chrisvoncsefalvay/vaers-outcomes huggingface dataset:
For the first several days from the date that the adverse event started, it began with stuffy nose, clear nasal discharge, and occasional sneezing. This was thought to be just seasonal allergies. As time went on, same symptoms continued, but skin around eyes and on neck under the chin developed puffy, itchy, dry and slightly red rash.  The rash in these areas got bad enough for me to report to a local urgent care facility, and the doctor that saw me prescribed Clobetasol cream, 0.05%, to treat the rash areas. Currently on the third day of applying the cream, the rash appears to be almost completely gone, however, the stuffy nose, sneezing, and clear nasal discharge still persist.
States that when she got her first vaccination  -     Pfizer 4/15/2021 (left arm) - states that she just had some soreness at the injection site.  Shoulder hurt - felt like she had been working out - took Aleve. She could move it.   Put muscle rub on it.  Had some tightness in her arm that soon resolved and then it was OK.    When she had her second one on 5/6/2021 (left arm), states that it stung a little bit while she was waiting her 15 minutes post injection.     The next day, (when she got off at 2 am), her arm hurt.   She went to sleep.  When she woke, she said that it felt like someone had "cut it open and poured fire in it."  States that it is a stinging unrelenting pain.   States that she asked at work and was told to give it 72 hours and to alternate heat and ice (which she did).    Hurts from top of her shoulder down to her elbow.  If she keeps it bent, it does not hurt so badly (rates this pain 7/10) .  If she stretches it out, has pain in the same area (rates 10/10).  Abduction of the shoulder does not cause pain, only extending the arm and straightening the elbow causes pain.    Wearing a Tommy Copper elbow sleeve.  She is  working using both hands.  States that she can't hold a cup in her left hand.      States that she also had some N/V for a couple of weeks  that she did not think was due to the pain.  She treated that successfully with Phenergan.    States that the only medicine she takes is for hypertension.  She never had any trouble with that before.   Advised that this is not something we would expect from a normal vaccine reaction.  Advised that we have no one here to see her or to treat her.    Advised that she needs to see her PCP with a hands-on visit.     She says she has called her PCP and is waiting for them to return her call. She is going to ask to be seen today.
Headache, Arthralgia, NauseaVomiting, inj site pain, discomfort, swelling, chills, swollen glands, fatigue Narrative:
pt recv vax 5SEP97 & 19SEP97 pt exp only two lesions both on back;it was reported that initially the lesions looked like red dots & progressed to a pimple like appearance;the lesions took a long time to vesiculate but once they scabbed over This is in follow-up to report(s) previously submitted on 1/16/1998. Information has been received from a physician concerning a 3 year old male patient who on 05-SEP-1997 was vaccinated with VARIVAX. On approximately 19-SEP-1997 the patient experienced "only two lesions both on his back". It was reported that "initially, the lesions looked like red dots and progressed to a pimple-like appearance" and the mother thought "they were bug bites". The lesions took "a long time to vesiculate, but once they scabbed over, they looked like typical chickenpox". The scabs "stayed on the vaccinee for approximately 10 to 14 days". It was reported that one of the patient's sibling had a similar experience (WAES 97101013 and 97120340). No further details were provided because the reporting physician had no additional information. Subsequently the patient's experience was reported in a published literature article. It was noted that the patient had two lesions and transmitted varicella to his sibling. No further information is expected.
Patient  under vaccinated with less than half Moderna Bivalent Booster; given 0.05ml. No adverse symptoms. Disease control advised patient be revaccinated with full dose of vaccine.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history concurrent conditions and concomitant medications was not provided. On 12-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 300 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Arm has a bit soreness; Redness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm has a bit soreness) and ERYTHEMA (Redness) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm has a bit soreness) and ERYTHEMA (Redness). At the time of the report, PAIN IN EXTREMITY (Arm has a bit soreness) and ERYTHEMA (Redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
About 8 hours after the shot I got chills, fever, and extreme fatigue.  Lasted about 12-16 hours and then I was fine.  Arm soreness as well, for about 10 days.
p/vax pt devel pink macular lesions over forehead & cheeks; rash gradually faded; no tx
Information has been received from a registered nurse concerning a 12 month old female patient with no drug reactions/allergies or pertinent medical history, who on 06-OCT-2009 was vaccinated with a dose of MMR II (Lot number 664801/0764Y). Concomitant therapy included VARIVAX (Lot number 665103/1001Y). The registered nurse reported that the patient developed a 1 inch wheal at the injection site on the right thigh immediately after administration of MMR II. Patient was also given VARIVAX in the left thigh during the same visit. The patient was treated with BENADRYL. Subsequently, the wheal went away after 15 to 20 minutes. The patient sought medical attention during the office visit. This is one of several reports received from the same source. Follow up information has been received from the physician concerning a female patient with no drug reactions/allergies or pertinent medical history who on 06-OCT-2009 was vaccinated SQ/RT with a dose of MMR II (Lot number 664801/0764Y). There was no illness at the time of vaccination. "Minutes" after vaccination, the patient developed a dime sized urticaria wheal adjacent to injection site. No respiratory symptoms. The patient was given 2.5 ml of BENADRYL. Subsequently 10 minutes later the rash resolved. No further information is available.
