chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NOT ADVERSE  but positive effect Broncial tubes opened up Breathing much improvedThank You; This is a spontaneous report from a contactable consumer, reporting for himself. A 75-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number en 6200) via an unspecified route of administration in left arm on 21Feb2021 11:00 at single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number en6208) via an unspecified route of administration in left arm on 14Mar2021 11:00 at single dose for COVID-19 immunisation. Relevant medical history included obesity and hypertension, the patient had no allergies. The patient was taking multiple other medications in two weeks (unspecified), but concomitant medications were not reported. The patient did not receive any other vaccine in four weeks and was not tested for COVID prior to vaccination. The patient had no adverse effects but positive effect, bronchial tubes opened up and breathing was much improved. Outcome of the event was unknown. The patient was not tested for COVID post vaccination.  No follow-up attempts are needed. No further information is expected.
Intense upper arm and shoulder pain, gradually diminished over a three week period. Numbness and tingling in right forearm , hand, and fingers, impinging on use of right hand, has gradually abated over athethree-week period since the injection but is still present.
Pt did not respond to 3 doses of Engerix-B given for the prevention of Hep B;
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers 61 of 84 patients. On an unspecified date in Oct-2017 (between  25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F. And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event and reporter's comment. Amended narrative accordingly.
This report describes the occurrence of inject site pain in an adult of unspecified age and gender who was vaccinated w/Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. On an unspecified date, the subject received an injection of Engerix-B (lot ENG5285D6); it was not known if the subject had received previous injections of Engerix-B. Subsequently, the subject experienced pain at the inject site. The pain resolved after an unspecified period of time.
2 hrs p/vax pt exp stuffy nose, scratchy throat; 3.5 hrs chest tight, dyspnea, throat tight used proventil inhaler, went to ER fever 101, nausea, fever, aching x 36 hrs; bad aches & pain all over; eyes were swollen, burning, bloodshot;
headaches on the right side of his forehead/scalp/eye socket area; skin in the headache area is also sensitive.; headaches on the right side of his eye socket area; headaches on the right side of his scalp; injection site shoulder and muscle pain; injection site shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 12th August 2020, less than a day after receiving Shingrix, the patient experienced injection site muscle pain and injection site joint pain. On 15th August 2020, the patient experienced headache, sensitive skin, aching eye socket and scalp pain. The patient was treated with ibuprofen and paracetamol (Tylenol). On 14th August 2020, the outcome of the injection site muscle pain and injection site joint pain were recovered/resolved. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the sensitive skin, aching eye socket and scalp pain were unknown.   It was unknown if the reporter considered the injection site muscle pain, injection site joint pain, headache, sensitive skin, aching eye socket and scalp pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and same day he developed injection site shoulder and muscle pain that lasted for less than 48 hours.  The patient started to get headaches on the right side of his forehead, scalp and eye socket area.  These headaches occur every 5-6 days and last for 3-4 hours.  The patient stated they resolve after treatment with tylenol or ibprofen.  The skin in the headache area was also sensitive. The consented to follow up and consents to HCP follow up.
I woke up feeling dizzy, I stumbled, I couldn't walk. I went about my day, everything was fine. Then next day it was much worse, I went to the hospital. I got tested for COVID-19 that came back negative, influenza that came back negative, RSV that came back negative. They were not sure what was causing the motion sickness, they did give me a steroid shot to help clear up any infection that may be in my body they also gave me a prescription for meclizine.
At 10:58, patient reported feeling of ?foggy ness ? which she stated was ?like air in my head? after receiving Janssen vaccination at 10:53. Patient was found sitting outside of vaccination bus, alert and oriented to person, time, place and event and did not appear to be in distress. Patient denied shortness of breath, dizziness, blurry vision, weakness to one side of body, feeling of syncope, and was negative to all signs of the Cincinnati stroke scale test. Patient?s vital signs were monitored for the duration of event. After 15 minutes of monitoring, patient stated that her feeing of ?foggy ness? had improved but that it still mildly lingered. Patient was offered a call for emergency services but patient denied them and stated that she would seek further medical help if her condition worsened, or continued. Patient stated that she was going to visit a medical facility after leaving vaccination clinic.
It started with my left ear itching.On Monday it started to swell and itch. Then went down the side of my face and swelling all the way.Itching got worse. By Thanksgiving it was hurting. Took Benadryl and Tylenol.Friday went to Dr.
