chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She was so dizzy; pain in her shoulder started; then it went under her arm, a throbbing pain; Then, it shot down to her calf, its weird; Her muscles just ache; she had no strength in her wrist; After the first shot she had a bruise on her arm for week after she got it; Around the second day she experienced head spinning; chest tightness; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 54 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 14Apr2021 13:00 (Batch/Lot Number: ER8733) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hepatitis from an unknown date and unknown if ongoing, Arthritis, Degenerative Joint Disease. The patient's concomitant medications were not reported. The patient experienced around the second day she experienced head spinning causing vertigo on 15Apr2021 with outcome of unknown, chest tightness causing chest discomfort on 15Apr2021 with outcome of unknown, she was dizzy on an unspecified date with outcome of unknown , pain in her shoulder started causing arthralgia on an unspecified date with outcome of recovered , then it went under her arm, a throbbing pain causing axillary pain on an unspecified date with outcome of recovered , then, it shot down to her calf, its weird causing pain in extremity on an unspecified date with outcome of recovered, her muscles just ache causing myalgia on an unspecified date with outcome of recovered , she had no strength in her wrist causing muscular weakness on an unspecified date with outcome of recovered, after the first shot she had a bruise on her arm for week after she got it causing vaccination site bruising on an unspecified date with outcome of recovered. Therapeutic measures were taken as a result of , her muscles just ache, Ointment Capsaicin Deep Penetrating, Odour Free for Arthritis Pain Relief. They gave her Naproxen but, she never took it,  Follow-up(11May2021):This is a follow-up spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that: Additional information regarding medical history, adverse events and therapeutic measures taken were added.    No follow-up attempts are needed. No further information is expected.
patient was 11 when getting Pfizer 5-11 yr vaccine as first dose and turned 12 years old already , we suggested to get adult Pfizer but parent checked with patient's pediatrician and doctor suggested keep the same Pfizer 5-11yr as second dose, So the pharmacist gave the Pfizer 5-11yr as second dose for the patient that just turned 12.
Patient states that he developed diffculty breathing and chest pain on 3/18/09 and went to the Emergency room where he was admitted for a pulmonary embolism.  He spent approximately 10 days at the hospital and was given heparin inthe hospital and was released on coumadin.  He will probably remain on coumadin for at least 6 months maybe longer depending on his hematologist.  Patient states that he had a DVT in 2008 that occurred while on a plane.  5/18/09 Hospital records received DOS 3/18/09 to 3/20/09. FINAL DIAGNOSIS: Pulmonary emboli Post vaccination: chest pain, back pain, shortness of breath.
Infant found not breathing and without a pulse by mother. Autopsy revealed that the cause of death was SIDS.
Swollen face; Sudden fever; Dizziness; Chest pain; Difficulty breathing deep; Coughing when breathing deep; Overly emotional; All around feeling ill; Tired/sleeping a lot; Tired/sleeping a lot; Severe arm pain; Legs feeling heavy/throbbing; Legs feeling heavy/throbbing; This is a spontaneous report from a non-contactable consumer, the patient. A 12-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Aug2021 at 14:30 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Jul2021 at 14:30 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. On 02Aug2021 at 09:15, the patient experienced swollen face, sudden fever, dizziness, chest pain, difficulty breathing deep, coughing when breathing deep, overly emotional, all around feeling ill, tired/sleeping a lot, severe arm pain and legs feeling heavy/throbbing. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen face, sudden fever, dizziness, chest pain, difficulty breathing deep, coughing when breathing deep, overly emotional, all around feeling ill, tired/sleeping a lot, severe arm pain and legs feeling heavy/throbbing was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Could not move arm at all; Painful arm; Really bad aches; didn't feel right; Headache; Marking on arm; it's weird; it's red, not inflamed or anything; it's probably like two quarters and has a little line/where the shot is; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration in the arm on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the COVID-19 vaccination, the first shot on Wednesday (06Jan2021). The patient had a very, like the patient had a marking on the arm, like it's weird where the shot was. It's red and it's not inflamed or anything. It's just very red filled, it's just concerning. The day the patient had on it was when the shot on Wednesday. Yesterday (07Jan2021), the patient could not move the patient's arm at all, had painful arm and the patient thought that was a flu shot before (could not be clarified). Then, the patient had really bad aches and just; the patient didn't feel right; and had headache. The patient took some Advil (Intent: Treatment) for the bad aches as it's said on the paperwork. The patient thought it works. Today (08Jan2021), the patient woke up and the patient's aches were gone, the patient's headache was gone but the patient still had just this mark on the arm, it's probably like two quarters and has a little line. It's very concerning to the patient. The patient was just worried, with some kind of a reaction to the shot. The patient had a nurse look at it where it was, and she didn't think it's major but the patient wanted to know if anybody else was having these issues. The outcome of the events "really bad aches" and "headache" was recovered on 08Jan2021; outcome of the event 'vaccination site erythema' was not recovered; and outcome of other events was unknown.  Information on the Lot/Batch number has been requested.
