chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 67 year old female patient. On 08-APR-2014 the patient was vaccinated with one dose of ZOSTAVAX (lot number# J013449, expiry date: 24-JAN-2015), once, subcutaneously into the back of left upper arm. The patient's past medical history, past drug history, and concomitant medications were unknown. On 09-APR-2014 (reported as 'next day') the patient reported that injection site became itchy and red. Over the next several days the redness progressed and moved up her left upper arm towards her left neck under left ear and her left neck gland became swollen and painful to the touch, and painful with talking and chewing. On 12-APR-2014 the consumer went back in to the pharmacy and told the pharmacist that she was taking ibuprofen (manufacturer unknown) for pain and wanted to know what else she could take for the pain because the pain was bothering her. Pharmacist also noticed that a purple and red bruise around the injection site that is a couple of inches in diameter and a raised rash around the injection site. The patient did not have a fever, was not having trouble breathing and was fully alert. The pharmacist contacted the physician who were concerned that it could be some cellulitis and advised the pharmacist to go to the emergency room. It was unknown if any relevant laboratory testing was performed. As of 12-APR-2014 it was unknown if the patient would receive another dose of ZOSTAVAX. The outcome of the events was unknown. The relatedness of the ZOSTAVAX and the events was unknown. Additional information is not expected.
1st injection, extreme pain in left arm. Unable to move it for 48 hrs prior to injection.  2nd injection, fever, aches and pain for two and a half days. Had night sweats off and on for two weeks after 2nd injection. Left arm was always a little tender.  In October, seven months later left arm began to ache and my range of motion was becoming limited.  Within weeks, both arms became sore and weaker when extending my arms upwards. My back was also becoming tender. Notice when doing my evening walks that I recently began  having shortness of breath. I'm starting to get a little concerned.
tired/exhaustion; cough; runny nose; fever 100 "oral"/fever 100.3; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 16Dec2020 08:45 at single dose on right arm for COVID-19 immunization. The patient's medical history reported as none and no Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included exemestane, thyroid (ARMOUR THYROID), ergocalciferol (VIT D), ascorbic acid (VIT C), acetylsalicylic acid (ASPIRINE). The most recent COVID-19 vaccine was administered in Workplace clinic. It was reported that nothing on Wednesday. On 17Dec2020 19:00 (07:00 PM) (Thursday evening), the patient was very tired, cough, runny nose and fever 100 "oral" (as reported), Friday (18Dec2020) exhaustion and fever 100.3 with cough and runny nose. The events were non-serious and no treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.
Tongue got tingly; Mouth is like if she's eating a sour gummy bear, it was very watery; Very tired; Not feeling well; Body was shaking when she was awake; Weird pain on her right side on her rib; pain shoulder; Pain under my breast; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that,  A 38-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0162) (at the age of 38 years old), dose 1 via an unspecified route of administration on 20Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced, she did not remember when she had her first shot. She received the first shot on 20Apr2021. When she had her first shot, her tongue got tingly, like a tingly sensation, and her mouth was like she was eating a sour gummy bear, it was very watery. She further described as it would come and go for the first day she took the vaccine, she thought the second one too. She was very tired, not feeling well, her body was shaking when she was awake. She also had this weird pain on her right side on her rib. She did not know what it was, it was still not going away. It was not like she broke something, but she had herself doing exercise or something, it was kind of there, the pain. She had never had the pain before, she did not know if it was due to vaccine. She had pain under her breast and shoulder and a few days after she received the shot, she had sour taste in her mouth, the latter has resolved in 2021. The outcome of all the events was unknown, and the outcome of the event mouth is like if she's eating a sour gummy bear, it was very watery was recovered on an unspecified date in 2021 and Weird pain on her right side on her rib was not recovered.  No follow-up attempts are needed. No further information is expected.