I had the 2nd vaccine on Thursday afternoon.  My arm was sore but that was it.  Then I woke up in middle of the night (3:00 am) Friday night/Saturday morning and noticed an itchy spot that felt like a mosquito bite.  I went back to sleep and when I got up around 7 I was itchy in several spots and had welts.  I had them on my left hip and part of stomach, on the right side under bra band, my left thigh, and my right arm.  it is not where the shot was, it is under part of arm from underarm to almost my elbow.  These all started about quarter size and are now as big as my hand or bigger.   One also came up on top of left shoulder but it is still small,  that one just came up around 7 pm.  And my lip swelled up a little around 5 pm but just on one side of top lip.  All of these welts are very itchy.
Very swollen lymph nodes around lower neck and clavicle bone area (swelling is much more pronounced on left side- looks like a golf ball). Pain radiates to left side of scalp, ear, shoulder, arm, forearm and ribs. Clavicle bones and upper back hurt on 12/30. It I did not notice the swelling until Friday 12/31.
Initial health care professional report received on 01 Dec 2009: The patient had received FLUVIRIN (batch no: 102042P1) intramuscularly on an unspecified date in Nov 2009. The patient complained of pain at injection site that began at day of injection and continued at the time of report. The patient also developed a knot it palpable at injection site in left deltoid. The outcome for event knot it palpable at injection site was not reported.
This case was reported by a physician via call center representative and described the occurrence of fever in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 4th March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The physician on the line stating the patient who got SHINGRIX the day before reporting and had a 101 degree fahrenheit fever. The lot number or expiry date was unknown. No further information captured.
Monovalent mRNA vaccine administered for a bivalent mRNA dose.  I hadn't been made aware that the monovalent vaccine had had it's EUA revoked by the FDA at the time of this vaccines administration..  My supervisor received e-mail notification from our health department on 05/02/2023 with a Department of Health and Human Services update for immediate release to Covid-19 vaccines. This update simply stated that individuals that were previously vaccinated with monovalent Covid-19 vaccines and who had not received a dose of Bivalent vaccine could receive a single dose of bivalent vaccine.   The press release/ immediate release (dated 05/01/2023) did NOT state that the EUA had been revoked  on 04/18/2023.  I received the e-mail forwarded to me  on 05/03/2023 which I then destroyed the remaining MDV of Pfizer monovalent Lot FP7136 vaccine.   This patient did NOT suffer any type of adverse reaction or event.    This patient was notified of this occurrence but declined  the bivalent vaccine when offered.   This patient was released from custody on 05/20/2023.
Initial information received on 14-Jun-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 12 months old patient who was vaccinated with a dose of QUADRACEL (batch number, expiry date, route and site of administration were not reported) instead of PENTACEL (batch number and expiry date were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. No adverse event was reported. 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 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. Documents held by sender: none.
patient received a double dose of the booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (patient received a double dose of the booster) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.    On 09-Nov-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 09-Nov-2021, the patient experienced EXTRA DOSE ADMINISTERED (patient received a double dose of the booster). On 09-Nov-2021, EXTRA DOSE ADMINISTERED (patient received a double dose of the booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Information has been received from a 54 year old female with no pertinent medical history and no drug reaction/allergies who was vaccinated (approximately 20-SEP-2011) with RECOMBIVAX HB 10 mcg/mL. There was no concomitant medication. The patient reported that following administration of the first dose of RECOMBIVAX HB, on approximately 20-Sep-2011 ("approximately three weeks ago"), she experienced injection site soreness and warmth within hours following the vaccination. The patient also reported that she began to develop headaches approximately two days after receiving the vaccine (on approximately 22-Sep-2011), and a twitch in left lower eyelid approximately one week following the vaccination (on approximately 27-SEP-2011). No lab diagnostics studies were performed. The patient did not seek medical attention. No treatment given for the events. At the time of reporting, the patient was recovering from all reported adverse events. Follow up information has been received from the physician who said this was not one of his patients. Additional information has been requested.
For a few days (7-10) I had pain in my scalp.  It was bothering me for days, aching, sore, tender to the touch, it really hurt.  Parting my hair it looked red on the left side of my head.  Eventually it went away.  Didn't realize it could have been a side effect of the Shingles Vaccine.
This spontaneous report was received from a Registered Medical Assistant (R.M.A) concerning an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (Lot # K010224; expiration date: 11-DEC-2016) orally (dose and anatomical location of administration were not reported). The temperature excursions reported were: 34.7F for 2 hours 23 minutes; and 53.2F for 1 hour 27 minutes. There was no previous temperature excursion. Digital data logger and product quality complaint were not involved. No adverse effects were reported. This is one of two cases from the same reporter. Additional information has been requested.
