chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt was received a second dose of shingrix on 6//04/2019  after few hour pt called back and stated she had pain in her shoulder .  pharmacist suggest  pt to have a dose of tylenol or ibuprofen.  Late in the night husband cameback and stated pt went to emergency room because of the pain.  pharmacist attempted to call pt up for the fowllow up not not get intouch until today 6/13/19.  Pt stated since she had severe arthritis and this could cause the pain any time so maybe coinsident.  pt also stated her doctor think maybe pharmacist hit the nerve while doing  injection .
raised reddened bumps on the left lower forearm, approximately 2 fingerbreadth below antecubital and redness on the left neck. Client seen and cleared by EMS
Had flu like symptoms; Muscle aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. In SEP-2022, an unknown time after receiving Shingrix and SHINGRIX, the patient experienced influenza-like symptoms (Verbatim: Had flu like symptoms) and muscle pain (Verbatim: Muscle aches). The outcome of the influenza-like symptoms and muscle pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms and muscle pain to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms and muscle pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-MAY-2023 The consumer reported that he received two doses of Shingrix two months apart and since last September he had flu like symptoms and muscle aches.  The consumer stated he already reported this to the Centers for Disease Control (CDC) and VAERS.
L deltoid pain, radiating to hand and into L side of neck, unable to sleep due to pain, area very sensitive to touch
Rash that extended from the site of the vaccination to the back, chest and legs. Rash that extended from the site of the vaccination to the back, chest and legs. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash that extended from the site of the vaccination to the back, chest and legs.) and VACCINATION SITE RASH (Rash that extended from the site of the vaccination to the back, chest and legs.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced RASH (Rash that extended from the site of the vaccination to the back, chest and legs.) and VACCINATION SITE RASH (Rash that extended from the site of the vaccination to the back, chest and legs.). At the time of the report, RASH (Rash that extended from the site of the vaccination to the back, chest and legs.) and VACCINATION SITE RASH (Rash that extended from the site of the vaccination to the back, chest and legs.) outcome was unknown.            No medical history was provided by the reporter. Treatment information topic and oral antihistamines was provided.
Receives immunizations 10/23/08.  Developes urticaria 10/24/08, also has fever & loose stools.  Family members had loose stools the previous week.
woke up next day for work @6am-huge intense migraine. then began nausea & diarrhea until approx 10am. no food -only drank water. stayed in bed w migraine until about 6pm.
a little soreness of the arm; bad rash all over his body including upper thighs, lower back, from his ankles to not quite his knees, and fingers; redness at the injection site; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (bad rash all over his body including upper thighs, lower back, from his ankles to not quite his knees, and fingers), PAIN IN EXTREMITY (a little soreness of the arm), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE SWELLING (Swelling at the injection site) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE SWELLING (Swelling at the injection site). On 17-Mar-2021, the patient experienced RASH (bad rash all over his body including upper thighs, lower back, from his ankles to not quite his knees, and fingers). On an unknown date, the patient experienced PAIN IN EXTREMITY (a little soreness of the arm). On 12-Mar-2021, INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE SWELLING (Swelling at the injection site) had resolved. At the time of the report, RASH (bad rash all over his body including upper thighs, lower back, from his ankles to not quite his knees, and fingers) was resolving and PAIN IN EXTREMITY (a little soreness of the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient's HCP advised him to take OTC diphenhydramine and prescribed a course of prednisone.
Patient is a 3 year old female who was being held by her mother to received the flu vaccine. As the vaccine was being administered by the technician, the patient's mother let go of her child which then caused the patient to move her arm away, which left half of the vaccine in the vial without being administered.
Patient received your hepatitis b vaccine twice within one day; This case was reported by a other health professional and described the occurrence of accidental overdose in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B) for prophylaxis.   On 22nd November 2020, the patient received the 1st dose of Pediarix. On an unknown date, the patient started Pediarix Pre-Filled Syringe Device. On 22nd November 2020, the patient received Engerix B. On 22nd November 2020, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Engerix B, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that Infant received hepatitis b vaccine twice within one day, which led to accidental overdose .  The reporter was concerned about this.
the vaccine was injected subcutaneously instead of intramuscularly; small bruise at the injection site; This is a spontaneous report from a contactable healthcare professional (patient) received via a Pfizer-sponsored program,  Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), subcutaneously, administered in arm, on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that the vaccine was injected to her subcutaneously instead of intramuscularly on an unspecified date. The patient also experienced small bruise at the injection site (upper arm), red rectangular area over the interior deltoid close to the above the muscle under the skin on an unspecified date. The patient wanted to know what antibodies test does Pfizer recommends to asses for immunity after vaccination. The outcome of event small bruise at the injection site was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
red, swollen, painful (L) arm was induration vaccine site Tx Keflex/ice
Moderna Inj given:  0830 Pt complaining of difficulty swallowing:  0839 Epi-Pen given:  0840  Pt sx:  Original complaint of difficulty swallowing.  Upon assessment, glands were noted to be swollen and red.  Pt was given Epi-Pen.  Pt had notable peri-orbital edema and his face was flushed.  Upon assessment of vital signs pt was noted to be tachycardiac with an elevated blood pressure.  No adventitious lung sounds.  When pt was loaded onto EMT gurney, his BIL LE were noted to be edematous.  0845                                    0849                                    0853                                    0856  T: 96.9                                 97.5                                     97.5                                     97.9 P: 110                                  95                                         77                                         78 R: 24                                    20                                         20                                         20 BP: 151/92                         169/80                                137/86                                137/95 O2: 99%                              99%                                     99%                                     97%  Ambulance arrived at 0856.  Pt transported via ambulance to Hospital for assessment and treatment.
