chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A painless feeling of pressure inside my head, a bit like a high with the feeling of an elevated mental acuity; A painless ocular pressure that seemed to intensify the forward looking focus or sharpness of my vision; feeling of an elevated mental acuity; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 10Mar2021 08:30 (Batch/Lot number: unknown) at the age of 61 years as dose 1, single and administered in arm left, administration date 31Mar2021 08:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. No other medications in 2 weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: HEAD DISCOMFORT (non-serious) with onset Mar2021, outcome "recovered" (31Mar2021), described as "A painless feeling of pressure inside my head, a bit like a high with the feeling of an elevated mental acuity"; OCULAR DISCOMFORT (non-serious) with onset Mar2021, outcome "recovered" (31Mar2021), described as "A painless ocular pressure that seemed to intensify the forward looking focus or sharpness of my vision"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Mar2021, outcome "recovered" (31Mar2021), described as "feeling of an elevated mental acuity". Therapeutic measures were not taken as a result of head discomfort, ocular discomfort, therapeutic response unexpected. Clinical course: A painless ocular pressure that seemed to intensify the forward looking focus or sharpness of vision when patient left the clinic 15 minutes after the second shot. A painless feeling of pressure inside the head, a bit like a high, with the feeling of an elevated mental acuity. Patient experienced the same feelings after the first dose. Patient was not complaining and do not think of it as "adverse", but wanted to report this effect. It has been 8-1/2 hours since the last injection and patient felt fine, no injection site or arm pain, no body aches or pain; felt completely normal. Additional information: Vaccine facility type was at a hospital. Since the vaccination, the patient has not been tested for COVID- 19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2/25/2021 OS became swollen to the point where she could not open her eye. It was swollen for two days. On 3/3/2021 OD became swollen. Pt seen at eye doctor 3/5/2021 who diagnosed eyelid edema of unknown cause and reccomended hot compresses bid. Full resolution today 3/8/2021.
Foster mom heard patient moving middle of the night in his crib. When she checked on him he was doing rapid movement with his body and foster dad noticed his eyes moving rapidly, wasn't responding to his name, not waking up - lasted about 30 seconds, EMS called, patient was then acting fine by the time paramedics arrived. Patient seen in office for follow up 1/18/22
She's been having issues after the vaccine her arm, the right arm (where she got the injection) is in a lot of pain; 2 of her fingers feel pain, and numb,; pain is all the way in the back and it's getting worse.; 2 of her fingers feel pain, and numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Apr2021 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "She's been having issues after the vaccine her arm, the right arm (where she got the injection) is in a lot of pain"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "2 of her fingers feel pain, and numb,"; BACK PAIN (non-serious), outcome "not recovered", described as "pain is all the way in the back and it's getting worse."; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "2 of her fingers feel pain, and numb". Therapeutic measures were taken as a result of vaccination site pain, pain in extremity, back pain, hypoaesthesia.  Additional Information: Patient had got the 2nd dose of the vaccine on 27Apr2021. She's been having issues after the vaccine her arm, the right arm (where she got the injection) is in a lot of pain, 2 of her fingers feel pain, and numb, pain is all the way in the back and it's getting worse. She been taking some medication ibuprofen 800mg 3 times a day but that's not helping. This has been going on for 2 weeks already. Patient dont know if this the side effect from the vaccine. If they put it in the wrong position or in the nerve. Shes not getting better and she's getting worse and it's past 7 days. Patient know 2 person (males: 41 years and 38 years) they are the same age they got allergic reactions (after he got the 2nd dose 9 days later and he ended up in the hospital 3 times felt like his throat was swollen and went to the ER they put some injection for allergies and he was getting better and now he is the process to figure out why he had that reaction. but it was between the 7 days (pfizer covid vaccines).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After receiving the new Moderna BiValent vaccine, I began to notice some visual changes the 2nd day, and worsening to some degree on the 3rd day. This also happened after my 2nd regular Moderna booster, and it was irritating for about 2 weeks, and cleared up without any treatment. I thought it was possibly allergies at the time. But, since this has occurred again, I felt I should let the FDA know. Distance vision has seemed stable, but reading was blurry when it happened before, and it seems the same this time. If it doesn't clear up in a few days, I will see my ophthalmologist for evaluation. I have experienced headaches after each vaccine and booster, but more severe with the 1st one. Also ran a low grade fever for about 2 days each time. Temp less than 100 degrees. All vaccines and boosters have been Moderna. I am 71 years of age, and in good health. No underlying medical conditions, and do not take any prescription meds on a regular basis. I do take vitamins and mineral supplements I have not had Covid to the best of my knowledge. I have been directly exposed several times, but have never tested positive.