Got the shot, as walking to the desk to check out patient started to feel dizzy and her throat was bothering her and sat down and put her head down. Was offered water.  After check out she was walking out of the front door of the building and claimed that she was starting to get tunnel vision and not feel right.  She passed out and was caught by me (mom) she was very pale and was sweating.  I have asked her and she told me she felt cold as well and that her ears were ringing and she couldn't feel her arms or legs.  Blood pressure was taken by a nurse and was extremely low, somewhere around 70/30 I believe.  Then she was escorted back into the doctors office to lay down for approximately 10 minutes.  As of right now, at 2:37PM the same day, she has a strong headache and feels very sore, weak, and exhausted. The full extent of event outcomes remain to be seen.
Itching over the neck and redness and itchy on right arm;  Benadryl 50 mg PO once
This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On unspecified dates approximately 2 to 3 years ago, the patient received the first two doses of RECOMBIVAX HB. The patient wanted to receive a third dose on 02-APR-2015 (Inappropriate schedule of drug administration). No adverse symptoms reported. Outcome of the event, inappropriate schedule of drug administration was unknown. Reporting pharmacist considered the event to be not related to RECOMBIVAX HB. Additional information has been requested.
Excruciating pain in right arm, enough to cause crying - unable to lift arm. Vaccine given too high up in arm.
Face felt swollen 20 min after injection. This subsided after 5 min.  General malaise 1 hr. after injection until bed.   These symptoms were felt upon waking up the following morning around 6am: Light-headed, nausea, vomiting, weakness, fatigue, muscle aches.  Symptoms worsened by 9am including: chills, all-body aches, light-headedness, dehydration, fever. Headache started that evening 7pm (a little more than 24hrs. after the injection).  Headache lasted all night and into following 2 days. Other symptoms subsided 48 hours after initial injection. Different type of headache continues after the 4th day.  More like a sensitivity on the scalp with movement and touch.  This is slowly subsiding.
There was an outpatient clinic at a long term care facility.  The patient received a THIRD vaccine for COVID-19.  It was not realized until inputting paperwork after the clinic that the patient already received two doses.
Trouble breathing. Peak flow at 150. Started at 14 Apr, 9:00 PM and continued until 9:00 AM 15 Apr. Treated with rescue inhaler and monitored with peak flow meter. Fever, dizziness, and fatigue occurred at the same time.  Arm soreness and swelling also at height during this time.
Patient developed urticaria on neck and bilateral upper extremities about 6 hours after HPV vaccine was given. Hives improved by the following morning but still some mild itching. Advised patient to start benadryl.
Tested positive for pneumonia; Covid-19; A spontaneous report was received from a consumer (patient) concerning a 70-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and tested positive for pneumonia (pneumonia) and COVID-19  No medical history was reported. No concomitant medications were provided.  On 19 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: not provided), intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient was taken to the hospital where he tested positive for pneumonia and COVID-19. On 05 Mar 2021, the patient was discharged. He had not experienced any other symptoms since.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events of tested positive for pneumonia (Pneumonia), COVID-19 was unknown.  The reporter did not assessment for the event of the tested positive for pneumonia (Pneumonia), COVID-19.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a pharmacist concerning a 35 year old female patient. The patient's pertinent medical history, drug reactions, allergies and concurrent conditions were not informed. The patient was not pregnant. The patient's concomitant therapies included a birth control medication and acetaminophen, hydrocodone bitartrate (NORCO). On 14-NOV-2016, the patient was vaccinated with the first dose of VARIVAX (lot #, expiration date and therapy route were not provided), for prophylaxis. On approximately 20-NOV-2016, reported as "1 week after received VARIVAX", the patient had complaints of tingling and pickling throughout her body, mainly in her hands and feet. The patient received her second dose of VARIVAX on 19-DEC-2016 and the pharmacist reported that the patient had complaints again of tingling and prickling within one week of received the VARIVAX. It was informed that the patient sought medical attention but no laboratory studies were performed and no treatment was given for the adverse events. The patient did not present any disability or incapacity. The outcome of tingling and prickling  was reported as not recovered at the time of the report. No product quality complaint (PQC) was involved.  Additional information has been requested.
