chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Milder case of shingles; It was still uncomfortable; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Milder case of shingles) and discomfort (Verbatim: It was still uncomfortable). The outcome of the shingles and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the shingles and discomfort to be related to Shingles vaccine.     It was unknown if the company considered the shingles and discomfort to be related to Shingles vaccine.   Additional Information: GSK receipt date: 15-MAR-2023 The case  was received from the patient via interactive digital media. The patient had the vaccine and 3 days later came down with a much milder case of shingles. The patient stated that it was still uncomfortable. The follow-up could not be possible as no contact details were available.
Initial report received on 05 September 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in an three-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3227AA received on 13 February 2009, 10 April 2009 and 11 June 2009, and 1 dose of DAPTACEL; lot number C3322BA received on 09 June 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms on 12 August 2012, approximately two years after the last dose. On 13 August 2012, the subject developed a cough and a week later (20 August 2012) developed a paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 24 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 24 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 27 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Very severe myalgias, tender muscles, skin and generalized fatigue and somnolence. Loss of appetite, bad taste, sore throat (one side), impaired taste and headache with delayed mentation. Felt I was going to die. Had a low grade fever of 100.4. My basal body temp is 97.6.
One hour after administration of LAIV had onset of rash, itching mostly on chest, neck, face and arms. 2 hours after LAIV, developed anxious feeling, tight sensation in chest. No SOB.
Headache, cough, sore throat, diarrhea, skin sensitivity, brain fog, shallow breathing
?Moderna COVID?19 Vaccine    ?I have have a dry cough with  clear phlegm. It started shortly after I received the vaccine. I have never had this problem in the past.
April 22nd, woke with neck pain.  Persisted for 2 days and developed  tingling of one side (left) of the tongue.  Continued pain and numbness until unspecified time when left sided paralysis began. Went to ER and was diagnosed with Bell?s Palsy.  Taking a steroid and Valtrex as prescribed by hcp.
Significant swelling in arm down toward mid forearm. Also warm to the touch and slightly red.
SNEEZING; SINUS PRESSURE; FELT ALOT OF SORENESS AND TENDERNESS IN HIS CHEEKS; LOSS OF APPETITE; SERIOUS DIGESTION ISSUES; STOMACH PROBLEMS; NAUSEA; STOMACH PAIN; RUNNY AND STUFFY NOSE; TASTED IT IN HIS THROAT; NORMAL CONGESTION; A spontaneous report has been received from a consumer. The report concerns a male patient born in 1996 (height 71 in, weight 130 lb).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) (batch number Unknown) 0.2 ml once/single administration, via nasal route, for flu prevention on 01-OCT-2020.     On an unknown date, the patient experienced sneezing (preferred term: Sneezing). On an unknown date, the patient experienced sinus pressure (preferred term: Paranasal sinus discomfort). On an unknown date, the patient experienced felt alot of soreness and tenderness in his cheeks (preferred term: Facial pain). On an unknown date, the patient experienced loss of appetite (preferred term: Decreased appetite). On an unknown date, the patient experienced serious digestion issues (preferred term: Dyspepsia). On an unknown date, the patient experienced stomach problems (preferred term: Abdominal discomfort). On an unknown date, the patient experienced nausea (preferred term: Nausea). On an unknown date, the patient experienced stomach pain (preferred term: Abdominal pain upper). On an unknown date, the patient experienced tasted it in his throat (preferred term: Taste disorder). On an unknown date, the patient experienced runny and stuffy nose (preferred term: Rhinorrhoea). On an unknown date, the patient experienced normal congestion (preferred term: Nasal congestion).     Treatment with Flumist Quadrivalent (influenza virus vaccine live, intranasal) was not changed.     The outcome of the event(s) of sneezing, sinus pressure, felt alot of soreness and tenderness in his cheeks, loss of appetite, serious digestion issues, stomach problems, nausea, stomach pain, runny and stuffy nose, tasted it in his throat and normal congestion was unknown.     The events were considered non-serious.
Patient developed fever and hallucinations one hour after receiving vaccination and symptoms lasted for about 3 hours.  Patient did not seek any treatment.
