chrisvoncsefalvay/vaers-outcomes huggingface dataset:
THE WORST THING WAS THE HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced the worst thing was the headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from the worst thing was the headache. This report was non-serious.
Memory Loss, Confusion, unable to complete sentences/thoughts, headache  12 hours of N/V after initial dose, fatigue, headache
MILD FLU LIKE SYMPTOMS; SORENESS IN INJECTED ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 16-NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 17-NOV-2021, the patient experienced mild flu like symptoms. On 17-NOV-2021, the patient experienced soreness in injected arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild flu like symptoms, and soreness in injected arm. This report was non-serious.
took the regular flu shot"and broke out in hives; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care profesisonal.  This case involves a female patient of unknown age who broke out in hives,after receiving vaccine 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 an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as Prophylactic vaccination.  On an unknown date, the patient broke out in hives (urticaria) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (broke out in hives).  At time of reporting, the outcome was Unknown for the event broke out in hives.
This spontaneous report was received from a Licensed Practical Nurse referring multiple unspecified patients of unknown age and genders whom on unknown dates, received unspecified doses of improperly stored RECOMBIVAX (Lot #, doses, route and sites of administration not reported). This is one of 8 reports from the same source. No additional information provided. Additional information has been requested.
Patient complained of intestinal distress, gas, bloating, soft stools, and fatigue after each dose of oral typhoid. Patient reported that she did not take her temperture, but felt wet and sweaty in the AM. She also reports that the symptoms have subsided with the completion of vaccination.Patient was given the vaccine 3/17/05 with other vaccinations and waited to take the oral typhoid at the end of May. She keep the vaccine refrigerated at all times.
Patient said that the people she was working with noticed that her eyes and face appeared to be drooping. The next day (10/28/2014) she went to the Dr. and was diagnosed with Bell's Palsy.
Tongue was numb for 3 hours. Then base of tongue  and throat were tingling and cold.
This spontaneous report was received from a licensed practical nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On unknown dates, the patient was vaccinated with VARIVAX lot N022995, expiry 23-AUG-2019, lot N012619, expiry 21-APR-2019, for prophylaxis and PROQUAD lot N023965, expiry 28-FEB-2019), lot N015625, expiry 15-NOV-2018 for prophylaxis. (routes of administration were not reported for any of the aforementioned vaccines). The sterile diluent (MERCK) used for reconstitution was properly stored (lot number and expiry date unknown). No adverse effects were reported. On unknown dates, the doses of VARIVAX and PROQUAD underwent temperature excursions of 6 degrees Fahrenheit (°F) to 14 °F (6.1°F) for 16 minutes. Previous temperature excursions were reported as follows: 6 °F to 14 °F (9.7°F) for 30 minutes, 6 °F to 14 °F (6.3°F) for 15 minutes and 6 °F to 14 °F (6.8°F) for 8 minutes. Total cumulative: 6 °F to 14 °F for 69 minutes. This is one of several cases received from the same reporter. Sender's Comments: US009507513-1802USA005899: US-009507513-1802USA005900: US-009507513-1802USA005898.
Patient complained of paralysis in right shoulder.  He also stated in the past, that shoulder had required rehabilitation in the right shoulder for movement
2nd day, Friday, soreness & redness,  approx 2 " in diameter, with left arm, fatigue, joint & body aches. Chills & nausea.  3rd day, Saturday, redness, approx 4-5" in diameter, & swelling with left arm increased & more of the same as mentioned. 4th day, Sunday, appearances started to lessen, still tender to touch. 5th day, Monday. Slightly swollen & smaller red area. Bruise where the injection site is.
large red rash at the injection site; large red rash at the injection site; hot to touch at the injection site; very itchy at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (large red rash at the injection site), VACCINATION SITE ERYTHEMA (large red rash at the injection site), VACCINATION SITE WARMTH (hot to touch at the injection site) and VACCINATION SITE PRURITUS (very itchy at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE RASH (large red rash at the injection site), VACCINATION SITE ERYTHEMA (large red rash at the injection site), VACCINATION SITE WARMTH (hot to touch at the injection site) and VACCINATION SITE PRURITUS (very itchy at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (large red rash at the injection site), VACCINATION SITE ERYTHEMA (large red rash at the injection site), VACCINATION SITE WARMTH (hot to touch at the injection site) and VACCINATION SITE PRURITUS (very itchy at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information not provided.
