chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tiredness and fever began on 3/1.  On 3/2/21, patient had phelgm in her lungs but unable to cough up.  She was admitted to the hospital on 3/4/21 and stayed for 5 days.  Patient was at the Pali Momi Medical Center in Aiea, HI.
At the injection site, there is a firm round mass under the skin that is tender to the touch. Otherwise, it doesn't bother me. The mass is about the size of a half dollar coin (2.5 cm)
Within 48-72 hours following vaccine receipt, patient noted swelling, redness, itching, warmth, and tenderness surrounding anthrax vaccination site.  She tried applying ice to the area to reduce pain and swelling, but felt it was not effective. The area affected went from her vaccination site to her elbow and was almost encircling her whole upper arm.  By 3 Sep, there was no significant improvement at her vaccination site, so she sought evaluation. Patient denied hives, fever, sore throat, cough, difficulty breathing, hoarseness, lump in throat, enlarged lymph nodes, headache, chest pain, abdominal pain, nausea, vomiting, diarrhea, difficulty with urination, and joint pain. On exam, the skin was described as: Warm and dry. Normal color. No rash. Normal turgor, small area of erythema with tenderness and warmth to right arm. No swelling or lymphangitis.  She was diagnosed with normal reaction to anthrax vaccine.  Acetaminophen or Motrin were recommended. On 5 Sep 2019, patient returned for medical evaluation after there was no significant improvement of her RUE. She reported redness, warmth, itching and tenderness affecting vaccination site on RUE. She denied fever, chills, headache, sore throat, skin rash, enlarged lymph nodes, abdominal pain, nausea, vomiting, and diarrhea. On exam, description of extremities noted:  Upper extremity signs of infection present (Right deltoid (faint erythema), No purulent drainage, serous drainage, lymphangitis, or fluctuance. No axillary adenopathy. Upper extremity capillary refill no prolonged.  She was diagnosed with right deltoid/bicep cellulitis, and was prescribed Keflex, Motrin and Benadryl.  Patient does not recall when RUE returned to normal, but it was by the end of the second week in Sep 2019. Patient denies significant restriction or limitations of ADLs and work-related duties due to vaccine reaction.
This spontaneous report as received from a registered nurse, refers to 10 patients of unknown age and gender, who on an unknown dates, were vaccinated with a doses of RECOMBIVAX HB (doses, routes and lot numbers not reported), that were exposed to 23F for 268 hours. The product was unsupported by in-house stability data for this temperature excursion. No adverse symptoms reported. This is one of several reports received from the same source (related MARRS #1305USA013465, #1305USA016228). Additional information has been requested.
Patient called complaing of redness at site of injection and pain with lifting arm but not pain in shoulder.  Patient also stated she had a fever
aches; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches), CHILLS (chills) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced MYALGIA (aches), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, MYALGIA (aches), CHILLS (chills) and PYREXIA (fever) outcome was unknown. No treatment information were reported by the reporter. This case was linked to MOD-2021-389054 (Patient Link).
Pt was sitting, conversing when suddenly pt head jerked back, hit head on wall, slumped to left convulsed 3-4 more times. Pt was moved to floor to raise legs up and resumed consciousness but had slurred speech, confusion. Got VS, Bld Glu and monitored, transported to ED for eval.
Fever, 101.3 - 101.9F, ongoing currently for 12-24hrs. Headache ongoing with no response from Advil.
Soreness at injection site; sharp pains in the chest resembling that of a full blown hiatal hernia acid reflux attack; General malaise did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of   in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (esophageal) (Acid reflux periodically).    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 07-Feb-2021, the patient experienced general malaise did not feel well and sharp pains in the chest resembling that of a full blown hiatal hernia acid reflux attack which were recovered on 08-Feb-2021. On 08-Feb-2021, the patient had sore at injection site which is ongoing. Treatment medication included milk of magnesia to relieve sharp pains in the chest resembling that of a full blown hiatal hernia acid reflux attack.
Joint pains in knees elbows and shoulders for about 4 weeks pain in the left knee to the point where I could barely walk. Started taking glucosamine and chondroitin and MSM. One day after taking vitamins. started feeling much better all symptoms cleared up one to two weeks after second shot of covid-19 Pfizer. Feeling good now able to go to the gym and start working out again.
