chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temperature excursion of vaccines that reached the lowest temperature 30 degree Fahrenheit, no Ae; Initial information received on 07-Dec-2020 regarding an unsolicited non-serious case from other health professional.  This case involves temperature excursion of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB], POLIOMYELITIS VACCINE (INACTIVATED) [IPOL], DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID [TD], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [DTAP], DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [TDAP] (lot numbers and expiry dates not reported) that reached the lowest temperature 30 degrees Fahrenheit (product storage error) and On 2-DEC-2020, a 7 months old female patient was vaccinated with the excursed 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number: UT7115LA and expiry date:30-JUN-2020) via intramuscular route in left deltoid for prophylactic vaccination.   This was potential medication error case due to product storage error temperature too low.  Case details: Dec 1 alarm time 14:12 2 hours 13 minutes 30 Fahrenheit (F) ; 13:29 51.3 Fahrenheit  for 23 minutes (mins) .Dec-2 1:37 am 39.9 F for 3 hours 41 mins. High of 14:53 46.6 F for 1 hour 3 mins. Dec 3 2:43 am 31.5 2 hours 52 mins. high 2:05 am 49.3 F 2 hours 47 mins. Dec 4 1:47 am 33.3 for 53 mins. 1:08 am high 47.5 for 1 hour 4 mins. Caller stated this information came from the day logger for Program. The thermostat inside of the refrigerator reading was normal inside has not a problem.  At the time of reporting 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.  There will be no information on the batch number for this case for the other reported vaccines.
pt recvd vax 8MAR94 24 hrs later exp swollen uvula, fatigue, arthritic joint pain, hives, & dizziness; sx resolved 5 days later;
reporter states approx 8 patients recv flu vax & they all devel flu-like sx;patients were all recovered as of the date of this report
2 days after vaccine-red, hot, itching and painful site of 10cm circumference. 1 week later, still the same, to (L) deltoid area. Antihistmaine increased.
Right thigh with localized reaction: 20mm x 12mm redness, tenderness, firm and warm to touch. Temp. 103.4 degrees F Ax. Reports fevers to 101 degrees F with past vaccinations.
my Blood Pressure went back down to normal but has since gone back up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 Immunization. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "recovered", described as "my Blood Pressure went back down to normal but has since gone back up". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flue like symptoms; Fever over 102 F°; Bodyache; Headche; Chills; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flue like symptoms), PYREXIA (Fever over 102 F°), MYALGIA (Bodyache), HEADACHE (Headche) and CHILLS (Chills) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.     Patient did not had any allergies.  Previously administered products included for Product used for unknown indication: pfizer vaccine (All previous doses). Past adverse reactions to the above products included No adverse event with pfizer vaccine.    On 15-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Aug-2022, the patient experienced INFLUENZA LIKE ILLNESS (Flue like symptoms), PYREXIA (Fever over 102 F°), MYALGIA (Bodyache), HEADACHE (Headche) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 100 mg every 8 hours and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flue like symptoms), PYREXIA (Fever over 102 F°), MYALGIA (Bodyache), HEADACHE (Headche) and CHILLS (Chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2022, Body temperature: over 102 Fahrenheit degrees.         No concomitant medication information provided. Patient never had side effects from previous doses of Pfizer. Patient had the symptoms for 6 days now and was very worried because he had already had the symptoms 6 days and they don´t seem to go away. Patient was looking for solutions. Treatment drug included antacid.
Site pain for 24 hours. Tylenol 3 and Gabepentin Severe nerve pain in the tongue for 15 hours. Tylenol 3 and Gabepentin.
I woke up at 2:30 in the morning with severe chills that lasted on and off for over twelve hours.  I also had diarrhea and and a  headache.  My sense of taste is also off, nothing taste right.
THE FOLLOWING WEEK HAD ABOUT TEN DIME SIZE BRUISES ON ARMS AND LEGS; SEVERE CHILLS; SORE ARM; HEADACHE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes( controlled with diet), hashimoto, sjogrens, celiac, and crohns. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced the following week had about ten dime size bruises on arms and legs, severe chills, sore arm, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe chills, and sore arm, and the outcome of headache and the following week had about ten dime size bruises on arms and legs was not reported. This report was non-serious.
