chrisvoncsefalvay/vaers-outcomes huggingface dataset:
joints would start hurting; tingling on the back sides in the rear of his tongue; recurring and metallic taste in his mouth; terrible headach; going to come down with the flu for several hours; mental agitation with anger, or not feeling well; erratic performance, described as breathing sometimes like having run three miles after climbing; walking; extraordinarily high level of anxiety; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (recurring and metallic taste in his mouth), PARAESTHESIA (tingling on the back sides in the rear of his tongue), HEADACHE (terrible headach), ARTHRALGIA (joints would start hurting) and ANXIETY (extraordinarily high level of anxiety) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Deep vein thrombosis in 2017, Atrial fibrillation (With cardioversion), Sleep apnea and Knee replacement (Double knee replacement.). Concomitant products included ROSUVASTATIN, RIVAROXABAN (XARELTO), LISINOPRIL, HCTZ, CURCUMIN (TURMERIC MERIVA), ACETAMINOPHEN and METOPROLOL SUCCINATE for an unknown indication.    On 21-Feb-2021 at 5:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ANXIETY (extraordinarily high level of anxiety). On 26-Feb-2021, the patient experienced GAIT DISTURBANCE (walking). On 01-Mar-2021, the patient experienced AGITATION (mental agitation with anger, or not feeling well) and HYPERVENTILATION (erratic performance, described as breathing sometimes like having run three miles after climbing). On an unknown date, the patient experienced DYSGEUSIA (recurring and metallic taste in his mouth), PARAESTHESIA (tingling on the back sides in the rear of his tongue), HEADACHE (terrible headach), ARTHRALGIA (joints would start hurting) and INFLUENZA (going to come down with the flu for several hours). On 04-Mar-2021, ANXIETY (extraordinarily high level of anxiety), GAIT DISTURBANCE (walking), AGITATION (mental agitation with anger, or not feeling well) and HYPERVENTILATION (erratic performance, described as breathing sometimes like having run three miles after climbing) outcome was unknown. At the time of the report, DYSGEUSIA (recurring and metallic taste in his mouth), PARAESTHESIA (tingling on the back sides in the rear of his tongue), HEADACHE (terrible headach), ARTHRALGIA (joints would start hurting) and INFLUENZA (going to come down with the flu for several hours) outcome was unknown.        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.
ACHE; FEVER; HEADACHE; NAUSEOUS; BURNING SENSATION ON RIGHT ARM DOWN TO WRIST; This spontaneous report received from a patient concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 100.7 F. On 07-MAY-2021, the subject experienced burning sensation on right arm down to wrist. On 08-MAY-2021, the subject experienced ache. On 08-MAY-2021, the subject experienced fever. On 08-MAY-2021, the subject experienced headache. On 08-MAY-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation on right arm down to wrist on 07-MAY-2021, had not recovered from fever, headache, and nauseous, and the outcome of ache was not reported. This report was non-serious.
Provider gave patient 0.2ml instead of 0.3 ml.  Dr was called.  It was instructed to reach out the patient's parents to let know what has happened and ask if they can return today to clinic for the  remaining dosage. Parent has agreed to return to clinic.  Dr has given the remaining amount to be given to the patient to  RN ( dose drawer of the day).
second dose couple of days after first dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   In October 2021, the patient received the 2nd dose of Shingrix. In October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received 1st dose on 4th October 2021. The patient received 2nd dose of Shingrix vaccine a couple of days after being administered the first dose, which led to shortening of vaccination schedule. At the time of the report, the patient has had no symptoms. The reporter consented to follow up.
I had started PAXLOVID due to my wife being positive for COVID-19 on 06/22/2022 or 06/23/2022. I took the medicine as instructed for 5 days. Starting 07/04/2022, I had watery eyes and runny nose which is normal for me twice yearly. However, it persisted and because my wife was still testing positive for COVID-19, I tested myself and was positive on 07/05/2022. Then, the same day, I called my doctor and he put me on molnupiravir. I am currently taking that now and I'm on day 3 of it. I am feeling a little better now but still have a cough and fatigue.
