chrisvoncsefalvay/vaers-outcomes huggingface dataset:
difficulty walking; severe swelling of the feet; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome unknown, described as difficulty walking; PERIPHERAL SWELLING (non-serious), outcome unknown, described as severe swelling of the feet.  Additional information: Caller also stated that the patient was scared to receive the second dose. Caller told a regulatory agent that he was wondering if Pfizer could offer some services to his family member to monitor the patient or screen for why this reaction happened. A regulatory agent states she told caller that he would have to speak to his doctor as Pfizer probably does not offer this type of service. Caller disconnected call before warm transfer could be made and did not provide any contact information for me to call him back.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shortness of breath; Tiredness; Sluggishness; I was sleeping a lot; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0818) via an unspecified route of administration in the left arm on 27Jun2021 at 12:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient did not take any other medications within two weeks of vaccination. On 28Jun2021, the patient experienced shortness of breath, tiredness, sluggishness and was sleeping a lot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Aug2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events shortness of breath, tiredness, sluggishness and was sleeping a lot were resolved on an unknown date in 2021.The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 18Jul2021 at 12:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation.
Rash on trunk of body started to appear 24 hours after flu vaccine given. Rash worsened (red and more profuse) on 10/4/2012 (24-48 hours post dose).  Rash started to improve on 10/5/12. Not yet resolved.
Patient began to have hives 3 hours after receiving varivax and influenza vaccine.  she began self treatment with bendaryl with good response.  No breathing difficulties or vomiting.
client c/o redness,swelling over back of rt. arm where varicella was adm. (4/12);symptoms first noticed by client 4/13/10;RN observed area of erythema and thickness of about 3 x 6 in. on back of rt. arm; some heat to touch noticed;client took Claritin D 4/13 pm due to "congestion"; reports swelling much worse initially but much improved upon report being made on 4/15/10
During administration, the patient pulled her arm away and she received only part of the vaccine. The rest went to the outside of her arm. Slight scrape from needle on the outside of her arm where she pulled away. Contacted the pediatrician to determine if an additional dose is needed and emailed her the information on I found from the CDC.
Pt had large erythematous, itchy, hot lesion on left thigh 10 cm in size. No fever or other systemic sx.
cried inconsolably for 6hr p/vax despite alternating doses of APAP & Motrin suspension;
Panic attacks; Anxiety; Neither him or I have been able to sleep for days.; This is a spontaneous report from a contactable consumer. A male patient (reporter's son) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on 06Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, Patient has developed anxiety and panic attacks. They had seen a doctor twice. Doctor prescribed the medications to calm him (patient) down. Consumer stated that they ended up calling (emergency number) twice and other two times to urgent care with severe panic attacks. Consumer stated that his son never suffered any of these before. Consumer has been trying to find psychological therapy without any luck and that was not a normal reaction, reported as please help us. neither him nor i have been able to sleep for days. The outcome of the event was unknown.  Information about lot/batch number has been requested.
I had the demote skin pain. It hurt to touch my skin. It lasted for about a week and then I broke out with the pus things that come with Shingles. I went to the doctor and was diagnosed with shingles. Was given a medication for them and they went. I have never had the shingles vaccine before
u1st Pfizer vaccine on 3/17/21 the next day I only has pain with swollen area in left arm around shot location. My 2nd Pfizer vaccine on 4/7/21 the next day around 4pm I started all the symptoms until chills,  aches and pains,  fever, and nausea,  This was severe Thursday evening  and most of Friday. Friday night I had swollen lymph nodes in the armpit and near the collarbone on my shot arm. This was very  uncomfortable. Saturday the chills,  aches and pains,  fever, and nausea started to go away. Sunday mostly swollen lymph nodes and aches and pain in joints.  Sunday night swollen lymph nodes stared to go down.  Monday am still a bit tired but feeling better
A nurse reported the occurrence of an injection site rash in 20-year-old female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt had no relevant medical history, concurrent medical conditions or concurrent medications. There were no known drug allergies. On an unspecified date, the pt received an injection of hepatitis B vaccine recombinant (Engerix-B) 20 mcg in the left arm (lot #ENG5299A4). On 11/18/2002, the pt developed chills. On 11/21/2002, the pt experienced fatigue, and developed an injection site rash. On an unspecified date, the pt experienced a headache. All events were experienced post-vaccination. The injection site rash resolved on 11/22/2002 while all the other events resolved by 11/25/2002. The reporter considered the events to be related to Engerix-B administration.
around 7:00 pm in the evening, she had a syncope episode. Video footage shows she is standing in line with other children, and just faints and falls to the floor. Initially she was not responding much to EMS and to FNP that received her, EKG was completed, and VS were within normal limits. She received lab work, UA, and CT of Head as she appeared to have hurt her head at time of fall.  Few hours later, when FNP checked on her again, about 9:50 pm, she was more responsive, answering his questions and doing much better than when she initially arrived to hospital around 8 pm. She was verbal, and VS were within normal limits during my time with her at the hospital
Started to feel itchy in the night time, throughout the next day, developed raised welts on B arms, R shoulder, lower abdomen and a few on thighs.