Patient called today to report an adverse event.  She states she developed an arm rash a week after her first Moderna vaccine.  it was red and bumpy and about 6 inches in length.  It lasted a few days and then went away. She had no adverse to her 2nd Moderna vaccine administered on 04/06/2021
Initial report received on 06 August 2012 from the investigator participating in a post-marketing observation surveillance study under the reference number MSA16. A case of pertussis disease in a eight-month-old male subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject had received 3 doses of PENTACEL; received on 09 January 2012, 09 March 2012 and 10 May 2012 (lot numbers, routes and sites of administration not reported). The subject developed a cough and had cold-like symptoms on 19 July 2012, approximately two months after the last dose. On 24 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 25 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 25 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 02 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.
Patient began to experience throat tightness, facial flushing, itching, and dizziness at 10:50.  Notes he experienced these same symptoms after his second dose of this vaccine.  Vital signs stable with BP 136/90, HR 91, RR 17 98% O2 sat on RA.  Patient received 25mg of IM diphenhydramine at 10:50.  Patient reported a worsening of symptoms despite diphenhydramine administration and required an additional dose of diphenhydramine administered at 11:26.  Vital signs remained stable throughout.  Symptoms improved after second administration of diphenhydramine.
Headache  Sore neck Sore arm Sore armpit  Sore throat  Right eye swelling and pain
This spontaneous report was received from a reporter who works in a physician's office, via company representative, concerning a 58 year old male patient. The patient's concurrent conditions included uncontrolled diabetes. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 22-APR-2015, the patient was vaccinated with PNEUMOVAX23, 1 vial, intramuscular (dose number, anatomical location, lot number and expiration date were unspecified). On 22-APR-2015 or 23-APR-2015, the patient called the physician's office and stated that he experienced pain, swelling and redness at the injection site and claimed that he had fever. In addition, the patient said "that injection you gave me knocked me to the floor" (adverse event following immunization). No treatment was given for the adverse events. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX23 was not reported. Additional information has been requested.
Notified that patient received the MONOVALENT version of the Pfizer COVID-19 booster vaccine rather than the intended BIVALENT version of the Pfizer COVID-19 booster vaccine on 09/13/2022.
On the 21st around 05:30pm I was having heart attack symptom. I was sweating, couldn't breathe, increase in heart rate, numbness and tingling, hot, very tired, dizzy. I couldn't stand up too fast without feeling like I was going to pass out. I was very weak. 2 days later I had to go back to the ER, I was admitted. Upset stomach not eating. I'm out of work and have to see and neurologist. I can't walk too much.
Mild numbness of the left cheek to the tip of nose and the outer canthus of the left eye.  Lasted about 4 hours and felt like novocaine wearing off.
