chrisvoncsefalvay/vaers-outcomes huggingface dataset:
****Pt administered first Moderna COVID-19 vaccine today.  Pt started complaining of "feeling like bad", and wife states he is very clammy- only a few minutes after injection. Pt alert and oriented to place and self.  Pt looks visibly clammy and pale.  He is cognitive and able to answer questions.  Pt denies CP, SOB, chest pressure, nausea, pain when asked. 1105am:  blood pressure (automatic cuff):  61/39, HR= 50. 1108am:  blood sugar:  148 Pt has been alert and answering questions, also able to drink water. Pt started to become less cognitive at this time, and there were delays with answering questions, also had to repeat questions more than once. 11:12am- Called Doctor over to assess pt (this is Doctor's pt) 11:16am- Per Doctor :  thready pulse and he is not as alert as normal- call EMS.  EMS called at 11:16am. 11:19am -Manual blood pressure reading: 64/38 with 'thready pulse' Pt is able to answer questions only occasionally, which his wife says is not his baseline/not normal. 11:25am- EMS arrived to take patient to Hospital, pt wife and son at bedside and will accompany pt to ER.   Pt's wife notified to contact us once discharged to schedule f/u appt (pt was scheduled to see Doctor later today)- also notified we will NOT administer his second Moderna COVID vaccine d/t his reaction to the first. Pt's wife verbalized understanding and very appreciative for assistance today.
w/in 24hr p/vax pt devel a fever of 103, nausea, body aches, chills, muscle spasms & an inj site rxn characterized by redness, warmth & swelling;
A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a five-year-old female who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history concomitant medications were reported. The patient is one of a pair of twin girls who received the FLUMIST on 02-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot # delivered to the clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associate with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding the concurrent condition or medical history was unknown. On 25-JUL-2017 the patient was vaccinated with an expired dose of PROQUAD (lot # M001151 with expiration date 05-JUL-2017, dose and route unknown) for prophylaxis. No adverse effects were reported.
2 days p/vax pt exp 6 hrs of tremors while sleeping; No further episode; schedule for eval by neurologists for 27JUL93;
Thought l had covid; Hurt all over; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced covid-19 (Verbatim: Thought l had covid) and pain (Verbatim: Hurt all over). The outcome of the covid-19 and pain were not reported.   It was unknown if the reporter considered the covid-19 and pain to be related to Shingles vaccine.   It was unknown if the company considered the covid-19 and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-Mar-2023 This case was reported by a patient via interactive digital media. The reporter stated that the shingles vaccine was hard on him/her. The reporter thought that he/she had covid or something. The reporter stated that hurt all over but after reading all of these testimonies the vaccine was a piece of cake and so sorry for all your pain. The follow up would not possible as no contact details were available.
This AM the patient reported feeling achey and like her head wasn't "right".  This subsided by the afternoon, but by the afternoon she was short of breath at rest and had a hard time catching her breath.
2 1/2wk p/vax c/o severe h/a, neck sore, rt eye swelled would not move;sent to neuro referred to TMC;MD inc production of spinal fluid, drain twice, on med;
This case was reported by a consumer via call center representative and described the occurrence of light headedness in a male patient who received Shingrix for prophylaxis. In July 2018, the patient received the 1st dose of Shingrix. In July 2018, immediately after receiving Shingrix, the patient experienced light headedness, tiredness and pain in arm. On an unknown date, the outcome of the light headedness, tiredness and pain in arm were recovered/resolved. It was unknown if the reporter considered the light headedness, tiredness and pain in arm to be related to Shingrix. Additional information was reported as follows: The case was reported by patient's wife. The batch number for Shingrix was not reported. In July 2018 at 12: 00, exactly two months before the date of reporting, the patient was vaccinated with the 1st dose of Shingrix. Less than a day after vaccination with Shingrix, the patient experienced arm soreness. 1 day after vaccination with Shingrix, the patient felt extremely tired and it lasted for a week to a week and a half before resolving. The patient experienced extreme arm soreness, which lasted for a week. This case was linked to case US2018165505 (wife's case) reported by the same reporter and with case US2018GSK171293 (dose 2) reported by the same reporter for the same patient.
Left arm 2 shots, cellulites, Keflex, Benadryl.
fever; has red dots on his body; felt awful; discomfort in his arm; headache; body aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 52-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th July 2022, the patient received Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced fever, skin red, feels awful, arm discomfort, headache and general body pain. On an unknown date, the outcome of the fever, feels awful, arm discomfort, headache and general body pain were unknown and the outcome of the skin red was not recovered/not resolved.   It was unknown if the reporter considered the fever, skin red, feels awful, arm discomfort, headache and general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09th July 2022, 11th July 2022 and 14th July 2022 Reporter's Comments: Reporter stated patient had Zoster vaccine and had red dots on body now, not itchy not hives not raised. Patient just got Shingles vaccine Thursday night. Patient felt awful with fever and discomfort in his arm, headache and body aches and now red dots were everywhere. Additional supportive information Reporter consented to follow up.
