chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This is a Spontaneous report . A contactable consumer (patient) reported that a female patient in her later 70s received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunisation. Medical history included she had arthritis since she was in her 20's and ongoing, has severe pain in back, problems with her hips, has bone spurs in one shoulder, and her hands and fingers sometimes hurt with the arthritis. The patient's concomitant medications were not reported. The patient experienced sore arm in Jan2021. Patient had her 1st shot on 16Jan, due for her 2nd shot and was experiencing arthritic symptoms which she claimed was pre-existing and not related to the vaccine. She wanted to know if she could take Tylenol. She was currently refraining from taking Tylenol. Patient explained that the only reason she was calling was regarding a couple of post that had been going around about the Pfizer vaccine. She wanted to know if she could take Tylenol or pain killers after having the vaccine. The post said that they cause the immune system to not function with the vaccine like it was supposed to. She is in her late 70's, because of arthritis she sometimes took Tylenol or her doctor would give her a pain pill. She had the fact sheets and paperwork, she knew everything she needed to know about the vaccine except this one thing. The patient confirmed she had taken the vaccine and had no reaction other than sore arm. The patient explained she was upset and didn't feel like going through a report as she had been on the phone for 15-20 minutes just to try and get to this agent. She had no problems and just wanted to know if she could take a pain pill. If she had to hold much longer she was just gonna take and if it messes it up, then it would just have to be messed up. Patient remarked she should never have called, she thought it was a simple question but should have known nothing was simple anymore. It required a conversation and all her information just got an answer to her question. She was upset and was going to hang up, she was tired being on the phone; she was not upset at this agent but at not being able to speak with some regarding this issue. The outcome of the event sore arm was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-Medium, Additional Details: After getting the Pfizer vaccine, patient started to feel fainted. Patient stated that she has lightheaded and ringing in her ear. Patient was helped to lie down on the ground with both feet elevated. After 20 minutes, patient was feeling better. Blood pressure at this moment was 101/69, and pulse was 74. Patient was able to stand up and walk around.
no upper body strength; Muscle Weakness / body muscle weakness; This case was reported by a other health professional via call center representative and described the occurrence of strength loss of in a 57-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   On 22nd October 2020, the patient received Fluarix Quadrivalent 2020-2021 season (intramuscular). On 22nd October 2020, 4 hrs after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced strength loss of and muscle weakness. On an unknown date, the outcome of the strength loss of was unknown and the outcome of the muscle weakness was not recovered/not resolved.   It was unknown if the reporter considered the strength loss of and muscle weakness to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient was a healthcare professional. On 22nd October 2020, the patient received Fluarix vaccine and he went for his routine work out at the gym approximately four hours later, and he had no upper body strength. The patient continued to had body muscle weakness after one week since the vaccine. The reporter consented to follow up.
Patient received vaccine out of age guidelines. Spoke with mother who reports no adverse effects. Doctor notified. Advised mother to report any adverse effects to Health Department and Doctor.
Pt. reported feeling "dizzy" and "woozy". Then worsening pain in neck, eyes, and head.
The patient's PFR COVID booster vaccine was given despite a temperature excursion. The vial was left out overnight instead of being discarded and was re-used the following morning past the 12-hour time allotment once punctured at room temperature.
12/10/21: Developed left lower extremity pain that progressively worsened and did not improve with stretching 12/11-12/20/21: worsening left lower extremity pain 12/21/21: Doppler ultrasound with acute deep vein thrombosis involving left soleal sinus and peroneal veins.  12/21/21: initiated therapeutic anticogulation with elliquis 12/22/21: pap smear and mammogram performed, normal 12/26/21: left lower extremity pain improving.
Got the booster dose too early, because of the negligence of the pharmacist. It was 24 days before the 5 months; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the booster dose too early, because of the negligence of the pharmacist. It was 24 days before the 5 months) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 037F21A and 939902) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the booster dose too early, because of the negligence of the pharmacist. It was 24 days before the 5 months). On 08-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the booster dose too early, because of the negligence of the pharmacist. It was 24 days before the 5 months) had resolved.            No concomitant medications were reported. No treatment medications were reported. The reporter denied side effects. It was reported that there was no product complaint associated with this case.   This case was linked to MOD-2022-467290, MOD-2022-467313 (Patient Link).