No adverse reaction reported by mother or noted at office visit to establish care at Family Practice on May 31/2019.   It was recommended by RN, BSN Educator  to report DTaP, Hib, Polio, Prevnar and Rotavirus given at 4 weeks of age, 2 week prior  to the earliest ACIP recommendation by patients provider prior to moving.   This is from RN's email to the Immunization Registry: Doses administered too close together or at too young an age can lead to a suboptimal immune response. Doses of any vaccine administered ?5 days earlier than the minimum interval or age should not be counted as valid doses and should be repeated as age appropriate. If the first dose in a series is given ?5 days before the recommended minimum age, the dose should be repeated on or after the date when the child reaches at least the minimum age.?  This is considered a vaccine administration error.  Please encourage the facility staff where the error occurred to determine how the error occurred and to take appropriate actions to put strategies in place to prevent it from happening in the future.  We also strongly suggest contacting the EMR vendor to determine if there is an error in their programing and/or what their forecasting is based on. In addition, we encourage providers to report all vaccine administration errors?even those not associated with an adverse event ? to the Vaccine Adverse Event Reporting System (VAERS).
About an hour after injection had hives come up followed by continuous itching. Then face and lips swelled up.
This spontaneous report as received from a nurse via a field representative refers to a female patient of unknown age. On around 11-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot#, strength and dosage unknown), frequency reported as a single shot, intramuscular. On 12-OCT-2014, the patient experienced cellulitis at the injection site after receiving PNEUMOVAX 23. The patient was admitted into hospital from 12-OCT-2014 to 16-OCT-2014 for cellulitis at the injection site. The patient had sought medical attention. Unspecified IV antibiotics was given for the event. The outcome of cellulitis at the injection site was unknown. Additional information has been requested.
About an hour to an hour and a half after the covid vaccine he developed horrible severe diarrhea that lasted into the evening.  The next day it stopped and he had no other symptoms other than a sore arm where the shot was given.  The second vaccine did not cause these same symptoms and he felt fine after the second.
11/30/2022 A little cough and started getting a headache.  Noticed later that day losing sense of smell.  Later participant felt unwell and tested with an At Home COVID-19 test, positive.  Televisit with Doctor proscribed Paxlovid and to treat symptomatically.  After 3 days on Paxlovid, participant got rapidly better, fatigue, headache diminished, and sense of taste returned.
Increased heart rate 90's to low 120's (normal being 60-80's). Periodic dizziness.
Muscle pain; Restlessness on the night; Flu like symptoms; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (Restlessness on the night), INFLUENZA LIKE ILLNESS (Flu like symptoms), ARTHRALGIA (Shoulder pain) and MYALGIA (Muscle pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced RESTLESSNESS (Restlessness on the night), INFLUENZA LIKE ILLNESS (Flu like symptoms) and ARTHRALGIA (Shoulder pain). On an unknown date, the patient experienced MYALGIA (Muscle pain). At the time of the report, RESTLESSNESS (Restlessness on the night), INFLUENZA LIKE ILLNESS (Flu like symptoms), ARTHRALGIA (Shoulder pain) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-036335 (Patient Link).
STEMI incident with subsequent cath lab procedure to remove clots and install stents in RCA
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant drugs were reported. No treatment drugs were reported.
There was slight swelling after injecting patient in left deltoid. The  vaccine was the Pfizer vaccine. I vaccinated the patient in her left deltoid muscle. I gently squeezed her upper arm and injected her with the needle. I pushed the needle in completely and it retracted back into the syringe. Immediately after I removed the needle, I noticed some bleeding. I then took a tissue and applied gentle pressure to stop the bleeding. After that I noticed some slight swelling. After noticing the swelling, I told a staff member to get an RN. I continued to moniter the patient until the RN and physician arrived. The vaccine was Pfizer. 0 pain at injection site.
Complex febrile seizures 12 hours after vaccine administration. Patient had full septic work up done and treated with antibiotics for 2 days prior to discharge. No focal neurology on discharge. 3/27/08-records received for DOS 3/8-3/10/08-DC DX Complex febrile seizure. Vaccine related febrile illness. Admitted with C/O febrile illness,  new onset seizure times 2 in last 24 hours with frothing from mouth. Fever 104.  No focal neuralgia, no signs of meningitis.
