chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 12-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.   This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
Injection site extremely red, swollen, and warm to the touch. Advised to take Benadryl 25mg every 8 hours for at least 3 doses and if no improvement in symptoms to contact their physician or go to urgent care facility
Pt received 1st vaccine on 3/20/21 and 2nd vaccine on 4/10/21 Pt. admitted to hospital from 8/3/21-8/6/21 for Disseminated varicella
Fever, Coughing, Vomiting, body aches, general feeling of yuckiness.
a few hrs p/vax pt became very limp & pallid, w/an unusal cry, which persisted for 1-2 hrs;
Sore right leg presented 8 hours after the second shot. Spread to soreness in right chest 32 hours after the second shot. Admitted to Emergency Room 33 hours after the second shot. Ultrasound and CATSCAN with blood work. Diagnosis Deep Vein Thrombosis and second blood clot in right lower leg. Treatment - eliquis (10 mg 2x's per day).
No adverse effect from vaccine. Tried to explain to phone rep. She still wanted me to fill this out!
Narrative: Patient received Moderna Covid vaccine #1 on 3/23/21 and #2 on 4/20/21. No notes in system or scanned records to indicate what happened from the time of second vaccine to recorded date of death of 5/16/21. He did however no show two primary care appointments between his first and second vaccine. There were 26 days from time of second vaccine to date of death. No autopsy report available.
I attended a school event on 5/7 with around 60-70 people that took place in a large tent. I began having symptoms, like a sore throat, fever, and chills on 5/10. The fever lasted around 3 days, the highest the temperature got was 38.5 degrees Celsius. I also experienced some runny nose and coughing. The fever broke 60 hours later and the sore throat only lasted around 48 hours. The coughing has lingered and still persists today. I did not take any medication other than some vitamins and supplements.
diagnosed with Covid; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with Covid) and DRUG INEFFECTIVE (Lack of efficacy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 03M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced COVID-19 (diagnosed with Covid) and DRUG INEFFECTIVE (Lack of efficacy). The patient was treated with REMDESIVIR on 05-Oct-2021 for COVID-19, at a dose of Infusion. At the time of the report, COVID-19 (diagnosed with Covid) outcome was unknown and DRUG INEFFECTIVE (Lack of efficacy) had resolved.            Concomitant medications were not provided.  This case concerns a 58-year-old, female patient with no reported medical history, who experienced the unexpected non-serious and AESI event of COVID-19. Drug ineffective was also reported. The event occurred 6 months and 4 days after second dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 58-year-old, female patient with no reported medical history, who experienced the unexpected non-serious and AESI event of COVID-19. Drug ineffective was also reported. The event occurred 6 months and 4 days after second dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report.
1st dose was given on Feb 14,2012, and on Feb 24,2012, the injection site was red, itchy, and swollen. The swelling did go down a bit on 2/23/21.
This spontaneous report was received from a nurse refers to a college aged patient of unknown demographics. On an unknown date the patient was vaccinated with 2 doses of MMR II (dose, route and lot # unspecified). No concomitant medications were reported. The nurse reported that she received an e-mail from one of her colleagues from student health center describing that a college-aged patient who received two doses of MMR II in the past, developed a confirmed case of mumps approximately in 2016. The SHC had been investigating a probable case of mumps in an undergraduate non-residential student that had now been confirmed by laboratory testing. It was assumed that this individual was contagious from 15-FEB-2016 through 20-FEB-2016 and was on-campus during a portion of this time. The outcome of mumps was unknown. Causality assessment was not reported. This is one of the two reports from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning an 11 year old male who on 23-JUL-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient fainted. Unspecified medical attention was sought. At an unspecified time the patient recovered. No other information was provided. There was no product quality complaint involved. Additional information received indicated that no additional information is available.