2/7/22 pt to ED via EMS with increasing SOB and cough x 1 wk; O2 sat 70% on RA; placed on 15 L NRB with O2 sat 75%; placed on BiPAP with improvement in O2 sats; CXR showed bilateral pneumonia; positive test for COVID; admitted; given Remdesivir, Decadron, Baricitinib; transferred to ICU; A Fib with RVR - treated; AKI; pt's condition worsened requiring intubation and mechanical ventilation; while being intubated, pt suffered cardiac arrest; ROSC achieved; sputum grew staph haemolyticus, given ABX; pt's condition worsened; pt extubated and placed on BiPAP; family decided to transition pt to DNR with comfort care measures; pt expired in the hospital
She wore sunglasses in her house because the light bothered her eyes; Eyes felt dry; Loss of vision in right eye; Hole in her retina; Bad headache for 3 days; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported similar events for 2 patients. This is 1st of 2 report.   A 61-year-old female consumer (patient) received 2nd dose of BNT162B2 (Covid Vaccine, lot number: EL1248) on 06Jan2021 at single dose in the right arm for COVID-19 immunisation. Medical history was not reported. Concomitant drug included Multivitamin, Vitamin C, Vitamin D Zinc all from Mar2020 and ongoing. Historical Vaccine was 1st dose of BNT162B2 (Batch/lot number: EK5730) on 18Dec2020 in the right arm. Patient got COVID vaccine and a few hours later or the next day she started getting a hole in her retina and started losing her site in right eye. she went to the doctor as she has a hole in her retina. Again, this may be totally unrelated but she wanted to call and get this reported. She is going to see a retinal specialist this afternoon. After she had her COVID vaccine she had a bad headache for 3 days. She wore sunglasses in her house because the light bothered her eyes. She noticed this on 16Jan2021 because she was looking at paperwork and her eyes felt dry. She blinked a few times and had opened one eye alone, and she noticed that her left eye was fine but the vision in her right was not. This could have been going on longer. She just never closes only one eye. When both are open, her vision is normal. She saw the eye doctor yesterday, and that is when they said she had a hole in her retina. They said she will have to have surgery to close the hole. She knows she is at the right age for this to spontaneously happen, but just in case it is related, she wanted to report it. Outcome of the event Loss of vision in right eye was Not Recovered, for headache was recovered, for other events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046804 same reporter, AE and drug, different patient
injection site was swollen, hot to the touch, and red.; injection site swelling, pain, redness, and hot to touch; injection site was swollen, hot to the touch, and red.; injection site was swollen, hot to the touch, and red.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received PF-06928316 (ABRYSVO), on 07Aug2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE oral (ongoing). Vaccination history included: Moderna covid vaccine (Moderna COVID vaccine), for immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 07Aug2023, outcome "recovering", described as "injection site swelling, pain, redness, and hot to touch"; VACCINATION SITE WARMTH (non-serious) with onset 07Aug2023, outcome "unknown", VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 07Aug2023, outcome "recovering" and all described as "injection site was swollen, hot to the touch, and red.".  Additional information: the patient had a very painful big red blotch on arm and much of the pain has gone away but not all, still notices some swelling, injection site swelling, pain, redness, and hot to touch. Clarifying that hot to touch was early on, pain was early on, some of the swelling has gone down, but redness at point of entry of vaccine still remains but is not as red. Very painful big red blotch on arm: Area is still visible and there isn't the kind of pain that there was. Thought about taking a photo of the area, has been massaging the area, but still red. The patient doesn't take other medications, eats well, exercises.  The information on the batch/lot number for PF-06928316 has been requested and will be submitted if and when received.
Information has been received from a physician concerning a 68 year old female patient who on 21-JAN-2009 was vaccinated with 0.65 ml of a dose of ZOSTAVAX (Lot not reported) in her left arm but very near to elbow. the patient developed golf ball size induration at the injection site after vaccination. As of 28-JAN-2009 the outcome of the patient was unknown. Additional information has been requested.