That evening after the shot, the patient felt very cold, dizzy, and ended up falling at her home. No hospitalization reported and no other symptoms since.
patient rec'd pfizer grey cap after it was stored in freezer for 22 days- have been trying to call parent but have not rec'd any answers back yet
Initially had a headache off and on. A few days later on or about April 12 she started getting tired more easily. On April 19 she was extremely tired and had a persistent headache.  Finally, on April 21 she had an excruciating headache and elevated blood pressure in the morning.  By 2:30 p.m. the headache continued and she had become jaundiced as noted by a classmate on the way to catch the school bus home.  At approximately 5:30 p.m. the headache worsened and she lost the feeling in her left side and could not speak clearly or smile. I called her pediatrician, and spoke with the afterhours nurse who told me to get patient to the emergency room for a catscan.
Temp of 102, nausea, red swollen site, ache in legs and arms
pt left WA state on 23OCT95 11 days p/vax to travel by car-1st sxs dry throat, lips tingling, tongue felt thick;3NOV h/a, legs shaky, legs gave out-hosp 20NOV-27NOV ascending paralysis;
patient received a dose of JnJ   after  already receiving 2 doses of Moderna   which is outside of our protocol and thus is being reported as soon as discovered!
Two days after vaccine administration, the patient developed facial hives from her chin to her ear on the right side of her face only.
Slight cough, eyes became bloodshot, Temperature of 103-104.  Progressed to Vomiting and Diarrhea.  Still with fever 12 hours after onset, and general malaise.
Patient states "within a couple of hours" of vaccination, Right upper arm became "itchy" and "stiff". No interventions were done at this time. Following morning, Right upper arm was "red, swollen, itchy & painful".  Patient denies any interventions and states he "continued with his daily activities".  Patient states symptoms continued over next several days with redness and swelling forming a "band-like" area around his Right upper arm.  At this time, he noted his Right upper arm was also warm to touch and hard around injection site.  Patient denies doing any interventions to alleviate symptoms.  On April 9, 2008 @ 1300, he returned to site of vaccination and asked to speak with head nurse.  Senior Nurse for Immunizations pulled client's record, assessed injection site, educated client on possible causes and gave intervention recommendations for symptom relief as well as provided contact information for follow-up.
No adverse events, but the lot number given was expired. This particular batch expired on 4/28/21 and was a short-dated batch that accidentally got administered.
I felt like I had a sinus infection and took OTC medications. Then the next day I had a dry cough and sinus pressure. I took 2 at home COVID-19 test that was positive. My symptoms progressed to cough, fever of 100.1, runny nose, headache, muscle aches, and fatigue. I contacted my doctor that advised me to drink plenty of liquids and vitamins. I ordered a blood oximeter and the lowest was 96.
Admitted to hosp 2/2 w/bilateral pneumonia. Treated with remdesivir and decadron. 2 L O2. Heated high flow BIPAP then Intubation 2/16, L internal jugular placement 2/16, chest tube 2/17, 5 units platelet transfusion, 2 units FFP unk dates. Principal dx: acute hypoxic and hypercarbic resp failure d/t COVID-19 pneumonia. 2ndary dx: severe thrombocytopenia possible DIC, coagulopathy, PE, hypothyroidism, DM, sepsis, AKI on CKD, hyperkalemia, duodenal ulcer, metabolic encephalopathy, tension pneumothorax, hematuria
There was NO adverse event, treatment, or outcome known at this time.  Patient received 2nd dose of Pfizer Ped. vaccine too early. Received vaccine on day 14 rather than on the recommend 21 days.
Could not sleep the night after the shot.  Slept through an entire day that day after that.  The following day, sever pain in heels.  A week later pain moved to lower back.  Another week later the pain moved to knees.  A week later pain also arose in tops of hands, then up the forearms.  Then a week or two until pain added in balls of feet.  A week later the pain moved up into the shoulder and up into the hip.  A week later pain appeared in the muscles of the forearms (in addition to top surface).  I am now 3 months since the shot and still in discomfort daily, needing pain medication to sleep through the night.
On 1/18/01, call from mom stating site on left arm was swollen with red area. No drainage and no streaking. Temperature was 100.2F and resolved with Tylenol. Advised to continue Tylenol. May try ibuprofen if approved PCP. On 1/19/01, call from mom that took child to ER last night with left arm swollen and bruised from IZ, per ER. Treated with warm compresses and Tylenol. On 2/2/01, per cousin, symptoms resolved in 3-4 days.
