chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Middle finger on right hand and on left hand ring finger became bit swollen and bit painful; Middle finger on right hand and on left hand ring finger became bit swollen and bit painful; Knee pain; Sinus infection; This spontaneous case was reported by a patient and describes the occurrence of SINUSITIS (Sinus infection), PERIPHERAL SWELLING (Middle finger on right hand and on left hand ring finger became bit swollen and bit painful), PAIN IN EXTREMITY (Middle finger on right hand and on left hand ring finger became bit swollen and bit painful) and ARTHRALGIA (Knee pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2022, ADALIMUMAB (HUMIRA) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. In March 2022, the patient experienced SINUSITIS (Sinus infection). On an unknown date, the patient experienced PERIPHERAL SWELLING (Middle finger on right hand and on left hand ring finger became bit swollen and bit painful), PAIN IN EXTREMITY (Middle finger on right hand and on left hand ring finger became bit swollen and bit painful) and ARTHRALGIA (Knee pain). At the time of the report, SINUSITIS (Sinus infection), PERIPHERAL SWELLING (Middle finger on right hand and on left hand ring finger became bit swollen and bit painful) and PAIN IN EXTREMITY (Middle finger on right hand and on left hand ring finger became bit swollen and bit painful) was resolving and ARTHRALGIA (Knee pain) had resolved.            No concomitant medications were provided. No treatment medications were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
tingling in her face on one side; This non-serious case was reported by a physician via sales rep and described the occurrence of tingling in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   On an unknown date, the patient received Arexvy, FLU VACCINE (NAME UNKNOWN) and COVID 19 VACCINE. On an unknown date, an unknown time after receiving Arexvy and an unknown time after receiving FLU VACCINE (NAME UNKNOWN), the patient experienced tingling (Verbatim: tingling in her face on one side). The outcome of the tingling was not reported.   It was unknown if the reporter considered the tingling to be related to Arexvy.     It was unknown if the company considered the tingling to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-OCT-2023 The patient was in her 80s. The patient was vaccinated at pharmacy with covid, flu and Arexvy at the same time. The patient reported tingling in her face on one side. Doctor was wondering if the combination of these 3 vaccines (covid, flu and Arexvy) caused the side effect. It was unknown if the reporter considered the tingling to be related to Covid vaccine and Flu vaccine.    The reporter consented to follow up. This case was linked with US2023AMR147002, same reporter different patient.; Sender's Comments:  US-GSK-US2023AMR147002:same reporter
Facial numbness, onset approximately 45 minutes-1 hour after vaccine dose. Not full numbness, still had some feeling but was very concerning. Worst numbness started to subside after about 1.5 hours but linger effects lasted until bedtime (5 hours) and were mostly gone after waking up the next day.
Within 20 minutes of vaccine I developed heavy, pulsing, constant chest pain. I went to the emergency room where they performed an EKG and chest x-ray and admitted me to the cardiac unit.
This spontaneous report was received from a licensed vocational nurse and refers to an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with improperly stored PNEUMOVAX23 (route of administrations, doses, lot numbers and expiry dates were not reported). It was reported that the vaccines were exposed to worst case 85F for 42.5 hours. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Case number PHEH2014US025349, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to an 87 years old male patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the right deltoid on 20 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error.
The 5-11 vaccine was not diluted prior to administration. No side effects or adverse effects reported by caregiver.
Went into A-Fib 2 days after receiving vaccine.  The heart rate variability recorded by my apple watch jumps 5 fold and has stayed at that level since. Had a regular heart rate before and no heart problems
16 year old male started oral vaccination against typhus with Vivotif on 06/26/2005, 3 days later, on 06/29/2005 the patient developed fever with glassy eyes, severe headache, faint, increased skin sensitivity and body aches.  The reported symptoms required an emergency room visit.  The patient recovered and all symptoms resolved with sequelae.
I am a volunteer and an RN. I received the vaccine as part of my pre-employment readiness. I am with my spouse overseas. I received the vaccine from the treatment facility.  I developed and itchy, red circular non-elevated, non-pustular rash near the injection site. It was very, slightly tender and swollen. My injection was bruised so I knew where it was. That pain from the injection and bruise diminished in 3 days post-injection. The rash developed next to the injection site. It started on day 7 after the administration and faded in about 36 hours. No other allergic-type reaction.