9:00am pt with vital signs (137/89), pt in complaining weakness, nausea, shivering. Keeping in observation. Pt denies any history of disease or current medication.
fever; chills; sore arm; This is a spontaneous report from a contactable consumer a Pfizer sponsored program with Regulatory Authority Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation.  Medical history included covid-19. On 18Mar2021 at 04:30, the patient experienced fever, chills and sore arm.  Therapeutic measures were taken as a result of fever. The patient stated the symptoms started at 430 this morning and she experienced Fever, chills, sore arm and now is starting to feel better. She stated she had Covid prior to the 1st dose and the nurse told her that she would be probably feel like this. She took tylenol to help with her fever. There were no unaddressed medical questions referred or forwarded to Medical Information. Outcome of the events were recovering.   No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Persistent pain in left deltoid muscle after receiving 2nd COVID vaccination shot. Pain began in sometime in May 2021 and has not subsided since.
On April 8, 2021, 19 days after the vaccine, I started experiencing COVID symptoms including a stuffy nose, headache, body aches, fatigue.  On April 12, 2021 I tested positive for COVID.  On April 13, 2021 I had a severe headache and doctor advised me to take a baby aspirin daily to avoid possible blood clots.
Arthralgia, Fever,  temperature 101.2F; body aches Narrative:  took Aleve for fever
Painful axillary lymphadenopathy on same arm as injection. Family would like to note that same reaction as triplet monozygotic sister. Fraternal triplet brother without reaction.
Acute pain in left arm at injection site.  Could not lift my arm.  Swollen, red, itchy.  Eyes swollen almost shut, swollen mouth/lips.  Severe joint aches, throbbing pain in abdominal cavity.  Extreme fatigue.  Unable to move without severe pain everywhere.  Tylenol did nothing to relieve pain.  No energy.  Acute symptoms lasted 48 hours.  Continued into third day.  Could finally lift my arm day 3.  Again, extreme fatigue.  Heart flutters and jittery (probably A-Fib) was severe day 3 in the morning.  Still feeling tired today (5/3/22).  Spoke with a cousin who had Covid and she said my symptoms were exactly what she felt.   While I had migraine headaches with the first Moderna shot, and throbbing pain in my abdominal cavity with the second shot, I had very little discomfort with the first booster.  THIS?  God awful!  I'm inclined to NOT do another.   Question:  Was a different carrier used with this booster?  I clearly had an allergic reaction.  My husband just had a sore arm.
Narrative: 88yo male with new diagnosis of AFib & hx of htn, CKD, HLD, cad, etoh abuse, BPH, goat, acute kidney failure, peripheral edema was vaccinated with covid vaccines on 1/15/21 & 2/12/21. On 5/25/21 pt died. No information available about patient's death. From notes, patient had outside cardiologist after diagnosed with AFib from ER visit on 12/14/2020. Not able access if pt's death was related to covid vaccinations.
45min p/vax pt exp n/v, h/a & dry mouth;pt was taken to ER;
First dose of vaccine gave me allergy (throat closing) have to take allergy medicine and got better. Second dose: next day body aches and fatigue. A few days later started to have a bad headache and left shoulder pain. Left arm started to get numb, after left side of the face and last left leg. Blood pressure was high and went to ER were they kept me overnight to ensure I was not having a stroke.
The pt was diagnosed with shingles. Her hip started to hurt. Yellow Jacket stinging, got rash, then  herpes zoster. Treated with anti viral medication. Not vaccine related.
AFTER RECEIVING 2ND DOSE OF SHINGRIX ON 10/18/2018, A RASH DEVELOPED FROM NECK AND CONTINUED TO SPREAD ALL OVER ARMS AND LEGS 2 DAYS LATER. THE RASHES WERE SPLOTCHY. PATIENT WENT TO SEE DOCTOR AND WAS TOLD TO TAKE CLARITIN AND BENADRYL. RASH WAS SEEN TO BE RESOLVING AS OF 11/2/2018.
Patient  Called on 11/02/2022 @  09:50 am and stated that he started to not feel well around 5 pm on 10/31/2022 after his vaccination. Patient stated that he vomited around 10 pm on 10/31/2022. Patient stated that he felt like he could not walk and that it progressed overnight on 10/31/2022. Patient stated that he had to call someone to come and help him get up.  Patient stated that he did not have a fever or a rash. Patient stated that he had never had a reaction to any other vaccines in the past and will not get the 2nd dose of the Shingrix due to this reaction.  Patient stated that he did not go to his physician or the hospital in regard to this reaction.