On 21AUG91 mom brought pt to clinic for immun; Mom reported that pt had a five hr screaming unconsolable episode; 19JUN91 called the MD gave APAP, next day pt was all right x/some fussiness;
This spontaneous report as received from a Nurse refers to a 17 year old female patient with drug allergy to amoxicillin that causes a rash like hives. On 22-JUL-1998, the patient was vaccinated with a dose of VARIVAX (Merck) (dose and route were not reported) lot number reported as: 0650H, expiration date: 21-OCT-1999 (route not reported). Patient was vaccinated a second time on 01-APR-2008 with a dose of VARIVAX (Merck) (dose and route were not reported) lot number reported as: 1593U, expiration date: 28-SEP-2009 (route not reported). Concomitant therapies included DESOGEN and naproxen. On 25-SEP-2014, the patient experienced paresthesia of the thumb and wrist, which spread to right side of neck. On 26-SEP-2014 the patient experienced rash on right side of neck and down the right arm. Patient was seen by an unspecified physician on an unknown date. Patient was also seen in an emergency room at the clinic on 27-OCT-2014 for shingles. On 05-DEC-2014, the patient was diagnosed with neuralgia right extremity, no lesions and a benign exam. The onset date of the events was reported as 25-SEP-2014. Patient was seen by Neurologist on 07-NOV-2014. Was also seen by infectious disease physician on 05-DEC-2014. Patient was treated with FAMVIR and NEUROTIN. The outcome of the events was reported as recovering. Additional information has been requested.
Hot/red-swollen. Dr prescribed AUGMENTIN 875 BID x 10 days.
Swelling locally in arm began within 12hrs. No systemic symptoms, started on dose pack (Medrol) antihistamines, Ice bag.
At the injection site my arm started hurting and then it started to go away. My arm was very red, swollen. and warm to the touch and I had a slight itch as well. I did put Cortisone 10 on it the next day and it started to go away. I never did reach out to a doctor because it went away on its own.
Patient stated that the injection site felt numb/like the injection was still being administered. This was immediately after the injection. Ice was applied, which the patient stated made it feel better. Patient remained in the immunization booth with administering pharmacist for approximately 10 minutes at which time, the patient said he was starting to feel better. Patient and his wife stated they had shopping to do in the store, stated they wanted to do their shopping and stop back before they left the store. Patient continued to use the ice pack while shopping. Approximately 10 minutes latter, he returned with his wife and stated that he was "back to normal" at which time they both left the store. The patient was called at 2:55 PM, his wife answered the telephone with him in the background. She stated that he was doing fine, I asked if he was "back to normal", she stated "yes".
She had redness at the injection site, and she developed cold like symptoms on February 5th. She had a sore throat, runny nose and a cough as well as a fever that came towards the end. After having the symptoms for over 2 weeks she was given amoxicillin to treat the symptoms along with Tylenol and Advil. The fever went away. After about 3 weeks, I started to see less mucus. The fever went away after a couple of days. She has not completely recovered from her symptoms, but she is on her way.
Received his second Pfizer COVID vaccine Tuesday 5/18/2021.  On Wednesday started developing systemic symptoms such as chills, headache, myalgia.  Also developed constant sub-sternal chest pain.  Worse with movement or deep inspiration.  No clear positional component.   CP persisted until he came to the ED today.  Initial ECG showed concave ST elevations lateral leads.  Given his history this was felt to be most consistent with pericarditis.  He received toradol, morphine and SL NTG with near complete relief of the pain.  Repeat ECG showed resolution ST elevations.  Troponin was elevated, peak 9.08 ng/ml.
