chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant (C.M.A.) who refers to a patient of unknown age and gender. It was reported that the patient was vaccinated with an expired dose of ZOSTAVAX (dose, and route not reported) (lot # 671190/1270AA, exp 05-NOV-2012) on 20-NOV-2012. No adverse symptoms reported. Additional information has been requested.
Permanent ringing in left ear since 7/14/03. Sporadic ringing in right ear since 7/14/03 also. I received my 2nd anthrax shot on that day.
patient received the covid pfizer monovalent vaccine in error and was supposed to get the pfizer covid bivalent
Starting a few hours after receiving the vaccine, I experienced a very upset stomach. Then, I got the chills and the next morning I felt very ill. I felt run down, no energy and felt like I had a bad flu. These symptoms lasted for over a week. Then, I developed the worst stomach pains I had ever had. I ended up going to the emergency room and, they did extensive testing, but couldn't pinpoint it on anything. I could feel my "intestines rolling" and they gave me a pill to calm my stomach down. Then, I was sent home and they advised me to see a GI doctor. I ended up finally finding one (just moved) and made an appointment. Before I made it to the appointment, I had another episode much worse than before. I called the GI doctor and they took me immediately. After seeing me, he scheduled me for an appointment for an upper and lower endoscopy 3 days later. After having the endoscopy, he could not pinpoint any issues and ruled out cancer. He gave me more of the same calming medicine I had from the ER for my stomach. Eventually it got better.
This spontaneous report as received from a health care worker refers to multiple unspecified patients with unknown demographics. No medical history was reported. On multiple unspecified dates, the multiple unspecified patients were vaccinated with a dose of an improperly stored GARDASIL 9, (dose, route and frequency: unknown, lot number L016429, expiry date: 09-AUG-2017). No adverse effect was reported. This is one of the two reports from the same reporter. Additional information has been requested.
Patient called c/o he could not move his arm, shot was given in, mild swelling, no fever, no SOB. instructed patient to take Motrin for discomfort and to ER if worsens, call office back if worsens , new s/s develop or no improvement in a few days.
16 days after receiving the shot, I broke out in hives all over the majority of my body.  I took 2 Benadryl, but the hives continued to spread.  My dr called out prednisone and I continued the Benadryl along with Pepcid.  By noon the following day most of the hives were mostly gone.  But within 6 hours new hives were forming.  I continued the prednisone, Pepcid and Benadryl.  The next morning  the hives had increased even more so I was given a shot of cortisone at my doctor?s office at 8am.  By 1pm that day, the hive had faded and were very faint to see.  By 10pm, new spots were visible.  Over the night the hives increased and I woke at 4am from the pain and severe itch.  I continued the Benadryl and Zyrtec and but stopped the prednisone bc it didn?t seem like it was helping and also appears like my body is trying to detox.  I currently have hive on my neck, torso, arms, and legs.
Pt cried, "screaming cry" for 5 hrs, difficult to console, APAP given x 2; no fever; fell asleep @ 3PM & was fine p/that; 21FEB92 recvd ped DT no crying, no fever;
Pt's arm was red and warm to touch at a site a few inches from  injecting site. Pt will let dr know if it becomes painful or increases in size.
A consumer reported that her 16 year old daughter received FluMist on 14 Dec 04 from her school clinic. Over the next 24 to 48 hours, the patient developed head cold, nasal congestion and tiredness. A couple of weeks later the patient still did not feel better. She was seen by her pediatrician, who on physical exam, said that the patient's nasal turbinate were swollen and clinically diagnosed her with sinus infection and prescribed oral Keflex (cephalexin) for 14 days. The symptoms, however continue. The pediatrician then prescribed Zyrtec (cetirizine hcl), Claritin (loratadine) and a saline nasal spray. In June 2005. she was referred to an allergist due to persistence of above symptoms. The patient underwent 60 different allergy testing which revealed that she was slightly allergic to pollen possibly from maple tree and ragweed. He prescribed oral Medrol. However, the allergist stated to the reporter that it was so mild that it should not produce the severity of the patient's symptoms. On 05 Jul 05, a CT scan of both sinuses showed sinus infection, swollen nasal turbinate and nasal septum deviation. The allergist prescribed Augmentin (co-amoxiclav) 1000 mg twice a day for 14 days and a nasal cortisone spray, which did not improve the patient's symptoms. In August 2005, the patient was referred to an ENT, who did a rhinoscope, which showed mild nasal septum deviation, sinus infection and excessive mucus production. The ENT physician suggested that a surgery to correct the nasal septum deviation should be done, but the reporter state she did not want the surgery done until the cause of the patient's chronic symptoms is known for sure. The reporter plans to bring patient back to the allergist and ask if a culture and sensitivity should be done. As of 06 Sep 05, the patient has not recovered from her symptoms, which now includes difficulty breathing due to the nasal congestion and pallor. The reporter state that the symptoms are possible related to FluMist.