Information has been received from a physician and a licensed practical nurse concerning a 15 year old female patient with CEFZIL and amoxicillin allergy and a history of syncope with blood draws who on 02-SEP-2009 was vaccinated IM with the first 0.5 mL dose of GARDASIL (LOT # 662404/0312Y). The patient concomitantly received FLUMIST (LOT # 500763P) and MENACTRA (LOT# U2925AA). On 02-SEP-2009 the patient fainted after getting the GARDASIL and then as the physician was coming to her, she experienced tonic-clonic movements for a short period of time. No laboratory or diagnostic tests were performed. It was reported that no treatment was needed and that the patient was not sent to the emergency room. It is unknown if the patient's mother will request subsequent GARDASIL doses. On an unknown date, the patient recovered. Upon internal review tonic-clonic movement was considered to be an other important medical event. No further information is available.
After the vaccine administration, the patient complained of (R) arm pain. She developed rhinorrhea which improved with BENADRYL (or other anti-histamine). She woke up that night with a nightmare, was lightheaded, went color blind and lost peripheral vision. The following day, she had prolonged tiredness.
appetite absent; lethargy; fever; vesiculat rash; Information has been downloaded from Agency(HQ6120719JAN2001).  This spontaneous report was received from a healthcare professional referring to a 12-month-old female patient. The patient's medical history, and concurrent conditions were not disclosed, her concomitant therapies included albuterol (reported as salbutamol).  On 30-NOV-2000, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dosage form, administered via subcutaneous route, lot number 1139K, expiration date not reported but upon internal validation was established as 20-JUL-2002. On that same day she was also vaccinated with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) 1 dosage form, administered via subcutaneous route, lot number 472-543 (expiration date not provided); haemophilus b conjugate (meningococcal protein conjugate) and hepatitis b (recombinant) vaccine (COMVAX) 1 dosage form, administered intramuscularly, lot number 1173K, expiration date not reported but upon internal validation was established as 06-FEB-2003; poliovirus vaccine inactivated (unspecified) (reported as POLIO VACCINE PASTEUR) 1 dosage form, administered via subcutaneous route, lot number T0161 (expiration date not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 1 dosage form, administered via subcutaneous route, lot number 1169K, expiration date not reported but upon internal validation was established as 26-JUL-2002. All these vaccines were administered as immunization (strengths, dose numbers, frequencies, and anatomical vaccination sites were not reported).  On 01-DEC-2000, the patient experienced fever (pyrexia) and vesicular rash (rash vesicular). On 06-DEC-2000, the patient had appetite absent (decreased appetite) and experienced lethargy.  On an unspecified date in December 2000, the patient had to be hospitalized due to these events.   At the reporting time, the outcomes of the events pyrexia, lethargy, decreased appetite and rash vesicular were unknown.  The causality assessment between the suspect therapies and the aforementioned events was not reported.  This is a new safety report and has been created due to safety report US-009507513-2007USA002568 having been submitted with an incorrect WWID reference HQ6120719JAN2001 that does not refer to an existing case. Case US-009507513-2007USA002568 will be nullified. The correct WWID US-009507513-2007USA007762 is referenced within this safety report and will be kept as the master case file.
Loss of smell; Loss of taste; This spontaneous case was reported by a dentist and describes the occurrence of ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste). At the time of the report, ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) outcome was unknown.        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 relevant concomitant medications were reported.  No treatment information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient stated that throughout the whole day he was doing just fine, but woke up in the middle of the night with severe body (muscle) aches. He had access to a hot tub that he got in during the night that he said helped a bit with the body aches. Denied any shortness of breath or breathing problems.  He felt that it could have been due to getting both the flu shot and SHINGRIX shot at the same time as he has not had any issues with the flu shot in the previous years or with the ZOSTAVAX shot.
Onset was almost exactly 12 hours after getting second Pfizer injection. Exhaustion hit all of the sudden (had to hold self up) fever of 100+ degrees, bones felt like they were breaking, would describe as worst flu like symptoms ever had for approximately 48 hours after 96  hours felt like returning to work.
Pain; Fatigue; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Pain) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 100 microgram. On an unknown date, the patient experienced PAIN (Pain) and FATIGUE (Fatigue). At the time of the report, PAIN (Pain) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided.   This case was linked to MOD-2022-461991 (Patient Link).
Low grade fever for 24 hours; Achy joints 3 days; lack of energy 5 days; gastrointestinal symptons, first 24 hrs extreme diarrhea & gas; 2 days later after eating extreme diarrhea gas & severe stomach cramps lasting 12 hours; 5 days later loose stools and slight nausa with some gas after eating meal.  This is day 5 feeling better but not 100% yet.
patient developed large local reaction in site of first moderna vaccination, right upper arm. 6 x 7 cm diam, red, raised.