Information has been received from a pharmacist concerning his mother, a 65 year old female, with rheumatoid arthritis, hypothyroidism and hypertension and the thyroid removed in the past, who in early Feb 2006, was vaccinated IM with the first dose 0.5 Pneumococcal 23v polysaccharide vaccine (lot unknown). Concomitant therapy included etobolac Lodine, Quinapril HCL Accupril and levothyroxine NA Synthroid. Within a day of vaccination, the pt developed a large, hard, painful, softball sized area of erythema with itching. The doctor was notified and unspecified medical attention was sought. The pt was treated with warm compresses and ibuprofen ore acetaminophen. At the time of the report the area was the size of a ping pong ball. The pt presented status was reported as improving but not resolved. No product quality complaint was involved. Additional information has been requested.
Within a couple of days patient had red/warm to touch arm. Had him take CLARITIN and apply warm compress and was gone by weekend. Was red along under part of arm not around injection site.
headache, chills, arm and skin hurt, hair hurt, fever, lethargic,lt arm itched, blotchy red
Next day, muscle swelling at site of injection; 4-5 inch rash around injection site (6 days); severe headache starting next day after injection lasting 2 days. Pain in muscles in neck.  Tenderness around injection area continues to be tender 3 weeks following injection.
tested positive after the first dose; tested positive after the first dose; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose on 25Jan2021 for COVID-19 immunisation. Medical history and concomitant medication were not reported. Caller was calling for her parents who tested positive after the first dose. Their first dose was last 25Jan. Caller was asking if they could take the second dose after they tested positive or they had to wait for a certain time before getting the second dose. COVID-19 test was positive on an unspecified date. The outcome of events was unknown.  The information about lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021209375 the same reporter, product and adverse events in different patients
I had relapse of Grave's disease and thyroid eye disease. I am still not recovered.
She got the vaccine, had no reaction initially and then went home and was tired, slept for a couple of hours and felt good.  When she went to bed had a fever under 101 degrees, and really bad headache and then muscle pain all the way down to her calves to the point that she was sick to her stomach.  This continued throughout the night.  This morning she is still having the chills, so believes she has a temperature, feels miserable.  About 1:30 AM she took 2 Tylenol for her symptoms.
A little over two weeks after my first dose of the Moderna vaccine, I received my period unexpectedly, and it was heavier than usual, and I had breakthrough bleeding after.
PT CAME IN ON 10/2 STATING THAT HER RIGHT ARM WAS STILL HURTING. AT INSPECTION OF THE INJECTION SITE, ARM WAS VERY RED. PT SAID IT HURTS AND WANTED TO COME BY THE PHARMACY TO CONSULT IF THERE WAS SOMETHING SHE COULD TAKE OVER THE COUNTER.  PT STATES SITE WAS WARM AND HAS BEEN LIKE THAT AFTER ADMINSTRATION AND ALMOST A WEEK AFTER
Patient reported numbness in left arm and left side of head. Described as if he had been laying on arm and went to sleep. Said he was sweating and felt woozy. Started 20 min after administration and lasted 20 min. He remained seated, gave air from fan, took Be and gave water.
Information regarding influenza virus vaccine (manufacturer unknown) was received from a consumer regarding a female patient who experienced symptoms of a head cold with a runny nose and nasal congestion.  The patient received a dose of an unspecified date in 2001.  No additional information was available at the date of this report.
fever axillary temp: 100.1 and temporal temp: 100.6.; muscle pain; leg weakness; This spontaneous case was reported by an other caregiver and describes the occurrence of MYALGIA (muscle pain), MUSCULAR WEAKNESS (leg weakness) and PYREXIA (fever axillary temp: 100.1 and temporal temp: 100.6.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    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 MYALGIA (muscle pain) and MUSCULAR WEAKNESS (leg weakness). On 11-Feb-2021, the patient experienced PYREXIA (fever axillary temp: 100.1 and temporal temp: 100.6.). At the time of the report, MYALGIA (muscle pain), MUSCULAR WEAKNESS (leg weakness) and PYREXIA (fever axillary temp: 100.1 and temporal temp: 100.6.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Pyrexia:. In July 2021, SARS-CoV-2 test: positive Positive. On an unknown date, Pyrexia: 100.6 100.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided. Treatment information was not provided.