2nd dose was store incorrectlyand was administered; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 7Z29K, expiry date 15th April 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 9th March 2021).   On 9th June 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix that was store incorrectly (room temperature over 72 hours), which led to incorrect storage of drug. The reporter consented to follow up. This case was linked with case US2021259946, reported by same repoprter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021259946:Same reporter
This spontaneous report as received from a registered pharmacist refers to a 11 years old female patient. The patient was vaccinated with the first dose of GARDASIL (lot number reported as 0475AE expiration date 14-DEC-2013) on 10-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 10-AUG-2012 the patient experienced headache. She was also experiencing pain, tingling and muscle weakness in the arm that received the GARDASIL. The patient sought medical attention by visiting the pharmacy. No treatment information was reported. The outcome of the headache, pain, tingling, and muscle weakness in the arm was reported as not recovered/not resolved. The causal relationship between the events and GARDASIL was not reported. Additional information has been requested.
Begin with localized tenderness and pain at injection site. Progressed to joint pain in the arm, loss of strength, tenderness and inability to move arm.
COVID-19 VIRUS TEST POSITIVE; COVID-19 VIRUS TEST POSITIVE; This spontaneous case was reported by an other health care professional and describes the occurrence of the first episode of SARS-COV-2 TEST POSITIVE (COVID-19 VIRUS TEST POSITIVE) and the second episode of SARS-COV-2 TEST POSITIVE (COVID-19 VIRUS TEST POSITIVE) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced the first episode of SARS-COV-2 TEST POSITIVE (COVID-19 VIRUS TEST POSITIVE). On 17-Mar-2021, the patient experienced the second episode of SARS-COV-2 TEST POSITIVE (COVID-19 VIRUS TEST POSITIVE). At the time of the report, last episode of SARS-COV-2 TEST POSITIVE (COVID-19 VIRUS TEST POSITIVE) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no Concomitant medications included. no treatment mentioned.
itchy; swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and SWELLING (swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PRURITUS (itchy) and SWELLING (swollen). On 20-Feb-2021, PRURITUS (itchy) and SWELLING (swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-035817 (Patient Link).
Patient reported back to the pharmacy experiencing tingling in their mouth and tightness  in their throat within 15 minutes of receiving the shot. Patient was given 25mg of Benadryl, water and candy and monitored for another 20 minutes. After about 15 to 20 minutes after receiving the Benadryl patient started feeling much better and felt comfortable leaving on their own accord. The pharmacist felt comfortable after examining and talking to the patient that an immediate concern had passed.
Magnet sticking to arm where vaccine was administered; This is a spontaneous report from a non contactable consumer (patient's wife).  This consumer reported for a male patient of an unknown age who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot Number and Expiration date was not reported) as a single dose for COVID immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter and her husband both got the Pfizer shot and then some people her husband worked with started to talk about this thing on the web where people talking about the magnet sticking to the shot. On an unknown date, the reporter and her husband thought they were kind of crazy but they tried it and the magnet does stick to their arms. Reporter stated that other people have told her if they have or didn't have the shot and states some of the people haven't tried the magnet thing and she would have never tried it except for the people at her husband's work mentioning it and they had obviously tried it and then they asked them didn't you just have the vaccine, so her husband tried it. Reporter stated she did not believe this conspiracy theory thing about a chip or anything like that but she was concerned that a magnet truly does stick to her arm it has been 21 days and it still does. Reporter stated they tried it last night because they have been on vacation and it still sticks, 21 days in and it was still sticking to their arms (vaccination site discomfort). The clinical outcome for the event was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021634416 same product and event, different patient;US-PFIZER INC-2021636192 same product and event, different patients
Pt states pt developed rash at injection site left thigh 8hr after immun. 11 days after pt developed pruritic papules all over trunk. No
rt arm swollen, sore, red, weakness, SOB, couldn't move arm; taken to clinic 845AM inc wheezing, extreme weakness, SOB-transferred to hosp from clinic @ 1115AM by rescue squad; given 02, IV DPH @ hosp;
Late for second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late for second dose) in a female patient of an unknown age 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late for second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late for second dose) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Concomitant medications was not provided by the reporter. Treatment information was not provided.