Fever of 102-104 every three hours for 72 hours. Swollen red eyes, swollen neck and cheeks, rash all over the body. Dizziness, lethargic.
Tdap 0.5 mL was given IM into left deltoid on 3-19-08. Arm was sore and pt had a slight fever. The next day she had a headache and slight arm swelling. On 3/21 in the late afternoon, she had a severe headache, gum throbbing, and her arm was very swollen. She left work to see a physician where she was diagnosed with cellulitis. Signs and symptoms resolved after treatment with Augmentin and Naprosyn.
injection site very sore and very warm to the touch for several days; mild fever for one day; lethargy for several days  ibuprofen seemed to ease the worst of the symptoms
Information has been received from a manager of a physician's office concerning a 79 year old male with no allergies and a history of coronary bypass surgery and recurrent pleural effusions who on 12/19/01 was vaccinated in the arm with a first dose of pneumococcal vaccine 23 polyvalent (lot # 640577/0995L). It was reported that the patient had quite an extensive medical history of being unwell. Concomitant therapy included warfarin sodium (Coumadin) lisinopril (Zestril), atorvasdtatin calcium (Lipitor), levothyroxine na (synthroid), pantoprazole sodium (Protonix) and hydrochlorothiazide (Hydrochlorithiazide Tablets (USP)). On 12/21/01, the patient called the office complaining of redness and itching at the  injection site. It was also reported that there was swelling at the injection site. The physician instructed the patient to keep an eye on the area and that if it became worse to go to the emergency room. The patient went to the ER where he was diagnosed with a staff infection, given antibiotics and released. It was reported that no cultures were done and the diagnosis was made on the visual appearance of the arm. It was noted that the patient was instructed not to receive a booster dose in the future. It was also noted that this was a multidose vial of 5 and that the other two patients who were given doses from this vial have not reported any problems. Additional information has been requested.
FEVER OF 102.9, CHILLS, HEADACHE, BODY ACHE, FATIGUE
Red, swollen, sore, hot (12/4/99 at 9:00pm), improved on 12/6/99.
Dizziness within 10 minutes of getting the vaccine. Had her lie down, elevated legs - resolved after 10-15 minutes.
initial more pain, swelling lasting 1 week with itching, then upper arm pain shoulder pain
Over a period of week, painful swollen lymph nodes in right armpit, right jaw and left back of head. Treated with ibuprofen. Over a period of several days, sore ankle, knee, hip joints. Treated with ibuprofen. Mild flu like symptoms and low-grade fever.
Injection site pain, discomfort, and redness Narrative:  Patient is a 60 year old female residing in community living center who received 2nd COVID-19 vaccine on 1/31/21. COVID-19 Screen note 1/14/21 @09:34: resident c/o soreness on the injection site and pain when she lifts her arm. PRN acetaminophen 650mg given. COVID-19 screen note 1/14/21@18:19 note: resident c/o soreness on the injection site and pain when she lifts her arm COVID-19 screen note 1/15/21@23:23: nurse noted some redness around L deltoid injection site but no swelling. Pt denied itching, pain, or discomfort sever times. No c/o chills or achy joints. No further reports of injection site pain/discomfort/redness.