Rash on his trunk and face; Rash on his trunk and face; Developed a rash; This spontaneous case was reported by a physician and describes the occurrence of the first episode of RASH (Rash on his trunk and face), the second episode of RASH (Rash on his trunk and face) and RASH (Developed a rash) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced the first episode of RASH (Rash on his trunk and face), the second episode of RASH (Rash on his trunk and face) and RASH (Developed a rash). At the time of the report, last episode of RASH (Rash on his trunk and face) and RASH (Developed a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant information provided. No treatment information provided.
2 to 3 days after injection I developed a rash on my left arm, covid arm
Site: Pain at Injection Site-Medium, Additional Details: Patient states pain radiates from injection site down to elbow since 2 days following vaccine. Patient has tried ice packs and tylenol and only receive temporary relief.
TESTED POSITIVE FOR COVID; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21300DZ1A, expiry:11-APR-2022) dose was not reported, administered on 26-JAN-2022 for prophylactic vaccination. No concomitant medications were reported.  On 22-JAN-2022, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 26-JAN-2022, the patient experienced tested positive for covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid was not reported. This report was non-serious.
about 20 minutes post ima, the patient noticed that her arm began to become discolored (dark grey in color) and continued to get darker over several days.  the area in size was 3 inches by 6 inches.  the spot lasted about 4 weeks long.  a week after the shot the patient got a bug bite on her leg and then got a large bruise over the area that was approximately 4 inches by 5 inches.  there is still a large bruise over the area.  Recommended to patient to hold off on second shot until we have more information.  the primary doctor said she needs to get it but should check with her pulmonary doctor, the pulmonary dr said she needs to get the shot but that she needs to ask more questions before doing so.
Patient states she went to ER b/c of chest pains (which she things was unrelated to vaccine) and was dx with H. pylori. She received 2 antibiotics and a stomach pill. Her arm and face became red and started swelling. She had a loss of appetite and couldn't focus on what she was reading. (Did a CT scan = it was OK). Had shot and Rx of steroids and a breathing tx; saw family MD. Took approximately 1 week for swelling to disappear.
Information has been received from a patient's mother concerning a 5 year old female with peanut oil allergy who in approximately 2006 was vaccinated with the first dose of MMR. The patient's mother reported that in approximately 2006 the patient broke out in hives a week after getting vaccinated. The patient's mother did not want to provide any specific information. It is unknown if the patient sought medical attention. The outcome is unknown. No additional information is expected.
perfect red circle 2 x 2 inch, not bumpy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (perfect red circle 2 x 2 inch, not bumpy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (perfect red circle 2 x 2 inch, not bumpy). At the time of the report, VACCINATION SITE ERYTHEMA (perfect red circle 2 x 2 inch, not bumpy) outcome was unknown.  Action taken with mRNA-1273 in response to the events was unknown.
Sore arm; Itcing at injection site; Redness at the injection site; Swelling at the injection site; Tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Itcing at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Tenderness at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Itcing at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Tenderness at the injection site). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Itcing at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Tenderness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Pain in my bones making it difficult to stand, sit, squat, lay down. There is no relief
Over the weekend had low grade fever and chills. On Monday developed bruising and rash that is itchy. Has malaise for several days.
Patient came in to get a flu shot on 10/18. However, after the shot was given, it was noted that she already got the flu shot on 10/5. We immediately contacted the patient and told her that she already had a flu shot. She said that she thought she only had Arexvy and not the flu shot. We told her to watch for any untoward side effects and let us know.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient informed that she hasn't eat anything since the morning.
This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were reported. Since 08-SEPT-2015, an unspecified number of improperly stored doses of ROTATEQ (lot # L013188), were inadvertently administered to an unspecified number of patients. No adverse effects have been reported. The reporter refers that was not product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a 21 year old female medical assistant who in October 2007, was vaccinated with a first dose of Gardasil.  Concomitant therapy included MENACTRA.  In October 2007, the patient experienced vomiting, tiredness and stomach cramps shortly after receiving the first dose of Gardasil.  Medical attention was sought.  On an unspecified date the patient recovered from the events with unspecified therapy.  Additional information has been requested.
2/17/21 - Moderna vaccination taken at approximately 4:45pm 2/23/21 - Approximately 3:30 pm right ear is stuffed, ear and nasal passages feel pressure, 5:00 pm right hear has lost hearing, 10:00pm experiencing severe vertigo, 10:30 admitted to Emergency Department, 11:30pm CT Scan taken, prescribed Meclazine 25mg tab and  Lorazepam 0.5mg tab, 5:00 am released with instructions to see family physician and  ENT 2/25/21 appointment with family physician, prescribed Amoxicillin-clav 875-125mg 3/5/21 appointment with Dr., ENT , informed of profound hearing loss in right ear, prescribed Prednisone 10mg tab 3/9/21 appointment with Dr., ENT, confirms total hearing loss of right ear 3/11/21 pending appointment for an MRI 3/12/21 pending appointment for 2nd audiology test