chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up the next morning after vaccine, with severe pain in my right shoulder. I had previously had had an injury and inflammation in that shoulder and I had been going to physical therapy and it was pretty much taken care of. But it was in pain when I woke up that morning and a few hours later all my joints started hurting. I had severe flu-like symptoms; I felt feverish but had no fever. All  of this lasted for five days. Towards the end of the five days it was getting better. I was in bed for three of those days. Pain in my right shoulder where it had all started first, it stayed  after the rest of the symptoms left; this didn't go away. I saw my doctor and got a cortisone shot. I did that about a month ago. The cortisone shot took the pain away for about three weeks. Right shoulder pain and inflammation came back really strong now. Also, on the following day of the shot, I had a Baseball size lump on injection site - that lasted for about five or six days.
arm got real sore; a little blood bruising dots all over her arm from the shot; red dots from the shot on her upper arm (bruise); This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 02Apr2021 (at the age of 73 years old; Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of Pfizer COVID vaccine on 02Apr2021. The patient mentioned that later that evening her arm got real sore and she developed a little blood bruising dots all over her arm from the shot and red dots from the shot on her upper arm (bruise) on 02Apr2021. The patient wondered if these has been reported and if these are possible side effects and was concerned about taking the 2nd dose. Outcome of the events was unknown.   Information on lot/batch number has been requested.
i went to get my second shot of the moderna vaccine today. i got into the clinic at 230pm and was given the shot at around 245 pm. However, when the shot was being injected into my left arm the solution in the syringe started to leak out  and the majority of the dose i was supposed to get was lost. its hard to tell how much of the vaccine i got into my body. But, what i find extremely concerning is that the clinic thought it should be ok for me to walk away and concluded that i finish the vaccine series . i was very uncomfortable with the outcome and decided to complain to the director of nursing. This person suggested i re-inject the full dose again. But since they don't have a protocol in place i refuse. I told them they should contact moderna immediately . they did not what do . i was concerned and called them and reported the situation . however they did not give me instructions as to what to do about , they said that the clinic should follow up. But what i find even more concerning is the fact that the nurse who injected said that the syringe was cheap and that the materials they get are not the best and that this has happened to to other patients and should be ok. i asked if re-injection was a possibility and nurse said, he wouldn't feel comfortable doing that as he doesn't know how much of it went into my body. But for the director of nursing to say that i should get re-injected again today was alarming to me. Because we have not facts on third re-injection and second dose being under-dose.
Case previously recorded as MA2009-3669. Initial case report received from a nurse via Med Com, on 04 NOV 2009. A 3.5 year old female patient was vaccinated with 0.5 ml S-OIV FLUVIRIN (batch no. 1007391P) i.m. into the deltoid on 03 NOV 2009. As the patient was a child the vaccination was an off-label use and is considered as inadvertent administration. No adverse event was reported. MedCom reference no.: NA09-007506.
Member went pale, sweaty and then passed out. Had to be woken up with Ammonia Salt. Member was disoriented and unable to stand or sit up for 1 hr after vaccine.
pt seen 28AUG95 for 6mo check up & recv vax w/o problems; less than 8-12 hrs later had fever, that cont x 72 hrs, emesis & diarrhea 48 hrs later;
booster dose for the patient on 27Sep2021; booster dose for the patient on 27Sep2021; warm sensations at and near injection site and pain; warm sensations at and near injection site and pain; Little small blisters and purple skin color developed near right above injection site area the evening of and the next day; Little small blisters and purple skin color developed near right above injection site area the evening of and the next day; This is a spontaneous report from a contactable pharmacist. A 67-year-old non-pregnant female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FC3181), via intramuscular route of administration in right arm on 27Sep2021 at 11:00 (at the age of 67 years old, not pregnant at the time of vaccination) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), via an unspecified route of administration in left arm from 27Sep2021 (Batch/Lot Number: UJ768AA) to 27Sep2021, at DOSE NUMBER UNKNOWN, SINGLE for influenza immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. Historical vaccine included first dose of BNT162B2 on 05Feb2021 and second dose on 26Feb2021 for covid-19 immunisation. 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 hasn't been tested for COVID-19. On 28Sep2021 patient experienced warm sensations at and near injection site and pain. Little small blisters and purple skin color developed near right above injection site area the evening of and the next day. It was a booster dose for the patient on 27Sep2021. Patient previously received 1st and 2nd dose on 05Feb2021 and 26Feb2021 respectively. Therapeutic measures were taken as a result of warm sensations at and near injection site and pain, little small blisters and purple skin color developed near right above injection site area the evening of and the next day with oral Antibiotic Clindamycin 300mg and Topical Mupirocin 2% Oint. The events resulted in doctor or other healthcare professional office/clinic visit. No prolonged hospitalization required. Reporter considered events as non-serious. The action taken in response to the events for influenza vaccine inact split 3v was not applicable. The outcome of evens was unknown.  Follow-Up (06Oct2021): Follow-up attempts are completed. No further information is expected.