Fainted approximately 1 to 2 minutes after the vacinnation.  Fell on head due to fainting.  Was sent to the emergency room for bleeding within my brain.  Was hospitalized for 3 days.  Resulted in permanent loss of my sense of smell due to head trauma.
This is a spontaneous report from a contactable consumer (patient's parent). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (reported as "this afternoon") (Batch/Lot number was not reported) (at 26-year-old) as first dose, single for COVID-19 immunisation. The patient's medical history was reported as no. Concomitant medications were not reported. Couple minutes into that he got light headed, his vision got blurred and then he had a complete vision loss. They cleared the room and called the paramedics. The paramedics came and said that both of his eyes were dilated and his blood pressure was high. They sat him for couple of minutes, then his vision return. So if they ask them make the total of vision loss lasted for seven minutes. His blood pressure went down. They kept him there and had a given a bottle of water and two container of fruit juice to bring his sugar level up. They made sure everything seems alright. And paramedics left and said that they thought it would be cause from some sort of blood reaction and allergic reaction to vaccine. And told them not to get the second shot. And let us want to he felt ok that it would be alright to go home. They did keep him there for about half an hour longer just to make sure he was alright and then sent him home. That was just a reaction and he should be ok now. No treatment received. The outcome of the events was resolved on an unspecified date. Information about batch/lot number has been requested.
Pt was given COVID vaccine, and then went to waiting area chair.  Shortly after he got up and requested water while standing at the consultation window at which time he then fainted.  He fell with his back in an upright position, falling against the wall of the window and coming down to a crouched position.  I immediately came out to him and he got water, at which time he was responsive and ok.  He had no complaints of any pain but did not recall the actual passing out.  He remarked being adverse to needles and wasn't surprised it happened.  Shortly after he felt better and was up in a chair.  After some time he then was continuing to feel well and left the pharmacy under his own power.
No adverse symptoms reported; the patient did not receive "a full dose" of MMR II.; This spontaneous report has been received from a nurse practitioner, referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not provided by reporter. The patient's concomitant therapy included sterile diluent.  On 07-JUL-2020, the reporter stated while she was administering a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (therapy type: recombinant Human albumin (rHA)) (M-M-R II) (lot # S015427 with 20-MAY-2021; route, strength and dose were unknown) for prophylaxis to the patient, the patient moved and a small amount of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (therapy type: recombinant Human albumin (rHA)) (M-M-R II) went into the reporter's eye. The reporter stated that the patient did not receive a full dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (therapy type: recombinant Human albumin (rHA)) (M-M-R II) (underdose). No adverse symptoms reported. AE (adverse event) for the reporter with eye exposure to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (therapy type: recombinant Human albumin (rHA)) (M-M-R II) documented in case 1633271.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA003124:
Non-responsive, listless, sleeping continually for 9 hours then waking for 1 ounce feeding then sleeping additional 6 then 5 hour spans, admitted to hospital 12/31/04; 3 days after shots. Suspected meningitis but LP was clear, CT scan indicated fluid on the brain, fontanelles extremely recessed. Medical Records received on 2/16/2005 states pharyngitis.
This spontaneous report was received from a pharmacist and refers to a 90 year old female patient with continuous positive airway pressure (CPAP) treatment and colitis. On 10-AUG-2015, the patient was vaccinated with ZOSTAVAX (lot number and expiration date were not provided) subcutaneous in the arm. There was no concomitant medication reported. On 10-AUG-2015, the patient experienced a "hard and warm lump behind the arm" (injection site reaction and injection site induration). On an unknown date the reporter stated that the patient had congestion and trouble breathing while lying down. She also stated that her "ears were stopped up and she had headache". In addition, it was reported that the patient's colitis was "acting up", but it could be because she ate two pears. It was reported that on an unspecified date the patient sought medical attention and was treated with ZYRTEC. At the reporting time, the outcome of respiratory tract congestion, headache, injection site induration, injection site reaction, colitis, ear disorder and dyspnoea was unknown. Additional information has been requested.