The form did not provide a place to enter the date of both doses of the vaccine.  The dates were: Covid-19 (Pfizer-BioNtech), given in right arm.  1st shot:  Lot # EN6198, time of vaccination unknown; 2nd shot:  Lot # EN6207, time of vaccination unknown.  On April 19, patient complained about left shoulder pain and went to see her general practitioner.  Tests were done to rule out heart issues.  On April 20, she called 911 and went to one of the two local hospitals, complaining of shoulder pain.  After an xray, the diagnosis was given as tendonitis and she was sent home and instructed to take 500mg Ibuprofen morning and evening.  On April 23, a rash became apparent on her left arm.  She had a follow-up appointment with her GP on April 27 and was  diagnosed with shingles.  She continued to get more uncomfortable and confused, and late on April 29,  a neighbor took her to the other local hospital where she was admitted.  A lumbar puncture test confirmed that she had herpes zoster virus in the spinal fluid.  She was treated in the hospital with acyclovir by IV and was released from the hospital on May 4 to a skilled nursing facility where she rehabilitated until May 14, when she was sent home.  She continues to be somewhat confused and has difficulty thinking of words - much more so than before her shingles episode.
Report 2001025056-1 describes an infection at the injection site in an 18 month old male who received an injection of Infanrix. This report was received from the vaccinee's father and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not specified. On 10/09/2001, the pt received his first injection of Infanrix. Approximatley sixteen hours post-vaccination, the pt developed a "red nickle-sized circle" on his leg about two inches below the injection site. The next morning, 10/10/2001, the redness increased in size to about 3.5 inches and was "giving off heat." On 10/11/2001, the pt was seen by a physician, who reportedly made a diagnosis of infection at the injection site and prescribed Keflex.
This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 11th February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue (serious criteria disability), feeling unwell (serious criteria disability) and general body pain (serious criteria disability). On an unknown date, the outcome of the fatigue, feeling unwell and general body pain were recovered/resolved. It was unknown if the reporter considered the fatigue, feeling unwell and general body pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced fatigue, body aches and feeling very sick for 2 months following SHINGRIX administration.
No adverse event; Pediatric patient received a 2nd booster dose from a vial with dark blue cap and a label with a purple border- Monovalent; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient received a 2nd booster dose from a vial with dark blue cap and a label with a purple border- Monovalent) and NO ADVERSE EVENT (No adverse event) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient received a 2nd booster dose from a vial with dark blue cap and a label with a purple border- Monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient received a 2nd booster dose from a vial with dark blue cap and a label with a purple border- Monovalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient received a 2nd booster dose from a vial with dark blue cap and a label with a purple border- Monovalent).    Concomitant product use was not provided by the reporter.  No treatment information was provided.
Initial unsolicited report received from a pharmacist on 27-Oct-2015. This case involves a 72-year-old female patient, who was vaccinated with a dose of FLUZONE HD (batch number- UI489AA, expiry date- 02-Jun-2016, route and site of administration were not reported) on 26-Oct-2015. Medical history and concomitant medications were not reported. Illness at time of vaccination was not reported and Pre-existing physician diagnosed allergies, birth defects, medical conditions included sulfa allergy. On 26-Oct-2015, same day four hours after vaccination, the patient had passed out while walking in neighborhood and also felt dizzy. It was reported that patient was referred to her own HCP for evaluation and treatment. Laboratory investigations and corrective treatments were not reported. As of 27-Oct-2015, the patient continued to be dizzy and was not recovered from the events. Upon medical review, the case was considered as serious due to important medical event: passed out. Follow up information received from pharmacist on 23-Nov-2015. The patient followed up with her (primary care physician) PCP on the same day. It was reported that the immunization was not responsible for syncope, prescriber had apparently altered hypertension therapy and determined an adjustment in patient's hypertension therapy medicines was responsible for the event. Documents held by sender: none; Sender's Comments: Follow up information received on 23 November 2015 changes the assessment: Syncope is listed with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Time to onset is compatible with a role of vaccination. The immunization was not responsible for the event syncope and an adjustment in her hypertension medications was the reason for the event.This case is poorly documented. Additional information regarding patient's medical history such as neurological pathologies as well as clinical and biological workup, previous vaccinations and their toleration, are needed to further assess the case. Bases on available information, case not fully assessable.
