chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Migraine; Had fallen so went to the ER; Severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), FALL (Had fallen so went to the ER) and HEADACHE (Severe headaches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A, 037A21B and 030H21B) for COVID-19 vaccination.     Patient don't have Allergies. It was reported that patient has never been diagnosed/tested Positive for COVID-19.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine), FALL (Had fallen so went to the ER) and HEADACHE (Severe headaches). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Migraine, at an unspecified dose and frequency; HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, MIGRAINE (Migraine), FALL (Had fallen so went to the ER) and HEADACHE (Severe headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: normal (normal) There was nothing wrong.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant products were reported.
This spontaneous report was received from a physician who refers to a 66-year-old female patient. The patient had no concomitant medications, pertinent medical history, drug reactions or allergies.  On an unknown date, the patient was vaccinated with PNEUMOVAX 23 injection intramuscularly (lot # N024384, expiration date: 18-MAY-2019, dose was not reported)) for prophylaxis (indication was reported as "vaccination"). On 20-NOV-2017, the patient experienced generalized facial flushing, lower back pain, and malaise. The patient sought a medical attention and the intervention to prevent serious criteria was administration of epinephrine. No lab diagnostics or studies were performed. The reporter believed that the events were a reaction to the administered PNEUMOVAX 23. the physician reported that the patient continued to have malaise. The outcome of the events was reported as not recovered. The reporter considered the events to be related to PNEUMOVAX 23. The physician considered the events of generalized facial flushing, lower back pain, and malaise to be medically significant, as intervention to prevent serious criteria was performed.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: nausea-Medium, Systemic: Nausea-Medium, Additional Details: patient fainted 30 sec or minutes after.patient was left with caretaker and caretaker left after pharmacist left after making sur pt is okay. patient fainted twice. after finding on floor rph rush and made sure pt is concious and vital are okay. made sure pt was not hurt after translating as language barrior. after 20 minute emergency services was called. paramedic came and check vital. after checking everything pt was sent home. rph consulted to paramedic and ask if everything is okay, paramedic reply wasm ok
Sore throat, ear drainage, low fever chest congestion.  Used inhaler (previously prescribed) and ibuprofen.
poss pertussis; 21SEP92 presented w/a cough; 26SEP92 returned w/worse cough; pertussis culture obtained; 25OCT92 neg culture for pertussis; 10NOV92 dx w/chronic cough;
Approximately 5 minutes after vaccines were administrated, mom was holding child and she became pale in color, lips turned dusky, her eyes rolled back, she arched her back and became lethargic/limp for a few seconds. Nurse took child from mom and stimulated her by swooping her up and down a couple times while supporting her head and neck until she opened her eyes and started looking around. Her color remained pale and lips dusky so checked her vitals and her O2 sats were 98% on room air but her pulse had dropped to 46 bpm and she was still acting a little sluggish and mom was concerned this is not how she acts so EMS was called to evaluate child
According to the mother, 45 minutes after receiving the vaccines, while on their way home in the car she started crying with a bad headache having chills and nausea and didn't want to eat. Around 9 pm (Approx 5 hours later) after getting some sleep, she started eating and feeling better.
I was admitted to the hospital in early May 2021 and had a stent inserted. Heart attack is the diagnosis, but it may have been going on for some time, even prior to my first shot. (I have now had a 2nd dose AND two boosters.) IAM MAKING NO CLAIM THAT THE SHOT AND MY HEART PROBLEMS WERE/ARE RELATED. As far as I know, they are not.
Pain, kidneys, muscle pain, or gall bladder; Pain, kidneys, muscle pain, or gall bladder; Pain, kidneys, muscle pain, or gall bladder; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of renal pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced renal pain, muscle pain, gallbladder pain and pain. On an unknown date, the outcome of the renal pain, muscle pain, gallbladder pain and pain were unknown.   It was unknown if the reporter considered the renal pain, muscle pain, gallbladder pain and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 28-APR-2022 Reporters comment: The patient self-reported the case via interactive digital media. After receiving Shingles vaccine, the patient had that same type of pain. Doctors thought it was his/her kidneys, muscle pain or gall bladder. The patient underwent CT scans and it showed nothing. The patient stated that, it was so strange. Additional supportive information: The follow up would not be possible as no contact details were provided.
