chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-FEB-2015, the patient was inoculated by the physician with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended. On or about MAY-2016, the male patient was treated by the same physician who administered the vaccine, and was diagnosed with Herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
I didn't get the full dose/I don't even think that he got the full dose in me; There was a large drop that went from the injection site down to my elbow; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (I didn't get the full dose/I don't even think that he got the full dose in me) and PRODUCT ADMINISTRATION ERROR (There was a large drop that went from the injection site down to my elbow) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (I didn't get the full dose/I don't even think that he got the full dose in me) and PRODUCT ADMINISTRATION ERROR (There was a large drop that went from the injection site down to my elbow). On 03-Jan-2022, ACCIDENTAL UNDERDOSE (I didn't get the full dose/I don't even think that he got the full dose in me) and PRODUCT ADMINISTRATION ERROR (There was a large drop that went from the injection site down to my elbow) 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 information were reported.
Injection site reaction of (R) deltoid - lump, swelling, warmth, tenderness, bruising.
Patient experience severe throbbing pain in the right arm. She stated that it started later that evening. When she came in to the report the reaction her left arm was red and warm to touch. The right arm was not affected.
subchorionic hematoma leading to fetal demise; subchorionic hematoma leading to fetal demise; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 33-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 Immunization. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. The following information was reported: MATERNAL EXPOSURE TIMING UNSPECIFIED (hospitalization, medically significant), SUBCHORIONIC HAEMATOMA (hospitalization, medically significant), outcome "unknown" and all described as "subchorionic hematoma leading to fetal demise". The event "subchorionic hematoma leading to fetal demise" required physician office visit and emergency room visit. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the available reported information, the causal association between the events of "subchorionic hematoma  and Maternal exposure during pregnancy and  the suspect drug BNT162B2 cannot be excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-202201198795 Same vaccine, different patient/event.
redness in the area, swelling in the area, and warmth within a week of the first dose of the vaccine
Fever started about 4 hours after injection and did not subside until about 30 hours later. I started to have a a dry cough and sore throat when I woke up the next morning, and my nose was really runny and congested. The cough, congestion, sore throat, and general malaise lasted approximately 11 days and I eventually developed laryngitis for about 5 of those days. I was incredibly dizzy and foggy headed the entire time and could barely stay awake throughout the day. I left work early three days because I could not focus on anything and was so tired.
tunnel vision; experienced a sudden onset of vertigo; presyncope; My hands became cold and numb; My hands became cold and numb; fatigue; sore arm, leg/thigh aching; sniffles; sore throat; brief dry cough; slight headache; neck ache; This is a spontaneous report from a contactable Nurse (patient). A 34-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 05Jan2021 at 12:30 at single dose in left arm for covid-19 immunization. Medical history included Mild ADHD/ADD. The patient's concomitant medications were not reported. Approximately 5 minutes after receiving vaccination, she was standing in the observation room (where they had all of them stay for at least 15 minutes to ensure no severe reactions) and experienced a sudden onset of vertigo, tunnel vision and pre-syncope. Her hands became cold and numb and she was trying to talk to another staff member who was arranging/scheduling her second vaccination dose at the same time when this event occurred, but it subsided quickly and she started to feel normal again. All these events occurred at 12:45 on 05Jan2021. She reported this event right away and they had her stay in the room longer. She was stable at that point but experienced these symptoms again but very mildly twice more while she walked back to her car to go home. Other side effects on 05Jan2021 that started in the evening and for the following 2-3 days included fatigue, sore arm, leg/thigh aching, sniffles/sore throat, brief dry cough and slight headache/neck ache. Very mild and tolerable symptoms. All events were reported as non-serious by reporter. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. The outcome of all events was resolved in Jan2021.   Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
reconstituted Hiberix with a sterile diluent/  for Merck, Sharp, Dohme; live virus vaccine, sterile water/ instead of the accompanying diluent; reconstituted Hiberix with a sterile diluent/  for Merck, Sharp, Dohme; live virus vaccine, sterile water/ instead of the accompanying diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On 17th June 2021, the patient received Hiberix. On 17th June 2021, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that she reconstituted Hiberix with sterile diluent (1 single dose-0.7 ml sterile dileunt for live virus vaccine, sterile water) instead of the accompanying diluent, and administered it to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The Nurse reported that  she did not have any patient or vaccine information. The reporter consented to follow up via postal.
RAPID  HEART  BEAT.........3:A.M.    B/P   UP SLIGHTLY..........3:A.M.