Client reported after taking first oral dose as ordered she developed rash to right side of face. Took the 2nd pill after skipping a day and the rash traveled to the left side of face and to neck. No itching or other symptoms.
within hrs of vaccination with AVA began to notice arm swelling, redness and discomfort. Sought care the following day, given steroids with resolution of sx within a couple of days. Swelling did not extend past deltoid. Did have LLR with previous AVA admin between 2003-05.  Symptoms: EDEMA, UNSPECIFIED(R609), OTHER ERYTHEMATOUS CONDITIONS(L53).
About an hour after vaccine my eyes started hurting....got worse....felt like they were on fire; eyes were swollen and bloodshot within 1-1/2 hrs of vaccine; vision blurry.  I applied cool/cold compresses rest of day and throughout night; took Tylenol .  By next morning eyes were better but still a little bloodshot. And also  had an ache behind the eyeball area.  Took more Tylenol and eyes continue to improve that day.
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Pt. pale, vasovagal syncope placed in supine position with legs elevated. Aroused right after placing pt. on floor with legs elevated. Placed cool towel on forehead. B/P, pulse, respirations-WNL. Left H.D. at 4:10 walking, talking with sunglasses on. Parents with her today and taking her home.
Shortly after injection feelings of dizziness and nausea while standing. Symptoms began to intensify within 5 minutes therafter, leading to blackout. Came to senses shortly after, drank some water. Light headedness and headache remain 2.5 hours after injection.
Fatigue Narrative:  Went to work for a few minutes -- really tired. Fellow employee said she should go home or be reported. First shot had a sore arm & a bit of a cold for a few hours and back to work. This time has sore arm and is more tired than usual. 98.7 F No cough, HA, N/V. No medications taken for s/e.
Started shaking about 10:30 PM.  I then got very cold.  Slept with four blankets.  Didn't sleep well.  Developed a headache and body aches.   Head hurt so much that when I stood up in the morning I almost vomited.  Went back to bed-bad headache and achy.  Tried to get up again about noon.  Tried to eat some yogurt.  Couldn't finish it.  Felt the same crappy way.  Went back to bed.  Got up about 5 PM.  Was able to eat then and started to feel better.
Pt was given 5-6 doses of Pfizer vaccine on 5/17/21.  Patient had no symptoms
pt recvd vax; exp abdo cramping,pain,nausea,vomiting p/ flu vax;hosp on 24dec93 & dx w/ acute GBS;exp full paralysis for 5 mo & then partial paralysis since may94;
Pt states getting a rash within 24 hours on face and head.  This rash he says is similar to the rash that develops when he eats gluten. Then today, he notices a "shingles-like" rash in his inner thigh on morning on 8/18/22. He alleges it's a shingles-like rash because he has shingles before
onset was day after flus shot; inc dizziness, inc weakness, headache, diplopia; pt was dx w/ esophageal cancer w/brain mets while in hospital;
Rash within 24 hours of 2nd shot.  Lasted 12 hours until I took liquid Benedryl. 5 weeks after 2nd Covid shot,  sudden onset of hearing loss. Tinnitus. Went to primary care doctor. 1 week of oral steroids. Sent to ENT doctor. Audiology tests showed hearing loss right ear. Put on 1 week of oral viral medication   No help. Had MRI. No pathology present. Hearing loss and tinnitus still present 4 months later.
This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 16-year-old female patient received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for an immunization. The patient medical history was not reported. There were no concomitant medications. The patient had a very high fever after administration of first dose of meningococcal group b rlp2086 with temperature of 103 Fahrenheit. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
I caught something from someone not sure what it was , that let to pneumonia and then it went to infection in the lungs. I had mucus at the bottom of my lung, they changed my medication and gave me an inhaler.
The pt experienced a 50 cent piece sized reaction, color change, flaking of skin, irritability and a knot.