PT report having night sweats for the 4 previous night after vaccine, lost weight with in the last 2 weeks. Pt was evaluated by PA and pt left and was seen at the urgent care for abdominal  pain.
Information has been received from a nurse concerning a patient who was vaccinated with GARDASIL. Subsequently the patient experienced nausea after receiving the vaccine. The patient sought unspecified medical attention and her outcome was not reported. Additional information has been requested.
He got his vaccine, he got a big zit at the inoculation site, pustulant about the size a pea about a month after the shot.  He went to the doctor and they did an UC and found he had calcified tendons and a pitted rotator cuff.  The zit popped and that was it, and there was nothing that they could do.  It was painful and has been giving him pain ever since that on the right shoulder.  He has not had any treatment for it as they did not know what to do as he was incarcerated.
feeling ill; itching on back; fatigue; rash and itching on arms, torso, neck and face.; headache; Diarrhea; Rash, redness and itching on back; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: EN6203), via an unspecified route of administration on Left Arm on 26Feb2021 at 15:45 hours (at the age of 53-years-old and the patient was not pregnant at the time of vaccination) as a single dose for COVID-19 Immunisation. Medical history included that patient had seasonal allergies and also to Sulfa drugs. Concomitant medications included Zinc (MANUFACTURER: UNKNOWN), Vitamins (MANUFACTURER: UNKNOWN), Aspirin (MANUFACTURER: UNKNOWN), and Allergy Medicine (MANUFACTURER: UNKNOWN). Past drug history has not been provided. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccine within four weeks. Since the vaccination, patient has not been tested for COVID-19. On first day of vaccination, patient was feeling ill and experienced Diarrhea, Headache, and Fatigue. On Third day of vaccination, patient experienced Rash, Redness and Itching on the back. On the Fifth day, the patient experienced Rash and Itching on arms, torso, neck and face. The adverse events resulted in the Doctor/Health care professional/Clinical visit. Therapeutic measures were taken as a result of the events and it included treatment with Benadryl from unspecified start date to end date. The clinical outcome of the all events were recovered. No follow-up attempts are needed. No further information is expected.
Neck pain; knee pain; Swollen knee; autoimmune disease-most likely lupus; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration, administered right arm on 04Mar2021 (at the age of 26-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received the first dose of bnt162b2 (lot number: EN6199) on an unspecified date in 2021. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Medical history included childhood epilepsy and migraines. The patient was not diagnosed with COVID-19 prior vaccination and since the vaccination she was not tested for COVID-19. Concomitant medication included sumatriptan taken for an unspecified indication, start and stop date were not reported. The patient reported that on 21May2021 (also reported about 2 months after 2nd dose) she experienced neck pain that has migrated down to her left knee. Left knee swelled up and remained swollen for 2 months. Blood tests indicated likely autoimmune disease-most likely lupus. The events were reported as serious (disability). The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care visit. The events were treated with Prednisone and hydroxychloroquine. The outcome of events was recovering.   Follow-up attempts are completed. No further information is expected.
Fever/severe pain and swelling at inoculation site/redness and infection at site of pneumococcal vaccine/chills/overall pain and fatigue/headache
Patient started feeling weak after immunization, face lips started turning pale blue approximately 5-10mins after getting the pediatric Pfizer  vaccine.. she passed out like minutes 10-15mins after the shot  as patient was given an EpiPen. patient was laid on the grown with feet elevated, but regain consciousness  within a very short time.  Benadryl was also given to the patient after she  regained consciousness.  Emergency help arrive, and  did and assessment on patient after which parent took patient to the ER
No additional AEs; an expired dose of V ARlV AX was inadvertently administered to one patient; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 09-MAR-2021, the patient was inadvertently vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S006019, expiration date 27-FEB-2021 (exact dose, anatomical location and route of administration were not reported) for prophylaxis. No additional adverse events (AEs) were reported.