Mononucleosis; This is a spontaneous report from a contactable consumer. This consumer (patient's parent) reported that:  An 18-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced mononucleosis. Stated that the reported had a child who got the first shot, she was 18 she got the first shot of Pfizer and in between getting the second shot she developed Mononucleosis. The reporter was concerned whether the patient should go for the second shot. The outcome of the event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a Licensed Practical Nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose, frequency and route were not reported) lot # M010483 with expiration date of 01-MAR-2018, lot # M040138 with expiration date of 28-SEP-2018 and lot # reported as M046005 with expiration date of 18-NOV-2018, for prophylaxis. The sterile diluents (lot # and expiration date were not reported) used to reconstitute the VARIVAX were properly stored. The temperature excursion of the VARIVAX was between 6°F and 14°F for a time frame of 18 hours and 15 minutes. No previous temperature incursion was reported. No adverse effects were reported. Data logger was involved. Additional information has been requested. Sender's Comments: US-009507513-1705USA001705: US-009507513-1705USA004704.
Sat pm 2/20/10-redness noted back of left hand, swollen with rash, pain, increased swelling; redness, pain with "knot" @ upper left forearm-taken to ER @ 11 p 2/20-redness, rash noted on face. Treated with ice, BENADRYL, MOTRIN. Afebrile pt had generalized rash which was partially cleared up 2/21 using BENADRYL cream and completely gone by 2/22/10.
Vaccinated with flu vaccine and H1N1 vaccine. Pt already had 2 doses flu vaccine (seasonal). Follow up 2/16/2010 She had no adverse effects from getting 3 seasonal flu vaccines.
red spot on injection arm , spot is size of a fist; spot does itch a little; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red spot on injection arm , spot is size of a fist) and PRURITUS (spot does itch a little) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced RASH MACULAR (red spot on injection arm , spot is size of a fist) and PRURITUS (spot does itch a little). At the time of the report, RASH MACULAR (red spot on injection arm , spot is size of a fist) and PRURITUS (spot does itch a little) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was not provided. No treatment information was not provided.
Red dots next to vaccine site. Hot to the touch and fever developed, pt unable to straighten left leg.
Bell's palsy symptoms, pulling of the face, drooping of the face, pain in the neck of the arm vaccinated, headaches, dizziness and tightness in the face.
Arm that received injection numb/tingly.  Following morning sore at armpit.  Seems tender at lymph node.
Chest pain, shortness of breath, hypertension, severe body aches, mild fever, cold sweats, neck, back and jaw pain, headaches, visual changes, dizziness, fatigue, and nausea
The patient was given the incorrect dose. He was given 0.5ml instead of the recommended 0.25ml booster dose of Moderna.
Feeling wiped out; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling wiped out) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) for CLL.    No Medical History information was reported.   On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started VENETOCLAX (VENCLEXTA) (Oral) 200 milligram once a day. On 15-Dec-2021, the patient experienced FATIGUE (Feeling wiped out). At the time of the report, FATIGUE (Feeling wiped out) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Tinnitus/Ringing in the ears began roughly 24 hours after administration of vaccine
I woke covered in hives and it was intensely itchy. I took an Allegra and it gave 80% relief. I woke Saturday and I was worse, my scalp, neck and back was covered with hives. I went to urgent care and was diagnosed with Urticaria. It also became hard for me to swallow and I became hoarse. I went to ER and was given an Epi-Pen.
Half an hour after vaccine my left arm started to get warm and red like a sunburn. It progressed into a blistered rash, itchy hard nodules under my skin, stiff neck, headache and eye pain. I went to urgent care and was given prednisone. Also tachycardia. They continued to get worse each day. I started having tremors before I went numb. A month later I lost feeling in my left leg and arm, facial drooping and problems holding my urine. I had been to the doctors several times but they never ordered any tests until I told them about my bladder problems and then they ordered a brain MRI which can back abnormal. MD sent me to a neurologist and a cardiologist. Neurology showed an abnormal spinal tap. I now have an MS diagnosis. EKG showed T-wave changes. I am currently on a Holter monitor and awaiting results of an echocardiogram.
About 5-10 minutes after vaccination, patient felt suddenly "dizzy like the room was spinning and felt lightheaded." Shortly after right eye started itching and was red. Then at 20 minutes after, patient started sneezing and reported itchy nose. At 30 minutes, she reported genralized itching on face, arms, and chest. No chest pain, shortness of breath, rashes or tongue swelling. Benedryl 50 mg IM was given at 30 minutes post vaccination. Vital signs normal throughout entire episode. Patient reported resolution of symptoms and was released to go home.
