and went to urgent care. They said it was a bacteria infection in my eye. Sat my eye had gotten worse. By Sunday I was at urgent care and they gave me a number of test CT scan, chest x ray, the ophthalmologist checked my eye and couldn't give a real diagnose.
Pt received vaccine: arm sore next day, gradually worsened to point could not raise arm. Severe muscle pain and weakness on left arm radiating up around neck and down right arm. Pt still experiencing pain and stiffness especially upon arising in AM.
Sleep all day lathargic when awake,Blood pressure 67/40 weak, swollen red arm
I got shingles on Sept 18th. I went a walk-in clinic and they just looked at it. They said it was shingles.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Additional Details: The patient has had issues with other vaccines. She felt light headed and sweaty. She had a head ache onthe onset. She left here feeling fine after we monitored her for a while.
booster shot; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 (Lot number: 301358A) at the age of 67 years as dose 3, (booster) single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "High Blood pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Diabetic" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing), notes: Fibromyalgia. Concomitant medication(s) included: ATORVASTATIN; PROPRANOLOL; LISINOPRIL; OMEPRAZOLE. Past drug history included: Ibuprofen, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9262 5121, Location of injection: Arm Left), administration date: 06Feb2021, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203 6121, Location of injection: Arm Right), administration date: 26Feb2021, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Oct2021, outcome "unknown", described as "booster shot"; DIARRHOEA (non-serious) with onset Oct2021, outcome "not recovered", described as "diarrhea". The event "diarrhea" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diarrhoea.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medication patient received within 2 weeks of vaccination: Atorvastatin, Propranolol, Lisinopril, Omeprazole. The patient reported that the patient did not have adverse effects from either of the first two doses of the Covid vaccines. However in late Aug2021 the patient started experiencing diarrhea. It continued even after booster shot (3rd overall shot). The Patient doctors has done a lot of blood work but everything came back normal (coloscopy is pending in Jan2022). The patients symptoms had not gotten any better. The patients diarrhea symptoms are anywhere from 3-8 times per day. The patient was not diagnosed with covid-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/14/00 and subsequently developed an injection site reaction characterized by burning, "severe" pain, swelling, and redness. No further information was available at the date of this report. The reporter indicated that a total of 5 pts from this facility experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Approximately thirty minutes after immunization was administered Mom reports that patient experienced a 20 second seizure. States she had some lip smacking and was tonic during seizure activity. Once seizure resolved patient was post ictal.
Red ring and pain surrounding injection site, swelling; Red ring and pain surrounding injection site, swelling; Swelling; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration in right arm dose on 28Jan2021 at 11:15 (at the age of 30 years) as single dose for COVID-19 immunization. The patient's medical history included AVM hemorrhage in 2014 (Arteriovenous malformation and Hemorrhage brain). The patient had no allergies. The patient had not taken any other vaccines within 4 weeks prior to the COVID vaccine and had not taken any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested positive for COVID-19. On 29Jan2021 06:00, the patient had red ring and pain surrounding injection site and swelling. The patient did not receive treatment for events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Seriousness criteria Other medically significant (OMIC). A 47 year old male with a medical history of plantar warts received an intramuscular right deltoid injection of Fluzone SV 2005 2006. lot number U1865AA, on Oct 24 2005. The patient maintained a log of his adverse events. One day later, he developed tail bone swelling. On Oct 26 2005, he experienced lip swelling. On Oct 27 2005, the back of his head was swollen, and he had welts in his hairline, beard and lips. The patient experienced shortness of breath. On Oct 30 2005, he developed tightness in his right thigh. On Oct 31 2005. he developed a cough, sore throat and swollen glands. On Nov 2 2005, the arches of his feet were painful, both hands were swollen, his palms had welts, and he could hardly walk. He was examined by a physician on Nov 2 2005 and prescribed extra strength ibuprofen and allergra. At the time of this report, he is still not well. The patient had no illness at the time of vaccination, and other medications were not reported. The patient had received three previous dosed of Fluzone. At the time of this report, the patient had not recovered.
injection site sore/ injection site tender; injection site swollen; headache; back of left hip painful; cannot put pressure on hip to stand up; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd March 2022, 1 days after receiving Shingrix, the patient experienced injection site tenderness, injection site swelling, headache, pain in hip and difficulty in standing. On an unknown date, the outcome of the injection site tenderness, injection site swelling, headache, pain in hip and difficulty in standing were not recovered/not resolved.   It was unknown if the reporter considered the injection site tenderness, injection site swelling, headache, pain in hip and difficulty in standing to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix in left arm, day before the reporting date and on the date of reporting when she woke up that the injection site was sore/tender and swollen, headache.  The caller also reported that the back of her left hip was painful and the patient could not put pressure on hip to stand up.  The caller would contact her health care professional if symptoms did not resolve. The caller did not gave permission to contact health care professional. The reporter did not consent to follow-up.
Information has been received from a licensed practical nurse (LPN), concerning a 15 year old female patient, who on 20-JUL-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot #656051/0244U). Concomitant therapy included lorazepam. On 18-SEP-2007 the patient developed a rash of unknown origin. All lab tests, including testing for mononucleosis and Lyme disease, were negative. The LPN indicated that "many different treatment options" were tried, with no success. On 08-Oct-2007, the patient was vaccinated with the second dose of GARDASIL vaccine (yeast). At the time of this report, the patient had not recovered. Additional information has been requested. On 08-OCT-2007, the patient returned to the office with a rash over the same areas as previouls y described. Treatment included ATARAX. All lab tests, including testing for mononucleosis and Lyme disease, were negative. On 18-OCT-2007, an injection of BENADRYL was administered and a DECADRON/DEXpak was prescribed; the patient reported her mother had given her TAGAMET. On 30-OCT-2007, the patient was given XYZAL, continued on KENALOG and DECODRON were administered IN. The LPN indicated that "many different treatment options" were tried with no success. At the tiem of this report, the outcome of the events was unknown. Additional information has been requested.
pt presented 6/26/21 and requested a covid shot, said it was dose 1. Was given moderna. She returned 7/30/20 for dose 2 and presented insurance this time. Upon rebilling dose 1, it was discovered that she got  Janssen dose  on 4/7/21. She said her daughter took her for that, and she was told it was a flu shot. I told her she would not need a second Moderna shot, and that she was covered for covid under current guidelines. She reported no adverse effects for the Moderna dose 1 she received.
Initial misuse report received from a healthcare professional on 02 May 2013. It was reported that MENACTRA was inadvertently administered instead of MMR to a 16-month-old patient. No adverse event was reported. Documents held by sender: none.