chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per history and physical on 1/13/22: "Patient is a 89 y.o. male past medical history of colon cancer s/p sigmoid colectomy, CAD, aortic valve stenosis s/p TAVR in 2017, s/p MI, dementia, a fib on Coumadin, GERD, history of Slutsky's ring and hypertension. Decreased appetite for the past few weeks, but has had productive cough for the past 3-4 days.  Patient's son was concerned that he had lost his sense of taste and smell because he had stopped eating and drinking.  The son reported to the APRN that patient has 2 caregivers who tested positive for COVID-19.  He reports that patient has had 10 to 12 pound weight loss over the past week. Son denied pt having any symptoms of shortness of breath or difficulty breathing.  Patient's history is limited by his advanced dementia.  Majority of history was obtained from ED record, chart review and patient's son.  Upon arrival to the ED patient was noted to be positive for COVID-19.  Was noted to have an INR > 10.  Patient is on Coumadin for atrial fib.  Patient's son had reported to the ED staff that he was having abdominal pain as well.  For CT of the abdomen and pelvis was obtained and CT of the chest was obtained in the ED. CT noted to have mucoid opacification of the "central segmental bronchi within the right lower lobe with patchy peripheral airspace infiltrate throughout the right lower lobe and minimal infiltrate in the posterior right lobe.  Correlate for infectious pneumonitis versus aspiration pneumonia."  CT of the abdomen and pelvis was noncontributory.  Due to these findings patient will be admitted to hospital service for further evaluation management. "
difficulty breathing; woke with 102 fever; Body aches; injection site soreness; Fatigue/extreme fatigue; This is a spontaneous report from a contactable healthcare professional. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular in right arm on 30Dec2020 13:00 at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior vaccination. The patient experienced fatigue, injection site soreness day of vaccine, following extreme fatigue on 30Dec2020 16:00. Five days after (04Jan2021), woke with 102 fever, body aches, fatigue, and difficulty breathing. The events resulted in doctor or other healthcare professional office/clinic visit. The events were treated with an unspecified antibiotic. The patient underwent lab test and procedures which included nasal swab and Rapid Saers on 04Jan2021 with negative results. The outcome of the events was not recovered.  Information on lot/batch number has been requested.
Severe headache, neck ache, rash upper arms and legs, fever, body aches, erythema at injection site. Starting to recover 11/30 after Benadryl and Vicodin.
no other AE associated with administration; an expired dose of ROTATEQ was administered; This spontaneous report was received from a nurse referring to a 2-month-old male patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 26-OCT-2020, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # 1660937, expiration date 25-OCT-2020, at a dose of 2 milliliter, orally for prophylaxis (formulation, strength, dose, frequency, route of administration, indication,  were not reported). The reporter said there were no other adverse events associated with administration.  Lot No.1660937 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ).
4/23/21 joint ache, fatigue.  4/28/21 swelling, hard, red and itchy injections site area. Red area about the size of my hand.   5/2/21 Still red and itchy, not as hard, but a knot in the are. Taken aleve and apply anti itch cream
Heartburn; Dizzy; Nauseated; Tiredness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn), DIZZINESS (Dizzy), NAUSEA (Nauseated), FATIGUE (Tiredness) and FATIGUE (Fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Small cell lymphocytic lymphoma. Concurrent medical conditions included Lymphocytic lymphoma. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. In April 2022, the patient experienced DYSPEPSIA (Heartburn), DIZZINESS (Dizzy), NAUSEA (Nauseated), FATIGUE (Tiredness) and FATIGUE (Fatigue). In April 2022, DIZZINESS (Dizzy), NAUSEA (Nauseated) and FATIGUE (Tiredness) had resolved. At the time of the report, DYSPEPSIA (Heartburn) and FATIGUE (Fatigue) had not resolved. No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
This spontaneous report as received from a physician via medical records refers to a 29 year old female patient. Patient's medical history included normal PAP Smears (Smear Cervix) (on an unspecified date). Her concurrent conditions included an allergy to amoxicillin and a high grade squamous intraepithelial lesion with Human Papilloma Virus Infection (HPV) DNA+ diagnosed in 2013. Historical drugs included LUTERA. Patient's last menstrual period was on 31-DEC-2014. On 12-JUN-2014, the patient was vaccinated with a first dose of expired GARDASIL (lot # 1702X exp 08-SEP-2011). Then on 14-AUG-2014, the patient was vaccinated with a second dose of expired GARDASIL (lot # 0053X exp. 28-JUL-2010). Finally, on 02-OCT-2014, the patient was vaccinated with the third dose of expired GARDASIL (lot # 0670Y exp. 20-JUN-2010). All doses were administered intramuscularly, in the left deltoid, with a dose of 0.5ml. A PAP smear test and a cone biopsy, performed on 23-JAN-2015 showed a high grade lesion (HSIL) and cervical intraepithelial neoplasm (CIN3) with free margins, respectively. The diagnoses was interpreted as high grade squamous intraepithelial lesion (cervical dysplasia); from moderate to severe dysplasia (CIN 2-3). This was considered as a vaccination failure. At the reporting time, the outcome of the cervical dysplasia was unknown. The causality between the events and therapy with GARDASIL was not stated. No product quality complaint was reported (PQC). The physician stated that he understood that the patient was not virginal at the time that the patient received the vaccine but he thought that maybe the lot numbers could be checked just to make sure about another unexpected outcomes associated with those batches. All available medical records will be provided upon request. Additional information has been requested.