Case number PHEH2014US025049, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 38 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 01 Dec 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
On Tuesday, April 25, 2023, I went to my doctor for my annual physical. Even though I had previously had PCV 13, she recommended that I get Prevnar 20. Of course my arm hurt. The next day I was very tired. Thursday morning I was still very tired. Seemed to feel better that afternoon, but then I felt ill. I was sitting at my kitchen table. I decided to go lie down. I stood up a few steps and felt woozy. My vision blurred and I saw flashes of light. I fell to my knees. After a few seconds, it was over. I felt fine except I did notice that my arm was slightly swollen, red and itchy. By May 1st, the redness and swelling were gone. The itching has not gone away completely, but has mostly subsided.
Lymph nodes in left armpit were swollen and painful. Got better after a few days.
Starting about 9pm day of vaccination extreme headache, fever chills, weakness (could hardly walk) for 3 days. Extreme exhaustion for 5 days. Tight chest for 2 days. Continued tiredness for two weeks.
High fever of 104.4 on the day after. Extreme dizziness, nausea, headache, fatigue and chills.
Redness in face, chest and back. Small pimples. Itching on back and face.
1wk p/vax pt devel fever of 102.9 for 2 days w/sl h/a & sore throat;
Sore arm; Clammy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), COLD SWEAT (Clammy) and FATIGUE (Tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20a) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), COLD SWEAT (Clammy) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Sore arm), COLD SWEAT (Clammy) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
red bumps on both arms; The lady who administered the vaccine did not go deeper in injecting the vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's mother) reported for her (daughter, the patient). A 12-year-old female patient received first dose of bnt162b2 (Pfizer BioNTech covid-19 mRNA vaccine, Solution for injection), via an unspecified route on 01Sep2021, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 02Sep2021 after the first dose of vaccine, reporter stated that the lady who administered the vaccine did not go deeper in injecting the vaccine and could have been an error on administration since today on 02Sep2021, patient started experiencing really red bumps on both of their arms (she and her daughter) where the injection site was. Reporter mentioned that her husband and two more daughters had the complete doses of the vaccine but did not have any adverse reactions and clarified that they were all fine. The clinical outcome of the events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
About 1 minute after receiving the vaccine, I suddenly felt hot and sweaty. After about 20 minutes, I began experiencing mild itching on my face, chest and upper body (no hives or rash) and my face was flush. At about 40 minutes, began experiencing nasal congestion, runny nose and and a slight tickle in the back of my throat. A few hours later, all symptoms resolved.
Covid vaccine received on 5/20/2021.  Patient went to another state over weekend and reported spending most of Sunday, June 13, 2021 in a vehicle.  Patient presented to cardiology outpatient appointment with dyspnea on 6/16/2021. Later that same day was loading hay in very hot weather (around 100 degrees Fahrenheit) and became dizzy. Later, that same day the dizziness remained and new symptoms of chest pain and shortness of breath.  Patient presented to ER that evening, and was admitted to the hospital for bilateral pulmonary emboli extending into all lobes of the lungs.
On 01/14/2021 Day after vaccine the side effect have hit very hard. Body aches, chills, horrible headache, extreme fatigue. As of today I still have various symptoms.  I had Covid in November. I have not went to the hospital. WHY DO THEY NOT HAVE WARNING ABOUT PEOPLE WHO HAVE ALREADY HAD COVID AND THE SIDE EFFECTS THAT COULD HAPPEN?
I had a concussion on December 30, 2020.  I was still recovering from that when  I got the vaccine and I had the Zambia injections 3 weeks before the first shot. So I think it was a coincidence that it happened after the vaccine. The most bothering thing is the night sweats.
administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 WRONG PRODUCT ADMINISTERED (administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster) and NO ADVERSE EVENT (No adverse event). On 10-Oct-2022, WRONG PRODUCT ADMINISTERED (administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster) outcome was unknown. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster).    No relevant concomitant medications were reported.   On 8 Oct 2022, 9 Oct 2022 and 10 Oct 2022 vaccine was administered. Reporter was not aware of any AEs after the vaccines were given.   No treatment medication reported.   This case refers to 3rd patient out of 26 patients.