No adverse event; patient was due to receive his first dose of pfizer covid 19 vaccine but got 0.25 ml moderna covid vaccine instead; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was due to receive his first dose of pfizer covid 19 vaccine but got 0.25 ml moderna covid vaccine instead) and NO ADVERSE EVENT (No adverse event) in an 11-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Obesity since 15-Apr-2016 and ADHD since 17-Jan-2019.    On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was due to receive his first dose of pfizer covid 19 vaccine but got 0.25 ml moderna covid vaccine instead). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 17-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was due to receive his first dose of pfizer covid 19 vaccine but got 0.25 ml moderna covid vaccine instead) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was due to receive his first dose of pfizer covid 19 vaccine but got 0.25 ml moderna covid vaccine instead).    Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was reported that patient was due to receive his first dose of pfizer covid 19 vaccine but got 0.25 ml moderna covid vaccine instead.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
I had my booster on Wednesday 2/23. I had fever and chills on Thursday and Friday. Woke up Saturday morning to no fever, no chills but horrible stomach pain and some diarrhea/nausea/headache. The GI symptoms got worse Saturday evening and didn't let up for three days. If I hadn't been just eating crackers and toast on Thursday and Friday I would've thought it was food poisoning but I had nothing of substance to eat since Wednesday when I got the booster. Tuesday afternoon 3/1 I was able to have some toast and ginger ale and didn't have any vomiting or diarrhea.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included psoriasis (but it was well controlled and that was usually just on patient's hands and fingers.). Previously administered products included ZOSTAVAX (in 2010). Concomitant products included SHINGRIX and acyclovir. On 20th January 2019, the patient received the 2nd dose of SHINGRIX. On 20th January 2019, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 21st January 2019, the patient experienced limbs stiffness, injected limb mobility decreased and tiredness. On 22nd January 2019, the patient experienced generalized rash, allergic reaction, itchy rash, hoarseness, hand swelling and erythema of extremities. The patient was treated with ZANTAC, ZYRTEC and prednisone. On an unknown date, the outcome of the injection site pain, limbs stiffness, injected limb mobility decreased, tiredness, generalized rash, allergic reaction, itchy rash, hoarseness, hand swelling and erythema of extremities were unknown. It was unknown if the reporter considered the injection site pain, limbs stiffness, injected limb mobility decreased, tiredness, generalized rash, allergic reaction, itchy rash, hoarseness, hand swelling and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: On 10th November 2018, the patient received 1st shot of SHINGRIX without issue. The patient did not have batch number or information on how much or how from pharmacy, where she got it. The patient experienced hurt when she got it. One day after receiving SHINGRIX, the patient experienced her arm was stiff hard to move her arm and she was very tired. Two days after receiving SHINGRIX, the patient experienced, rash on her arms and legs and her fingers and hands were swollen and red. The patient sounded hoarse on the phone while talking to her friend. The patient stated that the rash was on her left upper arm and under the arm and on the right (the side she had the shot on) the rash was on her lower arm and then on both thighs and it wrapped around the back of her legs to her buttocks. She noted it was flat and just slightly itchy. The patient physician prescribed a prednisone taper (starting at 6 tablets on Tuesday and decreasing from there) the tablets are 4mg tablets she states. She was also prescribed ZANTAC and ZYRTEC to help. She called at the date of reporting concerned these may reduce the effectiveness of the SHINGRIX. The patient also noted that she stopped taking acyclovir 48 hours before the vaccine and would remain off of it for 2 weeks, even though she knows she did not have to. She stated she also did this with the first shot as well. The reporter consented to follow up.
syncope 24 hours following 3 dose (booster) COMIRNATY; syncope 24 hours following 3 dose (booster) COMIRNATY; syncope 24 hours following 3 dose (booster) COMIRNATY; This is a spontaneous report from a contactable consumer. This consumer reported that a patient of unspecified age and gender received third dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as DOSE 3, SINGLE for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. It was reported that syncope 24 hours following 3 dose (booster) COMIRNATY. Event took place after use of product. Outcome of the event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sensation starting in head about 1 hour after administration eventually coming down through neck.  Rash developed later. Over next 10 days until resolved the rash extended down legs and up neck. Injection site arm had most severe rash development.
This case was reported by a consumer via call center representative and described the occurrence of malaise in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 23rd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mcg/mg. On 23rd April 2018, less than a day after receiving SHINGRIX, the patient experienced malaise, injection site pain and influenza-like symptoms. On an unknown date, the outcome of the malaise, injection site pain and influenza-like symptoms were unknown. It was unknown if the reporter considered the malaise, injection site pain and influenza-like symptoms to be related to SHINGRIX. Additional information was reported as follows: The patient stated that after vaccination with the dose of SHINGRIX, soreness in the upper arm where it was administered later in the same day. He also experienced a little malaise which he compared to the flu.
