chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 25-NOV-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 800 hours, with the highest recorded temperature of 48 degrees Fahrenheit and -1.66 and 8.88 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
fatigued, maliase, weakness for the first hour. unable to get out of bed. Mouth ulcers, hives, urticaria, lymphadenopathy  (1 month). lymph nodes are still slightly swollen and tender
Bottom lip began to start to swell 2 1/2 hours after receiving vaccine.  Took 50 mg Benadryl and swelling resolved after 3 hours.
My menstrual cycle changed drastically, temporarily, right around my vaccines. I am extremely regular with a normal cycle length of 26 or 27 days. I had my hormones checked less than a year prior to the vaccines as part of a routine exam and was told not to expect any age-related changes anytime soon. The cycle I was in when I received my first dose (12/30/20) was extended by about 3 days - not groundbreaking, but noticeable to me. Then following my second dose (1/27/21), I completely missed a period. So the 2 cycles during which I had my vaccines were 30 days and 53 days long instead of my usual 26-27. Now, a couple months later, I have returned to my usual schedule.  It was unsettling for my cycle to be affected and at first it didn't occur to me that it could have been related to the vaccine, but the timing was exactly aligned so it seems very likely it was causal.
This is a spontaneous report received from a noncontactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced lymphadenopathy (swollen lymphatic system), with outcome of unknown. Additional information: The patient wanted to know if they didn't get the second dose at 3 weeks (21 days), when could they receive the second dose of the Pfizer-BioNTech COVID-19 vaccine? The patient also wanted to know why their lymphatic system swelled-up, and inquired about the  ingredients included in the vaccine (preservative in the vaccine, components of the vaccine vial made with latex, vaccine contain live virus, emergency use authorization, manufacturer and wanted to participated in the Pfizer-BioNTech COVID-19 clinical trial. No follow-up attempts possible. No further information expected.
received the first dose / on 8/30/2018 and had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 30th August 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provide are as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received the 2nd dose, which led to incomplete course of vaccination. The reporter preferred not to disclose any information regarding the patients but clarified that there were two patients involved. The reporter had no further information but agreed to contacted for follow-up. The reporter consented to follow-up. This is one of two cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR170563:Same reporter
Swollen lymph node L armpit, extremely painful. Reduced/resolved, yet still painful on 10/27. Friday 10/29 L armpit lymph node swollen again with R armpit lymph node swollen. Very painful, stop swollen. Holler with backpack painful, difficult sleeping on both sides. PCP ordered CBC today, another appt scheduled.
RASH ON LEFT LEG, RIGHT LEG, AND LEFT ARM. RASH IS ON THE SITE OF INJECTIONS GIVEN. FEVER FOR 2 DAYS AFTER VACCINE GIVEN. NO TEMPERATURE WAS RECORDED.
Pt presented to office 3 days post vaccination stating day after injection site was "swollen", "burning" and "hot". Described on going "itching" at the site exam. Revealed urticaria at injection site and along the rt arm extending to the torso. No sc nodules or induration.
B/L hand, elbow and knee with several  1-2 mm coalescing erythematous papules with (+) ITP.
Large red circular spot appeared on the site of the injection about 10 days later. There was a rash, it was warm to the touch, slightly raised, and itchy.
More than 12 hrs after immunization for 5 year well child visit, mother noted painful swelling on (L) posterior upper thigh; Ibuprofen given and warm compress applied; Initial 10 cm induration reduced to 5 cm and no longer painful.
[Broke out in an active shingles] rash from underarm to nipple; Broke out in an active shingles [rash from underarm to nipple]; Information has been downloaded from Agency (US-BEH-2017077065).  Information has been received from a consumer referring to a 60 years old male patient. The patient's medical history, concurrent condition and concomitant medication were not provided.  On 13-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (subcutaneous; strength, dose, lot # and expiration date were unknown) for unknown indication. On the same day, the patient also vaccinated with influenza virus split virion 3v vaccine inactivated (AFLURIA) (0.5 ml, intramuscular; strength, lot # and expiration date were unknown) and pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (intramuscular; strength, dose, lot # and expiration date were unknown) for unknown indication.      On 22-OCT-2016, the patient experienced broke out in an active shingles [rash from underarm to nipple]. On an unknown date, the patient experienced [broke out in an active shingles] rash from underarm to nipple. The outcome of both events was unknown. The causality between both events and all the suspect therapies was not reported.      The agency considered both events to be medically significant.