"I" have swollen lymph nodes.; What should I do to help with pain; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 17Feb2021(at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 29Jan2021(at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 01Mar2021, the patient had swollen lymph nodes and lymph node pain. The patient did not know when his swollen lymph nodes would return to normal and what would help his pain. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph nodes and lymph node pain was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Aug2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) and on 21Jan2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing), notes: known allergies:  Penicillin; "MS" (unspecified if ongoing); "Ankylosing spondylitis" (unspecified if ongoing); "anemia" (unspecified if ongoing). Concomitant medication(s) included: TYSABRI, start date: Jan2011, stop date: 31Mar2022; TOPAMAX, start date: Jun2015; SULFASALAZINE, start date: Dec2021, stop date: 02Apr2022; COSENTYX, start date: 14Apr2022, stop date: 21Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "not recovered", COVID-19 (medically significant) with onset 07May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Negative, notes: tested negative 03May (6 days after original pos test); (07May2022) positive, notes: test positive on 07May. I'm still sick and positive on 11May; (11May2022) positive, notes: test positive on 07May. I'm still sick and positive on 11May. Therapeutic measures were not taken as a result of drug ineffective, covid-19. clinical course : Antiviral treatment of Paxlovid for COVID-19 were started from 26Apr2022 to 30Apr2022. Patient had recovered from COVID and tested negative 03May (6 days after original pos test) Then I felt sick again 3 days later and test positive on 07May. I'm still sick and positive on 11May.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 at 10:00 as dose 1, single (Lot number: EN6198), in left arm, on 23Mar2021 at 11:00 as dose 2, single (Lot number: ER2613), in right arm and on 03Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 30155BA) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Apr2022 at 11:00 as dose 4 (booster), single (Lot number: 002M21D), in right arm and on 07Sep2022 at 13:00 as dose 5 (booster), single (Lot number: AS7140C), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Oct2022, outcome "recovered" (03Nov2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Oct2022) Positive, notes: Tested Positive for COVID with antigen test 28Oct2022; (03Nov2022) Negative, notes: Tested Negative on 03Nov2022 and 05Nov2022; (05Nov2022) Negative, notes: Tested Negative on 03Nov2022 and 05Nov2022; (08Nov2022) Positive, notes: Tested Positive on 08Nov2022, 10Nov 11Nov, 13Nov, 15Nov, 17Nov2022; (10Nov2022) Positive, notes: Tested Positive on 08Nov2022, 10Nov 11Nov, 13Nov, 15Nov, 17Nov2022; (11Nov2022) Positive, notes: Tested Positive on 08Nov2022, 10Nov 11Nov, 13Nov, 15Nov, 17Nov2022; (13Nov2022) Positive, notes: Tested Positive on 08Nov2022, 10Nov 11Nov, 13Nov, 15Nov, 17Nov2022; (15Nov2022) Positive, notes: Tested Positive on 08Nov2022, 10Nov 11Nov, 13Nov, 15Nov, 17Nov2022; (17Nov2022) Positive, notes: Tested Positive on 08Nov2022, 10Nov 11Nov, 13Nov, 15Nov, 17Nov2022; (18Nov2022) Negative, notes: Tested Negative on Friday 18Nov2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Tested Positive for Covid with antigen test 28Oct2022 Started Paxlovid same day taken for 5 days.  Clinical course: vaccine received and no other medication with in 2 weeks.
Extreme swelling, pain and redness entire upper arm not reducing for 1 week. Fever, chills extreme weakness, muscle aches for 3 days. Unable to function, only able to lie down and rest/sleep for 3 days. Activate Asthma at 24hrs post injection, which had been well controlled needing nebulizer treatment.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient received a dose of GARDASIL injection (dose, route of administration, lot number and expiration date were not reported). Then, on an unknown date, the patient received a dose of GARDASIL 9 injection (dose, route of administration, lot number and expiration date were not reported). No adverse experience was reported. There was no product quality complaint involved in this case. Additional information has been requested.