My left arm is red where the shot; my arm is also sore; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 19Feb2021 13:30 (at the age of 66-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included multiple sclerosis (MS) from an unknown date. The patient was not pregnant at the time of vaccination. The patient has no known allergies. Concomitant medications included modafinil, anastrozole, colecalciferol (D3), calcium ascorbate (ESTER C), baclofen and pantoprazole sodium sesquihydrate (PANTOPRA) all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On 20Feb2021 00:00, the patient experienced my left arm is red where the shot was given and my arm is also sore. Since the vaccination the patient has been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a physician via patient's mother concerning a 16 year old female with asthma who on 31-AUG-2011 was vaccinated with the second dose of GARDASIL (lot# not reported). Concomitant therapy included ALLEGRA and montelukast sodium. The mother reported that she had a total of two doses and the date of the first dose is unknown. On 31-AUG-2011 the patient experienced pain in her back, heaviness in her legs and pain ascending from her legs go up or down stairs. Therapy with human papillomavirus vaccine was discontinued. The patient's pain in her back and heaviness in her legs and pain ascending from her legs go up or down stairs persisted. On 31-AUG-2011 she started having pain in her back and experienced a heaviness in her legs that is described as a feeling of "weight on her feet." She had pain ascending from her legs upward through her back. She was unable to go up or down stairs. Her doctor had her go to the emergency room (ER). She was seen in the ER on 31-AUG-2011, after the onset of the symptoms. The ER doctors thought she may have Guillain-Barre syndrome, and that was ruled out as a cause because she had reflexes. She was an athlete. They also thought it may be related to "athletic pain" but she says it feels different than athletic pain. She was given one liter of unknown IV fluids as a treatment in the ER. During the ER visit she had a Creatinine Kinase (CK) level of "around 1000," BUN and Creatinine "within normal levels." On 31-AUG-2011 she was discharged from the ER with orders to take MOTRIN and TYLENOL. From 31-AUG-2011 to 03-SEP-2011, she has been taking 600 mg of MOTRIN and 500 mg of TYLENOL, in alternating doses as needed for pain. As of 03-SEP-2011, she has not fully recovered from her pain and heaviness in her legs and she was no longer receiving doses of GARDASIL. Follow-up information was received from a physician indicating that he treated the patient (a doctor's adolescent daughter) in the Emergency Room. It was reported that the patient had received GARDASIL and the flu vaccine (manufacturer unknown) on an unspecified date. The patient presented to the Emergency Room with pain in her thighs and had difficulty walking. The patient's CK level was elevated. The patient was diagnosed with Rhabdomyolysis. The patient was treated with IV fluids and sent home. The patient was not admitted to the hospital. The physician stated that the patient had recovered. Upon internal review, rhabdomyolysis was determined to be an other important medical event. Additional information is not expected.
Local reaction of left arm. Approx. 1.5in x 1.5in of erythema, swelling and warmth.
She had a racing heart; Itchy; This is a spontaneous report from a Pfizer sponsored program with Regulatory Authority Support. A Non-contactable female consumer (patient) reported that who received first dose of BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller stated she had her first dose of the vaccine back in Feb2021. On an unspecified date in 2021, she had a racing heart and itchy. She wants to know if she should get the second dose. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Joint Pains, uncontrollable shaking, Weight loss 10lbs., upset stomach, Muscle weakness pain, fatigue, abdominal/chest pain, pressure in head, marks on skin, fainting, seizure like episode.
This spontaneous report was received from a nurse regarding unknown number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with GARDASIL 9, (lot # L036301 with expiry date 20-DEC-2017 and Lot# M026306 with expiry date 30-APR-2018) (dosing details, route of administration and anatomical location unknown), that were exposed to a temperature excursion of 1.1 Celsius (C) for 6 hours. No adverse effects were reported in any patients. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information is not expected as the reporter denied consent to be contacted.