PROQUAD RCV'D 09/03/2015. DEVELOPED MILD CASE OF CHICKEN-POX. LOCALIZED TO THE BACK AND NECK. AFEBRILE.
Severe pain in low back on movement.  Pain varied from day to day.  Had no pain killers.  On the 26th of Oct. increased pain in back and left shoulder caused me to go to the emergency room.  All lab tests and CT scan were normal.  Sent home with Motrin and Tylenol. Pain killers help, but low back continues on movement.  Sometimes so severe it makes my legs weak.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown demographics. On an unknown date, the patients received improperly stored with GARDASIL 9, 6 doses (lot # L00560, expiry: 15-JUN-2017). No adverse effects were reported. Outcome was unknown. This case is also related to 1509USA006365, 1509USA006821, 1509USA006822, 1509USA006823, 1509USA006824 and 1509USSSA006825 (same reporter link). Additional information has been requested.
Moderna COVID-19 EUA I have had three bad vivid dreams since second dose Moderna Covi-19 shot. On the fourth day, I had an afternoon nap and woke up due to vivid dream. I do not have a history of dreams, more so vivid dreams.
1 1/2 to 2 inch-diameter warm, firm red area at injection site. Pt also c/o increased discomfort for 3 days post-injection.
12hr p/vax pt devel irritability;low grade fever, decreased eating;post vax pt was very agitation & was sent to ER;
Dizziness, Headache, Fever, Tachycardia,  fever; dizziness; headache; high heart rate; red. swollen, painful arm Tylenol as needed
VIRAL SYNDROME / DEHYDRATION.  11/18/09 Hospital records, discharge summary received, service dates 11/6/09 to 11/10/09. Assessment: Weakness, anxiety disorder, panic attacks. Guillain Barre Syndrome dx'd on 10/12/09. Panic attacks, anxiety disorder. Patient had been having pain in legs requiring opioids, difficulty walking, this AM leg weakness worse. Stands unsteady, drags right foot. Sensation and proprioception subjectively decreased in right leg. IVIG administered. Continued antalgic gait, pain in thighs.  11/18/09 Physical Medicine Rehabilitation, additional hospital consults received service dates 10/29/09 to 11/16/09. Assessment: Relapse of Guillain-Barre  Transferred from another hospital and admitted for rehabilitation for Guillain-Barre. 4 weeks ago had weakness in upper and lower extremities, dx'd with Guillain-Barre syndrome, treated with IVIG. Went to rehab and had seizure like episodes. On 11/4/09 increased pain, increased weakness. Presumed diagnosis of relapse of Guillain-Barre with administration of IVIG. Possible seizure symptoms vs anxiety attack. Claustrophobia. Mild facial assymetry. Deep tendon reflexes decreased. Pain inner thighs, legs hurt. Right-sided head pain dx'd as migraine. Hands still painful. Numbness in feet persists. C/O vision problems and some difficulty urinating. Hyperventilation due to anxiety. Anxiety/Mood disorder.  12/07/09 Flu questionnaire received.  12/10/09 MR received for DOS 11/23/09. GBS started on 10/11/09, and Pt complained of loosing vision, dizziness, neuromuscular complaints. Eye exam was normal with exception of extraoccular movements due to nystagmus. Neuro exam: normal.   12/10/09 MR received for DOS 12/01/09. Pt presented to the hospital with extreme weakness, pain, trouble sleeping and anxious. Tx: Vicodin, but no help. Pt saw a psychiatrist. Other tx: Xanax, Klonopin, Cymbalta.  On examination, Pt fatigued, anxiety, vision problems. Goal is to wean Pt off pain meds. Pt had rehab. Pain resolved later on. Impression: Myopathy. Dr's opinion is that this is emotional related event.
-firstly, i experienced immense soreness in my arm, to the point it was painful to lift my laptop. around 7 pm began noticing feeling very cold and onset of sickness took temp and it was only 98. about 1-2 hours later, my temp was 100.4 , was experiencing chills, and pain throughout my body.
red area on lt arm not @ site of inject, but on inner aspect of upper arm & around the navel; diarrhea this AM;
This spontaneous report was received from a licensed vocational nurse and refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 16-FEB-2016, 17-FEB-2016 or 18-FEB-2016, the patients were vaccinated with GARDASIL 9 lot # L016429, expiration date 09-AUG-2017 (dose and route were not provided). Concomitant therapy information was not provided. On 16-FEB-2016, 17-FEB-2016 or 18-FEB-2016, there was an incorrect product storage as multiple unspecified patients received GARDASIL 9 that were improperly stored. No adverse events were reported. The highest temperature for the reported excursion was 48.32 F and it was during the timeframe of 25 minutes. There was no previous temperature excursion. The call to report this information was because of a data logger. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. This is one of several reports received from the same source. Additional information has been requested.
