chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vial was moved from the frezeer to the fridgeon 29-Apr-2022; Patient took expired on 06-May-2022 which expired on 05-May-2022/people vaccinated with the expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient took expired on 06-May-2022 which expired on 05-May-2022/people vaccinated with the expired vaccine) and PRODUCT STORAGE ERROR (Expired vial was moved from the frezeer to the fridgeon 29-Apr-2022) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient took expired on 06-May-2022 which expired on 05-May-2022/people vaccinated with the expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was moved from the freezer to the fridgeon 29-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient took expired on 06-May-2022 which expired on 05-May-2022/people vaccinated with the expired vaccine) and PRODUCT STORAGE ERROR (Expired vial was moved from the freezer to the fridge on 29-Apr-2022) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow up received contain non significant information event verbatim has been updated. On 11-May-2022: Follow up received contain significant information, date on which vial was removed from refrigeration has been updated.
Parent reports unsure of actual onset of rxn.  Brings child to this clinic. Both parents state that there is no apparent s/s of systematic infection. This nurse notes area of erythematous lesion c obvious induration.  Induration is measured at approximately 65*45mm oval shaped @ midline on child's RVL.  Child is anxious et guarded throughout exam but this rxn appears to be from anxiety r/t the previous vaccinations.  Pt does not show increased guarding as this RN palpates rxn site.  Discuss c father options r/t tx, including but not limited to warm or cool moist packs as well as APAP.  Also discuss s/s that should be reported to this RN or another qualified medical professional.  Parent asks appropriate questions et voices understanding.  Phone call also made to patients mother to explain situation as well as tx options, s/s requiring reporting, and possible causes for rxn.  Mother (who is an RN) also voices understanding. Both parents will call if c/o arise.
I recently have covid; I am having very bad indigestion; Not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I recently have covid), DYSPEPSIA (I am having very bad indigestion) and MALAISE (Not feeling well) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Had Two doses). Past adverse reactions to the above products included COVID-19 with Pfizer.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I recently have covid), DYSPEPSIA (I am having very bad indigestion) and MALAISE (Not feeling well). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ALKA-SELTZER) at an unspecified dose and frequency. At the time of the report, COVID-19 (I recently have covid), DYSPEPSIA (I am having very bad indigestion) and MALAISE (Not feeling well) outcome was unknown.            No Concomitant medication reported. It had been reported that the patient had two doses of Pfizer (suspect name not clarified hence, captured as Unspecified Product) and one booster of Moderna (suspect name not clarified hence, captured as Unspecified Product).   Company comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the non-serious unexpected, AESI of COVID-19. The event occurred after the mRNA-1273 vaccine, received as the booster dose of COVID-19 vaccination schedule, temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. Patient received treatment with nirmatrelvir, ritonavir. The outcome of the event was reported as unknown. Additionally, Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine Tozinameran dates not provided) was noted in the case. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the non-serious unexpected, AESI of COVID-19. The event occurred after the mRNA-1273 vaccine, received as the booster dose of COVID-19 vaccination schedule, temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. Patient received treatment with nirmatrelvir, ritonavir. The outcome of the event was reported as unknown. Additionally, Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine Tozinameran dates not provided) was noted in the case. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 1st December 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient experienced shingles a couple of days after receiving the dose of Shingrix. The reporter consented to follow up.
Patient was given two flu vaccines on the same day.  One private dose and one other was given.  One was given in left arm and one given in the right arm.  Patient forgot she had already received a flu shot.  No adverse reactions noted.
Member complains of "severe itching" head-to-toe. Member given BENADRYL and CLARITIN by doctor.
Has Bells Palsy as a result; Side of the body on which he received the Shingrix is weak; Sore arm; Felt lousy; First and only dose of Shingrix in June 2020; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant), hemiparesis (serious criteria GSK medically significant), pain in arm, feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the bell's palsy, hemiparesis, pain in arm, feeling bad and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the bell's palsy, hemiparesis, pain in arm and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of Shingrix, the patient had a sore arm, and feeling lousy.   He did not elaborate on what feeling lousy entailed.  Also, the patient's unknown side of the body on which he received the Shingrix was weak.  The patient also had bells palsy as a result. Till the time of reporting, the patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter did not consent to follow-up. The patient noted that, he reported this event previously, but call center representative could not find him in the system, or his phone number.  He did not wish to proceed with a safety report and did not wish to give me any demographics or further details.   The patient wanted to know whether he would have a reaction to COVID 19 vaccine due to his Shingrix experienced.   He was referred to his provider.
