chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received Moderna vaccine in the community on 2/10/2021.  Pt was told he would have to wait 8 weeks to receive his second dose, but the patient did not want to wait.   He called to schedule a "1st dose" of Pfizer.  When pt arrived to the clinic he did not tell anyone he already had been vaccinated with Moderna (as part of the CDC pre-vaccination screening form) therefore pt received a dose of Pfizer on 3/3.   I was alerted today that the pt received a second dose of an mRNA vaccine, therefore his "2nd dose" appointment on 3/24 has been canceled.   Pt does not require a 3rd dose of mRNA vaccine.
RED, SWELLING..BENADRYL Q 4-6 HRS PRN
Ear fullness/pressure onset within 8 hours of 2nd dose. Unilateral, on Left side, same as vaccine administration. No prior ear conditions or hearing difficulties prior to this event. Still experiencing this adverse event at time of reporting.
Very Sore Arm, 100 degree fever, lack of energy.  Resolved on the next day.
had both shingles shots/suspected vaccination failure; Shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both the shots and 3 years later the patient got the shingles twice. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Symptoms started at 12:00am, which included slurred speech, feeling of the tongue curling, and weakness in the bilateral upper extremities that progressed to weakness in the bilateral lower extremities, upon arrival to the emergency department within that same hour. Patient was not able to perform commands given in the emergency department, but she remained alert and oriented, respirations within normal limits. She was not able to open her mouth and had a persistent headache throughout the visit. Patient was treated with Benadryl, administration of fluids and IV potassium, in which her symptoms progressively diminished. Discharge noted to have been anywhere between the time of 1:00am to 3:00am. Later that day, symptoms had lessened.
Chills with teeth chatter; Severe joint aches; All over body aches; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via intramuscular route of administration in the left arm on 22Apr2021 at 11:15 (at the age of 48-year-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via intramuscular route of administration in the left arm on 31Mar2021 at 11:15 (at the age of 48-year-old), as a single dose for COVID-19 immunisation. On 23Apr2021 at 02:00, the patient experienced chills with teeth chatter, severe joint aches, all over body aches and extreme fatigue. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills with teeth chatter, severe joint aches, all over body aches and extreme fatigue was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
LEFT ARM PAIN, OVER ALL MUSCLE WEAKNESS AND PAIN, & FATIGUE.
On May 18, 2021, I thought I had bug bites but they turned into ulcers the size of my pinky nail above both ankles, I have about 35 ulcers all together. On June 2, 2021, I went to Urgent Care to have them look at my legs. They gave me antibiotic Sulfamethoxazole-Trimethoprim Suspension and Mupirocin Ointment I contacted my doctor and explained to him my symptoms, however, I could not get an appointment until June 8, 2021. On June 8th, 2021 my Dr. examined my legs referred me to a Wound Specialist on June 21th, 2021. On June 17th, Dr. sent me to Hospital and I had a pulse ultrasound done on my legs and feet and the results came back normal. I saw my Dr. the Wound Specialist on June 21st, 22nd, July 7th and today July 12, 2021. They treated both legs with medihoney and zinc oxide wraps on both legs from my knees to my toes.
This spontaneous report as received from a physician via a company representative refers to a 34 weeks (infant) old female patient. On 09-AUG-2011 the patient was vaccinated with the third dose of oral ROTATEQ (lot number, expiration date and via not reported). There was no concomitant medication reported. Additional information has been requested.
Patient had vaccines given at a different facility the day before presenting to the urgent care for the adverse reaction.  Patient is having left arm swelling and pain after receiving the Menactra, hepatitis A, and hepatitis B in her left arm and the Bexsero and Gardasill in her right arm.  I did call the administering facility that gave me the information but they did not give me any information about vaccine lot numbers or expiration dates.
mom reported baby slept 6 1/2hr then was difficult to wake up;p/wakening baby screaming x 2 1/2hr, leg red & swollen & was up all noc q 2hr;fever off & on during day;next day mom reported nl behavior;
Patient reported that a few hours after receiving the vaccine he began to feel weak and fell to the floor. He was then temporarily paralyzed for approximately 4 hours. Patient's wife called the patient's sons and they came and moved him into bed from the floor. EMS arrived and offered to transport to the hospital and patient declined. Patient states he has been weaker than baseline since this event occured.
7CM X 7CM SHOT REACTION SWOLLEN AND HOT TO TOUCH, RED RIGHT TIGHT. STARTED FRI NIGHT.
