chrisvoncsefalvay/vaers-outcomes huggingface dataset:
urticaria- chest, abd, back-face;joint swelling & pain-wrists, fingers, knees especially;edema of face accompanying rash;
Received vaccine after allowed expiry at room temperature; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine after allowed expiry at room temperature) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine after allowed expiry at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine after allowed expiry at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No relevant concomitant medications was reported.  Treatment information was not provided
I CANNOT STOP HAVING PAIN ON MY MUSCLES / HIPS/LEGS /FOOT (I DO NORMALY SUFFER OF PAIN DO TO MY HISTORY OF BACK PAIN, BUT NOT DAILY, SINCE I GOT THE VACCINE I HAVE NOT GOTEN A DAY W/ OUT PAIN.
BLOOD CLOTS; This spontaneous report received from a consumer via a company representative via social media  (J and J corporate account) concerned multiple patients. The patient's weight, height, and medical histories were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy dates were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients experienced blood clots. As per reporter, "me either after the talcum powder lawsuit at the vaccine for Covid alot of my friends got blood clots all kinds of stuff". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220851164-covid-19 vaccine ad26.cov2.s -blood clots . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
1st dose of Pfizer 12/12/20 2nd dose of Pfizer 1/11/21  Breakthrough COVID infection on 9/9/21 (diagnosed 9/9/21)
Swollen face, tongue feels fat, headache behind R ear, facial dropping, slurring words,  eye doesn't close all the way.  Started Sunday night to the morning went to ER.  Did blood test for Lymes. Diagnosed with Right sided BELLS PALSY Gave prednisone and Valtrex in ER and discharged on those meds too.
Headache, Fever, Diarrhea, Chills, ba Narrative:
Low grade fever, achy muscles, fever blisters in mouth/lips/nose, headache, nausea
Tingling sensation as well as tightening of muscles above both knee caps. I have also experienced right thigh, buttocks and tailbone pain. Pain in knee area when walking causing me to limp and hobble
Mom reports pt leg turned pink last PM & that ice was applied; Leg was somewhat swollen @ that time; high pitched cry for 45 min to 1 hr; Mom phoned MD & gave pt APAP; pt did have fever;
About three days after I got the shot, I started having strong gut pain, extreme gas, some nausea and distended stomach.  It felt much like a Celiac fair after eating gluten, but I had not eaten any gluten.  This continued for about a week.  Since that time, my gut has felt like it was always on the verge having the above symptoms.  The symptoms will flair up easily and stay longer than normal.
Migraines - phonophobia, photophobia, Nausea, Diarrhea, tinnitus. Has history of tension headaches from neck/shoulder pain although generally mild in nature and self-limiting within 1-2 days. Initial vaccine on 4/8/21 lead to similar symptoms although milder with worsening of overall symptoms within 2 hours of 2nd Modera vaccination.
Pt refers started with knee pains on 10/03/2005, then body aches, fever, headache, decreased appetite, nausea with vomiting x 2 on 10/04/2005. Was seen by MD on 10/05/2005 V/S fer 112 BPM, BP 12/68, T 100.0, recommended bedrest, Tylenol G 4hr and increased fluids.