Rash on forearm. Diphenhydramine 25mg tablet oral given. Monitored for 30 minutes. No additional adverse effects noted.
This spontaneous report as received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9 which had Lot number reported as M037700 with expiry date on 01-JUN-2019; lot # M017983 with expiry date on 30-MAY-2018 and lot # M034780 with expiration date on 14-APR-2019 (strength and route were not reported) for prophylaxis, however no adverse effects reported.  It was reported that the vaccines were exposed to temperature of > 8 but <25 Centigrade range for a time frame of 1 hour and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA008048: US-009507513-1703USA001827: US-009507513-1703USA008051: US-009507513-1703USA001850: US-009507513-1703USA008047: US-009507513-1703USA008049: US-009507513-1703USA008052:
MY MOTHER, PATIENT, HAD BEEN MANAGING HYPERTENSION AND DIABETES FOR NEARLY 30 YEARS VERY WELL. SHE RECEIVED THE J&J VACCINE ON 4/7. PEOPLE WHO SAW HER AND SPOKE TO HER DAYS AFTER REPORTED SHE FELT GOOD AND LOOKED GOOD. ON 4/12, 5 DAYS LATER, PATIENT, WAS DEAD. SHE WAS FOUND DECEASED IN HER APARTMENT ON 4/13 SLUMPED IN A CHAIR. SHE HAD EATEN BREAKFAST, GOTTEN DRESSED AND APPEARED TO BE ON HER WAY OUT THE DOOR TO AN EYE DOCTOR APPT WHEN SHE SAT IN A CHAIR TO TAKE A REST. THE MEDICAL EXAMINER'S OFC REFUSED TO DO AN AUTOPSY, STATING HER PRE-EXISTING CONDITIONS, DESPITE HER RECENTLY GETTING THE J&J SHOT.
Initial report received from a consumer on 24 Dec 2009: The patient was vaccinated with FLUVIRIN on 22 Dec 2009. On 23 Dec 2009, the patient began feeling nausea and headache which dissipated quickly. The patient also presented with two pimples on leg and a large hive on the right side of lower back. On an unspecified date, the patient received treatment with BENADRYL with no effect. The outcome of the events were reported as, ongoing. No other information was provided at the time of this report.
This is a spontaneous report from a contactable pharmacist and other healthcare professional via a sales representative. A 56-year-old female patient started to receive PREVNAR 13 at a single dose and FLU VACCINE VII at an unspecified dose; both via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had broken out in fever blisters around her mouth. Outcome of the event was unknown. Information on the lot/batch number has been requested.
On 12/24 was coughing and sore throat. No fever and general feeling of unwell. Took at home rapid home test and it was positive. Went to local ER and was prescribed PAXLOVID. 12/25 symptoms worsened and I spent all day in bed. 12/26 symptoms began improving after 3rd dose of PAXLOVID. 12/27 Symptoms completely resolved.
Initial report received from healthcare professional on 22 November 2013. A 76-year-old female patient whose medical history and concomitant medications were not reported, received FLUZONE HD (lot number, expiration date and site of administration intramuscular) at right deltoid (dose number not reported) on 01 October 2013. On 01 October 2013, the patient received vaccine and since that day she had pain in the arm where she received the vaccine. Her pain started that day and she could not raise her arm. It is now 7 weeks later and the pain continues and she is still unable to raise her arm. Laboratory investigation and corrective treatment were unknown. As of this report, the patient had not recovered from the event. Documents held by sender: none.
great deal of pain for several days; absolute monocytes which were slightly elevated; was weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 66-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 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 (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose number unknown: Booster), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "recovered", described as "great deal of pain for several days"; MONOCYTE COUNT INCREASED (non-serious), outcome "unknown", described as "absolute monocytes which were slightly elevated"; ASTHENIA (non-serious), outcome "recovered", described as "was weak". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient recently got new annual vaccine for Covid 19 after having all the available vaccines and boosters. The patient had a very strong reaction to the vaccine and was weak and in a great deal of pain for several days.  All symptoms have since resolved. The day after vaccine, the patient had CBC lab which had been previously scheduled.  All results were normal except the absolute monocytes which were slightly elevated. The patient asked if vaccine can cause elevated monocytes. Medical inquiry was forwarded to MI.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Went to ER due to numbness in left arm and hand. Neuropathy of half of hand up to elbow with elbow and hand pain, with spasms.
Swelling below jaw beginning 30 minutes after vaccine, persisting 24 hours after. Firm and painful when swallowing
No other AE/PQC reported; PROQUAD that expired yesterday was given today; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 17-SEP-2020, the patient was vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)) (PROQUAD) 0.5 milliliter, lot # S008571, expiration date 16-SEP-2020 (route of administration was not reported) for prophylaxis. There was no other adverse events or product quality complaint reported.