I believe the Moderna vaccine triggered my body to have a second period in the month of April. I have recorded my periods over the past year because of my POTS. I had my period on April 2nd and it ended on the 10th. Four days after the shot, I had the shot on April 26th, I got my period for a 2nd time 19 days after my period just ended. The 2nd period ended on May 6th. I have yet to recieve my period. Medication, stress levels and diet haven't changed for me so those weren't the trigger.
Patient described a lump at the site of injection along with some redness. She described redness going down over time, but not gone. She described the lump as small, boil-like, painless, and maintaining its size (not getting bigger).
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history was unknown. The reporter stated that expired RECOMBIVAX HB 2.5 micrograms/0.5 ml (lot # 0384AE, expiry date: 02-NOV-2014, dose and route of administration was unknown) was inadvertently administered to the patient on 03-NOV-2014. Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Patient had fast heart rate -- 156 bpm-- she felt fine otherwise. Patient took Benadryl and felt better later in the day.
About 1/2hour after I got up, I started feeling off with vision issues.  Next thing I knew I had passed out and was laying on the floor.  Then severe sweating with a headache and tiredness.  My left arm was quite sore.
This spontaneous report received from a nurse refers to a 12 month old patient. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 12-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot # L036851 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with public funds. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
"i" was having mass body inflammation; causing subluxation of several of "my" joints/subluxation of shoulder; at the site bruising (bruise is still healing now), and pretty bad; Brain fog; "I" deal with chronic pain and my usual treatment couldn't touch how painful it was; A quarter-sized raised lump at the site; Shoulder where the vaccine was given was very swollen; Extreme exhaustion; Extreme pain in "my" joints, especially on the right side; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0151) via an unspecified route of administration in the right arm on 09Apr2021 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included mast cell activation syndrome (MCAS) and joint hypermobility syndrome. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 19Mar2021 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. On 09Apr2021, when the patient received the vaccine, it felt like the needle actually moved something aside in her shoulder. Later that evening (on 09Apr2021), the patient was having mass body inflammation causing subluxation of several of her joints, extreme exhaustion and extreme pain in joints, especially on the right side. The patient stated, she dealt with chronic pain and her usual treatment could not touch how painful it was. As per the patient, the shoulder where the vaccine was given was very swollen, including a quarter-sized raised lump at the site plus bruising (bruise was still healing), and pretty bad subluxation of her shoulder. The worst of the pain and swelling resolved in 1-2 days, but the fatigue and brain fog persisted for 5 days. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chronic pain and shoulder where the vaccine was given was very swollen was resolved on an unknown date in Apr2021, after the duration of in 1-2 days. The clinical outcome of the events fatigue and brain fog was resolved on an unknown date in Apr2021, persisted for approximately 5 days. The clinical outcome of the events mass body inflammation, subluxation of several of joints/subluxation of shoulder, a quarter-sized raised lump, extreme exhaustion, extreme pain in joints, especially on the right side was resolved on an unknown date in Apr2021. The clinical outcome of the event bruising was resolving (also reported as still healing).  No follow-up attempts are needed. No further information is expected.
she was very tired; no energy; Initial information received on 14-Jul-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 59 years old female patient who was very tired and no energy while receiving vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE(TDAP).  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer, suspension for injection, (strength: unknown) lot number not reported via unknown route in unknown administration site as Prophylactic vaccination.  On an unknown date the patient was very tired (fatigue) and no energy (asthenia) (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.  It was unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for the events.
fever to 105 of w/in hrs of vax documented @ hosp; sponge bath, Ibuprofen workup for fever, CBC, Blood CX, CXR Rocephin given;
Flublok quadrivalent vaccine that was expired administered to a patient, with no reported adverse event; Initial information received on 16-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult and unknown gender patient who had flublok quadrivalent vaccine that was expired administered to a patient, with no reported adverse event after receiving vaccine influenza quadrivalent recombinant vaccine [flublok qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Jun-2023, the patient received a Booster dose, once of suspect influenza quadrivalent recombinant vaccine lot UJ891AA, 14-JUN-2023 via intramuscular route in the deltoid nos for Immunization.  On 15-JUN-2023 the patient developed a non-serious flublok quadrivalent vaccine that was expired administered to a patient, with no reported adverse event (expired product administered) (latency: same day).  Lab data was not reported.  Action taken was not applicable.  Outcome: Unknown for the event flublok quadrivalent vaccine that was expired administered to a patient, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
From telephone correspondence received at manufacturer on 05/10/2002, it was reported that a female received RIG (imogam) and first dose of Imovax on 04/06/2002. Several hours after vaccination, pt's lips and face became swollen, and generalized erythema noted. Pt was able to complete the series without event. Unable to determine if this was a reaction to the product or if some other etiology.