Patient slight erythema about 1/2 inch in diameter to VZV site. Advice to apply cold compress to decrease swelling and return to clinic if sign and system get worse.
It was reported that a 15 month of old male was given TriHIBIT on 8/14/02. Lot number for Tripedia is DTaP U0544AA, lot number for ActHIB is HIB UA686AA. Within 24 hrs of administration, the pt had a fever of 103F (axillary) and a swollen, red area at the vaccination site. The pt was seen in the office, treated and released.
On 09/13/2023 I woke up with chest pain.  thought it was indigestion.  However, after eating 6 minutes it got worse.  I then called 911 and within 45 minutes I was at the Emergency Room.  I tested my blood twice and saw abnormality and catheterized my heart and found out I had Myocarditis, when at first, they thought it was a heart attack.
Information has been received from a physician concerning a 22 year old female who on an unspecified date was vaccinated with a first dose of Gardasil (lot # unknown) 0.5mL injection. The physician reported that the patient passed out after receiving the first dose of Gardasil. Medical attention was sought. At the time of reporting on an unspecified date the patient had recovered. The patient is going to receive her second injection. No additional information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007.  Follow-up information was received from a healthcare worker.  On 03-JUL-2007 the patient recovered from passing out and near syncope.  The patient recovered with rest.  Additional information is not expected.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 12-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 24-FEB-2017) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had six temperature excursions: 1172, 336, 168, 80, 24 and 416 hours respectively. The lowest recorded temperatures were 30 (-1.111111111 Celsius degrees) and -3 (-3 Celsius degrees). The highest recorded temperatures were 49 (9.444444444 Celsius degrees), 47 (8.333333333 Celsius degrees), 59 (15 Celsius degrees) and 48 (8.888888889 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
a lot of sz activity; a lot of sleeping; no eye contact; lifeless; motionless, weak; back & forth in ER on med to control sz;; brain damage;
PATIENT HAD INJECTION SITE REACTION. REDNESS AND SWELLING ON UPPER RIGHT ARM. ADVISED PATIENT TO USE TOPICAL BENADRYL AND MONITOR SIZE AND THAT PT IS TO CONTACT MD IF IT DOES NOT GOT BETTER BY TOMORROW.
One week before getting the second Moderna shot husband got covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (One week before getting the second Moderna shot husband got covid) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for an unknown indication.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (One week before getting the second Moderna shot husband got covid). At the time of the report, COVID-19 (One week before getting the second Moderna shot husband got covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication was provided. It was reported that patient  waited to get  second shot in December since he had COVID-19 one week before the second shot. Company comment: This is a spontaneous case concerning a 65-year-old, male patient with no  medical history reported, who experienced the non- serious unexpected, according CCDS, AESI of COVID-19. The event occurred after the first dose of mRNA-1273 vaccine. The rechallenge is unknown, as the outcome of the event after the first dose has not been reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.     This case was linked to MOD-2021-435269 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 65-year-old, male patient with no  medical history reported, who experienced the non- serious unexpected, according to tj, AESI of COVID-19. The event occurred after the first dose of mRNA-1273 vaccine. The rechallenge is unknown, as the outcome of the event after the first dose has not been reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Lightheadedness and pallor with 1 minute after injections. Patient laid down flat. In 2-3 minutes patient fainted, eyes dilated, had circumoral cyanosis. Pulse and respirations WNL. Regained consciousness within 70-90 seconds. Legs elevated, cool damp cloth on forehead, and kept lying on the floor. Head placed on pillow. C/O nausea within 5 minutes. Had sips of water and Sprite at patient request. Vomited 40 minutes later. Left walking, accompanied by her father after appeared fully recovered, approx. 50 minutes after incident.
Mother called the clinic 6-19-08 3:47pm to report patient's left leg was red and warm to touch from knee to hip and that she was crying unconsolably.  Patient had received Prevnar and Act Hib that morning.  Our records indicated that Act Hib was given in the left vastus lateralis.