Feeling awful; Fever; Third dose administered/Booster dose; Third dose administered/Booster dose; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2587) via an unspecified route of administration in the left arm on 04Sep2021 at 13:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). The patient had no known allergies. 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 included acetylsalicylic acid (ASPIRIN) and cyanocobalamin (VITAMIN B12); both from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also second dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 04Sep2021 at 16:00, the patient experienced fever. The patient reported that she had a fever daily in the sundown hours since the vaccine. It was her booster third dose. It was reported that she felt awful every evening. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were 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 fever and feeling awful was not resolved at the time of this report.
Throat felt like it was closing and difficult breathing, and soreness to the body.  I went to the doctor 2 days later and told him about my reaction to the shot and he told me to report it.
Pins/needles/tingling/numbness in entire left leg and down through foot. Calf muscle extremely tight/contracted; began 4 hours after second vaccine dose and has not resolved yet, 48 hours later.
10 x 10 cm redness, swelling, induration, itchy, warm.
Facility received letter from patient in March 2005 stating that he had developed an exacerbation of Gullian Barre Syndrome as a severe reaction most likely due to the flu vaccine. Patient's initial bout of Guillian Barre Syndrom occured about March 23, 2004. Pt experienced total body paralysis and was on a ventilator for 5 days at another hospital.  On about May 20, 2004 patient had a relapse with full body paralysis again.  Pt stated he had a relapse 2 days after "flu shot" with weakness throughout body. On November 15, 2004, pt saw private MD and was prescribed prednisone 60mg (pt had been of prednisone) one month.  Pt continued to experience weakness. November 19, 2004 pt was admitted to another hospital. Pt received 5 days of plasma exchange and continue with prednisone. Pt has returned to his baseline prior to influenza shot.  6/24/05 Received hospital medical records of 11/19-11/24/2004. FINAL DX: chronic inflammatory demyelinating polyneuritis exacerbation Records reveal patient experienced ascending weakness, numbness in all extremities, clumsiness, sensory changes, double vision.  Similar to previous episodes of same in March & April, 2004.  Had self d/c steroids & symptoms recurred 2 da s/p flu vaccine.  Seen by PCP, restarted steroids.  Initially improved then relapsed & admitted.  Neuro consult done, areflexic.  Tx w/plasmapheresis, improved & d/c to home on continued steroids.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Aug2022) positive, notes: Tested positive for covid; (18Aug2022) negative, notes: Finally tested negative; (20Aug2022) positive, notes: Tested positive for covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine was received. Unknown if there was other medications in two weeks. No known allergies. Tested positive for covid 09Aug. Started paxlovid 09Aug. Finished paxlovid 13Aug. Stayed quarantined due to continued positive tests. Finally tested negative Thursday 18Aug. developed a sore throat Friday 19Aug. Tested positive for covid 20Aug. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded.
Pt received pneumococcal vaccine on 2/16/11 as part of an annual exam. On 2/17/11 he went to the ED with pain & swelling of the left tricep area. Diagnosed with cellulitis & treated with Clindamycin 300mg 4 times /day for 10 days.
Pt in observation, reported pruritis and fullness in throat. Redness and hives observed on face, neck, and chest. On site EMS notified, epinephrine administered and pt transported to hospital via ambulance.
Sore arm; This is a spontaneous report from a contactable consumer (patient)¬. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 11Jan2021 at 12:00 (at the age of 65-years-old) at a single dose for COVID-19 immunisation. Medical history included osteoporosis, stroke history (35-years-old), significant lactose intolerance, gastrointestinal (GI) issues, and allergy to Caine family of drugs. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included evolocumab (REPATHA SURECLICK) and lorazepam (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced sore arm in 2021. The event was reported as non-serious. The patient did not receive any treatment for the event. The clinical outcome of sore arm was recovered in 2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Itchy site of injection, readiness 1 in by 2 1/2 in, swelling. No treatment was recommended unless child uncomfortable.
Information has been received from a nurse referring to a patient of unknown age and gender. On 07-SEP-2016 the patient was vaccinated with an improperly stored dose of VAQTA (lot # M009786, expiration date 26-MAY-2017, dose and route were unknown). The vaccine was stored under 48.2F for 32.9 hours. There was no previous temperature excursion. Data logger was involved. The patient had not experienced an adverse effect. No PQC was involved. Additional information has been requested.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Tachycardia-Medium, Additional Details: aBOUT 26 HOURS AFTER GETTING THE VACCINE PATIENT HAS CHEST PAIN, PRESSURE, PALPITATIONS, HARD TO TAKE DEEP BREATH. pATIENT DOES NOT HAVE HISTORY FOR HEART DISEASE, ONLY HAS ANXIETY. 4 DAYS LATER SHE STILL HAS MILD SYMPTOMS. aCCORDING TO PATIENT THIS HAPPENED WITH ALL OF HER COVID DOSES, BOTH PFIZER AND MODERNA.
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable pharmacist. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/lot number not reported), as dose 1, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The pharmacist called for patient who received first dose of Pfizer COVID-19 vaccine on an unspecified date and then after receiving tested positive for COVID on an unspecified date. The pharmacist was wondering when can the patient get second dose, what would be recommended. The outcome of the events was unknown.   The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.