Patient received dose 1 Pfizer COVID vaccine at 1145. Patient reported to EMT that she felt nauseous. Patient was given emesis bag and transported by wheelchair to zero-gravity recliner. Patient vomited small amount twice. PHN  approached to assess the patient. Vital signs: blood pressure 140/90, pulse 80, respirations 16. Patient reported no known allergies. Medical condition includes "heart problems" and medication includes vitamin injections the patient received from her holistic provider. Patient reports consuming a protein shake and taking an OTC pill labeled "Energy." At 1205, vital signs: blood pressure 138/88, pulse 76, respirations 16. PHN offered patient Benadryl as patient continued to report nausea and another vomiting episode, patient accepted and received 50mg Benadryl IM at 1210. PHN encouraged patient to call 211 to obtain a medical provider to follow up with. PHN explained when to call 911. Patient contacted family member to pick her up. At 1210, vital signs: blood pressure 135/76, pulse 72, respirations 16. At 1215, vital signs: blood pressure 136/84, pulse 67, respirations 16. Patient reported symptoms resolving and increased drowsiness due to Benadryl side effects. At 1257, vital signs: blood pressure 128/82, pulse 70, respirations 16. Patient reported all symptoms had resolved. Patient left walking with steady gait, accompanied by family member at 1300.
Fever ranging from 100.3-101 F for 48 hours, followed by full body rash spreading from the trunk up to the neck and areas of the face.
BAD ACHES; CHILLS; FEVER; HEADACHE; FELT WIPED OUT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced bad aches. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced felt wiped out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad aches, chills, fever, headache, and felt wiped out on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210429180.
This is a spontaneous report from a non-contactable consumer.  A female patient of unspecified age and ethnicity received PREVNAR, via an unspecified route of administration, in Sep2016, as single dose for immunization. The patient's medical history and concomitant medications were not reported. In Sep2016, the patient developed a little pink raised area at the injection site and was itchy at the injection site. The details were reported as follows: the patient received the Prevnar vaccine a month ago and developed a little pink raised area at the injection site. The patient still has it although it is a month later; it is about 1/4 the size of a penny. It is itchy at the injection site, but not as severe as a hive or an allergic reaction. The action taken with pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) was not applicable.  The outcome of developed a little pink raised area at the injection site and itchy at the injection site was unknown. No follow-up attempts are possible. No further information is expected.
Before the end of the day she had what she described as severe swelling and soreness around the injection site and upper arm.  It persisted until she called the pharmacy to report the swelling 24 hours later.  The pharmacist advised her to take Benadryl and watch it for worsening or spreading.
Went to pcp two hours after vaccine. EKG given and was told by my doctor I was in AFIB and needed to go to the ER immediately. Spent a couple hours in the ER and then admitted for six days. I am still in AFIB
vaccine given outside of date range (12+) by relief pharmacist- No adverse events reported by parents as of todays date
Positive COVID PCR test on 30Dec21 reporting breakthrough infections; Positive COVID PCR test on 30Dec21 reporting breakthrough infections; Dose number: 3; This is a spontaneous report received from a non-contactable reporter (nurse).  A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 07Dec2021 (lot number: FF2589) at the age of 52-years as dose 3 (booster), single, administration date 27Mar2021 (lot number: EL3247) at the age of 52-years as dose 1, single and administration date 17Apr2021 (lot number: EP6955) at the age of 52-years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 07Dec2021, described as "Dose number: 3"; VACCINATION FAILURE (medically significant) and COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovering" and all described as "Positive COVID PCR test on 30Dec21 reporting breakthrough infections". The event "Positive COVID PCR test on 30Dec21 reporting breakthrough infections" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2021) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure and COVID-19.  No follow-up attempts are possible. No further information is expected.
Difficulty rasing left arm in abduction and external rotation about 85 degrees. Pain began about 1 week after injection. Referred to orthopedic surgery. Orthopedic surgery referred to physical therapy.
4hrs after vaccine chills, pain, redness of arm 15x15cm. Tx: meloxicam, TYLENOL, compresses.
Information has been received form a consumer concerning a female patient in her 60's who on an unspecified date was vaccinated with a first dose of PNEUMOVAX 23 (lot number and route not reported) in the left arm. The consumer reported that later the same evening she had the onset of swelling redness and tenderness over site of injection in the left arm. Also she had chills and arthralgias. It was reported that all symptoms resolved within three days except for some remaining redness and swelling at the injection site at the time of this report. The patient sought medical attention by seeing her physician but no specific therapy was prescribed. No further information is available.
ANAPHLACTIC REACTION, SOB, CHEST PRESSURE, TIGHTNESS IN THROAT, TACHYCARDIA
Pt given 0.25mL dose Moderna vaccine in right deltoid as third dose in vaccine series 15 days before due date. No signs or symptoms of distress or aderse reaction noted following administration. Administering nurse reported to RN and facility DON. Facility DON comfirmed understanding of event, states she has no concerns at this time.
Patient seen by Dr. 04/14/01.  Patient diagnosed with varicella zoster per Dr. Mother c/o fever on Sunday 04/15/01.  Woke up with rash 04/16/01 zero itching.
1 of 2 pts vaxed from the same lot# exp inject site react w/in 24 hrs p/vax; pt vaxed 19JAN93 & 20JAN devel erythema, swelling, hot to touch area 22-3 inches in diameter; rx'd symptomatically by phone; not seen by MD;