Initial and follow-up information has been received from a physician concerning a 14 year old female with unspecified mental health issues who on 28-AUG-2009 was vaccinated with a dose of GARDASIL (dose, route and LOT# not reported). On 22-SEP-2009 the patient started complaining of abdominal pain and weakness. The patient was admitted to hospital and felt fine when she discharged on 25-SEP-2009. On 27-SEP-2009 the patient went to emergency room and was admitted again for headache, weakness and being unable to walk. The labs CT of head and CT of spine were performed and no outcome provided, the GUILLAIN-BARRE Syndrome test was negative. The patient had been discharged on an unspecified date but she was still unable to walk and had weakness. No further information was available at this time of the report. The patient was hospitalized. The reporter considered the abdominal pain, weakness, headache and being unable to walk to be an incapacity or significant disability. Additional information has been requested.  11/9/09 medical records and discharge summary received for DOS 9/22-9/25 and subsequent admission 9/27/09-10/02/09. Final DX: 9/22 admission- Hiatal hernia.  FInak DX 9/27 admission -Migraine Headaches, Somataform Disorder, Diabetes, Obesity Patient initially admitted for stabbing epigastric/abd pain and pain in shuoulders and back, tingling in back. CT abd and pelvis neg. diagnosed w/small hiatal hernia by endoscopy. D/C to home.  Returned to ED with c/o LE weakness and back pain. Also c/o severe HA. Unable to bear weight and walks with walker.  DTRs 1/4. Normal sensation. Strength 5/5. All diags neg. Somataform disorder. Refer to psych and possible rehab/PT. Homehealth. D/C using walker. HA resolving.
Moderna COVID-19 vaccine EUA. 03/09/21- 10:30 pm skin sensitivity; 11:30pm chills and body aches; 03/10/21- 12:00 pm fever, chills, body aches, fever throughout the following day of 101 with tylenol, extreme fatigue, headache, body ache with emphasis on joints; 03/11/21- 3:30 am fever piques, extreme sweats; 9:00am side effects almost entirely subsided except for minor heaches
Hives from head to toe, Itching really bad,  nausea , and diarrhea  Took Benadryl
Sore arm. Violent shakes and chills in the middle of the night. Fever (highest recorded 100.3F, but likely higher during the night). Back soreness, eye pressure, headache, short bursts of nerve pain in hands and feet
An empty syringe, not filled vaccine, was utilized to "vaccinate" this patient.  This error was identified within 10 minutes and the patient was vaccinated appropriately without incident.  The parent was informed of the error at the time and a full investigation was completed.
pt recv vax 21AUG97 & 22AUG97 pt had whelps all over lt thigh, dec abd w/ brownish spot in center referred to MD ER called mom next day spike w/mom;stated child released OK;
Gave the injections and just within seconds of giving them she went pale, eyes closed, limp and twitched slightly. Appeared to be a syncopal episode. Lowered her back onto the exam table and she came around within 30 seconds. She made a full recovery and walked out of the exam room with her mother after we let her sit for 15 minutes after the event.
Hypotonic hyporesponsive event approx 8-12 hr after receiving vaccine.
When it was first injected it felt like it hit my bone. That evening it was very sore and by the morning it was excruciatingly painful. I needed to use my other arm to hold it up. In the afternoon I called my doctor and she prescribed oral steroid medication for the inflammation. I also took ibuprofen as instructed by her and I iced it. August 25th I went to a doctor to have it looked at hoping I could get an injection of steroids instead of taking them orally since I have crohns disease (been in remission for five years and I do not like to take medication.) It was x-rayed and I am currently in physical therapy to relieve the pain and gain movement.