Lymph-nodes on left side of body became inflamed, spleen became enlarged causing severe discomfort in thoracic cavity and abdomen. Fever, Intense Headache, blurred vision, impaired judgement and vomiting. Course of treatment bed rest for two weeks with hydration and nutrition focused on spleen health.
Episode of severe vasovagal syncope about 5 minutes following the vaccines Patient lost consciousness, fell backwards and hit her head, and had a period of nystagmus and agonal breathing She regained consciousness within a minute or two and did not require rescue breathing or resuscitation although oxygen was applied and her legs were elevated. She was taken to the ER via ambulance.
Initial report received from a physician on 4/7/06. An eight month old patient (gender not reported) with no significant medical history and no illness at the time of vaccination developed a fever of 103-106 degrees F, four days after receiving the IM injection of the third dose of Daptacel, lot number C2407AA, in the right thigh on 3/31/06. The patient received in concomitant Prevnar, lot number B08639A in the left thigh. The patient was admitted to the hospital on 4/4/06. Blood culture was negative, CBC-WC 16,900, and a urine culture is pending. Per the reporter, the patient had not recovered at the time of this report and this event has been reported to the manufacturer of Prevnar.
was stored in the refrigerator instead of the freezer since 01DEC2020 and has since then been administered to patients; It was also administered concomitantly with VARlVAX / intended to give MMRII but instead administered PROQUAD; intended to give MMRII but instead administered PROQUAD; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 01-DEC-2020, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored in the refrigerator instead of the freezer. It experienced the temperature excursion of 44 degrees Fahrenheit for 1506 hours. There was no previous temperature excursion. The digital data logger was not involved. On 01-FEB-2021, the patient was administered with the incorrectly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, lot # T025221, expiration date 19-JAN-2022 (route of administration was not reported) for prophylaxis, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. Additionally, on 01-FEB-2021, the patient received varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml (route of administration, lot # and expiration date were not reported) for prophylaxis. There was no adverse event reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2102USA000941: US-009507513-2102USA001248: US-009507513-2102USA001301: US-009507513-2102USA001487: US-009507513-2102USA001044:
This spontaneous report was received from a pharmacist regarding a female patient (reporter's wife) of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. On 24-NOV-2015, the patient was administered with a dose of ZOSTAVAX (lot, expiry date unknown, dose unknown) intramuscular rather than subcutaneously in the arm. Concomitant medications were not reported. On an unknown date in November 2015, the patient's arm became very sore. No treatment was rendered for the event. The action taken with the vaccine was not applicable. The outcome of the event pain in arm was resolving (reported as pain has begun to subside). Product quality complaint was not filed. Causality assessment was not provided. Additional information is not expected as the reporter did not wish to be contacted.
redness, swelling induration at all vaccine sites (R) and (L) leg, small (R) leg ecchymosis Fever as well
Second dose of Moderna: Almost immediate pain from injection shooting down arm towards front of elbow. Swollen arm very sore,  On the second day  being March 5th, fever, chills, arm swollen and headache. First noticed the bruising on March 6th, it is approx:  7" long, 3" wide starting at the injection point running down the arm towards the muscle of the arm.
Information has been received from a registered nurse concerning an approximately 14 year old female patient who on 22-AUG-2007, 19-OCT-2007 and 07-MAR-2008 was vaccinated with the series of GARDASIL (lot#: 658556/1060U) of all doses) at another office experienced lupus like symptoms with neurological issues. The patient did see a neurologist. The patient also received MENACTRA and DTAP on 15-AUG-2007 (confirmed different data than initial GARDASIL). Nurse did not wish to be contacted. No further information available at the time of reporting. Upon internal review, lupus like symptoms was determined to be an other important medical event. No further information is available.
vaccinated with a dose that was refrozen; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (vaccinated with a dose that was refrozen) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (vaccinated with a dose that was refrozen). On 02-Aug-2021, PRODUCT STORAGE ERROR (vaccinated with a dose that was refrozen) had resolved.            No concomitant medications were reported. No treatment information was reported.
a patient at a covid-19 booster clinic was administered a booster shot 2 months early. The patient's record was reviewed prior to vaccination but the date was missed. The facility also said they were aware of her vaccine date and accidentally left her on the list by mistake. The patient reported no adverse reactions and will not receive an additional dose.
fever for five days (100.5 to 103 degrees), body achiness for 6 days, red rash and swelling on arm from shot area down to the elbow (persisted from 48 hours after the shot til present time, 8 days), extreme soreness in the upper arm, causing moaning during sleep and waking from sleep if the arm was touched.  The muscle area of the arm is still extremely sore, swollen, and red, requiring pain medication. The doctor was seen after 72 hours, treatment: moist compresses on the red swollen area and pain medication.