FLUZONE HIGH DOSE QUADRIVALENT was administered post excursion with no adverse event; Initial information received on 19-Oct-2022 regarding an unsolicited valid non-serious case received from Nurse.  This case involves an unknown age and unknown gender patient to whom INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was administered post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at an unknown dose total (lot number, expiry date: not reported) via unknown route in unknown administration site for immunisation.  On an unknown date, fluzone high dose quadrivalent was administered post excursion with no adverse event (poor quality product administered) (same day latency).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Seizure, fever, diarrhea, bump where shot was given, rash, blood in stool, acting abnormal and fever lasted for 1 1/2 weeks. - Infants Motrin Drops was given for fever. - Blood work done at hospital
Brief seizure 15 min. after receiving vaccine-no prior illness, monitored and evaluated in office immediately after seizure, vitals stable, released to home with mother
Information has been received from a 40 year old male pharmacy technician with no pertinent medical history or drug allergies, who on 22-AuG-2007 was vaccinated with a dose of Recombivax HB. There was no concomitant medication. On 23-AUG-2007 the pharmacy technician developed a red spot at the injection site. No medical attention was sought. No labs or diagnostic studies were performed. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
pt recvd vax 26JAN93 @ 10AM & 530PM t104 & rapid heart beat;
rt upper arm 6 1/2 x 7 inch swelling & redness;it reports the swelling was worse last evening;A little tender;It hurts to raise arm, non itching;pt to use ice & observe;
Acute Guillian-Barre syndrome. Symptoms: numbness of hands and feet. Onset approximately 12/06/2001. Neurologist attributed to vaccine reaction. Treatment: 6 plasmapheresis treatments.
First Shot: Mild fatigue Second Shot: Mild fatigue and approximately 10 hours later convulsions with fever reaching over 100 degrees per oral testing.
I have been spotting ever since my covid shot and 3 days prior the skin peeled off of both my feet with layers of skin peeling off. I had to soak my feet to soften and lather lotion for weeks. I had such sever itching in different areas and had to apply hydrocortisone and numbing cream to alleviate the itching. I thought this has all been normal ?things? in my life?!?!? The spotting still has not stopped and my Pap smear was normal.
Fever started 48 hours after receiving MMR & VAQTA vaccines. Seizure on 1/30/10 and taken to ER. Transported to Hosp 1/31/10 for febrile seizures. Discharged home 1/31/10 - Rash stared 2/9/10.
Since the last check in, new diagnoses: chronic pancreatitis, postural orthostatic tachycardia syndrome (POTS), dizziness, fainting, muscle aches, low blood pressure.
Rt arm swollen and painful. The patient is a 4 year old male. Had pneumo and hib injection 3 days ago and yesterday arm was erythematous and swollen today it is more so and pruritic. No hx allergies. Child had 4 yr imm a few weeks ago and had similar reaction but not as large.
Skin reaction to Dtap on (R) thigh 7x9 cm area swollen, red, non tender but itchy.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ,  lot # K019372, expiration date: 16-JUL-2016 and lot# L000434, expiration date: 10-JUL-2016, orally, (dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
devel urticaria 30 minutes p/receiving 3rd dose of Imovax; treated w/DPH; several hrs later, devel SOB; recvd EPI, IV Solu-medrol & IV Cimetidine;
Superficial thrombophlebitis; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOPHLEBITIS SUPERFICIAL (Superficial thrombophlebitis) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history. ).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced THROMBOPHLEBITIS SUPERFICIAL (Superficial thrombophlebitis). At the time of the report, THROMBOPHLEBITIS SUPERFICIAL (Superficial thrombophlebitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The event Thrombophlebitis Superficial is NON-serious and not Medically Significant.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
A report was received from a health care professional on 11/06/03, concerning a 2 year old male vaccinee who received Fluvirin on 11/06/03. On 11/06/03, the vaccinee received a single of dose of Fluvirin intramuscularly. At the time of reporting the vaccinee did not exhibit any adverse symptoms from the vaccination. There was insufficient information to determine the reporter's causality assessment. Update 1, 05/10/04: Follow up information received from a health care professional indicated that the 2 year old vaccinee developed emesis and a temperature of 100.9 several hours after receiving Fluvirin on 11/06/03. Both events resolved on an unspecified date. The reporter indicated that the emesis and elevated temperature were possibly unrelated as when the patient was later examined he did have tonsillar hypertrophy without a high temperature. On 12/29/03, the patient tested positive for Influenza A. It was not reported if the vaccinee had recovered from the tonsillar hypertrophy and the Influenza A at the time of the report. There was insufficient information to determine the causality of the tonsillar hypertrophy and the Influenza A. Follow up pending.