feeling very very low and depressed and moody/ sadness, not myself/ events worsened yesterday its seems; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration on the left arm on an unspecified date (at the age of 61-years-old) as second dose, single dose for COVID-19 immunization. Medical history included ongoing depression (that was reported as currently and have this for several years on medication). Concomitant medications included venlafaxine hydrochloride (EFFEXOR), bupropion hydrochloride (WELLBUTRIN SR), quetiapine, atorvastatin (LIPITOR), amlodipine, levothyroxine sodium (SYNTHROID) and hydrochlorothiazide; all taken for an unspecified indication, start and stop dates were not reported. On an unspecified date in 2021 (reported as Saturday, yesterday), the patient experienced feeling very very low, depressed, moody, sadness and not herself. The events were reported as seemed to have worsened. The patient was not sure if the events were reaction to the second vaccine she had on Thursday and stated that it may be the vaccine was effecting. The event seriousness was unspecified by the reporter. There was no investigation assessment. No treatment was given as a result of the events. The outcome of the event was not recovered. The patient was querying if this could be experienced by the medication that she was taking.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was 37 weeks pregnant when she presented initially for monoclonal antibodies secondary to COVID-19 infection in pregnancy. Upon arrival, patient was noted to have elevated blood pressures 140s/90s. PreE panel was performed which showed P:C 0.3 on straight cath otherwise WNL. She has a mild headache otherwise is asymptomatic. Patient had planned a primary CS secondary to macrosomia at 39 weeks. Decision was made to proceed with cesarean section today secondary to gestational age of 37 weeks. All questions answered and agrees to proceed.  Estimated delivery date was 02/03/20. Birth weight was 8lb3oz
FEVER, HEADACHE, NAUSEA/VOMITING, LYMPHADENOPATHY  Narrative: SEVERE HEADACHE; LYMPHADENOPATHY OCCURRED ON THE LEFT SIDE (INJECTION SIDE) OF BODY
I woke up one day and I started seeing rashes on different areas. When i woke up other days, they developed in other places. I have it on my back, arms, back of legs, upper thighs on both legs. On the bottom of my legs from the knee down, I don't have any. Other than that, it's just every day is another part comes up. Some rashes are by themselves and others are in cluster forms. It's just something that's developed on a daily type basis. The itchiness started and it gets to the point where it can really itchy. I haven't tried taking any antihistamines, but I wear gloves when I go to bed at night so I don't scratch. I've seen pictures of it on the internet and they seem similar to the pictures I've seen. I know I haven't had COVID-19 because of the tests I've taken. I do still follow the safety protocols that I can do for myself. I've had lab work that cannot identify where the rash came from. I talked to my dermatologist and he said it was possible that it could be vaccine related. I've also had two biopsies that came back negative. I've received the other 4 Moderna vaccines before and I only had a sore arm, chills, and a fever. I never had any symptoms other than that and nothing like this before. For this vaccine, I did not experience any symptoms afterwards until the rash came two days later. I'm waiting on a referral to the  dermatology department. Otherwise, I may go to Clinic if that doesn't go through. I will also be seeing my PCP this coming Wednesday to do additional testing so he can take a look at what's going on.
Smell & taste became altered with a chemical and metallic taste/odor; Smell & taste became altered with a chemical and metallic taste/odor; Thick/white post nasal drip (congestion); also have a somewhat numb and thick-feeling tongue; also have a somewhat numb and thick-feeling tongue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 15:00 (Lot number: EN6200) at the age of 52 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications include Just one-a-day womens vitamin. The following information was reported: DYSGEUSIA (non-serious), PAROSMIA (non-serious) all with onset 31Mar2021 15:00, outcome "not recovered" and all described as "Smell & taste became altered with a chemical and metallic taste/odor"; NASAL CONGESTION (non-serious) with onset 31Mar2021 15:00, outcome "not recovered", described as "Thick/white post nasal drip (congestion)"; TONGUE DISORDER (non-serious), HYPOAESTHESIA ORAL (non-serious) all with onset 31Mar2021 15:00, outcome "not recovered" and all described as "also have a somewhat numb and thick-feeling tongue". Therapeutic measures were not taken as a result of dysgeusia, parosmia, nasal congestion, tongue disorder, hypoaesthesia oral.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Intramuscular formulation administered by other route; Tenderness; Redness; Swelling; This case was reported by a consumer via call center representative and described the occurrence of tenderness in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 4th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 3rd September 2019, the patient received the 2nd dose of Shingrix. On 4th July 2019, 30 min after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced tenderness, erythema and swelling. On 3rd September 2019, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the tenderness, erythema and swelling were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the tenderness, erythema and swelling to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. Approximately 30 minutes after the injection, the patient experienced tenderness, redness, and swelling. After 36 hours, the symptoms resolved. The patient received 2nd dose of Shingrix, was not administered intramuscularly because she didn't even feel the vaccine going into her muscle, which led to inappropriate route of vaccine administration. The patient experienced no local site reaction at all. The reporter consented to follow up. The reporter could follow-up with the patient directly.