symptoms 18May2022 pm and then positive Ag 20May2022; symptoms 18May2022 pm and then positive Ag 20May2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 49-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL3247), on 24Feb2021 as dose 2, single (Lot number: EL3247) and on 29Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18May2022, outcome "unknown" and all described as "symptoms 18May2022 pm and then positive Ag 20May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
CHIEF COMPLAINT:   Has been coughing for 3 weeks. CXR showed pneumonia. had a kidney transplant 6 yrs ago . was dirested to come here   HISTORY OF PRESENT ILLNESS:     50-year-old male with history of kidney transplant 6 years ago at Medical Center in town, currently on tacrolimus and   mycophenolic acid, comes to the ER for evaluation of productive cough for 1 to 2 weeks.  Patient was diagnosed with COVID-19 approximate 1 month ago.  He was vaccinated for COVID-19.  He says that he had an uneventful initial disease course when she was home for approximately 4 to 5 days.  He tells me that he made a complete recovery from COVID-19 at that time.  After about 1 week he started to have an increase in his cough and the cough is now become productive of yellowish sputum.  No fevers chills nausea vomiting chest pains or shortness of breath at this time.  No generalized malaise.  The patient says he otherwise feels completely fine.
Crying and very fussy. next day 12/10/2009 around 12:00 pm she started to get a rash on her armpit and i took her clothes off she was crying a lot in a couple hours it started to get worse I went to mobile clinic but they were full  then i went to another clinic were they give her the shot they said it was provably something us to take her to the doctor then I toked her to a Health Center they took her inside by then the rash has spread on her body the doctor administer benadryl and then in little time the rash got better and it stop spreading the next day her armpit skin peel off like if it was a burn and were she got red it got like if was a burn it feels rough she itches but she is much better
SORES IN THE MOUTH, ACHY, EXTREME FATIGUE FOR 1 WEEK
pt had Large local reaction in vaccination site, 2 weeks after the vaccination. Seen at urgent care and prescribed prednisone.
A NP reported that a 25 year old male inadvertently received DT for a wound on 1/14/00. Pt developed an injection site reaction characterized by erythema and soreness and malaise. His symptoms were reportedly "resolving" as of 1/18/00.
Before vaccines, I signed up for hearing aid trial because of my insurance company and everything was pointing to the fact that I would be candidate for hearing aids. I did a trial for 2 months and after trial I started feeling pressure built up. I kept mentioning to audiologist and I changed ENT doctors and continued to bring it up as a major symptom. I find it interesting that I've never had this issue of pressure swelling and fullness in my ears and it was around the time I had the vaccine. There were many different things they asked me to do during the  6 week period and they asked me to get an impression of my teeth so I could get a guard when I sleep and they also recommended therapy which I'm still going to therapy three days a week.
GBS reported in a pt who recvd flu vax on 10SEP91 & on 7OCT91 was admitted to hosp w/dx of GBS; tx meds sx improved but still devel septic arthritis (staphylococcal);
Began complaining of "don't feel well" the next day (Wednesday). On Thursday had congestion, throwing up, hot to touch, and had "white balls of" congestion with blood when he blew his nose. 7 days later he is "beginning to feel better".
blacked out; delayed anaphylactic reaction; Tongue Swelled; Couldn't swallow; Couldn't breathe right; Head felt weird; Felt Cold; lightheaded; This is a spontaneous report from a contactable consumer reporting for herself.   A 44-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 22Apr2021 at 11:30 (Batch/Lot Number: EW0171) as a single dose for COVID-19 immunization. There were no additional vaccines administered on the same date and no vaccination administered in the 4 weeks prior. Medical history included ongoing Hashimoto's Thyroid (diagnosed with this condition many, many years ago). There was no relevant family history.  The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 01Apr2021,  Lot Number: ER8737; in right arm. On 22Apr2021, about a half hour after the shot she states her head felt weird, she couldn't swallow, she felt cold, and she could not breathe right. On 23Apr2021, she was driving her husband and blacked out.  Her tongue also began to swell.  She just happened to be by the exit ramp to the hospital. She visited the Emergency Room. They told her she was having a delayed anaphylactic reaction. No relevant tests were performed according to the reporter. All of her symptoms recovered when she started prednisone on 23Apr2021. She was prescribed prednisone, taper dose with last dose 27Apr2021. She still remained with lightheadedness and still could not drive.  The only one persisting was the weird feeling in her head, almost like a lightheaded feeling. She could not drive due to this symptom There was no physician office visit for the events. The events delayed anaphylactic reaction, blacked out, tongue swelled, couldn't swallow, couldn't breathe right, and feeling cold were resolved on 23Apr2021. The lightheadedness and head felt weird were ongoing (not recovered).