upper left arm feels sore and tighter; upper left arm feels sore and tighter, it feels like there's a small lump present there; Pregnant at the time of vaccination: Yes; Pregnant at the time of vaccination: Yes; Pregnant at the time of vaccination: Yes; Sore arm for 2 days after receiving vaccine/upper left arm feels sore; exposed to 2 COVID positive coworkers in the pharmacy; This is a spontaneous report from a contactable pharmacist (patient herself). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown (reported as "misplaced/discarded")), intramuscular (left arm), on 31Dec2020 13:30, at single dose, for covid-19 immunization. Medical history included allergies: iodine and, postural orthostatic tachycardia. Concomitant medications included ergocalciferol (VITAMIN D); docosahexaenoic acid, eicosapentaenoic acid (OMEGA-3); probiotics NOS and; prenatal multivitamin. The patient was pregnant at the time of vaccination (last menstrual date: 05Dec2020, gestational period: 3 weeks, delivery date: 11Sep2021). The patient experienced sore arm for 2 days after receiving vaccine on 31Dec2020 (no treatment was received for this adverse event); no other side effects experienced. Then the patient was exposed to 2 COVID positive coworkers in the pharmacy on 31Dec2020, 02Jan2021, 03Jan2021, 04Jan2021, and 06Jan2021 (no treatment was received for this adverse event). The patient was informed about the exposure on 11Jan2021 and on the same day she had a PCR COVID test via nasal swab submitted. The test result came back on 12Jan2021 and it was negative. Today (13Jan2021 14:00), the patient stated that her upper left arm feels sore and tighter, it feels like there's a small lump present there (no treatment was received for these adverse events). The patient had no Covid prior to vaccination and had no other vaccine in four weeks. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
In the evening had chills, shaking, could not get warm, low grade fever, 01/13/2021next day all over body aches, 99.9 and then arm pain at injection site nausea and diarrhea 01/14/2021 nausea and diarrhea disappeared on 01/14 or 01/15/2021.  Nausea and diarrhea with first dose for two days.
Pain; Sore arm; Headache; Fatigue; A spontaneous report was received from a 35-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced headache, pain, sore arm and fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) for prophylaxis of COVID-19 infection.   On 06 Jan 2021, after receiving the vaccine, the patient experienced headache, pain, sore arm and fatigue. Treatment for the events was Ibuprofen.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events is Recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I felt a little off for 2 hours; sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt a little off for 2 hours) and VACCINATION SITE PAIN (sore left injection site arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced FEELING ABNORMAL (I felt a little off for 2 hours) and VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, FEELING ABNORMAL (I felt a little off for 2 hours) and VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) SARS-CoV-2 antibody test- Negative.         No concomitant medication was given by reporter. No treatment medication was given by reporter.
~24 hours after injection pt. had fever >102.0 degrees F, large red area around injection site moving up under armpit, "tingling sensation" in shoulder & neck.
Patient is 64 years old and received a Fluzone Quad High Dose vaccine. According to CDC: Fluzone High-Dose Quadrivalent vaccine is approved only for people 65 years and older. Fluzone High-Dose Quadrivalent is not approved for people younger than 65 years or for people of any age with a history of severe allergic reaction to any influenza vaccine or to vaccine components other than eggs. Information about vaccine ingredients is located in the manufacturer?s package insert. Manufacturer Package insert:
Prevnar given IM right thigh. Thigh turned red and baby is screaming / crying uncontrollably - gave Benadryl 3/4 tsp PO. Stopped crying about 15 mins after - ice pack applied to thigh - 30 mins after baby resting quietly. Redness and swelling gone.
pt feels dizzy and fell at home. Pt also experiences HA, N/D. Pt only takes tylenol at home to help with the headache.
CHIEF COMPLAINT:   Patient presents with fever and shortness of breath, Patient is deaf and has his wife interpreting, O2 on arriaval 88% on RA placed on 4L NC and came up to 94%   HISTORY OF PRESENT ILLNESS:     Patient presenting to the emergency department for shortness of breath and cough.  Patient is also been having persistent fevers.  He was diagnosed with Covid 8 days ago and symptoms been worsening over the last several days.  Patient was found to be 88% on room air and then down to 86% when arrival in the ED.  Patient denies any chest pain.  Patient Nuys any nausea vomiting.  Nursing note reviewed patient seen during the Covid pandemic.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with an expired dose of ZOSTAVAX for prophylaxis.
Chills, severe headache, dizziness, chest tightness, elevated heart rate.
Vacc 2 wks prior. Pain day after vacc. progressed to reduced range of motion and severe pain with movement day 9. Pain at vacc site, no redness or swelling, decreased ability to lift objects and undress.
