chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a prospective case. This 29-year-old female subject was enrolled in an open label study: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX or FLUARIX QUADRIVALENT or FLULAVAL or FLULAVAL QUADRIVALENT during pregnancy or within 28 days preceding conception. The subject received FLUARIX on 12th August 2015. Concomitant products included minerals nos + vitamins nos (Prenatal Vitamins). The subject's estimated date of delivery was 16th December 2015. The subject received FLU Seasonal QIV, the subject developed general body pain (Non-serious). Additional event(s) included vaccine exposure during pregnancy. The outcome of general body pain was not recovered/not resolved. the outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. The investigator considered the general body pain to be almost certainly related to FLUARIX. The investigator considered that there was no reasonable possibility that the vaccine exposure during pregnancy may have been caused by FLUARIX. The reporter is a pharmacist, but also the patient. Additional details provided are as follows: This case was not previously reported to anyone. The reported batch number for FLUARIX vaccine was C75ES (expiry date: 5th June 2016). The patient's last menstrual period date was not provided. The patient received FLUARIX during the second trimester of pregnancy (unknown weeks). The patient reported body aches about 24 hours after receiving the FLUARIX vaccine.
NEUROLOGIC SYMPTOMS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; SINUS CONGESTION; BODY ACHE; FEELING SNIFFY; SORE ARM; This spontaneous report received from a patient concerned a 56 year old white male of unspecified ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, cigarette smoker, alcohol use, and arthritis. The Patient had no known drug allergies. Blood type is A negative. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 07-SEP-2021) dose was not reported, dose number in series was 1, 01 in total, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAY-2021, after vaccination, the patient had sore arm for couple of hours. On 20-MAY-2021, the patient had body ache and was feeling sniffy. On 23-JAN-2022, the patient had sinus congestion. The patient reported having occasional sneezing (4 times in a row), congestion, runny nose (suspected covid-19 infection). The patient's symptoms got worse over the next two days, so he decided to test. On 25-JAN-2022, the patient woke up a little achy as he didn't take Ibuprofen. At night, while eating, patient noticed that he couldn't taste or smell and it continued the next day morning. Patient also felt tired/ lethargic. The patient tested positive using home test, COVID-19 virus test (NR: not provided) Positive, sent by the government at 19:00 hours (suspected clinical vaccination failure) (dose number in series was 1). Patient was unaware on how he contracted Covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on MAY-2021, was recovering from body ache, and feeling sniffy, had not recovered from suspected covid-19 infection and sinus congestion, and the outcome of neurologic symptoms and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0:20220150539-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 12Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DYMISTA, stop date: 13May2022. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive. Therapeutic measures were taken as a result of covid-19. Patient received "Paxlovid" to treat covid-19. Treatment start date: 13May2022, treatment stop date: 18May2022.
Site: Pain at Injection Site-Severe, Additional Details: patient called to report that since he received his vaccine, he cannot lift his entire arm or move it, if he does lift or move it it hurts greatly. this is located on the site where he received the injection.
Stool is Army Green for the last week.  This started the stool immediately following the vaccine and has lasted so far one week.  He never had this before.  He is formula fed and has not had any changes in his formula or eating habits.  He also has reduced sleep, but we are more concerned over the change in stool color immediately following and wonder what this could mean.
Dad recounts events. Pt ran fever all day after vaccines. At 9:00pm, pt started having grunting, nasal flaring, and periods of apnea with respiration. Parents took pt to ER, and she was admitted. Pt received IV fluids and was discharged 1/25/13 in the evening.
Acute Cellulitis involving upper left arm with redness spreading from elbow to shoulder.  Patient given Bicillin CR 900/300 units.  Advised to take Tylenol for pain and Benadryl 25mg for itching.
shock-collapse w/in 3-4 hrs of vax; no treatment recvd;
I developed a Harold patch followed by a generalized rash shortly after a mandatory influenza vaccination (about 4 days). I did not make this connection until today. Nov 4th, I went to my PCP and she recommended I went to the ED that day for IV steroids. Pityriasis Rosea was the possible diagnosis. I received Decadron IM and Prednisone taper. After researching this, my rash looked closer to a "Lichenoid drug eruption" than the typical Christmas tree pattern of PR. My rash is finally clearing up now, but I am still dealing with the residuals and itchiness of course. Should I be concerned about future vaccinations? as I stated, Influenza vaccine is mandatory for me.
Information has been received from a consumer concerning her 24 year old daughter who was vaccinated with the third 0.5 ml dose of GARDASIL. The patient had a PAP smear that showed positive for HPV after she received three doses of GARDASIL. Unknown medical attention was sought with the physician. At the time of reporting, patient had not recovered. No product quality complaint was involved. No further information is available.
fever, chills, arm pain, severe stomach cramping. Cramping lasted for 12 hours. Fever is continuing almost 72 hours after shot.