rash on his ankles, feet, upper back, back and sides of neck, around the injection site 2x3 inches, rash was getting darker around his ankles; rash around the injection site 2X3 inches and very dark red, down his arms to his wrists; This spontaneous case was reported by a nurse and describes the occurrence of RASH (rash on his ankles, feet, upper back, back and sides of neck, around the injection site 2x3 inches, rash was getting darker around his ankles) and VACCINATION SITE RASH (rash around the injection site 2X3 inches and very dark red, down his arms to his wrists) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced RASH (rash on his ankles, feet, upper back, back and sides of neck, around the injection site 2x3 inches, rash was getting darker around his ankles) and VACCINATION SITE RASH (rash around the injection site 2X3 inches and very dark red, down his arms to his wrists). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 50 mg every 6 hours; FAMOTIDINE (PEPCID AC) at a dose of 20 mg 1 tab at bedtime as needed and METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) at a dose of 24 mg titrating down for 6 days. At the time of the report, RASH (rash on his ankles, feet, upper back, back and sides of neck, around the injection site 2x3 inches, rash was getting darker around his ankles) and VACCINATION SITE RASH (rash around the injection site 2X3 inches and very dark red, down his arms to his wrists) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  Action taken with mRNA-1273 in response to events was not applicable.
Approximately 2 hours after receiving the vaccine, patient reported feeling pain in his left arm.  By the next morning, he noticed an area of redness approximately 4 inches in diameter, which was warm and sore.  Patient returned to the clinic on Friday, November 4th with the above findings, and was advised to see his private physician.
became more short of breath; Exacerbation of COPD; This is a spontaneous report received from a non-contactable Other HCP. A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/Lot EN6205), via an unspecified route of administration on 02Mar2021 at single dose for covid-19 immunization. The patient medical history and Concomitant medication were not reported. The patient previously took first dose of BNT162B2 at single dose for covid-19 immunization. Patient had end stage COPD and noted that she became more short of breath 1-2 days after receiving her 2nd dose on 02Mar2021. It was also reported that provider from the Covid-19 vaccine clinic called patient to follow up on her recent covid-19 vaccine that was done on 01Mar2021. She tried to manage it on her own at home but noted in the couple of weeks that it was not improving. She would be more short of breath with and w/o ambulation. Her husband, (Name), took her to an express care. Today (16Mar2021) whom evaluated her with blood work, chest x-ray and gave her a breathing tx. States she was prescribed abx and prednisone. She does not see much change yet since discharge. On her discharge paperwork, she notes that she was instructed to let covid vaccine clinic and pcp know about her potential reaction vs. Exacerbation of copd. Pt states she is scheduled to see her pcp on Monday, 22Mar2021, along with her pallative care team. Outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information, Short of breath is most likely related to the end stage COPD, which is not related to the suspected drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Left arm where injection was given, swollen and warm and tender to touch, pt seen in office 12/04/15 by MD, no s/s of cellulitis. Motrin/Benadryl and ice as needed. To follow up if worsens or no improvement in 48 hrs.
PT RECEIVED TDAP VACCINE ON 9/7/2018 DUE TO GETTING CUT ON RUSTY TOMATO CAGE. WAS ADMINISTERED THE INJECTION TO RIGHT DELTOID. AFTER RECEIVING THE VACCINE INCREASED AMOUNT OF PAIN TO RIGHT ARM THAT WAS SHOOTING DOWN TO ELBOW. DECREASED RANGE OF MOTION TO RIGHT ARM AFTER VACCINE THAT HAS BEEN ONGOING FOR >2 WEEKS WITHOUT ANY CHANGE. PT HAD TRIED OTC PAIN RELIEVER, PASSIVE RANGE OF MOTION, AND RELAXING IT WITHOUT ANY IMPROVEMENT. DENIED ANY REDNESS, SWELLING, OR WARMTH AT THE INJECTION SITE OR FEVER. NONE PRESENT ON EXAM ON 9/19/2018. PT WAS ORDERED XRAY OF RIGHT ARM/SHOULDER TO SEE IF ANY ACUTE FINDINGS.