WITHIN AN HOUR SINCE RECEIVING VACCINE THE PATIENT BEGAN VOMITING, TURNING BLUE, SHAKING, FEVER THAT BEGAN AT 103 AND CONTINUED TO CLIMB HIGHER, ALSO DIARRHEA. SHE IMMEDIATELY BECAME EXTREMELY LETHARGIC AND SLEPT FOR 3 DAYS, REFUSING TO EAT AND DRINK. THIS WENT ON FOR 7 DAYS. SHE WAS TAKEN TO HOSPITAL AND THE PEDI CENTER.
pruritus 5min p/vax;urticaria gen, 12hr later;hydrozyzine & pred given;
Sore injection site turned into severe sore shoulder joint and has persisted for the last three months.  My mother (who is 92 years old) and I both received the vaccination at same time, same facility by same pharmacist and BOTH of us have the identical symptoms.
* Vaccinated on 3/24/21 * Suddenly suffered tinnitus and hearing loss at my left ear on 3/30/21 * Tinnitus and hearing loss got better on 4/2/21 * Took Methy1PREDNISolone treatment starting 4/2/21 after seeing ENT doctor * As of 4/3/2021, the tinnitus at my left ear went away but still experiencing a small degree of hearing loss.
My Mom received her 2 shots at the same facility.The 1st shot no reaction the second shot she was in bed sick for 3 days.She did recover but seemed to feel very weak after that second shot.She kept saying she did not feel right.On April 21 her legs buckled she could not stand or walk.We put her back to bed and at  7 her legs buckled again.She was taken by ambulance to hospital where she stayed for 7 days .She was then transferred to another hospital for PT for 21 days.She never was able to stand or walk again.Neither of these facilities could say why it was a mystery.She was transferred to a nursing home because she could not stand or walk on May 24.She continued to go downhill and on July 4th she passed away.I cannot help but wonder if it was not this second shot.
First symptom was crawling delayed, speech delayed, he can not walk. Diagnosed with hypotonia, hyperflexia and motor delay skills.
Redness, pain, swelling at injection site; back pain, fever, sweats, fatigue, headache, left underarm pain, dizziness
Information has been received from a health professional concerning a 4-5 year old patient who was vaccinated with a dose of Varivax. "Within the past 2 weeks," in April or May 2006, the patient experienced mild breakthrough. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Initial report was received on 23 June 2014 from a health care professional. A 59 year-old female patient had received on an unspecified date ADACEL, lot number U4875AA (route and site of administration not reported) and unspecified amount of time later after administration, experienced cellulitis. No further information was provided at the time of the report. Outcome was not reported. Documents held by sender: none.
Rt arm pain -MD in ER said shot was given in wrong msucle; had pneumonia also; to hosp 16NOV;
This spontaneous report as received from a nurse refers to unknown number of patients of unknown age and gender. On an unknown date unknown number of patients was vaccinated with VAQTA (dose, route of administration and anatomical location unknown) which underwent an unsupported temperature excursion. Pertinent medical history and concomitant medications of patients were unknown. No adverse effects reported. The outcome of the events was unknown. No further information provided. This case is linked to case # 1407USA04195, 1407USA005730. 1407USA005731, 1407USA005736 via same reporter link. Additional information has been requested.
Pain at site,  shivering and fever, all-over body aches, Headache, dizziness and vomiting, very tired.
Throat swelling, hoarse voice, chest tightness and red rash. Allergic reaction.