Patient experienced his first gout attack. It resolved in a couple of days with treatment with OTC ibuprofen
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 75-year-old male patient who received SHINGRIX (batch number X5XY4, expiry date unknown) for prophylaxis. The patient's past medical history included shingles (the patient had shingles lesions 25 years ago.). On 3rd March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, 26 days after receiving SHINGRIX, the patient experienced shingles, injection site pain, fever and skin lesion. The patient was treated with ibuprofen. On an unknown date, the outcome of the shingles and skin lesion were unknown and the outcome of the injection site pain and fever were recovered/resolved. It was unknown if the reporter considered the shingles, injection site pain, fever and skin lesion to be related to SHINGRIX. Additional details were provided as follows: At the time of reporting, the expiry date of SHINGRIX was not reported. The patient received 1st dose of SHINGRIX 31 days ago. The patient experienced high grade fever of 101 F, few days after the infection and which resolved after about 3 to 4 days. The patient experienced injection site pain which lasted for about 10 days. 4 to 5 days ago, the patient developed lesions on his face, that looks like shingles lesions.
accidentally got the Moderna COVID-19 vaccine on 15Mar2021 after receiving the Pfizer COVID-19 vaccine on 24Feb2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (accidentally got the Moderna COVID-19 vaccine on 15Mar2021 after receiving the Pfizer COVID-19 vaccine on 24Feb2021) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (accidentally got the Moderna COVID-19 vaccine on 15Mar2021 after receiving the Pfizer COVID-19 vaccine on 24Feb2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (accidentally got the Moderna COVID-19 vaccine on 15Mar2021 after receiving the Pfizer COVID-19 vaccine on 24Feb2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: 001B21A) with no associated AEs.
Shaking; Heart rate was up; Brain fog; I could not just focus and I feel like crap; I am just weak I am dragging; Fever; Chills; I was very sick; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on 28Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient states they had vaccine on 28feb2021 Sunday morning, and was very sick on the same night (28Feb2021) got a little better. The patient had fever and chills which was uncontrollable chills on 28Feb2021, shaking not for chills, heart was up. Monday (01Mar2021) patient still had fever 101, Tuesday (02Mar2021) it went down to 99 but his/her temperature is normally 96, then yesterday patient felt okay and then patient got out for the first time and then patient had a brain fog you know patient could not just focus, this was like 5 in the afternoon, now today patient thought he/she would feel better and patient was just weak and was dragging, patient was like he/she mean when was this going to be over. Patient was a normal healthy person he/she do not get sick and patient feel like crap, and so when was this going to go away. Outcome of the event fever and was very sick was recovering and outcome of the other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
The first three days I had a sore arm, but that went away. On the 6th day, I had terrible vomiting, chills, and nausea. The reason I am reporting is that it was 6 days later. I have not heard of that? I am fine now.
Within 10 minutes I was numb with a hot, tingly sensation from my left knee up to my neck and my left wrist up my arm to my neck. Then I felt like I had been hit in the head with a bat, but the pain migrated from side to side in my head. It was a very strange feeling. The hot, tingly numbness lasted about 45 minutes to an hour, the headache began to subside after 2 hours. The next day I had a little raised redness and the injection site and a bad headache, but was otherwise fine. At the vaccination site they strongly advised I go to the ER, which I did. I have no history of vaccine reaction.
Menstrual cycle changes post vaccination; This spontaneous case was reported by a nurse and describes the occurrence of MENSTRUAL DISORDER (Menstrual cycle changes post vaccination) in a female patient of an unknown age 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 MENSTRUAL DISORDER (Menstrual cycle changes post vaccination). At the time of the report, MENSTRUAL DISORDER (Menstrual cycle changes post vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No treatment medications were reported.
Strong Metallic taste, in mouth, within 10 minutes after injection,  lasted over 30 minutes.  Lightheaded within 10 minutes after injection, lasting less than 5 minutes.  Mild, aching, posterior Headache that started within 1 hour after injection and has continued up to present time.
Patient was given 1st COVID-19 vaccine and was sitting for 15 minutes in order for him to be monitored for any Adverse reactions. When 15 min was up, pt. was asked if hehe was okay, but couldn't respond. 911 was called and we saw that he had history of convulsions in patient profile.