1) Began period on April 9,2021,  2days after 1st injection. Previous menstrual activity began June 24,2020, and lasted 8 days.  2) A feeling of a slightly constricted throat, a few weeks after final injection. Have never had anaphylaxis in previous history. Slight throat constriction is active approximately 75% of the time. If I tilt head backward, I can definitely feel a more open Feeling.
productive cough, sore throat, headache/heavy feeling, runny, chest congestion, chest tightness, shortness of breath, fatigue, diarrhea-3 times/no blood in stool, sinus congestion, nasal congestion,. starting 10/4/21
Arexvy administered during pregnancy.; 39-year-old patient received a dose of Arexvy; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 39-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-OCT-2023, the patient received Arexvy. On 20-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim:  39-year-old patient received a dose of Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy administered during pregnancy.). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date 20 Oct 2023: The physician called to inform that a 39-year-old patient received a dose of Arexvy. Also, that patient was pregnant, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up.
Pt recvd vax on 9OCT92 & devel Bell's palsy; It was felt that the exp resulted in a poss permanant disability; No further detials were provided;
Patient developed leg claudication in early October after Moderna COVID-19 vaccination in late September. These symptoms persisted for 3 months and he was hospitalized in early January 2022 where he was found to have aortitis on imaging. He was seen by vascular surgery and infectious diseases. Blood cultures were negative, he improved with steroids. Workup for possible vasculitis vs recurrent malignancy is underway.
diarrhea; shaky; vomiting; chills; runny nose; nausea; sore arm; swelling; headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), PAIN IN EXTREMITY (sore arm), SWELLING (swelling), DIARRHOEA (diarrhea) and TREMOR (shaky) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), SWELLING (swelling) and HEADACHE (headache). On 28-Mar-2021, the patient experienced RHINORRHOEA (runny nose), DIARRHOEA (diarrhea), TREMOR (shaky), VOMITING (vomiting), CHILLS (chills) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, RHINORRHOEA (runny nose), PAIN IN EXTREMITY (sore arm), SWELLING (swelling), DIARRHOEA (diarrhea), TREMOR (shaky), VOMITING (vomiting), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up was received on 07 July 2021 - Events outcome added.
I started with a sore throat and raspy voice. As the day progressed my head filled up with sinus pressure, drainage and congestion.  I went to urgent care and completed a COVID-19 PCR test, and it was negative on February 27, 2023. I had to wait until March 01, 2023, and went back because my home COVID-19 test was positive. I went back to urgent care and also received a positive COVID-19 test. I began taking Paxlovid the same day. I didn't have any fever until March 03, 2023, but I am no longer having that. I still have a cough and sinus drainage, so I am still recovering.
fluttering; heart started racing; diagnosed with MVPC, multiple ventricular premature complexes; fatigue; same heart issue.; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 29Oct2021 16:45 (Lot Number: FH8027) at age of 53-year-old as single dose for covid-19 immunisation.  Medical history included asthma, allergy to sulfur drugs, latex, guillain-barre syndrome, fibromyalgia.  The patient was not pregnant at time of vaccination. No covid prior vaccination. The other medications in two weeks included normal prescriptions. The patient previously took bnt162b2 (lot number=FF2587) dose 1 on 08Oct2021 04:45 PM at Left arm at age of 53-year-old for covid-19 immunisation, azithromycin (Z-PAK). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 30 minutes (29Oct2021 17:15), heart started racing, fluttering, palpitations. Patient went to the ER Saturday morning, diagnosed with MVPC, multiple ventricular premature complexes- V complexes w/ short R-R. A week later she was still feeling the same, now with fatigue, still have same heart issue.  She cannot get into a cardiologist as ER doctor recommended until 24Nov2021. All event onset date was 29Oct2021 17:15. The adverse event result in Emergency room/department or urgent care. No treatment received for the events. The covid was not tested post vaccination. The outcome of events was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
It was reported that a 31 year old male patient received a TD-Adult vaccination on 8 May 2000. Reportedly within 5 hours the patient developed a fever, chills, myalgia and a sore throat. The patient still experiences chills and fever at night. Further information requested. From additional information received on 7 Jun 2000, it was reported that the symptoms lasted for 72 hours and then resolved completely. The patient recovered from this experience.
Patient had a headache left sided radiating to her neck and upper back when she got out of her car to use the restroom.
Skin:        approx 2 cm local  erythema  at injection sites on Left deltoid. Noncontiguous  erythema, edema and tenderness in series of patches distal & medial along lower L biceps. from middeltoid to above elbow. No papules, vesicles or pustules.