This case was reported by a other health professional via sales rep and described the occurrence of rash in a female patient who received SHINGRIX. The patient's past medical history included heat rash (The patient had a heat rash or virus rash before). In January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced rash, pain in arm, injection site erythema and injection site warmth. On an unknown date, the outcome of the rash, pain in arm, injection site erythema and injection site warmth were recovered/resolved. It was unknown if the reporter considered the rash, pain in arm, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a hospital buyer. The age at vaccination was not reported. The patient received SHINGRIX into deltoid muscle, approximately 4 weeks before the date of reporting. The patient had a rash developed on her stomach shortly after receiving SHINGRIX. The patient said that, rash was similar to a heat rash or virus rash she has had before. The rash had resolved without any medical attention. The patient said she thought it was related to the vaccine. On an unknown date, less than a month after receiving SHINGRIX, the patient had very sore arm for a few days and redness at the injection site that was warm to the touch. The patient had no fever.
36 hour period of malaise/lethargy/muscle weakness that was the same experienced after the 2nd dose vaccination began on the evening of 4/23/21.  At the time of the second dose I also had fever and chills overnight (about 100.1). There was no fever the second time.  There were  brief (2-3 hour) periods of this same muscle weakness/unresponsiveness but I didn't put it together until the longer period occurred.  This sensation was unlike anything I have experienced before except post-dose 2 in February.  I cancelled activity for two days due to inability to move around without weakness
Patient began taking oral typhoid 10/12/2004. Felt nauseated on 10/13 and noticed one lesion 10/14 which quickly spread over body. Describes as pustular lesions with itch. Has 100 fever. 10/18/2004 telephone call to patient: no answer. Pt may have gone to India against my advice
Patient stated she experienced chills and sweats the evening following vaccine administration. The following morning she began to feel numbness throughout her body. For most of 4 days the patient was unable to feel her legs and was completely unable to walk. As of 09/26/18 the patient said she had fully recovered. The patient refused medical attention and was adamant that her physician not be contacted.
Pneumococcal vaccine (23 valent)  was given IM to the patient on 11/04/10 and he had previously received a PNEUMOVAX vaccine on 09/15/09.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents for second dose of vaccine reporting allergic reaction to first dose. After leaving vaccine clinic after first dose patient reports throat closing, lips going numb, and metallic taste. Patient went to urgent care that advised allergy medications and follow-up with an allergist. Before second dose patient took two doses of oral diphenhydramine and a few minutes after receiving immunization reported throat closing. Emergency response team called and patient was evaluated. Patient reported symptoms improving, declined emergency department evaluation, and left clinic in stable condition.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. Medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL, .5 ml for prophylaxis. The dose number, lot number, expiry date, route of administration and anatomical location were not reported. On an unknown date the patient experienced more frequent periods, the patient menstruated every two weeks. Prior to the vaccination with GARDASIL, the patient menstruated on a monthly basis. Furthermore the patient experienced that her periods were heavier, requiring more tampons, and the patients experienced more cramping. The outcome of more frequent periods, heavier period sand more cramping is unknown. The relatedness was not reported for any of the events for GARDASIL. Additional information has been requested.
Left arm red, painful, swollen at vaccine injection site 3 days ago. No fever. Upper arm with 3 inch area of A/P cellulitis; Keflex 250mg PO Tid cool compress Qid; Follow up 48 hours if not better.
left arm pain and swelling that started 2 days after vaccine, improved for a "few days" and then returned accompanied by itching at injection site and on upper left arm.
On 02/03/2021 (day after the vaccine) I woke up at 5:00AM  and started experiencing fever ranging from 100.5F-101F, whole body and muscle aches, pain and tenderness in the left arm and swollen and painful lymph nodes in the left armpit, limited movement of the left arm, chills, extreme tiredness, nausea, headache, weakness, lack of appetite, shivering. The symptoms lasted the whole day and were intense. Took a few doses of Tylenol throughout the day.  The next day most of the symptoms were gone. I still felt really tired and had pain in the left arm and armpit. Discomfort in the arm/armpit lasted for 4 more days.
Lose of taste and smell, chest and head congestion all beginning  11/29/2021.
My right arm was red and hard. It was where I got the shot in my right arm. My body felt ill, I had to go to bed, my head was hurting and my back. I felt bad. 11/9/09 I feel better after a large bowel movement.
Redness,swelling right upper leg with blistering. Induration lasted about 48 hours, and was treated with oral steroids x 5 day burst after ER visit.