COVID infection/ I received the Pfizer COVID vaccine in Feb2021 and Mar2021 and boosters in Oct2021 and May2022; COVID infection/ I received the Pfizer COVID vaccine in Feb2021 and Mar2021 and boosters in Oct2021 and May2022; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "Post hemithyroidectomy [thyroid cancer]" (unspecified if ongoing), notes: Post hemithyroidectomy [thyroid cancer]. Concomitant medication(s) included: SYNTHROID taken for thyroid cancer, start date: 1970. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID infection/ I received the Pfizer COVID vaccine in Feb2021 and Mar2021 and boosters in Oct2021 and May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Aug2022) Unknown results; (01Sep2022) Unknown results; (2022) Negative, notes: Tested positive after testing negative; (2022) Positive, notes: Tested positive after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid treatment for Covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (DRUG INEFFECTIVE, COVID-19) and BNT162B2.
Pt recvd vax on 15MAR92 & devel nodule @ inject site; No further details were provided;
This patient had a 16 x 5 1/2 " induration and redness at the injection site on her left arm, arthralgia left shoulder and arm. Prescribed Prednisone.
Information has been received from a nurse concerning a 15 year old female who on 30-AUG-2007 was vaccinated with Gardasil (Lot # 657617/0384U). The nurse reported that the physician had a patient who developed a 6 inch red, swollen area to her left arm below the injection site, after her first immunization with Gardasil. The site was not painful or warm to the touch. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007.  Information has been received from a registered nurse concerning a 15 year old female patient who on 30-AUG-2007 in the PM, was vaccinated into the left arm with a first dose of GARDASIL (Lot # 657617/0384U).  The nurse reported that the physician had a patient who developed a 6 inch red, swollen area to her left arm below the injection site, after her first immunization with GARDASIL.  The site was not painful or warm to the touch.  On 06-SEP-2007, the patient developed small small bruising around the injection site and roughly 10 cm from the injection site.  Distally there was an area of redness 10 cm long.  It was not warm to touch but was mildly swollen.  It was reported that there was mild erythema and tenderness with deep palpation.  On an unknown date, the patient recovered.  No product quality complaint was involved. Additional information is not expected.
Eczema; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema) and VACCINATION SITE PAIN (Vaccination site pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate Free. On an unknown date, the patient experienced ECZEMA (Eczema) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, ECZEMA (Eczema) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            On an unknown date, the patient had eczema on legs and sore arm after Covid vaccination.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.
Two hours after receiving her 2nd dose of the Pfizer Covid Vaccine, patient had a Stroke (large brain bleed).  She never recovered and passed away May 18th, 2021
Rapid onset of conjunctivitis, tired, achy and GI upset with heartburn.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included MULTIVITAMIN & MINERAL and MELATONIN for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information provided.; Sender's Comments:  :CROSSLINKED WITH DOSE 2
4:12 PM Patient c/o N/V   92/53  92 Paramedics responded. Mother with patient. 4:15 PM 120/76 93    O2 sat 100% room air 4:31 PM Patient stated better. 122/78 91   Room air 100%  EKG within Normal limt per paramedics. Patient waited 30 mins. escorted out by EMT
I went to the bathroom and I had a burning sensation and an urgency to go. An hour later I had the same issue. I had a UTI several years back, and I knew to go to the doctor because they typically get worse. He prescribed Nitrofurantoin Mono/MAC 100mg 10 capsules.  I also received a urinalysis. I am fine now.
This patient had some dizziness after the shot and was apprehensive in receiving it. He claimed he felt dizzy and in seconds had slumped off of his chair. He was unresponsive for a few seconds only about 5-10 seconds and we gave him an IM Benadryl as a precaution. He awoke complaining of a funny feeling in the mouth and tongue but had no rash or redness or swelling to indicate an allergic reaction. We decide to monitor closely for an escalation of symptoms but to have a EpiPen handy, and call an EMT unit. His blood pressure was low at first at around 107/68  then quickly come up in about 10 minutes to 130/80. With no other issues we believe he had a vasovagal syncope but wanted the ER to make sure we were correct. I called and checked on him after he was at the ER. and the nurse stated that he was doing very well and that they had seen this happen with the vaccine at other site locations.
The pt received vaccines on 12/11/01 and post vax, her mother noted a red and warm area on her right thigh and called the office, She was instructed to apply compresses and give Tylenol. She called 24 hours later and came in for appointment. The right thigh was erythematous, indurated and warm (about 10cm X 8cm area). It was very swollen and erythematous (2cm X 2cm area at center of induration with a small scratch. No fever. She was started on Keflex X 7 days. 24 hours later, she had decreased erythema. No fever. Follow-up to be in 72 hours. The site of cellulitis is at Prevnar injection.