PATIENT WAS PANICKINK BEFORE GETTING THE VACCINE.WAS VERY NERVOUS AND AFTER GOT THE SHOT HAD LITTLE SEIZURES AND FAINTED FOR FEW SECONDS.REGAINED CONSCIOUSNESS WITHIN FEW SECONDS.WAS TALKING AFTERWARDS.DID NOT WANT TO LIE DOWN SO MADE HER KEEP HER HEAD  BETWEEN THE LEGS FOR PROPER BLOOD FLOW.DID COLD COMPRESS FOR SOME TIME.PATIENT STARTED FEELING BETTER AFTERWARDS.PARAMEDICS HAD ARRIVED BY THAT TIME AND TOOK HER VITALS HICH SEEMED GOOD PER PARAMEDICS.PATIENT SIGNDE A WAIVER AND PARAMEDICS LEFT AFTREWARDS. WE GAVE PATIENT GATORADE TO DRINK AND HAVE ONE OF THE PHARMACY ASSOCIATE BE BY PATIENTS SIDE .AFTER STAYING IN THE PHARMACY FOR ABOUT AND HOUR PATIENT LEFT ALONG WITH HeR HUSBAND
Friday, I felt as if I was choking while eating an avocado but didn't think anything of it and thought I was tired. Saturday, I woke up still feeling like I had a swollen throat and then felt as if I had a sore throat and fever. I took my temperature and it read a normal body temperature. I had chills going up my back; I took my temperature again with a different thermometer and it read 104.5 degrees. I took ibuprofen and theraflu to tried to reduce my fever. No medicine aided, and then I started experiencing a cough and body aches. Sunday and Monday it continued, but on Monday I called my job and told them I felt sick to call into work. My supervisor advised me to take a rapid COVID-19 test. It came back positive for COVID-19. I went to the emergency room where they did chest x-ray and bloodwork on me as my case worsened; they discovered that COVID-19 caused a problem in my digestive system and esophagus and prescribed me Prilosec-OTC to help reduce the acid deterioration for the next 2 weeks. I was discharged 2 days later and my fever began to broke and recover.
Slight chill on his shoulder; This is a spontaneous report from a contactable consumer or other non-professional healthcare professional (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not provided), via an unspecified route of administration on 19Mar2021 as concentrated, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the caller called to report adverse event for his friend with the Pfizer COVID Vaccine. The caller stated that, he had the Pfizer injection and nothing happened to him, it was great. The caller ran a triage for a while in a rehab hospital in a correctional facility. Rehab clients would come in and he would take their temperature, vitals, do intake and get them ready for rehab. He was not a nurse, doctor or pharmacist. For himself the only adverse effect was a slight chill on his shoulder for 4 to 5 hours on an unspecified date in Mar2021. He received it on 19Mar2021 and it could have been the weather. It doesn't matter. The caller declined to do a report for himself about his experience with the Pfizer COVID vaccine. The outcome of the event was recovered on an unspecified date in Mar2021.  Information on the lot/batch number has been requested.
right arm pain, swelling, and warmth which has been progressive after receiving her first Moderna Covid vaccine on 1/22/21.  No weakness, numbness, or paresthesias of the right upper extremity.  Affected area has remained isolated around the injection site without significant spread.  No fevers, chills.  Patient has noted fatigue, headache, body aches, isolated rhinorrhea/sneezing a few days ago, and intermittent cough.  Known issues with postnasal drip.
No adverse reaction.  Patient had previously received the Moderna Bivalent Booster on 9/30/2022.  A second Moderna Bivalent Booster was given on 1/30/2023 at 1315.  Patient was kept in clinic from 1315 to 1345.  Patient felt fine.  Had no issues.  Patient educated on error and signs to watch for and encouraged to call with any questions or concerns.