2x4 inch oval shaped injection site reaction. Raised, inflamed, warm, itchy, sore.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 20-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 20 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "celiac artery compression syndrome" (unspecified if ongoing); "Reaction: Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Apr2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 with Paxlovid for treatment of COVID-19 (Batch/Lot number FT5400).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
On Saturday 1/22/22, about 18 hours post-vaccine, patient woke up with fever and body aches, which was treated with Tylenol during the day.  These symptoms resolved on Sunday morning (1/23/22). On Sunday 1/23/22, at 48 hours after vaccine, patient experienced vaginal bleeding (bright red with clotting, medium flow) and cramping in lower abdominal area.  On Monday 1/24/22, patient still reports vaginal bleeding but has decreased in severity.  Patient called the hospital Triage Nurse around 6:00pm on Sunday 1/23/22.  As of Monday 1/24/22, the office of Dr. is reaching out to  the provider and will then get in contact with the patient.
On Saturday morning I started to have some minor chest congestion. As the day went on I was feeling really fatigue and started to get achy. I started to run a fever of 100 and so I took a rapid test and it came back positive. The following day my fever got up to 101. I took 2 Tylenol to help reduce the fever and that seemed to help. That evening I did experience cold sweats and I felt very uncomfortable. I started to feel very itchy and anxious. I would compare it as if I took a stimulant or had a lot of caffeine. I also experienced diarrhea for 2 days. On 05/10/2022 I did have a PCR test which also came back positive. My chest congestion has cleared up for the most part just feeling a little weak.
weakness; hands are cold an clammy; cannot stop shaking; cough; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PERIPHERAL COLDNESS (hands are cold an clammy), TREMOR (cannot stop shaking) and COUGH (cough) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included nexium and ORPHENADRINE CITRATE (FLEXOR [ORPHENADRINE CITRATE]) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), PERIPHERAL COLDNESS (hands are cold an clammy), TREMOR (cannot stop shaking) and COUGH (cough). At the time of the report, ASTHENIA (weakness), PERIPHERAL COLDNESS (hands are cold an clammy), TREMOR (cannot stop shaking) and COUGH (cough) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs taken are Nexium and flexor-75mg. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Follow-up information received on 08-MAY-2021 contains No New Information.
28MAY92 recvd 1st dose of engerix-B & 29MAY92 devel mild vaginal yeast infect; 30MAY92 raw sores; 1JUN92 painful lesions; 1JUN92  pain was so severe went to ER; infection persisted until 15JUN92;
Flu-like type symptoms; Chills; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like type symptoms), CHILLS (Chills) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like type symptoms), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like type symptoms), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            The concomitant medications were not provided.
By 830PM on 8OCT pt had rash looking like mosquito bites; 9OCT AM covered body, itching; Went to school sick w/ n/v Wed PM & through Thursday; Rash became worse, pt scratched rash & leg "whelped up" & also on buttocks; given DPH; Seen in ER
about 1:25pm note increased sneezing, runny nose, water eyes. 1:40pm note throat pain, redness localized at right arm site of injection MMR, 1:50pm SQ epinephrine given, Contacted 2:15pm child taken to ER.
Legs is red-hot, swollen, hard lump parent advised to monitor for now and if any change come into be seen.
Sat at 10:00; side-effects started at 20:00 hours and continued for 24 hours: Headache, myalgia, arthralgia, chills, fever and skin felt like I had a total body sunburn.
the poison jabbies gave my mother shingles/suspected vaccination failure; shingles; pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles and pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: the poison jabbies gave my mother shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-APR-2023 The case  was received from the patient via interactive digital media. The patient stated that true he/she got it again after the shot but pain was no where was the level of pain before the shot. The patient stated that the shot definitely helped him/her. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report was received from a medical assistant of the physician refers to a 12 year old child of unknown gender. Medical history was reported as none. No known drug allergy was reported. On an unknown date the patient was vaccinated with VARIVAX (Merck) lot # J006732; expiry: 30-MAY-2015, dose: 0.5 ml (millilitres), subcutaneous in the right arm. Concomitant therapy was reported was none. On an unknown date the patient developed a rash at the injection site after administration of VARIVAX (Merck). The patients were evaluated in the office. No medical treatment was prescribed. The patient sought medical attention and had an office visit. The outcome of rash at the injection site was unknown. Causality assessment for the event was not provided. This case is linked to: 1402USA007622 (same reporter link). Additional information has been requested.