230PM c/o (R) lat neck - (R) hand tingling, coolness w/ patchy numbness w/ sensation of swelling, though not observed by me and other RN's. Some mottling of (R) arm - (R) hand greater than (L). Gen'l color good, skin W and D, fairly calm affect and A and O x 3 . No SOB, C. pain or dizziness, gait steady. 108/72 AP-80 BS - cl no WHZ observation by myself and other co-workers (RN's) continuously. TC to patient's PCP, sx given w/ req to RC. Both patient and I spoke w/ staff who agreed w/ MD or ER assess. 315PM c/o (R) leg and (R) jaw tingling 108/72 AP-80, BS - cl no WHZ or SOB. Called 911, transported to hospital. Color good, skin W and D, walked w/o assist to ambulance. Patient spoke w/ husband to inform of plan. 10-18-13 VMM - patient to ck status, req RC. 10-21-13 spoke w/ patient, reports ER RX IV/oral (home use) BENADRYL and cortisone x 3 days. ER D/C at 715PM 10-18-13.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 28-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 212 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 96 hours with the lowest recorded temperature of 29 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Chest pains/tightness started 4 days after 1st shot. Felt like panic attack.  Symptoms progressed in severity and became discomfort for 24/7.  Tingling developed down left arm to elbow.   Continued for 40+ days until progress started showing.
Redness of injection site and pain of muscle in upper arm.  After a few hrs the erythema extended to the popliteal area covering the entire upper arm. There was edema such that the circumference of the arm was 1.5 inches greater than the other arm. Intense pain and hyperemia as well as extreme warmth to the area. Improvement by day 3 but migration of erythema down arm. Swelling persists.
At 4hrs post vaccination experienced extreme muscular pain between shoulder blades. The following week, as far as I can recall, I began to have tingling from the right shoulder blade down to my hand. I thought I may have a pinched nerve and went to the walk in clinic to be seen by the nurse practitioner that is in the same office as my primary. She examined me and thought it sounded like a pinched nerve and said I was swollen in the area of complaint. Cervical and thoracic x rays were taken (normal) and was told to take Flexeril and steroids. Pain was getting worse and primary told me to  begin taking  Meloxicam and have physical therapy. I have been doing both beginning 1-11-2021. Pain continues with no  improvement. Do not know if my symptoms are caused from the Covid shot, but just seemed to me that it was quite a coincidence that muscle pain began on the same day as receiving the shot.
period is extremely heavier than it's ever been, I have large blood clots; period is extremely heavier than it's ever been, I have large blood clots; cramping; irritability; premenstrual symptoms like cramping and irritability were the worst they've ever been; This is a spontaneous report from a contactable consumer, reporting for herself.   A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the right arm on 15Apr2021 (Batch/Lot Number: Er8729) as a single dose (at the age of 30 years old) for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, levonorgestrel (SEASONIQUE) taken for an unspecified indication, start and stop date were not reported; spironolactone taken for an unspecified indication, start and stop date were not reported; magnesium taken for an unspecified indication, start and stop date were not reported; polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported, and an unspecified multivitamin taken for an unspecified indication, start and stop date were not reported. Historical vaccine information included BNT162B2, dose 1 via an unspecified route of administration, administered in the right arm on 25Mar2021 at 12pm (Batch/Lot Number: Er8730) as a single dose (at the age of 29 years old) for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced period is extremely heavier than it's ever been, she has large blood clots on 21Apr2021 at 08:00 with outcome of not recovered, cramping on 21Apr2021 at 08:00 with outcome of not recovered, irritability on 21Apr2021 at 08:00 with outcome of not recovered, and premenstrual symptoms like cramping and irritability were the worst they've ever been on 21Apr2021 at 08:00 with outcome of not recovered.  The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative on 31Mar2021. Treatment was not received for the events.
Severe chills, severe migraine, severe body aches, fever reaching 104.3 . 48 hours later GI issues and slight sore throat.
This spontaneous report as received from a registered nurse via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL. On an unknown date the patients cousin reported that the patient developed gastroparesis on an unknown date after receiving GARDASIL. The outcome of developed gastroparesis on an unknown date after receiving GARDASIL is unknown. Additional information has been requested.