Pharmacist administered SHINGRIX vaccine dose 1 to patient on 7/20/18 at around 9:50AM. Patient experienced swelling and pain at injection site. Patient also felt tired and had pains all over body including her knuckles. She experienced these side effects for about 3 days and the symptoms prevented her from doing her regular everyday activities. She came in on 7/24/18 to report thse adverse effects to pharmacist on duty (reporter) and patient stated that she is feeling better now and these symptoms went away.
fever; fatigue; muscle pain; swelling in the arm; This is a spontaneous report from a contactable consumer (patient).  This patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. On an unspecified date, after the second dose of the vaccine, the patient experienced fever, fatigue, muscle pain and swelling in the arm. All the events were considered as non-serious. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Localized reaction. Injection site redder, inflamed c/o itching at site some tenderness (L) lot Prox OE, 9x10cm area with 5mm induration. Benadryl/Aytec for 5x5.
Received expired first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-347607, MOD-2021-347368 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: follow up received on 14-oct-21 contain no new information
I seem to have erectile dysfunction, I cannot fully erect. I have had covid 19 about 3 times in the past and have never had this issue. for the past 4 days after receiving the vaccine i cannot get fully erect. this is very concering.
Abscess left hip approximately 1 1/2 inch reddened circle. With mobile mass felt beneath, warm compress to relieve redness/swelling.
Joint aches around 10 hours after vaccination. During sleep, the night after vaccination (hours 12-20 post vaccination), had increased respiratory rate, increased heart rate and decreased heart rate variability. Around 1 day after vaccine, noticed chest tightness on the right-side.
Three episodes of severe nausea and vomiting over four hour period.  Watery diarrhea for 48hrs.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. It was reported that since 24-DEC-2014 the patients were administered GARDASIL intramuscularly (dose and lot no. unspecified) which underwent supported temperature excursions. No adverse events were reported. Additional information has been requested.
since my 2nd shot about 8 to 10 days after my tonsils started to swell and week after week they have got increasingly larger its getting to the point where it hard to swallow , i never have had any kind of issue with my tonsils or through  until the covid shot   i need some kind of resolution to this problem  now
Covid medication to boost immunity and it made her kind of out of it for a bit; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Covid medication to boost immunity and it made her kind of out of it for a bit) in a 57-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation.    Co-suspect product included non-company product TREPROSTINIL SODIUM injection for Primary pulmonary hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   On 16-Apr-2021, the patient started TREPROSTINIL SODIUM (Subcutaneous) 0.047 microgram/kilogram, continuing. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Covid medication to boost immunity and it made her kind of out of it for a bit). At the time of the report, FEELING ABNORMAL (Covid medication to boost immunity and it made her kind of out of it for a bit) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  Patient also had trouble charging the Remodulin Remunity new pumps, with software changes and new cords. Patient tried using the old cords and everything worked correctly. Patient  stated that it might have been their outlet. The patient refused replacement cords. Treprostinil sodium (SQ Remodulin) was reported as continuing (prefilled with 2.4ml per cassette, pump rate 24 mcl/hour). NDA number was reported as 21-272.  No treatment medications were reported.
Injection was administered 8-10-11. Pt's mother reported rash took son to Dr. -> Dr. described it as a 10cm area of erythema & swelling and minor blistering, warm to touch.
I get Botox injections every 10-12 weeks for migraine prevention. Redness/red marks under both eyes with puffiness, itchiness/burning.
This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. During call back to healthcare professional, the HCP reported that he heard of 2 or 3 reports of patient who developed shingles after receiving SHINGRIX (one reported in case US2018091600), the reporter heard this from another HCP. No additional information was available and HCP did not have time to obtain additional information from other HCP for report but gave permission to be contacted if necessary at a later date. One of the patients received SHINGRIX at a local store. He was unsure if these others had been reported to GlaxoSmithKline. This case was considered as suspected vaccination failure, the details regarding vaccination schedule, TTO (time to onset) and confirmatory laboratory test were not reported. This case has been linked with case US2018091600, reported by the same reporter.
she developed a fever for about 2 days after getting both vaccines; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes virus infection. Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received in August 2022, refer case US2023072495) and valacyclovir.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: she developed a fever for about 2 days after getting both vaccines). Rechallenge with Shingrix was positive. The outcome of the fever was resolved (duration 2 days).   It was unknown if the reporter considered the fever to be related to Shingrix.     It was unknown if the company considered the fever to be related to Shingrix.   Additional Information: GSK receipt date: 22-MAY-2023 The patient stated that her second Shingrix vaccine within the 2 to 6 month range, between September and December 2022.   She reported that she developed a fever for about 2 days after getting both vaccines.   The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2023072495:1st dose
Woke up at 1:00 A.M. feeling nauseous then a little latter headache began.  Later in the morning I noticed all my joints and muscles felt like stretching and my legs were restless. Later I became very tired, hot and with cold chills.  I slept all day under heavy covers and could not eat. Today I feel better, but am weak and tired.