Information has been received from a registered nurse concerning an outbreak of chickenpox in child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected. This is one of several reports received from the same source.
pain all over my abdomen; lbm; I almost collapsed. My daughter brought me to ER; This case was reported by a consumer via interactive digital media and described the occurrence of abdominal pain in a female 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, less than 2 years after receiving Shingles vaccine, the patient experienced abdominal pain, loose bowel and presyncope. Shingles vaccine was discontinued. On an unknown date, the outcome of the abdominal pain, loose bowel and presyncope were recovered/resolved.   It was unknown if the reporter considered the abdominal pain, loose bowel and presyncope to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported. The patient had first shot of the latest shingle vaccine 2 years ago from the reporting date and did not take the 2nd dose because she had the bad reaction. The patient had pain all over her abdomen and lbm (loose bowel movement). The patient was almost collapsed and her daughter brought her to ER (emergency room). The reporter mentioned that, her husband got the first and 2nd dose with no reaction at all. The follow-up would not possible as no contact details were available.
chills; feverish; joint pain; muscle pain; A spontaneous report was received from a consumer concerning a 76-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, feverish, joint pain, muscle pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 13M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) chills, feverish, joint pain, muscle pain.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), chills, feverish, joint pain, muscle pain was unknown.
The next day his joints started hurting all over and he woke up with cold sweats.  His hands also had become swollen  He reports his hand swelling persisted He reports his elbows and shoulders have been stiff and sore. His neck and knees have been painful and stiff is well 10/28 patient still unable to close his hands all the way
Spinal cord pains (pain along the entire vertebra axis) Spotting blood for 3weeks Fever for 3 weeks General Body pain Loss of Appetite
Breakthrough case admission after 4 vaccines Pfizer 3/22/21 Lot# NOT GIVEN;  Pfizer 4/12/21 Lot# NOT GIVEN;  Pfizer 10/13/21 Lot# 30145BA; P fizer 5/13/22 Lot# FK9893
24 hours after administration patient broke out in hives. Hives worsened. Family sought follow up 5-3-16 when hives were diagnosed.
Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Tachycardia,  Chills, ShOB, Redness and swelling at injection site Narrative:
Left arm cellulitis treated with Keflex P.O of 8 hours and Motrin 1.5tsp PO of 8 hours by doctor.
Bedridden for 3 days. Had sudden onset of joint pains, which continues today. Had vertigo, dizziness, migraines, ear infections and worsened allergies. Incapacitated for 1 year and currently have chronic symptoms. Since receiving that Rubella vaccine, I have never been well nor without pain. I am currently seeking a medical retirement from work. The 60 day follow-up states arthritis (disabling arthritis); continue to have ear infections, fluid in the ear, vertigo, dizziness more than twice per year; very fatigued from pain. My children when vaccinated suffered chronic/acute ear infections and upper respritatory infections.  After 1 year with no vaccinations-children were rarely ill.  Note:  Since receiving that vaccine, I have never been well without pain.  I am currently seeking medical retirement from work.  I am not pregnant and I understand I should not be pregnant for at least 3 months.  I therefore give my consent to the physician to give me a rubella vaccine.  Follow up on 08/16/2001: "Patient never received the vaccine at this office and there are no adverse reactions noted in her chart."  Follow up on 09/12/2001: "This note is to inform you that on 12/03/1996, one of the tenants in the building moved out and left the heat turned off.  We did not know this until we went to the basement and it happened.  Apparently the pipes had broken.  All of the records in the two rooms were wet.  Some of them were just, repeats of the previous.  I am very sorry that this happened, we will not be able to complete this file.  If I can be of any more help in this matter, please feel free to contact the office.  Thank you for your understanding."
Case number PHEH2015US027166, is combine initial spontaneous report received from a pharmacist on 23 Dec 2015 and 24 Dec 2015. This report refers to a 07 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number and expiry date: not reported) at a dose of 0.5 ml on an unknown date when he was 07 years old. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
red raised itchy rash at the injection site, 4cm across and defined; red raised itchy rash at the injection site, 4cm across and defined; red raised itchy rash at the injection site, 4cm across and defined; soreness at injection site; injection site swelling in arm; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect (No reported medical history.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication and treatment provided; Reporter's Comments: Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported event sand the product use cannot be excluded.  Injection site erythema, Injection site rash, injection site pain and injection site pruritus are consistent with the known safety profile of the vaccine.
flu; sick; Initial information received on 13-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp (non health care professional).  This case involves patient with unknown demographics who experienced flu and sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer,dose,frequency,strength,lot number,expiry date via unknown route in unknown administration site for immunization.  On an unknown date the patient had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  On an unknown date the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (flu, sick).  At time of reporting, the outcome was Unknown for the events flu and sick.; Sender's Comments: Sanofi Company Comment dated on 21-Feb -2022: This case involves patient with unknown demographics who experienced flu while receiving vaccine INFLUENZA VACCINE. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect product cannot be excluded in occurrence of the event.   However, lack of information of past and concomitant medication/ vaccination, any family history and any relevant medical history of patient, any concurrent conditions, lab data precludes comprehensive case assessment. Based upon the reported information, the role of an individual vaccine cannot be assessed.