Very painful under arm beginning 6 days after injection on right side of the body (same side as injection); Visible swelling of under arm area on right side of the body; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Apr2021 at 16:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. The patient did not take any concomitant medication. 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. On 26Apr2021 at 07:00, 6 days after the injection, the patient experienced very painful under arm on right side of the body (same side as injection) and visible swelling of under arm area on right side of the body. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown, if the patient received any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very painful under arm on right side of the body (same side as injection) and visible swelling of under arm area on right side of the body was not resolved at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax;severe pain from finger tips&shoulder;unable to move arm;apap given;seen in ER;local rxn severe&unk;
Severe allergic reaction; injection site pain/It hurt way more than the first one; her arm still hurts/Hurt way more than the first one; Tiredness; Headache; Muscle pain; Chills; Joint pain; Feeling unwell; Difficulty breathing; Fast heartbeat; Dizziness; Weakness; This is a spontaneous report from a contactable other healthcare professional (patient). A 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was a healthcare worker and she got the second round of the Pfizer Covid-19 vaccine on 07Jan2021 (reported as yesterday). The patient had a severe allergic reaction in Jan2021. It hurt way more than the first one in Jan2021. It's been over 24 hours and her arm still hurts in Jan2021. The patient experienced: tiredness, headache, muscle pain, chills, joint pain, feeling unwell, difficulty breathing, fast heartbeat, dizziness, weakness in Jan2021. It happened once she was home, 5 hours after she had received the second dose of the vaccine in Jan2021 and these symptoms lasted 3 to 4 hours. She still had some weakness and kind of feeling unwell, injection site pain and tiredness. The patient was a patient care tech and work directly with Covid patients. The outcome of events Weakness, Feeling unwell, injection site pain and tiredness was not recovered. The outcome of the other events was unknown.  Information about lot/batch number has been requested.
Irregular heart rate pretty severe for a couple of hours then I had chills and enough to make my teeth clatter and also dry heave for some hours until I took the medicine under the tongue and it got better. I still have shaking in my hands and feet as well.
Temperature elevation of 107 rectal reported by parent, decreased responsiveness, lethargy, decreased feeding.
they administered the wrong vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (they administered the wrong vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (they administered the wrong vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (they administered the wrong vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (they administered the wrong vaccine).    No concomitant information provided  It was reported that that there was an administration error with the vaccine MI agent was not able to understand the caller as there was static-like sounds during the call. Caller refused to be callback.  No treatment information provided
This spontaneous report as received from a healthcare worker (also provided as an administrator) refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 16-AUG-2016, the patient was vaccinated with an improperly stored dose of PROQUAD injection, lot # M012985, expiration date: 12-SEP-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
This solicited report was received from a 60 year old female patient via Market Research referring to herself. There was no information about concurrent condition, concomitant medication and medical history. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced measles. The outcome of the event was unknown. The causality between the event and M-M-R II was not reported. Upon internal review, measles was determined to be medically significant. Additional information has been requested. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the therapy and the reported event cannot be established. The date of vaccination as well as the date of onset for the reported event are not provided. Company Comment- No changes to the product safety information are warranted at this time.  Merck and Co., Inc., known as MSD outside of the country, continues to monitor the safety profile of the product.
Received Prevnar #2 (Pneumococcal Conjugate 7) on 07/01/2003.  Simple vaccine administered.  Within 24 hours developed full-body rash.  Temperature max: 100 degrees F.  Axillary.  Rash and fever resolved spontaneously after 32 hours.
Low grade fever; My sinuses were very in distress; Headache; Small pimples which spread all over my head; then by yesterday it's all over my torso; it's very, very itchy; Small pimples which spread all over my head; then by yesterday it's all over my torso; it's very, very itchy; I developed itching on my scalp/Small pimples which spread all over my head; then by yesterday it's all over my torso; it's very, very itchy; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8737), via an unspecified route of administration on 15Mar2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8737), via an unspecified route of administration in right arm (upper) on 05Apr2021 at 09:00 (at the age of 65 years old) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included loratadine (CLARITINE) for allergies; vitamins nos for an unspecified indication, start and stop date were not reported. She stated, she just she spoke to her doctor this morning on the telephone regarding a possible reaction to the Pfizer Covid vaccine she received on Monday and he said that she should report it. She further stated she did have some reaction and that she was aware that may have occurred it was low grade fever and her sinuses were very in distress, headache and by Monday evening she developed itching on her scalp and small pimples which spread all over her head and then by yesterday it's all over her torso and it's very, very itchy, she sent her doctor a picture and he advised her what to do to get some relief and took some Benadryl. She stated, it was important to let her doctor know she mean specially if they have to do a booster or something and she had already had a reaction this way so. Consumer stated, for the rash and itching, to help with the itching, she took Benadryl. Therapeutic measures were taken as a result of i developed itching on my scalp/small pimples which spread all over my head; then by yesterday it's all over my torso; it's very, very itchy with Benadryl. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
SWOLLEN ARM , REDNESS, ITCHY AND WARM TO TOUCH, RASH