Patient said arm began to hurt that night and has continued to hurt continuously up to present time.  She has been treating with OTC ibuprofen.
Headache, NauseaVomiting, Injection site pain. Fatigue, Muscle pain, chills, Joint pain, Fever, Swollen lymph nodes. Narrative:
hives on my elbows and back of my thighs.; legs and arms felt like pins and needles; This is a spontaneous report from a contactable consumer (Patient). A 63-year-old non- pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 07Mar2021 09:15 (Lot Number: EN6206) (at the age of 63-year-old) as single dose for covid-19 immunisation. Medical history included Chronic hives, osteoporosis and known allergies to Penicillin. Concomitant medication included omalizumab (XOLAIR) from 01Mar2021 to 01Mar2021 (dose number 4) single. After 14 hours of receiving the covid shot patient woke up on 08Mar2021 at 12:00 with hives on her elbows and back of her thighs. Her legs and arms felt like pins and needles and her breathing was normal however she was aware of each breath her took. After two hours, the hives calmed down and her legs and arms were fine, her breathing was back to normal. She went back to sleep and woke 5 hours later, hives hardly noticeable, and she feel fine. She will contact her doctor day of report, too see what he recommends about taking the 2nd Shot. No treatment received for the events. Outcome of the events was recovered with sequelae.  No follow-up attempts are possible. No further information is expected.
Extreme Fatigue; Headache (lightheaded); chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme Fatigue), HEADACHE (Headache (lightheaded)) and CHILLS (chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, PROPRANOLOL, PRIMIDONE and LISINOPRIL for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced FATIGUE (Extreme Fatigue), HEADACHE (Headache (lightheaded)) and CHILLS (chills). On 06-Feb-2021, FATIGUE (Extreme Fatigue), HEADACHE (Headache (lightheaded)) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported.
No true adverse reaction, this is reporting a vaccination administration error - the vaccine was drawn up on 6/9 by Pharmacy, kept at proper temp in refrigerator and administered on 6/11. We understand now we should have administered it within 12 hours of being drawn up. The staff member receiving the vaccine did not experience an adverse reaction of any kind.
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant products were reported.No treatment drugs were reported.
Pt was visiting relatives when developed ataxia & weakness. Admitted on 12/22/11 - r/o stroke secondary to numerous vascular risk factors. Developed progressive ascending weakness causing respiratory compromise requiring mechanical ventilation. Report is filed per request of Infectious Disease MD. Dx: Guillain Barre syndrome.
tingling and numbness in arm and hand; tingling and numbness in arm and hand; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Jul2021 at 10:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Jul2021 at 07:00, the patient experienced tingling and numbness in arm and hand where she had received the shot. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event tingling and numbness in arm and hand was not resolved at the time of this report.  No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Fever; Body ache; Weakness; Chills; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 51-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Dec2021 11:00 (Lot number: FF8839) at the age of 51 years as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: XANAX. The following information was reported: PYREXIA (non-serious) with onset 07Dec2021 22:30, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 07Dec2021 22:30, outcome "recovering", described as "Body ache"; ASTHENIA (non-serious) with onset 07Dec2021 22:30, outcome "recovering", described as "Weakness"; CHILLS (non-serious) with onset 07Dec2021 22:30, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 07Dec2021 22:30, outcome "recovering", described as "Headache". Therapeutic measures were not taken as a result of pyrexia, pain, asthenia, chills, headache.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Product storage error; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 04-Nov-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.