Tinnitus in both ears is much worse; had a hard time hearing over it; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration in arm left on an unspecified date in 2021 as a dose 2, single for COVID-19 immunization. The patient's medical history included tinnitus, before I received the vaccine, I had slight tinnitus. Known allergies were reported as none. The patient's concomitant medications received within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID), taken for an unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN5318, Expiration date was not reported), via an unspecified route of administration in arm left on 31Jan2021 as a dose 1, single for COVID-19 immunization. It was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as yes. Covid test type post vaccination included was nasal swab, Covid test name post vaccination was reported as SARS-CoV-2 NAT, NP Swab, Symptomatic. On an unspecified date in Mar2021, the patient experienced tinnitus in both ears was much worse since the second dose of the vaccine. Before the patient received the vaccine, had slight tinnitus but since the second dose it has gotten so loud, she had a hard time hearing over it. Stated that, she was concerned if she got a booster shot, she will not be able to hear over the tinnitus. Stated that, she hadn't experienced any loud noises that would have caused it to worsen. The reporter considered the seriousness criteria of the events as non-serious. Treatment was not received for the events. On 13Aug2021, the patient underwent lab tests and procedures which included SARS-CoV-2 NAT,  Swab, Symptomatic (SARS-CoV-2 test), resulted as negative, SARS-CoV-2 NAT, Nasal Swab. The device date was on 17Aug2021. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
The night after the second injection, she started feeling tingling on the left hand fingers tips and pain in the left knee and ankle. After one to two days the pains subsided but the knee keeps warbling and shakes when she try to walk or stand on it.  Up to now, the tingling is not severe as at first but warbling is almost the same.
On the 8th day after receiving the injection in my left arm I?ve noticed a large red area on my outer arm that is hot to the touch, vaguely achy, and itchy. It does appear to have some swelling in the area as well.  Today, 9 days after the injection, the area appears just slightly larger than yesterday.
First injection of Shingrix just had sore muscle for about a week.  Second injection about ten hours late became fatigued, slightly nausous, chills, fever and joint aches and pains.  Felt like flu symptoms.  Day 2 had the same side effects.  Took day off work.
staff administer an  expired Moderna covid19 vaccine on the 2apr2022 that was expired on the 1apr2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (staff administer an  expired Moderna covid19 vaccine on the 2apr2022 that was expired on the 1apr2022) in a 73-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 026l21b) for COVID-19 vaccination.     History relating to mentioned AE and both Acute and chronic illness at the time of vaccination: NO. Other vaccine given within 1 month prior to moderna covid-19 vaccine: NO.     On 02-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (staff administer an  expired Moderna covid19 vaccine on the 2apr2022 that was expired on the 1apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (staff administer an  expired Moderna covid19 vaccine on the 2apr2022 that was expired on the 1apr2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Date the vial was initially stored in the refrigerator on 31March2022 and vial did not undergo any temperature excursions. Symptoms have been improved. No treatment information was reported.   This case was linked to MOD-2022-533307 (Patient Link).
Red raised rash  to right upper arm about 8 inches long by 3 inches wide,  irregular in shape, hot to touch, not itchy.  After about 4 days of rash being present, it is still present but less pronounced.
3in by 3in welt that is hot to the touch 10 days and counting after injection
pt recv vax 17OCT95 & dx GBS;19NOV95 pt exp sore throat & cough;pt cont to feel bad;29NOV95 head feeling strange-really heavy;h/a like a migraine, vision was affected;eyelids drooping-had double vision & balance affected;dizzy;
1 st,dose, no adverse reactions, other than a sore arm for a day or  too. ,   2nd  dose given on Nov, 3 rd, 2020. developed rt. side earache several weeks later..
Redness from shoulder to elbow; Itchiness from shoulder to elbow; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Redness from shoulder to elbow) and PRURITUS (Itchiness from shoulder to elbow) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced ERYTHEMA (Redness from shoulder to elbow) and PRURITUS (Itchiness from shoulder to elbow). On 17-Feb-2021, PRURITUS (Itchiness from shoulder to elbow) had resolved. On 21-Feb-2021, ERYTHEMA (Redness from shoulder to elbow) had resolved.            Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-061333 (Patient Link).
1. Patches of rash on skin (arms, legs and neck) 2. Bartholin's cyst 3. Intermittent migraine with nausea for 6 full days after injection
Patient given 0.25ml dose as primary dose, recognized after patient left the building. Consulted CDC errors and deviations document, patient notified and offered additional 0.25ml to complete primary dose. Patient agreed, vaccine administered.
In the weeks following Moderna COVID-19 vaccination, my angioedema which had been quiet for several years has recurred weekly, with swelling of tongue, swelling of lip, swelling of cheek, and possible swelling of foot.  Symptoms have subsided after a few days without need for epi-pen use.