After 5 minutes of being given the shot, I became clammy, pale, dizzy, heavy headed, and my BP was high.  My BP is never high.  I couldn't walk, and felt like I was passing out. EMT's came to check everything.  My BP went down, and about 15 mins later I felt ok.
Shingles; This case was reported by a physician via sales rep and described the occurrence of shingles in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient experienced shingles within one week of receiving Shingrix. The patient received Valtrex as a treatment for herpes zoster on forehead and not in eye. This case has been linked with cases US2019AMR167862, US2018GSK096361 and US2019AMR084177 reported by the same reporter.
Patient received a booster dose of Pfizer COVID-19 vaccine too early. Her second dose was 05/25/2021. She had not reached the 6 month mark yet.
Pt. reported throbbing pain to left arm, palm of hand and ring finger - lasted about 2 wks. but has since resolved. Started after receiving FLUZONE injection to (L) deltoid.
Migraine 48 hours Nausea 24 hours Dizzyness 48 hours Fatigue 48 hours High blood pressure started at 24 hours ended at 38 hours Low blood pressure started at 8 hours, ended at 24 hours Chest pain with high blood pressure
On the day of injection the patient was red and swollen at the injection sight. On the seventh day the patient had high pitched screaming for 2 days, high fever, immune damage, whopping cough, 4 months speech delay.
anaphylactic reaction; PEG(polyethylene glycols) is the ingredient that the patient allergic to; PEG(polyethylene glycols) is the ingredient that the patient allergic to; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylactic reaction"; POLYMERS ALLERGY (medically significant), ALLERGIC REACTION TO EXCIPIENT (medically significant), outcome "unknown" and all described as "PEG(polyethylene glycols) is the ingredient that the patient allergic to". The patient would like to get the second dose in the doctor's office, reporter would like to know what is the protocol and if that is allowed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious events cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate
A fee hours after my second dose my right side of my face started to hurt, it started in my gum but then 15 min after my upper and lower jaw on my left side was in excruciating pain, I am unable to open my mouth all the way and the pain goes up into the left side of my head. It felt as though my face was being beat in. This all started at the same time that my injection site got extremely sore. The site was sore after the shot but just got progressivly worse, but no redness, site felt warm to touch but other than that it seemed okay. My face and jaw still are in pain and the use of over the counter pain medication is doing nothing.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Additional Details: Immediately after patient received vaccine and went to a seat in the patient monitoring area she notified us that she felt that her throat did not feel right and felt like it was tighting. Therefore we guided her to lie down on the floor, elevated her feet, got her a bottle of water, put some ice packs behind her neck, and gave her 10 ml approximately of liquid benadryl.   Afterwards, she gave me permission to give her 2 Epipen injections and we called Ambulance.
Per history, patient experienced a ground-level fall early 4/16, and was noted to have weakness on his left side. Patient was brought to the ER 4/18 with concern for CVA, found to have acute pulmonary embolism.
bleeding was getting heavier byTuesday I was already going through 10 large pads/blood was gushing out of me; This is a spontaneous report from a contactable consumer (patient).   A 38-years-old female (non pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0183 and Expiration date: not reported), via an unspecified route of administration on 09May2021 at 10:00 (at the age of 38-years-old), as single dose for covid-19 immunization. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Medical history included patient provided a list of medications that she was allergic to. Patient received unspecified prescribed medicines within 2 weeks of vaccination. Patient provided the nurse, that gave her the shot, the list of prescribed medicines that she was taking. Nurse told her that she was ok to take the vaccine and we proceed. After the vaccine patient waited 30 mins sitting down then she was ok to go home. On 09May2021 at 14:00 hours, patient noticed that towards the evening her bleeding was getting heavier by Tuesday (11May2021) and she was already going through 10 large pads by 10:00 am. Patient was told to laid down with her feet up by her mother as her husband was at work and stated that we were going to go to the hospital on the evening. When her husband came home, she stated that we decided that we were going to go on Wednesday (12May2021) morning to the hospital. Patient's husband woke up that Wednesday morning, she was still asleep and screamed at her "you crazy we need to go to the hospital right now". Patient was cover waist down in blood and stated that they told her to try to get up and she felt that blood was gushing out of her (hospitalization). Ambulance was called. Since the vaccination, patient had not been tested for COVID-19. Patient had emergency room/department or urgent care visit. Patient received tranexamic acid, birth control, medroxyprogesterone as treatment for the adverse event. The outcome of the event was not recovered.