Patient had swelling, redness at injection site. Pain in Left arm and shoulder, several red blistering bumps around injection site a month after injection given.
Memory fog for a couple days after vaccination; very sore arm and muscle tightness for 3 days after vaccination; 7 days after vaccination began to form redness, swelling, and warmness to touch at injection site about 3-4 inches by 3 inches.
Muscle ache, headache, low grade fever, stuffed up.  Stayed in bed most of Friday, and Saturday. While this is my report, my wife got the shot on Thursday also, and we are both suffering.  We had no adverse effect from any of the prior shots.
Seemed to be more painful than usual almost immediately and gradually worsened. By around 10:00PM I had a low grade fever, muscle aches, and arm was severely sore. Could not lift high enough to even view the watch on my wrist. The next morning I woke up and still had a fever - I had not connected at that point that it could be from the vaccination so I actually went and had a Covid test done (was negative). My shoulder area continued to have great pain and I had almost no range of motion in that arm. I went to a routine doctor visit on 9/8 and mentioned to the nurse (who happened to be the same person who administered the vaccination) and she said I was probably just sore because I am small in stature. (I am 5'2", normally around 120-125 lbs.) I tried to "push through it" and hoped it would get better. After it continued to bother me and wake me all through the nights, I emailed my doctor on 9/9 to let her know something did not feel normal. On 9/10 I went back to Health where she indicated I may have frozen shoulder. Xrays were performed and she massaged my arm to get it moving a little more. After this I had bruising from my shoulder to my elbow, but my range of motion was better. As of today, I can move my arm much more but still have to modify movements at the gym and still have pain in my shoulder - especially when I lift my arm directly above my head - it is painful. Have also contacted MN Dep't of Health several times throughout this process but no one has been able to connect me to the correct person and my voicemail was never returned. I heard about VAERS after inquiring on social media if anyone else had this happen after a vaccination administered in the arm.
Patient notified recovery RN and nurse manager that she was feeling lightheaded and needed some water. Patient then started to feel anxious with increased respirations, nausea, and vomiting. BP was difficult to obtain. HR was at 60 BPM. 911 was called and paramedics arrived to assess patient. Patient felt better after vomiting and when the paramedics arrived. After paramedics assessed the patient, she declined further medical treatment and patient left clinic.
FLU-LIKE SYMPTOMS; NOT FEELING WELL; MUSCLE ACHES; FATIGUE; This spontaneous report received from a health care professional concerned a 63 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the subject experienced flu-like symptoms. On 13-APR-2021, the subject experienced not feeling well. On 13-APR-2021, the subject experienced muscle aches. On 13-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, muscle aches, not feeling well, and fatigue. This report was non-serious.
Within two hours after shots: high fever, went into a seizure. Taken to hospital by rescue squad. At hospital for 5 hours.
Arm Hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm Hurting".  Additional information: Reporter states, she is calling about a complaint about her arm. Reporter states, she took the shot; verified Pfizer COVID 19 Vaccine. Reporter states, she took her first shot last year at the end of Apr and it is still aching from that long ago and it is hard to bend it and it won't go away. Reporter states, her sister's arm is hurting too, she has the same problem.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Burning sensation at time if injection. All started about 2 1/2 hours after shot. Headache, Arm soreness and stiffness, fatigue.  Woke up on 3/25 @5:30 AM with headache still, nasuae, arm stiffness and soreness. Temperature of 99.9 around 2pm, fever of 101.2 at 6:30, body aches from neck to low back and still headache. No appetite.
elevated ongoing heart rate; fatigue; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed. Unknown manufacturer), for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "elevated ongoing heart rate"; FATIGUE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Description of Event: Report of elevated ongoing heart rate and fatigue. Took vaccine two days ago.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200091592 same drug/ae/reporter, different patient;