Chest pain on deep inhale and while coughing, onset within 24-48 hours of vaccine.
Abdominal pain woke me up from sleep. Blood pressure is all over the place. Propranolol has regulated BP to 110-120/80 for the last 9 years. BP  was 155/100 2 days ago, woke me from sleep. Went to ER, they said it was an anxiety attack. Only medication they gave was 4 baby aspirin.
Site: Itching at Injection Site-Mild, Additional Details: PER PT, UPPER LIP LITTLE SWELLING
diarrhea, cramps, took Imodium and has resolved. Now experiencing swollen, tenderness, and redness at injection site.
The injection was painfu. It was administred near the shoulder joint. I felt extreme pain in my entire arm starting 2 hours after the injection and I could not lift or use any part of it. The following night I barely slept and could not get out of bed the next day due to pain throughout my body. I also felt nauseous and vomited. Today I still cannot use my shoulder and lift my arm. As a result of motion restriction, I cannot go about my daily activities. I called the pharmacy and reported my side effects. The pharmacist agreed that I may present with SIRVA.
I actually had a better reaction in my  arm than previous vaccines. But I began experiencing a scratchy throat and some drainage and since my husband had already tested positive for Covid, I went to Urgent Care to be tested for Covid where I tested positive. I have been experiencing some stuffiness and congestion and one night of fever, but not much beyond that. At Urgent Care I was prescribed Paxlovid and have been taking that ever since.
Fever of 104.8 for over 36hours Tylenol did not do any thing to change my fever Fever went down after 5days horrible bodyaches confusion lost track of time i was not making a lot of sense to my adult children bizarre dreams Nausea terrible chills jaw was hearting for days racing heart rate Headache congestion sweating profusely Muscles aches I think i am allergic to the vaccination
Previously healthy 13 yo got flu shot 1 month ago. Developed urinary retention 10/15/10 requiring catheterization. Then had seizure + altered mental status. Now alert with ataxia + urinary retention. Brain + spine MRI show extensive cord gray matter inflammation + leptomeningeal enhancement.
*This is a reporting of an administration error and not of an adverse event.  68 year old patient came to flu clinic on 12/05/2022 for enhanced dose vaccine. Patient was administered regular dose ( Flulaval 6mth+) instead of the enhanced dose for 65 years and older. (65Yr+ old patients are recommended to receive the Fluad 65yr+, but if they specifically request to receive the Flulaval 6mth+, then the Flulaval can be administered to the patient. In this case, patient did not request for the Flulaval.) Vaccinator called the patient to inform of the situation, and that their primary care provider has been contacted for advice on the next step (if Fluad needs to be given still).
Sore arm; felt weak; felt very sleepy; itchiness at injection site; heart palpitations; short of breath feeling like after running; This is a spontaneous report from a contactable consumer or other non-HCP. A 49-year-old female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on 28Mar2021 as dose 2, single (at the age of 49-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Vaccination facility type was reported as School/Student Health Clinic. Patient medical history and concomitant medications were not reported. Patient allergies to food, or other products was reported as unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on 07Mar2021 as dose 1, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm, felt weak, felt very sleepy, itchiness at injection site, heart palpitations, short of breath feeling like after running on 28Mar2021. Therapeutic measures taken as a result of sore arm, felt weak, felt very sleepy, itchiness at injection site, heart palpitations, short of breath feeling like after running included Tylenol as treatment medication. The outcome of the events was resolved on an unspecified date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Case number PHEH2014US024316 is an initial spontaneous report from a nurse received on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This report refers to a 63 years old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 13 Nov 2014. The nurse reported that before vaccination the prefilled syringe of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