Reported Symptoms: 10042244:STROKE; Narrative: 10/03/2023- Admitted to Medical Center with A.Fib with RVR and Right facial drooping and dysarthria. MR brain without contrast showed focus of acute infarct involving the left frontal lobe Other Relevant HX: Other:
ONE MINUTE AFTER FIRST COVID 19 (MODERNA) VACCINE PT HAD A "METALLIAC TASTE) IN MOUTH-NO OTHER SYMPTOMS
Within 5 min of vaccines being given, patient presented with bilateral erythema with single urticarial lesion at sites of injection.  Dose of BENADRYL given in office, patient was monitored for 30 minutes.  Patient demonstrated no signs/ symptoms of a systemic reaction, only localized reaction noted.
Her lip started hurting in the evening after receiving the vaccine. The next morning, she had cold sores in her mouth. She went to her physician today & he told her he thought it was from a URI & took several biopsies. He gave her a medication for the sores.
This spontaneous report was received from a physician refers to unknown number of patients. On an unknown date, unspecified number of patients were vaccinated with first dose of GARDASIL (dose, route and frequency were not reported). On an unkown date, the unspecified number of patients experienced pain. The physician also reported that there was no adverse effects on the second and third dose of GARDASIL. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. This case is linked to the case 1404USA013021 (same reporter link). Additional information has been requested.
Basically I came after the shot, I drank about 6 beers and got something to eat. About 6 hours after receiving vaccine, I started to develop a chest cold, and started coughing a lot, I was coughing up phlegm and it had blood in it. Yesterday I had chills, my fingertips were kind of a white in color. My temperature was 99.7. I had like a rumbling feeling in my chest and it caused an urge to cough. It went through all the next the day and including all last night. This morning I feel fine.
This spontaneous report has been received from a Certified Medical Assistant (C.M.A.) referring to unspecified patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ, (lot #, strength, route of administration and dose were not provided). No adverse experiences were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Macular over entire back, low grade fever - 99.3 enlarged lymph node - left side of neck, felt sluggish.
This case was reported by a other health professional via call center representative and described the occurrence of fever in a 5-year-old male patient who received KINRIX (batch number GM7X3, expiry date 13th November 2017). Concomitant products included MMRV. On 9th August 2016, the patient received KINRIX .5 ml. On 10th August 2016, 1 days after receiving KINRIX, the patient experienced fever (serious criteria other: serious as per reporter), injection site redness, injection site swelling and injection site warmth. On an unknown date, the outcome of the fever, injection site redness, injection site swelling and injection site warmth were unknown. The reporter considered the fever, injection site redness, injection site swelling and injection site warmth to be almost certainly related to KINRIX. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by an administrator. The patient received KINRIX vaccine in his right thigh. On the same day, the patient received MMRV vaccine concomitantly. The patient experienced fever (101.4 degrees F) as well as injection site redness, swelling and warmth after receiving KINRIX vaccination. The patient had visited the emergency room. This case has been linked to case US2016117316, reported by the same reporter.
Fever as high as 103.8, fatigue, stomach pains, vomitting, dizziness, blurred vision
t104, bulging fontanel, vomiting, very irritable;no diarrhea;no URI sx;
I received the first does of the Covid Vaccine on April 13, 2021. Less than two weeks after being vaccinated with the Pfizer brand of vaccine I was hospitalized for an abdominal cyst and whilst in the hospital, I began having difficulty breathing and a CT scan of my chest showed that I had two blood clots [pulmonary embolism] in my right lung. I had to be placed on Heparin and I am currently on Eliquis.
became jittery & nervous;lightheadedness;saw MD on 11/8/99 was advised to see PMD;talked w/school nurse states pt told her neither MD;could confirm that had a rxn to vax;
Respiratory attack; Left arm was numb; Had muscle restrictions and spasms; Pain in the back; Pain in the arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY DISORDER (Respiratory attack), HYPOAESTHESIA (Left arm was numb), MUSCLE SPASMS (Had muscle restrictions and spasms) and BACK PAIN (Pain in the back) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced RESPIRATORY DISORDER (Respiratory attack) (seriousness criterion medically significant), HYPOAESTHESIA (Left arm was numb) (seriousness criterion intervention required), MUSCLE SPASMS (Had muscle restrictions and spasms) (seriousness criterion intervention required), BACK PAIN (Pain in the back) (seriousness criterion intervention required) and VACCINATION SITE PAIN (Pain in the arm). At the time of the report, RESPIRATORY DISORDER (Respiratory attack), HYPOAESTHESIA (Left arm was numb), MUSCLE SPASMS (Had muscle restrictions and spasms), BACK PAIN (Pain in the back) and VACCINATION SITE PAIN (Pain in the arm) outcome was unknown.            Treatment provided include morphine, tramadol 50 mg and meloxicam 50 mg.  Action taken with mRNA-1273 in response to the events was not applicable.   Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.