Systemic non-severe skin itching, including palms of hands and soles of feet for 2 weeks. Antihistamine (loratadine) relieved systems starting after one week. Still taking antihistamine in week 2 of symptoms.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-SEP-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K004281, expire date 22-MAR-2015; dose and route unknown). The total excursion time was 1128 hours with the lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
4 big knots on the opposite arm of injection; arm swelled up; itching on one finger; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (4 big knots on the opposite arm of injection), PERIPHERAL SWELLING (arm swelled up) and PRURITUS (itching on one finger) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced NODULE (4 big knots on the opposite arm of injection), PERIPHERAL SWELLING (arm swelled up) and PRURITUS (itching on one finger). At the time of the report, NODULE (4 big knots on the opposite arm of injection), PERIPHERAL SWELLING (arm swelled up) and PRURITUS (itching on one finger) outcome was unknown. Not Provided          No concomitant medication was reported. Treatment information not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-079258 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079258:2ND DOSE
Initial unsolicited literature report received from a physician on 04-Jan-2018. Literature reference:  This case involves a female patient of unknown age who was vaccinated with a dose of TETANUS TOXOID (TETANUS SHOT) (Lot number, expiry date, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced stabbing pain in left shoulder that worsened in days after her tetanus shot and felt like the arm was falling off. She couldn't carry her purse or hold a cup of coffee. She couldn't lift that arm above her head or place it on the steering wheel of her car. The patient's laboratory data and corrective treatment were not reported. The event's outcome was unknown. List of documents held by sender: none.
Patient received a COVID vaccine immediately after which she stated she passes out sometimes with shot. Immediately thereafter she became pale, her head fell backwards in the chair , eyes rolled back, her hands curled under, her body became ridged and she started shaking. She was unresponsive and was laid on the ground. in the process of turning her on her side she became conscious again but did not know where she was or why she was on the floor. She was sweating  and was still quite pale. She said she felt sick while she was laying on the floor at which point she sat up and we moved her to a chair. Upon sitting in the chair she was still feeling sick and was pale and sweating. she began to throw up a few times and I took her blood pressure after. 116/70 Pulse was 60. She did not want an ambulance. After about 10 minutes of sitting her color was back to normal she was no longer sweating and was alert and conversing normally. Pt was advised to head to urgent care or contact her doctor if she experienced any further symptoms as she may have experienced a seizure. She has no prior history of seizure and has only ever passed out from previous shots.
One hour after vaccine noticed increased warmth, swelling, pain. Next AM patient with fever, et arm pain, swelling, blister over mid arm and erythema with s.
first left my arm sore for most of a week; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: first left my arm sore for most of a week). The outcome of the pain in arm was resolved (duration 1 week).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR092464   Additional Information: GSK Receipt Date: 01-Jul-2023 This case was reported by a patient via interactive digital media. The first Shingles shot left his/her arm sore for most of a week. The reporter recommends getting the shot as Just the preview was enough to convince him. For tolerance of 2nd dose, refer case US2023AMR092464, reported by same reporter. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR092464:Case for second dose
This spontaneous report was received from a consumer (patient's husband) refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route of administration, lot # and expiry date not reported). On an unknown date the patient experienced a case of the shingles after receiving ZOSTAVAX. Outcome of the event was not reported. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-JAN-2017, the patient was vaccinated with improperly stored dose of M-M-R II lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case : 1705USA009742.
Fever with chills. Very sore and achey. Extremely tired. Much better today(2nd day).
Information has been received from a physician assistant referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reaction/allergies were not reported. On unknown dates between 25-OCT-2015 and 02-NOV02015, the patients received unspecified doses in the immunization series of M-M-R II lot # L008684, expiration date 13-MAY-2017, 1 dose (therapy type, route and dose were not reported) that were improperly stored. Concomitant drug was not reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a medical assistant referring to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates from 2005 to 2006, the patient was vaccinated with three doses of RECOMBIVAX HB (strength, lot#, expiration date and route were not reported), at the recommended 0, 1 and 6 month dosing schedule. On an unknown date, the patient had negative titers after receiving all the three doses in the series. It was reported that no treatment was given. The outcome of the event was reported as not recovered. The relatedness between the event and RECOMBIVAX HB was not reported. Additional information is not expected as there is no consent to contact the physician.
Pharmacist administered vaccine then upon filling out provider section of VAR noticed that vaccine expired 8/22/21
Apparently,  in reaction to the vaccine, a Cytokin storm occurred at my insulin port shutting off my insulin.  This resulted in me going into diabetic ketoacidosis.
Fever (102 F) followed by focal partial seizure.  Pt admitted to peds unit for observation. Received rocephin for 48 hrs. Blood cultures negative. CT scan negative.  No further seizure activity. 9/18/06 Received medical records from hospital which reveal patient experienced apparent seizure activity at home consisting of left sided head & eye deviation with rhythmic tongue movements lasting approx 2 min & accompanied by fever of 102 ax.  No activity while in ER but was admitted for overnight observation.  Neuro consult done.
Sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment and concomitant medicines were not included  Action taken with mRNA-1273 in response to the event was unknown