No adverse effect; administration of one dose of an improperly stored vaccine, VARIVAX, to one patient; Information has been received from a physician referring to a patient of unknown age and gender. Information about concurrent condition, concomitant therapies and medical history of the patient was not provided.  On 22-MAR-2019, the patient received one dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (from either Lot# reported as R827995 (invalid for varicella virus vaccine live (oka/merck) (VARIVAX)) with expiration date 01-OCT-2020 or Lot # R024023 with expiration date 21-AUG-2020; strength, dose, route were unknown) for prophylaxis. It was clear that it came from one of these Lot Numbers but could not say which one. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effect was reported.   The temperature excursion was 15.4 degrees Fahrenheit (F) for 10 minutes on 22-MAR-2019. Previous temperature excursion was 6 F for 20 minutes on 20-MAR-2019 and 7.7 F for 20 minutes on 21-MAR-2019. Digital data logger was involved.  This is one of two linked cases received from the same reporter.; Sender's Comments:  US-009507513-1904USA007137:
hyperpyrexia 105 48hr p/vax;adm to hosp told nothing was wrong but vax rxn;
Pt. received COVID19 Moderna vaccination (2nd dose) on 4/16/2021. That evening he developed a low grade fever which he took Tylenol for and it took it away. On Sunday 4/18/2021 in the evening Pt. states his tongue felt sluggish and he wasn't able to pronounce his words like he usually does. By Wednesday 4/21/2021- Pt. felt like mouth had been numbed by the dentist and he was having trouble swallowing. Pt. underwent CT Chest PE protocol as well as CT head to rule out thrombosis/ stroke. Testing was negative at that time. Pt. was changed to Aspirin 325mg and was told to follow up. On 4/26/2021 Pt. returns to clinic with 15 lb weight loss. Continued asphasia and dysphagic sx. An MRI w/w.o contrast of the brain is being ordered.
Headache, Sedation, Myalgia, low grade temperature Narrative: unable to complete work for the day and had to leave early due to severity of adverse effects
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-AUG-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-MAR-2016, the patient was treated at an urgent care center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles with complications. The patient was prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Patient seen in observation area with complaints of throat discomfort and "ball in her throat sensation" Initial BP 155/109, HR 80, oxygen saturation 98% RA, Respiratory rate 22.  Pt with persistent complaint of worsening  symptoms of throat discomfort. EMS contacted, airway assessed, no swelling noted.  IM Benadryl 50mg given. Vital rechecked WNL. Pt further evaluated by EMS, and reported improved symptoms. Pt transferred to hospital for further evaluation.
localized eruption to injection site that has since spread down the arm-- increasing redness, warmth, and itching. Treated for allergic reaction with antihistamines and cellulitis with doxycycline
a few days after receiving 1st vaccine i noticed a slight numbing sensation in right arm from shoulder to finger tips.  I would get this feeling in my arm only once a day for a few mins.  I noticed as more time went on that the numbing/tingling would last longer each time it came.  Now a little over 3 months my right arm is numb and tingling 24 hrs a day with a throbbing that wont go away from the top of my shoulder to my finger tips.
estimated 30min post vax devel urticaria, flushing & hives;routed from place of work in hosp to ER for tx;
09/23/2021- felt as if I had a sinus headache, nauseas-over several days that progressed day to day, lasted about a week, went to urgent care and there was not test, but since my family did-the Dr told it was Covid. Tested on a later date and it was positive.
4-25-08 - redness, pain & itching L thigh without fever.  Tx with Tylenol & Benadryl.  Sx resolved on or before 5/1/08.
Fever and aches all over body.  No appetite.  Sore are site of shot.
Two days following administrations of PNEUMOVAX 23 vaccine, patient presented to ER with significant left arm swelling, at the site where vaccine was administered. He experienced no pain, only extreme swelling of his left arm.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. 24-SEP-2014 the patient was vaccinated with GARDASIL (lot # J013324, expiration date 12-FEB-2016, dose and route were unknown). No adverse effects were reported. The vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours. The lowest recorded temperature and Celsius conversion of the lowest recorded temperature was 1 Celsius degree. The storage criteria of the vaccine and the type of excursion were refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Chills-Fever-Aching-Nausea-Vomiting- No Appetite
Severe fatigue, minimally  abated after 24 hours; Severe headache, minimally abated after 24 hours; Acute muscle aches over much of body, most pronounced across entire back, unabated after 24 hours; Acute muscle pain at sight of injection; Complete confusion and disorientation  in bed late at night; Physical inability to carry out normal activities, still continuing after 24 hours