1320: received initial injection of Pfizer 1330-1335: patient was not responding normally to husband and caregiver 1335: our initial evaluation revealed she was semi-conscious, initially looking up when her name was called but then she stopped responding. Pulse ox was 99% on 2L O2 (chronic use), pulse 35. Blood pressure could not be measured. EMS was called.  Pupils were both reactive to light but patient was not tracking.  Despite sternal rub and physical stimulation, patient was not responding. She exhibited excessive salivation but no tongue swelling. Cardiac auscultation revealed bradycardia  but regular rhythm. Lung sounds were normal bilaterally, no wheezing.  1340: EMS arrived, no vitals were obtained initially, patient taken to ED
Patient came in for a PPD skin test.  He came back in two days for the reading and his left arm had a blister about the size of a penny at the site that the test was placed.  Dr recommended a repeat on the opposite arm.  The PPD skin test was then placed on the right arm.  He came back in 48hrs and this time there was no blister.  The reading was negative.
p/vax possible delayed adverse rxn started 7/4 in AM w/axillary pain & sl lymph gland enlargement under both arms;progressed to rash w/itching 7/5/99 MA;
12 days following administration of these vaccines (on October 26th), patient developed tremors in her hands and legs causing problems with her gait.
Patient received the first dose of the Pfizer Vaccine.  About 5 to 10 minutes after the vaccine, patient complained of dizziness and some shortness of breath.   I did not see any swelling or noticeable difficulty in breathing.   Patient also complained of numbness and tingling on this hands.  Patient was told to be very relaxed on the chair in order to recover.  Patient then complained of losing sensation on his hands.  Also, patient said that he was going to pass out at any time.  Girlfriend was present with patient.  I told patient that I can call 911 immediately if they like.  We called 911 and within 5 minutes EMT ARRIVED.  EMT arrived and ran some tests on patient.  They said that patient 's respiration was getting back to normal capacity and confirmed that patient was having an anxiety attack.  EMT asked if he has been taking medication for his anxiety.  Patient said that he isn't on any medication for his anxiety.  Patient  was then taken to the ER.
pt fainted w/in 2 minutes of vax; pt fainted 3 more times @ home; mom reports when pt see's blood faints & did so for 6 months p/vax; MD felt was vasovagal reflux secondary to breath holding;
Around 12 hours post-vaccination with the 2nd dose, noticed severe chills, fatigue, headache, and full-body myalgias. Severe chills lasted ~6 hours, then subsided. Severe fatigue continued for ~24 hours (still feeling fatigued, but it is improving). Milder chills continued for ~24 hours but have mostly subsided. Headache and myalgias have improved over the last 24 hours but are still present despite use of ibuprofen 200mg Q6H.
Information has been received from a physician concerning a 4 month old female infant who on an unspecified date was vaccinated with ROTATEQ (Oka/Merck).  Subsequently, the patient developed c-difficile and a milk protein allergy since the first dose of ROTATEQ (Oka/Merck) was administered.  It was noted that the patient also had bloody stools.  At the time of the report that patient recovered on an unspecified date.  There was no product quality complaint involved.  Upon internal review "bloody stools" was considered an other important medical event.  Additional information has been requested.
Patient received first dose 2/16/2021 at 5 PM. Local site reaction (redness) for about 5 days after vaccination. Mild headache for first 12 hours post vaccination. Acute wrist, MCP, PIP and DIP joint pain with swelling, reduced range of motion, redness and warmth in both hands though began first in left hand. Significant pain to the point of not being able to pick up a glass of water. Worse in morning with mild improvement throughout the day. This is brand new symptom that began 2/25/21 temporarily associated with Moderna Covid19 vaccination first dose on 2/16/21.
After the first dose, I developed extreme nasal congestion , sinus pressure and pain, followed by sneezing fits, runny nose , cough and hives that covered my entire body with inner ear and throat itching. Symptoms still persist presently.  After the second dose, the aforementioned symptoms persisted and worsened along with flu- like symptoms ( fever, body aches and pain ).  I contacted my physician. I was told that studies are ongoing and there wasn?t any other information to conclude what I was experiencing. The symptoms persist today. My body is acting as though it suffers from seasonal allergies which I do not have a history of.
Shortness of breathe with reduced pulse Ox of 93, trouble breathing, body aches, arm soreness, chills, fever, headache, excessive burping, weakness, unable to care for self
whole upper arm swollen from shoulder to elbow red, hot to touch, hard;seen by someone in ER unofficially-?cellulitis;Saturday afternoon last noc normal;
Woke next morning with extreme lethargy, headache, flu like symptoms of extreme aches all over body. Had difficulty staying focused or awake. Called out of work.
Patient received a COVID-19 vaccine at the COVID vaccination clinic. The vaccines were shipped to vaccine site, by 2 employees who were hosting the vaccination clinic. The vaccination were alarming in transport and both Pfizer and both told of the employees stated that the vaccines were no longer viable and should not be given to the patients. Due to a lack of and miscommunication, 5 patients received the vaccines.