Pt was with mom and mom stated he started to say he did not feel good. He then started to pass out and walk into the walls of the aisle. She brought him outside for some fresh air. When I went out to the pt he was very pale and had a blank stare. Pt stated he was seeing black and white. He came out of it while I was calling 911. He walked back into the store and I gave him cold water., and waited for EMTs to get to the scene. Pt was talking and was responsive.
At aprox 36hrs post vaccine I developed a rapid onset of left arm and left sided body weakness. continuing near syncope episodes. diagnosed as a complex mograine which lasted 5-6hrs. and lingering headache for about 8days
The patient had her flu shot on 10/12/05. Patient called reporting fixed drug eruptions on face, back and chest.  She says they look like pimples.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M031802 exp date 09-NOV-2017) (dose not reported) orally. The detail of the storage was a temperature excursion to 35 F for 24 hours. No adverse effects were reported.       This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA006147: US-009507513-1701USA006148:
I have had chronic diarrhea since receiving the Moderna vaccine. This is the third week experiencing the symptoms.
Case number PHEH2016US028948, is an initial spontaneous report received from a nurse on 02 Nov 2016. This report refers to an 86 years old patient of an unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619221) 0.5 ml intramuscularly into the left deltoid on 13 Sep 2016. The administered vaccine had several temperature excursions prior administration (minus 2.7 Celsius for 6 hour and 4 minutes minus 3.6 Celsius for 21 hours and 48 minutes minus 3.4 Celsius for 21 hours and 2 minutes minus 3.3 Celsius for 21 hours and 3 minutes minus 3.3 Celsius for 8 hours and 4 minutes 1.2 Celsius for 1 hour and 1 minute 1.7 Celsius for 1 hour and 5 minutes was not frozen). It was reported that the patient had been revaccinated FLUVIRIN. No adverse event was reported following this medication error (incorrect storage of drug). The case was assessed as non serious by the nurse.
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 11-AUG-2017, the patient was vaccinated with two separate doses of GARDASIL 9 lot # N012093 (one in the left arm, and the other one in the right arm) for prophylaxis (inappropriate schedule of drug administration and overdose). No adverse event reported.
I woke up sometime in mid-July, roughly around 5 months since vaccination, when I woke up with intense vertigo and dizziness. The room was spinning and I couldn't sit or stand, I had to lie down in order to making the vertigo and dizziness stop. I was told by the ENT doctor that I had BPPV (Benign paroxysmal positional vertigo ), the treatment was Epley maneuver and I read online to take Calcium and Vitamin D3 supplements. I have never had this before in my life and it came out of no where.   Even up to today, around 3 months, I get dizzy if my head is in a certain position, but it felt like I was on amend and could deal with the mild dizziness. Until the vertigo came back strong out of no where  on 9/29/21 when I stood up from my desk, not as strong when I experienced it for the first time, but strong enough where it was making me nauseous and sweat. The day after, which is today (9/30) when I'm typing this, I feel better but I am dealing with the residual dizziness.
Pt received flu shot at 11:00am.  At 11:05, pt reported feeling numbness in left arm and lip, tingling in head, and flushing. Admin Benadryl 50 mg PO.  At 11:15 am, pt reports relief of symptoms.  No rash, itching, or hives noted at any times.  No resp symptoms present.
fully vaccinated and had 2 booster shots and got covid; fully vaccinated and had 2 booster shots and got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: ER2613) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "fully vaccinated and had 2 booster shots and got covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Follow-up attempts are completed. No further information is expected.
Had pain in her arm after the vaccine.  The pain radiated down the arm and she moved her arms around to work the soreness out.  Since the pain has radiated up to her shoulder.  Very painful.
Never came back for the remainder doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 42-year-old female patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix adult (1st dose received on 22nd July 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced incomplete course of vaccination (Verbatim: Never came back for the remainder doses). The outcome of the incomplete course of vaccination 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: 29-JUN-2023 The reporter wanted to know how to proceed with the Twinrix vaccine series. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Twinrix adult vaccine, which led to incomplete course of vaccination.