Reconstituted lyophilized component with Xylocaine; Reconstituted lyophilized component with Xylocaine and administered the doses; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number L4472) for prophylaxis.   In FEB-2023, the patient received the 1st dose of Shingrix. In FEB-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted lyophilized component with Xylocaine) and inappropriate dose of vaccine administered (Verbatim: Reconstituted lyophilized component with Xylocaine and administered the doses). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-MAR-2023 The licensed practical nurse reported that, they reconstituted Shingrix lyophilized component with 1 percent Xylocaine and administered the dose to patient back in early February 2023. The reporter mentioned for each patient was attempt at first dose of Shingrix. The reporter was unable to provide any vaccine or patient details. The reporter called to inquire that how to proceed. The reporter did not consent to follow-up. The reporter reported that, they reconstituted Shingrix lyophilized component with 1 percent Xylocaine and administered the dose to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023034624:same reporter US-GSK-US2023034626:same reporter
i had my third phizer covid booster shot on October 20 2021 and after that i started having fatigue and pain in both legs  which is same at rest or on ambulation and do not change.Has no swelling in legs and my pulses in both legs are same. i saw  my physician and ran blood test which only showed elevated blood sugar of 157 .i am not diabetic and has no symptoms of diabetes like polyurea or polydipsia.During my last annual check up in October my blood sugar was 110 which is same for  last 5 years and since last October i have l0st 30 pounds by changing my diet and walking 5 miles a day/my thyroid test were normal done two weeks ago.i am concerned that all this are due to vaccine.I am a retired internal medicine physician so I thought it is worth reporting to FDA.i still have leg pain and Fatigue and Feels more cold than other members of Family which is Quite opposite until Earlier this Year.If you need More information please let me know. I am only taking Loratadine 10 mg and Tamsulosin 0.4 mg Daily.
This non-serious spontaneous case, reported by a nurse on 28-Mar-2018, concerning a 25-year-old adult pregnant female patient. It was unknown whether, patient used any contraceptive methods. On 28-Mar-2018, pregnant patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported). The patient had provided the permission to be contacted by the research for pregnancy registry. It was reported that, patient's fetus did not experience any adverse event after the vaccination. The patient's estimated delivery date was 11-Apr-2018.
5 patients received a full vial (3.0 cc reconstituted dose) of yellow fever vaccine by mistake. There is currently no symptomatic complaints. This patient was identified as one of the possible recipients.
She has completed both moderna vaccines first one 01/17/21 and 2nd one  2/4/21.   on 02/21/21 she started with unexplained HIVES over arms, abd and back.  She has never had hives before  She took benadryl which helped some and was given cetirizine and triamcinolone.
Patient describes fatigue starting 1 hour after receiving vaccination. Patient now calls COVID19 hotline 3 days after initial symptoms and states fatigue is more moderate. Patient experiencing loose stool. Patient has hx of IBS however symptoms are worse than baseline.  Patient describes mild headache and increase in agitation/moodiness. Hx of bipolar disorder.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  The BUD of the vaccines was reported as 02-Feb-2022  Reporter stated that they had a group of 13 pharmacies and had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware that in some of the freezers there was a temperature excursion that their data logs showed. They were preparing for a CDC audit and wanted to reach out to see if the vaccines had been compromised. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures.   Reporter queried whether they need to take any action since they stored them in the freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  No treatment medications were provided.   This case was linked to MOD-2022-513803 (Patient Link).
This non-serious consumer report (initial receipt 05-Dec-2014) concerns a 62 year old female patient who had no relevant patient history. On the 28-Oct-2014, the patient received AFLURIA (batch number T50907) 0.5mL once via the intramuscular route. On the 30-Oct-2014, the patient noted the development of a two inch wide red to purplish ring around the injection site. The injection site was also puffy, sensitive and irritated. To date, there was still minor irritation and discolouration around the injection site, although the side effects have decreased since they initial presented. The puffiness had resolved two weeks from the initial presentation. Outcome was not recovered. Reporter comments: The reporter stated that the events were non-serious.
That night and for many nights after there was extreme pain in the left shoulder.  I did not sleep for several nights.  I went to the doctor and received a Medrol Dose Pack, Tramadol, and Ibuprofen 600 mg. I got a little relief but as soon as I finished the Medrol Dose Pack I was in pain again.  I have lose of range of motion in that arm.  I  wake up several times in the night in pain.  Just the natural swing of the arm when walking produces a nerve like pain.  Moving around in bed is very painful.  Now almost 6 months later I still have all these symptoms.