Tiredness, sleeping all the time, body pain, fever, runny nose, site throat, loss of appetite.
fatigue & sore arm starting 25FEB97 AM;slept in AM treated sore arm w/advil;arm still sore on day of report but improving;pt attending school;tingling & numbness yesterday 1&2MAR in calf ankle;began late 1MAR afternoon;no spring sports;
HCP reported an adverse event for GARDASIL 9. Caller explained a patient was administered an expired dose of GARDASIL 9. Caller confirmed the GARDASIL 9 has not had a temperature excursions. No additional AE or PQC reported. No additional information; HCP reported an adverse event for GARDASIL 9. Caller explained a patient was administered an expired dose of GARDASIL 9. Caller confirmed the GARDASIL 9 has not had a temperature excursions. No additional AE or PQC reported. No additional information; This spontaneous report was received from a medical assistant and refers to a 37-year-old female. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-APR-2022, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, 0.5ml, lot #1637641, administered for prophylaxis (strength, and route of administration were not provided). The dose of the vaccine expired on 16-FEB-2022.  The vaccine had no temperature excursions. By the time of reporting the patient was okay. No adverse events were reported.
Pt was given PREVNAR and FLUZONE HD around 6:30pm. Around 10-11pm woke up w/horrible hives/welts and tongue swelling. Contacted PCP and was told to go to ER via ambulance due to difficulty breathing.
Skin rash on arms, legs, hands, ankles, feet, thighs.  It is red, splotchy, and itchy. Discomfort on the joints when bent where the spots are.
On 11/6/02 mom reported for PPD reading, informed me of redness and swelling to upper left leg. Noted redness size 10.5cm w 8.5cm ht. cool to touch. 11/11/02 by phone mom report redness swelling disappeared 11/6/02. 11/12/02 call baby is OK. Similar unreported reaction with "6 mos shots."
Pain in the injection site, muscle weakness, extreme pain [from my neck down/no headaches], worsening forgetfulness, increased depression from the pain, and horrible chronic fatigue.  I've seen my PCP, a rheumatologist, went to the er for the pain, continued help from my therapists and dietician on ways to help me manage my pain, I've had to take Adavan, Tramadol, fish oil capsules, Turmeric/Curcumin, and increased doses of Gabapentin. I'm slowly do stretching and recently bought a treadmill so I can hopefully strengthen my body again.
Cellulitis R arm. Warm to touch, + erythemia, + edema, from shoulder to elbow.
Limited range of motion in left shoulder after vaccination, which continues to last 8 months after injection.  Could only lift arm 60 degrees, couldn't lift hand behind back, painful sleeping, painful with quick movements. Tried relaxing/resting muscle, simple exercises and aspirin for a couple months. Followed up with physician who suggested PT exercises and Naproxen for 4 weeks to regain full range of motion. I am still doing the exercises and have regained SOME range but not all.  Pain is still there.
No 2nd dose due to COVID pandemics, 1st dose 2019; This case was reported by a other health professional via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (patients were vaccinated on 2019 or 2020 with the first dose).   On an unknown date, the patients did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.    Additional Information: GSK Receipt Date: 14-NOV-2022 Reporter's comments: A health care professional had reported that several patients did not had receive the second dose at the time of reporting, due to the COVID pandemics. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2022AMR168777:Same reporter. 2020 case.
Initial report received from a reporter on 08-November-2013. A 44-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (Lot number UT4719AA) via intradermal route at left deltoid, on 18-September-2013. On 19-September-2013, within 24 hours after receiving vaccine the patient experienced stiff, sore arm and swollen side of neck. Corrective treatment was not reported. At the time of report events stiff sore arm were resolved and event swollen neck was ongoing. Documents held by sender: none.
received the first dose of Shingrix subcutaneously instead of intramuscular; slight itching; red arm; This case was reported by a nurse via call center representative and described the occurrence of pruritus in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2020, the patient received the 1st dose of Shingrix (subcutaneous). In September 2020, less than a week after receiving Shingrix, the patient experienced pruritus and erythema of extremities. On 23rd September 2020, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the pruritus and erythema of extremities were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the pruritus and erythema of extremities to be related to Shingrix.  Additional details were as follows: After receiving 1st dose of Shingrix, the patient experienced red arm and a slight itching. The patient received the first dose of Shingrix subcutaneously instead of intramuscular, which led to intramuscular formulation administered by another route. The reporter reported that, the adverse events lasted 2 days and the patient is completely fine now. The reporter mentioned that next dose will be administered intramuscularly.  No further information provided. The reporter consented to follow up.