Information has been received from a medical assistant concerning a female patient who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (lot# 665300/1314Y or 663012/1163X). Subsequently the patient developed cellulitis and went to the Emergency Room. It was reported that the patient took two unknown antibiotics. At the time of the report, the outcome of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
There was no immediate adverse effect after vaccine, but on March 14, 2022 during my daily walk, I started experiencing discomfort in my left leg. It felt like my muscles were pulling. It quickly worsened into pain and swelling from my knee down to my foot. The next morning, I was not better so I went to an urgent care. The doctor examined me and suspected that it could be blood clots. The ultrasound confirmed that by showing 3 blood clots located in my left leg. They started me on Xarelto while in the ER. I have been on that since March 15, 2022. The doctor said that I will need to be on Xarelto for at least 6 months and more than likely forever. My vital signs and chest was clear so they sent me home. 3 days later I saw my PCP for a follow up. Since there was no reason as to what caused these blood clots I wanted to see a hematologist. I saw the hematologist on March 31st. He examined me and ordered a series of blood test to evaluate the blood clotting factors and genetic mutations. I was told it could take 2 weeks to get these results. I have a follow up with the hematologist on July 5, 2022. I had ongoing pain and swelling in my left leg so I wasn't able to walk normally. The hematologist told me to wear compression stockings.
Diagnosed with Herpes Zoster (Shingles) by Dr. (a self described Infectious disease expert!) on 12/02/2017 at Urgent Care. Dr. prescribed VALTREX. Received the 1st stick of TWINRIX on 11/15/2017 at Primary Care by PA. The first symptom of burning/itching noticed on upper right back sometime on or about 11/20/2017.  Few days later noticed tenderness in right breast. Rash appeared on or about 11/28/17 on upper right back and chest.
Information has been received from a physician concerning a patient who in approximately 1996 was vaccinated with a first dose of varicella virus vaccine live. On approximately 05/15/2000, the patient developed a "severe case of chickenpox including a high fever that resulted in being absent from school for 1 week and loss of work for his parents. The patient sought unspecified medical attention. Subsequently, the patient recovered. The patient's brother had a similar experience following exposure to varicella virus vaccine live.
At 1140 on 5/5/15, pt returned to MD office with c/o Left arm swelling, mild discomfort, irritation, LGF, itching and redness where vaccine was administered.  Pt also had headache.  Pt had no other symptoms. MD instructed pt to apply ice to the area on arm affected, take acetaminophen prn for pain and take Claritin 10mg PO q12h prn for itching.  Pt was instructed to return to MD office if symptoms worsen or fail to improve.
Friday evening right arm swollen, hot, and red. Could not sleep.  Got up Sturday morning with chills and 102.4 fever.  Took aspirin.  Called school nurse.  She called back in afternoon and told me to call my doctor.  I called him and he told me to take 600 mg ADVIL every six hours and to continue the fluids.  I have been doing this since Saturday evening.  My are is still red, tender, and a little warm.
Patient was given a Gardasil vaccine and a flu vaccine during his appointment today. Patient was given the Gardasil while sitting on the exam table. Patient then stood up and went over to his chair. When he went over to his chair, his mother was reading the VIS to him. The patient's mother reported that the patient's eyes rolled back in his head and he had twitching. Patient's mother came out of exam room and alerted the staff that "there is something wrong". Patient had slid of the chair in the exam room as I was entering the exam room. It took several seconds for patient to be able to focus on the providers. PA-C and Dr. responded. Patient was moved to the exam table. A cool compress was applied to his forehead and neck. Dr. and PA-C checked patient's heart rate several times. They then applied a pulse oximeter for continuous monitoring of his pulse. Patient did eat a pack of animal crackers and drank a small cup of water.
Slight headaches; Fever of 100; Chills; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever of 100), CHILLS (Chills) and HEADACHE (Slight headaches) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes mellitus. Concomitant products included METFORMIN for Diabetes mellitus, LOSARTAN for Hypertension, PANCRELIPASE (ZENPEP) for Pancreas disorder.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PYREXIA (Fever of 100) and CHILLS (Chills). On an unknown date, the patient experienced HEADACHE (Slight headaches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, PYREXIA (Fever of 100), CHILLS (Chills) and HEADACHE (Slight headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 100 (High) 100 F.     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.   Treatment information included advil.
C/O pain down whole right arm post-immunization; started immediately after she was given the shot. However, it was better the following day. Today C/O pain down whole length of arm worse with movement. She took Advil but it didn't help. She will try heat when she gets home.
got both doses of Shingrix, has shingles/suspected vaccination failure; has shingles that's starting now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 03-APR-2022 Reporter's Comments: This case was received from patient's son/daughter via interactive digital media. The patient got both doses of Shingrix vaccine about 5 years ago but had shingles that was starting now. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Within 12 hours had severe chills with body shaking tremors, fever of over 100 degrees,  body aches, head ache and difficult to walk. Body shakes lasted two hours until the Tylenol kicked in. Body aches and head ache lasted another 10 hours or so.
Expired Twinrix administered/inadvertently administered an expired Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 24-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th February 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 25th February 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comments: The reporter inquired whether the patient should be revaccinated or was it was still good. The reporter did not give the consent to follow up. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used.