2 weeks after shot child developed a low grade temp (temp not taken) which lasted for 3 days.  This was followed by a maculopapular rash on face and trunk.  Child currently has rash.
pt recv vax & turned pale told to put head between knees, went limp, slumped in chair w/arms shaking 3-5seconds;states didn't remember anything about episode;mom stated eyes darting back & forth;rash, flu synd, fainted-diff breathing
Pt now lives in another city and 8 mos. old. Pt mother states pt became listless, fatigued for 48 hours post vaccines.
This spontaneous report as received from a nurse practitioner refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot # L028273, expiration date 28-JUL-2017). The excursion temperature was 33.8 degree Fahrenheit. The excursion time frames were 1hour 59 minutes and 1 hour and 43 minutes. The temperature was back in range. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
02/21/2008 7:00am pt awoke with numbness to left deltoid, radiating to radial aspect of elbow. No treatment given. Pt later saw his personal dentist at 10:00am, fell asleep during procedure. Awoke 30min later with no parestethias to LUE. Still c/o some residual tenderness to injection site, but states it is improving.
Patient appeared okay after flu vaccine was administered. About 10 minutes after vaccine administered, he complained of pain in the arm, abdomen and shortness of breath. EMS was called. They arrived shortly after.
pt recvd vax & 20 minutes p/inject exp a numb tongue, copious mucous production & arm swelling;
After a several weeks I notice my Vitilago  that I had previous been the same for 30 years with no changes or spreading. Weeks after the 1st dose of Moderna my lower arms started spread like crazy and then on my lover legs.
Not having her normal monthly menstrual period; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 02Jan2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, after the first dose of vaccination, the patient was not having her normal monthly menstrual period. The outcome of the event was unknown. The patient had received the second dose of vaccination on 27Jan2021.  Follow-up attempts are completed. No further information is expected.
On 2/22/2022 I had a full body anaphylactic skin reaction covering my feet, legs, buttocks, back, arms, hands, scalp, chest, stomach, neck, and face. It began presenting as bright red splotches with raised, moderately swollen itchy bumps in ~3 inch by ~3 inch patches at approximately 11:30 pm, localized to elbows, knees, both upper arms and upper back region. Within an hour it had spread to completely cover my body (as described earlier) and was extremely painful. Skin was red, bumpy,  severely swollen, and extremely irritated to the touch. At this time I was also experiencing lightheadedness, prolonged nausea, and what felt like a heat flash. I took a lukewarm shower and a 24-hour Zyrtec pill at approximately 12 am but did not feel any relief until I woke up a few hours later around 5:30 am to find that the visible skin reaction was gone. It is currently 11:59 am and my skin still itches slightly, but there is no visible reaction anymore.
Information has been received from a consumer concerning herself who on 10-MAR-2009 was vaccinated with a dose of ZOSTAVAX (Merck).  On 11-MAR-2009 the patient had an itchy, red and hot area (the area is 2 1/2 "x2" in size) where the injection was given.  Additional information has been requested.
Rash started on lower arm of vaccine arm on 6/16 (Day after vaccine) and another rash appeared near the vaccine site on 6/20. the rash is not itchy or painful. Patient is going to consult doctor on Monday on whether he should get the 2nd dose
Pain in my knee joints; headache; fatigue; muscle soreness; body aches; pain/welt on the right arm of the injection site; redness/itchiness on the arm; enlarged and sore lymph node on the right side of my collarbone.
8hrs p/vax pt had hives & swollen eyes-taken to ER & given DPH
Day of and day after?sore arm. 3/16/21 arm at injection site and surrounding area is red, hot and itchy