Pt developed headache after vaccine.  He has history of recurrent headaches, 2-3x per week, treated at home with Tylenol.  Headache today is 5/10, right sided, pressure, similar in character to his chronic recurrent headaches.  No nausea, no vomiting.  No respiratory symptoms or swelling.  I offered him Tylenol during his waiting period, and he accepted.
Severe hives all over body, beginning 14 days after 3rd shot (Booster). RX antihistamine required for 3 months to get the urticaria under control, with occasional wheals observed still. OTC antihistamine taken 2-3x week to control chronic urticaria.
arm sore; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet regarding a case in litigation for zoster vaccine live (ZOSTAVAX) (2101USA009217), referring to an elderly male patient.  Information about medical history, concurrent conditions and concomitant therapies was not provided.   On 15-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced arm sore. The outcome of the event was unknown. The causality assessment was related.  This case was split from a legal case regarding the same patient.
tired after the first one but not really; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 39 year-old male patient received bnt162b2 (BNT162B2) (Lot number: EW0185, Expiration Date: Aug2021) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired after the first one but not really".  Additional information: number of Covid-19 Vaccine was unknown. Reporter stated 3 weeks ago he took his first dose of Pfizer, after this first dose he said he was tired.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021738239 similar report from same reporter
Sudden onset of complete numbness of hands and feet bilaterally approximately 5 weeks post 2nd vaccine shot.   Symptoms have not improved.  She did have covid 19 in I believe in February or march of last 2020.
fever, nausea, vomiting, weakness onset; approx 6 hrs p/inject; duration 48 hrs; no treatment;
The liver enzymes went from 50's to 500 approximately two weeks after the shot. AST was 306, and ALT was 524. The baseline ALT was 77 and AST was 29.
Dark, granular diarrhea w unusual, intense odor Fever Fatigue Headache
I had blockage or fluid in my right ear, I saw my doctor on 12/09/2022. I had no fever but I had sinus blockage on my right side as well. Doctor noted amber fluid noted behind right ear.
After dose 1 my period for that month was skipped. After dose 2 my period came early and has been unrelenting. I am know on day 22 of bleeding. This duration has NEVER happened in all my life!!!!! Not only am I bleeding for an unhealthy length, it is very heavy bleeding with terrible cramping and clot sloughing unlike I have ever seen.  THIS IS NOT SAFE FOR A CHRONIC ANEMIC!
Can not seem to gain any energy back.; Headaches; Severe exhaustion for 3 days after plus heightened previously existing conditions; Loose stool; This is a spontaneous report from a contactable other health care professional. A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the left arm on 09Mar2021 at 12:45 (at the age of 34-years-old) as a single dose for COVID-19 Immunisation. The patient medical history included gout, chronic depression, HF (high functioning) anxiety and BPD 2 (borderline personality disorder). The patient concomitant medications included colchicine (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 09Mar2021 at 15:30, the patient experienced loose stools, headaches, exhaustion for 3 days plus heightened previously existing conditions. After 7 days, severe exhaustion and heightened conditions continues, coming in waves. It was also reported that the patient could not seem to gain any energy back. The patient did not receive treatment for adverse events. The clinical outcome of the loose stools, headaches, exhaustion, condition aggravated and loss of energy were not recovered.   No follow-up attempts are needed. No further information is expected.
Moderna COVID-19 Vaccine EUA itchiness and what looked like hives (small raised light colored bumps and redness around them) at the injection site. resolved in approx 24 hours.
Redness, warmth, swelling, measured 4 inches h x 3 1/2 inches w and burning.
after injection, less than 24 hours i was having leg cramps and charlie horses in both legs; i purchased bayer aspirin 81 mg low dosage pills and within 2 days the cramps stopped; but, if i do not take the aspirin on a daily basis the cramps in both legs will resume along with charlie horses
Severe injection site swelling 4 hours after until 21-Jan 15:00 Severe body aches and overall malaise 19-Jan 12:00 until 21-Jan 22:00 Migraine headaches 20-Jan until 22-Jan
Patient has a swollen ankle that has consistently bothered her. She could barely wear a shoe. The pain started right after the shot. She stated it is slowly getting better but has greatly affected her way of life. Patient also stated she went to the doctor and they stated that it was the vaccine that gave her the side effects.