"Stomach cramps. Not severe enough to cause bad pain, but severe enough to keep me from eating more than a bite here and there".; This is a spontaneous report received from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the right arm on 24May2021 at 08:15(at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no allergies to food, medications or other products. Concomitant medications included norethisterone acetate, ethinylestradiol (AUROVELA) for unspecified indication from an unknown start date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0167) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. On 24May2021 at 13:00, the patient reported that she had stomach cramps not severe enough to cause bad pain, but severe enough to keep her from eating more than a bite here and there. The patient did not receive any treatment for the adverse event. The event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event stomach cramps not severe enough to cause bad pain, but severe enough to keep her from eating more than a bite here and there was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Flu vaccine was given at the clinic. Patient states approximately 5 hours after getting the flu shot his eyes got very red, itchy and swollen. The patient did notify the clinic where the injection was given and the doctor's office.
Patient was sitting in the observation area after his vaccine and his companion alerted us that he had fainted. He slumped to the  side for a  few seconds, we held him up and he came to rather quickly. He said he had felt dizzy. He had some water and sat for about 20 more minutes until he felt back to normal.
This is a spontaneous report received from contactable reporter(s) (Other HCP). An 89 old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization complete, Unknown manufacturer), for covid-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "patient has had sore throat after receiving COVID booster shot". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Besides sore arm no side effects to vaccine for first week.  At 7 days since vaccination, injection site very reddened, hot and sore.  Benadryl dissipated symtoms.  Every day for 6 days, symptoms came back either later in afternoon or at night worsening each day, but with Benadryl continuing to dissipate symptoms.  At day 14 past initial vaccination symptoms are gone and no other effects.  Will receive second vaccination  May 5.   Never had any other reaction or side effects other than this "covid arm."
Pt vaccinated w/DTP/OPV mother states infant ate more than normal was given liquidprin after immuization; Slept 1-2 hrs was fussy; began crying, cry became high pitched & continued. MD called prescribed Liquiprin stated infant OK.
PATIENT HAD CHILLS, ACHES AND PAINS, AND DIARRHEA. HE WAS CONFINED TO THE BED FOR ABOUT 72 HOURS AND WAS VERY WEAK.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 32-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number TA422, expiry date 30th June 2019) for prophylaxis. This case was associated with a product complaint. On 11th October 2018 11:30, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 11th October 2018, immediately after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site pain. On an unknown date, the patient experienced syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the injection site pain, syringe issue and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site pain to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by the pharmacist for herself. The patient received FLULAVAL QUADRIVALENT on the left deltoid. The patient believed that there was more air in the FLULAVAL QUADRIVALENT syringes this year than in previous years. The patient was an experienced user of the product. On the day of reporting her facility had a flu vaccination clinic for staff. The patient noted the unusual amount of air in syringe, as well as, experienced pain during the vaccination and could feel the vaccine being injected. The patient reported that the syringes are filled 1/3 to 1/2 with air and the rest of the space was product. The patient indicated that she had not experienced this with previous vaccinations with the product. The patient did not ask for replacement of the product. However, she wanted to report this in case there was a quality issue. The patient provided the lot number of another syringe which appears the same, batch number 4MA57 and expiry date 11th June 2019. The patient was initially speaking with a representative in Medical Information but she reports that they were unable to tell her this was acceptable. The patient provided two pictures of the syringe to GSK. The patient did not want to send a sample of one of the FLULAVAL syringes because all doses were allocated and felt that the pictures she emailed would be sufficient. This case has been linked with the case US2018185712 and US2018GSK197109, reported by same reporter.
This spontaneous report was received from a nurse and it concerns a potential product confusion. The reporter stated that she has heard of many healthcare providers almost mistaking RECOMBIVAX HB pre-filled syringes with FLUZONE for patient younger than 3 years of age as the products look very similar. The reporter was not aware of any instances in which the wrong product was administered to a patient as a result of this confusion. No adverse effects were reported. This is one of the two reports received from the same source. Additional information has been requested.