chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a female in her 50"s who on approximately 03-SEP-2005 began self administrating pneumococcal 23v polysaccharide vaccine daily (duration not reported).  Subsequently, the patient experienced dizziness.  The patient was seen in the clinic and was asked to bring the bottle of medication to the clinic.  On 03-OCT-2005 the patient returned to the clinic and brought 9 empty vials of pneumococcal 23v polysaccharide vaccine.  The pharmacist indicated that the patient was clinically stable with no dizziness.  No product quality complaint involved.  Follow up information was received.  On 05-OCT-2005, the pharmacist reported that the pharmacy had given the patient a box of pneumococcal 23v polysaccharide vaccine vials instead of insulin.  The pharmacy had mistakenly labeled a box of pneumococcal 23v polysaccharide vaccine as insulin.  There was no confusion on the part of the pharmacy regarding the label of the products themselves.  It was described by the pharmacist as a mistake on the part of the pharmacy labeling the box incorrectly.  As of 05-OCT-2005 the patient had not developed any other problems.
pt recvd vax;devel severe arm pain above & lateral to inject site; rxn associated w/ redness & swelling at inject site;pain resolved w/in 2 wks;tx w/ Motrin,apap & ice;
Severe myalgias, arthralgias, HA and fatigue followed by eryethema of L. arm and fever to 102.8.
This spontaneous report as received fro a female consumer of unknown age refers to herself. On 22-APR-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported). The patient reported that on 24-APR-2014, she experienced the same tingling sensation and the injection site got really red, after she received ZOSTAVAX. The patient explained the tingling sensation was brief and the redness and tingling resolved on an unspecified date. No treatment was given for adverse event. The patient did not seek medical attention. Additional information has been requested.
Thrombosed hemorrhoid that bled for four days before I contacted a doctor. Treated with Proctofoam and basic cleansing. Gradually cleared up over the course of 2 weeks.
48 hours after the vaccine, I felt fatigue. I got sick from the vaccine within 48 hours. I didn't see a doctor for that. I saw Dr. in May. She told me I was pregnant. I just had pregnancy related stuff.  I conceived 2 weeks after the 2nd vaccine, 03/26/201. I tested positive for COVID -19  on 09/03/2021.
Headache; extreme fatigue; joint and general muscle ache; joint and general muscle ache; This is a spontaneous report from a contactable Other HCP (patient).  This adult female patient of unknown age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot # EC1283), intramuscular, on 11Dec2021 at 09:30 AM at single dose for COVID-19 immunisation. Vaccine location was right arm.  Facility type vaccine was hospital. Medical history included seasonal allergies, pet allergies, penicillin allergy. Historical vaccine included first dose of BNT162B2 (lot # EH9899), on 21Dec2020 at 09:00 AM, intramuscular right arm, and flu vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC), ibuprofen (ADVIL) and diphenhydramine hydrochloride (BENADRYL). On 12Jan2021 at 12:00 PM, the patient experienced headache, extreme fatigue, joint and general muscle ache. No treatment was given for the events. Outcome was not recovered.
Client reported arm hurt like a tetanus shot on 6/28. On 6/29, arm hurt worse, lymph nodes under arm were the size of a small apricot, couldn't place arm down close to side. On 6/29, arm felt hot to the touch, injection site was as large as her hand. Client was seen in an Urgent Care Center and diagnosed with cellulitis or a possible abscess. Client received IV antibiotic 6/29, two doses 6/30, and one dose 6/31; unable to determine name of medication. She also took doxycycline for 10 days. Client reported her arm cleared after treatment.
Patient received second dose of Pfizer-BioNtech Covid-19 vaccine today and after 5-7 minutes reported to a pharmacy technician she was feeling nauseous. Patient wanted to keep her head down because she experienced light sensitivity; I placed cold compresses on her neck. Patient worsened over the next 10 minutes, complaining of feeling dizzy, anxious, intense headache. At this time, 15 minutes after being vaccinated, I (the vaccinating pharmacist) moved the patient to a private booth to have her lie down on the floor with her feet elevated. The patient was able to communicate the entire time and called her relatives to come pick her up from work. Emergency services were called as the patient was not experiencing anaphylaxis, but was increasingly more anxious and was afraid she'd fall or faint. Emergency medical services arrived after the patient had been laying down with feet elevated for almost 30 minutes. Patient did not complain of trouble breathing but did request use of her inhaler. Patient did not state on her patient questionnaire and consent form that she has asthma; she mentioned this during her episode. Patient was taking to a local hospital.