Pt had covid-19 infection in the past. She received her covid 19 first dose without incident. she received her 2nd moderna covid 19 vaccine on  10/11/2021  and on october 29th 2021 suddenly developed a body wide rash with macular, red lesions across her neck, arms, trunk, back and legs. The rash has been persistent and not improving. She is a breastfeeding mother of twins and has noticed 3 days after she developed the rash her infant son and daughter are also beginning to develop lesions on their hands that appear similar in appearance. The lesions are only mildly pruritic and easily blanch to pressure
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 28-OCT-2014, an unspecified number of patients were vaccinated with improperly stored GARDASIL lot # H020901, expiration date: 05-JUL-2015 (dose and route of administration were not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Vaccine was reconstituted incorrectly. 0.8ml instead of 1.8ml of diluent was used. 3 patients received the higher concentrated doses. patients were notified. No adverse reactions have been reported.
This spontaneous report was received from a nurse, referring to several unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and  concomitant medications were not provided. On 11-SEP-2017, three patients were vaccinated with and incorrect stored dose of PROQUAD lot # N010115 with expiration date on 24-SEP-2018 (strength and route were not reported) for prophylaxis, however no adverse effects reported. other patients were vaccinated in unmentioned dates. It was reported that the vaccines were exposed to temperature of 15 to 46 Farenheit grades range. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved.
On June 7, 2022, patient had an unprovoked, unexplained seizure. She had seizures in 2015, which were controlled with medication. She had been seizure free since August of 2015. It has almost been 7 years without any issues. I don't know if the vaccination lowered her threshold, but I felt it was the only thing that was different in her life during that period of time worth reporting. She was hospitalized on June 7th, 2022.  There was no explanation for the seizure.
internal hives/had internal hives inside her torso; Itchy; First dose of Covid Vaccine was on 09Mar2021; Second dose on 06May2021; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0176), via an unspecified route of administration on 06May2021 (at the age of 66-year-old) as single dose for covid-19 immunization. Medical history included Ongoing Hashimoto's (when asked how long she has had this condition the patient stated she has had thyroid issues for 40 years). The patient had no family medical history relevant to AE(s). There were no concomitant medications. The patient had no additional vaccines administered on same date of the Pfizer Suspect considered as suspect. The patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) and no AE(s) following prior vaccinations. The patient previously received first dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534), via an unspecified route of administration on 09Mar2021 (at the age of 65-year-old) as single dose for covid-19 immunization and experienced hives. About 2 and a half weeks after each dose of the Covid Vaccine she started getting internal hives. States they were itchy in her torso. Patient emphasizes that the hives were not on the outside of her skin, but on the inside. They were on her entire lower torso and upper thighs. Nothing seemed to help them. Her sister in law recommended Benadryl cream, the patient states that helped. States the itching was worse at night. Patient states the reaction was worse the first time around. She did not know if it was a side effect of the vaccine at that time. When it happened again with the exact same timing after the second vaccine, she thought it must be related to the vaccine. The patient was reporting a side effect related to the Covid Vaccine. Says it did not occur to her that it was related to the vaccine until after she had both doses. Patient states she waited longer between shots because she had the hives right before the second dose was due and the doctor told her to wait until they subsided. Once they had subsided the doctor told her to go ahead and try and get the second dose. Patient states her doctor thinks the patient had a Cytokine reaction. The patient states that she has Hashimoto's. Patient said she experienced unusual reactions to both the first and second dose of the Pfizer COVID Vaccine. She he had internal hives inside her torso and not on the skin on 17 days after getting both the first and second dose. She said that these were not normal hives. And scratching does not help. She was asking for any analysis why she was getting this. The patient had no relevant tests. Outcome of the events Itchy internal hives was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Feel itching on the back of his neck and around the sides of his neck; Fever; Chills; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th April 2021, the patient received the 1st dose of Shingrix (intramuscular). On 24th April 2021, 2 hrs after receiving Shingrix, the patient experienced fever, chills and tiredness. On 14th May 2021, the patient experienced pruritus. On 26th April 2021, the outcome of the fever, chills and tiredness were recovered/resolved. On an unknown date, the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, tiredness and pruritus to be related to Shingrix.  Additional details were provided as follows: The case was reported by wife of the patient. About 2 hours after receiving the 1st Shingrix vaccine, the patient began to get fever, chills and tiredness and resolved two days later. The patient began to feel itching on the back of his neck and around the sides of his neck about one week ago from the date of reporting. The itching had not resolved. Caller reported her husband would contact his health care professional (HCP) for advice. The reporter did not consent to follow-up. The case had been linked with US2021109078 patient's wife case reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021109078:Same reporter. Wife's case.
Pericarditis, after experiencing achy joints  Excruciating stabbing pain in back through to chest
face swelling, fever, dizziness, falling a lot, sensitive to light, chest pain, eyes swollen, fatigue, extremely tired, horrid headaches. I couldn't get out of bed
Swelling, redness and warmth from (L) deltoid to elbow, developed chills.