Inflammation and pain in right hand and wrist increased. Blood was tested for rheumatoid arthritis and came back with none of the markers for RA. Xray was done on hand and is normal. Being referred to orthopedic.
Dizziness upon standing and walking, nausea, clamy and warm skin, sweaty, pale, tunnel vision, loss of acute memory, vision, and hearing. Patient was watched from 3pm (right after dose) to  3:30pm. He was feeling these symptoms from 3pm to about 3:15pm. He was given water after 5 minutes and cold wash rags to put on his forehead and neck. He was also told to breath deep breaths slowly. He said his throat felt sore and was provided with a throat lozenge. Color in his face returned after roughly 10 to 15 minutes and he verbally said he was feeling much better. Pharmacy associates watched him for another 15 minutes to make sure he was okay.
Patient itching in the throat approximately 20-25 min after recieving vaccine. pt did not report this at time of injection. Pt came back to site for second injection and reported the reaction during the screening. Pt was not given the second dose.
Hard of hearing; can hardly drive; This is a spontaneous report from a contactable consumer. A 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient called to ask what her appointment time on 03Feb2021 was to get the second dose of the Pfizer Vaccine. She has called several numbers and no one can tell her that. She was hard of hearing and has no computer. She can hardly drive, she needs crutches to walk. She was at the place she went to get the first Pfizer Vaccine. There at the condo where she lives was another person who called her and said in the afternoon at the Facility the Governor came on in the Place and said they did not need an appointment with these locations for the Pfizer Vaccine. There was nothing in the newspaper; so they ran out of the vaccine; she got Pfizer Vaccine at 11:45 which she was very happy of, but they had 2.5 hour delay; and she waited for 4.5 hours to get the vaccine because they ran out of the vaccine; but she was able to get the vaccine. Since then she has tried to find a phone number to call and she called the Facility but when she got through to someone who told her to get on the computer. She does not have a computer, can't afford a computer, does not want a computer and does not have access to a computer; cannot drive to the library to use a computer because she does not know how to use a computer. She has the vaccination record card but it just shows the date and was told to bring this back when she comes back, it does not have a time. A couple of the numbers she called just did not answer. She was spicy for an old lady and if she gets there and they tell her she has to have an appointment time she may have a nervous breakdown. The outcome of the events was unknown.  Information about lot/batch number was requested.
Patient began experiencing hives on face after vaccine administration. Benadryl 50 mg PO administered. Patient monitored for 30 minutes after administration and hives resolved. No other adverse reactions observed or reported. Patient ambulatory from clinic.
PATIENT CALLED INTO THE PHARMACY ON 9/21/17. SHE COMPLAINED THAT SHE WAS SLIGHTLY ITCHY ON THE INJECTION SITE AND RED. I TOLD HER THAT SHE MAY WANT TO CHECK IT WITH A DOCTOR JUST TO MAKE SURE. IT IS A POSSIBLE SIDE EFFECT OF ZOSTAVAX. THE ITCHING AND REDNESS STARTED YESTERDAY ON 9/20/17.