sore throat; headache; 101.5 fever; chills; whole body hurts; short of breath; This is a spontaneous report from a contactable consumer or other HCP. A 41-year-old non-pregnant female patient received bnt162b2 (Pfizer BioN Tech Covid-19 MRNA vaccine, Formulation: Solution for injection, Batch/Lot number: Unknown ) via unspecified route of administration on anatomical location left arm on 09Feb2021 (age at the time of vaccination was 41-year-old)  (at 03:30) Dose number Unknown Single for covid-19 immunization. Medical history included lupus and epilepsy. The patient had no known allergies. The patient received other medication Gabapentin in two weeks. The patient did not receive other vaccine four weeks. The patient had no covid prior vaccination and did not tested for covid post vaccination. On 10Feb2021 (at 15:00), the patient experienced 101.5 fever, chills, whole body hurts, short of breath, sore throat and headache. The patient did not receive any treatment for the events. The outcome of the events was recovering.    Information on the lot/batch number has been requested  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
29 y/o male with no medical history presents with dizziness and diaphoresis post vaccination. Patient states that this is his first vaccination in the two-dose series. Patient states that he received the vaccination to the left arm. Patient denies previous reaction to vaccinations in the past. NP, RN and Paramedics at patient side. Patient placed in. Patient vitals within normal limits (111/56 BP, 99% RA, 12 Resp.) Within 5 minutes patient states that he is feeling better and that he feels that he was scared because of the needle. Patient states that this has occurred with blood draws in the past. Patient provided with bottle of water and observed for 10 minutes more. Patient cleared to go home. Patient discharged in stable condition with brother at side.
/ Now he has had a recurrence that has lasted about a month with extrenme pain; This spontaneous case was reported by a consumer and describes the occurrence of HENOCH-SCHONLEIN PURPURA (/ Now he has had a recurrence that has lasted about a month with extrenme pain) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Henoch-Schonlein purpura (Patient had HSP when he was 5 years old with relatively short flare ups about every 10 years.).    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HENOCH-SCHONLEIN PURPURA (Henoch-Schönlein purpura/ Now he has had a recurrence that has lasted about a month with extrenme pain) (seriousness criterion hospitalization). The patient was treated with MORPHINE for Adverse event, at an unspecified dose and frequency. At the time of the report, HENOCH-SCHONLEIN PURPURA (Henoch-Schönlein purpura/ Now he has had a recurrence that has lasted about a month with extrenme pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reportedly did not read the fine print that people that had Henoch-Schonlein purpura (HSP) should not get the vaccine. Patient had HSP when he was 5-years-old with relatively short flare-ups about every 10 years.  Now, he had a recurrence that has lasted about a month and was in the hospital with extreme pain, bleeding and on a feeding tube because of difficulty eating.   No concomitant medications were reported.  Additional reatment included "potent painkillers" as well as corticosteroids.   Company Comment:  This report concerns a case of 42 year old male patient with concurrent medical condition of henoch-schonlein purpura who was hospitalized for the recurrence of henoch-schonlein purpura (serious unexpected event) after unknown duration following vaccination with mRNA-1273. The medical history of henoch-schonlein purpura remains a confounder for the recurrence of the event. The benefit-risk relationship of mRNA-1273  in not affected by this report.; Sender's Comments: This report concerns a case of 42 year old male patient with concurrent medical condition of henoch-schonlein purpura who was hospitalized for the recurrence of henoch-schonlein purpura (serious unexpected event) after unknown duration following vaccination with mRNA-1273. The medical history of henoch-schonlein purpura remains a confounder for the recurrence of the event. The benefit-risk relationship of mRNA-1273  in not affected by this report.
pt recv vax 19AUG96 & 17OCT97 pt devel a break through case of mild chickenpox;pt recovered on approx 14OCT97;
Took 2 weeks to start being comfortable sleeping on arm; This case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included TETANUS VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and TETANUS VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was recovered/resolved.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-Aug-2022 Reporter's comment: The patient self-reported the case via via interactive digital media. The patient stated that he/she made a mistake of taking Shingles and Tetanus shot at same time in same arm, left one.  It took him/her two weeks to start being comfortable sleeping on that arm.  The patient would get the second dose of the shingles shot in November and hoped it goes better. Additional Supportive Information: Follow-up would not possible as no contact details were available. It was unknown if the reporter considered the arm discomfort to be related to Tetanus vaccine.
Information has been received from a nurse concerning a 17 year old female who at the "end of December" was vaccinated with a second dose of HPV VLP vaccine (yeast) (0.5 ml). Subsequently, the patient experienced meningitis like symptoms and cervical neck stiffening.  Unspecified medical attention was sought.  At the time of the report, th patient was recovering.  Additional information is not expected.