Nausea and vomiting approximately 4 hours after receiving the first dose of the vaccine, nausea lasted about an hour, vomited only once
red, swollen arm @ inj site; hot & tender to the touch; cool compresses on site;
onset of sx few seconds p/vax;pt head tipped forward as though becoming faint, then face, head & neck twitching movements  for approx 6-7seconds;became faint p/twitching movements ceased;pt wetting bed in middle of noc;
I was just aching with the first injection; This is a spontaneous report from a contactable consumer (patient). An 85-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication stated as yes, details were not provided (other products: yes). The patient experienced just aching with the first injection on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included laboratory test: unknown results on 05Feb2021 and stated it was a long result. Patient called after she got the first injection because she had so many questions that weren't answered for her (not clarified if called in Pfizer drug safety, hence case was marked as initial). Height was stated as probably about 5'3". Facility name where the vaccine was administered, consumer stated as continuing care residency, well they were issued by or distributed by (pharmacy name) pharmacy. When asked about concomitant medication, patient stated she take lot of medications, and to hold, to let her get list of meds. Patient stated she had no problem; she was just aching with the first injection. When asked about product details (LOT# and expiration date) for first dose: Consumer stated to have the first date and guessed as 18Jan and said no. Consumer was informed about Pfizer Medical information department. Patient wanted to know was the injection effective even though she had that itching, concern because she has long list of symptoms that Pfizer gave her, the literature that she had and that was not one of them and just wanted to be sure because it was different, and her results of receiving and having a medication effectiveness was not hampered. Clinical outcome of event was unknown.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
general arthralgia; This non-serious case was reported by a nurse via call center representative and described the occurrence of arthralgia in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number HF5016) for prophylaxis.   On 18-SEP-2023, the patient received Arexvy. In SEP-2023, 1 week after receiving Arexvy, the patient experienced arthralgia (Verbatim: general arthralgia). The outcome of the arthralgia was unknown.   It was unknown if the reporter considered the arthralgia to be related to Arexvy.     It was unknown if the company considered the arthralgia to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-OCT-2023 A nurse practitioner called to inform that a patient that got a dose of RSV vaccine a week after the patient reported general arthralgia. The reporter said that it was unknown if the dose of the vaccine was from GlaxoSmithKline or from Pfizer. The reporter consented to follow up.  The vaccine administration facility is the same as primary reporter.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:53 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:53 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 27.77.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021. On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 4036 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
I got infected with the covid-19 virus after receiving the first dose of the covid-19 vaccine by Pfizer/bioNtech symptoms started on February 22nd and I received the first does of the vaccine on February 11th
Pt passed out immediately after getting GARDASIL.  She was unresponsive for <1 minute.  She did have tonic clonic movements for 15-20 seconds.  Pt was fasting with glucose 64.
Impaired memory/cognition, constant headache since 1/4/00; chest pains; 3 syncopal episodes (totaled car) (lost license), fatigue, personality change, episodes of disorientation with abnormal EEG; episodic atrial fibrillation and pool balance.  Follow up report on 09/07/2001: "As of 08/31/2001, his status is unchanged."
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 11-NOV-2015, the patient was vaccinated with ZOSTAVAX (0.5 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 49 days (Incorrect product storage and incorrect dose administered). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Subjective fever, irritability, twitching (shaking, chills, tremor, doubt seizure).
chronic urticaria/hives/hives on the waistband of jeans and where a grocery bag rubs against her; headache; aches; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA CHRONIC (chronic urticaria/hives/hives on the waistband of jeans and where a grocery bag rubs against her), HEADACHE (headache) and PAIN (aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Eczema.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced HEADACHE (headache) and PAIN (aches). In June 2021, the patient experienced URTICARIA CHRONIC (chronic urticaria/hives/hives on the waistband of jeans and where a grocery bag rubs against her). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Adverse event, at an unspecified dose and frequency. In January 2021, HEADACHE (headache) and PAIN (aches) had resolved. At the time of the report, URTICARIA CHRONIC (chronic urticaria/hives/hives on the waistband of jeans and where a grocery bag rubs against her) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After the reactions, patient went to an allergist and had done multiple of tests including thyroid tests.  Patient has a history of eczema and used to take allergy shots as a kid
Headache, Sneeze, Earache, Sore throat, Nauseous, Coughing and running nose.
received covid vaccine yesterday afternoon. today at 1100 she began to experience body aches and she states a fever. took Tylenol at 1230. when she arrived here she was slightly tachycardic at 115 but afebrile. exam normal.
Received 3rd GARDASIL 3/4/14 in (L) arm. Mom noticed (L) arm swelling and redness and itchiness starting 3/6. Came in for MD visit 3/7/14. Dr. reported erythematous, tender and warm area 8 cm x 9 cm LUA.