Headache; Fever 101deg F; body aches; joint pain; mild nausea; Advil, liquid, rest, cool bath. Heavy chest; Throat swelling
Patient's vaccine arm started with redness about the size of a silver dollar the day after given, then the redness spread down and around the arm to about the elbow and not quite all the circumference of the arm. It was also warm to the touch, but not painful.
I had my second dose after 47 days; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had my second dose after 47 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received 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 (I had my second dose after 47 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had my second dose after 47 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
Patient reported redness of arm at approximately 1 in radius about injection site, pain and hardness for approximately 1 week after getting vaccination. Did not seek medical attention and reported that the reaction resolved after 1 week. Reported 2/9/2019 to pharmacy.
roughly 1-2 hours after vaccination patient went home had fatigue, syncope, pain in ears and throat lasting throughout the day.  She called the pharmacy the next morning with the same symptoms.  Pharmacy advised her to call a doctor.  Dr advised her that she did not need antibiotics and to take benadryl.  Pharmacy followed up the same afternoon to ascertain recovery, patient still had pain after the vaccination.
Immediate dizziness, followed by several days feeling run down, combination of intermittent dizziness and nausea, tightness breathing, constant smell of smoke in my nose for about 2 weeks.  Approx. 4 weeks later, still feeling intermittent dizziness and on intermittent days, any kind of physical activity (walking across a room, housework, going up 1 flight of stairs) can leave me winded and increase my heart rate.  Have sought treatment from the nurse who gave the vaccination, and from my primary care physician.  Neither have recommended further action at this time.  (Was diagnosed with a viral infection on 12/15/2009 and am on antibiotics now).
Frequent dizziness most of the day, all days; mouth sores and general soreness in mouth; rash on stomach and lower back, later also on forehead and front part of both ears
pt recv vax 18SEP95 & 16JUN97 pt devel chickenpox w/150 lesions;
After the 2nd dosage my husband started having numbness and tingling in his hands and feet. Which then progressed to him walking while holding on to furniture and than proceeding to me having to carry him because he couldn't walk. In October it got so bad he couldn't control his bowels, couldn't swallow, couldn't walk at all. He was then admitted to the hospital for Guillen Barre Syndrome and 8 months later his still not walking but he's getting monthly IVIG treatments, PT, OT, and a nurse comes to the home due to him not being ambulatory.
This is a spontaneous report from a non-contactable consumer. An adult non-pregnant female patient received second dose BNT162B2 (Solution for injection, Lot number was not reported), via an unspecified route of administration on Feb2021 at 01:30 as second dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior vaccination, the patient had not COVID-19. Post vaccination, the patient had not tested COVID-19. No other vaccine received in four weeks. The patient previously took BNT162B2 (COVID-19) at first dose for COVID-19 immunization. It was reported that within 24 hours of receiving second dose, individual developed a fever of 101.8 F that was reduced with medication and resolved within 48 hours. The patient underwent lab tests and procedures which included body temperature: 101.8 Fahrenheit on Feb 2021. Therapeutic measures were taken as a result of developed a fever of 101.8 f. The outcome of the event was resolved in Feb 2021. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Patient called on 10/04/18 and said started feeling "really bad" and the area that she got her shot became red, swollen and warm. She said her temperature was 103 for 2 days. Patient reported that she took TYLENOL, BENADRYL and used a cool compress on her arm. She started feeling better on 10/06/18. No further problems per patient.
4 cm area of redness at injection site on (R) upper, post, arm. Headache, polymyalgias, eye redness, fatigue, chills.
After receiving vaccines, patient waited in an exam to observe any possible allergic reactions with her mother. Approximately 10 minutes after receiving the vaccines, the patient's mother reported red lesions on the child's forehead and trunk. The patient's provider was notified immediately. The provider diagnosed the lesions as urticaria caused by an allergic reaction to the vaccines. The provider prescribed PO Benadryl that was given to the patient immediately. Patient was observed by nursing staff in the clinic for 30 minutes and was evaluated by the provider prior to be allowed to leave. Patient's mother reported no further issues.
Information has been received from a nurse concerning her 12 year old daughter who on an unspecified date was vaccinated with a 0.5 mL dose of Gardasil. On the same day, the patient was concomitantly vaccinated with a dose of Varivax (MSD). Subsequently, the patient developed a swollen eye and acne. The patient sought unspecified medical attention. Subsequently, the patient recovered from swollen eye and acne. Additional information has been requested.
Left arm swelling from shoulder to elbow with redness, area warm to touch also tender to tender. Referred to MD.
1 day after injection severe hives/rash on torso front and back down to pubic bone and some on inner thighs.
Pt was given a vaccine (gray cap) that was left out at room temperature beyond 12 hours (given expired vaccine). No adverse reaction or outcome.
Took three doses of Vivotif which were unrefrigerated; Spontaneous report received on 09DEC2019.  A female consumer reported that she "took three doses of Vivotif which were unrefrigerated" (PT: Product storage error). She was receiving oral Vivotif (lot number: 3003297; expiry date: SEP2020) for typhoid fever prophylaxis/ trip. The consumer took the first dose of Vivotif, which was left unrefrigerated. Then she refrigerated the remaining dose after her first dose. However, she took three doses of Vivotif that were already unrefrigerated. She took the third dose of Vivotif on 08DEC2019. Action taken with Vivotif with respect to the reported event was not applicable. Outcome of the reported event was unknown at the time of report.  Company Comment: A consumer took three doses of Vivotif which were unrefrigerated (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not related.; Sender's Comments: A consumer took three doses of Vivotif which were unrefrigerated (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not related.
Patient reacted the following day by having a fever and chills that put her out of commission for 3 days. Now she her arm is swollen with a red non itchy rash from below the injection sites to her elbow. She has taken Motrin. She was advised to take Benadryl and if no response to go to the doctor.
Heart slow but it's better now; Dry mouth; Dizziness; Nausea; Headache; Fatigue; Muscle pain; Eyes kind of hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HEART RATE DECREASED (non-serious) with onset 17Dec2021, outcome "recovering", described as "Heart slow but it's better now"; DRY MOUTH (non-serious) with onset 17Dec2021, outcome "unknown", described as "Dry mouth"; DIZZINESS (non-serious) with onset 17Dec2021, outcome "unknown", described as "Dizziness"; NAUSEA (non-serious) with onset 17Dec2021, outcome "unknown", described as "Nausea"; HEADACHE (non-serious) with onset 17Dec2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset 17Dec2021, outcome "unknown", described as "Fatigue"; MYALGIA (non-serious) with onset 17Dec2021, outcome "unknown", described as "Muscle pain"; EYE PAIN (non-serious) with onset 17Dec2021, outcome "unknown", described as "Eyes kind of hurt". The lot number for bnt162b2 was not provided and will be requested during follow up.   .
After injection light rash appeared on both arms with bumps. Itching on right shoulder above where vaccine was given. Face itching a little, face already pink but got a little darker pink.
pulmonary embolism/Blood clots in the lung; heart attack; Shortness of breath; headache; jaw hurt; Shin hurt; heart burn; This is a spontaneous report from a contactable consumer (patient's son). A 63-year-old female patient (mom) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration in arm in Feb2021 (reported as in the first week of Feb2021) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 in Jan2021 for COVID-19 immunization. Reporter (patient's son) received his first dose of Pfizer COVID vaccine on Wednesday and wanted to know if this vaccine could cause blood clot. He stated his mom (patient) in the hospital due to pulmonary embolism from 24Feb2021, 2.5 weeks after her second shot. He stated his anxiety levels were higher than normal. He had strong response to flu vaccine this year and experienced chill, shakes, fever, received antibiotic, and loss sense of taste from the flu vaccine. Reporter read online that some people commented that they have DVTs (deep vein thrombosis) and blood clots from the Pfizer COVID vaccine. Patient experienced blood clots in the lung in Feb2021 and hospitalized on 24Feb2021. Patient got her second shot about 2 weeks before and she ended up in the hospital with pulmonary embolism. They looked at her lungs and found all the blood clots. Patient had really bad shortness of breath, headache, her jaw hurt, and her shin hurt. She was helping out at vaccine clinic and she was out of breath, she said the old people in strollers were passing her. Patient began to make complaints about how she was feeling in mid of Feb2021. Patient said in rare cases 2 weeks after the second dose reactions could happen. Patient got done working in ICU, and helped with PPE, then at 11 she left work at the hospital, she was experiencing heart burn for 3 days and so she thought had a heart attack drove to an ER (emergency room) on the way home, and then was admitted to the hospital on that same day 24Feb2021, she was supposed to be discharged today (26Feb2021). Patient had been feeling out of breath for past 2 month, it was possible it might seem like it was related to the vaccine but it could also not be related. Reporter stated that on the internet he saw how a 1000 deaths happened after the vaccine, it was all old people, but in the autopsies there was no link to the vaccine, they were going to die regardless. Lab data included: She did get a test before for Factor 5 Leiden but it was negative. They did test for COVID, it was negative, while in the hospital. In the hospital they were also testing her again for the Factor 5 Leiden, the results hadn't come back yet. They did test for blood clots, they did an MRI (magnetic resonance imaging) in Feb2021, it was positive for blood clots (blood clots in the lungs). When she was admitted her oxygen was 85%. Outcome of the events was unknown.  Information on lot and batch number has been requested.